E.P.A.R s  Editing

Επεξεργασία E.P.A.R s

 ΟΔΗΓΙΕΣ  (κλικ για εμφάνιση/απόκρυψη)

ΒΑΣΙΚΕΣ ΛΕΙΤΟΥΡΓΙΕΣ ...για βιαστικούς 😀


1. Κάντε κλικ στο αρχικό γράμμα της ονομασίας του φαρμάκου που αναζητάτε
 (η περιοχή αυτή με κουμπιά της Αγγλικής αλφαβήτου βρίσκεται παρακάτω).
2. Επιλέξτε εμπορική ονομασία (αμέσως κάτω από την Αγγλική αλφάβητο).
3. Μεταφέρεστε αυτόματα στην κάρτα του φαρμάκου που επιλέξατε.


ΑΝΑΛΥΤΙΚΟΤΕΡΑ


Παρουσιάζουμε τις περιλήψεις των E.P.A.Rs (European Public Assessment Reports = Ευρωπαϊκές Δημοσίες Εκθέσεις Αξιολόγησης) για το κοινό, από τον ΕΜΑ* (European Medicines Agency = Ευρωπαϊκός Οργανισμός Φαρμάκων), όλων των κεντρικά αδειοδοτημένων φαρμάκων.
*Για όσους δε γνωρίζουν, ο ΕΜΑ είναι (με 'δυο λέξεις') η ανώτατη αρχή για τα φάρμακα στην Ευρωπαϊκή Ένωση.

Πρόκειται για απλές και κατανοητές (όσον αφορά στον απλό αναγνώστη) αναφορές για όσα φαρμακευτικά προϊόντα αδειοδοτούνται μέσω Κεντρικής Διαδικασίας (Central Procedure) και -κατ' επέκταση- μπορούν να κυκλοφορούν σε όλες τις χώρες της Ευρωπαϊκής ένωσης.

Εκτός της μετατροπής (των περίπου 1400 αρχείων PDF όλων αυτών των φαρμάκων) σε επεξεργάσιμο Αγγλικό κείμενο, έχουμε συμπεριλάβει τα original PDFs αυτών των E.P.A.Rs σε 23 γλώσσες της EU στις οποίες μεταφράστηκαν.
Μπορείτε να επιλέξετε γλώσσα κάνοντας κλικ στο μπλε banner λίγο πριν το τέλος της κάρτας φαρμάκου (στο banner αναγράφεται: "Read the original document in your language")

Στην Ελλάδα (Οκτώβριος 2023) από τα περίπου 1400 κεντρικά αδειοδοτημένα φάρμακα, κυκλοφορούν περίπου τα 600.



ΕΠΕΞΕΡΓΑΣΙΑ ΚΕΙΜΕΝΟΥ

ΣΗΜΑΝΤΙΚΟ: Η επεξεργασία κειμένου δεν προσφέρεται για οθόνες μικρότερες των 440px.

  • Εαν επιθυμείτε -εκτός της ανάγνωσης- να επεξεργαστείτε την EPAR και να προσθέσετε τα δικά σας σχόλια και σημειώσεις, κάντε κλικ μέσα στο κείμενο της κάρτας.
    Γύρω από το κείμενο θα εμφανιστεί πλαίσιο, δηλώνοντας έτσι ότι είστε σε 'κατάσταση επεξεργασίας' (edit mode).

  • Προσθέστε, αφαιρέστε, πληκτρολογείστε, επικολλήστε κείμενα ή και εικόνες.

  • Μορφοποιήστε το κείμενο (αφού το επιλέξετε) με τη βοήθεια του πλαισίου μορφοποίησης του Farmako.net Editor®
    Το πλαίσιο Μορφοποίησης βρίσκεται κάτω από την Αγγλική αλφάβητο και δίπλα από τις εμπορικές ονομασίες.

  • Για να προσθέσετε τις σημειώσεις σας, τις λέξεις-κλειδιά ή τις ετικέτες (που θα σας βοηθήσουν να θυμάστε το φάρμακο που διαβάζετε όσο καλύτερα μπορείτε), κάντε κλικ μέσα στο μπλε πλαίσιο (στο κάτω μέρος της κάρτας, που περιέχει το σύμβολο '#') και ξεκινήστε να γράφετε.
    Όταν τελειώσετε με αυτήν τη σημείωση - και ενώ βρίσκεστε μέσα στο μπλε πλαίσιο - πατήστε enter στο πληκτρολόγιό σας για να προσθέσετε ένα νέο. Προσθέστε όσα μπλε πλαίσια θέλετε.

  • Όταν είστε έτοιμοι, πατήστε εκτύπωση (στο κάτω μέρος της κάρτας) για εκτύπωση σε χαρτί ή pdf, δημιουργώντας έτσι τη δική σας έντυπη ή ηλεκτρονική βιβλιοθήκη από σύντομες μονογραφίες με το προσωπικό σας ύφος, σημειώσεις και παρατηρήσεις για όσα φάρμακα είναι του ενδιαφέροντος σας.

  • Αν είστε επαγγελματίας υγείας μπορείτε (στο κάτω μέρος κάθε κάρτας) να μεταβείτε στο site του EMA, αποκτώντας πρόσβαση σε πρόσθετες πληροφορίες τις οποίες στη συνέχεια μπορείτε να αντιγράψετε και να επικολλήσετε εδώ.
 INSTRUCTIONS  (click to show/hide)

QUICK GUIDE ...for those in a rush 😀


1. Tap the first letter of the medicine's name you're searching for
 (you'll find the English alphabet buttons below).
2. Pick the brand name right after the English alphabet.
3. You'll be automatically taken to the card of the drug you selected.


DETAILED GUIDE


We've got E.P.A.Rs (European Public Assessment Reports) summaries for the public, from the ΕΜΑ* (European Medicines Agency) for All of Central Procedure Authorized Medicines
*For those who aren't familiar, EMA is the top authority for medicines in the European Union.

These reports explain pharmaceutical products in a way that's easy to understand for most readers.

Because of these products are licensed through the Central Procedure, they can be circulated across all European Union countries.

In addition to converting (the approximately 1400 PDF files of all these medicines) into editable English text, we have included the original PDFs of these E.P.A.Rs in 23 EU languages into which they were translated.
You can choose a language by clicking on the blue banner just before the end of the medicine card (the banner says: "Read the original document in your language")



TEXT EDITING

IMPORTANT: Text editing is not available for screens smaller than 440 pixels.

  • If you want to do more than just read, and you wish to edit the EPAR by adding your comments and notes, simply click within the text of the card.
    A box will pop up around the text, letting you know that you're in 'edit mode'.

  • You can add, remove, type, paste texts, or images.

  • After selecting the text you want, you can format it using the 'Farmako.net Editor®' format box, located below the English alphabet and beside the brand names.

  • To add your notes, keywords or tags to help you remember the medicine you're reading as best you can, click inside the blue box (near the end of the card, with '#' in it) and start writing.
    When you're done with this note - and while you're inside the blue box - press enter on your keyboard to add a new one. Add as many blue boxes as you want.

  • Once you're done, hit Print at the bottom of the card to create your personalized collection of concise monographs in your unique style, including notes and insights about any drugs that catch your interest, either on paper or as a PDF for your electronic library.

  • If you are a healthcare professional, there is a link at the bottom of each card that you can click to visit the medicine's E.M.A page, accessing additional information which you can then copy and paste here.



Κλικ στο αρχικό γράμμα της ονομασίας του φαρμάκου που αναζητάτε
Click on the initial letter of the name of the medicine you are looking for

Εμπορικές ονομασίες / Brand names

Μορφοποίηση / Formatting Farmako.net Editor®

Για να φανούν τα Ελληνικά, επιλέξτε
πρώτα μια οποιαδήποτε άλλη γλώσσα.

Dabigatran Etexilate Accord


What is Dabigatran Etexilate Accord and what is it used for?

Dabigatran Etexilate Accord is an anticoagulant medicine used for:• preventing the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee;• preventing stroke (caused by a blood clot in the brain) and systemic embolism (a blood clot in another organ) in adults who have an abnormal heartbeat called 'non-valvular atrial fibrillation' and are considered to be at risk of stroke;• treating deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (PE, a clot in a blood vessel supplying the lungs) in adults, and preventing these conditions from occurring again.• treating blood clots in veins and preventing them from occurring again in children.Dabigatran Etexilate Accord is a 'generic medicine'. This means that Dabigatran Etexilate Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU. The reference medicine for Dabigatran Etexilate Accord is Pradaxa. For more information on generic medicines, see the question-and-answer document here.Dabigatran Etexilate Accord contains the active substance dabigatran etexilate.

How is Dabigatran Etexilate Accord used?

Dabigatran Etexilate Accord is available as capsules for adults and children above 8 years of age. The medicine is to be taken by the mouth once or twice a day, and the duration of treatment and the dose depend on the condition the medicine is being used to treat or prevent and other medicines the patient is taking.In all patients, kidney function should be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected. When Dabigatran Etexilate Accord is used long term in patients with non-valvular atrial fibrillation, or when it is used in patients with DVT or PE, kidney function should be assessed at least once a year if their kidney function is mildly to moderately reduced or if they are over 75 years old.The medicine can only be obtained with a prescription.For more information about using Dabigatran Etexilate Accord, see the package leaflet or contact your doctor or pharmacist.

How does Dabigatran Etexilate Accord work?

The active substance in Dabigatran Etexilate Accord, dabigatran etexilate, is a 'prodrug' of dabigatran. This means that it is converted into dabigatran in the body. Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating (clotting). It blocks a substance called thrombin, which is central to the process of blood clotting.

How has Dabigatran Etexilate Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Pradaxa, and do not need to be repeated for Dabigatran Etexilate Accord.As for every medicine, the company provided studies on the quality of Dabigatran Etexilate Accord.The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Dabigatran Etexilate Accord?

Because Dabigatran Etexilate Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.For the list of side effects and restrictions with Dabigatran Etexilate Accord, see the package leaflet.

Why is Dabigatran Etexilate Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Dabigatran Etexilate Accord has been shown to have comparable quality and to be bioequivalent to Pradaxa. Therefore, the Agency's view was that, as for Pradaxa, the benefits of Dabigatran Etexilate Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dabigatran Etexilate Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dabigatran Etexilate Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dabigatran Etexilate Accord are continuously monitored. Suspected side effects reported with Dabigatran Etexilate Accord are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dacogen


What is Dacogen?

Dacogen is a powder that is made up into a solution for infusion (drip) into a vein. It contains the active substance decitabine.

What is Dacogen used for?

Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines).Because the number of patients with AML is low, the disease is considered 'rare', and Dacogen was designated an 'orphan medicine' (a medicine used in rare diseases) on 8 June 2006.

How is Dacogen used?

Dacogen can only be obtained with a prescription. Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.Dacogen is given as an infusion into a vein over one hour. The dose is calculated using the patient's height and weight. In a 4-week treatment cycle, Dacogen is given daily for the first 5 days. At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control. If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment.

How does Dacogen work?

The active substance in Dacogen, decitabine, is a cytidine deoxynucleoside analogue. This means that it is similar to cytidine deoxynucleoside, a fundamental component of the DNA (genetic material) of cells. In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs). These enzymes promote the development and progression of cancer. By blocking DNMTs, decitabine will prevent the increase of tumour cells and lead to their death.

How has Dacogen been studied?

Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy. Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine). Treatment was given for as long as patients benefited from it. The main measure of effectiveness was how long the patients lived.

What benefit has Dacogen shown during the studies?

Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.

What is the risk associated with Dacogen?

The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count). The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia.Dacogen must not be used in people who are breastfeeding. As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding, they must discontinue breastfeeding if they require treatment with Dacogen.For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet.

Why has Dacogen been approved?

The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy. There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia were more common with Dacogen. The CHMP decided that Dacogen's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Dacogen?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet.


Summarize this document



Read the original document in your language

Dafiro


What is Dafiro?

Dafiro is a medicine that contains two active substances, amlodipine and valsartan. It is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).

What is Dafiro used for?

Dafiro is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. 'Essential' means that the hypertension has no obvious cause.The medicine can only be obtained with a prescription

How is Dafiro used?

Dafiro is taken by mouth as one tablet once a day with some water. The dose of Dafiro to be used depends on the doses of amlodipine or valsartan that the patient was taking before. The patient may need to take separate tablets or capsules before switching to the combination tablet.

How does Dafiro work?

Dafiro contains two active substances, amlodipine and valsartan. Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s. They work insimilar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.Valsartan is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen.

How has Dafiro been studied?

Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out. Two studies (involving almost 3,200 patients) compared amlodipine, valsartan or a combination of both substances with placebo (a dummy treatment). Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan. The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats). The blood pressure was measured in 'millimetres of mercury' (mmHg).The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Dafiro and people taking the separate medicines.

What benefit has Dafiro shown during the studies?

The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone. In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively. Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.

What is the risk associated with Dafiro?

The most common side effects with Dafiro (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes. For the full list of all side effects reported with Dafiro, see the package leaflet.Dafiro must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the 'dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients. It must notbe used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Dafiro must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure). Dafiro must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment. For the full list of restrictions, see the package leaflet.

Why has Dafiro been approved?

The CHMP decided that Dafiro's benefits are greater than its risks and recommended that it be given marketing authorisation.


Summarize this document



Read the original document in your language

Dafiro Hct


What is Dafiro HCT?

Dafiro HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide. It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg and 10/320/25 mg.

What is Dafiro HCT used for?

Dafiro HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide. 'Essential' means that the hypertension has no obvious cause.The medicine can only be obtained with a prescription.

How is Dafiro HCT used?

Dafiro HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning. The dose of Dafiro HCT to be used is the same as the doses of three individual active substances that the patient was taking before. The daily dose of Dafiro HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.

How does Dafiro HCT work?

The three active substances in Dafiro HCT are anti-hypertensive medicines that are already in use in the European Union (EU).Amlodipine is a 'calcium channel blocker'. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and helps the blood vessel walls to relax and widen, thereby reducing blood pressure.Valsartan is an 'angiotensin II receptor antagonist', which means that it blocks the action of a body hormone called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to reduce.Hydrochlorothiazide is a diuretic. It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure.The combination of the three active substances has an additive effect, reducing the blood pressure more than the individual medicines alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

How has Dafiro HCT been studied?

Because the combination of the three active substances has been in use for a number of years, the company presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Dafiro HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide). Patients received either Dafiro HCT or one of the three combinations containing only two of the active substances for eight weeks. The main measure of effectiveness was the average change in the blood pressure.

What benefit has Dafiro HCT shown during the studies?

Treatment with the highest strength of Dafiro HCT was more effective at treating hypertension than dual combinations containing any of the two active substances. The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Dafiro HCT compared with 32/19.7 mmHg,33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.

What is the risk associated with Dafiro HCT?

The most common side effects with Dafiro HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention). For the full list of all side effects reported with Dafiro HCT, see the package leaflet.Dafiro HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Dafiro HCT. It must not be used in women who are more than three months pregnant. It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (acondition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique). Finally, Dafiro HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.Dafiro HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.

Why has Dafiro HCT been approved?

The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Dafiro HCT which combines the three substances in a single tablet. The main study showed the benefit of the highest strength of Dafiro HCT in lowering the blood pressure. For all doses, Dafiro HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately. The CHMP therefore decided that Dafiro HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.


Summarize this document



Read the original document in your language

Dapagliflozin Viatris


What is Dapagliflozin Viatris and what is it used for?

Dapagliflozin Viatris is a medicine used to treat type 2 diabetes, chronic (long-term) heart failure and chronic kidney disease.In type 2 diabetes, Dapagliflozin Viatris is used in adults and children from 10 years of age whose condition is not controlled well enough. It is used with appropriate diet and exercise in patients who cannot take metformin (another diabetes medicine). It can also be used as 'add-on' treatment to other diabetes medicines.In chronic heart failure (inability of the heart to pump enough blood around the body), Dapagliflozin Viatris is used in adults who have symptoms of the disease and reduced ejection fraction (a measure of how well the heart pumps blood).Dapagliflozin Viatris is also used in adults with chronic kidney disease.Dapagliflozin Viatris is a 'generic medicine'. This means that Dapagliflozin Viatris contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Forxiga. For more information on generic medicines, see the question-and-answer document here.Dapagliflozin Viatris contains the active substance dapagliflozin.

How is Dapagliflozin Viatris used?

Dapagliflozin Viatris is available as tablets and can only be obtained with a prescription.For type 2 diabetes, chronic heart failure and chronic kidney disease, the recommended dose of Dapagliflozin Viatris is 10 mg once a day.For type 2 diabetes, if Dapagliflozin Viatris is used with insulin or medicines that help the body produce insulin, the doses of these medicines may need to be reduced to prevent hypoglycaemia (low blood sugar levels).For more information about using Dapagliflozin Viatris, see the package leaflet or contact your doctor or pharmacist.Send

How does Dapagliflozin Viatris work?

The active substance in Dapagliflozin Viatris, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). As blood is filtered by the kidneys, SGLT2 stops the kidneys passing glucose from the blood into the urine. Patients with diabetes have high levels of glucose in the blood. By blocking the action of SGLT2, dapagliflozin causes the kidneys to pass more glucose into the urine, thereby reducing the levels of glucose in the blood.Blocking the action of SGLT2 also supports heart function in patients with chronic heart failure and kidney function in patients with chronic kidney disease, regardless of having diabetes. Dapagliflozin's actions increase the removal of salt and water in the urine. This decreases the overall blood volume, reducing the effort needed for the heart to pump blood, thereby improving its function in patients with heart failure and also preserving kidney function.

How has Dapagliflozin Viatris been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Forxiga, and do not need to be repeated for Dapagliflozin Viatris.As for every medicine, the company provided studies on the quality of Dapagliflozin Viatris. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Dapagliflozin Viatris ?

Because Dapagliflozin Viatris is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Dapagliflozin Viatris authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, DapagliflozinViatris has been shown to have comparable quality and to be bioequivalent to Forxiga. Therefore, the Agency's view was that, as for Forxiga, the benefits of Dapagliflozin Viatris outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dapagliflozin Viatris?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dapagliflozin Viatris have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dapagliflozin Viatris are continuously monitored. Suspected side effects reported with Dapagliflozin Viatris are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Daptomycin Hospira


What is Daptomycin Hospira and what is it used for?

Daptomycin Hospira is an antibiotic medicine used to treat the following bacterial infections:• complicated infections of the skin and 'soft tissue' below the skin in patients from 1 year of age. 'Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect how well treatment works;• right-sided infective endocarditis (infection of the lining or the valves of the right side of the heart) caused by the bacterium Staphylococcus aureus (S. aureus) in adults. The decision to treat this infection with Daptomycin Hospira should be based on the likelihood that the medicine will work against the infection and on advice from an expert;• bacteraemia (infection of the blood) caused by S. aureus. It is used in adults, when the bacteraemia is associated with either of the two infections above, or in adolescents and children from 1 year of age when the bacteraemia is associated with complicated infections of the skin and soft tissue.Prescribers should consider the official guidance on the use of antibiotics.Daptomycin Hospira contains the active substance daptomycin. It is a 'generic medicine'. This means that Daptomycin Hospira contains the same active substance and works in the same way as a 'reference medicine' already authorised in the European Union (EU) called Cubicin. For more information on generic medicines, see the question-and-answer document here.

How is Daptomycin Hospira used?

Daptomycin Hospira is given by infusion (drip) into a vein.In adults, for skin or soft tissue infections without bacteraemia, Daptomycin Hospira is given at a dose of 4 mg/kg body weight once a day. For endocarditis and for skin or soft tissue infection with bacteraemia, the dose is 6 mg/kg once a day. Daptomycin Hospira is given into a vein as an infusion lasting 30 minutes or as an injection lasting 2 minutes.In children, the dose of Daptomycin Hospira for skin or soft tissue infection without bacteraemia depends on the child's age and ranges between 5 and 10 mg/kg body weight once a day. Higher doses (between 7 and 12 mg/kg once a day) are used if the skin or soft tissue infection is associated with bacteraemia. Daptomycin Hospira is given by infusion lasting 60 minutes in children aged 1 to 6 years and 30 minutes in those aged above 7 years.The duration of treatment with Daptomycin Hospira depends on the risk of complications and official recommendations.The medicine can only be obtained with a prescription. For more information about using Daptomycin Hospira, see the package leaflet or contact your doctor or pharmacist.

How does Daptomycin Hospira work?

The active substance in Daptomycin Hospira, daptomycin, is an antibiotic that belongs to the group 'lipopeptides'. It can stop the growth of certain types of bacteria by attaching to the membrane surrounding the bacterial cell and upsetting the essential functions that keep the cell alive.

How has Daptomycin Hospira been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Cubicin, and do not need to be repeated for Daptomycin Hospira.As for every medicine, the company provided studies on the quality of Daptomycin Hospira. There was no need for 'bioequivalence' studies to investigate whether Daptomycin Hospira is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Daptomycin Hospira is given into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Daptomycin Hospira?

Because Daptomycin Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Daptomycin Hospira authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, DaptomycinHospira has been shown to be comparable to Cubicin. Therefore, the Agency's view was that, as for Cubicin, the benefit of Daptomycin Hospira outweighs the identified risk and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Daptomycin Hospira?

The company that markets Daptomycin Hospira will provide all doctors who are expected to use this medicine with a dosage card to ensure the safe use of Daptomycin Hospira. In addition, the company will also provide a leaflet for laboratories explaining how to test to see if an infection is likely to respond to the medicine.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daptomycin Hospira have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Daptomycin Hospira are continuously monitored. Side effects reported with Daptomycin Hospira are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Darunavir Krka


What is Darunavir Krka and what is it used for?

Darunavir Krka is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Darunavir Krka may be given to adults or children from 3 years of age and weighing at least 15 kg.Darunavir Krka contains the active substance darunavir.Darunavir Krka is a 'generic medicine'. This means that Darunavir Krka contains the same active substance and works in the same way as a 'reference medicine' already authorised in the European Union (EU) called Prezista. For more information on generic medicines, see the question-and-answer document here.

How is Darunavir Krka used?

Darunavir Krka can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV.Darunavir Krka is available as tablets. The medicine is always taken with low-dose ritonavir and with other HIV medicines, and should be taken with food.

How does Darunavir Krka work?

The active substance in Darunavir Krka, darunavir, is a protease inhibitor. It blocks protease, an enzyme involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down its multiplication in the body. Darunavir Krka is always given with ritonavir. Ritonavir reduces the breakdown of darunavir, increasing the levels of darunavir in the blood. This allows effective treatment while avoiding a higher dose of darunavir.Darunavir Krka, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Darunavir Krka does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Darunavir Krka been studied?

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Krka.As for every medicine, the company provided studies on the quality of Darunavir Krka. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Darunavir Krka?

Because Darunavir Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Darunavir Krka approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka has been shown to have comparable quality and to be bioequivalent to Prezista. Therefore, the Agency's view was that, as for Prezista, the benefit outweighs the identified risk. The Agency recommended that Darunavir Krka be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Darunavir Krka?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Krka have been included in the summary of product characteristics and the package leaflet.


Summarize this document



Read the original document in your language

Darunavir Mylan


What is Darunavir Mylan and what is it used for?

Darunavir Mylan is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is given with low-dose ritonavir or, in adults, with cobicistat. Darunavir Mylan may be given to adults or children from 3 years of age and weighing at least 15 kg.Darunavir Mylan contains the active substance darunavir.Darunavir Mylan is a 'generic medicine'. This means that Darunavir Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the European Union (EU) called Prezista. For more information on generic medicines, see the question-and-answer document here.

How is Darunavir Mylan used?

Darunavir Mylan can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV infection.Darunavir Mylan is available as tablets (75, 150, 300, 400, 600 and 800 mg). The medicine is always taken either with cobicistat (in adults) or with low-dose ritonavir (in adults and children) and with other HIV medicines, and should be taken with food.For adults who have not been treated before, the recommended dose is 800 mg once a day. For adults who have been treated before, the dose is 600 mg twice a day. Previously treated patients can also take a dose of 800 mg once a day provided that their HIV infection is well controlled and is not likely to be resistant to darunavir.For children aged 3 to 17 years and weighing at least 15 kg who have not be treated before, the recommended dose varies between 600 and 800 mg once daily depending on their weight. For previously treated children the usually recommended dose varies between 375 and 600 mg twice a day depending on their weight.For further information, see the package leaflet.

How does Darunavir Mylan work?

The active substance in Darunavir Mylan, darunavir, is a protease inhibitor. It blocks protease, an enzyme involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down its multiplication in the body. Darunavir Mylan is always given with ritonavir or cobicistat. Ritonavir and cobicistat reduce the breakdown of darunavir, increasing the levels of darunavir in the blood. This allows effective treatment while avoiding a higher dose of darunavir.Darunavir Mylan, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Darunavir Mylan does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Darunavir Mylan been studied?

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Mylan.As for every medicine, the company provided studies on the quality of Darunavir Mylan. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Darunavir Mylan?

Because Darunavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Darunavir Mylan approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Darunavir Mylan has been shown to have comparable quality and to be bioequivalent to Prezista. Therefore, the CHMP's view was that, as for Prezista, the benefit outweighs the identified risk. The Committee recommended that Darunavir Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Darunavir Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Mylan have been included in the summary of product characteristics and the package leaflet.


Summarize this document



Read the original document in your language

Darzalex


What is Darzalex and what is it used for?

Darzalex is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). In patients with newly diagnosed multiple myeloma it is used:• in combination with the medicines lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone in patients who cannot have autologous stem cell transplant (a transplant of the patient's own blood-producing cells). Bortezomib, lenalidomide and melphalan are used for treating multiple myeloma and dexamethasone and prednisone suppress the immune system;• in combination with bortezomib, thalidomide (another medicine used to treat multiple myeloma), and dexamethasone, in patients who can have autologous stem cell transplant.In patients with previously treated multiple myeloma it is used:• in combination with dexamethasone plus either lenalidomide or bortezomib;• on its own when the disease has come back after treatment with cancer medicines (including medicines known as proteasome inhibitors) and immunomodulatory medicines (that act on the immune system), or when the disease has not improved with these medicines.Multiple myeloma is rare and Darzalex was designated an 'orphan medicine' (a medicine used in rare diseases) on 17 July 2013. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation Darzalex contains the active substance daratumumab.

How is Darzalex used?

Darzalex can only be obtained with a prescription and should be given by a healthcare professional in a setting where severe reactions can be quickly treated.It is given by infusion (drip) into a vein or by injection under the skin. The recommended dose depends on the way the medicine is given. How often Darzalex is given depends on which other medicines arebeing given with it. Treatment usually starts with one dose of Darzalex once a week. Before and after treatment with Darzalex, patients are given medicines to reduce the risk of reactions. If the patient has severe infusion-related reactions, the doctor may slow down the infusion rate or stop treatment.For more information about using Darzalex, see the package leaflet or contact your doctor or pharmacist.

How does Darzalex work?

The active substance in Darzalex, daratumumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the protein CD38, which is found in high amounts on multiple myeloma cells. By attaching to CD38 on the multiple myeloma cells, daratumumab activates the immune system to kill the cancer cells.

What benefits of Darzalex have been shown in studies?

Previously treated multiple myelomaDarzalex on its own was investigated in two main studies involving a total of 196 multiple myeloma patients whose disease came back after, or did not respond to, at least two previous treatments including a proteasome inhibitor and an immunomodulatory medicine. The main measure of effectiveness was the proportion of patients who responded to treatment (as measured by the disappearance of, or at least a 50% reduction in, a protein found in multiple myeloma cells). Around 29% of the patients receiving Darzalex at a dose of 16 mg/kg (31 out of 106 patients) responded to treatment in one study and 36% (15 out of 42 patients) in the second study. In these studies Darzalex was not compared with any other treatment.Darzalex, given together with dexamethasone and either lenalidomide or bortezomib, was investigated in two further main studies involving patients whose multiple myeloma came back after treatment with other medicines or did not respond to the treatment. The main measure of effectiveness was how long patients lived without their disease getting worse. In the first of these studies involving 569 patients, 78% of patients receiving Darzalex and dexamethasone plus lenalidomide for 18 months lived without their disease getting worse compared with 52% of those receiving dexamethasone plus lenalidomide. In the second study involving 498 patients, 61% of patients receiving Darzalex and dexamethasone plus bortezomib for 12 months lived without their disease getting worse compared with 27% of those receiving dexamethasone plus bortezomib.Another study, involving 522 patients with multiple myeloma that came back after previous treatment or had not responded, showed that Darzalex by injection under the skin was no less effective in treating the condition than Darzalex by infusion into a vein; the disease responded in 41% (108 of 263) of patients given the injection and 37% (96 of 259) of patients given the infusion.Newly diagnosed multiple myelomaDarzalex given together with dexamethasone and lenalidomide was compared with dexamethasone plus lenalidomide in patients with newly diagnosed multiple myeloma who could not have an autologous stem cell transplant. The study involved 737 patients and 70% of patients receiving Darzalex and dexamethasone plus lenalidomide lived for 36 months without their disease getting worse compared with 39% of those receiving dexamethasone plus lenalidomide.Darzalex in combination with bortezomib, melphalan and prednisone was compared with bortezomib, melphalan and prednisone in a study involving 706 patients with newly diagnosed multiple myeloma who could not have autologous stem cell transplantation. After about 28 months of starting the study, 70% (246 out of 350) of patients treated with Darzalex in combination with the other 3 medicines were alive with no worsening of their disease compared with 49% (174 out of 356) of patients treated with bortezomib, melphalan and prednisone.Darzalex has also been studied in patients who could have autologous stem cell transplantation. In the study, which involved 1,085 patients, Darzalex combined with bortezomib, thalidomide and dexamethasone was compared with a combination of bortezomib, thalidomide and dexamethasone without Darzalex, both given for 4 treatment cycles before transplantation and 2 cycles afterwards. After 100 days following transplantation, all signs of the myeloma were absent in around 29% of patients given the Darzalex combination and 20% of those given bortezomib, thalidomide and dexamethasone alone.

What are the risks associated with Darzalex?

The most common side effects with Darzalex (which may affect at least 1 in 5 patients) are infusion reactions, tiredness, weakness, fever, nausea (feeling sick), diarrhoea, constipation, peripheral oedema (swelling of the ankles and feet), cough, upper respiratory tract infections (such as nose and throat infections), difficulty breathing, neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts) and peripheral sensory neuropathy (damage to the nerves in the arms and legs).Serious side effects are pneumonia (infection of the lungs), bronchitis (inflammation of the airways in the lungs), upper respiratory tract infection, pulmonary oedema (fluid build-up in the lungs), sepsis (blood poisoning), flu, fever, dehydration, diarrhoea and atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).For the full list of side effects and restrictions with Darzalex, see the package leaflet.

Why is Darzalex authorised in the EU?

The European Medicines Agency decided that Darzalex's benefits are greater than its risks and it can be authorised for use in the EU. Darzalex on its own was effective at treating multiple myeloma in patients whose disease had progressed despite at least two other medicines. Darzalex used together with dexamethasone plus either lenalidomide or bortezomib has also been found effective in patients who had received other treatment for multiple myeloma. Darzalex used with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone was effective at treating patients with newly diagnosed multiple myeloma who cannot have autologous stem cell transplantation; combination with bortezomib, thalidomide and dexamethasone was of benefit in patients who can have such transplantation. Patients with multiple myeloma had limited treatment options and Darzalex, which works in a different way to existing treatments, represented an alternative. Darzalex's side effects are considered acceptable and manageable.Darzalex was originally given 'conditional authorisation' because there was more evidence to come about the medicine. As the company has provided the additional information necessary, the authorisation has been switched to full approval.

What measures are being taken to ensure the safe and effective use of Darzalex?

The company that markets Darzalex will provide educational material to all healthcare professionals expected to use the medicine, to inform them that the medicine can affect the result of a blood test (indirect Coombs test) used to determine suitability for blood transfusions. Patients who are prescribed Darzalex will be provided with a patient alert card with similar information.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darzalex have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Darzalex are continuously monitored. Side effects reported with Darzalex are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dasselta


What is Dasselta?

Dasselta is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).Dasselta is a 'generic medicine'. This means that Dasselta is similar to a 'reference medicine' already authorised in the European Union (EU) called Aerius. For more information on generic medicines, see the question-and-answer document here.

What is Dasselta used for?

Dasselta is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).The medicine can only be obtained with a prescription.

How is Dasselta used?

The recommended dose for adults and adolescents (12 years of age and over) is one tablet once a day.

How does Dasselta work?

The active substance in Dasselta, desloratadine, is an antihistamine. It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

How has Dasselta been studied?

Because Dasselta is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Dasselta?

Because Dasselta is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Dasselta been approved?

The CHMP concluded that, in accordance with EU requirements, Dasselta has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the CHMP's view was that, as for Aerius, the benefit outweighs the identified risk. The Committee recommended that Dasselta be given marketing authorisation.


Summarize this document



Read the original document in your language

Datscan


What is DaTSCAN?

DaTSCAN is a solution for injection that contains the active substance ioflupane (123I).

What is DaTSCAN used for?

DaTSCAN is for diagnostic use only. It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):• movement disorders such as those seen in Parkinson's disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles. Because tremor can also occur in 'essential tremor' (tremor whose cause is unknown), DaTSCAN is used to help distinguish between essential tremor and diseases related to Parkinson's disease;• dementia (loss of intellectual function). DaTSCAN is used to help distinguish between a type of dementia known as 'dementia with Lewy bodies' and Alzheimer's disease.The medicine can only be obtained with a prescription.

How is DaTSCAN used?

DaTSCAN should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia. DaTSCAN is only handled and given by people who have experience in the safe handling of radioactive materials.DaTSCAN is given by slow injection lasting no less than 15 to 20 seconds into an arm vein. A scan is taken three to six hours after the injection. When receiving DaTSCAN, patients must also take another medicine, such as iodine tablets, to prevent their thyroid gland from taking up the iodine contained in DaTSCAN. This is taken one to four hours before DaTSCAN.Resuscitation equipment should be available before DaTSCAN is given, in case the patient has an allergic reaction.

How does DaTSCAN work?

The active substance in DaTSCAN, ioflupane (123I), is a radiopharmaceutical. It contains a substance called ioflupane, which is labelled with 123I (iodine-123), a radioactive form of the chemical element iodine. Ioflupane attaches specifically to structures on the surface of nerve cell endings in the striatum that are responsible for the transport of dopamine.When DaTSCAN is injected, ioflupane (123I) is distributed through the body in the blood and accumulates in the striatum, where it attaches to the structures that transport dopamine. This can be seen using a special imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine-123.In patients with Parkinson's disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of nerve cells in the striatum containing dopamine. If this happens, the amount of DaTSCAN attaching to these nerve cells is greatly reduced, which can be seen on the scan. This enables diseases related to Parkinson's disease to be distinguished from essential tremor, and for Lewy body dementia to be distinguished from Alzheimer's disease.

How has DaTSCAN been studied?

In movement disorders, DaTSCAN has been studied in 254 adults in two main studies. In the studies, images obtained in 45 healthy volunteers were compared with those obtained in 180 patients with Parkinson's disease or related diseases, and in 29 patients with essential tremor.In dementia, DaTSCAN has been studied in one main study involving 288 adults who had been diagnosed with dementia with Lewy bodies or Alzheimer's disease, or another form of dementia.In all of the studies, the main measure of effectiveness was the accuracy of the diagnosis based on the images from the scan compared with the diagnosis made by a specialist doctor.

What benefit has DaTSCAN shown during the studies?

In movement disorders, DaTSCAN was effective at detecting changes in the brain due to Parkinson's disease or related diseases. In the larger of the two studies, the sensitivity of DaTSCAN was 97%. This means that the disease identified by the doctor reading the images obtained using DaTSCAN matched the existing diagnosis of the patients in 97% of cases.In dementia, the sensitivity of DaTSCAN in distinguishing dementia caused by Lewy bodies from other types of dementia ranged from 75 to 80%.

What is the risk associated with DaTSCAN?

No serious side effects have been reported with DaTSCAN. The most common side effect with DaTSCAN (seen in between 1 and 10 patients in 100) is headache. The risk caused by radioactivity is thought to be very low. For the full list of all side effects reported with DaTSCAN, see the package leaflet.DaTSCAN should not be used in people who may be hypersensitive (allergic) to ioflupane or any of the other ingredients. It must not be used in women who are pregnant.

Why has DaTSCAN been approved?

The CHMP decided that DaTSCAN's benefits are greater than its risks and recommended that it be given marketing authorisation.


Summarize this document



Read the original document in your language

Daurismo


What is Daurismo and what is it used for?

Daurismo is a cancer medicine for treating adults with newly-diagnosed acute myeloid leukaemia (AML), a cancer of white blood cells.It is used in combination with a low dose of cytarabine (another cancer medicine) when the patient cannot be treated with standard chemotherapy.The active substance in Daurismo is glasdegib.Acute myeloid leukaemia is rare, and Daurismo was designated an 'orphan medicine' (a medicine used in rare diseases) on 16 October 2017. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3171923.

How is Daurismo used?

Daurismo can only be obtained with a prescription and treatment should be prescribed and supervised by a doctor experienced in using cancer medicines.Daurismo is available as tablets and the recommended starting dose is 100 mg once daily taken by mouth. The medicine is given together with a low dose of cytarabine, which is given by injection under the skin. Treatment can continue for as long as the patient benefits from it. If certain side effects occur, the doctor may reduce the dose of Daurismo or stop the treatment temporarily or permanently. Treatment with Daurismo together with other medicines that speed up the breakdown of Daurismo in the body called 'moderate CYP3A4 inducers' should be avoided, or if it cannot be avoided, the dose of Daurismo should be increased.For more information about using Daurismo, see the package leaflet or contact your doctor or pharmacist.

How does Daurismo work?

The active substance in Daurismo, glasdegib, blocks a protein called 'SMO'. When SMO is not working normally, it can play a role in growth of cancer cells and prevent cancer medicines from working. Blocking SMO reduces the ability of cancer cells to survive and grow while helping to make cancer treatment more effective.

What benefits of Daurismo have been shown in studies?

In a main study with 116 patients with newly-diagnosed AML who were not able to have standard chemotherapy, Daurismo with cytarabine prolonged patients' lives compared with patients receiving cytarabine alone. Patients receiving Daurismo and low dose of cytarabine lived on average 8.3 months compared with 4.3 months for those receiving low-dose cytarabine alone.

What are the risks associated with Daurismo?

The most common side effects with Daurismo (which may affect more than 2 in 10 people) are anaemia (low red blood cell counts), bleeding, febrile neutropenia (low white blood cell counts with fever), nausea (feeling sick), decreased appetite, tiredness, muscle spasms, thrombocytopenia (low blood platelet counts), fever, diarrhoea, pneumonia (lung infection), dysgeusia (taste disturbances), peripheral oedema (swelling especially of the ankles and feet), constipation, abdominal (belly) pain, rash, dyspnoea (difficulty breathing), vomiting and decrease in weight.Daurismo can harm the unborn child, causing severe and life-threatening birth defects or death in the womb or shortly after birth. Daurismo must therefore never be used by women who are pregnant. Women who are able to become pregnant should always use effective contraception during treatment and for at least 30 days after the last dose.Daurismo may be present in semen. Male patients should always use effective contraception with their female partners, including a condom (with spermicide, if available), during treatment and for at least 30 days after the last dose.Daurismo could impair fertility in men. Men may wish to consult their doctor about fertility preservation before starting treatment.For the full list of side effects and restrictions of Daurismo, see the package leaflet.

Why is Daurismo authorised in the EU?

Daurismo has been shown to prolong patients' lives when added to a low dose of cytarabine in patients with acute myeloid leukaemia who have a poor prognosis and few alternatives as they are not able to have standard chemotherapy as a first treatment. Side effects are considered manageable. The European Medicines Agency therefore decided that Daurismo's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Daurismo?

The company that markets Daurismo will provide an alert card to be given to male patients informing them about the medicine passing into semen, measures to avoid risks of harm to the unborn child and the potential effects on fertility.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daurismo have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Daurismo are continuously monitored. Side effects reported with Daurismo are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Daxas


What is Daxas and what is it used for?

Daxas is a medicine used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.Daxas is not used on its own but as an 'add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).Daxas contains the active substance roflumilast.

How is Daxas used?

Daxas is available as tablets (250 and 500 micrograms) and can only be obtained with a prescription.The recommended dose of Daxas for treatment is one 500-microgram tablet once a day, but treatment is started with one 250-microgram tablet daily to reduce side effects that might make patients stop taking the medicine. The tablets should be taken at the same time each day. After taking250 micrograms daily for 4 weeks, the dose is increased to 500 micrograms daily. Patients may need to take Daxas 500 micrograms for several weeks before it starts to have an effect.For more information about using Daxas, see the package leaflet or contact your doctor or pharmacist.

How does Daxas work?

The active substance in Daxas, roflumilast, belongs to a group of medicines called 'phosphodiesterase type 4 (PDE4) inhibitors'. It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD. By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient's symptoms or to prevent them from getting worse.

What benefit of Daxas have been shown in studies?

Daxas 500 micrograms was shown to be more effective than placebo (a dummy treatment) at treating COPD in two main studies. These involved over 3,000 adults with severe COPD who had had at leastone flare-up of their disease in the past year. The patients could continue to receive treatment with a bronchodilator during the study. The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment. FEV1 is the most air a person can breathe out in one second.At the beginning of the studies, both groups of patients had an FEV1 of around 1 litre (1,000 ml). After a year, the patients who took Daxas had an average increase of 40 ml while those given placebo had an average decrease of 9 ml. In addition, the patients who took Daxas had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.Another 12-week study involving 1,323 patients examined the effect of starting treatment with Daxas 250 micrograms daily for 4 weeks before increasing the dose to 500 micrograms daily, compared with starting at the higher dose. Around 18% (81 of 441 patients) of those started at 250 micrograms daily dropped out of the study, compared with 25% (109 of 443) of those starting with 500 micrograms daily. Patients started on the lower dose had fewer side effects. The benefits in improving FEV1 were similar in both groups at the end of the study; however, patients who could not take 500 micrograms daily and were then just given 250 micrograms daily did not show an improvement in lung function.

What are the risks associated with Daxas?

The most common side effects with Daxas (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache). Because patients taking Daxas may lose weight, they are advised to weigh themselves on a regular basis. The doctor may stop treatment with Daxas if the patient loses too much weight. For the full list of side effects of Daxas, see the package leaflet.Daxas must not be used in patients who have moderate or severe problems with their liver. For the full list of restrictions, see the package leaflet.

Why is Daxas authorised in the EU?

The European Medicines Agency noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas 500 micrograms in patients with severe COPD. This benefit was seen on top of the effects of the treatments that the patients were already receiving. Although a dose of 250 micrograms daily does not improve lung function it was useful in preventing patients from dropping out because of side effects when starting treatment. After considering all of the available data on the effects of the medicine, the Agency decided that Daxas's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Daxas?

The company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used. The company will also provide cards for patients, telling them what information about their symptoms and past illnesses they need to give their doctor to help the doctor determine whether Daxas is appropriate for them. The card will include an area where patients can record their weight.The company is also carrying out an observational study on the long-term safety of the medicine.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daxas have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Daxas are continuously monitored. Side effects reported with Daxas are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dectova


What is Dectova and what is it used for?

Dectova is an antiviral medicine used to treat complicated and potentially life-threatening influenza (flu) caused by either the influenza A or B virus in adults and children from 6 months of age. Complicated influenza is a severe flu infection that requires hospitalisation of the patient.The medicine is used when the virus is resistant to other flu treatments or when other antiviral treatments, including inhaled zanamivir are not suitable for the patient.Dectova contains the active substance zanamivir.

How is Dectova used?

Dectova is given as an infusion (drip) into a vein. The recommended dose for adults is 600 mg twice daily for 5 to 10 days while for children the dose is adjusted based on weight. Lower doses are given to adults and children with reduced kidney function.Treatment is started as soon as possible and usually within 6 days after symptoms start.Dectova can only be obtained with a prescription. For more information about using Dectova, see the package leaflet or contact your doctor or pharmacist.

How does Dectova work?

The active substance in Dectova, zanamivir, prevents the flu virus from spreading by blocking some of the enzymes on the surface of the virus called neuraminidases. When the neuraminidases are blocked, the virus cannot spread. Dectova works on neuraminidases of both influenza A (the most common type) and influenza B viruses.

What benefits of Dectova have been shown in studies?

Dectova has been shown to work as well as Tamiflu (the standard of care for complicated flu) in one main study involving 626 patients who had been hospitalised. The main measure of effectiveness was how long it took for patients to leave hospital or for 4 out of the following 5 flu symptoms to resolve: fever, decreased levels of oxygen in the blood, raised breathing rate, raised heart rate and abnormal blood pressure. It took around 5.1 days for symptoms to resolve or patients to leave the hospital with Dectova compared with 5.6 days with Tamiflu.Although Tamiflu was used as the comparator, there is some uncertainty about how effective this medicine is in complicated influenza as it has not been compared with placebo (a dummy treatment) in hospitalised influenza patients.Further evidence on benefits of Dectova comes from supporting clinical studies and other laboratory studies.

What are the risks associated with Dectova?

The most common side effects with Dectova (which may affect up to 1 in 10 people) are diarrhoea, raised levels of transaminases (liver enzymes), liver injury and rash. The most serious side effect is liver injury.For the full list of side effects and restrictions, see the package leaflet.

Why is Dectova authorised in the EU?

A main study showed that Dectova works as well as Tamiflu, with comparable time to discharge patients from hospital or resolution of most of the influenza symptoms. Evidence from laboratory and other clinical studies also supported the effectiveness of Dectova.Dectova is expected to be effective against some flu strains that do not respond to other flu treatments. Its side effects, the most important one being liver injury, are similar to those seen with Tamiflu.The European Medicines Agency therefore decided that Dectova's benefits are greater than its risks and it can be authorised for use in the EU.However, because uncertainties remain about the size of the effect of Tamiflu (and by extension the size of Dectova's effect), Dectova has been authorised under 'exceptional circumstances'. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Dectova?

Since Dectova has been authorised under exceptional circumstances, the company that markets the medicine will conduct two observational studies in patients with complicated influenza to obtain further data on the effectiveness.

What measures are being taken to ensure the safe and effective use of Dectova?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dectova have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dectova are continuously monitored. Side effects reported with Dectova are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Deferasirox Accord


What is Deferasirox Accord and what is it used for?

Deferasirox Accord is a medicine used to treat chronic iron overload (an excess of iron in the body) in:• patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin [protein that carries oxygen around the body] in the blood) and who receive frequent blood transfusions;• children aged 2 to 5 years with beta thalassaemia major who receive frequent blood transfusions, when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate;• patients from 2 years of age with beta thalassaemia major who receive infrequent blood transfusions, when deferoxamine cannot be used or is inadequate;• patients from 2 years of age who suffer from other types of anaemia (low levels of haemoglobin in the blood) and who receive blood transfusions, when deferoxamine cannot be used or is inadequate;• patients from 10 years of age with non-transfusion-dependent thalassaemia syndromes, when deferoxamine cannot be used or is inadequate. Non-transfusion-dependent thalassaemia syndromes are blood disorders similar to beta thalassaemia major but which do not require blood transfusions. In these patients, iron overload is caused by excess absorption of iron from the gut.Deferasirox Accord contains the active substance deferasirox and is a 'generic medicine'. This means that Deferasirox Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Exjade. For more information on generic medicines, see the question-and-answer document here.

How is Deferasirox Accord used?

The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload.Deferasirox Accord is available as film-coated tablets (90 mg, 180 mg and 360 mg), to be taken once a day at around the same time.SendThe starting dose of Deferasirox Accord depends on the patient's body weight, what the medicine is used for, and the level of iron overload. The dose is then adjusted as needed, every 3 to 6 months, according to the iron levels in the blood.For more information about using Deferasirox Accord, see the package leaflet or contact your doctor or pharmacist.

How does Deferasirox Accord work?

When the body cannot remove iron effectively, the excess iron can cause damage. The active substance in Deferasirox Accord, deferasirox, is an 'iron chelator'. It attaches to excess iron in the body to form a compound called a 'chelate' that can be removed by the body, mainly in the stool. This helps to correct the iron overload and prevents damage to organs such as the heart or liver from excess iron.

How has Deferasirox Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Exjade, and do not need to be repeated for Deferasirox Accord.As for every medicine, the company provided studies on the quality of Deferasirox Accord. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Deferasirox Accord?

Because Deferasirox Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Deferasirox Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, DeferasiroxAccord has been shown to have comparable quality and to be bioequivalent to Exjade. Therefore, the Agency's view was that, as for Exjade, the benefits of Deferasirox Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Deferasirox Accord?

The company that markets Deferasirox Accord must issue an education pack to healthcare professionals. This pack aims to inform them about the treatment recommendations with Deferasirox Accord, including choosing the right dose and the need to monitor the patient's health, especially kidney function. The company will also prepare a similar pack for patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deferasirox Accord have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Deferasirox Accord are continuously monitored. Side effects reported with Deferasirox Accord are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Deferasirox Mylan


What is Deferasirox Mylan and what is it used for?

Deferasirox Mylan is a medicine used to treat chronic iron overload (an excess of iron in the body) in:• patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin - the protein that carries oxygen around the body - in the blood) and who receive frequent blood transfusions;• children aged 2 to 5 years with beta thalassaemia major who receive frequent blood transfusions, when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate;• patients from 2 years of age with beta thalassaemia major who receive infrequent blood transfusions, when deferoxamine cannot be used or is inadequate;• patients from 2 years of age who suffer from other types of anaemia (low levels of haemoglobin in the blood) and who receive blood transfusions, when deferoxamine cannot be used or is inadequate;• patients from 10 years of age with non-transfusion-dependent thalassaemia syndromes, when deferoxamine cannot be used or is inadequate. Non-transfusion-dependent thalassaemia syndromes are blood disorders similar to beta thalassaemia major but which do not require blood transfusions. In these patients iron overload is caused by excess absorption of iron from the gut.Deferasirox Mylan contains the active substance deferasirox and is a 'generic medicine'. This means that Deferasirox Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Exjade. For more information on generic medicines, see the question-and-answer document here.

How is Deferasirox Mylan used?

Deferasirox Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload.Deferasirox Mylan is available as film-coated tablets (90 mg, 180 mg and 360 mg), to be taken once a day at around the same time.SendThe starting dose of Deferasirox Mylan depends on the patient's body weight, what the medicine is used for, and on the level of iron overload. The dose is then adjusted as needed, every 3 to 6 months, according to the iron levels in the blood.For more information about using Deferasirox Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Deferasirox Mylan work?

When the body cannot remove iron effectively, the excess iron can cause damage. The active substance in Deferasirox Mylan, deferasirox, is an 'iron chelator'. It attaches to excess iron in the body to form a compound called a 'chelate' that can be removed by the body, mainly in the stool. This helps to correct the iron overload and prevent damage to organs such as the heart or liver from excess iron.

How has Deferasirox Mylan been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Exjade, and do not need to be repeated for Deferasirox Mylan.As for every medicine, the company provided studies on the quality of Deferasirox Mylan. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Deferasirox Mylan?

Because Deferasirox Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Deferasirox Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, DeferasiroxMylan has been shown to have comparable quality and to be bioequivalent to Exjade. Therefore, the Agency's view was that, as for Exjade, the benefits of Deferasirox Mylan outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Deferasirox Mylan?

The company that markets Deferasirox Mylan must issue an education pack to healthcare professionals. This pack aims to inform them about the treatment recommendations with Deferasirox Mylan, including choosing the right dose and the need to monitor the patient's health, especially kidney function. The company will also prepare a similar pack for patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deferasirox Mylan have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Deferasirox Mylan are continuously monitored. Side effects reported with Deferasirox Mylan are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Deferiprone Lipomed


What is Deferiprone Lipomed and what is it used for?

Deferiprone Lipomed is an 'iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major. This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body.Deferiprone Lipomed is used:• on its own, when standard iron chelator treatment cannot be used or is inadequate;• in combination with another iron chelator, when treatment with one iron chelator on its own is ineffective or when prevention or treatment of life-threatening conditions requires rapid or intensive correction of iron levels.Deferiprone Lipomed contains the active substance deferiprone and is a 'generic medicine'. This means that Deferiprone Lipomed contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Ferriprox. For more information on generic medicines, see the question-and-answer document here.

How is Deferiprone Lipomed used?

Deferiprone Lipomed can only be obtained with a prescription and treatment should be started and maintained by a doctor who has experience in the treatment of patients with thalassaemia.Deferiprone Lipomed is available as 500 mg tablets to be taken by mouth. The usual dose ofDeferiprone Lipomed is 75 mg per kilogram body weight each day, divided into three separate doses. Doses above 100 mg/kg a day are not recommended because of a potentially increased risk of side effects. The doctor may adjust the dose of Deferiprone Lipomed depending on the patient's response, which should be measured every two to three months with blood tests. The doctor may interrupt treatment if iron levels in the body get too low.For more information about using Deferiprone Lipomed, see the package leaflet or contact your doctor or pharmacist.

How does Deferiprone Lipomed work?

Patients with thalassaemia major need frequent blood transfusions. When patients receive repeated transfusions, the transfused red cells bring iron into the body. However, the body does not have a natural way of removing excess iron, so it builds up. Over time, the excess iron can damage important organs such as the heart or liver. The active substance in Deferiprone Lipomed, deferiprone, is an iron chelator. It attaches to iron in the body to form a compound that can be excreted by the body, mainly in the urine, and to a lesser extent in the stools. This helps to correct the iron overload and prevent damage due to excess iron.

How has Deferiprone Lipomed been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Ferriprox, and do not need to be repeated for Deferiprone Lipomed.As for every medicine, the company provided studies on the quality of Deferiprone Lipomed. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Deferiprone Lipomed?

Because Deferiprone Lipomed is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Deferiprone Lipomed authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Deferiprone Lipomed has been shown to have comparable quality and to be bioequivalent to Ferriprox. Therefore, the Agency's view was that, as for Ferriprox, the benefit of Deferiprone Lipomed outweighs the identified risk and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Deferiprone Lipomed?

The company that markets Deferiprone Lipomed will ensure that patients taking the medicine, or their carers, are provided with a reminder card with information on how to take the medicine safely.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deferiprone Lipomed have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Deferiprone Lipomed are continuously monitored. Side effects reported with Deferiprone Lipomed are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Defitelio


What is Defitelio and what is it used for?

Defitelio is a medicine used to treat severe veno-occlusive disease (VOD) in patients undergoing haematopoietic (blood) stem cell transplantation. VOD is a condition in which the veins in the liver become blocked and stop the liver working properly. Defitelio is used in adults and in children from one month of age.Defitelio contains the active substance defibrotide.VOD is rare, and Defitelio was designated an 'orphan medicine' (a medicine used in rare diseases) on 29 July 2004. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.

How is Defitelio used?

Defitelio can only be obtained with a prescription and it must be prescribed and given by a doctor experienced in the management of complications of blood stem cell transplantation. It is given by infusion (drip) into a vein over 2 hours 4 times a day. The dose depends on the patient's bodyweight. Treatment should last for at least 3 weeks and continue until the patient no longer has symptoms. For more information about using Defitelio, see the package leaflet or contact your doctor or pharmacist.

How does Defitelio work?

VOD is usually a complication resulting from a treatment known as 'myeloablative chemotherapy' given before blood stem cell transplantation. Myeloablative chemotherapy is used to clear the patient's bone marrow of cells before receiving healthy stem cells. The medicines used for this treatment can damage the lining of the blood vessels in the liver, leading to the formation of clots and obstruction of the vessels seen in VOD.The active substance in Defitelio, defibrotide, works by increasing the breakdown of clots in the blood.In addition, defibrotide may protect the cells that line blood vessels.

What benefits of Defitelio have been shown in studies?

Severe VOD has a high mortality rate of 75% or higher. In one main study involving 102 patients with severe VOD following blood stem cell transplantation, Defitelio was compared with past records of patients who had received standard supportive care. Defitelio lowered the mortality rate to 62% at 100 days after transplantation, and 24% of patients had no symptoms of severe VOD after 100 days.Benefits of Defitelio were also seen in data from a United States patient registry (information about patients collected in a standard way), where patients with severe VOD after blood stem cell transplantation who received Defitelio plus standard care had better outcomes than those given standard care alone, including a higher 100-day survival rate (39% versus 31%) and a higher proportion of patients whose VOD resolved (51% versus 29%).

What are the risks associated with Defitelio?

The most common side effects with Defitelio are hypotension (low blood pressure) and bleeding. For the full list of side effects of Defitelio, see the package leaflet.Defitelio must not be used together with other medicines that break down blood clots. For the full list of restrictions, see the package leaflet.

Why is Defitelio authorised in the EU?

The European Medicines Agency decided that Defitelio's benefits are greater than its risks and it can be authorised for use in the EU. Defitelio had been shown to improve survival in patients with severe VOD. Although it was not possible to conduct a study directly comparing Defitelio with placebo (dummy treatment), the company had provided sufficient data to show that patients treated with the medicine had improved chances of survival. The side effects seen, such as bleeding, were considered manageable and it was not possible to determine with certainty whether they were caused by Defitelio.Defitelio has been authorised under 'exceptional circumstances'. This is because it has not been possible to obtain complete information about Defitelio due to the rarity of the disease. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Defitelio?

Since Defitelio has been authorised under exceptional circumstances, the company that markets the medicine is required to provide results of an ongoing study on safety of the medicine when used for prevention of VOD in adults and children undergoing hematopoietic stem cell transplantation. The company will also analyse data on transplant outcomes in VOD patients who have and have not been treated with Defitelio.

What measures are being taken to ensure the safe and effective use of Defitelio?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Defitelio have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Defitelio are continuously monitored. Side effects reported with Defitelio are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Delstrigo


What is Delstrigo and what is it used for?

Delstrigo is an antiviral medicine used to treat adults and adolescents from 12 years of age weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).The medicine is only used in patients where the virus has not developed resistance to medicines that work in the same way as Delstrigo's active substances.It is only used in adolescents if other HIV medicines without tenofovir disoproxil cannot be used because of side effects.Delstrigo contains the active substances doravirine, lamivudine and tenofovir disoproxil.

How is Delstrigo used?

Delstrigo can only be obtained with a prescription and treatment should be started by a doctor experienced in managing HIV infection.Delstrigo is available as tablets, each containing 100 mg of doravirine, 300 mg of lamivudine and 245 mg of tenofovir disoproxil. The recommended dose is one tablet daily.For more information about using Delstrigo, see the package leaflet or contact your doctor or pharmacist.

How does Delstrigo work?

All three active substances in Delstrigo block the activity of reverse transcriptase, a virus enzyme that allows HIV to reproduce itself in the cells it has infected. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI). Tenofovir disoproxil is a 'prodrug' of tenofovir, meaning that it is converted in the body to the active substance tenofovir. Tenofovir is a nucleotide reverse transcriptase inhibitor.Delstrigo keeps the amount of HIV in the blood at a low level. It does not cure HIV infection or AIDS but it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Delstrigo have been shown in studies?

Delstrigo was as effective at keeping HIV infection under control as a similar HIV combination treatment in a main study involving adult patients with HIV infection who had not been treated before. In the study with 728 adult patients, 84% of patients treated with Delstrigo had undetectable levels of HIV in their blood (fewer than 40 copies/ml) after 48 weeks of treatment compared with 80% of patients given a combination of efavirenz, emtricitabine and tenofovir disoproxil.A second study that included 43 adolescent patients aged 12 to 18 years who had been previously treated for HIV showed that Delstrigo was also effective at keeping viral load below 40 copies/ml in this age group; 95% (41 of 43 patients) had undetectable levels after 24 weeks, and 93% (40 of 43 patients) had undetectable levels after 48 weeks.

What are the risks associated with Delstrigo?

The most common side effects with doravirine (which may affect up to 1 in 10 people) are nausea (feeling sick) and headache.Delstrigo must not be used with certain medicines that may reduce its effectiveness. For the full list of side effects and restrictions with Delstrigo, see the package leaflet.

Why is Delstrigo authorised in the EU?

Delstrigo was shown to be effective at keeping HIV infection under control in both adults and adolescent from 12 years of age. In addition, Delstrigo's side effects are mostly mild.The European Medicines Agency therefore decided that Delstrigo's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Delstrigo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Delstrigo have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Delstrigo are continuously monitored. Side effects reported with Delstrigo are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Deltyba


What is Deltyba and what is it used for?

Deltyba is a medicine that is used in adults, adolescents, children and infants weighing at least 10 kg who have tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines).It is used together with other tuberculosis medicines and only when other standard medicine cannot be used either because the disease is resistant to them or because of their side effects.Deltyba contains the active substance delamanid. Tuberculosis is rare in the EU, and Deltyba was designated an 'orphan medicine' (a medicine used in rare diseases) on 1 February 2008. Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307524

How is Deltyba used?

Deltyba can only be obtained with a prescription and treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis. It should be used according to official guidelines on treating multi-drug resistant tuberculosis.The medicine is available as 50 mg tablets and 25 mg dispersible tables which are taken with food. The 25 mg dispersible tablets are only for children and infants weighing between 10 and 30 kg. The recommended dose for adults is 100 mg twice a day, while the dose for children and infants depends on the patient's body weight.Deltyba is given for 6 months together with other tuberculosis medicines. Treatment with these medicines should continue after Deltyba treatment, as recommended by official guidelines. For more information about using Deltyba, see the package leaflet or contact a doctor or pharmacist.

How does Deltyba work?

Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis). The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis. Although the way it works is unclear, delamanid is known to block the production of methoxy-mycolic and keto-mycolic acids, two essential components of the cell walls of M. tuberculosis, which will cause the bacteria to die.

What benefits of Deltyba have been shown in studies?

The effects of Deltyba have been looked at in one main study involving 481 adults with tuberculosis resistant to standard treatments. Patients in the study were given Deltyba or placebo (a dummy treatment) for 2 months in addition to their other treatments. The main measure of effectiveness was the proportion of patients who no longer had the bacteria in their sputum (phlegm). After 2 months of treatment more than 40% of the patients who were taking Deltyba no longer had the bacteria in their sputum compared with 30% of the patients who were taking placebo.After the main study had finished, patients had the option to receive treatment with Deltyba for 6 months in an extension study. In addition, a majority of patients who entered the main study were followed up for up to 24 months afterwards. Looking at the results of these follow-up studies together, 2 years after starting treatment 75% of patients who received Deltyba for 6 months or more had no bacteria in their sputum compared with 55% of patients who received Deltyba for 2 months or less.Additional data indicate that the medicine will be as effective in children, including infants, as it is in adults.

What are the risks associated with Deltyba?

The most common side effects with Deltyba (which may affect more than 1 patient in 10) are nausea, vomiting, headache, insomnia (sleeping problems), dizziness, tinnitus (ringing or buzzing in the ears), blood tests showing low potassium levels in the blood, gastritis (inflammation of the stomach lining), decreased appetite and weakness. For the full list of side effects of Deltyba, see the package leaflet.Deltyba must not be used in patients who have low levels of albumin (a blood protein). It must also not be used in patients who are taking certain other medicines that affect the way Deltyba is broken down in the body. For the full list of restrictions, see the package leaflet.

Why is Deltyba authorised in the EU?

The European Medicines Agency decided that Deltyba's benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung. Although the main study was of short duration and the follow-up studies had shortcomings, the Agency considered that the effects shown after the initial 2 months of treatment are likely to be sustained for the full treatment duration. The Agency noted that an on-going clinical study will provide confirmation on the long-term effectiveness.The safety profile was considered manageable and several measures were introduced to minimise the risks, including a study to confirm the long-term safety. Furthermore, the medical need for new agents to treat multi-drug resistant tuberculosis was highlighted.Deltyba has been given 'conditional authorisation'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Deltyba?

Since Deltyba has been given conditional authorisation, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba.

What measures are being taken to ensure the safe and effective use of Deltyba?

The company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely to avoid problems such as the development of resistance and side effects on the heart, as well as the risks in pregnancy or women who are breast-feeding.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deltyba have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Deltyba are continuously monitored. Side effects reported with Deltyba are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dengvaxia


What is Dengvaxia and what is it used for?

Dengvaxia is a vaccine used to help protect against dengue disease in people aged 6 to 45 years who have had a previous dengue virus infection.Dengue disease is a mosquito-borne tropical disease caused by the dengue virus, leading to mild, flulike symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage. The risk of severe disease is higher in people who have been infected a second time.There are several varieties (called serotypes) of dengue virus and Dengvaxia protects against serotypes 1, 2, 3 and 4.Dengvaxia contains attenuated (weakened) yellow fever viruses that have been modified so that they contain proteins from dengue virus.

How is Dengvaxia used?

Dengvaxia must only be given to people who have had a positive test result showing a previous infection with dengue virus. The vaccine is given as three doses, six months apart. The injection is given under the skin, preferably in the upper arm.Dengvaxia can only be obtained with a prescription and should be used according to official recommendations. For more information about using Dengvaxia, see the package leaflet or contact your doctor or pharmacist.

How does Dengvaxia work?

Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend the body against a disease. Dengvaxia contains weakened viruses that do not cause disease. When a person is given the vaccine, the immune system recognises the dengue proteins in the weakened viruses as 'foreign' and makes antibodies against them. In the future, when the person comes into contact withdengue virus, these antibodies together with other components of the immune system will be able to kill the virus and help protect against the disease.

What benefits of Dengvaxia have been shown in studies?

Three studies were carried out in Asia and Latin America involving over 35,000 children aged 2 to 16 years. The studies included both children who had and had not been infected with dengue virus in the past. Children were given either three injections of Dengvaxia or three injections of placebo (a dummy vaccine) with six months between each injection. Cases of dengue disease were recorded for one year, starting from four weeks after the last injection.Overall, among children aged between 6 and 16 years and who had had previous dengue infection, there were close to 80% fewer cases of dengue disease in children vaccinated with three doses of Dengvaxia compared with those given placebo. This means that the vaccine had an efficacy of close to 80% in children who had dengue in the past. However, among children who had not had previous dengue infection, the risk of severe dengue disease if they later became infected with the virus was higher in those vaccinated than in those given placebo.Additional studies suggest that the vaccine is also effective in people aged 16 to 45 years.Available data are not sufficient to confirm how well the vaccine works and whether it is sufficiently safe in children younger than 6 years of age and previously infected by dengue virus.

What are the risks associated with Dengvaxia?

The most common side effects with Dengvaxia (which may affect more than 1 in 10 people) are headache, redness and pain at the injection site, feeling generally unwell, muscle pain, weakness and fever. Allergic reactions, which may be severe, are a very rare side effect of Dengvaxia.Dengvaxia must not be given to people with weakened immune systems, including people whose immune system has been weakened by HIV infection or medicines such as cancer medicines or high doses of corticosteroids. Dengvaxia must also not be given to women who are pregnant or breastfeeding.For the full list of side effects and restrictions with Dengvaxia, see the package leaflet.

Why is Dengvaxia authorised in the EU?

Dengvaxia is effective at reducing the number of cases of dengue disease in people aged between 6 and 45 years who have had the infection in the past. However, people who have not had dengue infection in the past may have a higher risk of severe dengue disease if they become infected with the virus after vaccination with Dengvaxia. Therefore, the vaccine should only be given to people who have had a previous dengue infection, as confirmed by laboratory testing.There is no other vaccine for dengue disease and neither is there a specific treatment. Dengvaxia's side effects are usually mild or moderate and do not last longer than three days.The European Medicines Agency therefore decided that Dengvaxia's benefits are greater than its risks and it can be authorised for use in the EU in areas where dengue disease is endemic.

What measures are being taken to ensure the safe and effective use of Dengvaxia?

The company that markets Dengvaxia will provide educational material for healthcare professionals with information on the use of Dengvaxia including the need to test for previous dengue infection and how to detect early dengue disease.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dengvaxia have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dengvaxia are continuously monitored. Side effects reported with Dengvaxia are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Descovy


What is Descovy and what is it used for?

Descovy is an antiviral medicine used in combination with other medicines to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults and adolescents aged over 12 years and who weigh at least 35 kg.Descovy contains the active substances emtricitabine and tenofovir alafenamide.

How is Descovy used?

Descovy can only be obtained with a prescription and treatment should be started by a doctor experienced in managing HIV infection.Descovy is available as tablets, each containing 200 mg of emtricitabine and either 10 or 25 mg of tenofovir alafenamide. The recommended dose is one tablet per day, and the strength of Descovy tablet chosen by the doctor depends on which other medicines it is given with. For further information, see the summary of product characteristics (also part of the EPAR).

How does Descovy work?

Tenofovir alafenamide is a 'prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors. They block the activity of reverse transcriptase, an enzyme made by the virus that allows it to reproduce itself in the cells it has infected. By blocking reverse transcriptase, Descovy reduces the amount of HIV in the blood and keeps it at a low level. It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

What benefits of Descovy have been shown in studies?

The active substances in Descovy (emtricitabine and tenofovir alafenamide) are already approved to treat HIV infection together with two other active substances (elvitegravir and cobicistat) as part of the combination medicine Genvoya. The company therefore presented data from the studies previously used to approve Genvoya, including 2 studies in 1,733 previously untreated adults, where around 90% of patients responded to treatment, and another study showing benefit was maintained when patients treated with other effective combinations were switched to Genvoya.The company also provided data from supporting studies including studies looking at the way Descovy was absorbed in the body. These studies showed that Descovy produces comparable levels of emtricitabine and tenofovir alafenamide in the body to Genvoya.

What are the risks associated with Descovy?

The most common side effect with Descovy (which may affect 1 in 10 people) is nausea (feeling sick). Other common side effects include diarrhoea and headache. For the full list of all side effects and restrictions with Descovy, see the package leaflet.

Why is Descovy approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Descovy's benefits are greater than its risks and recommended that it be approved for use in the EU. Descovy contains tenofovir alafenamide which is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects. Similarly to Genvoya, Descovy offers an alternative option to giving emtricitabine with tenofovir disoproxil

What measures are being taken to ensure the safe and effective use of Descovy?

A risk management plan has been developed to ensure that Descovy is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Descovy, including the appropriate precautions to be followed by healthcare professionals and patients.


Summarize this document



Read the original document in your language

Desloratadine Actavis


What is Desloratadine Actavis?

Desloratadine Actavis is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).Desloratadine Actavis is a 'generic medicine'. This means that Desloratadine Actavis is similar to a 'reference medicine' already authorised in the European Union (EU) called Aerius. For more information on generic medicines, see the question-and-answer document here.

What is Desloratadine Actavis used for?

Desloratadine Actavis is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).The medicine can only be obtained with a prescription.

How is Desloratadine Actavis used?

The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.

How does Desloratadine Actavis work?

The active substance in Desloratadine Actavis, desloratadine, is an antihistamine. It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normallyattaches itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

How has Desloratadine Actavis been studied?

Because Desloratadine Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Desloratadine Actavis?

Because Desloratadine Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Desloratadine Actavis been approved?

The CHMP concluded that, in accordance with EU requirements, Desloratadine Actavis has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the CHMP's view was that, as for Aerius, the benefit outweighs the identified risk. The Committee recommended that Desloratadine Actavis be given marketing authorisation.


Summarize this document



Read the original document in your language

Desloratadine Ratiopharm


What is Desloratadine ratiopharm and what it is used for?

Desloratadine ratiopharm is a medicine used in adults to relieve the symptoms of the following conditions:• allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example hay fever or allergy to dust mites).• chronic idiopathic urticaria (a recurrent skin condition with symptoms including itching and hives) as diagnosed by a doctor. 'Idiopathic' means that the cause of the disease is unknown.Desloratadine ratiopharm contains the active substance desloratadine and is a 'generic medicine'. This means that Desloratadine ratiopharm contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Aerius. For more information on generic medicines, see the question-and-answer document here.

How is Desloratadine ratiopharm used?

Desloratadine ratiopharm can be obtained without a prescription. The medicine is available as tablets.The recommended dose is one tablet once a day. The duration of treatment depends on the condition being treated.If symptoms persist for more than 7 days or worsen, patients should seek medical advice. For more information about using Desloratadine ratiopharm, see the package leaflet or contact your doctor or pharmacist.

How does Desloratadine ratiopharm work?

The active substance in Desloratadine ratiopharm, desloratadine, is an antihistamine. It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

How has Desloratadine ratiopharm been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Aerius, and do not need to be repeated for Desloratadine ratiopharm.As for every medicine, the company provided studies on the quality of Desloratadine ratiopharm.The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Desloratadine ratiopharm?

Because Desloratadine ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Desloratadine ratiopharm authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Desloratadine ratiopharm has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the Agency's view was that, as for Aerius, the benefits of Desloratadine ratiopharm outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Desloratadine ratiopharm?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Desloratadine ratiopharm have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Desloratadine ratiopharm are continuously monitored. Side effects reported with Desloratadine ratiopharm are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Desloratadine Teva


What is Desloratadine Teva?

Desloratadine Teva is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).Desloratadine Teva is a 'generic medicine'. This means that Desloratadine Teva is similar to a'reference medicine' already authorised in the European Union (EU) called Aerius. For more information on generic medicines, see the question-and-answer document here.

What is Desloratadine Teva used for?

Desloratadine Teva is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).The medicine can only be obtained with a prescription.

How is Desloratadine Teva used?

The recommended dose for adults and adolescents (12 years of age and over) is one tablet once a day.

How does Desloratadine Teva work?

The active substance in Desloratadine Teva, desloratadine, is an antihistamine. It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

How has Desloratadine Teva been studied?

Because Desloratadine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Desloratadine Teva?

Because Desloratadine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Desloratadine Teva been approved?

The CHMP concluded that, in accordance with EU requirements, Desloratadine Teva has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the CHMP's view was that, as for Aerius, the benefit outweighs the identified risk. The Committee recommended that Desloratadine Teva be given marketing authorisation.


Summarize this document



Read the original document in your language

Dexdor


What is Dexdor and what is it used for?

Dexdor is a medicine used to sedate (calm or make sleepy) adult patients in the following settings:• in hospital intensive care units to bring about a light level of sedation in which the patient can still respond to verbal stimulation (corresponding to a score of between 0 and -3 on the Richmond Agitation-Sedation Scale);• before or during diagnostic or surgical procedures where the patient remains awake (awake sedation).Dexdor contains the active substance dexmedetomidine.

How is Dexdor used?

Dexdor can only be obtained with a prescription and should be given by a healthcare professional skilled in managing patients in intensive care or giving anaesthetic during diagnostic or surgical procedures.Dexdor is given by infusion (drip) into a vein using a controlled infusion device.When Dexdor is used in intensive care, the dose is adjusted to achieve the desired level of sedation. If sedation with the maximum dose is not adequate, the patient can be switched to other medicines.When Dexdor is used for awake sedation in diagnostic or surgical procedures, the starting dose depends on the type of procedure and the dose is adjusted to achieve the desired effect. In some cases, the patient is also given a local anaesthetic, painkillers and other sedative medicines. The patient's blood pressure, heart rate, breathing and oxygen levels should be monitored closely during the procedure.Care should be taken when using Dexdor in patients with reduced liver function and the dose may be reduced.For more information about using Dexdor, see the package leaflet or contact your doctor or pharmacist.

How does Dexdor work?

The active substance in Dexdor, dexmedetomidine, is a selective alpha-2 receptor agonist. It works by blocking receptors in the brain called alpha-2 receptors and reduces the activity of the sympathetic nervous system which is involved in controlling anxiety, arousal and sleep as well as blood pressure and heart rate. By reducing the activity of the sympathetic nervous system, dexmedetomidine helps to make patients calm or sleepy.

What benefits of Dexdor have been shown in studies?

Sedation in intensive careDexdor was compared with other sedative medicines (propofol or midazolam) in two main studies involving 1,000 patients who required sedation in intensive care units. The main measures of effectiveness were how well the medicines maintained the required sedation level and the time patients needed to spend on a mechanical ventilator (a machine that 'breathes' for the patient).In the first study, 65% of patients given Dexdor maintained the required level of sedation compared with 65% of those receiving propofol. In the second study, 61% of patients given Dexdor maintained the required level of sedation compared with 57% of those receiving midazolam. The studies also showed that Dexdor reduced the duration of mechanical ventilation.Awake sedation during diagnostic or surgical proceduresDexdor was compared with placebo (a dummy treatment) in two main studies involving 431 patients. A higher proportion of patients treated with Dexdor did not require additional treatment with midazolam (another sedative medicine) to maintain the desired sedation level.The first study involved patients undergoing surgery or a procedure under an anaesthetic block (where sensation to a part of the body is blocked). Patients in the Dexdor group received either 0.5 or 1 microgram/kg bodyweight. Midazolam treatment was not required in 40% of patients receiving the lower dose of Dexdor and 54% of those receiving the higher dose compared with 3% of patients receiving placebo.The second study involved patients undergoing a fibreoptic intubation (inserting a breathing tube through the nose or the mouth into the windpipe) while patients are awake. Midazolam treatment was not required in 53% of patients receiving Dexdor compared with 14% receiving placebo.

What are the risks associated with Dexdor?

The most common side effects with Dexdor (which may affect more than 1 in 10 people) when it is used in intensive care are low or high blood pressure and bradycardia (slow heart rate). The most common side effects when it is used for awake sedation are low blood pressure, respiratory depression (reduced ability to breathe) and bradycardia.Dexdor must not be used in patients with advanced heart block (a type of heart rhythm disorder), patients with uncontrolled low blood pressure and in patients with conditions such as stroke that affect the blood supply to the brain.For the full list of side effects and restrictions with Dexdor, see the package leaflet.

Why is Dexdor authorised in the EU?

The studies in intensive care showed that Dexdor compared well with other sedatives. It is effective for awake sedation during procedures but sometimes an additional sedative medicine as well as Dexdor may be needed. Dexdor is an additional alternative medicine for achieving lighter levels of sedation in suitable patients. As dexmedetomidine has been in use in several countries as a sedative agent, its risks are well known and are considered to be manageable. The European Medicines Agency therefore decided that Dexdor's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dexdor?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dexdor have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dexdor is continuously monitored. Side effects reported with Dexdor are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dexmedetomidine Accord


What is Dexmedetomidine Accord and what is it used for?

Dexmedetomidine Accord is a medicine used to sedate (calm or make sleepy) adults in the following settings:• in hospital intensive care units to bring about a light level of sedation in which the patient can still respond to verbal stimulation (corresponding to a score of between 0 and -3 on the Richmond Agitation-Sedation Scale);• before or during diagnostic or surgical procedures where the patient remains awake (awake sedation).Dexmedetomidine Accord contains the active substance dexmedetomidine.Dexmedetomidine Accord is a 'generic medicine'. This means that Dexmedetomidine Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Dexdor. For more information on generic medicines, see the question-and-answer document here.

How is Dexmedetomidine Accord used?

Dexmedetomidine Accord can only be obtained with a prescription and should be given by a healthcare professional skilled in managing patients in intensive care or giving anaesthetic during diagnostic or surgical procedures.Dexmedetomidine Accord is given by infusion (drip) into a vein using a controlled infusion device.When Dexmedetomidine Accord is used in intensive care, the dose is adjusted to achieve the desired level of sedation. If sedation with the maximum dose is not adequate, the patient should be switched to other medicines.When Dexmedetomidine Accord is used for awake sedation in diagnostic or surgical procedures, the starting dose depends on the type of procedure and the dose is adjusted to achieve the desired effect.In some cases, the patient is also given a local anaesthetic, painkillers and other sedative medicines. The patient's blood pressure, heart rate, breathing and oxygen levels should be monitored closely during the procedure.SendCare should be taken when using Dexmedetomidine Accord in patients with reduced liver function and the dose may be reduced.For more information about using Dexmedetomidine Accord, see the package leaflet or contact your doctor or pharmacist.

How does Dexmedetomidine Accord work?

The active substance in Dexmedetomidine Accord, dexmedetomidine, is a selective alpha-2 receptor agonist. It works by acting on receptors (targets) in the brain called alpha-2 receptors and reducing the activity of the sympathetic nervous system which is involved in controlling anxiety, arousal and sleep as well as blood pressure and heart rate. By reducing the activity of the sympathetic nervous system, dexmedetomidine helps to make patients calm or sleepy.

How has Dexmedetomidine Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Dexdor, and do not need to be repeated for Dexmedetomidine Accord.As for every medicine, the company provided studies on the quality of Dexmedetomidine Accord. There was no need for 'bioequivalence' studies to investigate whether Dexmedetomidine Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Dexmedetomidine Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Dexmedetomidine Accord?

Because Dexmedetomidine Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Dexmedetomidine Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements,Dexmedetomidine Accord has been shown to be comparable to Dexdor. Therefore, the Agency's view was that, as for Dexdor, the benefits of Dexmedetomidine Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dexmedetomidine Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dexmedetomidine Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dexmedetomidine Accord are continuously monitored. Side effects reported with Dexmedetomidine Accord are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Diacomit


What is Diacomit?

Diacomit is an anti-epileptic medicine that contains the active substance stiripentol. It is available as capsules and sachets (250 and 500 mg). The sachets contain a powder that is used to make up an oral suspension (a liquid with solid particles in it).

What is Diacomit used for?

Diacomit is used in children with a very rare type of epilepsy called 'severe myoclonic epilepsy in infancy' (SMEI), also known as Dravet's syndrome. This type of epilepsy first appears in young children during the first year of life. Diacomit is used as an add-on to clobazam and valproate (other anti-epileptic medicines) to treat generalised tonic-clonic seizures (major fits, including loss of consciousness) when these are not adequately controlled with clobazam and valproate.Because the number of patients with SMEI is low, the disease is considered 'rare', and Diacomit was designated as an 'orphan medicine' (a medicine used in rare diseases) on 5 December 2001.The medicine can only be obtained with a prescription.

How is Diacomit used?

Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in children (a paediatrician or paediatric neurologist). The recommended dose is 50 mg per kilogram bodyweight, divided into two or three doses during the day.Treatment starts with a dose of 20 mg per kg bodyweight, which is gradually increased to the recommended dose over a number of weeks depending on the patient's age. After starting Diacomit, the dose of clobazam may need to be reduced. The dose of valproate does not normally need to be adjusted.The main studies of Diacomit were in children over three years of age. Decisions regarding the use of Diacomit in younger children should be made on a patient-by-patient basis: it can only be given to younger children if the diagnosis of SMEI has been confirmed.Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).

How does Diacomit work?

The exact way in which stiripentol, the active substance in Diacomit, acts as an anti-epileptic medicine is not fully known. It has been shown in experimental models to increase the levels of a'neurotransmitter' called gamma aminobutyric acid (GABA) in the brain. GABA is the main substance in nerve cells responsible for reducing the electrical activity of the brain. It is also known to amplify the effects of other anti-epileptic medicines and to slow down the rate at which they are broken down by the liver.

How has Diacomit been studied?

Diacomit has been studied in two main studies involving 65 children between three and 18 years of age. The studies compared Diacomit capsules or sachets with placebo (a dummy treatment), when they were added to the children's existing treatment with clobazam and valproate. The main measure of effectiveness was the number of patients who 'responded' to treatment. A patient was classified as a 'responder' if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.

What benefit has Diacomit shown during the studies?

More patients responded to treatment with Diacomit than to placebo. In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20). Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).

What is the risk associated with Diacomit?

The most common side effects with Diacomit (seen in more than 1 in 10 patients) are loss of appetite, weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co-ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders). For the full list of all side effects reported with Diacomit, see the package leaflet.Diacomit must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations). Care must be taken when Diacomit is used at the same time as other medicines. See the package leaflet for the full list of restrictions.

Why has Diacomit been approved?

The CHMP concluded that Diacomit had shown its effectiveness in SMEI, albeit studies were limited and did not last as long as the Committee expected. It decided that Diacomit's benefits are greater than its risks and recommended that it be given marketing authorisation.Diacomit was originally given 'conditional approval' because there was more evidence to come about the medicine, in particular regarding its short-term and long-term effectiveness and safety. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.


Summarize this document



Read the original document in your language

Dificlir


What is Dificlir and what is it used for?

Dificlir is a medicine used to treat children and adults with infections of the gut caused by bacteria called Clostridioides difficile.Dificlir contains the active substance fidaxomicin.

How is Dificlir used?

Dificlir is available as tablets (200 mg) or granules for oral suspension (40 mg/ml) and can only be obtained with a prescription.In adults and children weighing at least 12.5 kg, the recommended dose is 200 mg twice a day (every 12 hours) for 10 days. For children weighing less than 12.5 kg, the dose depends on the bodyweight.For more information about using Dificlir, see the package leaflet or contact your doctor or pharmacist.

How does Dificlir work?

C. difficile are bacteria that are present naturally in the gut and do not cause any problems in healthy people. This is because they are kept under control by other 'good' bacteria which are beneficial to the body and enhance health. However, some antibiotics that are used to treat infections can interfere with the balance and kill the 'good' bacteria in the gut. When this happens, C. difficile bacteria can multiply and produce toxins (poisons) which cause illness such as diarrhoea and fever. At this point, a person is said to be infected with C. difficile.The active substance in Dificlir, fidaxomicin, is an antibiotic that belongs to the class of macrocylic antibiotics. When it is swallowed most of the active substance does not get absorbed into the blood stream but acts locally on C. difficile bacteria in the gut. It works by blocking the bacterial enzyme RNA polymerase, which is used to produce the genetic material that the bacteria need to make proteins. This stops the C. difficile bacteria from growing and multiplying, thereby reducing the symptoms of the disease.

What benefits of Dificlir have been shown in studies?

Dificlir was at least as effective as vancomycin (another antibiotic for C. difficile infections) in three main studies in patients with mild to moderately severe C. difficile infection. The results of two studies involving a total of 1,147 adults showed that 92% of patients taking Dificlir were cured after 10 days compared with 90% of patients taking vancomycin.In the third study, which involved 148 patients aged from birth to 18 years, 78% of patients taking Dificlir were cured 2 days after the end of treatment, compared with 71% of patients taking vancomycin.

What are the risks associated with Dificlir?

The most common side effects with Dificlir (which may affect up to 1 in 10 people) are nausea (feeling sick), vomiting and constipation. For the full list of side effects and restrictions with Dificlir, see the package leaflet.

Why is Dificlir authorised in the EU?

Dificlir is effective at curing C. difficile infections and is generally well tolerated. Its side effects are similar to those of vancomycin by mouth. The European Medicines Agency therefore decided that the benefits of Dificlir are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dificlir?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dificlir have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dificlir are continuously monitored. Side effects reported with Dificlir are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dimethyl Fumarate Accord


What is Dimethyl fumarate Accord and what is it used for?

Dimethyl fumarate Accord is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. It is used in adults and adolescents from 13 years of age with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).Dimethyl fumarate Accord is a 'generic medicine'. This means that Dimethyl fumarate Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU. The reference medicine for Dimethyl fumarate Accord is Tecfidera. For more information on generic medicines, see the question-and-answer document here.Dimethyl fumarate Accord contains the active substance dimethyl fumarate.

How is Dimethyl fumarate Accord used?

Dimethyl fumarate Accord can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.Dimethyl fumarate Accord is available as capsules to be taken by mouth with food. The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day. The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal (stomach and gut) problems.For more information about using Dimethyl fumarate Accord, see the package leaflet or contact your doctor or pharmacist.

How does Dimethyl fumarate Accord work?

In multiple sclerosis, the immune system (the body's natural defences) attacks and damages the protective insulation around the nerves and the nerves themselves in the brain and spinal cord. The active substance in this medicine, dimethyl fumarate, is thought to work by activating a protein called'Nrf2' that regulates certain genes that produce 'antioxidants' involved in protecting cells from damage.SendDimethyl fumarate has been shown to reduce inflammation and modulate the activity of the immune system.

How has Dimethyl fumarate Accord been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Tecfidera, and do not need to be repeated for Dimethyl fumarate Accord.As for every medicine, the company provided studies on the quality of Dimethyl fumarate Accord. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Dimethyl fumarate Accord?

Because Dimethyl fumarate Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Dimethyl fumarate Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Dimethyl fumarate Accord has been shown to have comparable quality and to be bioequivalent to Tecfidera. Therefore, the Agency's view was that, as for Tecfidera, the benefits of Dimethyl fumarate Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dimethyl fumarate Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dimethyl fumarate Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dimethyl fumarate Accord are continuously monitored. Suspected side effects reported with Dimethyl fumarate Accord are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dimethyl Fumarate Mylan


What is Dimethyl fumarate Mylan and what is it used for?

Dimethyl fumarate Mylan is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. It is used in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).Dimethyl fumarate Mylan contains the active substance dimethyl fumarate and is a 'generic medicine'. This means that Dimethyl fumarate Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Tecfidera. For more information on generic medicines, see the question-and-answer document here.

How is Dimethyl fumarate Mylan used?

Dimethyl fumarate Mylan can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.Dimethyl fumarate Mylan is available as capsules to be taken by mouth with food. The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day. The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal (stomach and gut) problems.For more information about using Dimethyl fumarate Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Dimethyl fumarate Mylan work?

In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and the optic nerve of the eye), causing inflammation that damages the nerves and the insulation around them. The active substance, dimethyl fumarate, is thought to work by activating a protein called 'Nrf2' that regulates certain genes that produce 'antioxidants' involved in protecting cells from damage. Dimethyl fumarate has been shown to reduce inflammation and modulate the activity of the immune system.Send

How has Dimethyl fumarate Mylan been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Tecfidera, and do not need to be repeated for Dimethyl fumarate Mylan.As for every medicine, the company provided studies on the quality of Dimethyl fumarate Mylan. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Dimethyl fumarate Mylan?

Because Dimethyl fumarate Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Dimethyl fumarate Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Dimethyl fumarate Mylan has been shown to have comparable quality and to be bioequivalent to Tecfidera. Therefore, the Agency's view was that, as for Tecfidera, the benefits of Dimethyl fumarate Mylan outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dimethyl fumarate Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dimethyl fumarate Mylan have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dimethyl fumarate Mylan are continuously monitored. Suspected side effects reported with Dimethyl fumarate Mylan are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dimethyl Fumarate Neuraxpharm


What is Dimethyl fumarate Neuraxpharm and what is it used for?

Dimethyl fumarate Neuraxpharm is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. It is used in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).Dimethyl fumarate Neuraxpharm contains the active substance dimethyl fumarate and is a 'generic medicine'. This means that Dimethyl fumarate Neuraxpharm contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Tecfidera. For more information on generic medicines, see the question-and-answer document here.

How is Dimethyl fumarate Neuraxpharm used?

Dimethyl fumarate Neuraxpharm can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.Dimethyl fumarate Neuraxpharm is available as capsules to be taken by mouth with food. The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day. The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal (stomach and gut) problems.For more information about using Dimethyl fumarate Neuraxpharm, see the package leaflet or contact your doctor or pharmacist.

How does Dimethyl fumarate Neuraxpharm work?

In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and the optic nerve of the eye), causing inflammation that damages the nerves and the insulation around them. The active substance, dimethyl fumarate, is thought to work by activating a protein called 'Nrf2' that regulates certain genes that produce 'antioxidants' involved in protecting cells from damage. Dimethyl fumarate has been shown to reduce inflammation and modulate the activity of the immune system.Send

How has Dimethyl fumarate Neuraxpharm been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Tecfidera, and do not need to be repeated for Dimethyl fumarate Neuraxpharm.As for every medicine, the company provided data on the quality of Dimethyl fumarate Neuraxpharm.The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Dimethyl fumarate Neuraxpharm?

Because Dimethyl fumarate Neuraxpharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Dimethyl fumarate Neuraxpharm authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Dimethyl fumarate Neuraxpharm has been shown to have comparable quality and to be bioequivalent to Tecfidera. Therefore, the Agency's view was that, as for Tecfidera, the benefits of Dimethyl fumarate Neuraxpharm outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dimethyl fumarate Neuraxpharm?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dimethyl fumarate Neuraxpharm have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dimethyl fumarate Neuraxpharm are continuously monitored. Suspected side effects reported with Dimethyl fumarate Neuraxpharm are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dimethyl Fumarate Polpharma


What is Dimethyl fumarate Polpharma and what is it used for?

Dimethyl fumarate Polpharma is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. It is used in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).Dimethyl fumarate Polpharma contains the active substance dimethyl fumarate and is a 'generic medicine'. This means that Dimethyl fumarate Polpharma contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Tecfidera. For more information on generic medicines, see the question-and-answer document here.

How is Dimethyl fumarate Polpharma used?

Dimethyl fumarate Polpharma can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.Dimethyl fumarate Polpharma is available as capsules to be taken by mouth with food. The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day. The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal (stomach and gut) problems.For more information about using Dimethyl fumarate Polpharma, see the package leaflet or contact your doctor or pharmacist.

How does Dimethyl fumarate Polpharma work?

In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and the optic nerve of the eye), causing inflammation that damages the nerves and the insulation around them. The active substance, dimethyl fumarate, is thought to work by activating a protein called 'Nrf2' that regulates certain genes that produce 'antioxidants' involved in protecting cells from damage. Dimethyl fumarate has been shown to reduce inflammation and modulate the activity of the immune system.Send

How has Dimethyl fumarate Polpharma been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Tecfidera, and do not need to be repeated for Dimethyl fumarate Polpharma.As for every medicine, the company provided data on the quality of Dimethyl fumarate Polpharma. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Dimethyl fumarate Polpharma?

Because Dimethyl fumarate Polpharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Dimethyl fumarate Polpharma authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Dimethyl fumarate Polpharma has been shown to have comparable quality and to be bioequivalent to Tecfidera. Therefore, the Agency's view was that, as for Tecfidera, the benefits of Dimethyl fumarate Polpharma outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dimethyl fumarate Polpharma?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dimethyl fumarate Polpharma have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dimethyl fumarate Polpharma are continuously monitored. Suspected side effects reported with Dimethyl fumarate Polpharma are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dimethyl Fumarate Teva


What is Dimethyl fumarate Teva and what is it used for?

Dimethyl fumarate Teva is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. It is used in adults and children from 13 years of age with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).Dimethyl fumarate Teva is a 'generic medicine'. This means that Dimethyl fumarate Teva contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Tecfidera. For more information on generic medicines, see the question-and-answer document here.Dimethyl fumarate Teva contains the active substance dimethyl fumarate.

How is Dimethyl fumarate Teva used?

Dimethyl fumarate Teva can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.Dimethyl fumarate Teva is available as capsules to be taken by mouth with food. The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day. The dose may be reduced temporarily in patients experiencing flushing and gastrointestinal (stomach and gut) problems as side effects.For more information about using Dimethyl fumarate Teva, see the package leaflet or contact your doctor or pharmacist.

How does Dimethyl fumarate Teva work?

In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and the optic nerve of the eye), causing inflammation that damages the nerves and the insulation around them. The active substance in this medicine, dimethyl fumarate, is thought to work by activating a protein called 'Nrf2'. This protein regulates certain genesSendproducing 'antioxidants' that help protect cells from damage. Dimethyl fumarate has been shown to reduce inflammation and modulate the activity of the immune system.

How has Dimethyl fumarate Teva been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Tecfidera, and do not need to be repeated for Dimethyl fumarate Teva.As for every medicine, the company provided studies on the quality of Dimethyl fumarate Teva. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Dimethyl fumarate Teva?

Because Dimethyl fumarate Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Dimethyl fumarate Teva authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Dimethyl fumarate Teva has been shown to have comparable quality and to be bioequivalent to the reference medicine. Therefore, the Agency's view was that, as for Tecfidera, the benefits of Dimethyl fumarate Teva outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dimethyl fumarate Teva?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dimethyl fumarate Teva have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dimethyl fumarate Teva are continuously monitored. Suspected side effects reported with Dimethyl fumarate Teva are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Docetaxel Accord


What is Docetaxel Accord and what is it used for?

Docetaxel Accord is a cancer medicine used to treat the following types of cancer:• breast cancer. Docetaxel Accord can be used on its own after other treatments have failed. It can also be used with other cancer medicines (capecitabine, cyclophosphamide, doxorubicin or trastuzumab) in patients who have not yet received treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;• non-small-cell lung cancer. Docetaxel Accord can be used on its own after other treatments have failed. It can also be used with cisplatin (another cancer medicine) in patients who have not yet received any treatment for their cancer;• prostate cancer that has spread to other parts of the body (metastatic). Docetaxel Accord is used with androgen-deprivation therapy (therapy greatly reducing the body's production of testosterone) when such treatment still works. Docetaxel Accord is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer is castration resistant (androgendeprivation therapy does not work);• metastatic gastric adenocarcinoma (a stomach cancer) in patients who have not yet received any treatment for metastatic cancer. Docetaxel Accord is used with cisplatin and fluorouracil (other cancer medicines);• head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Docetaxel Accord is used with cisplatin and fluorouracil.Docetaxel Accord is a 'generic medicine'. This means that Docetaxel Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Taxotere. For more information on generic medicines, see the question-and-answer document here.Docetaxel Accord contains the active substance docetaxel.An agency of the European

How is Docetaxel Accord used?

Docetaxel Accord can only be obtained with a prescription and should only be used in units specialising in giving chemotherapy (medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.Docetaxel Accord is given as a 1-hour infusion (drip) into a vein every 3 weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated and the patient's weight and height. An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Accord infusion. The dose of Docetaxel Accord may need to be reduced, or treatment interrupted or discontinued, if the patient develops certain side effects.For more information about using Docetaxel Accord, see the package leaflet or contact your doctor or pharmacist.

How does Docetaxel Accord work?

The active substance in Docetaxel Accord, docetaxel, belongs to the group of cancer medicines known as taxanes. Docetaxel blocks the ability of cells to break down the internal 'skeleton' that allows them to divide. With the skeleton still in place, the cells cannot divide and they eventually die. Because docetaxel works on dividing cells, it also affects non-cancer cells such as blood cells, which can cause side effects.

How has Docetaxel Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Taxotere, and do not need to be repeated for Docetaxel Accord.As for every medicine, the company provided studies on the quality of Docetaxel Accord. There was no need for 'bioequivalence' studies to investigate whether Docetaxel Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Docetaxel Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Docetaxel Accord?

Because Docetaxel Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Docetaxel Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Docetaxel Accord has been shown to be comparable to Taxotere. Therefore, the Agency's view was that, as for Taxotere, the benefits of Docetaxel Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Docetaxel Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Docetaxel Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Docetaxel Accord are continuously monitored. Side effects reported with Docetaxel Accord are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Docetaxel Kabi


What is Docetaxel Kabi and what is it used for?

Docetaxel Kabi is a cancer medicine used to treat the following types of cancer:• breast cancer. Docetaxel Kabi can be used on its own after other treatments have failed. It can also be used with other cancer medicines (capecitabine, cyclophosphamide, doxorubicin or trastuzumab) in patients who have not yet received treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;• non-small-cell lung cancer. Docetaxel Kabi can be used on its own after other treatments have failed. It can also be used with cisplatin (another cancer medicine) in patients who have not yet received any treatment for their cancer;• prostate cancer that has spread to other parts of the body (metastatic). Docetaxel Kabi is used with androgen-deprivation therapy (therapy greatly reducing the body's production of testosterone) when such treatment still works. Docetaxel Kabi is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer is castration resistant (androgendeprivation therapy does not work);• metastatic gastric adenocarcinoma (a stomach cancer) in patients who have not yet received any treatment for metastatic cancer. Docetaxel Kabi is used with cisplatin and fluorouracil (other cancer medicines);• head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Docetaxel Kabi is used with cisplatin and fluorouracil.Docetaxel Kabi is a 'generic medicine'. This means that Docetaxel Kabi is similar to a 'reference medicine' already authorised in the European Union (EU) called Taxotere. For more information on generic medicines, see the question-and-answer document here.Docetaxel Kabi contains the active substance docetaxel.

How is Docetaxel Kabi used?

Docetaxel Kabi can only be obtained with a prescription and should only be used in units specialising in giving chemotherapy (medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.An agency of the EuropeanDocetaxel Kabi is given as a 1-hour infusion every 3 weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated and the patient's weight and height. An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Kabi infusion. The dose of Docetaxel Kabi may need to be reduced, or treatment interrupted or discontinued, if the patient develops certain side effects.For more information about using Docetaxel Kabi, see the package leaflet or contact your doctor or pharmacist.

How does Docetaxel Kabi work?

The active substance in Docetaxel Kabi, docetaxel, belongs to the group of cancer medicines known as taxanes. Docetaxel blocks the ability of cells to break down the internal 'skeleton' that allows them to divide. With the skeleton still in place, the cells cannot divide and they eventually die. Because docetaxel works on dividing cells, it affects non-cancer cells such as blood cells, which can cause side effects.

How has Docetaxel Kabi been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Taxotere, and do not need to be repeated for Docetaxel Kabi.As for every medicine, the company provided studies on the quality of Docetaxel Kabi. There was no need for 'bioequivalence' studies to investigate whether Docetaxel Kabi is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Docetaxel Kabi is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Docetaxel Kabi?

Because Docetaxel Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Docetaxel Kabi authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Docetaxel Kabi has been shown to be comparable to Taxotere. Therefore, the Agency's view was that, as for Taxotere, the benefits of Docetaxel Kabi outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Docetaxel Kabi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Docetaxel Kabi have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Docetaxel Kabi are continuously monitored. Side effects reported with Docetaxel Kabi are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Doptelet


What is Doptelet and what is it used for?

Doptelet is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to long-standing liver disease. Patients with thrombocytopenia have reduced number of platelets (components in the blood that help it to clot), which can cause excessive bleeding.The medicine is for use in patients having an invasive procedure (a medical procedure that involves cutting into or puncturing the skin or inserting instruments into the body).Doptelet contains the active substance avatrombopag.

How is Doptelet used?

Doptelet can only be obtained with a prescription. It is available as 20-mg tablets.Treatment with Doptelet should start at least 10 days before the procedure. The dose is 2 or 3 tablets (depending on the platelet count at the start of treatment), daily for 5 days. A blood test on the day of the procedure is necessary to ensure that the platelet count is adequate and not unexpectedly high.For more information about using Doptelet, see the package leaflet or contact your doctor or pharmacist.

How does Doptelet work?

In the body, a hormone called thrombopoietin stimulates the production of platelets by attaching to receptors (targets) in the bone marrow. The active substance in Doptelet, avatrombopag, attaches to the same receptors as thrombopoietin, helping to increase the platelet count.

What benefits of Doptelet have been shown in studies?

Two main studies in 435 patients with low levels of platelets due to long-standing liver disease found Doptelet effective at increasing platelet levels before an invasive procedure. The main measure of effectiveness was the number of patients who did not require a transfusion of platelets or other treatment ('rescue procedure') to prevent excessive bleeding after starting Doptelet treatment and for up to 7 days after their invasive procedure.In these studies, 88% of patients who received Doptelet 40 mg daily did not require a transfusion or rescue procedure compared with 36% of patients who were given placebo (a dummy treatment). Among patients with more severe thrombocytopenia, 67% of those given Doptelet 60 mg daily did not require a transfusion or rescue procedure compared with 29% of those who received placebo.

What are the risks associated with Doptelet?

The most common side effect with Doptelet (which may affect up to 1 in 10 people) is tiredness. For the full list of side effects and restrictions with Doptelet, see the package leaflet.

Why is Doptelet authorised in the EU?

Studies have found that Doptelet reduced the need for platelet transfusions or other rescue treatments to prevent excessive bleeding before an invasive procedure and for up to 7 days afterward. The platelet count increased in patients treated with Doptelet. Any unwanted effects during treatment with Doptelet were thought to result from patients' medical condition and the nature of the invasive procedure for which it was used.The European Medicines Agency decided that Doptelet's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Doptelet?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Doptelet have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Doptelet are continuously monitored. Side effects reported with Doptelet are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dovato


What is Dovato and what is it used for?

Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used to treat adults and adolescents over 12 years old who weigh at least 40 kg.This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.

How is Dovato used?

Dovato can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine. The recommended dose is one tablet once a day. For more information about using Dovato, see the package leaflet or contact your doctor or pharmacist.

How does Dovato work?

The two active substances in Dovato, dolutegravir and lamivudine, block the activity of enzymes that the virus uses to make new copies of itself in the body. Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of another enzyme called reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).Both active substances have already been authorised in the EU as separate tablets: dolutegravir in 2014 and lamivudine in 1996.Dovato does not cure HIV infection, but it reduces the amount of virus in the body and keeps it at a low level. This holds off damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Dovato have been shown in studies?

Two main studies, involving 1,441 patients, have shown that the combination of the two active substances in Dovato is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).In these studies, 91% of patients with HIV-1 who took the Dovato combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 weeks compared with 93% of those who were taking the triple combination. In both studies there were no cases of resistance to treatment after 48 weeks.

What are the risks associated with Dovato?

The most common side effects with Dovato (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea (feeling sick) and difficulty sleeping. The most common serious side effects (which may affect up to 1 in 100 people) are allergic reactions, including rash and severe liver problems.Dovato must not be used together with certain medicines such as fampridine (a multiple sclerosis medicine, also called dalfampridine), as this may increase the level of such medicines in the body, resulting in serious side effects.For the full list of side effects and restrictions, see the package leaflet.

Why is Dovato authorised in the EU?

Triple combination therapy is used for HIV treatment to reduce the chance of the virus becoming resistant to treatment. In two main studies, the Dovato combination was just as effective as a triple combination in patients with HIV-1, with no cases of resistance developing in these patients.Furthermore, both active substances are available in a single tablet and are acceptably safe.The European Medicines Agency therefore decided that Dovato's benefits are greater than its risks and that it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dovato?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dovato have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dovato are continuously monitored. Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Drovelis


What is Drovelis and what is it used for?

Drovelis is a combined hormonal contraceptive. It contains the active substances drospirenone and estetrol monohydrate.

How is Drovelis used?

Drovelis can only be obtained with a prescription. It comes in blisters containing 28 tablets (24 'active' tablets and 4 'inactive' tablets that do not contain the active substances).Tablets are taken by mouth in sequence, starting on the first day of the menstrual cycle with the active tablets, followed by the 4 inactive tablets. Each subsequent pack is started the day after finishing the previous pack, for as long as contraception is required. For more information about using Drovelis, see the package leaflet or contact your doctor, pharmacist or prescriber.

How does Drovelis work?

Drovelis is a combined contraceptive pill that contains two active substances, drospirenone (a progestogen) and estetrol (an oestrogen). Estetrol is a synthetic version of an oestrogen that is naturally present during pregnancy, and drospirenone is a hormone with similar effects to the progesterone produced during the menstrual cycle. Both these substances change the body's hormonal balance to prevent ovulation.

What benefits of Drovelis have been shown in studies?

Drovelis was found to be effective at preventing unwanted pregnancies in 2 main studies involving a total of around 3,400 women.The main measure of effectiveness was the number of unwanted pregnancies in 100 women-years (corresponding to 100 women taking contraception for one year). This measure is known as the Pearl Index, and a lower Pearl Index represents a lower chance of getting pregnant.In a first study conducted in 1,553 women between the ages of 18 and 50, the Pearl Index was 0.44 in the group aged 18 to 35 and 0.38 in the whole group. This was considered a sufficiently low value for an oral contraceptive.In a second study, conducted in 1,864 women aged 16 to 50 years old, where more pregnancies were reported, the Pearl Index was 2.42 in women aged 16 to 35 and 2.30 in the group aged 16 to 50.

What are the risks associated with Drovelis?

The most common side effects with Drovelis (which may affect up to 1 in 10 people) are irregular bleeding between periods (metrorrhagia), headache, acne, vaginal bleeding and painful periods (dysmenorrhoea). For the full list of side effects of Drovelis, see the package leaflet.Drovelis should not be used by women with a history of blood clots in the veins or arteries, or by women with risk factors for blood clots. It should also not be used by women who have experienced severe liver and kidney problems, liver tumours, hormone-dependent cancers, or abnormal bleeding from the genital area of unknown cause. For the full list of restrictions, see the package leaflet.

Why is Drovelis authorised in the EU?

Overall, Drovelis was considered effective at preventing unwanted pregnancies. In terms of safety, the side effects of Drovelis are similar to those of other combined hormonal contraceptives and are in line with what would be expected with an oestrogen and a progestogen pill. The European Medicines Agency therefore decided that Drovelis's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Drovelis?

The company that markets Drovelis will provide a checklist for healthcare professionals and an information card for women to help manage the risk of thromboembolic events.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Drovelis have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Drovelis are continuously monitored. Side effects reported with Drovelis are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Duaklir Genuair


What is Duaklir Genuair and what is it used for?

Duaklir Genuair is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Duaklir Genuair is used for maintenance (regular) treatment.Duaklir Genuair contains two active substances: aclidinium bromide and formoterol fumarate dihydrate.

How is Duaklir Genuair used?

Duaklir Genuair is available as an inhalation powder in a portable inhaler device. The inhaler delivers 340 micrograms of aclidinium and 12 micrograms of formoterol fumarate dihydrate for each inhalation. The recommended dose of Duaklir Genuair is one inhalation twice a day. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.Duaklir Genuair can only be obtained with a prescription.

How does Duaklir Genuair work?

The two active substances in Duaklir Genuair, aclinidium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily.Aclidinium bromide is a long-acting muscarinic antagonist. This means that it widens the airways by blocking some receptors in muscle cells in the lungs called muscarinic (also known as cholinergic) receptors, which control the contraction of muscles. When aclidinium bromide is inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.Long-acting muscarinic antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD. Aclidinium bromide has been authorised in the EU as Bretaris Genuair and Eklira Genuair since July 2012; formoterol has been marketed in the EU since the 1990s.

What benefits of Duaklir Genuair have been shown in studies?

Duaklir Genuair has been studied in 2 main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment). The main measure of effectiveness was based on changes in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after six months.Results showed that, after six months of treatment, the increase in FEV1 (measured one hour after an inhalation) was 293 milliliters (ml) more with Duaklir Genuair than with placebo and 118 ml more with Duaklir Genuair than with aclidinium alone. However the improvement over formoterol alone was small and not considered clinically significant: FEV1 measured in the morning before the inhalation was 68 ml more with Duaklir Genuair than with formoterol alone. Duaklir Genuair was also shown to increase the percentage of patients who had an improvement in breathlessness compared with placebo.

What are the risks associated with Duaklir Genuair?

Side effects with Duaklir Genuair are similar to those with the individual components. The most common side effects (seen in around 7 patients in 100) are nasopharyngitis (inflammation of the nose and throat) and headache.For the full list of all side effects and restrictions with Duaklir Genuair, see the package leaflet.

Why is Duaklir Genuair approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duaklir Genuair's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that Duaklir Genuair was shown to significantly improve lung function in patients with COPD compared with placebo, although the improvement observed when Duaklir Genuair was compared with one of the components on its own, formoterol, was small.Regarding safety, the number of side effects reported with Duaklir Genuair was low and did not raise any major safety concern. In addition, the safety profile of the two components is well known, and there is no evidence that the combination is worse than the individual components.

What measures are being taken to ensure the safe and effective use of Duaklir Genuair?

A risk management plan has been developed to ensure that Duaklir Genuair is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duaklir Genuair, including the appropriate precautions to be followed by healthcare professionals and patients.In addition, as long-acting muscarinic antagonists may have an effect on the heart and blood vessels, the company that markets Duaklir Genuair will provide the results of studies to further evaluate the cardiovascular safety of the medicine.Further information can be found in the summary of the risk management plan.


Summarize this document



Read the original document in your language

Duavive


What is Duavive and what is it used for?

Duavive is a medicine used for the treatment of symptoms (such as hot flushes) caused by low blood levels of the female hormone oestrogen in women who have been through the menopause. It is used in women who still have their uterus (womb) and who cannot be treated with progestogen-containing medicines (medicines derived from the hormone called progesterone).Duavive contains two active substances: conjugated oestrogens and bazedoxifene.

How is Duavive used?

Duavive can only be obtained with a prescription. It is available as modified release tablets (containing 0.45 mg conjugated oestrogens and 20 mg bazedoxifene) which release bazedoxifene immediately and conjugated oestrogens over a longer period of time.The recommended dose of Duavive is one tablet once a day. Treatment should be for the shortest duration possible as long as benefits outweigh risks.

How does Duavive work?

One of the active substances in Duavive, conjugated oestrogens, works as hormone replacement therapy. It replaces the oestrogen hormones that are no longer produced naturally in women who have been through the menopause, thereby alleviating symptoms such as hot flushes.However, oestrogens used alone can cause hyperplasia (growth) of the endometrium (lining of the womb) which could lead to endometrial cancer. Duavive therefore also contains the active substance bazedoxifene, which blocks the effects of oestrogens on the womb and so reduces the risk of endometrial cancer.Both active substances have been available in the European Union (EU) for a number of years. Conjugated oestrogens have been available for many years as hormone replacement therapy and bazedoxifene has been authorised in 2009 for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.

What benefits of Duavive have been shown in studies?

Duavive was compared with placebo (a dummy treatment) in two main studies in 996 women who have been through the menopause, investigating the effects on either hot flushes or vulvovaginal atrophy (dryness, irritation and soreness around the genital area). An additional study also looked at the effects of Duavive on osteoporosis.In the study investigating the effects on hot flushes, treatment with Duavive (conjugated oestrogen 0.45 mg and bazedoxifene 20 mg) over 12 weeks reduced the average daily number of moderate and severe hot flushes by 7.6 compared with 4.9 for placebo. Treatment with Duavive also led to a greater average fall in the daily severity score of hot flushes than placebo treatment: 0.9 versus 0.3. Similar results were seen with a higher strength of conjugated oestrogen (0.625 mg) plus bazedoxifene 20 mg when compared with placebo.The study looking at the effects of Duavive on vulvovaginal atrophy found an improvement in some of the signs of vaginal atrophy but not in the most bothersome symptoms when compared with placebo.Because studies with the higher strength combination did not sufficiently show that this strength was more effective than the approved strength of Duavive, the company withdrew its application for the former. One of the studies also looked at the effects of Duavive on osteoporosis; however, as there was no benefit of Duavive over the individual components the company withdrew its application for Duavive in the treatment of osteoporosis.

What are the risks associated with Duavive?

The most common side effect with Duavive (which may affect more than 1 in 10 people) is abdominal pain (stomach ache).Some women must not use Duavive including those who have had problems with venous thromboembolism (blood clots in the veins) such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye), or are at an increased risk of such problems. It must not be used in women who have had a stroke or heart attack. It must also not be used in women who have, are likely to have or have had breast cancer or other cancers that are known to be oestrogen-dependent. Duavive is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.For the full list of all side effects and restrictions with Duavive, see the package leaflet.

Why is Duavive approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duavive's benefits are greater than its risks and recommended that it be approved for use in the EU. Duavive was shown to improve the symptoms caused by lack of oestrogen in postmenopausal women when compared withplacebo. Because the observed treatment effects were smaller than what is seen with alternative treatments (progestogen-containing treatments) the CHMP therefore concluded that Duavive should be reserved for women who cannot take these alternative medicines.Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies to be carried out. The CHMP also noted that long-term use of Duavive is associated with a risk of stroke and venous thromboembolism which is similar to the risk with conjugated oestrogens and bazedoxifene when used alone.

What measures are being taken to ensure the safe and effective use of Duavive?

A risk management plan has been developed to ensure that Duavive is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duavive, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.


Summarize this document



Read the original document in your language

Dukoral


What is Dukoral and what is it used for?

Dukoral is a vaccine that is given by mouth to protect people against cholera, a serious disease that causes severe diarrhoea. It is used in people aged from 2 years who will be visiting areas with high risk of cholera. Cholera is caused by the bacterium Vibrio cholerae (V. cholerae), which is caught from contaminated food or water.Dukoral should be used according to official recommendations, taking into account where cholera occurs and the risk of catching the disease.The vaccine contains 4 different inactivated strains (types) of V. cholerae serotype O1, and part of a toxin from one of these strains as active substances.

How is Dukoral used?

Dukoral can only be obtained with a prescription. It is available as a liquid mixture in a bottle together with powder in a sachet. The powder is dissolved in water to make an effervescent solution and the Dukoral liquid is added to this solution before the person drinks it. Food, drink and other medicines should be avoided for 1 hour before and 1 hour after taking the vaccine.In adults and children from 6 years of age, Dukoral is given as two doses, 1 to 6 weeks apart. Children aged between 2 and 6 years should receive three doses, with an interval of 1 to 6 weeks between each dose. The course should be completed at least 1 week before potential exposure to cholera. For continuous protection against cholera, a single booster dose is recommended within 2 years for adults and children from 6 years of age, and within 6 months for children aged between 2 and 6 years.For more information about using Dukoral, see the package leaflet or contact your doctor or pharmacist.

How does Dukoral work?

Dukoral is a vaccine. Vaccines work by preparing the immune system (the body's natural defences) to defend the body against a specific disease. Dukoral contains small amounts of inactivated (killed) bacteria that cause cholera and a fragment of the cholera toxin called the 'B subunit'. When a person is given the vaccine, the immune system recognises the killed bacteria and the toxin fragment in thevaccine as 'foreign' and makes antibodies against them. If, later on, the bacteria (from contaminated food or drink) enter the gut of a vaccinated person, the antibodies will be able to prevent the bacteria and their toxin from attaching to the walls of the gut and entering the body's cells.

What benefits of Dukoral have been shown in studies?

The company presented data from the published literature as well as results of 3 main studies, involving a total of almost 113,000 people, to support the use of Dukoral. In all 3 studies, Dukoral, given as either two or three doses, was compared with placebo (a dummy vaccine). The studies took place in areas where cholera is found. The main measure of effectiveness was the 'protective effectiveness' of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and after receiving placebo.The first study involved over 89,000 people in Bangladesh and compared Dukoral with the same vaccine without the toxin and with placebo. In this study, Dukoral was made using cholera toxin extracted from cholera bacteria in place of the newer recombinant toxin. The protective effectiveness of Dukoral was 85% over 6 months. Protection lasted for 6 months in children and 2 years in adults. In adults, 2 doses of the vaccine were as effective as 3.The other two studies compared Dukoral (containing recombinant cholera toxin) with placebo in over 22,000 people in Peru. In the first of the two studies, the protective effectiveness of Dukoral was 85% for the first 5 months. The people in the second study also received a booster dose 10 to 12 months later. The protective effectiveness of Dukoral after the booster dose was 61% during the second year of follow-up.The company also presented information on the use of Dukoral for the prevention of a severe type of traveller's diarrhoea caused by a bacterium called 'enterotoxigenic Escherichia coli'. However, the information was not sufficient to support the use of Dukoral in traveller's diarrhoea.

What are the risks associated with Dukoral?

Side effects with Dukoral are not common and those that can affect up to 1 in 100 people are headache, diarrhoea, and abdominal (belly) effects such as pain, cramps, gurgling (gas) or discomfort.Dukoral must not be used in people who are hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to formaldehyde. Its use should be postponed in patients with fever or short-lived illness affecting the stomach or gut.For the full list of side effects and restrictions of Dukoral, see the package leaflet.

Why is Dukoral authorised in the EU?

The risk of cholera for regular tourists is minor, but the European Medicines Agency considered that Dukoral could be important for certain groups, such as healthcare workers in cholera epidemics or travellers visiting areas where cholera is present. Side effects with Dukoral are uncommon and generally mild. The Agency therefore decided that Dukoral's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dukoral?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dukoral have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dukoral are continuously monitored. Side effects reported with Dukoral are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Duloxetine Lilly


What is Duloxetine Lilly and what is it used for?

Duloxetine Lilly is a medicine that is used to treat adults with the following diseases:• major depression;• pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).This medicine contains the active substance duloxetine and is the same as Cymbalta, which is already authorised in the European Union (EU). The company that makes Cymbalta has agreed that its scientific data can be used for Duloxetine Lilly ('informed consent').

How is Duloxetine Lilly used?

Duloxetine Lilly is available as gastroresistant capsules (30 mg and 60 mg). 'Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being destroyed by the acid in the stomach. The medicine can only be obtained with a prescription.For major depression, the recommended dose of Duloxetine Lilly is 60 mg once a day. A response is usually seen in two to four weeks. In patients who respond to Duloxetine Lilly, treatment shouldcontinue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day. The response to treatment should be assessed regularly.For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response. Most patients will need to take 60 mg per day. Patients who also have major depression should start with 60 mg once a day. In patients who respond to Duloxetine Lilly, treatment should continue for several months, to prevent the disorder coming back.The dose of Duloxetine Lilly should be reduced gradually when stopping treatment.

How does Duloxetine Lilly work?

The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor. It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.Neurotransmitters are chemicals that allow nerve cells to communicate with one another. By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells. Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.

What benefits of Duloxetine Lilly have been shown in studies?

For major depression, Duloxetine Lilly has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients. Six of the studies looked at the treatment of depression and measured the change in symptoms over up to six months. The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Duloxetine Lilly, including 288 patients with a history of repeated episodes of depression for up to five years. Although the results of the depression studies varied, Duloxetine Lilly was more effective than placebo in four of the studies. In the two studies where the approved dose of Duloxetine Lilly was compared with placebo, Duloxetine Lilly was more effective. It also took longer for symptoms to return in patients taking Duloxetine Lilly than in those taking placebo.For neuropathic pain, Duloxetine Lilly has been compared with placebo in two 12-week studies in 809 diabetic adults. The main measure of effectiveness was the change in the severity of pain each week. These studies showed that Duloxetine Lilly was more effective at reducing pain than placebo. In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks.For generalised anxiety disorder, Duloxetine Lilly has been compared with placebo in five studies involving a total of 2,337 patients. Four studies looked at the treatment of the disorder by measuring the reduction in symptoms after nine to 10 weeks. The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Duloxetine Lilly. Duloxetine Lilly was shown to be more effective than placebo at treating the disorder and preventing symptoms returning.

What are the risks associated with Duloxetine Lilly?

The most common side effects with Duloxetine Lilly (which may affect more than 1 in 10 people) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness. Most of these are mild or moderate, starting early in treatment and getting milder as treatment continues. For the full list of all side effects reported with Duloxetine Lilly, see the package leaflet.Duloxetine Lilly must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotics). Duloxetine Lilly must also not be used in patients with reduced liver function or patients with severely reduced kidney function. Treatment must not be started in patients with uncontrolled hypertension (high blood pressure), because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).For the full list of restrictions, see the package leaflet.

Why is Duloxetine Lilly approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duloxetine Lilly's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Duloxetine Lilly?

A risk management plan has been developed to ensure that Duloxetine Lilly is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Lilly, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.


Summarize this document



Read the original document in your language

Duloxetine Mylan


What is Duloxetine Mylan and what is it used for?

Duloxetine Mylan is used to treat adults with the following diseases:• major depression;• pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).Duloxetine Mylan contains the active substance duloxetine and is a 'generic medicine'. This means that Duloxetine Mylan is similar to a 'reference medicine' already authorised in the European Union (EU) called Cymbalta. For more information on generic medicines, see the question-and-answer document here.

How is Duloxetine Mylan used?

Duloxetine Mylan is available as gastroresistant capsules (30 and 60 mg). 'Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being destroyed by the acid in the stomach. The medicine can only be obtained with a prescription.For major depression, the recommended dose of Duloxetine Mylan is 60 mg once a day. A response is usually seen in two to four weeks. In patients who respond to Duloxetine Mylan, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day. The response to treatment should be assessed regularly.For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response. Most patients will need to take 60 mg per day. Patients who also have major depression should start with 60 mg once a day. In patients who respond to Duloxetine Mylan, treatment should continue for several months, to prevent the disorder coming back.The dose of Duloxetine Mylan should be reduced gradually when stopping treatment.

How does Duloxetine Mylan work?

The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor. It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.Neurotransmitters are chemicals that allow nerve cells to communicate with one another. By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells. Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.

How has Duloxetine Mylan been studied?

Because Duloxetine Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cymbalta. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Duloxetine Mylan?

Because Duloxetine Mylan is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine's.

Why is Duloxetine Mylan approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Mylan has been shown to have comparable quality and to be bioequivalent to Cymbalta. Therefore, the CHMP's view was that, as for Cymbalta, the benefit outweighs the identified risk. The Committee recommended that Duloxetine Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Duloxetine Mylan?

A risk management plan has been developed to ensure that Duloxetine Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of productcharacteristics and the package leaflet for Duloxetine Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.


Summarize this document



Read the original document in your language

Duloxetine Zentiva


What is Duloxetine Zentiva and what is it used for?

Duloxetine Zentiva is used to treat adults with the following diseases:• major depression;• pain due to diabetic peripheral neuropathy (damage to the nerves in the feet, legs, hands and arms that can occur in patients with diabetes);• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).Duloxetine Zentiva contains the active substance duloxetine and is is a 'generic medicine'. This means that Duloxetine Zentiva is similar to a 'reference medicine' already authorised in the European Union (EU) called Cymbalta. For more information on generic medicines, see the question-and-answer document here.

How is Duloxetine Zentiva used?

Duloxetine Zentiva is available as gastroresistant capsules (30 and 60 mg). 'Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being destroyed by the acid in the stomach. The medicine can only be obtained with a prescription.For major depression, the recommended dose of Duloxetine Zentiva is 60 mg once a day. A response is usually seen in two to four weeks. In patients who respond to Duloxetine Zentiva, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of up to 120 mg per day. The response to treatment should be assessed regularly.For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response. Most patients will need to take 60 mg per day. Patients who also have major depression should start with 60 mg once a day. In patients who respond to Duloxetine Zentiva, treatment should continue for several months, to prevent the disorder coming back.The dose of Duloxetine Zentiva should be reduced gradually when stopping treatment.

How does Duloxetine Zentiva work?

The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor. It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.Neurotransmitters are chemicals that allow nerve cells to communicate with one another. By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between nerve cells, increasing the level of communication between the cells. Since these neurotransmitters are involved in maintaining mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.

How has Duloxetine Zentiva been studied?

Because Duloxetine Zentiva is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine's.

What are the benefits and risks of Duloxetine Zentiva?

Because Duloxetine Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Duloxetine Zentiva approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Zentiva has been shown to have comparable quality to Cymbalta and to be bioequivalent to Cymbalta. Therefore, the CHMP's view was that, as for Cymbalta, the benefit outweighs the identified risk. The Committee recommended that Duloxetine Zentiva be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Duloxetine Zentiva?

A risk management plan has been developed to ensure that Duloxetine Zentiva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.


Summarize this document



Read the original document in your language

Duoplavin


What is DuoPlavin and what is it used for?

DuoPlavin is a medicine used to prevent problems caused by blood clots and hardening of the arteries, such as a myocardial infarction (heart attack), in adults who are already taking both clopidogrel and acetylsalicylic acid (also known as aspirin) as separate tablets. It can be used in the following groups of patients who have a condition known as acute coronary syndrome:• patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ST-segment elevation (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube in an artery to prevent it closing up) inserted as part of a percutaneous coronary intervention (a procedure that unblocks blood vessels of the heart to restore its blood supply);• patients being treated for heart attack with ST-segment elevation who are having a percutaneous coronary intervention or for whom the doctor thinks that they would benefit from thrombolytic or fibrinolytic treatment (treatments to dissolve blood clots).DuoPlavin contains the active substances clopidogrel and acetylsalicylic acid.

How is DuoPlavin used?

DuoPlavin is available as a tablet and can only be obtained with a prescription.DuoPlavin is taken once a day as one tablet containing 75 mg clopidogrel and either 75 mg or 100 mg acetylsalicylic acid and is taken in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately. The medicine can be taken for up to 12 months.For more information about using DuoPlavin, see the package leaflet or contact your doctor or pharmacist.

How does DuoPlavin work?

Both active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are antiplatelet medicines. This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent heart problems, such as heart attack.Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a receptor on their surface. This stops the platelets becoming 'sticky', reducing the risk of a blood clotforming. Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase. This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together. The combination of the two active substances has an additive effect, reducing the risk of blood clots forming, more than either medicine alone.Both active substances have been available in the EU for a number of years. Clopidogrel has been authorised since 1998 and is often used in combination with acetylsalicylic acid. Acetylsalicylic acid has been used for over 100 years.

What benefits of DuoPlavin have been shown in the studies?

Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in DuoPlavin are absorbed in the body in the same way when taken in a single tablet as when taken separately.DuoPlavin was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.In addition, the company presented the results from 3 previous studies in 61,000 patients with unstable angina or who had had a heart attack, which showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.A further study also showed that DuoPlavin was effective at reducing the occurrence of heart attack, stroke or death in patients undergoing percutaneous coronary intervention.

What are the risks associated with DuoPlavin?

Bleeding reactions are the most common side effects reported with DuoPlavin. The most common of these (which may affect up to 1 and 10 people) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), bruising and bleeding where the skin is punctured.Other side effects (which may affect up to 1 in 10 people) are diarrhoea, abdominal pain (stomach ache) and dyspepsia (heartburn).For the full list of side effects of DuoPlavin, see the package leaflet.DuoPlavin must not be used in people who are hypersensitive (allergic) to clopidogrel, non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in DuoPlavin. It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells). It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose). DuoPlavin must not be used during the last three months of pregnancy.

Why is DuoPlavin authorised in the EU?

The European Medicines Agency noted that DuoPlavin is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single tabletsimplifies treatment for patients as they will need to take fewer tablets. The Agency therefore decided that DuoPlavin's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of DuoPlavin?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of DuoPlavin have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of DuoPlavin are continuously monitored. Suspected side effects reported with DuoPlavin are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Duoresp Spiromax


What is DuoResp Spiromax and what is it used for?

DuoResp Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used to treat asthma in adults and adolescents aged 12 years and above for whom a combination product is considered appropriate. It can be used in patients whose disease is not adequately controlled with other asthma medicines called corticosteroids and 'short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled with corticosteroids and 'longacting beta-2 agonists' (such as budesonide and formoterol) taken by inhalation.DuoResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.DuoResp Spiromax is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' containing the same active substances, but DuoResp Spiromax is given using a different inhaler. The reference medicine for DuoResp Spiromax is Symbicort Turbohaler.

How is DuoResp Spiromax used?

The medicine can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine. DuoResp Spiromax 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever. It can also be used for the treatment of COPD symptoms in adult patients. The higher strength, DuoResp Spiromax 320/9 micrograms (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD symptoms.For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used, age and the severity of the asthma. As asthma reliever therapy, patients can take 1 or 2 additional inhalations of DuoResp Spiromax 160/4.5 microgram only to relieve their symptoms. If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.SendFor the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.For further information, see the package leaflet or contact your doctor or pharmacist.

How does DuoResp Spiromax work?

The two active substances in DuoResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.

How has DuoResp Spiromax been studied?

Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Symbicort Turbohaler, and do not need to be repeated for DuoResp Spiromax.As for every medicine, the company provided studies on the quality of DuoResp Spiromax. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of DuoResp Spiromax?

Because DuoResp Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is DuoResp Spiromax authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, DuoResp Spiromax 160/4.5 microgram and 320/9 micrograms have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler. Therefore, the Agency's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of DuoResp Spiromax?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of DuoResp Spiromax have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of DuoResp Spiromax are continuously monitored. Suspected side effects reported with the medicine are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Duotrav


What is DuoTrav?

DuoTrav is a clear eye drop solution. It contains two active substances: travoprost (40 micrograms per millilitre) and timolol (5 mg/ml).

What is DuoTrav used for?

DuoTrav is used to reduce the pressure inside the eye. It is used in adults with 'open angle glaucoma' or 'ocular hypertension' who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).Ocular hypertension is when the pressure in the eye is higher than normal. In open angle glaucoma the high pressure is caused by fluid being unable to drain out of the eye.DuoTrav can only be obtained with a prescription.

How is DuoTrav used?

The dose of DuoTrav is one drop in the affected eye(s) once a day, in the morning or evening, at the same time every day. If more than one type of eye drop is being used, each one should be given at least five minutes apart.

How does DuoTrav work?

When the pressure inside the eye rises, it causes damage to the retina (the light sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can result in serious vision loss and even blindness. By lowering the pressure, DuoTrav reduces the risk of damaging these structures.DuoTrav contains two active substances, travoprost and timolol, which lower the pressure in the eye in different ways. Travoprost is a prostaglandin analogue (a man-made copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Travoprost on its own has been authorised in the European Union as Travatan since 2001. Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been used to treat glaucoma since the 1970's. The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.

How has DuoTrav been studied?

DuoTrav has been studied in five main studies involving a total of 1,482 patients (aged 18 to 91) with open-angle glaucoma or ocular hypertension. The studies lasted between six weeks and 12 months. One study compared DuoTrav taken in the morning with DuoTrav taken in the evening. Three studies compared DuoTrav with travoprost and timolol either given on their own, or together but as separate eye drops. The fifth was a 12-month study that compared DuoTrav with eye drops containing a combination of latanoprost (another prostaglandin analogue) and timolol.In all of the studies, the main measure of effectiveness was the change in pressure inside the eye measured in 'millimetres of mercury' (mmHg). In a patient with glaucoma, the eye pressure is usually higher than 21 mmHg.

What benefit has DuoTrav shown during the studies?

DuoTrav reduced the pressure inside the eye by about a third in all of the studies (the average reduction was about 8-10 mmHg).DuoTrav taken in the evening was as effective as DuoTrav taken in the morning. DuoTrav was more effective at reducing the pressure inside the eye than timolol on its own, or travoprost on its own. It was as effective as the two medicines given as separate eye drops, and as effective as eye drops containing both latanoprost and timolol.

What is the risk associated with DuoTrav?

The most common side effects with DuoTrav (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to redness) and eye irritation. For the full list of all side effects reported with DuoTrav, see the package leaflet.DuoTrav should not be used in people who may be hypersensitive (allergic) to travoprost, timolol (and other beta-blockers), or any of the other ingredients. DuoTrav must not be used in people with asthma or severe lung disease, or in people with some heart conditions. It must also not be used in people with severe allergic rhinitis (inflammation of the nasal passages caused by an allergy) and corneal dystrophies (disorders that cause clouding of the cornea, the transparent layer in front of the eye).DuoTrav contains benzalkonium chloride which is known to discolour soft contact lenses. Therefore, care should be taken by people who wear soft contact lenses. DuoTrav may cause the iris of the eye to change colour (darken) and the eyelashes to thicken, darken or lengthen.

Why has DuoTrav been approved?

The CHMP decided that DuoTrav's benefits are greater than its risks and recommended that it be given marketing authorisation.


Summarize this document



Read the original document in your language

Dupixent


What is Dupixent and what is it used for?

Dupixent is a medicine used to treat:• moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry) in patients aged 12 years and over when treatments applied to the skin are not sufficient or appropriate. Patients from 6 months up to 12 years of age can also be given the medicine if their condition is severe.• severe asthma in patients aged 6 years and over, whose asthma is not properly controlled by appropriate combination therapy (corticosteroids taken by inhalation plus another medicine used for the prevention of asthma). Dupixent is added to maintenance treatment and is only for use in patients with a type of inflammation of the airways called 'type 2 inflammation'.• inflammation of the nose and sinuses together with growths (polyps) obstructing the airways in the nose (chronic rhinosinusitis with nasal polyposis). It is used in adults added to local treatment with corticosteroids when other treatments have not worked well enough.• moderate-to-severe prurigo nodularis (a long-term skin disease with a rash causing lumps with intense itching) in adults. It is used with or without topical (applied to the skin) corticosteroids.• eosinophilic oesophagitis (an allergic condition of the food pipe) in adults and children above 12 years of age who cannot take conventional treatment or for whom it is not working.Dupixent contains the active substance dupilumab.

How is Dupixent used?

Dupixent is available as pre-filled pens or syringes of various strengths containing dupilumab in a solution for injection under the skin, usually in the thigh or belly. Higher doses are given as 2 injections in 2 different sites. The dose depends on the patient's age and weight, and the condition being treated.Dupixent can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the conditions Dupixent is used to treat. Patients or their carers may inject the medicine themselves if their doctor or nurse considers it appropriate and once they have been trained to do so. The medicine is for long-term use and the need to continue taking the medicine should be assessed by the doctor at least yearly.Dupilumab can be used with or without topical corticosteroids.For more information about using Dupixent, see the package leaflet or contact your doctor or pharmacist.

How does Dupixent work?

Patients with atopic dermatitis, some types of asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis and eosinophilic oesophagitis produce high levels of proteins called interleukin 4 and interleukin 13 (IL-4 and IL-13), which can cause inflammation of the skin,airways and oesophagus leading to the symptoms of these diseases. The active substance in Dupixent, dupilumab, is a monoclonal antibody (a type of protein) designed to block receptors (targets) for IL-4 and IL-13. By blocking the receptors, dupilumab prevents IL-4 and IL-13 from working and relieves disease symptoms.

What benefits of Dupixent have been shown in studies?

Atopic dermatitisDupixent was more effective than placebo (a dummy treatment) at reducing the extent and severity of atopic dermatitis in 3 main studies in adults with moderate to severe disease. In the first study, which involved 740 patients, participants were given Dupixent or placebo, both in combination with a topical corticosteroid (a medicine for inflammation applied to the skin). Dupixent or placebo was used on its own in the other two studies involving a total of 1,379 patients.After 16 weeks of treatment, 39% of patients treated with Dupixent every two weeks in the first study showed clearing or almost clearing of their atopic dermatitis compared with 12% of patients on placebo. Taking the results of the other two studies together, 37% of patients treated with Dupixent every two weeks had clearing or almost clearing of their atopic dermatitis compared with 9% of patients on placebo.A study was also carried out in 251 adolescents aged from 12 to less than 18 years with moderate to severe atopic dermatitis. In this study, after 16 weeks atopic dermatitis had cleared up or almost cleared up in around 24% of those given Dupixent every 2 weeks compared with around 2% of those given placebo.A further study looked at 367 children between 6 and 12 years of age with severe atopic dermatitis in whom medicines applied to the skin had proved insufficient or were unsuitable. After 16 weeks, measures of severity showed that atopic dermatitis had cleared up or almost cleared up in around 33% of those given Dupixent with a topical corticosteroid compared with around 11% of those given placebo with a corticosteroid.In addition, a study involving children between 6 months and less than 6 years of age with moderate to severe dermatitis showed that a 16-week treatment with Dupixent and a topical corticosteroid led to skin clearing in 28% of patients (23 out of 83 patients) compared with 4% of patients (3 out of 79 patients) given placebo and a topical corticosteroid. Overall 53% of patients (44 out of 83 patients) treated with Dupixent and a corticosteroid had an improvement in their skin of at least 75% compared with at least 11% (8 out of 11 patients) with placebo and a corticosteroid.AsthmaDupixent was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving patients with asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and other medicines. In the first study, involving 1,902 patients aged 12 years or above, the number of severe flare-ups per year was 0.46 in patients taking 200 mg Dupixent and 0.52 in patients taking 300 mg Dupixent, compared with 0.87 or 0.97 in patients given placebo. After 12 weeks of treatment, Dupixent improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 320 ml (for 200 mg Dupixent) or 340 ml (for 300 mg Dupixent) compared with 180 ml and 210 ml for placebo.The second study, involving 210 patients taking corticosteroids by mouth for their asthma, showed that in 70% of patients given Dupixent their condition improved to the extent that they could reduce their corticosteroid dose compared with 42% of those given placebo.A subsequent third study involved 408 children 6 to 11 years of age with severe asthma that was not adequately controlled by a combination of medium-to-high-dose inhaled corticosteroids and other medicines. It showed that the number of severe flare-ups of asthma per year was 0.31 in those with type 2 inflammation given Dupixent compared with 0.75 in similar children given a dummy treatment. After 12 weeks of treatment Dupixent improved patients' predicted FEV1 by 10.5% compared with5.3% in those given placebo.Chronic rhinosinusitis with nasal polyposisAdding Dupixent to treatment with a corticosteroid nasal spray has been shown to improve symptoms of the condition more than placebo in 2 main studies as measured by scoring systems for the extent of nasal polyps and patients' perception of nasal congestion. In the first study, involving 276 adults, after around 6 months nasal polyp score fell by 1.89 with Dupixent and increased by 0.17 with placebo. Similarly, patients' score for nasal congestion fell by 1.34 with Dupixent versus 0.45 with placebo. In the second study, involving 448 adults, the polyp score fell by 1.71 with Dupixent and increased by0.10 with placebo, and the congestion score fell by 1.25 versus 0.38, respectively.Prurigo nodularisDupixent was more effective than placebo at reducing the extent and severity of itching caused by prurigo nodularis in 2 main studies involving a total of 311 adults with moderate to severe disease. The studies measured improvements in symptoms of itching using the Worst Itch Numeric Rating Scale (WI-NRS).After 24 weeks of treatment, 59% of patients treated with Dupixent had a significant improvement in their symptoms (as measured by a reduction of at least 4 points in the WI-NRS) compared with 19% of patients on placebo.Eosinophilic oesophagitisIn a study of 321 patients with eosinophilic oesophagitis, Dupixent was more effective than placebo in reducing oesophageal inflammation. In this study, more patients treated with Dupixent treatment had low levels of eosinophils in their blood (a sign of reduced inflammation) compared with patients who had placebo. Patients treated with Dupixent treatment also had greater improvements in their symptom scores for swallowing difficulties.

What are the risks associated with Dupixent?

The most common side effects with Dupixent (which may affect up to 1 in 10 people) are injection-site reactions (such as redness, swelling including due to fluid build-up, itching and pain), conjunctivitis (redness and discomfort in the eye) including conjunctivitis due to allergy, joint pain, cold sores and increased blood levels of a type of white blood cell called eosinophils. In eosinophilia oesophagitis patients also had injection site bruising.There have been very rare cases of serum sickness (allergy to the proteins in the medicine) and serum sickness-like reactions, anaphylaxis (sudden, severe allergic reactions) and ulcerative keratitis (inflammation and damage to the clear layer at the front of the eye).For the full list of side effects and restrictions of Dupixent, see the package leaflet.

Why is Dupixent authorised in the EU?

Dupixent has been shown to reduce the extent and severity of atopic dermatitis and prurigo nodularis in patients with moderate to severe disease, for whom available therapies are limited. Similarly, in chronic rhinosinusitis with nasal polyposis, Dupixent produced clinically meaningful improvements in symptoms. In the treatment of type 2 inflammatory asthma, Dupixent has been shown to reduce the number of asthma flare-ups and the need for oral corticosteroid treatment. In the treatment of eosinophilic oesophagitis, Dupixent has been shown to reduce eosinophilic inflammation. Regarding safety, Dupixent's side effects are generally mild and manageable.The European Medicines Agency therefore decided that Dupixent's benefits are greater than its risks and it can be authorised in the EU.

What measures are being taken to ensure the safe and effective use of Dupixent?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dupixent have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dupixent are continuously monitored. Side effects reported with Dupixent are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dynastat


What is Dynastat and what is it used for?

Dynastat is a painkilling medicine for use in adults for the short-term relief of pain after an operation.It contains the active substance parecoxib.

How is Dynastat used?

Dynastat is available as an injection and it can only be obtained with a prescription.Dynastat can be given into a vein or a muscle. The first dose of 40 mg is followed by further doses of 20 or 40 mg every 6 to 12 hours, up to a maximum total dose of 80 mg a day.For more information about using Dynastat, see the package leaflet or contact your doctor or pharmacist.

How does Dynastat work?

The active substance in Dynastat, parecoxib, is converted to valdecoxib in the body. Valdecoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors. It blocks the COX-2 enzyme, resulting in reduced production of prostaglandins, substances that are involved in inflammation. By reducing prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.

What benefits of Dynastat have been shown in studies?

Dynastat was studied in over 2,500 adults who had surgical procedures including dental, orthopaedic (bone) and gynaecological surgery (surgery on the female reproductive system). Dynastat was compared with placebo (a dummy treatment) as well as with other painkillers such as ibuprofen, ketorolac, morphine, tramadol and valdecoxib. Dynastat was generally more effective than placebo and as effective as other painkillers. Dynastat also reduced the need for morphine.

What are the risks associated with Dynastat?

The most common side effect with Dynastat (which may affect more than 1 in 10 people) is nausea (feeling sick). The most serious side effects (which may affect fewer than 1 in 100 people) include myocardial infarction (heart attack), severe reduction in blood pressure and allergic reactions.Dynastat must not be used in patients who have had a serious allergic reaction to a medicine, have allergies to a class of medicines called sulfonamides or have certain illnesses including those affecting the gastrointestinal system, liver and heart. Women must not be given Dynastat during the last 3 months of pregnancy or if they are breast-feeding. It must not be used to relieve pain after certain types of heart surgery.For the full list of side effects and restrictions of Dynastat, see the package leaflet.

Why is Dynastat authorised in the EU?

Dynastat was found effective for relieving pain after surgery and its side effects are manageable.The European Medicines Agency therefore decided that Dynastat's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dynastat?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dynastat have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dynastat are continuously monitored. Side effects reported with Dynastat are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Dzuveo


What is Dzuveo and what is it used for?

Dzuveo is an opioid pain medicine used to treat moderate to severe pain in adults.It is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' (called Sufenta Forte) containing the same active substance. The difference between the products is that Dzuveo is available as sublingual tablets (tablets to be dissolved under the tongue) while the reference medicine is a solution for injection.Dzuveo contains the active substance sufentanil.

How is Dzuveo used?

Dzuveo is available as 30 µg sublingual tablets. Using a disposable applicator, the healthcare professional should place one tablet under the patient's tongue and leave it to dissolve. The tablet must not be chewed or swallowed.Patients should not eat or drink and should talk as little as possible for the 10 minutes after taking the tablet. They can be given the tablets as needed but should wait at least one hour after one tablet before having another. Dzuveo should not be used for more than 48 hours.Dzuveo can only be obtained with a prescription. It should be given by a healthcare professional experienced in treating pain and in a place (such as a hospital) where the patient can be monitored. For more information about using Dzuveo, see the package leaflet or contact your doctor or pharmacist.

How does Dzuveo work?

The active substance in Dzuveo, sufentanil, is an opioid that works by attaching to receptors (targets) in the brain known as μ-opioid receptors. Attaching to these receptors in the brain helps relieve the patient's pain.

What benefits of Dzuveo have been shown in studies?

Two main studies have shown that Dzuveo left to dissolve under the tongue is effective at reducing severe pain following surgeries. Both studies used a pain rating scale known as SPID12 which tracks reduction in pain over 12 hours.In the first study in 163 patients who had undergone abdominal surgery, pain reduced by 26 points with Dzuveo compared with 13 points with placebo (a dummy treatment). In the second study in 101 patients after foot surgery, pain reduced by around 6 points with Dzuveo and increased by around 7 points with placebo.

What are the risks associated with Dzuveo?

The most serious side effects with sufentanil are severe breathing problems, which occur in around 6 people in 1,000. The most common side effects (which may affect more than 1 in 10 people) are nausea, vomiting and fever.Dzuveo must not be used in patients with serious lung or breathing problems. For the full list of side effects and restrictions with Dzuveo, see the package leaflet.

Why is Dzuveo authorised in the EU?

Studies show that Dzuveo is effective at reducing severe pain following surgeries. The side effects seen with Dzuveo are those expected with opioids, and are considered manageable. The European Medicines Agency therefore decided that Dzuveo's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dzuveo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dzuveo have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Dzuveo are continuously monitored. Side effects reported with Dzuveo are carefully evaluated and any necessary action taken to protect patients.


Summarize this document



Read the original document in your language

Χρησιμοποιούμε cookies για να διασφαλίσουμε βασικές λειτουργίες του ιστοτόπου μας και να σας παρέχουμε καλύτερες υπηρεσίες.  Διαβάστε περισσότερα.

We use cookies to ensure basic functions of our website and to provide you with better services.   Read more.