Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
deferasirox
Accord Healthcare S.L.U.
V03AC03
deferasirox
All other therapeutic products, Iron chelating agents
Iron Overload; beta-Thalassemia
Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (
Revision: 5
Authorised
2020-01-09
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DEFERASIROX ACCORD 90 MG FILM-COATED TABLETS DEFERASIROX ACCORD 180 MG FILM-COATED TABLETS DEFERASIROX ACCORD 360 MG FILM-COATED TABLETS deferasirox READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Deferasirox Accord is and what it is used for 2. What you need to know before you take Deferasirox Accord 3. How to take Deferasirox Accord 4. Possible side effects 5. How to store Deferasirox Accord 6. Contents of the pack and other information 1. WHAT DEFERASIROX ACCORD IS AND WHAT IT IS USED FOR WHAT DEFERASIROX ACCORD IS Deferasirox Accord contains an active substance called deferasirox. It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload). It traps and removes excess iron which is then excreted mainly in the stools. WHAT DEFERASIROX ACCORD IS USED FOR Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can cause a build-up of excess iron. This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions. In patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, mainly due to increased absorption of dietary iron in response to low blood cell counts. Over time, the excess iron can dama Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Deferasirox Accord 90 mg film-coated tablets Deferasirox Accord 180 mg film-coated tablets Deferasirox Accord 360 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Deferasirox Accord 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox. _Excipients with known effect _ Each 90 mg tablet also contains 27 mg of lactose (as monohydrate) and 2.95 mg of castor oil. Deferasirox Accord 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox. _Excipients with known effect _ Each 180 mg tablet also contains 54 mg of lactose (as monohydrate) and 5.9 mg of castor oil. Deferasirox Accord 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox. _Excipients with known effect _ Each 360 mg tablet also contains 108 mg of lactose (as monohydrate) and 11.8 mg of castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Deferasirox Accord 90 mg film-coated tablets Yellow colored, film coated oval, biconvex tablets with beveled edges debossed with ‘D’ on one side and ‘90’ on another side. Approximate tablet dimensions 11.0 mm x 4.20 mm. Deferasirox Accord 180 mg film-coated tablets Yellow colored, film coated oval, biconvex tablets with beveled edges debossed with ‘D’ on one side and ‘180’ on another side. Approximate tablet dimensions 14.0 mm x 5.50 mm. Deferasirox Accord 360 mg film-coated tablets Yellow colored, film coated oval, biconvex tablets with beveled edges debossed with ‘D’ on one side and ‘360’ on another side. Approximate tablet dimensions 17.0 mm x 6.80 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 3 Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions ( _≥_ 7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. Deferasirox Accord is also indicated for the treatment of Pročitajte cijeli dokument