Երկիր: Եվրոպական Միություն
Լեզու: անգլերեն
Աղբյուրը: EMA (European Medicines Agency)
deferasirox
Mylan Pharmaceuticals Limited
V03AC03
deferasirox
Iron chelating agents
Iron Overload; beta-Thalassemia
Deferasirox Mylan is indicated forthe 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 olderthe 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: 9
Authorised
2019-09-26
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE USER DEFERASIROX MYLAN 90 MG FILM-COATED TABLETS DEFERASIROX MYLAN 180 MG FILM-COATED TABLETS DEFERASIROX MYLAN 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 only for you or your child. 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 Mylan is and what it is used for 2. What you need to know before you take Deferasirox Mylan 3. How to take Deferasirox Mylan 4. Possible side effects 5. How to store Deferasirox Mylan 6. Contents of the pack and other information 1. WHAT DEFERASIROX MYLAN IS AND WHAT IT IS USED FOR WHAT DEFERASIROX MYLAN IS Deferasirox Mylan 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 MYLAN 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 dam Կարդացեք ամբողջական փաստաթուղթը
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Deferasirox Mylan 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox. Deferasirox Mylan 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox. Deferasirox Mylan 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Deferasirox Mylan 90 mg film-coated tablets A blue, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF’ on the other side. Approximate tablet dimensions 10.00 mm × 4.5 mm. Deferasirox Mylan 180 mg film-coated tablets A blue, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 1’ on the other side. Approximate tablet dimensions 12.8 mm × 6.00 mm. Deferasirox Mylan360 mg film-coated tablets A blue, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 2’ on the other side. Approximate tablet dimensions 17 mm × 6.7 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deferasirox Mylan 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. 3 Deferasirox Mylan 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 b Կարդացեք ամբողջական փաստաթուղթը