Țară: Țările de Jos
Limbă: olandeză
Sursă: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DEFERASIROX
Pharmascience International Ltd Lampousas 1 1095 NICOSIA (CYPRUS)
V03AC03
DEFERASIROX
Dispergeerbare tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551)
Oraal gebruik
Deferasirox
2018-07-10
1 _Version 4, 02/2016 _ PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Deferasirox Pharmascience 125 mg, dispergeerbare tabletten Deferasirox Pharmascience 250 mg, dispergeerbare tabletten Deferasirox Pharmascience 500 mg, dispergeerbare tabletten 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 pharmacis. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Deferasirox Pharmascience is and what it is used for 2. What you need to know before you take Deferasirox Pharmascience 3. How to take Deferasirox Pharmascience 4. Possible side effects 5. How to store Deferasirox Pharmascience 6. Contents of the pack and other information 1. WHAT DEFERASIROX PHARMASCIENCE IS AND WHAT IT IS USED FOR WHAT DEFERASIROX PHARMASCIENCE IS Deferasirox Pharmascience 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 PHARMASCIENCE 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 increas Citiți documentul complet
1 _Version 4, 02/2016 _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Deferasirox Pharmascience 125 mg, dispergeerbare tabletten Deferasirox Pharmascience 250 mg, dispergeerbare tabletten Deferasirox Pharmascience 500 mg, dispergeerbare tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 125 mg deferasirox. Each tablet contains 250 mg deferasirox. Each tablet contains 500 mg deferasirox. Excipient(s) with known effect: Each 125 mg tablet contains 109.82 mg lactose (as lactose monohydrate). Each 250 mg tablet contains 219.63 mg lactose (as lactose monohydrate). Each 500 mg tablet contains 439.25 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersible tablets Off-white, round, bevel-edged flat tablet of approximately 12 mm x 3.7 mm, debossed with “D” on top and “125” below on one side and plain on the other side. Off-white, round, bevel-edged flat tablet of approximately 15 mm x 4.7 mm, debossed with “D” on top and “250” below on one side and plain on the other side. Off-white, round, bevel-edged flat tablet of approximately 20 mm x 5.4 mm, debossed with “D” on top and “500” below on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deferasirox Pharmascience 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 Pharmascience 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 Citiți documentul complet