Država: Nizozemska
Jezik: nizozemščina
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DEFERASIROX 360 mg/stuk
Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)
DEFERASIROX 360 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE U SE R Deferasirox betapharm 90 mg filmomhulde tabletten Deferasirox betapharm 180 mg filmomhulde tabletten Deferasirox betapharm 360 mg filmomhulde tabletten Deferasirox READ ALL OF THIS LEAFLET C A R EF U LLY B EFO R E YOU START TAKING THIS MEDICINE BECAUSE IT CO N T A I N S IMPORTANT INFORMATION FOR YO U . - 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 LE A FLE T 1. What Deferasirox betapharm is and what it is used for 2. What you need to know before you take Deferasirox betapharm 3. How to take Deferasirox betapharm 4. Possible side effects 5. How to store Deferasirox betapharm 6. Contents of the pack and other information 1. WHAT DEFERASIROX BETAPHARM IS AND WHAT IT IS USED FOR WHAT DEFERASIROX BETAPHARM IS Deferasirox betapharm 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 BETAPHARM 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 co Preberite celoten dokument
1 1. NAME OF THE MEDICINAL PRO DU CT Deferasirox betapharm 90 mg, filmomhulde tabletten Deferasirox betapharm 180 mg, filmomhulde tabletten Deferasirox betapharm 360 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE CO M PO S I T I O N Deferasirox betapharm 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox. Deferasirox betapharm 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox. Deferasirox betapharm 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 FOR M Film-coated tablet Deferasirox betapharm 90 mg film-coated tablets Light blue, ovaloid, biconvex, film-coated tablets with bevelled edges, embossed with ‘90’ on one side and plain on the other side. The dimensions of the tablet are approximately 10.3 mm x 4.1 mm. Deferasirox betapharm 180 mg film-coated tablets Medium blue, ovaloid, biconvex, film-coated tablets with bevelled edges, embossed with ‘180’ on one side and plain on the other side. The dimensions of the tablet are approximately 13.4 mm x 5.4 mm. Deferasirox betapharm 360 mg film-coated tablets Dark blue, ovaloid, biconvex, film-coated tablets with bevelled edges, embossed with ‘360’ on one side and plain on the other side. The dimensions of the tablet are approximately 16.6 mm x 6.6 mm. 4. CLINICAL P A RT I C U L A R S 4.1 THERAPEUTIC I ND IC A T IO N S Deferasirox betapharm 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 betapharm 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 Preberite celoten dokument