Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DEFERASIROX 180 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
DEFERASIROX 180 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 Stada 90 mg, filmomhulde tabletten Deferasirox Stada 180 mg, filmomhulde tabletten Deferasirox Stada 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 Stada is and what it is used for 2. What you need to know before you take Deferasirox Stada 3. How to take Deferasirox Stada 4. Possible side effects 5. How to store Deferasirox Stada 6. Contents of the pack and other information 1. WHAT DEFERASIROX STADA IS AND WHAT IT IS USED FO R WHAT DEFERASIROX STADA IS Deferasirox Stada 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 STADA IS USED FO R 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 da Perskaitykite visą dokumentą
1 1. NAME OF THE MEDICINAL P RO DU C T Deferasirox Stada 90 mg, filmomhulde tabletten Deferasirox Stada 180 mg, filmomhulde tabletten Deferasirox Stada 360 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE CO M P O S I T I O N Deferasirox Stada 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox. Deferasirox Stada 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox. Deferasirox Stada 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 F OR M Film-coated tablet Deferasirox Stada 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 Stada 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 Stada 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 R T I C U L A R S 4.1 THERAPEUTIC I ND IC A T IO N S Deferasirox Stada 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 Stada 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 patie Perskaitykite visą dokumentą