País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DEFERASIROX 90 mg/stuk
DEFERASIROX 90 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; 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 user Deferasirox Stada 90 mg, filmomhulde tabletten Deferasirox Stada 180 mg, filmomhulde tabletten Deferasirox Stada 360 mg, filmomhulde 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 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. Whatis and what it is used for 2. What you need to know before you take Leer el documento completo3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR WHAT IS 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 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 damage important organs such as the liver and hea
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Deferasirox Stada 90 mg, filmomhulde tabletten Deferasirox Stada 180 mg, filmomhulde tabletten Deferasirox Stada 360 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Deferasirox Stada 90 mg, filmomhulde tabletten: Each film-coated tablet contains 90 mg deferasirox. Deferasirox Stada 180 mg, filmomhulde tabletten: Each film-coated tablet contains 180 mg deferasirox. Deferasirox Stada 360 mg, filmomhulde tabletten: Each film-coated tablet contains 360 mg deferasirox. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Deferasirox Stada 90 mg, filmomhulde tabletten Light blue, ovaloid, biconvex, film-coated tablet with bevelled edges, debossed with ‘90’ on one side and plain on the other side. Approximate tablet dimensions 10.3 mm x 4.1 mm. Deferasirox Stada 180 mg, filmomhulde tabletten Medium blue, ovaloid, biconvex, film-coated tablet with bevelled edges, debossed with ‘180’ on one side and plain on the other side. Approximate tablet dimensions 13.4 mm x 5.4 mm. Deferasirox Stada 360 mg, filmomhulde tabletten Dark blue, ovaloid, biconvex, film-coated tablet with bevelled edges, debossed with ‘360’ on one side and plain on the other side. Approximate tablet dimensions 16.6 mm x 6.6 mm. 4. Clinical particulars 4.1 THERAPEUTIC INDICATIONSis 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. Leer el documento completois 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