Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DEFERASIROX 180 mg/stuk
Demo SA Pharmaceutical Industry 21st Km Nat. Rd. Athens-Lamia 14568 KRIONERI, ATTICA (GRIEKENLAND)
V03AC03
DEFERASIROX 180 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Deferasirox
1900-01-01
1 M1.3.1_03.DFX.tab.001.02.NL.4518.02 PACKAGE LEAFLET: INFORMATION FOR THE USER SIDIPAST 90 MG, FILMOMHULDE TABLETTEN SIDIPAST 180 MG, FILMOMHULDE TABLETTEN SIDIPAST 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. What SIDIPAST is and what it is used for 2. What you need to know before you take SIDIPAST 3. How to take SIDIPAST 4. Possible side effects 5. How to store SIDIPAST 6. Contents of the pack and other information 1. WHAT SIDIPAST IS AND WHAT IT IS USED FOR SIDIPAST 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 [PRODUCT NAME] 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 heart. Medicines called _iron chelators _are used to Прочетете целия документ
1. NAME OF THE MEDICINAL PRODUCT SIDIPAST 90 mg, filmomhulde tabletten SIDIPAST 180 mg, filmomhulde tabletten SIDIPAST 360 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg deferasirox. Excipient(s) with known effect Each film-coated tablet contains 1.16 mg lactose monohydrate. Each film-coated tablet contains 180 mg deferasirox. Excipient(s) with known effect Each film-coated tablet contains 1.54 mg lactose monohydrate. Each film-coated tablet contains 360 mg deferasirox. Excipient(s) with known effect Each film-coated tablet contains 3.08 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Light blue, oval biconvex film-coated tablet, approximately 10 mm long by 6 mm wide and debossed with ‘D7FX’ on one side and ‘90’ on the other. Medium blue, oval biconvex film-coated tablet, approximately 13 mm long by 7 mm wide and debossed with ‘D7FX’ on one side and ‘180’ on the other. Blue, oval biconvex film-coated tablet, approximately 15 mm long by 9 mm wide and debossed with ‘D7FX’ on one side and ‘360’ on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SIDIPAST 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. SIDIPAST 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 (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 ye Прочетете целия документ