Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk
Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)
L01XE01
IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Imatinib
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2015-02-25
PACKAGE LEAFLET: INFORMATION FOR THE USER IMATINIB DEVATIS 100 MG FILMOMHULDE TABLETTEN IMATINIB DEVATIS 400 MG FILMOMHULDE TABLETTEN Imatinib mesilate 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Imatinib Devatis is and what it is used for 2. What you need to know before you take Imatinib Devatis 3. How to take Imatinib Devatis 4. Possible side effects 5. How to store Imatinib Devatis 6. Contents of the pack and other information 1. WHAT IMATINIB DEVATIS IS AND WHAT IT IS USED FOR Imatinib Devatis is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer. IMATINIB DEVATIS IS A TREATMENT FOR ADULTS AND CHILDREN FOR: - CHRONIC MYELOID LEUKAEMIA (CML). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control. - PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA (PH-POSITIVE ALL) . Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib Devatis inhibits the growth of these cells. IMATINIB DEVATIS IS ALSO A TREATMENT FOR ADULTS FOR: - MYELODYSPLASTIC/MYELOPROLIFERA Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imatinib Devatis 100 mg filmomhulde tabletten Imatinib Devatis 400 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg imatinib (as mesilate). Each film-coated tablet contains 400 mg imatinib (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 100 mg Tablets: Dark yellow to brownish-orange coloured, round, score on one side, biconvex film-coated tablets and with a diameter of 10.1 mm. approximately. The tablet can be divided into two equal doses. 400 mg Tablets: Dark yellow to brownish-orange coloured, capsule-shaped, biconvex film-coated tablets with dimensions 21.3 mm x 9.6 mm approximately. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib is indicated for the treatment of - adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. - adult patients with relapsed or refractory Ph+ ALL as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement. The effect of imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib is indicated for - the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). - the adjuva Lees het volledige document