Држава: Холандија
Језик: Холандски
Извор: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IMATINIBMESILAAT SAMENSTELLING overeenkomend met ; IMATINIB
Devatis GmbH
L01XE01
IMATINIBMESILAAT COMPOSITION corresponding to ; IMATINIB
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 200 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. In adult patients Imatinib Devatis is used to treat a late stage of chronic myeloid leukaemia called „blast crisis“. In children and adolescents however it may be used to treat all stages of the illness. - 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 leukae Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imatinib Devatis 100 mg filmomhulde tabletten Imatinib Devatis 200 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 200 mg imatinib (as mesilate) Each film-coated tablet contains 400 mg imatinib (as mesilate) 3. PHARMACEUTICAL FROM 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. 200 mg Tablets: Dark yellow to brownish-orange coloured, capsule-shaped, biconvex film-coated tablets with dimensions 17.3 mm x 8.4 mm approximately. 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 - 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. - paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult patients with Ph+ CML in 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 Прочитајте комплетан документ