国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk
Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)
L01XE01
IMATINIBMESILAAT 478 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 400 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B),
Oraal gebruik
Imatinib
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B);
2012-11-22
11/23 EPAR 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMAKREBIN 100 MG FILMOMHULDE TABLETTEN IMAKREBIN 400 MG FILMOMHULDE TABLETTEN imatinib 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 Imakrebin is and what it is used for 2. What you need to know before you take Imakrebin 3. How to take Imakrebin 4. Possible side effects 5. How to store Imakrebin 6. Contents of the pack and other information 1. WHAT IMAKREBIN IS AND WHAT IT IS USED FOR Imakrebin 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. IMAKREBIN 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 inhibits the growth of these cells. IMAKREBIN IS ALSO A TREATMENT FOR ADULTS FOR: - MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are a group of blood diseases in which so 阅读完整的文件
11/23 EPAR 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Imakrebin 100 mg filmomhulde tabletten Imakrebin 400 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Imakrebin 100 mg film-coated tablets Each film-coated tablet contains 100 mg imatinib (as imatinib mesilate). Imakrebin 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as imatinib mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Imakrebin 100 mg film-coated tablets Dark yellow to brownish-orange, round shaped, film-coated tablets of 10.1 mm (± 5%) diameter with a break-line on one side and ‘100’ on the other side. The tablet can be divided into equal doses. Imakrebin 400 mg film-coated tablets Dark yellow to brownish-orange, ovaloid shaped, film-coated tablets, 21.6 mm long and 10.6 mm wide (± 5%) with a break-line on one side and ‘400’ on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imakrebin 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-PDGFR rearrangement. The effect of imatinib on the outcome of bo 阅读完整的文件