מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
IMATINIB
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
L01XE01
IMATINIB 100 mg
FILM-COATED TABLET
IMATINIB 100 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2014-08-01
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMATINIB FAIR-MED 100 MG FILM-COATED TABLETS 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 Imatinib Fair-Med is and what it is used for 2. What you need to know before you take Imatinib Fair-Med 3. How to take Imatinib Fair-Med 4. Possible side effects 5. How to store Imatinib Fair-Med 6. Contents of the pack and other information 1. WHAT IMATINIB FAIR-MED IS AND WHAT IT IS USED FOR Imatinib Fair-Med 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 FAIR-MED 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 b קרא את המסמך השלם
Page 1 of 23 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imatinib Fair-Med 100 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg imatinib (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 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. 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. • adult and paediatric 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-PDGFR α 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 קרא את המסמך השלם