Land: Malta
Språk: engelsk
Kilde: Medicines Authority
IMATINIB
Generics UK Limited
L01XE01
IMATINIB
FILM-COATED TABLET
IMATINIB 400 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMATINIB MYLAN 400 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 or pharmacist. 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 Mylan is and what it is used for 2. What you need to know before you take Imatinib Mylan 3. How to take Imatinib Mylan 4. Possible side effects 5. How to store Imatinib Mylan 6. Contents of the pack and other information 1. WHAT IMATINIB MYLAN IS AND WHAT IT IS USED FOR Imatinib Mylan 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 MYLAN IS A TREATMENT FOR ADULTS AND CHILDREN WITH 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 Mylan 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. IMATINIB MYLAN IS ALSO A TREATMENT FOR ADULTS FOR: 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 w Les hele dokumentet
Page 1 of 29 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imatinib Mylan 400 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 Dark yellow to brownish-orange, ovaloid shaped, film-coated tablets, 21.6 mm long & 10.6mm 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 Imatinib Mylan 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 with Ph+ CML in blast crisis. adult 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 Imatinb Mylan on the outcome of bone marrow transplantation has not been determined. Page 2 of 29 the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic re Les hele dokumentet