البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
IMATINIB
hameln rds GmbH Langes Feld 13, 31789 Hameln, Germany
L01XE01
IMATINIB 400 mg
FILM-COATED TABLET
IMATINIB 400 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2014-05-05
PACKAGE LEAFLET: INFORMATION FOR THE USER Imatinib Siegfried 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, 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 Siegfried is and what it is used for 2. What you need to know before you take Imatinib Siegfried 3. How to take Imatinib Siegfried 4. Possible side effects 5. How to store Imatinib Siegfried 6. Contents of the pack and other information 1. WHAT IMATINIB SIEGFRIED IS AND WHAT IT IS USED FOR Imatinib Siegfried 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 SIEGFRIED 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 Siegfried 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 leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphobla اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imatinib Siegfried 100 mg film-coated tablets Imatinib Siegfried 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Imatinib Siegfried 100 mg film-coated tablets: Each film-coated tablet contains 100 mg imatinib (as mesilate). Imatinib Siegfried 400 mg film-coated tablets: 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 Imatinib Siegfried 100 mg film-coated tablets are round tablets with light brown film coating and a diameter of 8 mm, score on one side, debossed with “IM” on the same side and with “100” on the other side. Imatinib Siegfried 400 mg film-coated tablets are oval tablets with light brown film coating, 17 mm long and 8 mm wide, score on both sides, debossed with “IM” on one side and with “400” on the other side. The tablets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib Siegfried 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 اقرأ الوثيقة كاملة