Страна: Малта
Език: английски
Източник: Malta Medicines Authority
TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany
L01EA01
IMATINIB MESILATE 400 mg
FILM-COATED TABLET
IMATINIB MESILATE 400 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-06-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMATINIB TAD 100 MG FILM-COATED TABLETS IMATINIB TAD 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 TAD is and what it is used for 2. What you need to know before you take Imatinib TAD 3. How to take Imatinib TAD 4. Possible side effects 5. How to store Imatinib TAD 6. Contents of the pack and other information 1. WHAT IMATINIB TAD IS AND WHAT IT IS USED FOR Imatinib TAD 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 TAD 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 TAD inhibits the growth of these cells. IMATINIB TAD IS ALSO A TREATMENT FOR ADULTS FOR: - MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are a group of blood di Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imatinib TAD 100 mg film-coated tablets Imatinib TAD 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 mg film-coated tablets Each film-coated tablet contains 100 mg imatinib (as mesilate). Excipient with known effect: Each film-coated tablet contains 114 mg lactose (as monohydrate). 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as mesilate). Excipient with known effect: Each film-coated tablet contains 456 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) 100 mg: Orange-brown, round (diameter 11 mm), slightly biconvex film-coated tablets with bevelled edges and a score line on one side. The tablet can be divided into equal doses. 400 mg: Orange brown, oval (dimensions: 22 mm x 9 mm), biconvex film-coated tablets. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib TAD 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-PDGFRα rearrangement. The effect of Imatinib TAD on the outcome of bone marrow transplantation has not been determined. Imatinib TAD is indic Прочетете целия документ