国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Imatinib
Wockhardt UK Limited
L01X
Imatinib
400 milligram(s)
Film-coated tablet
oral use
10, 30 and 90 film-coated tablets.
Product subject to prescription which may not be renewed (A)
CP Pharmaceuticals Ltd
protein-tyrosine kinase inhibitor
OTHER ANTINEOPLASTIC AGENTS
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 or blast crisis. adult patients 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. adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) an
Not marketed
2015-09-25
PACKAGE LEAFLET: INFORMATION FOR THE USER IMATINIB 100MG FILM-COATED TABLETS IMATINIB 400MG FILM-COATED TABLETS Imatinib (referred to as Imatinib Tablets in the remainder of this leaflet) 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 Tablets are and what they are used for 2. What you need to know before you take Imatinib Tablets 3. How to take Imatinib Tablets 4. Possible side effects 5. How to store Imatinib Tablets 6. Contents of the pack and other information 1. WHAT IMATINIB TABLETS ARE AND WHAT THEY ARE USED FOR Imatinib Tablets 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 TABLETS 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 Tablets inhibits the growth of these cells. IMATINIB TABLETS IS ALSO A TREATMENT FOR A 阅读完整的文件
Health Products Regulatory Authority 08 January 2020 CRN0095LK Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imatinib 400mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400mg imatinib (as mesilate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Brownish, oval, biconvex, film-coated tablets embossed with 400 on one side and NI on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib 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 lymophoblastic 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 rearrangment. adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery The effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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 response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response 阅读完整的文件