Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Imatinib mesilate
Wockhardt UK Ltd
L01XE01
Imatinib mesilate
400mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5012727912721 5012727913018
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • New regulatory text 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 ADULTS FOR: • MYELODYSPLASTIC/MYELOPROLIFERATIVE DI Citiți documentul complet
OBJECT 1 IMATINIB 400MG FILM-COATED TABLETS Summary of Product Characteristics Updated 22-Aug-2017 | Wockhardt UK Ltd 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 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. • 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 ob Citiți documentul complet