Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Imatinib mesilate
Actavis Group PTC ehf
L01X
Imatinib mesilate
100 milligram(s)
Film-coated tablet
oral use
Pack sizes: 30, 60, 90 and 120 film-coated tablets.
Product subject to prescription which may not be renewed (A)
Actavis Group PTC ehf
antineoplastic agents, protein kinase inhibitor
OTHER ANTINEOPLASTIC AGENTS
Imatinib Actavis Group 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.
Marketed
2015-10-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER IMATINIB ACTAVIS GROUP 100 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 Actavis Group is and what it is used for 2. What you need to know before you take Imatinib Actavis Group 3. How to take Imatinib Actavis Group 4. Possible side effects 5. How to store Imatinib Actavis Group 6. Contents of the pack and other information 1. WHAT IMATINIB ACTAVIS GROUP IS AND WHAT IT IS USED FOR Imatinib Actavis Group 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 ACTAVIS GROUP 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 Actavis Group is intended for use in the most advanced phase of the disease (blast crisis). In children and adolescents, Imatinib Actavis Group can be used in different phases of the disease (chronic, accelerated phase and blast crisis). 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 lymphoblast read_full_document
Health Products Regulatory Authority 19 August 2019 CRN008JGD Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imatinib Actavis Group 100mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 119.5 mg imatinib mesilate corresponding to 100 mg of imatinib. Excipient with known effect: Each film-coated tablet contains 76 mg lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Imatinib Actavis Group 100 mg film-coated tablets: brownish-orange, round, 10.5 mm in diameter, biconvex, film-coated tablets with no scoring or markings. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib Actavis Group 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 of imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Actavis Group is indicated for - 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 read_full_document