Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Imatinib mesylate
Koanaa Healthcare Limited
L01XE; L01XE01
Imatinib mesylate
400 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Protein kinase inhibitors; imatinib
Not marketed
2017-08-04
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER IMATINIB KOANAA 100 MG FILM-COATED TABLETS IMATINIB KOANAA 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 or 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 Koanaa film-coated tablets is and what it is used for 2. What you need to know before you take Imatinib Koanaa film-coated tablets 3. How to take Imatinib Koanaa film-coated tablets 4. Possible side effects 5. How to store Imatinib Koanaa film-coated tablets 6. Contents of the pack and other information 1. WHAT IMATINIB KOANAA FILM-COATED TABLETS IS AND WHAT IT IS USED FOR Imatinib Koanaa film-coated 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 KOANAA FILM-COATED TABLETS IS A TREATMENT 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 Koanaa film-coated tablets 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. IMATINIB KOANAA FILM-COATED TABLETS IS A TREATMENT FOR ADULTS AND CHILDREN FOR: − PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLA Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 30 November 2020 CRN00C245 Page 1 of 26 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imatinib Koanaa 400 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of Imatinib (as mesilate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet: Dark yellow to brownish orange coloured, film-coated tablets, round (7.00 mm), biconvex with bevelled edges debossed with ’ S’ and ‘1’ on either side of break line on one side and plain on other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 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 is indicated for the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit Olvassa el a teljes dokumentumot