Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
IMATINIB MESILATE
Rowex Ltd Newtown Bantry, Co. Cork, , Ireland
L01EA
IMATINIB MESILATE 100 mg
FILM-COATED TABLET
IMATINIB MESILATE 100 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2021-01-28
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMATINIB ROWEX 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 Rowex is and what it is used for 2. What you need to know before you take Imatinib Rowex 3. How to take Imatinib Rowex 4. Possible side effects 5. How to store Imatinib Rowex 6. Contents of the pack and other information 1. WHAT IMATINIB ROWEX IS AND WHAT IT IS USED FOR Imatinib Rowex 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 ROWEX 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 Rowex inhibits the growth of these cells. IMATINIB ROWEX IS ALSO A TREATMENT FOR ADULTS FOR: Page 2 of 9 • MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD) . These are a group Leggi il documento completo
Page 1 of 39 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imatinib Rowex100 mg film-coated tablets _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of imatinib (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Very dark yellow to brownish orange, round, biconvex with bevelled edges, debossed with “NVR” on one side and “SA” and score between the letters on the other side. Approximate diameter 9.2 mm. Very dark yellow to brownish orange, ovaloid, biconvex with bevelled edges, debossed with “400” on one side and score on the other side and SL on each side of the score. Approximate length 19.2 mm and width 7.7 mm. The film-coated tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib Rowex 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 on the outcome of bone marrow transplantation has not been determined. Page 2 of 39 Imatinib Rowex is indicated for • the treatment of adult patients with Kit (CD117)-positive unresectable and/or metastatic Leggi il documento completo