Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Imatinib mesilate
Rowex Ltd
L01XE; L01XE01
Imatinib mesilate
400 milligram(s)
Film-coated tablet
oral use
Pack size: 10, 30 and 90 tablets
Product subject to prescription which may not be renewed (A)
Lek Pharmaceuticals d.d
protein-tyrosine kinase inhibitor
Protein kinase inhibitors; imatinib
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-PDGFR rearrangement. adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurre
Marketed
2015-12-04
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMATINIB ROWEX 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, 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: • MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD) . These are a group of blood diseases in Les hele dokumentet
HealthProductsRegulatoryAuthority 10February2023 CRN00D9R5 Page1of29 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ImatinibRowex400mgFilm-coatedtablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachfilm-coatedtabletcontains400mgofimatinib(asmesilate). Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Film-coatedtablet. Verydarkyellowtobrownishorange,ovaloid,biconvexwithbevellededges,debossedwith“400”ononesideandscoreonthe othersideandSLoneachsideofthescore.Approximatelength19.2mmandwidth7.7mm. Thefilm-coated tabletcanbedividedintoequaldoses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ImatinibRowexisindicatedforthetreatmentof adultandpaediatricpatientswithnewlydiagnosedPhiladelphiachromosome(bcr-abl)positive(Ph+)chronic myeloidleukaemia(CML)forwhombonemarrowtransplantationisnotconsideredasthefirstlineoftreatment. adultandpaediatricpatientswithPh+CMLinchronicphaseafterfailureofinterferon-alphatherapy,orin acceleratedphaseorblastcrisis. adultandpaediatricpatientswithnewlydiagnosedPhiladelphiachromosomepositiveacutelymphoblastic leukaemia(Ph+ALL)integratedwithchemotherapy. adultpatientswithrelapsedorrefractoryPh+ALLasmonotherapy. adultpatientswithmyelodysplastic/myeloproliferativediseases(MDS/MPD)associatedwithplatelet-derived growthfactorreceptor(PDGFR)genere-arrangements. adultpatientswithadvancedhypereosinophilicsyndrome(HES)and/orchroniceosinophilicleukaemia(CEL)with FIP1L1-PDGFRαrearrangement. Les hele dokumentet