Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Imatinib mesilate
KRKA, d.d., Novo mesto
L01XE; L01XE01
Imatinib mesilate
100 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Protein kinase inhibitors; imatinib
Marketed
2016-01-15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMATINIB KRKA D.D. 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 Krka d.d. is and what it is used for 2. What you need to know before you take Imatinib Krka d.d. 3. How to take Imatinib Krka d.d. 4. Possible side effects 5. How to store Imatinib Krka d.d. 6. Contents of the pack and other information 1. WHAT IMATINIB KRKA D.D. IS AND WHAT IT IS USED FOR Imatinib Krka d.d. 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 KRKA D.D. 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 Krka d.d. inhibits the growth of these cells. IMATINIB KRKA D.D. IS ALSO A TREATMENT FOR ADULTS FOR: - MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD). These are Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 05 October 2022 CRN00D38C Page 1 of 29 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imatinib Krka d.d 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg imatinib (as mesilate). Excipient with known effect: Each film-coated tablet contains 114 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Orange-brown, round (diameter 11 mm), slightly biconvex film-coated tablets with bevelled edges and a score line on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imatinib Krka d.d. 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 Krka d.d. on the outcome of bone marrow transplantation has not been determined. Imatinib Krka d.d. 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 follow Διαβάστε το πλήρες έγγραφο