Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
CAMBER LABORATORIES SDN. BHD.
IMATINIB MESYLATE
3 x 10s Tablets
Hetero Labs Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ IMATERO 100 (IMATINIB TABLET 100MG) IMATERO 400 (IMATINIB TABLET 400MG) Imatinib Mesylate (100mg/400mg) 1 WHAT IS IN THIS LEAFLET 1. What IMATERO is used for 2. How IMATERO works 3. Before you use IMATERO 4. How to use IMATERO 5. While you are using it 6. Side effects 7. Storage and Disposal of IMATERO 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IMATERO IS USED FOR IMATERO is a medicine to treat cancer. IMATERO is a treatment for adults and children for: - chronic myeloid leukaemia (CML). - acute lymphoblastic leukaemia (ALL) with Philadelphia chromosome positive (Ph-positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. CML and ALL are cancers of the blood which makes the body produce too many abnormal white blood cells IMATERO is also a treatment for adults for: • certain types of gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. • Certain types of dermato- fibrosarcoma protuberans (DFSP). They arise from uncontrolled cell growth. • Certain types of myelodysplastic/myeloproliferative diseases (MDS/MPD), a group of blood diseases which make the body produce too many abnormal blood cells. • Certain types of aggressive systemic mastocytosis (ASM). • Hypereosinophilic syndrome (HES)and/or chronic eosinophilic leukemia (CEL), blood diseases which make the body produce too many blood cells. HOW IMATERO WORKS IMATERO works by slowing the growth of abnormal cells. IMATERO kills the abnormal cells while leaving normal cells alone in the diseases listed above. If you have any questions about how IMATERO works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE IMATERO Your IMATERO treatment will be prescribed by a doctor with experience in the use of anticancer therapies. Follow all the doctor’s instructions carefully. They may differ from the general information contained in this Perskaitykite visą dokumentą
IMATERO 100 (IMATINIB TABLETS 100MG) IMATERO 400 (IMATINIB TABLETS 400MG) ACTIVE INGREDIENT IMATERO 100 Each film-coated tablet contains 100mg imatinib. IMATERO 400 Each film-coated tablet contains 400mg imatinib. DOSAGE FORM Oral film coated Tablets PRODUCT DESCRIPTIONS IMATERO 100 White to off white coloured, round, bevel edged scored film coated tablets, debossed with H on one side and 19 on the other side, 1 and 9 separated by a score line. IMATERO 400 White to off white coloured, capsule shaped, bevel edged scored film coated tablets, debossed with H on one side and 20 on the other side, 2 and 0 separated by a score line. PHARMACODYNAMICS Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC code: L01EA01 Mechanism of action Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the BCR-ABL tyrosine kinase (TK), as well as several receptor TKs: KIT, the receptor for stem cell factor (SCF) coded for by the c- KIT proto-oncogene, the discoidin domain receptors (DDR1) and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta). Imatinib can also inhibit cellular events mediated by activation of these receptor kinases. Pharmacodynamic effects Imatinib is a protein-tyrosine kinase inhibitor, which potently inhibits the breakpoint cluster region-Abelson (BCR- ABL) tyrosine kinase at the in vitro, cellular, in vivo levels. The compound selectively inhibits proliferation and induces apoptosis in BCR-ABL positive cell lines as well as fresh leukemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukemia (ALL) patients. In colony transformation assays using ex vivo peripheral blood and bone marrow samples, imatinib shows selective inhibition of BCR-ABL positive colonies from CML patients. In vivo the compound shows anti-tumour activity as a single agent in animal models using BCR-ABL positive tumour cells. Imatinib is also an inhibitor of the Perskaitykite visą dokumentą