Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
ACCORD HEALTHCARE SDN.BHD.
IMATINIB MESYLATE
3X10 Tablets
INTAS PHARMACEUTICALS LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ ACCORD IMATINIB TABLET Imatinib (100mg & 400mg) 1 WHAT IS IN THIS LEAFLET 1. What Accord Imatinib tablet is used for 2. How Accord Imatinib tablet works 3. Before you use Accord Imatinib tablet 4. How to take Accord Imatinib tablet 5. While you are using Accord Imatinib tablet 6. Side effects 7. Storage and disposal of Accord Imatinib tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ACCORD IMATINIB IS USED FOR Accord Imatinib is indicated in treatment of some types of cancer. Accord Imatinib is a treatment for adults and children and adolescents 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, it is intended for use in the most advanced phase of the disease (blast crisis). In children and adolescents, it can be used in different phases of the disease (chronic, accelerated phase and blast crisis). • 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. Accord Imatinib inhibits the growth of these cells. Accord Imatinib is a treatment for adults for: • Myelodysplastic/myeloproli ferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Accord Imatinib inhibits the growth of these cells in a certain subtype of these diseases. • Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Accord Imatinib in Læs hele dokumentet
PACKAGE INSERT ACCORD IMATINIB 100 & 400 (IMATINIB TABLETS 100 & 400 MG) NAME AND STRENGTH OF ACTIVE INGREDIENT ACCORD IMATINIB 100: Imatinib Mesilate 119.5 mg equivalent to Imatinib….. 100 mg ACCORD IMATINIB 400: Imatinib Mesilate 478 mg equivalent to Imatinib….. 400 mg PRODUCT DESCRIPTION ACCORD IMATINIB 100: Brownish orange, round, biconvex, film-coated tablets, debossed with ‘IM’ and “T1” on either side of breakline on one side and plain on other side. The breakline is not intended for breaking the tablet. ACCORD IMATINIB 400: Brownish orange, oval shaped, biconvex, film-coated tablets, debossed with “IM” and “T2” on either side of breakline on one side and plain on the other side. The breakline is not intended for breaking the tablet. PHARMACODYNAMIC PROPERTIES 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 protooncogene, 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 Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels. The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients. The compound shows anti-tumour activity as a single agent. Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF-mediated cellular events. Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as Læs hele dokumentet