Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
ABG PHARMA SDN BHD
IMATINIB MESYLATE
60 Capsules
JOINT-STOCK COMPANY GRINDEKS
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ IMATINIB GRINDEKS 100MG HARD CAPSULE _IMATINIB (AS MESYLATE) _100MG Page 1 WHAT IS IN THIS LEAFLET 1. What Imatinib Grindeks is used for 2. How Imatinib Grindeks works 3. Before you use Imatinib Grindeks 4. How to use Imatinib Grindeks 5. While you are using it 6. Side effects 7. Storage and Disposal of Imatinib Grindeks 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT IMATINIB GRINDEKS IS USED FOR Imatinib Grindeks is a medicine containing an active substance called imatinib. Imatinib Grindeks is used in the treatment for adult 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 Grindeks inhibits the growth of these cells Imatinib Grindeks is also used in the treatment for adult for: • Myelodysplastic/myeloproliferativ e diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Grindeks 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. Imatinib Grindeks inhibits the growth of these cells in a certain subtype of these diseases. • Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth Belgenin tamamını okuyun
PACK INSERT 1. PRODUCT NAME Imatinib Grindeks 100 mg hard capsules 2. NAME AND STRENGTH OF ACTIVE INGREDIENT Each hard capsule contains imatinib mesilate corresponding to 100 mg of imatinib. 3. PRODUCT DESCRIPTION Brownish-orange hard gelatine capsules. The content – white to light yellow or brownish yellow powder. 4. PHARMACODYNAMICS 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 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 Bcr-Abl tyrosine kinase at the, cellular 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 in animal models using Bcr- Abl positive tumour cells. Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF- R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events. Imatinib inhibits proliferation and induces apoptosis in gastrointestinal stromal tumour (GIST) cells, which express an activating kit mutation. Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP. Imatinib inhibits signalling and proliferation of cells dr Belgenin tamamını okuyun