Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
DUOPHARMA HAPI SDN. BHD.
IMATINIB MESYLATE
30 Tablets
DUOPHARMA HAPI SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 TREVIVE TABLET Imatinib Mesylate (100mg, 400mg) WHAT IS IN THE LEAFLET 1. What _Trevive_ is used for 2. How _Trevive _ works 3. Before you use _Trevive_ 4. How to use _Trevive_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Trevive_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT _TREVIVE_ IS USED FOR _Trevive_ 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. In adult patients, _Trevive_ is intended for use in the most advanced phase of the disease (blast crisis). In children and adolescents, _Trevive_ can be used in different phases of the disease (chronic, accelerated phase and blast crisis). • PHILADELPHIA CHROMOSOME POSITIVE ACUTELYMPHOBLASTIC 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. _Trevive_ inhibits the growth of these cells. _Trevive _ is a treatment for adults for: • MYELODYSPLASTIC/MYELOPROLIFER ATIVE DISEASES (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. _Trevive_ inhibits the growth of these cells in a certain subtype of these diseases. • HYPEREOSINOPHILIC SYNDROME (HES) AND/OR CHRONICEOSINOPHILIC LEUKAEMIA (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. _Trevive_ 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 g Aqra d-dokument sħiħ
[DUOPHARMA (M) SDN BHD] TREVIVE TABLETS IMATINIB MESYLATE TABLETS DESCRIPTION: TREVIVE TABLETS 100 MG: Brownish, round, biconvex, film coated tablets debossed with "100" on one side, and score line on the other side with "C" on one side of the score line and "I" on the other side of the score line. TREVIVE TABLETS 400 MG: Brownish, oval, biconvex, film coated tablets debossed with "400" on one side and "CI" on the other side. COMPOSITION: TREVIVE TABLETS 100 MG: Each film-coated tablet contains imatinib mesylate equivalent to imatinib 100 mg TREVIVE TABLETS 400 MG: Each film-coated tablet contains imatinib mesylate equivalent to imatinib 400 mg PHARMACODYNAMICS: Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC code: L01XE01 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. Pharmacodynamics 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. 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 BcrAbl positive tumour cells. Imatinib is also an inhibitor of the receptor tyrosi Aqra d-dokument sħiħ