País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
IDAMAN PHARMA MANUFACTURING SDN. BHD.
IMATINIB MESYLATE
30 Tablets
Shilpa Medicare Limited
_Consumer Medication Information Leaflet (RiMUP) _ IMINOX TABLET Imatinib (100 mg, 400 mg) 1 WHAT IS IN THIS LEAFLET 1. What IMINOX is used for 2. How IMINOX works 3. Before you use IMINOX 4. How to use IMINOX 5. While you are using it 6. Side effects 7. Storage and Disposal of IMINOX 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IMINOX IS USED FOR IMINOX 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 blood cells usually help the body to fight infection. Acute lymphoblastic leukaemia in which certain abnormal white blood cells (named lymphoblasts) start growing out of control. Imatinib inhibits the growth of these cells. IMINOX is also a treatment for adults for: • MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD) . These are a group of blood diseases in which some blood cells start growing out of control. 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 eosinophills) start growing out of control. Imatinib 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 of the supporting tissues of these organs. • DERMATOFIBROSARCOMA PROTUBERANS (DFSP) . DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib inhibits the growth of these cells. • AGGRESSIVE SYSTEMIC MASTOCYTOSIS ( Llegiu el document complet
45xxxxx xxx 45xxxxx xxx Front Page 872 mm 170 mm 30 mm Imatinib 100 mg&400 mg - KLD Leaflet Size : 170 x 872 mm Folding size: 170x30 mm Font Size: 8pt NAME OF THE MEDICINE IMINOX TABLET 100MG IMINOX TABLET 400MG COMPOSITION ACTIVE INGREDIENT: IMINOX TABLET 100MG Each film-coated tablet contains imatinib mesilate equivalent to 100mg imatinib. IMINOX TABLET 400MG Each film-coated tablet contains imatinib mesilate equivalent to 400mg imatinib. EXCIPIENTS: 100MG AND 400MG FILM-COATED TABLETS Povidone K-30 (Plasdone K-29/32), Magnesium Stearate, Opadry Brown 02F86982. DESCRIPTION IMINOX TABLET 100MG Dark yellow to brownish orange colored, film coated tablets, round, biconvex with beveled edges debossed with ‘S’ and ‘1’ on either side of break line on one side and plain on other side. IMINOX TABLET 400MG Dark yellow to brownish orange colored, film coated tablets, capsule shaped, biconvex with beveled edges debossed with 'S' and '2' on either side of break line on one side and plain on other side. 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 ofthese 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 and _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 positi Llegiu el document complet