Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
PHARMAFORTE (MALAYSIA) SDN. BHD.
IMATINIB MESYLATE
30tablet Tablets
APOTEX INC
APO-IMATINIB TABLETS Imatinib Mesylate (100mg, 400mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Apo-Imatinib is used for 2. How Apo-Imatinib works 3. Before you use Apo-Imatinib 4. How to use Apo-Imatinib 5. While you are using it 6. Side effects 7. Storage and Disposal of Apo- Imatinib 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT APO-IMATINIB IS USED FOR Apo-Imatinib 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 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. Apo-Imatinib inhibits the growth of these cells. Apo-Imatinib 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. Apo- 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. Apo-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. Apo-Imatinib in Läs hela dokumentet
APO‐IMATINIB 100MG AND 400MG TABLETS Imatinib Mesylate Tablets PRODUCT DESCRIPTION 100 MG: Brownish orange, round biconvex, beveled‐edge film‐ coated tablets. Engraved "IMA" over score "100" on one side, "APO" on the other side. 400 MG: Brownish orange, capsule shaped, biconvex film‐ coated tablets. Engraved "IMA" score "400" on one side, "APO" on the other side. PHARMACOLOGY Pharmacodynamics: 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 _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 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 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. _In _ _vitro_, 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 o Läs hela dokumentet