국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
UNIMED SDN BHD
IMATINIB MESYLATE
30 Tablets; 60 Tablets
Shilpa Medicare Limited
IMAMED 100 & 400 Imatinib Mesylate Tablets 100mg / Imatinib Mesylate Tablets 400mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What IMAMED is used for 2. How IMAMED works 3. Before you use IMAMED 4. How to use IMAMED 5. While you are using it 6. Side effects 7. Storage and Disposal of IMAMED 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT IMAMED IS USED FOR IMAMED 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. IMAMED is also a treatment for adults 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 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 o 전체 문서 읽기
45xxxxx xxx 45xxxxx xxx Size: 170 x 600 mm Folding Size: 170 x28 mm Font Name: Times New Roman Font Size: 7 pt R05 : 07.12.2022 Market: ROW (Malaysia) Designed by: Krishna Nooli IMATINIB TABLETS 100 MG AND IMATINIB TABLETS 400 MG PRODUCT NAME Imamed 100 Imatinib Mesylate Tablets 100 mg Imamed 400 Imatinib Mesylate Tablets 400 mg NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Imatinib Mesylate 100 mg Each film coated tablet contains Imatinib Mesylate equivalent to Imatinib ...100 mg Imatinib Mesylate 400 mg Each film coated tablet contains Imatinib Mesylate equivalent to Imatinib ...400 mg PRODUCT DESCRIPTION Imatinib Mesylate Tablets 100 mg: Dark yellow to brownish orange colored, film coated tablets, round, biconvex with bevelled edges debossed with ‘S’ and ‘1’ on either side of break line on one side and plain on other side. Imatinib Mesylate Tablets 400 mg: Dark yellow to brownish orange colored, film coated tablets, capsule shaped, biconvex with bevelled edges debossed with ‘S’ and ‘2’ on either side of break line on one side and plain on other side. PHARMACODYNAMICS Imatinib is a protein-tyrosine kinase inhibitor, which potently inhibits the breakpoint cluster region-Abelson (BCR-ABL) tyrosine kinase at the in vitro, cellular, 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 positive CML and acute lymphoblastic leukemia (ALL) patients. In colony transformation assays using ex vivoperipheral blood and bone marrow samples, imatinib shows selective inhibition of BCR-ABL positive colonies from CML patients. In vivo the compound shows anti-tumor activity as a single agent in animal models using BCR-ABL positive tumor cells. Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF) and stem cell factor (SCF), KIT, and inhibits PDGF- and SCF-mediated cellular events. In vitro, imatinib inhibits proliferation and induces apoptosis in 전체 문서 읽기