Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMATINIB MESYLATE
CIPLA MALAYSIA SDN BHD
IMATINIB MESYLATE
30 Tablets
CIPLA LTD
IMATIB FILM COATED TABLETS _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ IMATINIB MESILATE (100 MG, 400 MG) _______________________________________________________________________________ Page | 1 WHAT IS IN THIS LEAFLET 1. What Imatib is used for 2. How Imatib works 3. Before you use Imatib 4. How to use Imatib 5. While you are using Imatib 6. Side effects 7. Storage and Disposal of Imatib 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT IMATIB IS USED FOR Imatib is a medicine to treat cancer. Imatib is a treatment for adults and children for : • Chronic myeloid leukaemia (CML) • Acute lymphoblastic leukemia (ALL) with Philadelphia chromosome positive (Ph- positive ALL). _ _ Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. CML and ALL are cancers of the blood which makes the body produce too many abnormal white blood cells. Imatib is also a treatment for adults for: • Certain types of gastrointestinal stromal tumors (GIST). GIST are cancers of the stomach and the bowels. _ _ • Certain types of dermatofibrosarcoma protuberans (DFSP). _ _ They arise from uncontrolled cell growth. _ _ • Certain types of myelodysplastic/myeloproliferati ve diseases (MDS/MPD) , a group of blood diseases which make the body produce too many abnormal blood cells. • Certain types of aggressive systemic mastocytosis (ASM). • Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL), blood diseases which make the body produce too many blood cells. HOW IMATIB WORKS Imatib works by slowing the growth of abnormal cells. Imatib kills the abnormal cells while leaving normal cells alone in the diseases listed above. If you have any questions about how Imatib works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE IMATIB Your Imatib treatment will be prescribed by a doctor with experience in the use of anticancer therapies. Follow all the doctor’s instructi Lugege kogu dokumenti
1 _For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only OR for Specialist _ _Use only _ IMATIB 100 MG FILM COATED TABLETS IMATIB 400 MG FILM COATED TABLETS Imatinib mesilate 100 / 400 mg COMPOSITION Imatinib mesilate 100 mg Each film coated tablet contains imatinib mesilate equivalent to imatinib 100 mg Imatinib mesilate 400 mg Each film coated tablet contains imatinib mesilate equivalent to imatinib 400 mg DOSAGE FORM Film Coated Tablet PRODUCT DESCRIPTION Imatinib mesilate 100 mg, divisible Very dark yellow to brownish orange, film coated tablets, round, biconvex with bevelled edges, debossed with "C211"on one side with score on other side. Imatinib mesilate 400 mg, divisible Very dark yellow to brownish orange, film coated tablets, Ovaloid, biconvex with bevelled edges, debossed with "C212" on one side with score on other side. The tablet can be divided into equal doses. PHARMACOLOGY _ _ _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. 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. _ _ 2 Imatinib is also an inhibitor of the receptor tyros Lugege kogu dokumenti