Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Imatinib mesilate 119.5mg equivalent to Imatinib 100 mg
Apotex NZ Ltd
Imatinib mesilate 119.5 mg (= Imatinib 100 mg)
100 mg
Film coated tablet
Active: Imatinib mesilate 119.5mg equivalent to Imatinib 100 mg Excipient: Colloidal silicon dioxide Crospovidone Hyprolose Hypromellose Iron oxide red Iron oxide yellow Macrogol 8000 Magnesium stearate
Prescription
Apotex Pharmachem Inc
Treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+CML). Treatment of adult and paediatic patients with Ph+CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
Package - Contents - Shelf Life: Blister pack, Alu/Alu cold form in outer cardboard carton - 20 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Alu/Alu cold form in outer cardboard carton - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Alu/Alu cold form in outer cardboard carton - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Alu/Alu cold form in outer cardboard carton - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Alu/Alu cold form in outer cardboard carton - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, 75cc round, white, opaque HDPE with blue PP child resistant cap and desiccant - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, 75cc round, white, opaque HDPE with blue PP child resistant cap and desiccant - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, 75cc round, white, opaque HDPE with blue PP screw cap and desiccant - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, 75cc round, white, opaque HDPE with blue PP screw cap and desiccant - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture
2012-05-24
NEW ZEALAND DATA SHEET APO-IMATINIB IMATINIB 100MG AND 400MG TABLETS Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 PRESENTATION Apo-Imatinib 100mg: Brownish orange, round biconvex, bevelled-edge, film-coated tablets. Engraved “IMA” over score “100” on one side, “APO” on the other side. Apo-Imatinib 400mg: Brownish orange, capsule shaped biconvex film-coated tablets. Engraved “IMA” score “400” on one side, “APO” on the other side. USES ACTIONS Imatinib mesilate referred further as “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 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 Bcr-Abl positive tumour cells. Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF) 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 PDGFR or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP. In addition, constitutive activation of c-Kit or the PDGFR has been implicated in the pathogenesis of SM. Imatinib inhibits signalling and proliferation of cells driven by dysregulated PDGFR, Kit and Baca dokumen lengkapnya