Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PACLITAXEL
MYLAN HEALTHCARE SDN. BHD.
PACLITAXEL
5ml mL; 16.7ml mL; 50ml mL
Mylan Laboratories Limited (OTL)
COMPOSITION: Each mL contains Paclitaxel 6 mg. PRODUCT DESCRIPTION: Clear, colorless to slightly yellow viscous solution free from visible particles. PHARMACOLOGY: Paclitaxel is an antimicrotubule antineoplastic agent. It promotes microtubule assembly by enhancing the polymerisation of tubulin, the protein subunit of spindle microtubules even in the absence of the mediators normally required for microtubule assembly (eg, guanosine triphosphate [GTP]) thereby inducing the formation of stable, non-functional microtubules. While the precise mechanism of action of the drug is not completely known, paclitaxel disrupts the dynamic equilibrium within the microtubule system and blocks cells in the late G2 phase and M phase of the cell cycle, inhibitting cell replicaton and impairing function of nervous tissue. PHARMACOKINETICS Following intravenous administration, Paclitaxel exhibits a biphasic decline in plasma concentrations. The 1 st phase shows rapid decline representing distribution of Paclitaxel to the peripheral compartment and elimination. This initial phase is followed by a relatively slow elimination of Paclitaxel from the peripheral compartment. The following ranges for the pharmacokinetic parameters have been determined in patients given doses of 135 and 175 mg/m 2 as 3- and 24-hr infusions of Paclitaxel: Mean terminal half-life: 3-52.7 hrs; total body clearance: 11.6-24 L/hr/m 2 ; mean steady-state volume of distribution: 198-688 L/m 2 . These indicate extensive distribution of Paclitaxel outside the vascular system and/ or tissue binding. The following mean values for the pharmacokinetic have been reported following a 3-hr infusion of 175 mg/m 2 Paclitaxel: Mean terminal half-life: 9.9 hrs; mean total body clearance: 12.4 L/hr/m 2 . The serum protein-binding of paclitaxel is 89%. The liver is thought to be the primary site of metabolism for Paclitaxel. The mean cumulative urinary recovery of unchanged Pactitaxel has been reported as 1.8-12.6% of the dose. INDICATIONS: Paclitaxel is indicated in the primary Perskaitykite visą dokumentą