Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Paclitaxel 6 mg/mL
Bristol-Myers Squibb (NZ) Limited
Paclitaxel 6 mg/mL
6 mg/mL
Concentrate for infusion
Active: Paclitaxel 6 mg/mL Excipient: Ethanol Polyoxyl 35 castor oil
Vial, glass, single dose, (not marketed), 5 mL
Prescription
Prescription
Swords Laboratories Limited Subsidiary of Bristol-Myers Squibb Company
Package - Contents - Shelf Life: Vial, glass, single dose, - 5 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 16.7 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 25 mL -
1992-09-18
Taxol V3.0 1 NEW ZEALAND DATA SHEET NAME OF MEDICINE TAXOL (PACLITAXEL) CONCENTRATE FOR INJECTION 6MG/ML. PRESENTATION TAXOL (PACLITAXEL) Injection for Dilution is supplied as a nonaqueous clear, colourless to slightly yellow viscous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. TAXOL is available in 300mg (50mL) vials. Each mL of sterile nonpyrogenic solution contains 6mg PACLITAXEL, 527mg of Cremophor 1 [/TaxolConcinj.html#14] EL (polyoxyethylated castor oil) and 49.7% (v/v) dehydrated alcohol. USES Ac tio n s PACLITAXEL is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers. It stabilises microtubules by preventing depolymerisation resulting in the inhibition of the normal dynamic reorganisation of the microtubule network essential for cellular functions. PACLITAXEL also induces abnormal arrays of "bundles" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis. P h a rm a c o kin e tic s The pharmacokinetics of PACLITAXEL have been evaluated over a wide range doses, up to 300 mg/m 2 , and infusion schedules, ranging from 3 to 24 hours. Following intravenous administration, PACLITAXEL exhibits a biphasic decline in plasma concentrations. The initial rapid decline represents distribution to the peripheral compartment and elimination; the later phase is due, in part, to a relatively slow efflux of PACLITAXEL from the peripheral compartment. In patients treated with doses of 135 and 175 mg/m 2 given as 3 and 24 hour infusions, mean terminal half-life has ranged from 3.0 to 52.7 hours, and total body clearance has ranged from 11.6 to 24.0 L/h/m 2 . Mean steady state volume of distribution following single Lees het volledige document