Taxol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Paclitaxel 6 mg/mL

Available from:

Bristol-Myers Squibb (NZ) Limited

INN (International Name):

Paclitaxel 6 mg/mL

Dosage:

6 mg/mL

Pharmaceutical form:

Concentrate for infusion

Composition:

Active: Paclitaxel 6 mg/mL Excipient: Ethanol Polyoxyl 35 castor oil

Units in package:

Vial, glass, single dose, (not marketed), 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Swords Laboratories Limited Subsidiary of Bristol-Myers Squibb Company

Product summary:

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 -  

Authorization date:

1992-09-18

Summary of Product characteristics

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