ANZATAX Concentrate for solution for injection Ref.[50346] Active ingredients: Paclitaxel

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2021  Publisher: Pfizer Australia Pty Ltd, Level 17, 151 Clarence Street, Sydney NSW 2000, Toll Free number: 1800 675 229, www.pfizer.com.au

Product name and form

ANZATAXT – Paclitaxel.

Pharmaceutical Form

Concentrate for solution for injection.

Anzatax Injection Concentrate has a pH of 6 to 7. It is a clear to pale yellow solution, free of visible particles.

Qualitative and quantitative composition

Paclitaxel is an anticancer agent from the taxane class of drugs.

Anzatax Injection Concentrate is a sterile solution containing 6 mg/mL paclitaxel. It is a white powder. Paclitaxel is extremely hydrophobic, and is therefore formulated in PEG-35 castor oil and ethanol.

Excipients with known effect: Ethanol

For the full list of excipients, see section 6.1 List of excipients.

Chemical structure

Paclitaxel is described chemically as (2S,5R,7S,10R,13S)-10,20-bis(acetoxy)-2-benzoyloxy1,7-dihydroxy-9-oxo-5,20-epoxytax-11-en-13-yl (3S)-3-benzoylamino-3-phenyl-D-lactate.

The chemical structure of Paclitaxel is shown below:

Molecular weight: 853.9

CAS number: 33069-62-4

Active Ingredient Description
Paclitaxel

Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation. This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.

List of Excipients

Citric acid
PEG-35 castor oil
Ethanol

Pack sizes and marketing

Anzatax Injection Concentrate is available in glass vial in single packs in the following mpresentations:

Anzatax Injection Concentrate 30 mg/5 mL vials.
Anzatax Injection Concentrate 100 mg/16.7 mL vials.
Anzatax Injection Concentrate 150 mg/25 mL vials.
Anzatax Injection Concentrate 300 mg/50 mL vials.

Marketing authorization holder

Pfizer Australia Pty Ltd, Level 17, 151 Clarence Street, Sydney NSW 2000, Toll Free number: 1800 675 229, www.pfizer.com.au

Marketing authorization dates and numbers

30 mg/5 mL: 12 January 1995
100 mg/16.7 mL: 24 February 2005
150 mg/25 mL: 12 January 1995
300 mg/50 mL: 7 January 2003

Drugs

Drug Countries
ANZATAX Hong Kong, New Zealand, Singapore, Tunisia, Turkey, South Africa

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