EBETAXEL Concentrate for solution for infusion Ref.[50343] Active ingredients: Paclitaxel

Source: Health Products Regulatory Authority (IE)  Revision Year: 2012  Publisher: Ebewe Pharma Ges.mb.H Nfg.KG, Mondseestrasse 11, 4866 Unterach, Austria

Product name and form

Ebetaxel 6mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Clear, light yellow solution.

Qualitative and quantitative composition

Each 1ml of concentrate for solution for infusion contains 6mg paclitaxel.

A vial of 5ml contains 30mg paclitaxel.
A vial of 16.7ml contains 100mg paclitaxel.
A vial of 25ml contains 150mg paclitaxel.
A vial of 50ml contains 300mg paclitaxel.
A vial of 100ml contains 600mg paclitaxel.

Excipients: Polyoxyl castor oil (macrogolglycerol ricinoleate) (522.4mg/ml), ethanol anhydrous (401.7 mg/ml) (see 4.4).

For a full list of excipients, see 6.1.

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

Polyoxyl castor oil (macrogolglycerol ricinoleate)
Ethanol, anhydrous

Pack sizes and marketing

Type 1 glass vials (with butyl rubber stopper) containing 5ml, 16.7ml, 25ml, 50ml or 100ml of solution.

The 1, 5 or 10 vials are packaged with or without protective plastic overwrap (ONCO-SAFE) in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Ebewe Pharma Ges.mb.H Nfg.KG, Mondseestrasse 11, 4866 Unterach, Austria

Marketing authorization dates and numbers

PA 789/14/1

Date of first authorisation: 27th April 2007
Date of last renewal: 23rd August 2009

Drugs

Drug Countries
EBETAXEL Austria, Hong Kong, Israel, Singapore, Tunisia, Turkey, South Africa

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