Source: Health Products Regulatory Authority (IE) Revision Year: 2012 Publisher: Ebewe Pharma Ges.mb.H Nfg.KG, Mondseestrasse 11, 4866 Unterach, Austria
Ebetaxel 6mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear, light yellow solution. |
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) |
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.
Ebewe Pharma Ges.mb.H Nfg.KG, Mondseestrasse 11, 4866 Unterach, Austria
PA 789/14/1
Date of first authorisation: 27th April 2007
Date of last renewal: 23rd August 2009
| Drug | Countries | |
|---|---|---|
| EBETAXEL | Austria, Hong Kong, Israel, Singapore, Tunisia, Turkey, South Africa |
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