Active ingredients: Docetaxel
TAXOTERE 20 mg/1 ml concentrate for solution for infusion.
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a pale yellow to brownish-yellow solution.
Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Excipient with known effect: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
For the full list of excipients, see section 6.1.
Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin.
Polysorbate 80
Ethanol anhydrous
Citric acid
7 ml clear glass (type I) vial with a green aluminium seal and a green plastic flip-off cap containing 1 ml of concentrate.
Each box contains one vial.
Not all pack sizes may be marketed.
Aventis Pharma S.A.
20 avenue Raymond Aron
92165 Antony Cedex
France
Date of first authorisation: 27 November 1995
Date of latest renewal: 27 November 2005
EU/1/95/002/003