Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Teva B.V., Swensweg 5, 2031 GA, Haarlem, The Netherlands
Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate and solvent for solution for infusion. The concentrate is a clear viscous, yellow to brown-yellow solution. The solvent is a colourless solution. |
Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg docetaxel. Each ml of concentrate contains 27.73 mg docetaxel.
Excipients with known effect: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (181 mg of anhydrous ethanol).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Docetaxel |
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. |
| List of Excipients |
|---|
|
Concentrate vial: Polysorbate 80 Solvent vial: Water for injections |
Each carton contains:
6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
This vial contains 0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml). This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and “dead-volume”. This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg/0.72 ml per vial.
6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml). The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Teva B.V., Swensweg 5, 2031 GA, Haarlem, The Netherlands
EU/1/09/611/001
Date of first authorisation: 26 January 2010
Date of latest renewal: 22 May 2014
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
