Unopened vial
3 years
After opening of the vial
Each vial is for single use and should be used immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Once added to the infusion bag
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. It should be used within 6 hours (including the one hour infusion intravenous administration).
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.
Polysorbate 80
Ethanol anhydrous
Citric acid
The carcinogenic potential of docetaxel has not been studied.
Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse. However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay. These results are consistent with the pharmacological activity of docetaxel.
Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
12th May 2016
Aventis Pharma S.A., 20 avenue Raymond Aron, 92165 Antony Cedex, France
Do not store above 25°C.
Store in the original package in order to protect from light.
7 ml clear glass (type I) vial with a magenta aluminium seal and a magenta plastic flip-off cap containing 4 ml of concentrate.
Each box contains one vial.
Not all pack sizes may be marketed.
EU/1/95/002/004
TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions. The use of gloves is recommended.
If TAXOTERE concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If TAXOTERE concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Preparation for the intravenous administration
Preparation of the infusion solution
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
TAXOTERE 80 mg/4 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Each vial is of single use and should be used immediately.
If the vials are stored under refrigeration, allow the required number of boxes of TAXOTERE concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
More than one vial of TAXOTERE concentrate for solution for infusion may be necessary to obtain the required dose for the patient. Aseptically withdraw the required amount of TAXOTERE concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
In TAXOTERE 80 mg /4 ml vial the concentration of docetaxel is 20 mg/ml.
The required volume of TAXOTERE concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Mix the infusion bag or bottle manually using a rocking motion.
The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
As with all parenteral products, TAXOTERE infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Date of first authorisation: 27 November 1995
Date of latest renewal: 27 November 2005
