What TAXOTERE contains
- The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mgdocetaxel as trihydrate.
- The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.
What TAXOTERE looks like and contents of the pack
TAXOTERE concentrate for solution for infusion is a pale yellow to brownish-yellow solution. The concentrate is supplied in a 15 ml clear colourless glass vial with a blue aluminium seal and a blue plastic flip-off cap.
Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Marketing Authorisation Holder
Aventis Pharma S.A.
20 avenue Raymond Aron
92165 Antony Cedex
Aventis Pharma, Dagenham
Rainham Road South
Essex RM10 7XS
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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Tel: +370 5 2755224
This leaflet was last approved in
The following information is intended for medical or healthcare professionals only:
PREPARATION GUIDE FOR USE WITH TAXOTERE 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
It is important that you read the entire contents of this procedure prior to the preparation of the TAXOTERE infusion solution.
Recommendations for the safe handling:
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling itand preparing its 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 it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Preparation of the intravenous administration :
Preparation of the infusion solutionDO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
TAXOTERE 160 mg/8 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 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. More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient. For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
- Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe. In TAXOTERE 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
- Then, inject 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.
- From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution 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 IV 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°C 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.
- As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.