What Docetaxel Winthrop 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 Docetaxel Winthrop looks like and contents of the pack
Docetaxel Winthrop 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.
BelgiëBelgiqueBelgien sanofi-aventis Belgium TélTel 32 02 710 54 00 LuxembourgLuxemburg sanofi-aventis Belgium TélTel 32 02 710 54 00 BelgiqueBelgien
sanofi-aventis Bulgaria EOOD . 359 02 970 53 00 Magyarország sanofi-aventis zrt., Magyarország Tel. 36 1 505 0050
eská republika sanofi-aventis, s.r.o. Tel 420 233 086 111 Malta sanofi-aventis Malta Ltd. Tel 356 21493022
Danmark sanofi-aventis Denmark AS Tlf 45 45 16 70 00 Nederland sanofi-aventis Netherlands B.V. Tel 31 0182 557 755
Deutschland Winthrop Arzneimittel GmbH Tel 49 0180 2 222010 Norge sanofi-aventis Norge AS Tlf 47 67 10 71 00
Eesti sanofi-aventis Estonia OÜ Tel 372 627 34 88 Österreich sanofi-aventis GmbH Tel 43 1 80 185 0
sanofi-aventis AEBE 30 210 900 16 00 Polska sanofi-aventis Sp. z o.o. Tel. 48 22 280 00 00
España sanofi-aventis, S.A. Tel 34 93 485 94 00 Portugal sanofi-aventis - Produtos Farmacêuticos, S.A. Tel 351 21 35 89 400
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Ireland sanofi-aventis Ireland Ltd. Tel 353 0 1 403 56 00 Slovenija sanofi-aventis d.o.o. Tel 386 1 560 48 00
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. Tel 421 2 33 100 100
Italia sanofi-aventis S.p.A. Tel 39 02 393 91 SuomiFinland sanofi-aventis Oy PuhTel 358 0 201 200 300
sanofi-aventis Cyprus Ltd. 357 22 871600 Sverige sanofi-aventis AB Tel 46 08 634 50 00
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UAB sanofi-aventis Lietuva
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 DOCETAXEL WINTHROP 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 Docetaxel Winthrop 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 Docetaxel Winthrop 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 (Docetaxel Winthrop 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Docetaxel Winthrop 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 Docetaxel Winthrop 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.