What TAXOTERE concentrate vial contains
- The active substance is docetaxel. Each ml of docetaxel solution contains 40 mg of docetaxel anhydrous. One vial contains 80 mg/2 ml docetaxel.
- The other ingredients are polysorbate 80 and citric acid.
What solvent vial contains
13% (w/w) ethanol 95% in water for injections.
What TAXOTERE looks like and contents of the pack
TAXOTERE 80 mg/2 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution.
Each blister pack contains:
- one single-dose vial of concentrate and,
- one single-dose vial of solvent.
Marketing Authorisation Holder
Aventis Pharma S.A.
20 avenue Raymond Aron
92165 Antony Cedex
France
Manufacturer
Aventis Pharma, Dagenham
Rainham Road South
Dagenham
Essex RM10 7XS
United Kingdom
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
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This leaflet was last approved in {MM/YYYY}.
The following information is intended for medical or healthcare professionals only:
PREPARATION GUIDE FOR USE WITH TAXOTERE 80 mg/2 ml CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE
It is important that you read the entire contents of this procedure prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution
1. FORMULATION
TAXOTERE 80 mg/2 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid. The solvent for TAXOTERE is a 13% w/w solution of ethanol 95% in water for injections.
2. PRESENTATION
TAXOTERE is supplied as single-dose vials.
Each box contains one TAXOTERE vial (80 mg/2 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.
TAXOTERE vials should be stored between 2°C and 25°C and protected from light. TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.
2.1 TAXOTERE 80 mg/2 ml vial
- The TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a red flip-off cap.
- The TAXOTERE 80 mg/2 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
- Each TAXOTERE 80 mg/2 ml vial contains 2.0 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/2.36 ml). This volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix (see section 4) 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 TAXOTERE vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg/2 ml per vial.
2.2 Solvent for TAXOTERE 80 mg/2 ml vial
- The solvent for TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a transparent colourless flip-off cap.
- The solvent for TAXOTERE composition is a 13% w/w solution of ethanol 95% in water for injections.
- Each solvent for TAXOTERE 80 mg/2 ml vial contains 7.33 ml. This volume has been established based on the fill volume of the TAXOTERE 80 mg/2 ml vial. The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 80 mg/2 ml vial ensures a premix concentration of 10 mg/ml docetaxel.
3. RECOMMENDATIONS FOR THE SAFE HANDLING
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, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
4. PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
4.1 Preparation of the TAXOTEREpremix solution (10 mg docetaxel/ml)
4.1.1 If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature below 25C for 5 minutes.
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
4.1.3 Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds. Do not shake.
4.1.5 Allow the premix vial to stand for 5 minutes at room temperature below 25C and then check that the solution is homogenous and clear foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation. The premix solution contains 10 mgml docetaxel and should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2C and 8C or at room temperature below 25C.
4.2 Preparation of the infusion solution
4.2.1 More than one premix vial may be necessary to obtain the required dose for the patient. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mgml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
4.2.2 Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5 glucose solution or sodium chloride 9 mgml 0.9 solution for infusion. If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mgml docetaxel is not exceeded.
4.2.3 Mix the infusion bag or bottle manually using a rocking motion.
4.2.4 The TAXOTERE infusion solution should be used within 4 hours and should be aseptically
administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
4.2.5 As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
5. DISPOSAL
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.