What Docetaxel Teva Generics powder for concentrate for solution for infusion contains
- The active substance is docetaxel; 1 ml of reconstituted solution contains 5 mg docetaxel anhydrous. One vial contains 80 mg docetaxel.
- The other ingredients are povidone K-12, hydroxypropylbetadex and glucose monohydrate.
- Each carton box contains 80 mg of docetaxel in one single-dose vial and 13.4 ml solvent (water for injections) in one single-dose vial
What Docetaxel Teva Generics solvent for concentrate for solution for infusion contains
- The solvent vial contains 13.4 ml of water for injections.
What Docetaxel Teva Generics powder for concentrate for solution for infusion looks like and contents of the pack
Docetaxel Teva Generics, powder for concentrate for solution for infusion is a white, powder or cake in a colourless glass vial with bromobutyl rubber stopper, aluminium seal and polypropylene snap-cap. The solvent is a clear and colourless solution.
Each pack contains one single-dose vial of docetaxel and one single-dose vial of solvent (water for injections).
What Docetaxel Teva Generics solvent for concentrate for solution for infusion looks like
Solvent for Docetaxel Teva Generics, powder for concentrate for solution for infusion is a colourless liquid in a colourless glass vial with chlorobutyl rubber stopper, aluminium seal and polypropylene snap-cap.
The vials are supplied in cartons each containing two vials.
- One single-dose vial of docetaxel powder for solution for infusion and,
- One single-dose vial of solvent.
In het register ingeschreven onder:
Marketing Authorisation Holder:
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
Manufacturer:
[To be completed nationally]
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
This medicinal product is authorised in the Member States of the EEA under the following names:
<{Name of the member state}> <{Name of the medicinal product}>
This leaflet was last approved in november 2011.
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The following information is intended for medical or healthcare professionals only:
Preparation of the reconstituted solution (5 ml docetaxel/ml)
If the vials are stored under refrigeration, allow the required number of Docetaxel Teva Generics 80 mg boxes to stand at room temperature (below 25°C) for 5 minutes.
Using a syringe fitted with a needle, aseptically withdraw 13.4 ml of the solvent for Docetaxel Teva Generics 80 mg vial by partially inverting the vial.
Inject the entire contents of the syringe into the corresponding Docetaxel Teva Generics 80 mg vial.
Remove the syringe and needle and mix manually by repeated inversions until all powder is dissolved (within 5 minutes).
Visually check that the solution is homogeneous, clear and free from visible particles.
The vial contains 80 mg of docetaxel with povidone K-12, hydroxypropylbetadex and glucose monohydrate as excipients (fill volume 81.5 mg/16.3 ml).This fill volume has been established during development for ease of withdrawing 16.0 ml of reconstituted solution. The overfill ensures that after reconstitution with 13.4 ml of the accompanying solvent for Docetaxel Teva Generics 80 mg vial, there is a minimal extractable reconstituted volume of 16 ml containing 5 mg/ml docetaxel which corresponds to the labelled amount of 80 mg per vial. The premix is for single use only.
Chemical and physical in-use stability has been demonstrated for 24 hours when stored either at room temperature (below 25°C) or between 2°C and 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Preparation of the infusion solution
More than one reconstituted 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 reconstituted volume containing 5 mg/ml docetaxel from the appropriate number of reconstituted vials using graduated syringes fitted with a needle. For example, a dose of 100 mg docetaxel would require 20 ml docetaxel reconstituted solution.
Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.
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 mg/ml docetaxel is not exceeded.
Mix the infusion bag or bottle manually using a rocking motion.
Chemical and physical in-use stability has been demonstrated for 4 hours when stored at room temperature (below 25°C) and 24 hours when stored at between 2°C and 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
The solution should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
As with all parenteral products, Docetaxel Teva Generics 80 mg reconstituted solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
For single use only. Discard any unused solution.
Any unused product or waste material should be disposed of in accordance with local requirements.
