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Storage condition for unopened vial: Store below 30°C. If the vials are stored under refrigeration (2°C to 8°C), allow the required number of boxes of Docetaxel concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Store in the original package in order to protect from light.
Storage condition with dilution: 0.9 % w/v Sodium Chloride: Store up to 6 hours at room temperature 25°C and up to 24 hours when stored between 2 to 8°C into the infusion bag.
5 % w/v Dextrose Injection: Store up to 6 hours at room temperature 25°C and up to 24 hours when stored between 2 to 8°C into the infusion bag.
Shelf-Life: Unopened vial: 2 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 IV administration).
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in PVC bags up to 24 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.
