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Preparation for the Intravenous Administration: A) Preparation of Docetaxel premix solution: Take vials of Docetaxel should be allowed to stand for five minutes to bring to room temperature. The vial is then appropriately diluted aseptically with the solvent (provided) withdrawn into a syringe to obtain an initial Docetaxel concentration of 10 mg/ml. Shake the vial for 15 seconds by manual rotation and allow to stand for five minutes at room temperature. The solution thus obtained should be clear and homogenous.
B) Preparation of the infusion solution: The required amount of Docetaxel premix solution is withdrawn aseptically with a calibrated syringe and the premix volume is injected into an infusion bag or bottle of either 0.9% Sodium Chloride injection or 5% Dextrose Injection to produce a final Docetaxel concentration of 0.3 to 0.9 mg/ml. The concentration of Docetaxel in final solution should never exceed 0.9 mg/ml. The infusion solution should then be thoroughly mixed by manual rotation.
Docetaxel infusion solution is administered as one hour intravenous infusion under room temperature and normal lighting conditions.
Stability: Vexdo (Docetaxel Injection) is stable for 4 hr at 2°C to 25°C after constitution with Diluent (Solvent for Injection). Final dilution of Vexdo (Docetaxel Injection) for infusion (in either 0.9% Sodium Chloride solution or 5% Dextrose solution) should be used within 4 hours.
