Decita Caution For Usage

Instruction for use: Decitabine for Injection is a cytotoxic drug and caution should be exercised when handling and preparing Decitabine for Injection.
Decitabine for Injection should be aseptically reconstituted with 10 mL of Sterile Water for Injection; upon reconstitution, each mL contains approximately 5.0 mg of decitabine at pH 6.7-7.3. Immediately after reconstitution, the solution should be further diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final drug concentration of 0.1-1.0 mg/mL. Unless used within 15 minutes of reconstitution, the diluted solution must be prepared using cold (2˚C-8˚C) infusion fluids and stored at 2˚C-8˚C (36˚F-46˚F) for up to a maximum of 4 hours until administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if there is evidence of particulate matter or discoloration.
Reconstituted and diluted solution: Within 15 minutes of reconstitution, the concentrate (in 10 mL of sterile water for injections) must be further diluted with cold (2°C-8°C) infusion fluids. This prepared diluted solution for intravenous infusion can be stored at 2°C-8°C for up to a maximum of 3 hours, followed by up to 1 hour at room temperature (20°C-25°C) before administration.
From a microbiological point of view, the product should be used within the time period recommended above. It is the responsibility of the user to follow the recommended storage times and conditions and ensure that reconstitution has taken place in aseptic conditions.