Gemita Caution For Usage

Handling and Disposal: Use of 0.5M sulphuric acid and 0.1M potassium permanganate solution/two hours is recommended as neutralizing agent in cases of spills or leak of this solution.
Reconstitution: Reconstitute Gemcitabine for Injection USP 200 mg with 5 ml of Sterile 0.9% w/v Sodium Chloride Injection, Gemcitabine for Injection USP 1 g with 25 ml of Sterile 0.9% w/v Sodium Chloride Injection, Gemcitabine for Injection USP 1.4 g with 35 ml of Sterile 0.9% w/v Sodium Chloride Injection. Shake gently to make a clear solution. These dilutions each yield a gemcitabine concentration of 38 mg/ml which includes accounting for the displacement volume of the lyophilized powder (0.26 ml for 200 mg vial or 1.3 ml for 1 g vial or 1.82 ml for 1.4 g vial). The total volume upon reconstitution will be 5.26 ml or 26.3 ml or 36.82 ml respectively. Complete withdrawal of vial contents will provide 200 mg or 1 g or 1.4 g of gemcitabine, respectively. It may further be diluted with 0.9% Sodium Chloride Injection to concentration as low as 0.1 mg/ml. Due to solubility consideration, the maximum concentration for gemcitabine upon reconstitution is 40 mg/ml. Reconstitution at concentration greater than 40 mg/ml may result in incomplete dissolution and should be avoided. The reconstituted solutions should be used immediately or may be used within 24 hours if stored at controlled room temperature (30°C).
Discard unused portion.
Solution of reconstituted gemcitabine should not be refrigerated, as crystallization may occur.
Inspect the reconstituted solution visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is found, do not administer.
The compatibility of gemcitabine with other drug has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.
Proper procedures for handling and disposal of cytotoxics should be followed for injection USP.
Incompatibilities: None Identified.