Gemvex-200/Gemvex-1000 Caution For Usage

Handling: It is compulsory that injectable solutions of cytotoxic agents be prepared by specialized, trained staff with knowledge of the drugs used, under conditions which ensure protection of the environment, and particularly of the drug handling staff. Preparation requires a room reserved for this purpose. Smoking, eating and drinking are prohibited in this room. The handling staff must have a set of appropriate equipment for handling particular long-sleeved coats, protective masks, caps, protective goggles, sterile disposable gloves, worktop protection sheets and waste collection containers and bags. Excreta and vomitus must be handled with care. Pregnant women must be warned and avoid handling cytotoxic agents. All broken containers must be treated with the same precautions and regarded as contaminated waste. Contaminated waste is to be disposed of by incineration in rigid containers labeled for this purpose.
Instructions for Use/Handling: The recommended diluent for reconstitution of Gemcitabine is 0.9% Sodium Chloride Injection without preservatives. Due to solubility considerations, the maximum concentration for Gemcitabine upon reconstitution is 40 mg/ml. Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.
To reconstitute, add 5 ml of 0.9% Sodium Chloride Injection to the 200 mg vial or 25 ml of 0.9% Sodium Chloride Injection to the 1000 mg vial. Shake to dissolve. 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 the 200 mg vial or 1.3 ml for the 1000 mg vial). The total volume upon reconstitution will be 5.26 ml or 26.3 mL, respectively. Complete withdrawal of the vial contents will provide 200 mg or 1000 mg of Gemcitabine, respectively. The appropriate amount of drug may be administered as prepared or further diluted with 0.9% Sodium Chloride Injection to concentrations as low as 0.1 mg/ml.
Reconstituted Gemcitabine is a clear, colorless to light straw-colored solution. After reconstitution with 0.9% Sodium Chloride Injection, the pH of the resulting solution lies in the range of 2.7 to 3.3. The solution should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution or container permits. If particulate matter or discoloration is found, do not administer.
When prepared as directed, Gemcitabine solutions are stable for 24 hours at room temperature (Below 30°C) Discard unused portion. Solutions of reconstituted Gemcitabine should not be refrigerated, as crystallization may occur. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.
Unopened vials of Gemcitabine are stable until the expiration date indicated on the package when stored at Below 30°C. Caution should be exercised in handling and preparing Gemcitabine solutions. The use of gloves is recommended. If Gemcitabine solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.
Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.