Gemibine-200/Gemibine-1000 Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in special precaution for disposal and other handling.
Special precautions for disposal and other handling: Handling: The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses. If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water.
Instructions for reconstitution (and further dilution, if performed): The only approved diluent for reconstitution of gemcitabine sterile powder is sodium chloride 9 mg/mL (0.9%) solution for injection (without preservative). 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.
1. Use aseptic technique during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration.
2. To reconstitute, add 5 ml of sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, to the 200 mg vial or 25 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, to the 1 g vial. The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1 g vial) respectively. This yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder. Shake to dissolve. Further dilution with sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative can be done. Reconstituted solution is a clear colourless to light straw-coloured solution.
3. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
Any unused product or waste material should be disposed of in accordance with local requirements.