Gemtero Caution For Usage

Instructions for use/handling: Reconstitution: Gemcitabine has only been shown to be compatible with 0.9% Sodium Chloride Injection. Accordingly, only this diluent should be used for reconstitution. Compatibility with other drugs has not been studied, therefore, it is not recommended to mix GEMTERO with other drugs when reconstituted. 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 at least 5 mL of 0.9% Sodium Chloride Injection to the 200 mg vial (GEMTERO 200 mg) or at least 25 mL of 0.9% Sodium Chloride Injection to the 1 g vial (GEMTERO 1 g). Shake to dissolve. The appropriate amount of drug may be administered as prepared or further diluted with 0.9% Sodium Chloride Injection. Reconstituted solution should be used immediately or may be stored for 24 hours if prepared in an appropriately controlled aseptic environment. Parenteral drugs should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit.
Guidelines for the safe handling of antineoplastic agents: Cytotoxic preparations should not be handled by pregnant staff. Trained personnel should reconstitute the drug. This should be performed in a designated area. The work surface should be covered with disposable plastic-backed absorbent paper.
Adequate protective gloves, masks clothing should be worn. Precautions should be taken to avoid the drug accidentally coming into contact with the eyes. If accidental contamination occurs, the eye should be washed with water thoroughly and immediately. Use luer-lock fitting on all syringes and sets. Large bore needles are recommended to minimize pressure and the possible formation of aerosols. The latter may also be reduced by the use of a venting needle.
Adequate care and precaution should be taken in the disposal of items used to reconstitute GEMTERO. Any unused dry product or contaminated materials should be placed in a high risk waste bag. Sharp objects (needles, syringe, vials, etc) should be placed in a suitable rigid container. Personnel concerned with the collection and disposal of this waste should be aware of the hazard involved. Waste material should be destroyed by incineration. Any excess drug solution should be flushed directly into a drain with copious amounts of water.