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Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).
Shelf life: Unopened vial of drug product - BiCNU - 3 years.
After reconstitution as recommended, BiCNU is stable for 24 hours under refrigeration (2° - 8°C, 36° - 46° F).
Co-pack of drug product with sterile diluent - 2 years.
Reconstituted vials should be examined for crystal formation prior to use. If crystals are observed, they may be redissolved by warming the vial to room temperature with agitation.
Vials reconstituted as directed and further diluted to a concentration of 0.2 mg/mL in 5% Dextrose Injection, USP, should be stored at room temperature, protected from light and utilized within 8 hours.
Glass containers were used for the stability data provided in this section. Only use glass containers for BiCNU administration.
Important Note: BiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.
