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BUSULFAN INJECTION How Supplied/Storage and Handling (busulfan injection)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Busulfan Injection is packaged as a sterile solution in 10 mL single-dose clear glass vials.

Busulfan Injection is available as follows:

Unit of SaleConcentration
NDC 0409-1112-01
Carton containing 8 Single-dose vials
60 mg/10 mL (6 mg/mL)

16.2 Storage and Handling

Unopened vials of Busulfan Injection must be stored under refrigerated conditions between 2°C to 8°C (36°F to 46°F). Discard unused portion.

Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time.

Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time.

Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures1.

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