Preparation, storage & handling for ZERBAXA

ZERBAXA does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparing the infusion solution.
Constitute the vial with 10 mL of sterile water for injection or 0.9% Sodium Chloride for Injection, USP (normal saline) and gently shake to dissolve. The final volume is approximately 11.4 mL.
Caution: The constituted solution is not for direct injection.
To prepare the required dose, withdraw the appropriate volume as shown below from the reconstituted vial. Add the withdrawn volume to an infusion bag containing 100 mL of 0.9% Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP.
ZERBAXA dose | Volume to withdraw from reconstituted vial |
---|---|
1.5 g (1 g and 0.5 g) | 11.4 mL (entire contents) |
750 mg (500 mg and 250 mg) | 5.7 mL |
375 mg (250 mg and 125 mg) | 2.9 mL |
150 mg (100 mg and 50 mg) | 1.2 mL |
Inspect drug products visually for particulate matter and discoloration prior to use. ZERBAXA infusions range from clear, colorless solutions to solutions that are clear and slightly yellow. Variations in color within this range do not affect the potency of the product.
Compatibility
Compatibility of ZERBAXA with other drugs has not been established. ZERBAXA should not be mixed with other drugs or physically added to solutions containing other drugs.
Storage and handling
- ZERBAXA vials should be stored refrigerated at 2 to 8°C (36–46°F) and protected from light.
- The reconstituted solution, once diluted, may be stored for 24 hours at room temperature or for 7 days under refrigeration at 2–8°C (36–46°F).
Storage of constituted solutions
- Upon constitution with sterile water for injection or 0.9% sodium chloride injection, reconstituted ZERBAXA solution may be held for 1 hour prior to transfer and dilution in a suitable infusion bag.
- Following dilution of the solution with 0.9% sodium chloride or 5% dextrose, ZERBAXA is stable for 24 hours when stored at room temperature or 7 days when stored under refrigeration at 2–8°C (36–46°F).
- Constituted ZERBAXA solution or diluted ZERBAXA infusion should not be frozen.