Preparation, storage, & handling for ZERBAXA® (ceftolozane and tazobactam)
Preparation of solutions
ZERBAXA does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparing the infusion solution.
Preparation of doses
Constitute each vial of ZERBAXA with 10 mL of sterile water for injection or 0.9% Sodium Chloride for Injection, USP and gently shake to dissolve. The final volume is approximately 11.4 mL per vial.
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(s). Add the withdrawn volume to an infusion bag containing 100 mL of 0.9% Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP. For doses above 1.5 g, reconstitute a second vial in the same manner as the first one, withdraw an appropriate volume as shown below, and add to the same infusion bag. Discard unused portion.
|ZERBAXA (ceftolozane and tazobactam) dose||Volume to withdraw from reconstituted vial(s)|
|3 g (2 g and 1 g)||Two vials of 11.4 mL each (entire contents from two vials)|
|2.25 g (1.5 g and 0.75 g)||11.4 mL from one vial (entire contents) and 5.7 mL from a second vial|
|1.5 g (1 g and 0.5 g)||11.4 mL (entire contents from one vial)|
|750 mg (500 mg and 250 mg)||5.7 mL|
|450 mg (300 mg and 150 mg)||3.5 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 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 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 to 8°C (36 to 46°F). Discard unused portion.
Constituted ZERBAXA solution or diluted ZERBAXA infusion should not be frozen.