ZERBAXA POWDER FOR SOLUTION FOR INJECTION 1G/0.5G

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD PHARMA (SINGAPORE) PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, FOR SOLUTION

**2\. DOSAGE AND ADMINISTRATION** **2.1 General** **Recommended Dosage** The recommended dosage regimen of ZERBAXA for injection is 1.5 gram (g) (ceftolozane 1 g and tazobactam 0.5 g) for cIAI and cUTI and 3 g (ceftolozane 2 g and tazobactam 1 g) for nosocomial pneumonia administered every 8 hours by intravenous infusion over 1 hour in patients 18 years or older and creatinine clearance (CrCL) greater than 50 mL/min. The duration of therapy should be guided by the severity and site of infection and the patient's clinical and bacteriological progress as shown in Table 1.  **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 determined from Table 2 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 Add the withdrawn volume to an infusion bag containing 100 mL of 0.9% Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP.  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. **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 (below 25°C) or 7 days when stored under refrigeration at 2 to 8°C (36 to 46°F). Constituted ZERBAXA solution or diluted ZERBAXA infusion should not be frozen. **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. **2.2 Renal Impairment** Dose adjustment is required for patients whose CrCL is 50 mL/min or less. Renal dose adjustments are listed in Table 3. For patients with changing renal function, monitor CrCL at least daily and adjust the dosage of ZERBAXA accordingly \[see Warnings and Precautions (4.1) and Use in Special Populations (6.5) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].  **2.3 Hepatic impairment** No dose adjustment is necessary in patients with hepatic impairment.