Zidebactam and cefepime

Recommended Dosage in Adult Patients with Renal Impairment Table 1 shows the recommended intravenous dosage of ZAYNICH for patients with varying degrees of renal function. Dosage adjustment of ZAYNICH is recommended in adult patients with renal impairment who have an eGFR of less than 60 mL/min, including patients receiving intermittent hemodialysis (IHD) [ see Use in Specific Populations ].

The duration of treatment is 7 days to 10 days. Administer each intravenous infusion over 1 hour. [See table below.]

Preparation and Administration Instructions for ZAYNICH Preparation ZAYNICH is supplied as a sterile dry powder in a single-dose vial that must be reconstituted and further diluted prior to intravenous infusion as outlined below. ZAYNICH does not contain preservatives. Aseptic techniques must be used for reconstitution and dilution.

Prepare the required dose for intravenous infusion using the steps described below: 1. Reconstitute the powder in the ZAYNICH vial with 10 mL of 0.9% Sodium Chloride Injection, or 5% Dextrose Injection, or Lactated Ringer's solution from a 100 mL infusion bag or with 10 mL of sterile Water for Injection. 2. Mix gently to dissolve the content.

The reconstituted ZAYNICH solution will have a resultant concentration of approximately 240 mg/mL. The final volume is approximately 13 mL. 3. The reconstituted ZAYNICH solution is not for direct injection and must be further diluted, prior to administration as described in Step 4 below. 4. The reconstituted solution should be used immediately after preparation or within the stability period, as described below: 5.

The reconstituted ZAYNICH solution can be stored for up to 6 hours at 20°C to 25°C (68°F to 77°F) or up to 12 hours at 2°C to 8°C (36°F to 46°F). After reconstitution, retain the vial in the outer carton to protect it from light. 6. The reconstituted solution must be diluted further in the 100 mL infusion bag used in Step 1.

For example: If reconstitution in Step 1 is performed with 5% dextrose, the dilution in Step 3 should be performed with the 100 mL infusion bag of 5% dextrose from Step 1. 7. To dilute the reconstituted solution, withdraw the full or partial reconstituted vial contents and add it into the infusion bag in accordance with Table 2 below. 8.

If the ZAYNICH powder is reconstituted in sterile Water for Injection, withdraw 10 mL volume from a 100 mL infusion bag (0.9% Sodium Chloride Injection, or 5% Dextrose Injection, or Lactated Ringer's solution), discard the 10 mL volume withdrawn from the infusion bag and use this bag for the dilution of the reconstituted solution. 9.

Administer the final diluted ZAYNICH solution for infusion within 12 hours, if stored at room temperature 20°C to 25°C (68°F to 77°F) or within 24 hours, if stored refrigerated at 2°C to 8°C (36°F to 46°F). [See table below.] 1.5 grams (1 gram cefepime and 0.5 grams zidebactam) 1 vial 6.5 mL 100 mL Administration ZAYNICH is administered by intravenous infusion over 1 hour after reconstitution and further dilution as described above.

Visually inspect the diluted ZAYNICH solution. Parenteral drug products should be inspected visually for absence of particulate matter and discoloration prior to administration, whenever solution and container permit. Similar to other cephalosporins, the reconstituted solution of ZAYNICH in the vial or the final solution for infusion may develop a yellow to amber color.

Use only if prepared solution is clear and free from particulate matter. Administer the entire volume of the final diluted ZAYNICH solution for infusion by intravenous infusion over 1 hour [ see Dosage and Administration ( 2.1 , 2.2 ) ].

Drug Compatibility ZAYNICH is compatible with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Lactated Ringer's solution, and sterile Water for Injection. Compatibility of ZAYNICH solution for administration with other drugs has not been established.