CEFTAZIDIME 1g / AVIBACTAM 0.5g, concentrate, vial

• In the WHO list of Essential Medicines 2025

Anti-infective for systemic use

Combination of a third-generation cephalosporin (ceftazidime) with a beta lactamase inhibitor (avibactam).

Active against extensively resistant/Carbapenem-Resistant aerobic Gram-negative bacteria incl. Enterobacterales (CRE), Difficult-to-treat Pseudomonas aeruginosa (DTR-P), and Stenotrophomonas maltophilia.

Treatment of severe infections caused by extensively resistant/Carbapenem-Resistant Enterobacterales (CRE) confirmed or suspected metallo-beta-lactamase producer (in combination with aztreonam), and non-severe infections when treatment options are limited.

Treatment of severe infections caused by Difficult-to-treat Pseudomonas aeruginosa (DTR-P), and non-severe infections when treatment options are limited.

Third-line treatment of infections caused by Stenotrophomonas maltophilia, in combination with aztreonam.

Must be given as IV infusion:

• Reconstitute the power vial with 10 ml of water for injection to obtain a concentrated solution at 167.3 mg/ml ceftazidime and 41.8 g avibactam.
• Withdraw the needle and shake the vial until complete dissolution of the contents. The solution must be clear.
• Insert a needle through the vial closure after the dissolution to relieve the internal pressure (important to preserve product sterility).
• Dilute the reconstituted solution by transferring a calculated volume of the reconstituted solution in 0.9% NaCl, 5% dextrose or ringer lactate to obtain a solution at 8-40 mg/ml ceftazidime.
• The total time interval between starting reconstitution and completing preparation of the IV infusion should not exceed 30 min.

Dosage should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient.

The antibiotic treatment will be started only once culture and antibiotic susceptibility testing (AST) results are available (in case of an outbreak in hospital settings, discuss with specialist).

Only to be used in health settings where validated microbiology laboratory is available to confirm antimicrobial susceptibility (particularly for Enterobacterales) and detection of carbapenemases.