ZAVICEFTA, (ceftazidime/avibactam), cephalosporin and β-lactamase inhibitor
INFECTIOUS DISEASES - New medicinal product
Opinions on drugs - Posted on Feb 03 2017
Reason for request
Minor improvement in the treatment of infections caused by extended-spectrum beta-lactamase-producing enterobacteriaceae or by P. aeruginosa as an alternative to treatment with carbapenem
- ZAVICEFTA has Marketing Authorisation in the treatment of complicated intra-abdominal infections, complicated urinary tract infections including acute pyelonephritis, hospital-acquired pneumonia including ventilator-associated pneumonia, infections due to aerobic Gram-negative bacteria in adults for whom therapeutic options are limited.
- Its potential benefit lies in its action against certain resistant Gram-negative bacteria, making it possible to treat patients with suspected or documented enterobacter infections due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae or to Pseudomonas aeruginosa, within the framework of a carbapenem-sparing regimen. It may be offered in infections due to Gram-negative bacteria, as an alternative to the use of carbapenems, in case of documented or highly suspected resistance to third-generation cephalosporins, and when use of the ceftazidime/avibactam combination is appropriate.
- There is insufficient documentation of its clinical efficacy in severe infections and/or infections caused by multidrug-resistant bacteria.
Improvement in actual benefit
Évaluation des médicaments