ZERBAXA, (ceftolozane/tazobactam), cephalosporin and β-lactamase inhibitor

INFCTIOUS DISEASES - New medicinal product
Opinions on drugs - Posted on Nov 04 2016

Reason for request

Inclusion

No clinical benefit demonstrated in the management of intra-abdominal infections, acute pyelonephritis and complicated urinary tract infections

  • ZERBAXA has Marketing Authorisation in the treatment of complicated intra-abdominal infections, acute pyelonephritis and complicated urinary tract infections.
  • 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.
  • The documentation of its clinical efficacy is insufficient in complicated urinary infections (including pyelonephritis) and in complicated intra-abdominal infections, severe intra-abdominal infections and/or intra-abdominal infections due to multiresistant bacteria.
  • It can be offered on bacteriological documentation in infections due to susceptible ESBL-producing enterobacteriaceae or Pseudomonas aeruginosa.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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