Zavicefta (EU), Avycaz (US) · Pneumonia, intra-abdominal infections and urinary tract infections in adolescents and children
Zavicefta (EU), Avycaz (US)
Licence extension / variation
Development and Regulatory status
Nov 20 · Approved in the EU .
Sep 20 · EU positive opinion to extend the licence from use only in adults to include treatment of adolescents and children (and to make some other changes to wording of the indication). The proposed new indication is use in adults and children aged 3 months and older for the treatment of the following infections: Complicated intra-abdominal infection (cIAI); Complicated urinary tract infection (cUTI), including pyelonephritis; Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and children aged 3 months and older with limited treatment options (previously only adults) .
Cephalosporin and a beta-lactamase inhibitor
HAP occurs mostly in patients who are severely debilitated, immunocompromised or mechanically ventilated. Infection occurring less than five days after hospital admission is usually caused by S. pneumoniae. Infection occurring after this time is usually caused by H. influenzae , methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and other non-pseudomonal Gram-negative bacteria .
Pneumonia, intra-abdominal infections and urinary tract infections in adolescents and children