dm+d

31009911000001106

Refrigerated Storage

Zerbaxa Merck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
Zerbaxa
Concentrate for solution for infusion, 1g/0.5g

Contact MSD in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

21 February 2022
London MI Service

New Medicines

Zerbaxa Acute pyelonephritis, complicated intra-abdominal and UTI in infants and children

Information

Zerbaxa
Licence extension / variation
Cubist
Cubist

Development and Regulatory status

None
Recommended for approval (Positive opinion)
None
Jun 22CHMP recommends a change to the indications for Zerbaxa to permit use in children from birth (previously only licensed for use in adults). The proposed revised indication is for the treatment of “complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections” in adult and paediatric patients [1].

Category

Combination of a novel cephalosporin (CXA-101) with the beta-lactamase inhibitor tazobactam
Complicated intra-abdominal infections are often defined as extending beyond the hollow viscus of origin into the peritoneal space with associated abscess formation or peritonitis. They are potentially serious conditions that require an invasive procedure for source control. The overall incidence is difficult to establish & varies with the underlying abdominal disease processes.
Acute pyelonephritis, complicated intra-abdominal and UTI in infants and children
Intravenous