ceftazidime / avibactam
Table of contents
Zavicefta is an antibiotic used in adults and children aged 3 months and older to treat the following infections:
- complicated (difficult to treat) infections of the tissues and organs in the belly (intra-abdominal infections);
- complicated (difficult to treat) infections of the urinary tract, including pyelonephritis (kidney infection);
- infections of the lungs caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, a machine that helps a patient to breathe).
Zavicefta can also be used for infections of the blood (bacteraemia) associated with any of the above infections.
Zavicefta can be used in adults and children aged 3 months and older for infections caused by aerobic Gram-negative bacteria (types of bacteria) when other treatments might not work.
Zavicefta contains the active substances ceftazidime and avibactam.
Zavicefta : EPAR - Medicine overview (PDF/151.33 KB)
First published: 14/07/2016
Last updated: 20/11/2020
Zavicefta : EPAR - Risk-management-plan summary (PDF/116.04 KB)
First published: 05/09/2018
Last updated: 20/11/2020
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This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
Pfizer Ireland Pharmaceuticals
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Operations Support Group
Ringaskiddy, County Cork
22/04/2022 Zavicefta - EMEA/H/C/004027 - IB/0029
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Antibacterials for systemic use
Zavicefta is indicated in adults and paediatric patients 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 paediatric patients aged 3 months and older with limited treatment options.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 202018/09/2020