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Adverse event reporting can be found at the bottom of the page
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Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.
ZAVICEFTA is indicated for the treatment of adult and paediatric patients aged 3 months and older with the following infections:1
- Complicated urinary tract infection (cUTI), including pyelonephritis
- Complicated intra-abdominal infection (cIAI)
- Hospital-acquired pneumonia, including ventilator-associated pneumonia (HAP/VAP)
- Infections due to aerobic Gram-negative organisms in patients with limited treatment options†
ZAVICEFTA demonstrated similar effectiveness to comparator therapies (meropenem or cefepime) when assessed in paediatric trials*2,3
ZAVICEFTA has a similar safety and tolerability profile in paediatric patients aged 3 months and older with cIAI and cUTI to that observed in adults*1-3
The safety assessment in paediatric patients is based on data from two trials in which 61 patients with cIAI and 67 patients with cUTI aged 3 months to < 18 years received ZAVICEFTA1
Most common adverse reactions (>3%) for ZAVICEFTA were vomiting, diarrhoea, rash, and infusion site phlebitis2,3
Low rates of discontinuation due to adverse effects and no deaths were reported in either study2,3
Meet our paediatric patients (aged 3 months and older) with cUTI and cIAI
† Data support the use of ZAVICEFTA in adult patients with Limited Treatment Options including in primary bacteraemia, cSSTI, BJI, meningitis, febrile neutropenia, cystic fibrosis, post-transplant patients due to KPC and OXA-48 resistance mechanisms, and MDR Pseudomonas.4-18
* ZAVICEFTA has been evaluated in paediatric patients aged 3 months to < 18 years in two Phase II single-blind, randomised, comparative clinical studies, one in patients with cIAI and one in patients with cUTI (N=128). In the cIAI trial, patients received ZAVICEFTA plus metronidazole, and in the cUTI trial, patients received ZAVICEFTA alone. The primary objective in each study was to assess safety and tolerability of ZAVICEFTA (+/- metronidazole). Secondary objectives included assessment of pharmacokinetics and efficacy; efficacy was a descriptive endpoint in both studies.1,2,3
ZAVICEFTA has broad spectrum coverage against Gram-negative pathogens including in vitro activity against MDR P.aeruginosa, CRE, including KPC- and OXA-48 producing strains, and ESBL- and AmpC-producing bacteria1-4.
Identifying patients at risk of MDR Gram-negative infections is vital for appropriate selection of adequate, early antimicrobial therapy to reduce the risk of fatal outcomes5.
Abbreviations:
cUTI, complicated urinary tract infection, cIAI, complicated intra-abdominal infection; HAP, hospital-acquired pneumonia; VAP, ventilator-associated pneumonia; MDR, multi-drug resistant; KPC, Klebsiella pneumoniae carbapenemase; OXA, oxacillinase; BJI, bone and joint infection;
Prescribing information
Click here for Zavicefta® (ceftazidime and avibactam) Prescribing Information
Click here for Meronem® (meropenem trihydrate) Prescribing Information
Click here for Tazocin® (piperacillin sodium, tazobactam sodium) Prescribing Information
Click here for Tygacil® (tigecycline) Prescribing Information for Great Britain
Click here for Tygacil® (tigecycline) Prescribing Information Northern Ireland
Click here for Zyvox® (linezolid) Prescribing Information
Click here for Amikacin (amikacin sulfate) Prescribing Information
Click here for Dalacin® (clindamycin hydrochloride) Prescribing Information
References
Listen to speakers Professor Louis Grandjean and Dr James Hatcher discuss this topic at BSAC Spring 2023
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Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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PP-PFE-GBR-3863. November 2021