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AboutIndicationsBroad CoverageEfficacyEfficacyLimited Treatment OptionsSafetySafety

Safety Profile Summary 

DosingAdult DosingPaediatric Dosing

Prescribing Information

Safety
Zavicefta (ceftazidime-avibactam) has a safety and tolerability profile consistent with both cephalosporins and carbapenems1-4
  • Overall rates of any AE were low in the ZAVICEFTA (ceftazidime–avibactam) and comparator arms1-4
  • Rates of all other categories of AEs were low and balanced across treatment arms1-4
  • Most common (≥ 5%) AEs for ZAVICEFTA were positive direct Coombs test, nausea and diarrhoea5*
  • Nausea and diarrhoea were usually mild or moderate in intensity1-5
  • No requirement for routine monitoring and a low potential for drug–drug interactions5
  • In four Phase III clinical trials, the adverse-event profile of ZAVICEFTA was similar to that seen with either best-available therapy, doripenem or meropenem.1-4

*Based on data from seven Phase II and Phase III clinical trials in 2024 adult patients treated with ZAVICEFTA.5

Prescribing information

Zavicefta® (avibactam sodium, ceftazidime pentahydrate)

Zavicefta® (avibactam sodium, ceftazidime pentahydrate) 2g/0.5g powder for concentrate for
solution for infusion)

Meronem® (meropenem trihydrate) 

Meronem® (Meropenem Trihydrate) Meronem I.V. 1g

Abbreviations:AE, adverse event; References:Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.Torres A, et al. Lancet Infect Dis 2018;18:285–95.Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62.

ZAVICEFTA. Summary of Product Characteristics.

Safety

Legal Category: S1A

Further information available upon request
PP-ZVA-IRL-0288. December 2024

Adverse events should be reported.

If you wish to make a medical information inquiry or report an adverse event please contact Pfizer on 1800 633 363 
or email Pfizer at [email protected] or visit www.PfizerMedicalInformation.ie

Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

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