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Adverse event reporting can be found at the bottom of the page

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AboutAboutPathogen CoveragePatient Risk FactorsAntimicrobial Subscription Model PilotDosingDosingDosingPreparation GuideShelf Life and StorageEfficacy & SafetyEfficacy & SafetyMechanism of ActionREPROVE Phase III trial(HAP/VAP)RECLAIM Phase III trial(cIAI)RECAPTURE Phase III trial(cUTI)REPRISE Phase III trial(cIAI and cUTI)Safety and TolerabilityEfficacy and Safety Data for Paediatric PatientsSupport & ResourcesSupport & ResourcesAMS ResourcesSepsisWebinars (Live and On-demand)KOL Videos - ZaviceftaKOL Videos - Gram-negativeKOL Videos - Clinical experienceVideosMaterials

Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.

ZAVICEFTA® (ceftazidime-avibactam): Broad-spectrum Gram-negative coverage with consistent dosing across indications1–5

Preparation Guide

Shelf life and Storage

1. Reconstitute

Aseptically inject each vial with 10 mL
sterile water for injections (not supplied) and use immediately1,5.

2. Mix

Withdraw the needle and shake the vial to give a clear solution.

Insert a gas relief needle through the vial closure after the product has dissolved to relieve the internal pressure (this is important to preserve product sterility)1,5.

3. Dilute

Infusion bag: Further dilute the solution by transferring an appropriate volume to an infusion bag containing an infusion dilutent listed below1,5.
Infusion syringe: Further dilute the solution by transferring an appropriate volume, combined with sufficient volume of either sodium chloride 9 mg/mL (0.9%) or dextrose 50 mg/mL (5%) solution for injection, to an infusion syringe1,5.

  Steps 1 to 3 above should not exceed 30 minutes1
Please refer to the full dosing table in the SmPC for more information

Paediatric Use1,5

Paediatric doses may be prepared in an appropriately sized infusion bag or infusion syringe. Care should be taken when calculating the volume of administration of the dose.

Please refer to the SmPC for steps to prepare for use in an infusion syringe in paediatric patients aged 3 to 12 months.

Infusion diluents1,5

Suitable infusion diluents for infusion bags:

  • Sodium chloride 9 mg/mL (0.9%) solution for injection
     
  • Dextrose 50 mg/mL (5%) solution for injection
 
  • Lactated Ringer’s solution
 

Important

Zavicefta (ceftazidime/avibactam) is a combination product; each vial contains 2 g of ceftazidime and 0.5 g of avibactam in a fixed 4:1 ratio. Dosage recommendations are based on the ceftazidime component only.
  • Parenteral medicinal products should be inspected visually for particulate matter prior to administration1,5
     
  • The compatibility of ZAVICEFTA with other medicines has not been established1,5
     
  • ZAVICEFTA should not be mixed with or physically added to solutions containing other medicinal products1,5
     
  • Each vial is for single use only1,5
Access results of ZAVICEFTA Phase III clinical trials in adult patients with cUTI, cIAI or HAP/VAPAccess case studies and videos

Abbreviations

cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract infection; HAP, hospital-acquired pneumonia; VAP, ventilator-associated pneumonia; AMR, Antimicrobial Resistance.

Prescribing information

Click here for Prescribing Information for Zavicefta® (ceftazidime and avibactam)
 

References

ZAVICEFTA. Summary of Product Characteristics (Great Britain) Liscio JL, et al. Int J Antimicrob Agents 2015;46:266–7Nicolau DP, et al. J Antimicrob Chemother 2015;70:2862–9Mazuski JE, et al. Surg Infect 2017;18:1–76ZAVICEFTA. Summary of Product Characteristics (Northern Ireland)
PP-ZVA-GBR-1738. March 2023.
Shelf life and storage1,5
Scroll left to view table
Dry powder vial
  • Store in the original package in order to protect from light
     
  • The vial has a shelf life of three years
After reconstitution
  • Parenteral medicinal products should be inspected visually for particulate matter prior to administration
     
  • The compatibility of ZAVICEFTA with other medicines has not been established 
     
  • ZAVICEFTA should not be mixed with or physically added to solutions containing other medicinal products
     
  • Each vial is for single use only
     
  • The reconstituted vial should be used immediately
After dilution
  • Final ceftazidime concentration of 8 mg/mL have demonstrated chemical and physical in-use stability up to 12 hours at 2-8°C, followed by up to 4 hours at not more than 25°C. All other ceftazidime concentrations (> 8 mg/mL to 40 mg/mL) have demonstrated chemical and physical in-use stability up to 4 hours at not more than 25°C.
 
  • Infusion bags: The chemical and physical in-use stability has been demonstrated (from initial vial puncture) for up to 6 hours at not more than 25°C.
 
  • From a microbiological point of view, the medicinal product should be used immediately, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Access results of ZAVICEFTA Phase III clinical trials in adult patients with cUTI, cIAI or HAP/VAPAccess case studies and videos

Abbreviations

cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract infection; HAP, hospital-acquired pneumonia; VAP, ventilator-associated pneumonia; AMR, Antimicrobial Resistance.

Prescribing information

Click here for Prescribing Information for Zavicefta® (ceftazidime and avibactam)

References

ZAVICEFTA. Summary of Product Characteristics (Great Britain)Liscio JL, et al. Int J Antimicrob Agents 2015;46:266–7Nicolau DP, et al. J Antimicrob Chemother 2015;70:2862–9Mazuski JE, et al. Surg Infect 2017;18:1–76ZAVICEFTA. Summary of Product Characteristics (Northern Ireland)
PP-ZVA-GBR-1738. March 2023.
Learn more about the tolerability data of ZAVICEFTA from four Phase III clinical trials. View tolerability profile LoadingQuick LinksPaediatric Dosing Learn more about treating Paediatric Patients Loading

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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