Zavicefta Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Presentation/Packing Brand Resources

Full Prescribing Info

Adverse Reactions

In seven Phase 2 and Phase 3 clinical trials, 2024 adults were treated with CAZ-AVI. The most common adverse drug reactions occurring in ≥5% of patients treated with CAZ-AVI were Coombs direct test positive, nausea, and diarrhoea. These were usually mild or moderate in intensity. No clinically significant differences were observed in the safety profile across indications.
The following adverse drug reactions have been reported with ceftazidime alone and/or identified during all Phase 2 and Phase 3 clinical trials with CAZ-AVI (N=2024). (See Table 19.)

Click on icon to see table/diagram/image

Paediatric population: The safety assessment in paediatric patients is based on the safety data from two trials in which 61 patients with cIAI (aged from 3 years to less than 18 years) and 67 patients with cUTI (aged from 3 months to less than 18 years) received Zavicefta. Overall, the safety profile in these 128 paediatric patients was similar to that observed in the adult population with cIAI and cUTI.

View ADR Monitoring Form

Zavicefta Adverse Reactions

ceftazidime + avibactam

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma