Zavicefta | Adverse Reactions

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

The information highlighted (if any) are the most recent updates for this brand.

Full Prescribing Info

Adverse Reactions

Summary of the safety profile: In seven Phase 2 and Phase 3 clinical trials, 2024 adults were treated with Zavicefta. The most common adverse reactions occurring in ≥5% of patients treated with Zavicefta were Coombs direct test positive, nausea, and diarrhoea. Nausea and diarrhoea were usually mild or moderate in intensity.
Tabulated list of adverse reactions: The following adverse reactions have been reported with ceftazidime alone and/or identified during all Phase 2 and Phase 3 clinical trials with Zavicefta. Adverse reactions are classified according to frequency and System Organ Class. Frequency categories are derived from adverse reactions and/or clinically significant laboratory abnormalities, and are defined according to the following conventions: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1,000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Unknown (cannot be estimated from the available data). (See Table 7.)

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Paediatric population: The safety assessment in paediatric patients is based on the safety data from two trials in which 61 patients (aged from 3 years to less than 18 years) with cIAI 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.

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Zavicefta Adverse Reactions

ceftazidime + avibactam

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma