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Rapivab injection
儿科标签批准日期
2021/1/28 0:00:00
特定指示/秒
Acute uncomplicated influenza in pediatric patients 6 months and older
标签更改摘要
- Safety and effectiveness for the treatment of influenza has been established in pediatric patients 6 months to 17 years.
- Use for this indication is supported by evidence from adequate and well-controlled trials in adults with additional data from a randomized, active-controlled trial of 130 adolescent and pediatric patients with acute uncomplicated influenza who received open-label treatment with a single dose of peramivir or 5 days of treatment with oseltamivir administered within 48 hours of onset of symptoms of influenza.
- Safety and effectiveness of peramivir in pediatric patients less than 6 months have not been established. No data are available for peramivir use in pediatric patients 6 months to less than 2 years with creatinine clearance less than 50 mL/min to inform a recommendation for dosage adjustment.
- Information on dosing, adverse reactions, PK parameters, and clinical trial.
- Postmarketing study.