通用名称

peramivir

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.

治疗类别

Antivirals

立法类型

PREA Only

产品说明书链接