Zovirax__儿科研究特征电子表格

Zovirax

通用名称

acyclovir

儿科标签批准日期

2019/1/25 0:00:00

特定指示/秒

Neonatal herpes virus infection (HSV)

标签更改摘要

- New dose: Post Menstrual Age (PMA) of at least 34 Weeks: 20 mg/kg every 8 hours for 21 days. PMA of less than 34 Weeks: 20 mg/kg every 12 hours for 21 days. Previously approved dose: Birth to 3 months: 10 mg/kg every 8 hours for 10 days. - In an open-label clinical trial, Zovirax 20 mg/kg every 8 hours (60 mg/kg/day) was compared with 15 mg/kg every 8 hours (45 mg/kg/day) to neonates ≤28 days old with suspected HSV infection. In total, 88 neonates were enrolled in the trial and received IV acyclovir for 21 days. The mean gestational ages (GA) were 37.5 and 37.9 weeks for the 45-mg/kg/day and 60-mg/kg/day doses, respectively. The number of premature infants (≤37 weeks GA) receiving 45 mg/kg/day and 60 mg/kg/day were 7 (54%) and 22 (33%), respectively. - Among 69 patients with proven systemic (disseminated or CNS) herpes infection, 57 were randomized to receive Zovirax (20 mg/kg every 8 hours) while the remaining 12 patients received a lower dose of Zovirax every 8 hours. - Overall, the mortality among patients treated with Zovirax 20 mg/kg every 8 hours was lower compared with patients who received a lower dose of Zovirax. - Information on dosing and clinical trial. - Off-patent written request

治疗类别

N/A

立法类型

409I(BPCA)

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