通用名称

abametapir

儿科标签批准日期

2020/7/24 0:00:00

特定指示/秒

Head lice infestation in patients 6 months of age and older

标签更改摘要

-Safety and effectiveness have been established two controlled trials of 704 patients with head lice, 6 months and older. - Safety and effectiveness have not been established in pediatric patients below the age of 6 months. - Not recommended in pediatric patients under 6 months of age because of the potential for increased systemic absorption due to a high ratio of skin surface to body mass and the potential for an immature skin barrier. - Xeglyze contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. The “gasping syndrome” has been associated with intravenously administered benzyl alcohol dosages >99 mg/kg/day in neonates and low birthweight infants. - The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. - Because of the risk of accidental ingestion, Xeglyze should be administered to pediatric patients only under direct adult supervision. - Information on safety profile, and clinical trial. - New drug.

治疗类别

Pediculicides/Lice Agents (Topical)

立法类型

PREA Only

产品说明书链接

书号

2.0 1.0

研究年龄

6 MONTHS - 16 YEARS 6 MONTHS - 16 YEARS

学习类型

Efficacy,Safety Efficacy,Safety

研究设计

Randomized,Double-Blind,Parallel Group,Vehicle Controlled Randomized,Double-Blind,Parallel Group,Vehicle Controlled

登记的患者

108 108

患者分析

N/A N/A

中心的数量

7 7

国家数量

1 1

西班牙裔拉美裔/拉丁裔总计

N/A N/A

非西班牙裔/非拉丁裔总人数

N/A N/A

总数#种族不明

N/A N/A

亚裔学生总数

N/A N/A

黑人总数

N/A N/A

白人总数

N/A N/A

夏威夷或太平洋岛民总数

N/A N/A

美洲印第安人/阿拉斯加本地人总数

N/A N/A

其他种族总计

N/A N/A

未知种族总数

N/A N/A

国家

United States United States