通用名称

ceftaroline fosamil

儿科标签批准日期

2019/9/13 0:00:00

特定指示/秒

Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) to include pediatric patients from birth to less than 2 months

标签更改摘要

- Safety and effectiveness in the treatment of ABSSSI have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age); previously approved down to 2 months. - Use of Teflaro in pediatric patients less than 2 months of age was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age. - Safety and effectiveness in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age for the treatment of ABSSSI have not been established. - Adverse reactions were similar to those observed in adults. - Information on dosing, adverse reactions, and clinical trial. - Postmarketing study.

治疗类别

Anti-Infective

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

0 YEARS - 1 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic,Tolerability

研究设计

Open-Label

登记的患者

11

患者分析

N/A

中心的数量

4

国家数量

2

西班牙裔拉美裔/拉丁裔总计

N/A

非西班牙裔/非拉丁裔总人数

N/A

总数#种族不明

N/A

亚裔学生总数

N/A

黑人总数

N/A

白人总数

N/A

夏威夷或太平洋岛民总数

N/A

美洲印第安人/阿拉斯加本地人总数

N/A

其他种族总计

N/A

未知种族总数

N/A

国家

N/A