通用名称

piperacillin/tazobactam

儿科标签批准日期

2020/5/26 0:00:00

特定指示/秒

Nosocomial pneumonia to include patients from 2 months to 17 years

标签更改摘要

- Use in pediatric patients 2 months of age and older with nosocomial pneumonia is supported by evidence from well-controlled studies in adults with nosocomial pneumonia, a simulation study performed with a population pharmacokinetic model, and a retrospective, cohort study of pediatric patients with nosocomial pneumonia in which 140 pediatric patients were treated with Zosyn and 267 patients treated with comparators including ticarcillin-clavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin. - Safety and effectiveness have not been established in pediatric patients less than 2 months of age. - Information on dosing, adverse reactions and clinical trial. - Postmarketing study.

治疗类别

Antibacterials

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

2 MONTHS - 17 YEARS

学习类型

Safety

研究设计

Active Comparator,Retrospective

登记的患者

407

患者分析

N/A

中心的数量

N/A

国家数量

1

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

United States