通用名称

piperacillin/tazobactam

儿科标签批准日期

2021/7/29 0:00:00

特定指示/秒

Nosocomial pneumonia in pediatric patients 2 months and older

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 (which included ticarcillin-clavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin) - Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of ZOSYN Injection supplied in GALAXY Containers, and to avoid unintentional overdose, this product is not recommended for use if a dose of ZOSYN Injection in GALAXY Containers that does not equal 2.25 g, 3.375 g, or 4.5 g is required and an alternative formulation of ZOSYN should be considered. - Safety and effectiveness have not been established in pediatric patients less than 2 months. - Information on dosing, PK parameters, adverse reactions, and clinical trials. - Postmarketing study.

治疗类别

Antibacterials

立法类型

Pediatric Rule

产品说明书链接

书号

N/A

研究年龄

N/A

学习类型

N/A

研究设计

N/A

登记的患者

N/A

患者分析

N/A

中心的数量

N/A

国家数量

N/A

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