通用名称

ceftazidime/avibactam

儿科标签批准日期

2019/3/14 0:00:00

特定指示/秒

Treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) to include patients 3 months to less than 18 years

标签更改摘要

- Safety and effectiveness in the treatment of cUTI and cIAI have been established in pediatric patients 3 months to less than 18 years. Use in these age groups is supported by evidence from adequate and well-controlled studies of Avycaz in adults with cUTI and cIAI and additional pharmacokinetic and safety data from pediatric trials. - Safety and effectiveness in pediatric patients below the age of 3 months with cUTI or cIAI have not been established. - Safety and effectiveness in pediatric patients less than 18 years of age with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia have not been established. - Dosage adjustment is required in pediatric patients with cIAI or cUTI and renal impairment from 2 years to < 18 years with eGFR 50 mL/min/1.73 m2 or less. There is insufficient information to recommend a dosing regimen for pediatric patients younger than 2 years of age with cIAI or cUTI and renal impairment. - Safety in patients ages 3 months to less than 18 years was similar to that observed in adults. - Information on recommended dosing, dosing in renal impairment patients, PK parameters and clinical trials in patients ages 3 months to less than 18 years. - Postmarketing study.

治疗类别

Anti-Infective

立法类型

PREA Only

产品说明书链接

书号

2.0 1.0

研究年龄

3 MONTHS - 17 YEARS 3 MONTHS - 17 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic,Tolerability Efficacy,Safety,Pharmacokinetic,Tolerability

研究设计

Single-Blind,Active Control Single-Blind,Active Control

登记的患者

86 101

患者分析

N/A N/A

中心的数量

25 29

国家数量

9 10

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

N/A N/A