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

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