通用名称

micafungin

儿科标签批准日期

2019/12/20 0:00:00

特定指示/秒

Treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age

标签更改摘要

- Safety and effectiveness at a dose of 4 mg/kg once daily have been established in pediatric patients without meningoencephalitis and/or ocular dissemination younger than 4 months. - This use and dose are supported by evidence from adequate and well-controlled studies in adult and pediatric patients 4 months and older with additional pharmacokinetic and safety data in pediatric patients younger than 4 months of age. - Safety and effectiveness have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months as a higher dose may be needed. - Safety and effectiveness in pediatric patients younger than 4 months have not been established for (1) the treatment of esophageal candidiasis and (2) prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. - Information on dosing, adverse reactions, PK parameters and clinical trials. - Postmarketing study.

治疗类别

Antifungal

立法类型

PREA Only

产品说明书链接

书号

2.0 1.0

研究年龄

0 DAYS - 180 DAYS 0 DAYS - 120 DAYS

学习类型

Efficacy,Pharmacokinetic Efficacy,Safety

研究设计

Trad PK Single-Blind,Active Control

登记的患者

35 30

患者分析

N/A N/A

中心的数量

1 17

国家数量

1 11

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