通用名称

anidulafungin

儿科标签批准日期

2020/9/22 0:00:00

特定指示/秒

Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in patients 1 month and older

标签更改摘要

- Safety and effectiveness for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis, have been established in pediatric patients 1 month and older. - Use for this indication in this age group is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety data in pediatric patients 1 month of age and older - Safety and effectiveness in patients younger than 1 month with candidemia/invasive candidiasis has not been established. - Candidemia/invasive candidiasis in pediatric patients younger than 1 month of age has a higher rate of central nervous system (CNS) and multi-organ dissemination than in older patients. In addition, in patients younger than 1 month Eraxis carries a potential risk of life-threatening toxicity associated with high doses of polysorbate 80, an inactive ingredient in ERAXIS. - Safety and effectiveness in pediatric patients with esophageal candidiasis has not been established. - Contraindicated in adult and pediatric patients with HFI. Because a diagnosis of HFI may not yet be established in pediatric patients, obtain a careful history of HFI symptoms with fructose/sucrose exposure prior to administration of Eraxis. - Information on dosing, adverse reactions, PK parameters, clinical trials. - Postmarketing study.

治疗类别

Antivirals

立法类型

PREA Only

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