当前位置：药药网 / 数据中心 / 儿科研究特征电子表格
Eraxis
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.