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Mycamine
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.