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ArmonAir RespiClick inhalation powder
通用名称
fluticasone propionate
儿科标签批准日期
2021/7/9 0:00:00
特定指示/秒
Maintenance treatment of asthma as prophylactic therapy in pediatric patients 4 to 11 years
标签更改摘要
- Safety and effectiveness in the maintenance treatment of asthma as prophylactic therapy in pediatric patients 4 years and older have been established.
- Use for this indication in adolescents ages 12 to 17 years is supported by evidence from two adequate and well-controlled trials in adult and adolescent patients 12 years old and older with persistent symptomatic asthma despite ICS or ICS/LABA therapy (Trials 1 and 2).
- Use for this indication in pediatric patients aged 4 to 11 years is supported by evidence from one adequate and well-controlled trial.
- In this trial, 419 pediatric patients received Armonair Respiclick 30 mcg or 55mcg one inhalation twice daily.
- Safety and effectiveness in patients below the age of 4 years have not been established.
- Information on dosing, adverse reactions, and clinical trial.
- Postmarketing study.