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Botox injection
儿科标签批准日期
2021/2/9 0:00:00
特定指示/秒
Pediatric neurogenic detrusor overactivity in pediatric patients 5 years and older
标签更改摘要
- Safety and effectiveness for detrusor overactivity associated with a neurologic condition have been established in pediatric patients 5 years and older who have an inadequate response to or are intolerant of anticholinergic medication.
- Use in this patient population is based on the results of a randomized, double-blind, parallel group trial in 113 pediatric patients 5 to 17 years with detrusor overactivity associated with a neurologic condition and a long-term, multicenter, double-blind, long-term extension trial.
- The most common adverse reactions in this population were urinary tract infection, bacteriuria, hematuria, and leukocyturia.
- Safety and effectiveness have not been established in patients with neurogenic detrusor overactivity younger than 5 years of age.
- Information on adverse reactions, and clinical trial.
- Postmarketing study.