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Zipsor capsules
通用名称
diclofenac potassium
儿科标签批准日期
2021/5/25 0:00:00
特定指示/秒
Mild to moderate acute pain in pediatric patients 12 years of age and older
标签更改摘要
- Safety and effectiveness in pediatric patients 12 to 17 years have been established.
- Use in pediatric patients 12 to 17 years is based on extrapolation of efficacy from adequate and well-controlled studies in adults and supported by pharmacokinetic and safety data from two open-label studies in 49 patients 12 to 17 years with mild to moderate acute pain and one active-controlled study in 76 pediatric patients 12 to 16 years with orthodontic discomfort.
- The safety profile in adolescent patients was similar to adults.
- Safety and effectiveness in patients less than 12 years of age have not been established.
- Information on dosing, and clinical trials.
- Postmarketing study.