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Quzyttir
通用名称
cetirizine hydrochloride
儿科标签批准日期
2019/10/4 0:00:00
特定指示/秒
Treatment of acute urticaria in adults and children 6 months of age and older
标签更改摘要
- Safety and efficacy have been established in patients 6 months to 17 years of age.
- Efficacy for the treatment of acute urticaria down to 6 months is based on extrapolation of the efficacy of Quzyttir in adults with acute urticaria and supported by pharmacokinetic data with oral cetirizine hydrochloride in patients 6 months to 17 years of age.
- Based upon the known PK profile of oral cetirizine hydrochloride, the exposure of IV cetirizine hydrochloride in pediatric patients 6 months to 17 years is expected to be similar to the exposure of IV cetirizine hydrochloride in adults at the labeled doses.
- Safety in children 6 months to 17 years of age is supported by safety information from placebo-controlled clinical trials with oral cetirizine hydrochloride in patients 6 months of age and older.
- Quzyttir demonstrates a higher Cmax compared to oral cetirizine hydrochloride in adults.
- Because of the absence of pharmacokinetic and safety information for cetirizine hydrochloride in children below 6 years with impaired renal or hepatic function, use in this impaired patient population is not recommended.
- Safety and efficacy in patients less than 6 months of age has not been established.
- Information on PK parameters and clinical trials.
- New dosage form.