Despite the pharmacokinetic gender effect observed in healthy young subjects, no noticeable differences in the safety profile were observed in the subgroup analyses of adverse events by gender as well as in the assessment of residual effects by gender in adult patients. Additionally, there was no influence on efficacy results. In elderly patients, there was no influence of age or gender on efficacy and safety results.
The adverse event profile of zolpidem MR was similar to that of the current zolpidem marketed product, including headache, somnolence, dizziness, and nausea as the most frequently observed TEAEs. No unexpected adverse events were recorded. In consequence, no specific safety monitoring procedure has to be applied for zolpidem MR.
subjects试验主体,受试者
subgroup analyses 亚组分析
adverse events不良反应
safety profile:安全药历
profile:药历,是一个病人用药处方的总和
residual effects残余效应(影响),注意不是副作用(side effect)
zolpidem:唑吡坦(安眠药)
嗜睡:Somnolence
dizziness:眩晕
nausea恶心
TEAEs:是一个缩写的复数形式,可惜没搞明白,这并不影响翻译进行。
尽管健康年轻受试者中发现了药物动力学的性别效应(男女反应有差异的意思),但在两性不良反应亚组分析及成年病人药物残余效应评价中没有观察到其安全药历有显著不同。此外,对药效的结果没有影响。大龄病人中,年龄或性别对药效和药物安全性没有影响。
“唑吡坦 MR”的不良反应包括头痛、嗜睡、眩晕和恶心等最常观察到的药历和当今市售的唑吡坦产品相似。没有意外的不良反应记录。所以,没有必要对“唑吡坦 MR”使用特殊的安全性检测步骤。
这是用工具翻译的,其中没有翻译的单词,估计是你打错了!
The adverse event profile of zolpidem MR was similar to that of the current zolpidem marketed product, including headache, somnolence, dizziness, and nausea as the most frequently observed TEAEs. No unexpected adverse events were recorded. In consequence, no specific safety monitoring procedure has to be applied for zolpidem MR.