这些规定旨在确保质量控制、建立不良反应报告机制和规范成分标签。
The regulations aim to ensure quality control, reporting of adverse effects and proper labelling of contents.
该药标签中的“警告”和“过量”栏目正在被修改,以反映上述潜在的不良事件。
The "warnings" and "overdosage" sections of the drug's labeling are being changed to reflect these potential adverse events.
这也表明尽管目前在目前在标签上增加了关于引起腱断裂的警告,仍有大量的腱相关不良反应持续报道。
It also demonstrates that despite the current warning of tendon rupture in the labelling, large Numbers of tendon-related adverse events continue to be reported.
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