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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XTAMPZA ER safely and effectively. See full prescribing information for XTAMPZA ER. XTAMPZA
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Serious and life-threatening risks refer to conditions or situations that pose a significant threat to an individual's health or safety, potentially resulting in severe harm or death.
Organizations and individuals, typically in the healthcare, pharmaceutical, or environmental sectors, are required to file reports of serious and life-threatening risks when they become aware of such risks affecting patients, employees, or the public.
To fill out a report on serious and life-threatening risks, one should gather all relevant information, complete the designated forms accurately, provide detailed descriptions of the risks, and submit the paperwork to the appropriate regulatory authority.
The purpose of reporting serious and life-threatening risks is to ensure public safety by informing relevant authorities, enabling prompt investigation, and facilitating necessary interventions or regulations to mitigate potential harm.
Information that must be reported includes the nature of the risk, the severity, potential outcomes, specific products or practices involved, and any actions taken to mitigate the risk.
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