Safety Monitoring During Treatment Administration Sample Clauses

Safety Monitoring During Treatment Administration. Appropriate resuscitation equipment and trained personnel must be available at the site to treat any life-threatening emergencies (e.g. anaphylaxis, autonomic dysreflexia or cardiorespiratory arrest) during the IMP administration and during the immediate post-treatment observation period. All subjects must be monitored throughout the procedure if sedatives or general anaesthesia are being used, per local site practice. In addition, subjects with SCI with a vertebral lesion above T6 are at a greater risk of developing autonomic dysreflexia during invasive procedures [19]. Therefore, these subjects must: • Have their blood pressure (BP) and heart rate (HR) continually monitored throughout the treatment administration procedure. There is no need to record BP or HR monitoring data, other than abnormalities that are clinically significant in the investigator’s opinion; which should be reported as AEs. If there are any symptoms or signs of autonomic dysreflexia developing, then: • Immediate treatment for the autonomic dysreflexia should be instituted per local site practice and appropriate guidelines • The treatment procedure should be immediately stopped until the autonomic dysreflexia has resolved. The treatment procedure should only be recommenced if deemed clinically safe • An occurrence of autonomic dysreflexia during treatment administration must be reported as an AE.
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Safety Monitoring During Treatment Administration. 71 6.3 Intradetrusor Treatment Paradigm 72
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