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use only if needed, under medical advice.","Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with BRIVIACT use during pregnancy.",[282],{"source":33,"section":283},"8.1",{"level":276,"text":285,"quote":288,"refs":289},{"fa":286,"en":287},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Data from published literature indicate that brivaracetam is present in human milk.",[290],{"source":33,"section":291},"8.2",{"level":276,"text":293,"quote":296,"refs":297},{"fa":294,"en":295},"برچسب برای کودکان شرط، محدودیت سنی یا نکته دارد؛ جمله برچسب در زیر آمده است.","The label has conditions, age limits or notes for children; the label sentence is quoted below.","Safety and effectiveness of BRIVIACT have been established in pediatric patients 1 month to less than 16 years of age.",[298],{"source":33,"section":299},"8.4",{"level":276,"text":301,"quote":304,"refs":305},{"fa":302,"en":303},"برچسب: در سالمندان با احتیاط و معمولاً از دوز پایین شروع شود.","Label: use with caution in older adults, usually starting at the low end of the dose range.","In general, dose selection for an elderly patient should be judicious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .",[306],{"source":33,"section":307},"8.5",{"kind":309,"refs":310,"id":258},"NDA",[311],{"source":33,"section":312},"SPL approval \u002F marketing category",1792156165478]