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Dangerous in pregnancy.","Clinical Considerations Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ACULAR during late pregnancy should be avoided.",[156],{"source":32,"section":157},"8.1",{"level":159,"text":160,"quote":163,"refs":164},"caution",{"fa":161,"en":162},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Because many drugs are excreted in human milk, caution should be exercised when ACULAR is administered to a nursing woman.",[165],{"source":32,"section":166},"8.2",{"level":159,"text":168,"quote":171,"refs":172},{"fa":169,"en":170},"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.","The safety and effectiveness of ACULAR have not been established in pediatric patients younger than 2 years old.",[173],{"source":32,"section":174},"8.4",{"level":176,"text":177,"quote":180,"refs":181},"ok",{"fa":178,"en":179},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety or effectiveness have been observed between elderly and other adult patients.",[182],{"source":32,"section":183},"8.5",{"kind":185,"refs":186,"id":137},"NDA",[187],{"source":32,"section":188},"SPL approval \u002F marketing category",1792115185028]