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use only if needed, under medical advice.","Risk Summary Prolonged experience with mirtazapine in pregnant women, based on published observational studies and postmarketing reports, has not reliably identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",[132],{"source":32,"section":133},"8.1",{"level":126,"text":135,"quote":138,"refs":139},{"fa":136,"en":137},"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 report the presence of mirtazapine in human milk at low levels with relative infant doses for mirtazapine ranging between 0.6 and 2.8% of the maternal weight-adjusted dose (see Data) .",[140],{"source":32,"section":141},"8.2",{"level":143,"text":144,"quote":147,"refs":148},"avoid",{"fa":145,"en":146},"هشدار جعبه‌ای برچسب درباره کودکان.","Boxed warning in the label about children.","Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.",[149],{"source":32,"section":150},"Boxed Warning",{"level":126,"text":152,"quote":155,"refs":156},{"fa":153,"en":154},"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.","Caution is indicated when administering mirtazapine to elderly patients [see Warnings and Precautions (5.12) , (5.15) and Clinical Pharmacology (12.3) ] .",[157],{"source":32,"section":158},"8.5",{"kind":160,"refs":161,"id":111},"ANDA",[162],{"source":32,"section":163},"SPL approval \u002F marketing category",1792440737699]