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pregnancy, or females of reproductive potential not using effective contraception; hypersensitivity; current leflunomide.",[68,70],{"source":34,"section":69},"4",{"source":34,"section":71},"Boxed Warning",[73],{"text":74,"refs":77},{"fa":75,"en":76},"هشدار جعبه‌ای: سمیت کبدی (ALT ماهانه ۶ ماه اول) و سمیت جنینی (رد بارداری قبل از شروع؛ حذف سریع با کلستیرامین یا زغال فعال).","Boxed warning: hepatotoxicity (monthly ALT for 6 months) and embryofetal toxicity (exclude pregnancy before starting; accelerated elimination with cholestyramine or charcoal).",[78,79],{"source":34,"section":71},{"source":34,"section":80},"5",[],[],[],{"status":85,"reviewer":86,"date":86},"unverified",null,[88],{"regimen":46,"formulation":23,"input":89,"expect":92},{"ageYears":90,"weightKg":91},35,65,{"perDose":28,"tabletsPerDoseRounded":5,"upperPerDose":40},[94],"L04AK02",{"status":96,"forms":97,"refs":106},"registered",[98,102],{"code":99,"en":100,"fa":101},"52932","TERIFLUNOMIDE 7MG TAB","قرص تریفلونوماید ۷ میلی‌گرم",{"code":103,"en":104,"fa":105},"22698","TERIFLUNOMIDE 14MG TAB","قرص تریفلونوماید ۱۴ میلی‌گرم",[107],{"source":108,"section":109,"url":110},"darooyab-generic","G-3853\u002FTeriflunomide","https:\u002F\u002Fwww.darooyab.ir\u002FG-3853\u002FTeriflunomide",{"kind":112,"refs":113,"id":116},"NDA",[114],{"source":34,"section":115},"SPL approval \u002F marketing category","NDA202992",[118,121,125,128,131],{"kind":119,"url":120,"label":116},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=202992",{"kind":122,"url":123,"label":124},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=4650d12c-b9c8-4525-b07f-a2d773eca155","FDA Aubagio",{"kind":126,"url":127,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa613010.html",{"kind":129,"url":130,"label":94},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AK02",{"kind":132,"url":110,"label":8},"darooyab",{"pregnancy":134,"lactation":142,"pediatric":151,"geriatric":160,"reproductive":169},{"level":135,"text":136,"quote":139,"refs":140},"contraindicated",{"fa":137,"en":138},"برچسب: در بارداری منع مصرف دارد.","Label: contraindicated in pregnancy.","Severe hepatic impairment ( 4 , 5.1 ) Pregnancy ( 4 , 5.2 , 8.1 ) Hypersensitivity ( 4 , 5.5 ) Current leflunomide treatment ( 4 ) AUBAGIO is contraindicated in\u002Fwith: Patients with severe hepatic impairment [see Warnings and Precautions (5.1) ] .",[141],{"source":34,"section":69},{"level":143,"text":144,"quote":147,"refs":148},"avoid",{"fa":145,"en":146},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the potential for adverse reactions in a breastfed infant from AUBAGIO, women should not breastfeed during treatment with AUBAGIO.",[149],{"source":34,"section":150},"8.2",{"level":152,"text":153,"quote":156,"refs":157},"not-established",{"fa":154,"en":155},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness in pediatric patients have not been established.",[158],{"source":34,"section":159},"8.4",{"level":161,"text":162,"quote":165,"refs":166},"caution",{"fa":163,"en":164},"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.","Clinical studies of AUBAGIO did not include patients over 65 years old.",[167],{"source":34,"section":168},"8.5",{"level":161,"text":170,"quote":173,"refs":174},{"fa":171,"en":172},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Females Females of reproductive potential should use effective contraception while taking AUBAGIO.",[175],{"source":34,"section":176},"8.3",1792156197110]