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CrCl زیر ۵۰: کاهش دوز طبق جدول ۲ برچسب.","On an empty stomach (2 h after a meal and 2 h before the next). CrCl \u003C50: reduce per label Table 2.",[73,75],{"source":33,"section":74},"2.1",{"source":33,"section":76},"2.4",{"id":78,"disease":54,"label":79,"population":82,"type":62,"unit":28,"dose":84,"refs":85,"notes":87},"lam-adult",{"fa":80,"en":81},"هپاتیت B — مقاوم به لامیوودین یا سیروز جبران‌نشده، ۱۶ سال به بالا: ۱ mg روزانه","Hepatitis B — lamivudine-refractory or decompensated, ≥16 y: 1 mg daily",{"minAge":83},{"value":60,"unit":61},{"perDose":5,"dosesPerDay":5},[86],{"source":33,"section":66},[88],{"text":89,"refs":90},{"fa":70,"en":71},[91,92],{"source":33,"section":74},{"source":33,"section":76},{"id":94,"disease":54,"label":95,"population":98,"type":103,"unit":28,"dose":104,"refs":130,"notes":133},"naive-child",{"fa":96,"en":97},"هپاتیت B — کودک ۲ سال به بالا بدون درمان قبلی: بر اساس وزن","Hepatitis B — child ≥2 y, treatment-naive: by weight",{"minAge":99,"maxAge":101,"minWeightKg":102},{"value":100,"unit":61},2,{"value":60,"unit":61},10,"weightBand",{"weightBands":105},[106,110,113,116,119,122,125,128],{"minWeightKg":107,"maxWeightKg":108,"perDose":109,"dosesPerDay":5},9.99,11,0.15,{"minWeightKg":108,"maxWeightKg":111,"perDose":112,"dosesPerDay":5},14,0.2,{"minWeightKg":111,"maxWeightKg":114,"perDose":115,"dosesPerDay":5},17,0.25,{"minWeightKg":114,"maxWeightKg":117,"perDose":118,"dosesPerDay":5},20,0.3,{"minWeightKg":117,"maxWeightKg":120,"perDose":121,"dosesPerDay":5},23,0.35,{"minWeightKg":120,"maxWeightKg":123,"perDose":124,"dosesPerDay":5},26,0.4,{"minWeightKg":123,"maxWeightKg":126,"perDose":127,"dosesPerDay":5},30,0.45,{"minWeightKg":126,"maxWeightKg":129,"perDose":27,"dosesPerDay":5},null,[131],{"source":33,"section":132},"2.3, Table 1",[134,141],{"text":135,"refs":138},{"fa":136,"en":137},"تا ۳۰ kg محلول خوراکی. بالای ۳۰ kg: ۱۰ mL محلول یا یک قرص ۰٫۵ mg.","Oral solution up to 30 kg. Over 30 kg: 10 mL solution or one 0.5 mg tablet.",[139],{"source":33,"section":140},"2.3",{"text":142,"refs":143},{"fa":70,"en":71},[144,145],{"source":33,"section":74},{"source":33,"section":76},{"id":147,"disease":54,"label":148,"population":151,"type":103,"unit":28,"dose":154,"refs":168,"notes":170},"lam-child",{"fa":149,"en":150},"هپاتیت B — کودک ۲ سال به بالا با سابقه لامیوودین: بر اساس وزن (دو برابر)","Hepatitis B — child ≥2 y, lamivudine-experienced: by weight (double)",{"minAge":152,"maxAge":153,"minWeightKg":102},{"value":100,"unit":61},{"value":60,"unit":61},{"weightBands":155},[156,157,158,159,161,163,165,167],{"minWeightKg":107,"maxWeightKg":108,"perDose":118,"dosesPerDay":5},{"minWeightKg":108,"maxWeightKg":111,"perDose":124,"dosesPerDay":5},{"minWeightKg":111,"maxWeightKg":114,"perDose":27,"dosesPerDay":5},{"minWeightKg":114,"maxWeightKg":117,"perDose":160,"dosesPerDay":5},0.6,{"minWeightKg":117,"maxWeightKg":120,"perDose":162,"dosesPerDay":5},0.7,{"minWeightKg":120,"maxWeightKg":123,"perDose":164,"dosesPerDay":5},0.8,{"minWeightKg":123,"maxWeightKg":126,"perDose":166,"dosesPerDay":5},0.9,{"minWeightKg":126,"maxWeightKg":129,"perDose":5,"dosesPerDay":5},[169],{"source":33,"section":132},[171,177],{"text":172,"refs":175},{"fa":173,"en":174},"بالای ۳۰ kg: ۲۰ mL محلول یا یک قرص ۱ mg.","Over 30 kg: 20 mL solution or one 1 mg tablet.",[176],{"source":33,"section":140},{"text":178,"refs":179},{"fa":70,"en":71},[180,181],{"source":33,"section":74},{"source":33,"section":76},[],[184],{"text":185,"refs":188},{"fa":186,"en":187},"هشدار جعبه‌ای: تشدید شدید هپاتیت B پس از قطع؛ در عفونت همزمان HIV بدون درمان ضدرتروویروسی خطر مقاومت HIV؛ اسیدوز لاکتیک و کبد چرب شدید.","Boxed warning: severe hepatitis B flare after stopping; HIV resistance risk in untreated HIV co-infection; lactic acidosis and severe hepatomegaly with steatosis.",[189],{"source":33,"section":190},"Boxed Warning",[],[],[],{"status":195,"reviewer":129,"date":129},"unverified",[197,202,208,211],{"regimen":53,"formulation":22,"input":198,"expect":201},{"ageYears":199,"weightKg":200},40,70,{"perDose":27,"tabletsPerDoseRounded":5},{"regimen":94,"formulation":43,"input":203,"expect":206},{"ageYears":204,"weightKg":205},3,12,{"perDose":112,"mlPerDose":207},4,{"regimen":78,"formulation":36,"input":209,"expect":210},{"ageYears":199,"weightKg":200},{"perDose":5,"tabletsPerDoseRounded":5},{"regimen":147,"formulation":43,"input":212,"expect":213},{"ageYears":204,"weightKg":205},{"perDose":124,"mlPerDose":214},8,[216],"J05AF10",{"status":218,"forms":219,"refs":231},"registered",[220,224,228],{"code":221,"en":222,"fa":223},"11471","ENTECAVIR 0.5MG TAB","قرص انتکاویر ۰٫۵ میلی‌گرم",{"code":225,"en":226,"fa":227},"12741","ENTECAVIR 1MG  TAB","قرص انتکاویر ۱ میلی‌گرم",{"code":229,"en":230,"fa":223},"52677","ENTECAVIR TABLET ORAL 0.5 mg",[232],{"source":233,"section":234,"url":235},"darooyab-generic","G-4727\u002FEntecavir","https:\u002F\u002Fwww.darooyab.ir\u002FG-4727\u002FEntecavir",[237,241,245,248,251],{"kind":238,"url":239,"label":240},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021797","NDA021797",{"kind":242,"url":243,"label":244},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20","FDA Baraclude",{"kind":246,"url":247,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa605028.html",{"kind":249,"url":250,"label":216},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AF10",{"kind":252,"url":235,"label":8},"darooyab",{"pregnancy":254,"lactation":263,"pediatric":271,"geriatric":279},{"level":255,"text":256,"quote":259,"refs":260},"caution",{"fa":257,"en":258},"برچسب خطر مشخصی برای بارداری ذکر نکرده یا داده کافی ندارد؛ فقط در صورت لزوم و با نظر پزشک.","Label states no clear risk or has limited data; use only if needed, under medical advice.","Risk Summary Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes.",[261],{"source":33,"section":262},"8.1",{"level":255,"text":264,"quote":267,"refs":268},{"fa":265,"en":266},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","When administered to lactating rats, entecavir was present in milk (see Data).",[269],{"source":33,"section":270},"8.2",{"level":255,"text":272,"quote":275,"refs":276},{"fa":273,"en":274},"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.","BARACLUDE was evaluated in two clinical trials of pediatric subjects 2 years of age and older with HBeAg-positive chronic HBV infection and compensated liver disease.",[277],{"source":33,"section":278},"8.4",{"level":255,"text":280,"quote":283,"refs":284},{"fa":281,"en":282},"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.","Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.4) ].",[285],{"source":33,"section":286},"8.5",{"kind":288,"refs":289,"id":240},"NDA",[290],{"source":33,"section":291},"SPL approval \u002F marketing category",1792108421775]