[{"data":1,"prerenderedAt":165},["ShallowReactive",2],{"drug-hepatitis-a-vaccine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":34,"contraindications":71,"warnings":81,"renal":82,"monitoring":83,"interactions":84,"review":85,"examples":87,"atc":97,"iran":99,"links":111,"populations":126,"usApproval":160},"hepatitis-a-vaccine",1,{"fa":7,"en":8},"واکسن هپاتیت A","Hepatitis A vaccine","anti-infectives",{"fa":11,"en":12},"واکسن غیرفعال","Inactivated vaccine",[14],{"name":15,"market":16},"Havrix","US",[18,19,20],"havrix","هاوریکس","واکسن هپاتیت آ",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":29,"refs":30},"susp","injection","im","0.5 mL (child) or 1 mL (adult)",{"amount":5,"unit":28,"perVolumeMl":5},"mL",[16],[31],{"source":32,"section":33},"fda-havrix","3",[35],{"id":36,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":57,"durationDays":60,"notes":61},"std","immunization",{"fa":39,"en":40},"۱۲ ماه تا ۱۸ سال: ۰٫۵ mL؛ ۱۹ سال به بالا: ۱ mL — دوز یادآور ۶ تا ۱۲ ماه بعد","12 months–18 y: 0.5 mL; ≥19 y: 1 mL — booster 6–12 months later",{"minAge":42},{"value":43,"unit":44},12,"month","ageBand",{"bands":47},[48,54],{"minAge":49,"maxAge":50,"perDose":53,"dosesPerDay":5},{"value":43,"unit":44},{"value":51,"unit":52},19,"year",0.5,{"minAge":55,"maxAge":56,"perDose":5,"dosesPerDay":5},{"value":51,"unit":52},null,[58],{"source":32,"section":59},"2.3",{"min":5,"max":5},[62],{"text":63,"refs":66},{"fa":64,"en":65},"دست‌کم ۲ هفته پیش از مواجهه احتمالی. عضلانی، نه در باسن.","At least 2 weeks before expected exposure. IM, not in the buttock.",[67,69],{"source":32,"section":68},"1",{"source":32,"section":70},"2.2",[72],{"id":73,"severity":74,"text":75,"refs":78},"allergy","block",{"fa":76,"en":77},"آنافیلاکسی به دوز قبلی واکسن هپاتیت A یا اجزای آن (از جمله نئومایسین).","Anaphylaxis to a previous hepatitis A vaccine dose or a component (including neomycin).",[79],{"source":32,"section":80},"4",[],[],[],[],{"status":86,"reviewer":56,"date":56},"unverified",[88,92],{"regimen":36,"formulation":23,"input":89,"expect":91},{"ageYears":90,"weightKg":43},2,{"perDose":53,"mlPerDose":53},{"regimen":36,"formulation":23,"input":93,"expect":96},{"ageYears":94,"weightKg":95},30,70,{"perDose":5,"mlPerDose":5},[98],"J07BC02",{"status":100,"forms":101,"refs":106},"registered",[102],{"code":103,"en":104,"fa":105},"51974","HEPATITIS A, INACTIVATED, WHOLE VIRUS INJECTION, SUSPENSION PARENTERAL 50 [iU]\u002F1mL","سوسپانسیون تزریقی هپاتیت A غیرفعال‌شده کامل ویروس ۵۰ واحد بین‌المللی \u002F ۱ میلی‌لیتر",[107],{"source":108,"section":109,"url":110},"darooyab-generic","G-3467\u002FHepatitis-A-Vaccines","https:\u002F\u002Fwww.darooyab.ir\u002FG-3467\u002FHepatitis-A-Vaccines",[112,116,120,123],{"kind":113,"url":114,"label":115},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103475","BLA103475",{"kind":117,"url":118,"label":119},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=f9499a4d-1288-4bd3-9d59-1d72092c38cd","FDA Havrix",{"kind":121,"url":122,"label":98},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J07BC02",{"kind":124,"url":110,"label":125},"darooyab","Hepatitis-A-Vaccines",{"pregnancy":127,"lactation":136,"pediatric":144,"geriatric":152},{"level":128,"text":129,"quote":132,"refs":133},"caution",{"fa":130,"en":131},"برچسب: داده‌های موجود افزایش خطر نقص مادرزادی یا سقط را نشان نمی‌دهد؛ مطالعه کنترل‌شده کافی نیست.","Label: available data do not suggest an increased risk of major birth defects or miscarriage; no adequate controlled studies.","Available data do not suggest an increased risk of major birth defects and miscarriage in women who received HAVRIX during pregnancy",[134],{"source":32,"section":135},"8.1",{"level":128,"text":137,"quote":140,"refs":141},{"fa":138,"en":139},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information regarding the presence of HAVRIX in human milk, the effects on the breastfed child, or the effects on milk production.",[142],{"source":32,"section":143},"8.2",{"level":128,"text":145,"quote":148,"refs":149},{"fa":146,"en":147},"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 HAVRIX have not been established in pediatric patients younger than 12 months.",[150],{"source":32,"section":151},"8.4",{"level":128,"text":153,"quote":156,"refs":157},{"fa":154,"en":155},"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 HAVRIX did not include sufficient numbers of participants aged 65 years and older to determine whether they respond differently from younger participants.",[158],{"source":32,"section":159},"8.5",{"kind":161,"refs":162,"id":115},"BLA",[163],{"source":32,"section":164},"SPL approval \u002F marketing category",1792108425103]