[{"data":1,"prerenderedAt":194},["ShallowReactive",2],{"drug-hepatitis-b-vaccine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":34,"contraindications":69,"warnings":79,"renal":80,"monitoring":81,"interactions":82,"review":83,"examples":85,"atc":95,"iran":97,"links":133,"populations":155,"usApproval":189},"hepatitis-b-vaccine",1,{"fa":7,"en":8},"واکسن هپاتیت B","Hepatitis B vaccine","anti-infectives",{"fa":11,"en":12},"واکسن نوترکیب","Recombinant vaccine",[14],{"name":15,"market":16},"Engerix-B","US",[18,19,20],"engerix","heberbiovac","واکسن هپاتیت ب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":29,"refs":30},"susp","injection","im","0.5 mL (10 mcg) or 1 mL (20 mcg)",{"amount":5,"unit":28,"perVolumeMl":5},"mL",[16],[31],{"source":32,"section":33},"fda-engerix","3",[35],{"id":36,"disease":37,"label":38,"population":41,"type":42,"unit":28,"dose":43,"refs":56,"durationDays":59,"notes":60},"primary","immunization",{"fa":39,"en":40},"سری اولیه — تولد تا ۱۹ سال: ۰٫۵ mL؛ ۲۰ سال به بالا: ۱ mL (ماه ۰، ۱ و ۶)","Primary series — birth to 19 y: 0.5 mL; ≥20 y: 1 mL (months 0, 1, 6)",{},"ageBand",{"bands":44},[45,53],{"minAge":46,"maxAge":49,"perDose":52,"dosesPerDay":5},{"value":47,"unit":48},0,"day",{"value":50,"unit":51},20,"year",0.5,{"minAge":54,"maxAge":55,"perDose":5,"dosesPerDay":5},{"value":50,"unit":51},null,[57],{"source":32,"section":58},"2.3",{"min":5,"max":5},[61],{"text":62,"refs":65},{"fa":63,"en":64},"۳ دوز در ماه ۰، ۱ و ۶. همودیالیز: ۲ mL در ماه ۰، ۱، ۲ و ۶. عضلانی، نه در باسن.","3 doses at months 0, 1 and 6. Haemodialysis: 2 mL at months 0, 1, 2 and 6. IM, not in the buttock.",[66,67],{"source":32,"section":58},{"source":32,"section":68},"2.2",[70],{"id":71,"severity":72,"text":73,"refs":76},"allergy","block",{"fa":74,"en":75},"آنافیلاکسی به دوز قبلی واکسن هپاتیت B یا اجزای آن (از جمله مخمر).","Anaphylaxis to a previous hepatitis B vaccine dose or a component (including yeast).",[77],{"source":32,"section":78},"4",[],[],[],[],{"status":84,"reviewer":55,"date":55},"unverified",[86,90],{"regimen":36,"formulation":23,"input":87,"expect":89},{"ageDays":5,"weightKg":88},3.3,{"perDose":52,"mlPerDose":52},{"regimen":36,"formulation":23,"input":91,"expect":94},{"ageYears":92,"weightKg":93},30,70,{"perDose":5,"mlPerDose":5},[96],"J07BC01",{"status":98,"forms":99,"refs":128},"registered",[100,104,108,112,116,120,124],{"code":101,"en":102,"fa":103},"07058","VACCINE-HEPATITIS B VIRUS 100MCG 10DOSE VIAL","ویال واکسن–هپاتیت B ویروس ۱۰۰ میکروگرم ۱۰ دوز",{"code":105,"en":106,"fa":107},"01841","VACCINE-HEPATITIS B VIRUS 100MCG 1DOSE VIAL","ویال واکسن–هپاتیت B ویروس ۱۰۰ میکروگرم ۱ دوز",{"code":109,"en":110,"fa":111},"01715","VACCINE-HEPATITIS B VIRUS 10MCG 1DOSE VIAL","ویال واکسن–هپاتیت B ویروس ۱۰ میکروگرم ۱ دوز",{"code":113,"en":114,"fa":115},"01844","VACCINE-HEPATITIS B VIRUS 10MCG 20DOSE VIAL","ویال واکسن–هپاتیت B ویروس ۱۰ میکروگرم ۲۰ دوز",{"code":117,"en":118,"fa":119},"02690","VACCINE-HEPATITIS B VIRUS 20MCG 1DOSE AMP","آمپول واکسن–هپاتیت B ویروس ۲۰ میکروگرم ۱ دوز",{"code":121,"en":122,"fa":123},"01532","VACCINE-HEPATITIS B VIRUS 20MCG\u002FML 10DOSE VIAL","ویال واکسن–هپاتیت B ویروس ۲۰ میکروگرم \u002F میلی‌لیتر ۱۰ دوز",{"code":125,"en":126,"fa":127},"51828","HEPATITIS B VIRUS INJECTION PARENTERAL 1 {dose} 1 mL","فرآورده تزریقی هپاتیت B ویروس ۱ { دوز } ۱ میلی‌لیتر",[129],{"source":130,"section":131,"url":132},"darooyab-generic","G-3469\u002FHepatitis-B-Vaccines","https:\u002F\u002Fwww.darooyab.ir\u002FG-3469\u002FHepatitis-B-Vaccines",[134,138,142,146,149,152],{"kind":135,"url":136,"label":137},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103239","BLA103239",{"kind":139,"url":140,"label":141},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=2ec65f7e-4aa2-4b41-b578-885ea59d6e9d","FDA Engerix-B",{"kind":143,"url":144,"label":145},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607014.html","Hepatitis B (Recombinant) Vaccine",{"kind":143,"url":147,"label":148},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa626045.html","Hepatitis B (recombinant) vaccine, Adjuvanted",{"kind":150,"url":151,"label":96},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J07BC01",{"kind":153,"url":132,"label":154},"darooyab","Hepatitis-B-Vaccines",{"pregnancy":156,"lactation":165,"pediatric":173,"geriatric":181},{"level":157,"text":158,"quote":161,"refs":162},"caution",{"fa":159,"en":160},"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 ENGERIX-B during pregnancy",[163],{"source":32,"section":164},"8.1",{"level":157,"text":166,"quote":169,"refs":170},{"fa":167,"en":168},"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 ENGERIX-B in human milk, the effects on the breastfed child, or the effects on milk production.",[171],{"source":32,"section":172},"8.2",{"level":157,"text":174,"quote":177,"refs":178},{"fa":175,"en":176},"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.","Safety and effectiveness of ENGERIX‑B have been established in all pediatric age-groups.",[179],{"source":32,"section":180},"8.4",{"level":157,"text":182,"quote":185,"refs":186},{"fa":183,"en":184},"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 ENGERIX‑B used for licensure did not include sufficient numbers of participants aged 65 years and older to determine whether they respond differently from younger participants.",[187],{"source":32,"section":188},"8.5",{"kind":190,"refs":191,"id":137},"BLA",[192],{"source":32,"section":193},"SPL approval \u002F marketing category",1792108425213]