[{"data":1,"prerenderedAt":189},["ShallowReactive",2],{"drug-hpv-vaccine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":35,"contraindications":87,"warnings":97,"renal":98,"monitoring":99,"interactions":100,"review":101,"examples":104,"atc":113,"iran":115,"links":135,"populations":150,"usApproval":184},"hpv-vaccine",1,{"fa":7,"en":8},"واکسن HPV (پاپیلومای انسانی)","HPV vaccine (9-valent)","anti-infectives",{"fa":11,"en":12},"واکسن نوترکیب","Recombinant vaccine",[14],{"name":15,"market":16},"Gardasil 9","US",[18,19,20,21],"gardasil","گارداسیل","واکسن زگیل تناسلی","HPV",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":30,"refs":31},"syr-05","injection","im","0.5 mL prefilled syringe \u002F vial",{"amount":5,"unit":29,"perVolumeMl":5},"mL",[16],[32],{"source":33,"section":34},"fda-gardasil","3",[36,62],{"id":37,"disease":38,"label":39,"population":42,"type":48,"unit":29,"dose":49,"refs":51,"durationDays":54,"notes":55},"std","immunization",{"fa":40,"en":41},"۰٫۵ mL عضلانی — ۹ تا ۱۴ سال: ۲ دوز (ماه ۰ و ۶ تا ۱۲)؛ ۱۵ تا ۴۵ سال: ۳ دوز (ماه ۰، ۲ و ۶)","0.5 mL IM — 9–14 y: 2 doses (0, 6–12 months); 15–45 y: 3 doses (0, 2, 6 months)",{"minAge":43,"maxAge":46},{"value":44,"unit":45},9,"year",{"value":47,"unit":45},46,"fixed",{"perDose":50,"dosesPerDay":5},0.5,[52],{"source":33,"section":53},"2.1",{"min":5,"max":5},[56],{"text":57,"refs":60},{"fa":58,"en":59},"اگر دوز دوم زودتر از ۵ ماه پس از اول زده شد، دوز سوم دست‌کم ۴ ماه بعد.","If the second dose is given less than 5 months after the first, give a third dose at least 4 months later.",[61],{"source":33,"section":53},{"id":63,"disease":64,"label":65,"population":68,"type":48,"unit":29,"dose":71,"refs":72,"durationDays":74,"notes":75},"warts-prevent","genital-warts",{"fa":66,"en":67},"پیشگیری از زگیل تناسلی (HPV نوع ۶ و ۱۱) — واکسیناسیون ۹ تا ۴۵ سال","Prevention of genital warts (HPV 6 and 11) — vaccination 9–45 y",{"minAge":69,"maxAge":70},{"value":44,"unit":45},{"value":47,"unit":45},{"perDose":50,"dosesPerDay":5},[73],{"source":33,"section":53},{"min":5,"max":5},[76,80],{"text":77,"refs":78},{"fa":58,"en":59},[79],{"source":33,"section":53},{"text":81,"refs":84},{"fa":82,"en":83},"برچسب Gardasil 9: پیشگیری از زگیل تناسلی (کوندیلوما) ناشی از HPV نوع ۶ و ۱۱. درمان زگیل موجود نیست.","Gardasil 9 label: prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11. It does not treat existing warts.",[85],{"source":33,"section":86},"1.1",[88],{"id":89,"severity":90,"text":91,"refs":94},"allergy","block",{"fa":92,"en":93},"حساسیت شدید به اجزای واکسن (از جمله مخمر) یا دوز قبلی.","Severe hypersensitivity to a component (including yeast) or a previous dose.",[95],{"source":33,"section":96},"4",[],[],[],[],{"status":102,"reviewer":103,"date":103},"unverified",null,[105,110],{"regimen":37,"formulation":24,"input":106,"expect":109},{"ageYears":107,"weightKg":108},12,40,{"perDose":50,"mlPerDose":50},{"regimen":63,"formulation":24,"input":111,"expect":112},{"ageYears":107,"weightKg":108},{"perDose":50,"mlPerDose":50},[114],"J07BM03",{"status":116,"forms":117,"refs":130},"registered",[118,122,126],{"code":119,"en":120,"fa":121},"10319","VACCINE-HUMAN PAPILLOMA VIRUS 4-VALENT VIAL","ویال واکسن–انسانی پاپیللوما ویروس ۴–والنت",{"code":123,"en":124,"fa":125},"53081","VACCINE-HUMAN PAPILLOMA VIRUS 9-VALENT VIAL","ویال واکسن–انسانی پاپیللوما ویروس ۹–والنت",{"code":127,"en":128,"fa":129},"53082","HUMAN PAPILLOMAVIRUS VACCINE (BIVALENT) INJECTION PARENTERAL 0.5 mL","فرآورده تزریقی واکسن انسانی پاپیللوماویروس (بیوالنت) ۰٫۵ میلی‌لیتر",[131],{"source":132,"section":133,"url":134},"darooyab-generic","G-3473\u002FHuman-Papilloma-Virus-Vaccines","https:\u002F\u002Fwww.darooyab.ir\u002FG-3473\u002FHuman-Papilloma-Virus-Vaccines",[136,140,144,147],{"kind":137,"url":138,"label":139},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125508","BLA125508",{"kind":141,"url":142,"label":143},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=a21f4f4b-b891-4f25-b747-cb9ec7d865d6","FDA Gardasil 9",{"kind":145,"url":146,"label":114},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J07BM03",{"kind":148,"url":134,"label":149},"darooyab","Human-Papilloma-Virus-Vaccines",{"pregnancy":151,"lactation":160,"pediatric":168,"geriatric":176},{"level":152,"text":153,"quote":156,"refs":157},"caution",{"fa":154,"en":155},"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 All pregnancies have a risk of birth defect, loss, or other adverse outcomes.",[158],{"source":33,"section":159},"8.1",{"level":152,"text":161,"quote":164,"refs":165},{"fa":162,"en":163},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Available data are not sufficient to assess the effects of GARDASIL 9 on the breastfed infant or on milk production\u002Fexcretion.",[166],{"source":33,"section":167},"8.2",{"level":152,"text":169,"quote":172,"refs":173},{"fa":170,"en":171},"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 have not been established in pediatric patients below 9 years of age.",[174],{"source":33,"section":175},"8.4",{"level":152,"text":177,"quote":180,"refs":181},{"fa":178,"en":179},"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.","The safety and effectiveness of GARDASIL 9 have not been evaluated in a geriatric population, defined as individuals aged 65 years and over.",[182],{"source":33,"section":183},"8.5",{"kind":185,"refs":186,"id":139},"BLA",[187],{"source":33,"section":188},"SPL approval \u002F marketing category",1792191874911]