[{"data":1,"prerenderedAt":161},["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":62,"warnings":72,"renal":73,"monitoring":74,"interactions":75,"review":76,"examples":79,"atc":85,"iran":87,"links":107,"populations":122,"usApproval":156},"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],{"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},[63],{"id":64,"severity":65,"text":66,"refs":69},"allergy","block",{"fa":67,"en":68},"حساسیت شدید به اجزای واکسن (از جمله مخمر) یا دوز قبلی.","Severe hypersensitivity to a component (including yeast) or a previous dose.",[70],{"source":33,"section":71},"4",[],[],[],[],{"status":77,"reviewer":78,"date":78},"unverified",null,[80],{"regimen":37,"formulation":24,"input":81,"expect":84},{"ageYears":82,"weightKg":83},12,40,{"perDose":50,"mlPerDose":50},[86],"J07BM03",{"status":88,"forms":89,"refs":102},"registered",[90,94,98],{"code":91,"en":92,"fa":93},"10319","VACCINE-HUMAN PAPILLOMA VIRUS 4-VALENT VIAL","ویال واکسن–انسانی پاپیللوما ویروس ۴–والنت",{"code":95,"en":96,"fa":97},"53081","VACCINE-HUMAN PAPILLOMA VIRUS 9-VALENT VIAL","ویال واکسن–انسانی پاپیللوما ویروس ۹–والنت",{"code":99,"en":100,"fa":101},"53082","HUMAN PAPILLOMAVIRUS VACCINE (BIVALENT) INJECTION PARENTERAL 0.5 mL","فرآورده تزریقی واکسن انسانی پاپیللوماویروس (بیوالنت) ۰٫۵ میلی‌لیتر",[103],{"source":104,"section":105,"url":106},"darooyab-generic","G-3473\u002FHuman-Papilloma-Virus-Vaccines","https:\u002F\u002Fwww.darooyab.ir\u002FG-3473\u002FHuman-Papilloma-Virus-Vaccines",[108,112,116,119],{"kind":109,"url":110,"label":111},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125508","BLA125508",{"kind":113,"url":114,"label":115},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=a21f4f4b-b891-4f25-b747-cb9ec7d865d6","FDA Gardasil 9",{"kind":117,"url":118,"label":86},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J07BM03",{"kind":120,"url":106,"label":121},"darooyab","Human-Papilloma-Virus-Vaccines",{"pregnancy":123,"lactation":132,"pediatric":140,"geriatric":148},{"level":124,"text":125,"quote":128,"refs":129},"caution",{"fa":126,"en":127},"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.",[130],{"source":33,"section":131},"8.1",{"level":124,"text":133,"quote":136,"refs":137},{"fa":134,"en":135},"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.",[138],{"source":33,"section":139},"8.2",{"level":124,"text":141,"quote":144,"refs":145},{"fa":142,"en":143},"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.",[146],{"source":33,"section":147},"8.4",{"level":124,"text":149,"quote":152,"refs":153},{"fa":150,"en":151},"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.",[154],{"source":33,"section":155},"8.5",{"kind":157,"refs":158,"id":111},"BLA",[159],{"source":33,"section":160},"SPL approval \u002F marketing category",1792108425253]