[{"data":1,"prerenderedAt":146},["ShallowReactive",2],{"drug-rsv-vaccine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":36,"contraindications":64,"warnings":74,"renal":75,"monitoring":76,"interactions":77,"review":78,"examples":81,"atc":87,"iran":89,"usApproval":96,"links":102,"populations":113},"rsv-vaccine",1,{"fa":7,"en":8},"واکسن RSV بزرگسال","RSV vaccine (adult)","anti-infectives",{"fa":11,"en":12},"واکسن نوترکیب با ادجوانت","Recombinant adjuvanted vaccine",[14],{"name":15,"market":16},"Arexvy","US",[18,19,20,21],"arexvy","abrysvo","واکسن RSV","ویروس سنسیشیال",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":31,"refs":32},"vial-05","injection","im","0.5 mL dose after reconstitution",{"amount":29,"unit":30,"perVolumeMl":29},0.5,"mL",[16],[33],{"source":34,"section":35},"fda-arexvy","3",[37],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":30,"dose":48,"refs":49,"durationDays":54,"notes":55},"std","immunization",{"fa":41,"en":42},"پیشگیری از عفونت تحتانی RSV — ۶۰ سال به بالا، یا ۱۸ تا ۵۹ سال پرخطر: یک دوز ۰٫۵ mL","Prevention of RSV lower respiratory disease — ≥60 y, or 18–59 y at increased risk: single 0.5 mL dose",{"minAge":44},{"value":45,"unit":46},18,"year","fixed",{"perDose":29,"dosesPerDay":5},[50,52],{"source":34,"section":51},"2.1",{"source":34,"section":53},"1",{"min":5,"max":5},[56],{"text":57,"refs":60},{"fa":58,"en":59},"برای بارداری نیست. زیر ۲ سال احتمالاً ناایمن (بیماری تشدیدشونده تنفسی در مدل حیوانی).","Not for use in pregnancy. Likely unsafe under 2 y (enhanced respiratory disease in animal models).",[61,62],{"source":34,"section":53},{"source":34,"section":63},"8.4",[65],{"id":66,"severity":67,"text":68,"refs":71},"allergy","block",{"fa":69,"en":70},"واکنش آلرژیک شدید (آنافیلاکسی) به اجزای واکسن یا دوز قبلی.","Severe allergic reaction (anaphylaxis) to a vaccine component or a previous dose.",[72],{"source":34,"section":73},"4",[],[],[],[],{"status":79,"reviewer":80,"date":80},"unverified",null,[82],{"regimen":38,"formulation":24,"input":83,"expect":86},{"ageYears":84,"weightKg":85},65,70,{"perDose":29,"mlPerDose":29},[88],"J07BX05",{"status":90,"refs":91},"not-found",[92],{"source":93,"section":94,"url":95},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=RSV%20vaccine",{"kind":97,"refs":98,"id":101},"BLA",[99],{"source":34,"section":100},"SPL approval \u002F marketing category","BLA125775",[103,106,110],{"kind":104,"url":105,"label":101},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125775",{"kind":107,"url":108,"label":109},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=1e50f275-002e-413f-a840-66ee3cb3740c","FDA Arexvy",{"kind":111,"url":112,"label":88},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J07BX05",{"pregnancy":114,"lactation":123,"pediatric":131,"geriatric":138},{"level":115,"text":116,"quote":119,"refs":120},"caution",{"fa":117,"en":118},"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.",[121],{"source":34,"section":122},"8.1",{"level":115,"text":124,"quote":127,"refs":128},{"fa":125,"en":126},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","No human or animal data are available to assess the effects of AREXVY on the breastfed infant or on milk production\u002Fexcretion.",[129],{"source":34,"section":130},"8.2",{"level":115,"text":132,"quote":135,"refs":136},{"fa":133,"en":134},"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.","Evidence from an animal model strongly suggests that AREXVY would be unsafe in individuals younger than 2 years of age because of an increased risk of enhanced respiratory disease.",[137],{"source":34,"section":63},{"level":115,"text":139,"quote":142,"refs":143},{"fa":140,"en":141},"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.","Of the total number of participants (N = 24,966) who received AREXVY or placebo in study 1, 13,943 (55.8%) were 60 to 69 years of age, 8,978 (36.0%) were 70 to 79 years of age, and 2,045 (8.2%) were 80 years of age and older [see Adverse Reactions ( 6.1 ), Use in Specific Populations ( 8.6 ), and Clinical Studies ( …",[144],{"source":34,"section":145},"8.5",1792156194638]