[{"data":1,"prerenderedAt":161},["ShallowReactive",2],{"drug-rotavirus-vaccine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":23,"regimens":37,"contraindications":63,"warnings":73,"renal":81,"monitoring":82,"interactions":83,"review":84,"examples":87,"atc":93,"iran":95,"usApproval":123,"links":129,"populations":143},"rotavirus-vaccine",1,{"fa":7,"en":8},"واکسن روتاویروس (خوراکی)","Rotavirus vaccine (oral)","anti-infectives",{"fa":11,"en":12},"واکسن زنده ضعیف‌شده خوراکی","Live attenuated oral vaccine",[14],{"name":15,"market":16},"Rotarix","US",[18,19,20,21,22],"rotarix","rotateq","روتاریکس","روتاویروس","واکسن اسهال",[24],{"id":25,"form":26,"route":27,"label":28,"concentration":29,"markets":32,"refs":33},"oral-15","solution","oral","1.5 mL oral dosing applicator",{"amount":30,"unit":31,"perVolumeMl":30},1.5,"mL",[16],[34],{"source":35,"section":36},"fda-rotarix","3",[38],{"id":39,"disease":40,"label":41,"population":44,"type":50,"unit":31,"dose":51,"refs":52,"durationDays":55,"notes":56},"std","immunization",{"fa":42,"en":43},"شیرخوار — ۲ دوز ۱٫۵ mL خوراکی: از ۶ هفتگی، با فاصله دست‌کم ۴ هفته، تا ۲۴ هفتگی","Infants — 2 oral doses of 1.5 mL: from 6 weeks, ≥4 weeks apart, completed by 24 weeks",{"minAge":45,"maxAge":48},{"value":46,"unit":47},6,"week",{"value":49,"unit":47},24,"fixed",{"perDose":30,"dosesPerDay":5},[53],{"source":35,"section":54},"2.1",{"min":5,"max":5},[57],{"text":58,"refs":61},{"fa":59,"en":60},"اگر شیرخوار بیشتر دوز را بیرون داد، می‌توان در همان مراجعه یک دوز جایگزین داد. دو نوع واکسن روتاویروس با هم ترکیب نشوند.","If the infant spits out most of the dose, one replacement dose may be given at the same visit. Do not mix different rotavirus vaccines in one series.",[62],{"source":35,"section":54},[64],{"id":65,"severity":66,"text":67,"refs":70},"ci","block",{"fa":68,"en":69},"حساسیت به واکسن؛ ناهنجاری مادرزادی اصلاح‌نشده گوارش مستعد انواژیناسیون؛ سابقه انواژیناسیون؛ نقص ایمنی شدید ترکیبی (SCID).","Hypersensitivity to the vaccine; uncorrected congenital GI malformation predisposing to intussusception; history of intussusception; severe combined immunodeficiency (SCID).",[71],{"source":35,"section":72},"4",[74],{"text":75,"refs":78},{"fa":76,"en":77},"خطر انواژیناسیون (به‌ویژه ۷ روز پس از دوز اول).","Risk of intussusception (mainly within 7 days of the first dose).",[79],{"source":35,"section":80},"5",[],[],[],{"status":85,"reviewer":86,"date":86},"unverified",null,[88],{"regimen":39,"formulation":25,"input":89,"expect":92},{"ageMonths":90,"weightKg":91},2,5,{"perDose":30,"mlPerDose":30},[94],"J07BH01",{"status":96,"forms":97,"refs":118},"registered",[98,102,106,110,114],{"code":99,"en":100,"fa":101},"52640","ROTAVIRUS VACCINE, MONOVALENT, LIVE ATTENUATED POWDER, FOR SUSPENSION ORAL  1.5 mL","سوسپانسیون خوراکی واکسن روتاویروس تک‌ظرفیتی زنده تضعیف‌شده ۱٫۵ میلی‌لیتر",{"code":103,"en":104,"fa":105},"52771","ROTAVIRUS VACCINE, MONOVALENT, LIVE ATTENUATED POWDER, FOR SUSPENSION ORAL  2.5 mL","سوسپانسیون خوراکی واکسن روتاویروس تک‌ظرفیتی زنده تضعیف‌شده ۲٫۵ میلی‌لیتر",{"code":107,"en":108,"fa":109},"52171","ROTAVIRUS VACCINE, PENTAVALENT, LIVE SOLUTION ORAL 1 {dose} 2 mL","محلول خوراکی واکسن روتاویروس پنتاوالنت زنده ۱ { دوز } ۲ میلی‌لیتر",{"code":111,"en":112,"fa":113},"52996","ROTAVIRUS VACCINE, PENTAVALENT, LIVE POWDER, FOR SUSPENSION ORAL  2.5 mL","سوسپانسیون خوراکی واکسن روتاویروس پنتاوالنت زنده ۲٫۵ میلی‌لیتر",{"code":115,"en":116,"fa":117},"52997","ROTAVIRUS VACCINE, PENTAVALENT, LIVE POWDER, FOR SUSPENSION ORAL  5 mL","سوسپانسیون خوراکی واکسن روتاویروس پنتاوالنت زنده ۵ میلی‌لیتر",[119],{"source":120,"section":121,"url":122},"darooyab-generic","G-3509\u002FRotavirus-Vaccines","https:\u002F\u002Fwww.darooyab.ir\u002FG-3509\u002FRotavirus-Vaccines",{"kind":124,"refs":125,"id":128},"BLA",[126],{"source":35,"section":127},"SPL approval \u002F marketing category","BLA125265",[130,133,137,140],{"kind":131,"url":132,"label":128},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125265",{"kind":134,"url":135,"label":136},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=f3182470-1965-4e20-dbaf-e3506f893ea5","FDA Rotarix",{"kind":138,"url":139,"label":94},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J07BH01",{"kind":141,"url":122,"label":142},"darooyab","Rotavirus-Vaccines",{"pediatric":144,"pregnancy":153},{"level":145,"text":146,"quote":149,"refs":150},"caution",{"fa":147,"en":148},"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 ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated.",[151],{"source":35,"section":152},"8.4",{"level":145,"quote":154,"text":155,"refs":158},"مصرف در بارداری واکسن روتاویروس گروه C در شرايط خاص و نظارت ويژه پزشك قابل استفاده است:",{"fa":156,"en":157},"دارویاب: گروه C — فقط اگر فایده بیشتر از خطر باشد.","Darooyab: category C — only if benefit outweighs risk.",[159],{"source":120,"section":160,"url":122},"G-3509\u002FRotavirus-Vaccines — مصرف در بارداری",1792156194557]