[{"data":1,"prerenderedAt":144},["ShallowReactive",2],{"drug-idarucizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":62,"warnings":63,"renal":64,"monitoring":65,"interactions":66,"review":67,"examples":70,"atc":77,"iran":79,"usApproval":91,"links":97,"populations":110},"idarucizumab",1,{"fa":7,"en":8},"ایداروسیزوماب","Idarucizumab","various",{"fa":11,"en":12},"آنتی‌دوت اختصاصی دابیگاتران","Specific dabigatran reversal agent",[14],{"name":15,"market":16},"Praxbind","US",[18,19,20],"praxbind","پراکسبایند","آنتی دوت دابیگاتران",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"vial-25","injection","iv","2.5 g\u002F50 mL vial (dose = 2 vials)",{"amount":28,"unit":29,"perVolumeMl":30},2500,"mg",50,[16],[33],{"source":34,"section":35},"fda-praxbind","3",[37],{"id":38,"disease":39,"label":40,"population":43,"type":44,"unit":29,"dose":45,"refs":47,"durationDays":50,"notes":51},"rev","anticoagulant-reversal",{"fa":41,"en":42},"برگرداندن اثر دابیگاتران (جراحی اورژانس یا خونریزی تهدیدکننده) — ۵ g وریدی","Dabigatran reversal (emergency surgery or life-threatening bleeding) — 5 g IV",{},"fixed",{"perDose":46,"dosesPerDay":5},5000,[48],{"source":34,"section":49},"2.1",{"min":5,"max":5},[52],{"text":53,"refs":56},{"fa":54,"en":55},"دو ویال ۲٫۵ g پشت سر هم (انفوزیون یا بولوس). داده محدود برای ۵ g دوم. ضدانعقاد هرچه زودتر از نظر پزشکی شروع مجدد شود؛ دابیگاتران ۲۴ ساعت بعد.","Two 2.5 g vials consecutively (infusions or bolus). Limited data for a second 5 g. Restart anticoagulation as soon as medically appropriate; dabigatran after 24 h.",[57,58,60],{"source":34,"section":49},{"source":34,"section":59},"2.3",{"source":34,"section":61},"2.4",[],[],[],[],[],{"status":68,"reviewer":69,"date":69},"unverified",null,[71],{"regimen":38,"formulation":23,"input":72,"expect":75},{"ageYears":73,"weightKg":74},75,70,{"perDose":46,"mlPerDose":76},100,[78],"V03AB37",{"status":80,"forms":81,"refs":86},"registered",[82],{"code":83,"en":84,"fa":85},"52463","IDARUCIZUMAB INJECTION, SOLUTION PARENTERAL 2.5 g\u002F50mL","محلول تزریقی ایداروسیزومب ۲٫۵ گرم \u002F ۵۰ میلی‌لیتر",[87],{"source":88,"section":89,"url":90},"darooyab-generic","G-5494\u002FIdarucizumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5494\u002FIdarucizumab",{"kind":92,"refs":93,"id":96},"BLA",[94],{"source":34,"section":95},"SPL approval \u002F marketing category","BLA761025",[98,101,105,108],{"kind":99,"url":100,"label":96},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761025",{"kind":102,"url":103,"label":104},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c7400f8a-dcf4-a6df-6d07-983081b1bf34","FDA Praxbind",{"kind":106,"url":107,"label":78},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=V03AB37",{"kind":109,"url":90,"label":8},"darooyab",{"pregnancy":111,"lactation":120,"pediatric":128,"geriatric":136},{"level":112,"text":113,"quote":116,"refs":117},"caution",{"fa":114,"en":115},"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 There are no available data on PRAXBIND use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.",[118],{"source":34,"section":119},"8.1",{"level":112,"text":121,"quote":124,"refs":125},{"fa":122,"en":123},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Because many drugs are excreted in human milk, caution should be exercised when PRAXBIND is administered to a nursing woman.",[126],{"source":34,"section":127},"8.2",{"level":112,"text":129,"quote":132,"refs":133},{"fa":130,"en":131},"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.",[134],{"source":34,"section":135},"8.4",{"level":112,"text":137,"quote":140,"refs":141},{"fa":138,"en":139},"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.","A total of 454 (90%) patients treated with idarucizumab in the case series trial were 65 years of age and older, and 318 (63%) were 75 years of age and older.",[142],{"source":34,"section":143},"8.5",1792191548816]