[{"data":1,"prerenderedAt":171},["ShallowReactive",2],{"drug-edaravone":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":19,"regimens":45,"contraindications":67,"warnings":77,"renal":85,"monitoring":86,"interactions":87,"review":88,"examples":91,"atc":92,"iran":94,"usApproval":110,"links":116,"populations":136},"edaravone",1,{"fa":7,"en":8},"اداراوون","Edaravone","nervous-system",{"fa":11,"en":12},"آنتی‌اکسیدان (پاک‌کننده رادیکال آزاد)","Free-radical scavenger",[14],{"name":15,"market":16},"Radicava","US",[18,7],"radicava",[20,34],{"id":21,"form":22,"route":23,"label":24,"concentration":25,"markets":29,"refs":30},"bag-30","injection","iv","30 mg\u002F100 mL bag (dose = 2 bags)",{"amount":26,"unit":27,"perVolumeMl":28},30,"mg",100,[16],[31],{"source":32,"section":33},"fda-radicava","3",{"id":35,"form":36,"route":37,"label":38,"concentration":39,"markets":42,"refs":43},"ors","suspension","oral","Radicava ORS 105 mg\u002F5 mL oral suspension",{"amount":40,"unit":27,"perVolumeMl":41},105,5,[16],[44],{"source":32,"section":33},[46],{"id":47,"disease":47,"label":48,"population":51,"type":55,"unit":27,"dose":56,"refs":60},"als",{"fa":49,"en":50},"ALS — دوره‌ای: ۶۰ mg وریدی یا ۱۰۵ mg خوراکی روزانه ۱۴ روز، ۱۴ روز استراحت؛ سپس ۱۰ از ۱۴ روز","ALS — cycles: 60 mg IV or 105 mg oral daily for 14 days, 14 days off; then 10 of 14 days",{"minAge":52},{"value":53,"unit":54},18,"year","notCalculated",{"reason":57},{"fa":58,"en":59},"دوره اول: روزانه ۱۴ روز، سپس ۱۴ روز بدون دارو. دوره‌های بعد: ۱۰ روز از ۱۴ روز، سپس ۱۴ روز بدون دارو. وریدی ۶۰ mg (دو کیسه ۳۰ mg) در ۶۰ دقیقه؛ خوراکی ۱۰۵ mg (۵ mL) صبح ناشتا و تا ۱ ساعت بعد غذا نخورد.","First cycle: daily for 14 days, then 14 days off. Later cycles: 10 of 14 days, then 14 days off. IV 60 mg (two 30 mg bags) over 60 min; oral 105 mg (5 mL) in the morning fasting, no food for 1 h after.",[61,63,65],{"source":32,"section":62},"2.1",{"source":32,"section":64},"2.2",{"source":32,"section":66},"2.3",[68],{"id":69,"severity":70,"text":71,"refs":74},"hyper","block",{"fa":72,"en":73},"سابقه حساسیت به اداراوون یا اجزای فرآورده.","History of hypersensitivity to edaravone or its inactive ingredients.",[75],{"source":32,"section":76},"4",[78],{"text":79,"refs":82},{"fa":80,"en":81},"واکنش حساسیتی؛ حاوی سدیم بی‌سولفیت (واکنش آلرژیک و آسم در افراد حساس به سولفیت).","Hypersensitivity; contains sodium bisulfite (allergic reactions and asthma in sulfite-sensitive people).",[83],{"source":32,"section":84},"5",[],[],[],{"status":89,"reviewer":90,"date":90},"unverified",null,[],[93],"N07XX14",{"status":95,"forms":96,"refs":105},"registered",[97,101],{"code":98,"en":99,"fa":100},"52366","EDARAVONE INJECTION, SOLUTION PARENTERAL 30 mg\u002F20mL","محلول تزریقی اداراوون ۳۰ میلی‌گرم \u002F ۲۰ میلی‌لیتر",{"code":102,"en":103,"fa":104},"52367","EDARAVONE INJECTION, SOLUTION PARENTERAL 30 mg\u002F100mL","محلول تزریقی اداراوون ۳۰ میلی‌گرم \u002F ۱۰۰ میلی‌لیتر",[106],{"source":107,"section":108,"url":109},"darooyab-generic","G-1656\u002FEdaravone","https:\u002F\u002Fwww.darooyab.ir\u002FG-1656\u002FEdaravone",{"kind":111,"refs":112,"id":115},"NDA",[113],{"source":32,"section":114},"SPL approval \u002F marketing category","NDA209176",[117,120,124,128,131,134],{"kind":118,"url":119,"label":115},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=209176",{"kind":121,"url":122,"label":123},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11","FDA Radicava",{"kind":125,"url":126,"label":127},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa617027.html","Edaravone Injection",{"kind":125,"url":129,"label":130},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa622056.html","Edaravone Oral",{"kind":132,"url":133,"label":93},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N07XX14",{"kind":135,"url":109,"label":8},"darooyab",{"pregnancy":137,"lactation":146,"pediatric":154,"geriatric":163},{"level":138,"text":139,"quote":142,"refs":143},"caution",{"fa":140,"en":141},"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 adequate data on the developmental risk associated with the use of RADICAVA or RADICAVA ORS in pregnant women.",[144],{"source":32,"section":145},"8.1",{"level":138,"text":147,"quote":150,"refs":151},{"fa":148,"en":149},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.",[152],{"source":32,"section":153},"8.2",{"level":155,"text":156,"quote":159,"refs":160},"not-established",{"fa":157,"en":158},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of RADICAVA or RADICAVA ORS in pediatric patients have not been established.",[161],{"source":32,"section":162},"8.4",{"level":138,"text":164,"quote":167,"refs":168},{"fa":165,"en":166},"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 184 patients with ALS who received RADICAVA in 3 placebo-controlled clinical trials, a total of 53 patients were 65 years of age and older, including 2 patients 75 years of age and older.",[169],{"source":32,"section":170},"8.5",1792156176430]