[{"data":1,"prerenderedAt":325},["ShallowReactive",2],{"drug-onabotulinumtoxina":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":23,"regimens":46,"contraindications":176,"warnings":186,"renal":201,"monitoring":202,"interactions":203,"review":204,"examples":207,"atc":236,"iran":238,"links":270,"populations":285,"usApproval":320},"onabotulinumtoxina",1,{"fa":7,"en":8},"بوتاکس (اونابوتولینوم‌توکسین A)","OnabotulinumtoxinA (Botox)","musculoskeletal",{"fa":11,"en":12},"نوروتوکسین بوتولینوم","Botulinum neurotoxin",[14],{"name":15,"market":16},"Botox","US",[18,19,20,21,22],"botox","بوتاکس","botulinum","بوتولینوم","سم بوتولینوم",[24,38],{"id":25,"form":26,"route":27,"label":28,"concentration":29,"markets":33,"refs":34},"vial-100","powder-for-injection","im","100 Units vial",{"amount":30,"unit":31,"perUnit":32},100,"unit","vial",[16],[35],{"source":36,"section":37},"fda-botox","3",{"id":39,"form":26,"route":27,"label":40,"concentration":41,"markets":43,"refs":44},"vial-200","200 Units vial",{"amount":42,"unit":31,"perUnit":32},200,[16],[45],{"source":36,"section":37},[47,74,94,106,120,142,160],{"id":48,"disease":49,"label":50,"population":53,"type":57,"unit":31,"dose":58,"refs":60,"durationDays":63,"notes":64},"cm","migraine-prophylaxis",{"fa":51,"en":52},"پیشگیری میگرن مزمن — ۱۵۵ واحد عضلانی (۵ واحد در هر نقطه، ۷ ناحیه سر و گردن)","Chronic migraine prophylaxis — 155 Units IM (5 Units per site across 7 head\u002Fneck areas)",{"minAge":54},{"value":55,"unit":56},18,"year","fixed",{"perDose":59,"dosesPerDay":5},155,[61],{"source":36,"section":62},"2.5",{"min":5,"max":5},[65],{"text":66,"refs":69},{"fa":67,"en":68},"واحدهای بوتاکس با سایر فرآورده‌های بوتولینوم قابل تبدیل نیستند. در هر ۳ ماه: بزرگسال حداکثر ۴۰۰ واحد؛ کودک کمتر از ۱۰ واحد\u002Fkg یا ۳۴۰ واحد.","Botox units are not interchangeable with other botulinum products. In any 3 months: adults max 400 Units; children the lesser of 10 Units\u002Fkg or 340 Units.",[70,72],{"source":36,"section":71},"2.1",{"source":36,"section":73},"2",{"id":75,"disease":76,"label":77,"population":80,"type":57,"unit":31,"dose":82,"refs":83,"durationDays":86,"notes":87},"oab","overactive-bladder",{"fa":78,"en":79},"مثانه بیش‌فعال — ۱۰۰ واحد داخل دترسور (۲۰ نقطه × ۵ واحد)","Overactive bladder — 100 Units intradetrusor (20 sites × 5 Units)",{"minAge":81},{"value":55,"unit":56},{"perDose":30,"dosesPerDay":5},[84],{"source":36,"section":85},"2.3",{"min":5,"max":5},[88],{"text":89,"refs":92},{"fa":90,"en":91},"عفونت ادراری نباشد؛ آنتی‌بیوتیک پیشگیری (غیر آمینوگلیکوزید) ۱ تا ۳ روز قبل تا بعد؛ ضدپلاکت ۳ روز قبل قطع.","No UTI; prophylactic antibiotics (not aminoglycosides) 1–3 days before to after; stop antiplatelets 3 days before.",[93],{"source":36,"section":85},{"id":95,"disease":96,"label":97,"population":100,"type":57,"unit":31,"dose":102,"refs":103,"durationDays":105},"ndo","neurogenic-bladder",{"fa":98,"en":99},"بیش‌فعالی دترسور نوروژنیک بزرگسال — ۲۰۰ واحد داخل دترسور (۳۰ نقطه)","Adult neurogenic detrusor overactivity — 200 Units intradetrusor (30 sites)",{"minAge":101},{"value":55,"unit":56},{"perDose":42,"dosesPerDay":5},[104],{"source":36,"section":85},{"min":5,"max":5},{"id":107,"disease":108,"label":109,"population":112,"type":57,"unit":31,"dose":114,"refs":116,"durationDays":119},"hh","hyperhidrosis",{"fa":110,"en":111},"تعریق شدید زیربغل — ۵۰ واحد داخل‌جلدی در هر زیربغل","Severe axillary hyperhidrosis — 50 Units intradermally per axilla",{"minAge":113},{"value":55,"unit":56},{"perDose":115,"dosesPerDay":5},50,[117],{"source":36,"section":118},"2.9",{"min":5,"max":5},{"id":121,"disease":122,"label":123,"population":126,"type":130,"unit":31,"dose":131,"refs":135,"limits":138,"durationDays":141},"sp-ul","spasticity",{"fa":124,"en":125},"اسپاستیسیته اندام فوقانی کودک — ۳ تا ۶ واحد\u002Fkg کل (حداکثر ۲۰۰) بین عضلات","Paediatric upper-limb spasticity — 3–6 Units\u002Fkg total (max 200) divided among muscles",{"minAge":127,"maxAge":129},{"value":128,"unit":56},2,{"value":55,"unit":56},"weightBased",{"perKgPerDose":132,"perKgPerDoseMax":133,"intervalHours":134},3,6,24,[136],{"source":36,"section":137},"2.7",{"maxPerDose":42,"refs":139},[140],{"source":36,"section":137},{"min":5,"max":5},{"id":143,"disease":122,"label":144,"population":147,"type":130,"unit":31,"dose":150,"refs":153,"limits":155,"durationDays":159},"sp-ll",{"fa":145,"en":146},"اسپاستیسیته اندام تحتانی کودک — ۴ تا ۸ واحد\u002Fkg کل (حداکثر ۳۰۰)","Paediatric lower-limb spasticity — 4–8 Units\u002Fkg total (max 300)",{"minAge":148,"maxAge":149},{"value":128,"unit":56},{"value":55,"unit":56},{"perKgPerDose":151,"perKgPerDoseMax":152,"intervalHours":134},4,8,[154],{"source":36,"section":137},{"maxPerDose":156,"refs":157},300,[158],{"source":36,"section":137},{"min":5,"max":5},{"id":161,"disease":122,"label":162,"population":165,"type":167,"unit":168,"dose":169,"refs":173},"sp-adult",{"fa":163,"en":164},"اسپاستیسیته بزرگسال — اندام فوقانی تا ۴۰۰ واحد؛ تحتانی ۳۰۰ تا ۴۰۰ واحد بین عضلات","Adult spasticity — upper limb up to 400 Units; lower limb 300–400 Units divided among muscles",{"minAge":166},{"value":55,"unit":56},"notCalculated","mg",{"reason":170},{"fa":171,"en":172},"دوز هر عضله طبق جداول برچسب و راهنمای EMG\u002Fسونوگرافی تعیین می‌شود.","Per-muscle doses follow the label tables with EMG\u002Fultrasound guidance.",[174],{"source":36,"section":175},"2.6",[177],{"id":178,"severity":179,"text":180,"refs":183},"ci","block",{"fa":181,"en":182},"حساسیت به هر فرآورده بوتولینوم؛ عفونت در محل تزریق؛ تزریق دترسور در عفونت ادراری یا احتباس ادرار (PVR >۲۰۰ mL) بدون سونداژ متناوب.","Hypersensitivity to any botulinum toxin product; infection at the injection site; intradetrusor injection with UTI or urinary retention (PVR >200 mL) without clean intermittent catheterisation.",[184],{"source":36,"section":185},"4",[187,194],{"text":188,"refs":191},{"fa":189,"en":190},"هشدار جعبه‌ای: انتشار دوردست اثر سم (ضعف عمومی، دوبینی، افتادگی پلک، اختلال بلع و تنفس — گاه کشنده)، ساعت‌ها تا هفته‌ها بعد؛ بیشترین خطر در کودکان با اسپاستیسیته.","Boxed warning: distant spread of toxin effect (generalised weakness, diplopia, ptosis, swallowing and breathing difficulty — can be fatal), hours to weeks later; highest risk in children treated for spasticity.",[192],{"source":36,"section":193},"Boxed Warning",{"text":195,"refs":198},{"fa":196,"en":197},"اختلال بلع و تنفس؛ عفونت ادراری و احتباس ادرار پس از تزریق مثانه؛ زخم قرنیه در بلفارواسپاسم؛ دیسرفلکسی اتونوم.","Dysphagia and breathing difficulties; UTI and urinary retention after bladder injection; corneal ulceration in blepharospasm; autonomic dysreflexia.",[199],{"source":36,"section":200},"5",[],[],[],{"status":205,"reviewer":206,"date":206},"unverified",null,[208,213,218,222,226,231],{"regimen":48,"formulation":39,"input":209,"expect":212},{"ageYears":210,"weightKg":211},40,65,{"perDose":59},{"regimen":75,"formulation":25,"input":214,"expect":217},{"ageYears":215,"weightKg":216},60,70,{"perDose":30},{"regimen":95,"formulation":39,"input":219,"expect":221},{"ageYears":220,"weightKg":216},45,{"perDose":42},{"regimen":107,"formulation":25,"input":223,"expect":225},{"ageYears":224,"weightKg":216},30,{"perDose":115},{"regimen":121,"formulation":25,"input":227,"expect":229},{"ageYears":133,"weightKg":228},20,{"perDose":215,"upperPerDose":230},120,{"regimen":143,"formulation":25,"input":232,"expect":233},{"ageYears":133,"weightKg":228},{"perDose":234,"upperPerDose":235},80,160,[237],"M03AX01",{"status":239,"forms":240,"refs":265},"registered",[241,245,249,253,257,261],{"code":242,"en":243,"fa":244},"17768","BOTULINIUM A TOXIN 100IU VIAL","ویال بوتولینوم A توکسین ۱۰۰ واحد بین‌المللی",{"code":246,"en":247,"fa":248},"21097","BOTULINIUM A TOXIN 50IU VIAL","ویال بوتولینوم A توکسین ۵۰ واحد بین‌المللی",{"code":250,"en":251,"fa":252},"11798","BOTULISM A TOXIN 1 VIAL","ویال بوتولیسم A توکسین ۱",{"code":254,"en":255,"fa":256},"19172","BOTULISM A TOXIN 300IU VIAL","ویال بوتولیسم A توکسین ۳۰۰ واحد بین‌المللی",{"code":258,"en":259,"fa":260},"03623","BOTULISM A TOXIN 500IU VIAL","ویال بوتولیسم A توکسین ۵۰۰ واحد بین‌المللی",{"code":262,"en":263,"fa":264},"24400","BOTULINUM A TOXIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 200 [iU]","محلول تزریقی بوتولینوم A توکسین ۲۰۰ واحد بین‌المللی",[266],{"source":267,"section":268,"url":269},"darooyab-generic","G-2786\u002FBotulinum-Toxins","https:\u002F\u002Fwww.darooyab.ir\u002FG-2786\u002FBotulinum-Toxins",[271,275,279,282],{"kind":272,"url":273,"label":274},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103000","BLA103000",{"kind":276,"url":277,"label":278},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=33d066a9-34ff-4a1a-b38b-d10983df3300","FDA Botox",{"kind":280,"url":281,"label":237},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=M03AX01",{"kind":283,"url":269,"label":284},"darooyab","Botulinum-Toxins",{"pregnancy":286,"lactation":295,"pediatric":303,"geriatric":311},{"level":287,"text":288,"quote":291,"refs":292},"caution",{"fa":289,"en":290},"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 studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX in pregnant women.",[293],{"source":36,"section":294},"8.1",{"level":287,"text":296,"quote":299,"refs":300},{"fa":297,"en":298},"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 BOTOX in human or animal milk, the effects on the breastfed infant, or the effects on milk production.",[301],{"source":36,"section":302},"8.2",{"level":287,"text":304,"quote":307,"refs":308},{"fa":305,"en":306},"برچسب: در برخی اندیکاسیون‌ها (اسپاستیسیته، مثانه نوروژنیک از ۵ سالگی) ثابت شده؛ خطر انتشار سم در کودکان با اسپاستیسیته بیشتر است.","Label: established for some indications (spasticity, neurogenic bladder from 5 y); toxin-spread risk is greatest in children treated for spasticity.","The safety and effectiveness of BOTOX for detrusor overactivity associated with a neurologic condition have been established in pediatric patients 5 years of age and older.",[309],{"source":36,"section":310},"8.4",{"level":312,"text":313,"quote":316,"refs":317},"ok",{"fa":314,"en":315},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety were observed between elderly patients and adult patients younger than 65 years of age.",[318],{"source":36,"section":319},"8.5",{"kind":321,"refs":322,"id":274},"BLA",[323],{"source":36,"section":324},"SPL approval \u002F marketing category",1792191558317]