[{"data":1,"prerenderedAt":227},["ShallowReactive",2],{"drug-alteplase":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":23,"regimens":43,"contraindications":114,"warnings":124,"renal":125,"monitoring":126,"interactions":127,"review":128,"examples":131,"atc":147,"iran":149,"usApproval":169,"links":175,"populations":192},"alteplase",1,{"fa":7,"en":8},"آلتپلاز (اکتیلیز)","Alteplase","blood",{"fa":11,"en":12},"ترومبولیتیک (tPA)","Thrombolytic (tPA)",[14],{"name":15,"market":16},"Activase","US",[18,19,20,21,22],"activase","actilyse","tPA","آلتپلاز","اکتیلیز",[24,36],{"id":25,"form":26,"route":27,"label":28,"concentration":29,"markets":31,"refs":32},"vial-50","powder-for-injection","iv","50 mg vial (1 mg\u002FmL after reconstitution with 50 mL)",{"amount":5,"unit":30,"perVolumeMl":5},"mg",[16],[33],{"source":34,"section":35},"fda-activase","3",{"id":37,"form":26,"route":27,"label":38,"concentration":39,"markets":40,"refs":41},"vial-100","100 mg vial (1 mg\u002FmL after reconstitution with 100 mL)",{"amount":5,"unit":30,"perVolumeMl":5},[16],[42],{"source":34,"section":35},[44,76,98],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":30,"dose":55,"refs":57,"limits":62,"durationDays":66,"notes":67},"stroke","acute-ischemic-stroke",{"fa":48,"en":49},"سکته ایسکمیک حاد (ظرف ۳ ساعت) — ۰٫۹ mg\u002Fkg کل (حداکثر ۹۰ mg)","Acute ischaemic stroke (within 3 h) — 0.9 mg\u002Fkg total (max 90 mg)",{"minAge":51},{"value":52,"unit":53},18,"year","weightBased",{"perKgPerDay":56,"dividedDoses":5},0.9,[58,60],{"source":34,"section":59},"2.1",{"source":34,"section":61},"2",{"maxPerDose":63,"refs":64},90,[65],{"source":34,"section":61},{"min":5,"max":5},[68],{"text":69,"refs":72},{"fa":70,"en":71},"۱۰٪ کل دوز به‌صورت بولوس در ۱ دقیقه، بقیه در ۶۰ دقیقه انفوزیون. فقط پس از رد خونریزی مغزی و رعایت معیارهای منع مصرف.","10% of the total as a bolus over 1 min, the rest infused over 60 min. Only after excluding haemorrhage and checking contraindications.",[73,74],{"source":34,"section":61},{"source":34,"section":75},"4.1",{"id":77,"disease":78,"label":79,"population":82,"type":84,"unit":30,"dose":85,"refs":87,"durationDays":90,"notes":91},"pe","pulmonary-embolism",{"fa":80,"en":81},"آمبولی ریه حاد وسیع — ۱۰۰ mg وریدی در ۲ ساعت","Acute massive pulmonary embolism — 100 mg IV over 2 h",{"minAge":83},{"value":52,"unit":53},"fixed",{"perDose":86,"dosesPerDay":5},100,[88],{"source":34,"section":89},"2.3",{"min":5,"max":5},[92],{"text":93,"refs":96},{"fa":94,"en":95},"هپارین پس از پایان انفوزیون وقتی PTT یا زمان ترومبین به ۲ برابر یا کمتر برگشت.","Start heparin after the infusion once PTT or thrombin time is ≤2× normal.",[97],{"source":34,"section":89},{"id":99,"disease":100,"label":101,"population":104,"type":106,"unit":30,"dose":107,"refs":111},"ami","acute-coronary-syndrome",{"fa":102,"en":103},"انفارکتوس حاد قلبی — رژیم سریع بر اساس وزن (حداکثر ۱۰۰ mg)","Acute MI — accelerated weight-based regimen (max 100 mg)",{"minAge":105},{"value":52,"unit":53},"notCalculated",{"reason":108},{"fa":109,"en":110},"برچسب، جدول ۱: بالای ۶۷ kg ← بولوس ۱۵ mg، ۵۰ mg در ۳۰ دقیقه، ۳۵ mg در ۶۰ دقیقه بعد. ۶۷ kg و کمتر ← بولوس ۱۵ mg، ۰٫۷۵ mg\u002Fkg در ۳۰ دقیقه، ۰٫۵ mg\u002Fkg در ۶۰ دقیقه. همراه هپارین و آسپرین. جمع حداکثر ۱۰۰ mg.","Label Table 1: >67 kg → 15 mg bolus, 50 mg over 30 min, 35 mg over the next 60 min. ≤67 kg → 15 mg bolus, 0.75 mg\u002Fkg over 30 min, 0.5 mg\u002Fkg over 60 min. With heparin and aspirin. Total ≤100 mg.",[112],{"source":34,"section":113},"2.2, Table 1",[115],{"id":116,"severity":117,"text":118,"refs":121},"general","block",{"fa":119,"en":120},"خونریزی داخلی فعال؛ جراحی یا ضربه اخیر مغز یا نخاع؛ ضایعه داخل جمجمه با خطر خونریزی؛ اختلال خونریزی؛ فشار خون شدید کنترل‌نشده. سکته: خونریزی داخل جمجمه یا زیر عنکبوتیه. MI و PE: سکته اخیر.","Active internal bleeding; recent intracranial or intraspinal surgery or serious head trauma; intracranial conditions raising bleeding risk; bleeding diathesis; severe uncontrolled hypertension. Stroke: intracranial or subarachnoid haemorrhage. MI and PE: recent stroke.",[122],{"source":34,"section":123},"4",[],[],[],[],{"status":129,"reviewer":130,"date":130},"unverified",null,[132,138,142],{"regimen":45,"formulation":37,"input":133,"expect":136},{"ageYears":134,"weightKg":135},65,70,{"perDose":137,"mlPerDose":137},63,{"regimen":45,"formulation":37,"input":139,"expect":141},{"ageYears":134,"weightKg":140},120,{"perDose":63},{"regimen":77,"formulation":37,"input":143,"expect":146},{"ageYears":144,"weightKg":145},50,80,{"perDose":86,"mlPerDose":86},[148],"B01AD02",{"status":150,"forms":151,"refs":164},"registered",[152,156,160],{"code":153,"en":154,"fa":155},"11407","ALTEPLASE 10MG VIAL","ویال آلتپلاز ۱۰ میلی‌گرم",{"code":157,"en":158,"fa":159},"22174","ALTEPLASE 20MG VIAL","ویال آلتپلاز ۲۰ میلی‌گرم",{"code":161,"en":162,"fa":163},"05775","ALTEPLASE 50MG VIAL","ویال آلتپلاز ۵۰ میلی‌گرم",[165],{"source":166,"section":167,"url":168},"darooyab-generic","G-1517\u002FAlteplase","https:\u002F\u002Fwww.darooyab.ir\u002FG-1517\u002FAlteplase",{"kind":170,"refs":171,"id":174},"BLA",[172],{"source":34,"section":173},"SPL approval \u002F marketing category","BLA103172",[176,179,183,187,190],{"kind":177,"url":178,"label":174},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103172",{"kind":180,"url":181,"label":182},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c669f77c-fa48-478b-a14b-80b20a0139c2","FDA Activase",{"kind":184,"url":185,"label":186},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa625001.html","Alteplase Injection",{"kind":188,"url":189,"label":148},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=B01AD02",{"kind":191,"url":168,"label":8},"darooyab",{"pregnancy":193,"lactation":202,"pediatric":210,"geriatric":219},{"level":194,"text":195,"quote":198,"refs":199},"caution",{"fa":196,"en":197},"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 Published studies and case reports on alteplase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.",[200],{"source":34,"section":201},"8.1",{"level":194,"text":203,"quote":206,"refs":207},{"fa":204,"en":205},"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 alteplase in human milk, the effects on the breastfed infant, or the effects on milk production.",[208],{"source":34,"section":209},"8.2",{"level":211,"text":212,"quote":215,"refs":216},"not-established",{"fa":213,"en":214},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of Activase in pediatric patients have not been established.",[217],{"source":34,"section":218},"8.4",{"level":194,"text":220,"quote":223,"refs":224},{"fa":221,"en":222},"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.","Acute Ischemic Stroke In exploratory, multivariate analyses of Studies 1 and 2, age greater than 77 years was one of several interrelated baseline characteristics associated with an increased risk of intracranial hemorrhage.",[225],{"source":34,"section":226},"8.5",1792156161314]