[{"data":1,"prerenderedAt":219},["ShallowReactive",2],{"drug-tenecteplase":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":37,"contraindications":113,"warnings":123,"renal":131,"monitoring":132,"interactions":133,"review":134,"examples":136,"atc":147,"iran":149,"usApproval":161,"links":167,"populations":184},"tenecteplase",1,{"fa":7,"en":8},"تنکتپلاز","Tenecteplase","blood",{"fa":11,"en":12},"فعال‌کننده پلاسمینوژن بافتی (ترومبولیتیک)","Tissue plasminogen activator (thrombolytic)",[14],{"name":15,"market":16},"TNKase","US",[18,19,7,20],"tnkase","metalyse","متالیز",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"vial-5","powder-for-injection","iv","25 mg or 50 mg vial; 5 mg\u002FmL after reconstitution",{"amount":28,"unit":29,"perVolumeMl":5},5,"mg",[16],[32,35],{"source":33,"section":34},"fda-tnkase","3",{"source":33,"section":36},"2.3",[38,79],{"id":39,"disease":40,"label":41,"population":44,"type":48,"unit":29,"dose":49,"refs":67,"durationDays":70,"notes":71},"ais","acute-ischemic-stroke",{"fa":42,"en":43},"سکته ایسکمیک حاد (ظرف ۳ ساعت) — بولوس واحد بر اساس وزن، حداکثر ۲۵ mg","Acute ischaemic stroke (within 3 h) — single weight-based bolus, max 25 mg",{"minAge":45},{"value":46,"unit":47},18,"year","weightBand",{"weightBands":50},[51,55,58,61,64],{"minWeightKg":52,"maxWeightKg":53,"perDose":54,"dosesPerDay":5},0,59.99,15,{"minWeightKg":53,"maxWeightKg":56,"perDose":57,"dosesPerDay":5},69.99,17.5,{"minWeightKg":56,"maxWeightKg":59,"perDose":60,"dosesPerDay":5},79.99,20,{"minWeightKg":59,"maxWeightKg":62,"perDose":63,"dosesPerDay":5},89.99,22.5,{"minWeightKg":62,"maxWeightKg":65,"perDose":66,"dosesPerDay":5},null,25,[68],{"source":33,"section":69},"2.1, Table 1",{"min":5,"max":5},[72],{"text":73,"refs":76},{"fa":74,"en":75},"بولوس وریدی در ۵ ثانیه. فشار خون حین و پس از تزریق کنترل شود.","IV bolus over 5 seconds. Monitor and control blood pressure during and after.",[77],{"source":33,"section":78},"2.1",{"id":80,"disease":81,"label":82,"population":85,"type":48,"unit":29,"dose":87,"refs":99,"durationDays":102,"notes":103},"stemi","acute-coronary-syndrome",{"fa":83,"en":84},"STEMI حاد — بولوس واحد بر اساس وزن، حداکثر ۵۰ mg","Acute STEMI — single weight-based bolus, max 50 mg",{"minAge":86},{"value":46,"unit":47},{"weightBands":88},[89,91,93,95,97],{"minWeightKg":52,"maxWeightKg":53,"perDose":90,"dosesPerDay":5},30,{"minWeightKg":53,"maxWeightKg":56,"perDose":92,"dosesPerDay":5},35,{"minWeightKg":56,"maxWeightKg":59,"perDose":94,"dosesPerDay":5},40,{"minWeightKg":59,"maxWeightKg":62,"perDose":96,"dosesPerDay":5},45,{"minWeightKg":62,"maxWeightKg":65,"perDose":98,"dosesPerDay":5},50,[100],{"source":33,"section":101},"2.2, Table 2",{"min":5,"max":5},[104],{"text":105,"refs":108},{"fa":106,"en":107},"بولوس وریدی در ۵ ثانیه هرچه زودتر پس از شروع علائم. با دکستروز رسوب می‌کند — قبل و بعد با سالین شستشو.","IV bolus over 5 s as soon as possible after symptom onset. Precipitates with dextrose — flush with saline before and after.",[109,111],{"source":33,"section":110},"2.2",{"source":33,"section":112},"2.5",[114],{"id":115,"severity":116,"text":117,"refs":120},"ci","block",{"fa":118,"en":119},"خونریزی داخلی فعال؛ جراحی یا ترومای داخل جمجمه یا نخاع در ۲ ماه اخیر؛ اختلال خونریزی‌دهنده؛ فشار خون شدید کنترل‌نشده؛ ضایعه داخل جمجمه (تومور، AVM، آنوریسم). سکته: خونریزی فعال داخل جمجمه. STEMI: سابقه خونریزی مغزی.","Active internal bleeding; intracranial or intraspinal surgery or trauma within 2 months; bleeding diathesis; severe uncontrolled hypertension; intracranial lesion (neoplasm, AVM, aneurysm). Stroke: active intracranial haemorrhage. STEMI: history of intracranial haemorrhage.",[121],{"source":33,"section":122},"4",[124],{"text":125,"refs":128},{"fa":126,"en":127},"خونریزی (از جمله داخل مغز)؛ آمبولی کلسترول؛ آریتمی ریپرفیوژن.","Bleeding (including intracranial); cholesterol embolisation; reperfusion arrhythmias.",[129],{"source":33,"section":130},"5",[],[],[],{"status":135,"reviewer":65,"date":65},"unverified",[137,143],{"regimen":39,"formulation":23,"input":138,"expect":141},{"ageYears":139,"weightKg":140},65,75,{"perDose":60,"mlPerDose":142},4,{"regimen":80,"formulation":23,"input":144,"expect":145},{"ageYears":139,"weightKg":140},{"perDose":94,"mlPerDose":146},8,[148],"B01AD11",{"status":150,"forms":151,"refs":156},"registered",[152],{"code":153,"en":154,"fa":155},"51682","TENECTEPLASE 50 MG POWDER FOR INJECTION","پودر تزریقی تنکتپلاس ۵۰ میلی‌گرم",[157],{"source":158,"section":159,"url":160},"darooyab-generic","G-1899\u002FTenecteplase","https:\u002F\u002Fwww.darooyab.ir\u002FG-1899\u002FTenecteplase",{"kind":162,"refs":163,"id":166},"BLA",[164],{"source":33,"section":165},"SPL approval \u002F marketing category","BLA103909",[168,171,175,179,182],{"kind":169,"url":170,"label":166},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103909",{"kind":172,"url":173,"label":174},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=e647640d-c395-4b4b-a0be-1162f9c21d84","FDA TNKase",{"kind":176,"url":177,"label":178},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa625007.html","Tenecteplase Injection",{"kind":180,"url":181,"label":148},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=B01AD11",{"kind":183,"url":160,"label":8},"darooyab",{"pregnancy":185,"lactation":194,"pediatric":202,"geriatric":211},{"level":186,"text":187,"quote":190,"refs":191},"caution",{"fa":188,"en":189},"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 risks to the mother and fetus from acute ST elevation myocardial infarction and acute ischemic stroke, which are medical emergencies in pregnancy and can be fatal if left untreated (see Clinical Considerations ).",[192],{"source":33,"section":193},"8.1",{"level":186,"text":195,"quote":198,"refs":199},{"fa":196,"en":197},"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 tenecteplase in either human or animal milk, the effects on the breastfed infant, or the effect on milk production.",[200],{"source":33,"section":201},"8.2",{"level":203,"text":204,"quote":207,"refs":208},"not-established",{"fa":205,"en":206},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of TNKase in pediatric patients have not been established.",[209],{"source":33,"section":210},"8.4",{"level":186,"text":212,"quote":215,"refs":216},{"fa":213,"en":214},"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 total number of TNKase-treated patients within 0-3 hours in Trial 1 for acute ischemic stroke (AIS), 426 (72%) were 65 years of age and older, and 290 (49%) were 75 years of age and older [see Clinical Studies (14.1) ].",[217],{"source":33,"section":218},"8.5",1792156196811]