[{"data":1,"prerenderedAt":203},["ShallowReactive",2],{"drug-kcentra":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":37,"contraindications":92,"warnings":102,"renal":119,"monitoring":120,"interactions":121,"review":122,"examples":125,"atc":143,"iran":145,"usApproval":152,"links":158,"populations":169},"kcentra",1,{"fa":7,"en":8},"کنسانتره کمپلکس پروترومبین ۴ فاکتوری (PCC)","Prothrombin complex concentrate, 4-factor (Kcentra)","blood",{"fa":11,"en":12},"فاکتورهای انعقادی II، VII، IX، X","Coagulation factors II, VII, IX, X",[14],{"name":15,"market":16},"Kcentra","US",[4,18,19,20,21],"pcc","beriplex","برپلکس","کمپلکس پروترومبین",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":32,"refs":33},"vial-1000","powder-for-injection","iv","1000 unit vial (factor IX units; actual potency on carton)",{"amount":29,"unit":30,"perUnit":31},1000,"unit","vial",[16],[34],{"source":35,"section":36},"fda-kcentra","3",[38,60,76],{"id":39,"disease":40,"label":41,"population":44,"type":48,"unit":30,"dose":49,"refs":52,"limits":55,"durationDays":59},"inr2","anticoagulant-reversal",{"fa":42,"en":43},"برگشت اثر وارفارین در خونریزی حاد یا جراحی فوری — INR ۲ تا \u003C۴: ۲۵ واحد\u002Fkg (حداکثر ۲۵۰۰)","Reversal of warfarin for acute major bleeding or urgent surgery — INR 2–\u003C4: 25 units\u002Fkg (max 2500)",{"minAge":45},{"value":46,"unit":47},18,"year","weightBased",{"perKgPerDose":50,"intervalHours":51},25,24,[53],{"source":35,"section":54},"2.1, Table 1",{"maxPerDose":56,"refs":57},2500,[58],{"source":35,"section":54},{"min":5,"max":5},{"id":61,"disease":40,"label":62,"population":65,"type":48,"unit":30,"dose":67,"refs":69,"limits":71,"durationDays":75},"inr4",{"fa":63,"en":64},"برگشت اثر وارفارین — INR ۴ تا ۶: ۳۵ واحد\u002Fkg (حداکثر ۳۵۰۰)","Warfarin reversal — INR 4–6: 35 units\u002Fkg (max 3500)",{"minAge":66},{"value":46,"unit":47},{"perKgPerDose":68,"intervalHours":51},35,[70],{"source":35,"section":54},{"maxPerDose":72,"refs":73},3500,[74],{"source":35,"section":54},{"min":5,"max":5},{"id":77,"disease":40,"label":78,"population":81,"type":48,"unit":30,"dose":83,"refs":85,"limits":87,"durationDays":91},"inr6",{"fa":79,"en":80},"برگشت اثر وارفارین — INR بالای ۶: ۵۰ واحد\u002Fkg (حداکثر ۵۰۰۰)","Warfarin reversal — INR >6: 50 units\u002Fkg (max 5000)",{"minAge":82},{"value":46,"unit":47},{"perKgPerDose":84,"intervalHours":51},50,[86],{"source":35,"section":54},{"maxPerDose":88,"refs":89},5000,[90],{"source":35,"section":54},{"min":5,"max":5},[93],{"id":94,"severity":95,"text":96,"refs":99},"ci","block",{"fa":97,"en":98},"آنافیلاکسی یا واکنش شدید به اجزا (هپارین، فاکتورها، پروتئین C و S، آنتی‌ترومبین، آلبومین)؛ DIC؛ HIT شناخته‌شده (حاوی هپارین).","Anaphylaxis or severe reaction to any component (heparin, factors, proteins C and S, antithrombin, albumin); DIC; known HIT (contains heparin).",[100],{"source":35,"section":101},"4",[103,112],{"text":104,"refs":107},{"fa":105,"en":106},"هشدار جعبه‌ای: ترومبوآمبولی شریانی و وریدی (کشنده و غیرکشنده). همراه ویتامین K داده شود؛ تکرار دوز توصیه نمی‌شود؛ وزن بالای ۱۰۰ kg = ۱۰۰ kg.","Boxed warning: arterial and venous thromboembolism (fatal and non-fatal). Give with vitamin K; repeat dosing not recommended; weight above 100 kg counts as 100 kg.",[108,110],{"source":35,"section":109},"Boxed Warning",{"source":35,"section":111},"2.1",{"text":113,"refs":116},{"fa":114,"en":115},"فرآورده مشتق از پلاسمای انسانی — خطر نظری انتقال عوامل عفونی.","Human plasma-derived — theoretical risk of transmitting infectious agents.",[117],{"source":35,"section":118},"5.3",[],[],[],{"status":123,"reviewer":124,"date":124},"unverified",null,[126,131,135,138],{"regimen":39,"formulation":24,"input":127,"expect":129},{"ageYears":128,"weightKg":128},70,{"perDose":130},1750,{"regimen":61,"formulation":24,"input":132,"expect":133},{"ageYears":128,"weightKg":128},{"perDose":134},2450,{"regimen":77,"formulation":24,"input":136,"expect":137},{"ageYears":128,"weightKg":128},{"perDose":72},{"regimen":77,"formulation":24,"input":139,"expect":142},{"ageYears":140,"weightKg":141},60,120,{"perDose":88},[144],"B02BD01",{"status":146,"refs":147},"not-found",[148],{"source":149,"section":150,"url":151},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Prothrombin%20complex%20concentrate%2C%204-factor",{"kind":153,"refs":154,"id":157},"BLA",[155],{"source":35,"section":156},"SPL approval \u002F marketing category","BLA125421",[159,162,166],{"kind":160,"url":161,"label":157},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125421",{"kind":163,"url":164,"label":165},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=eee1afb8-324c-42e4-8bf0-f0c9da5e6d42","FDA Kcentra",{"kind":167,"url":168,"label":144},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=B02BD01",{"pregnancy":170,"lactation":179,"pediatric":187,"geriatric":195},{"level":171,"text":172,"quote":175,"refs":176},"caution",{"fa":173,"en":174},"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 data with KCENTRA use in pregnancy to inform on drug-associated risk.",[177],{"source":35,"section":178},"8.1",{"level":171,"text":180,"quote":183,"refs":184},{"fa":181,"en":182},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information regarding the excretion of KCENTRA in human milk, the effect on the breastfed infant, or the effects on milk production.",[185],{"source":35,"section":186},"8.2",{"level":171,"text":188,"quote":191,"refs":192},{"fa":189,"en":190},"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.","The safety and efficacy of KCENTRA in the pediatric population has not been studied.",[193],{"source":35,"section":194},"8.4",{"level":171,"text":196,"quote":199,"refs":200},{"fa":197,"en":198},"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 subjects (431) with acute major bleeding or with the need for an urgent surgery\u002Finvasive procedure treated to reverse VKA anticoagulation in three clinical studies, 66% were 65 years old or greater and 39% were 75 years old or greater.",[201],{"source":35,"section":202},"8.5",1792444699420]