[{"data":1,"prerenderedAt":297},["ShallowReactive",2],{"drug-infliximab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":37,"contraindications":166,"warnings":176,"renal":192,"monitoring":193,"interactions":194,"review":195,"examples":198,"atc":226,"iran":228,"usApproval":240,"links":246,"populations":263},"infliximab",1,{"fa":7,"en":8},"اینفلیکسیمب","Infliximab","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده TNF","TNF blocker",[14],{"name":15,"market":16},"Remicade","US",[18,19,20,21],"remicade","رمیکید","اینفلیکسیماب","infimab",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":32,"refs":33},"vial-100","powder-for-injection","iv","100 mg vial",{"amount":29,"unit":30,"perUnit":31},100,"mg","vial",[16],[34],{"source":35,"section":36},"fda-remicade","3",[38,71,91,117,130,148],{"id":39,"disease":40,"label":41,"population":44,"type":48,"unit":30,"dose":49,"refs":52,"durationDays":57,"notes":58},"crohn","crohns",{"fa":42,"en":43},"کرون — بزرگسال و کودک ۶ سال به بالا: ۵ mg\u002Fkg هر نوبت (هفته ۰، ۲، ۶ و سپس هر ۸ هفته)","Crohn’s — adults and children ≥6 y: 5 mg\u002Fkg per infusion (weeks 0, 2, 6, then every 8 weeks)",{"minAge":45},{"value":46,"unit":47},6,"year","weightBased",{"perKgPerDose":50,"intervalHours":51},5,24,[53,55],{"source":35,"section":54},"2.1",{"source":35,"section":56},"2.2",{"min":5,"max":5},[59,65],{"text":60,"refs":63},{"fa":61,"en":62},"القا در هفته ۰، ۲ و ۶، سپس نگهدارنده هر ۸ هفته (نه روزانه). انفوزیون وریدی دست‌کم ۲ ساعت.","Induction at weeks 0, 2 and 6, then maintenance every 8 weeks (not daily). IV infusion over at least 2 hours.",[64],{"source":35,"section":54},{"text":66,"refs":69},{"fa":67,"en":68},"بزرگسال با از دست رفتن پاسخ: ۱۰ mg\u002Fkg ممکن است. بدون پاسخ تا هفته ۱۴ ادامه سودی ندارد.","Adults who lose response: 10 mg\u002Fkg may be considered. No response by week 14 — unlikely to respond.",[70],{"source":35,"section":54},{"id":72,"disease":73,"label":74,"population":77,"type":48,"unit":30,"dose":79,"refs":80,"durationDays":85,"notes":86},"uc","ulcerative-colitis",{"fa":75,"en":76},"کولیت اولسروز — بزرگسال و کودک ۶ سال به بالا: ۵ mg\u002Fkg هر نوبت","Ulcerative colitis — adults and children ≥6 y: 5 mg\u002Fkg per infusion",{"minAge":78},{"value":46,"unit":47},{"perKgPerDose":50,"intervalHours":51},[81,83],{"source":35,"section":82},"2.3",{"source":35,"section":84},"2.4",{"min":5,"max":5},[87],{"text":88,"refs":89},{"fa":61,"en":62},[90],{"source":35,"section":54},{"id":92,"disease":93,"label":94,"population":97,"type":48,"unit":30,"dose":100,"refs":102,"durationDays":105,"notes":106},"ra","rheumatoid-arthritis",{"fa":95,"en":96},"آرتریت روماتوئید — ۳ mg\u002Fkg هر نوبت همراه متوترکسات","Rheumatoid arthritis — 3 mg\u002Fkg per infusion with methotrexate",{"minAge":98},{"value":99,"unit":47},18,{"perKgPerDose":101,"intervalHours":51},3,[103],{"source":35,"section":104},"2.5",{"min":5,"max":5},[107,111],{"text":108,"refs":109},{"fa":61,"en":62},[110],{"source":35,"section":54},{"text":112,"refs":115},{"fa":113,"en":114},"پاسخ ناکافی: تا ۱۰ mg\u002Fkg هر ۸ هفته یا هر ۴ هفته.","Incomplete response: up to 10 mg\u002Fkg every 8 weeks or as often as every 4 weeks.",[116],{"source":35,"section":104},{"id":118,"disease":119,"label":120,"population":123,"type":48,"unit":30,"dose":125,"refs":126,"durationDays":129},"as","ankylosing-spondylitis",{"fa":121,"en":122},"اسپوندیلیت آنکیلوزان — ۵ mg\u002Fkg (هفته ۰، ۲، ۶، سپس هر ۶ هفته)","Ankylosing spondylitis — 5 mg\u002Fkg (weeks 0, 2, 6, then every 6 weeks)",{"minAge":124},{"value":99,"unit":47},{"perKgPerDose":50,"intervalHours":51},[127],{"source":35,"section":128},"2.6",{"min":5,"max":5},{"id":131,"disease":132,"label":133,"population":136,"type":48,"unit":30,"dose":138,"refs":139,"durationDays":142,"notes":143},"psa","psoriatic-arthritis",{"fa":134,"en":135},"آرتریت پسوریاتیک — ۵ mg\u002Fkg هر نوبت","Psoriatic arthritis — 5 mg\u002Fkg per infusion",{"minAge":137},{"value":99,"unit":47},{"perKgPerDose":50,"intervalHours":51},[140],{"source":35,"section":141},"2.7",{"min":5,"max":5},[144],{"text":145,"refs":146},{"fa":61,"en":62},[147],{"source":35,"section":54},{"id":149,"disease":150,"label":151,"population":154,"type":48,"unit":30,"dose":156,"refs":157,"durationDays":160,"notes":161},"pso","psoriasis",{"fa":152,"en":153},"پسوریازیس شدید مزمن — ۵ mg\u002Fkg هر نوبت","Chronic severe plaque psoriasis — 5 mg\u002Fkg per infusion",{"minAge":155},{"value":99,"unit":47},{"perKgPerDose":50,"intervalHours":51},[158],{"source":35,"section":159},"2.8",{"min":5,"max":5},[162],{"text":163,"refs":164},{"fa":61,"en":62},[165],{"source":35,"section":54},[167],{"id":168,"severity":169,"text":170,"refs":173},"ci","block",{"fa":171,"en":172},"دوز بیش از ۵ mg\u002Fkg در نارسایی قلبی متوسط یا شدید؛ حساسیت شدید قبلی به اینفلیکسیمب یا پروتئین موشی.","Doses >5 mg\u002Fkg in moderate or severe heart failure; previous severe hypersensitivity to infliximab or murine proteins.",[174],{"source":35,"section":175},"4",[177,184],{"text":178,"refs":181},{"fa":179,"en":180},"هشدار جعبه‌ای: عفونت جدی (سل، قارچی، فرصت‌طلب) و بدخیمی. پیش از شروع تست سل نهفته و در صورت مثبت بودن درمان آن.","Boxed warning: serious infections (TB, fungal, opportunistic) and malignancy. Test for latent TB before starting and treat if positive.",[182],{"source":35,"section":183},"Boxed Warning",{"text":185,"refs":188},{"fa":186,"en":187},"لنفوم سلول T کبدی-طحالی (بیشتر جوانان با آزاتیوپرین یا ۶-MP)؛ واکنش انفوزیون؛ فعال شدن هپاتیت B.","Hepatosplenic T-cell lymphoma (mostly young patients on azathioprine\u002F6-MP); infusion reactions; hepatitis B reactivation.",[189,190],{"source":35,"section":183},{"source":35,"section":191},"5",[],[],[],{"status":196,"reviewer":197,"date":197},"unverified",null,[199,205,211,216,219,223],{"regimen":39,"formulation":24,"input":200,"expect":203},{"ageYears":201,"weightKg":202},30,70,{"perDose":204},350,{"regimen":72,"formulation":24,"input":206,"expect":209},{"ageYears":207,"weightKg":208},10,35,{"perDose":210},175,{"regimen":92,"formulation":24,"input":212,"expect":214},{"ageYears":213,"weightKg":202},50,{"perDose":215},210,{"regimen":118,"formulation":24,"input":217,"expect":218},{"ageYears":208,"weightKg":202},{"perDose":204},{"regimen":131,"formulation":24,"input":220,"expect":222},{"ageYears":221,"weightKg":202},45,{"perDose":204},{"regimen":149,"formulation":24,"input":224,"expect":225},{"ageYears":221,"weightKg":202},{"perDose":204},[227],"L04AB02",{"status":229,"forms":230,"refs":235},"registered",[231],{"code":232,"en":233,"fa":234},"05831","INFLIXIMAB 100MG VIAL","ویال اینفلیکسیمب ۱۰۰ میلی‌گرم",[236],{"source":237,"section":238,"url":239},"darooyab-generic","G-105\u002FInfliximab","https:\u002F\u002Fwww.darooyab.ir\u002FG-105\u002FInfliximab",{"kind":241,"refs":242,"id":245},"BLA",[243],{"source":35,"section":244},"SPL approval \u002F marketing category","BLA103772",[247,250,254,258,261],{"kind":248,"url":249,"label":245},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103772",{"kind":251,"url":252,"label":253},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257","FDA Remicade",{"kind":255,"url":256,"label":257},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa604023.html","Infliximab Injection",{"kind":259,"url":260,"label":227},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AB02",{"kind":262,"url":239,"label":8},"darooyab",{"pregnancy":264,"lactation":273,"pediatric":281,"geriatric":289},{"level":265,"text":266,"quote":269,"refs":270},"caution",{"fa":267,"en":268},"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 Available observational studies in pregnant women exposed to REMICADE showed no increased risk of major malformations among live births as compared to those exposed to non-biologics.",[271],{"source":35,"section":272},"8.1",{"level":265,"text":274,"quote":277,"refs":278},{"fa":275,"en":276},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Published literature show that infliximab is present at low levels in human milk.",[279],{"source":35,"section":280},"8.2",{"level":265,"text":282,"quote":285,"refs":286},{"fa":283,"en":284},"برچسب: در کرون و کولیت اولسروز ۶ تا ۱۷ سال ثابت شده؛ هشدار جعبه‌ای لنفوم و بدخیمی در کودکان و نوجوانان.","Label: established for CD and UC at 6–17 y; boxed warning of lymphoma and malignancy in children and adolescents.","The safety and effectiveness of REMICADE have been established in pediatric patients 6 to 17 years of age for induction and maintenance treatment of CD and UC.",[287],{"source":35,"section":288},"8.4",{"level":265,"text":290,"quote":293,"refs":294},{"fa":291,"en":292},"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.","… re close monitoring of geriatric patients for the development of serious infections is recommended [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .",[295],{"source":35,"section":296},"8.5",1792156182342]