[{"data":1,"prerenderedAt":197},["ShallowReactive",2],{"drug-epirubicin":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":66,"warnings":76,"renal":84,"monitoring":85,"interactions":86,"review":87,"examples":90,"atc":98,"iran":100,"links":132,"populations":149,"usApproval":192},"epirubicin",1,{"fa":7,"en":8},"اپی‌روبیسین","Epirubicin","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتراسایکلین","Anthracycline",[14],{"name":15,"market":16},"Ellence","US",[18,19,20],"ellence","pharmorubicin","اپیروبیسین",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"inj-2","injection","iv","2 mg\u002FmL (50 mg\u002F25 mL, 200 mg\u002F100 mL)",{"amount":28,"unit":29,"perVolumeMl":5},2,"mg",[16],[32],{"source":33,"section":34},"fda-ellence","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":29,"dose":47,"refs":49,"durationDays":52,"notes":53},"breast","breast-cancer",{"fa":40,"en":41},"سرطان پستان کمکی (گره مثبت) — ۱۰۰ تا ۱۲۰ mg\u002Fm² وریدی هر ۳ تا ۴ هفته (روز ۱ یا تقسیم روز ۱ و ۸)","Adjuvant node-positive breast cancer — 100–120 mg\u002Fm² IV every 3–4 weeks (day 1, or split days 1 and 8)",{"minAge":43},{"value":44,"unit":45},18,"year","bsa",{"perM2PerDay":48,"dividedDoses":5},100,[50],{"source":33,"section":51},"2.2",{"min":5,"max":5},[54,60],{"text":55,"refs":58},{"fa":56,"en":57},"فقط زیر نظر پزشک متخصص شیمی‌درمانی و در مرکز مجهز. عدد ماشین‌حساب = mg\u002Fm² برچسب × سطح بدن (Mosteller)؛ پروتکل، فاصله دوره‌ها، تنظیم بر اساس CBC و عملکرد کلیه\u002Fکبد با تیم انکولوژی.","Only under an oncologist in an equipped centre. Calculator = label mg\u002Fm² × BSA (Mosteller); protocol, cycle interval and adjustment for CBC and renal\u002Fhepatic function rest with the oncology team.",[59],{"source":33,"section":51},{"text":61,"refs":64},{"fa":62,"en":63},"عدد ماشین‌حساب حد پایین است. CEF-120: ۶۰ mg\u002Fm² روز ۱ و ۸؛ FEC-100: ۱۰۰ mg\u002Fm² روز ۱.","Calculator gives the lower bound. CEF-120: 60 mg\u002Fm² days 1 and 8; FEC-100: 100 mg\u002Fm² day 1.",[65],{"source":33,"section":51},[67],{"id":68,"severity":69,"text":70,"refs":73},"ci","block",{"fa":71,"en":72},"نارسایی شدید میوکارد؛ انفارکتوس اخیر یا آریتمی شدید؛ دریافت قبلی حداکثر دوز تجمعی آنتراسایکلین؛ سرکوب پایدار شدید مغز استخوان؛ نارسایی شدید کبد (Child-Pugh C یا بیلی‌روبین بالای ۵)؛ حساسیت شدید به آنتراسایکلین‌ها.","Severe myocardial insufficiency; recent MI or severe arrhythmias; prior maximum cumulative anthracycline dose; severe persistent myelosuppression; severe hepatic impairment (Child-Pugh C or bilirubin >5 mg\u002FdL); severe hypersensitivity to anthracyclines.",[74],{"source":33,"section":75},"4",[77],{"text":78,"refs":81},{"fa":79,"en":80},"هشدار جعبه‌ای: سمیت قلبی وابسته به دوز تجمعی (۰٫۹٪ در ۵۵۰ mg\u002Fm² تا ۳٫۳٪ در ۹۰۰)؛ بدخیمی ثانویه (AML)؛ نکروز بافت با نشت؛ سرکوب شدید مغز استخوان.","Boxed warning: cumulative-dose cardiotoxicity (0.9% at 550 mg\u002Fm² to 3.3% at 900); secondary malignancies (AML); tissue necrosis with extravasation; severe myelosuppression.",[82],{"source":33,"section":83},"Boxed Warning",[],[],[],{"status":88,"reviewer":89,"date":89},"unverified",null,[91],{"regimen":37,"formulation":23,"input":92,"expect":96},{"ageYears":93,"weightKg":94,"heightCm":95},55,80,180,{"perDose":97,"mlPerDose":48},200,[99],"L01DB03",{"status":101,"forms":102,"refs":127},"registered",[103,107,111,115,119,123],{"code":104,"en":105,"fa":106},"00491","EPIRUBICIN HCL 10MG VIAL","ویال اپی‌روبیسین هیدروکلراید ۱۰ میلی‌گرم",{"code":108,"en":109,"fa":110},"20696","EPIRUBICIN HCL 200MG VIAL","ویال اپی‌روبیسین هیدروکلراید ۲۰۰ میلی‌گرم",{"code":112,"en":113,"fa":114},"15976","EPIRUBICIN HCL 2MG\u002FML 10ML VIAL","ویال اپی‌روبیسین هیدروکلراید ۲ میلی‌گرم \u002F میلی‌لیتر ۱۰ میلی‌لیتر",{"code":116,"en":117,"fa":118},"14532","EPIRUBICIN HCL 2MG\u002FML 25ML VIAL","ویال اپی‌روبیسین هیدروکلراید ۲ میلی‌گرم \u002F میلی‌لیتر ۲۵ میلی‌لیتر",{"code":120,"en":121,"fa":122},"18435","EPIRUBICIN HCL 2MG\u002FML 5ML VIAL","ویال اپی‌روبیسین هیدروکلراید ۲ میلی‌گرم \u002F میلی‌لیتر ۵ میلی‌لیتر",{"code":124,"en":125,"fa":126},"00492","EPIRUBICIN HCL 50MG VIAL","ویال اپی‌روبیسین هیدروکلراید ۵۰ میلی‌گرم",[128],{"source":129,"section":130,"url":131},"darooyab-generic","G-992\u002FEpirubicin","https:\u002F\u002Fwww.darooyab.ir\u002FG-992\u002FEpirubicin",[133,137,141,144,147],{"kind":134,"url":135,"label":136},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=050778","NDA050778",{"kind":138,"url":139,"label":140},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=0a03c798-a652-4895-b29c-3b521a89ba42","FDA Ellence",{"kind":142,"url":143,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa603003.html",{"kind":145,"url":146,"label":99},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01DB03",{"kind":148,"url":131,"label":8},"darooyab",{"pregnancy":150,"lactation":159,"pediatric":167,"geriatric":176,"reproductive":184},{"level":151,"text":152,"quote":155,"refs":156},"avoid",{"fa":153,"en":154},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on findings from animal studies and its mechanism of action, ELLENCE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] ; avoid the use of ELLENCE during the 1 st trimester.",[157],{"source":33,"section":158},"8.1",{"level":151,"text":160,"quote":163,"refs":164},{"fa":161,"en":162},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the potential for serious adverse reactions in the breastfed child, advise lactating women not to breastfeed during treatment with ELLENCE and for at least 7 days after the last dose.",[165],{"source":33,"section":166},"8.2",{"level":168,"text":169,"quote":172,"refs":173},"caution",{"fa":170,"en":171},"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.","Safety and effectiveness of ELLENCE have not been established in pediatric patients.",[174],{"source":33,"section":175},"8.4",{"level":168,"text":177,"quote":180,"refs":181},{"fa":178,"en":179},"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.","In elderly female patients, closely monitor for increased toxicity due to the risk of decreased clearance of epirubicin [see Clinical Pharmacology (12.3) ].",[182],{"source":33,"section":183},"8.5",{"level":168,"text":185,"quote":188,"refs":189},{"fa":186,"en":187},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Females ELLENCE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .",[190],{"source":33,"section":191},"8.3",{"kind":193,"refs":194,"id":136},"NDA",[195],{"source":33,"section":196},"SPL approval \u002F marketing category",1792444396550]