[{"data":1,"prerenderedAt":211},["ShallowReactive",2],{"drug-bendamustine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":19,"formulations":24,"regimens":38,"contraindications":83,"warnings":93,"renal":101,"monitoring":102,"interactions":103,"review":104,"examples":107,"atc":121,"iran":123,"links":143,"populations":161,"usApproval":206},"bendamustine",1,{"fa":7,"en":8},"بنداموستین","Bendamustine","antineoplastic-immunomodulating",{"fa":11,"en":12},"عامل آلکیله‌کننده","Alkylating agent",[14,17],{"name":15,"market":16},"Bendeka","US",{"name":18,"market":16},"Treanda",[20,21,22,23,7],"bendeka","treanda","ribomustin","ریبوموستین",[25],{"id":26,"form":27,"route":28,"label":29,"concentration":30,"markets":33,"refs":34},"inj-25","injection","iv","25 mg\u002FmL, 100 mg\u002F4 mL multiple-dose vial",{"amount":31,"unit":32,"perVolumeMl":5},25,"mg",[16],[35],{"source":36,"section":37},"fda-bendeka","3",[39,64],{"id":40,"disease":41,"label":42,"population":45,"type":49,"unit":32,"dose":50,"refs":52,"durationDays":55,"notes":57},"cll","chronic-lymphocytic-leukemia",{"fa":43,"en":44},"CLL — ۱۰۰ mg\u002Fm² وریدی ۱۰ دقیقه، روز ۱ و ۲ هر ۲۸ روز، تا ۶ دوره","CLL — 100 mg\u002Fm² IV over 10 min on days 1 and 2 every 28 days, up to 6 cycles",{"minAge":46},{"value":47,"unit":48},18,"year","bsa",{"perM2PerDay":51,"dividedDoses":5},100,[53],{"source":36,"section":54},"2.1",{"min":56,"max":56},2,[58],{"text":59,"refs":62},{"fa":60,"en":61},"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.",[63],{"source":36,"section":54},{"id":65,"disease":66,"label":67,"population":70,"type":49,"unit":32,"dose":72,"refs":74,"durationDays":77,"notes":78},"nhl","b-cell-lymphoma",{"fa":68,"en":69},"لنفوم غیرهوچکین سلول B ایندولنت پیشرفته پس از ریتوکسیماب — ۱۲۰ mg\u002Fm² روز ۱ و ۲ هر ۲۱ روز، تا ۸ دوره","Indolent B-cell NHL progressing after rituximab — 120 mg\u002Fm² on days 1 and 2 every 21 days, up to 8 cycles",{"minAge":71},{"value":47,"unit":48},{"perM2PerDay":73,"dividedDoses":5},120,[75],{"source":36,"section":76},"2.2",{"min":56,"max":56},[79],{"text":80,"refs":81},{"fa":60,"en":61},[82],{"source":36,"section":76},[84],{"id":85,"severity":86,"text":87,"refs":90},"hyper","block",{"fa":88,"en":89},"حساسیت به بنداموستین، پلی‌اتیلن گلیکول ۴۰۰، پروپیلن گلیکول یا مونوتیوگلیسرول.","Hypersensitivity to bendamustine, polyethylene glycol 400, propylene glycol or monothioglycerol.",[91],{"source":36,"section":92},"4",[94],{"text":95,"refs":98},{"fa":96,"en":97},"سرکوب مغز استخوان؛ عفونت (شامل PML)؛ آنافیلاکسی و واکنش انفوزیون؛ سندرم لیز تومور؛ واکنش پوستی شدید؛ سمیت کبدی؛ بدخیمی دیگر؛ آسیب نشت؛ سمیت جنینی.","Myelosuppression; infections (including PML); anaphylaxis and infusion reactions; tumour lysis syndrome; severe skin reactions; hepatotoxicity; other malignancies; extravasation injury; embryo-fetal toxicity.",[99],{"source":36,"section":100},"5",[],[],[],{"status":105,"reviewer":106,"date":106},"unverified",null,[108,116],{"regimen":40,"formulation":26,"input":109,"expect":113},{"ageYears":110,"weightKg":111,"heightCm":112},55,80,180,{"perDose":114,"mlPerDose":115},200,8,{"regimen":65,"formulation":26,"input":117,"expect":118},{"ageYears":110,"weightKg":111,"heightCm":112},{"perDose":119,"mlPerDose":120},240,9.6,[122],"L01AA09",{"status":124,"forms":125,"refs":138},"registered",[126,130,134],{"code":127,"en":128,"fa":129},"13245","BENDAMUSTIN 100MG  INJ","فرآورده تزریقی بنداموستین ۱۰۰ میلی‌گرم",{"code":131,"en":132,"fa":133},"17381","BENDAMUSTIN 25MG  INJ","فرآورده تزریقی بنداموستین ۲۵ میلی‌گرم",{"code":135,"en":136,"fa":137},"52690","BENDAMUSTINE HYDROCHLORIDE INJECTION PARENTERAL 25 mg\u002F1mL 4 mL","فرآورده تزریقی بنداموستین هیدروکلراید ۲۵ میلی‌گرم \u002F ۱ میلی‌لیتر ۴ میلی‌لیتر",[139],{"source":140,"section":141,"url":142},"darooyab-generic","G-951\u002FBendamustine","https:\u002F\u002Fwww.darooyab.ir\u002FG-951\u002FBendamustine",[144,148,152,156,159],{"kind":145,"url":146,"label":147},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=208194","NDA208194",{"kind":149,"url":150,"label":151},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=ace9a43b-f9bd-4896-abfe-0ef4fec67ddf","FDA Bendeka",{"kind":153,"url":154,"label":155},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa608034.html","Bendamustine Injection",{"kind":157,"url":158,"label":122},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01AA09",{"kind":160,"url":142,"label":8},"darooyab",{"pregnancy":162,"lactation":171,"pediatric":179,"geriatric":188,"reproductive":197},{"level":163,"text":164,"quote":167,"refs":168},"avoid",{"fa":165,"en":166},"برچسب: می‌تواند به جنین آسیب برساند؛ پیشگیری مؤثر لازم است.","Label: can cause fetal harm; effective contraception required.","Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use an effective method of contraception.",[169],{"source":36,"section":170},"5.10",{"level":163,"text":172,"quote":175,"refs":176},{"fa":173,"en":174},"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 patients that breastfeeding is not recommended during treatment with BENDEKA, and for 1 week after the last dose.",[177],{"source":36,"section":178},"8.2",{"level":180,"text":181,"quote":184,"refs":185},"not-established",{"fa":182,"en":183},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness in pediatric patients have not been established.",[186],{"source":36,"section":187},"8.4",{"level":189,"text":190,"quote":193,"refs":194},"ok",{"fa":191,"en":192},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety were observed between patients ≥65 years of age and younger patients.",[195],{"source":36,"section":196},"8.5",{"level":198,"text":199,"quote":202,"refs":203},"caution",{"fa":200,"en":201},"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 Advise female patients of reproductive potential to use effective contraception during treatment with BENDEKA and for 6 months after the last dose.",[204],{"source":36,"section":205},"8.3",{"kind":207,"refs":208,"id":147},"NDA",[209],{"source":36,"section":210},"SPL approval \u002F marketing category",1792444380771]