[{"data":1,"prerenderedAt":181},["ShallowReactive",2],{"drug-insulin-degludec":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":43,"contraindications":84,"warnings":94,"renal":104,"monitoring":105,"interactions":106,"review":107,"examples":110,"atc":117,"iran":119,"links":126,"populations":142,"usApproval":176},"insulin-degludec",1,{"fa":7,"en":8},"انسولین دگلودک","Insulin degludec","alimentary-metabolism",{"fa":11,"en":12},"انسولین پایه بسیار طولانی‌اثر","Ultra-long-acting basal insulin",[14],{"name":15,"market":16},"Tresiba","US",[18,19,20],"tresiba","ترسیبا","دگلودک",[22,35],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"u100","injection","sc","100 units\u002FmL (U-100) FlexTouch pen or vial",{"amount":28,"unit":29,"perVolumeMl":5},100,"unit",[16],[32],{"source":33,"section":34},"fda-tresiba","3",{"id":36,"form":24,"route":25,"label":37,"concentration":38,"markets":40,"refs":41},"u200","200 units\u002FmL (U-200) FlexTouch pen",{"amount":39,"unit":29,"perVolumeMl":5},200,[16],[42],{"source":33,"section":34},[44,68],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":29,"dose":55,"refs":57,"notes":60},"t2-naive","type-2-diabetes",{"fa":48,"en":49},"دیابت نوع ۲، شروع انسولین — ۱۰ واحد یک بار در روز","Type 2 diabetes, insulin-naive — 10 units once daily",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":56,"dosesPerDay":5},10,[58],{"source":33,"section":59},"2.3",[61],{"text":62,"refs":65},{"fa":63,"en":64},"هر روز در هر ساعتی؛ تنظیم دوز هر ۳ تا ۴ روز بر اساس قند ناشتا.","Any time of day; titrate every 3–4 days by fasting glucose.",[66],{"source":33,"section":67},"2.2",{"id":69,"disease":70,"label":71,"population":74,"type":76,"unit":77,"dose":78,"refs":82},"t1","type-1-diabetes",{"fa":72,"en":73},"دیابت نوع ۱ — یک‌سوم تا نیمی از کل دوز روزانه به‌صورت پایه","Type 1 diabetes — one-third to one-half of total daily insulin as basal",{"minAge":75},{"value":5,"unit":53},"notCalculated","mg",{"reason":79},{"fa":80,"en":81},"بیمار بدون انسولین قبلی: کل انسولین روزانه حدود ۰٫۲ تا ۰٫۴ واحد\u002Fkg؛ یک‌سوم تا نیمی از آن دگلودک یک بار در روز و بقیه انسولین کوتاه‌اثر با غذا. تنظیم هر ۳ تا ۴ روز.","Insulin-naive: total daily insulin about 0.2–0.4 units\u002Fkg; one-third to one-half as degludec once daily, the rest as short-acting with meals. Titrate every 3–4 days.",[83],{"source":33,"section":59},[85],{"id":86,"severity":87,"text":88,"refs":91},"hypo","block",{"fa":89,"en":90},"هنگام هیپوگلیسمی؛ حساسیت به انسولین یا اجزای فرآورده.","During episodes of hypoglycaemia; hypersensitivity to the insulin or its excipients.",[92],{"source":33,"section":93},"4",[95],{"text":96,"refs":99},{"fa":97,"en":98},"هیپوگلیسمی؛ هیپوکالمی؛ قلم مشترک ممنوع؛ برای کتواسیدوز نه.","Hypoglycaemia; hypokalaemia; never share pens; not for diabetic ketoacidosis.",[100,102],{"source":33,"section":101},"5",{"source":33,"section":103},"1",[],[],[],{"status":108,"reviewer":109,"date":109},"unverified",null,[111],{"regimen":45,"formulation":23,"input":112,"expect":115},{"ageYears":113,"weightKg":114},55,90,{"perDose":56,"mlPerDose":116},0.1,[118],"A10AE06",{"status":120,"refs":121},"not-found",[122],{"source":123,"section":124,"url":125},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Insulin%20degludec",[127,131,135,139],{"kind":128,"url":129,"label":130},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=203314","BLA203314",{"kind":132,"url":133,"label":134},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=456c5e87-3dfd-46fa-8ac0-c6128d4c97c6","FDA Tresiba",{"kind":136,"url":137,"label":138},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615055.html","Insulin Degludec (rDNA Origin) Injection",{"kind":140,"url":141,"label":118},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=A10AE06",{"pregnancy":143,"lactation":152,"pediatric":160,"geriatric":168},{"level":144,"text":145,"quote":148,"refs":149},"caution",{"fa":146,"en":147},"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 data from one unpublished trial and the published literature with TRESIBA use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.",[150],{"source":33,"section":151},"8.1",{"level":144,"text":153,"quote":156,"refs":157},{"fa":154,"en":155},"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 insulin degludec in human milk, the effects on the breastfed infant, or the effects on milk production.",[158],{"source":33,"section":159},"8.2",{"level":144,"text":161,"quote":164,"refs":165},{"fa":162,"en":163},"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 effectiveness of TRESIBA to improve glycemic control in pediatric patients 1 year of age and older with diabetes mellitus have been established.",[166],{"source":33,"section":167},"8.4",{"level":144,"text":169,"quote":172,"refs":173},{"fa":170,"en":171},"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 controlled clinical trials [see Clinical Studies ( 14 )] a total of 77 (7%) of the 1102 TRESIBA-treated patients with type 1 diabetes were 65 years or older and 9 (1%) were 75 years or older.",[174],{"source":33,"section":175},"8.5",{"kind":177,"refs":178,"id":130},"BLA",[179],{"source":33,"section":180},"SPL approval \u002F marketing category",1792115184080]