[{"data":1,"prerenderedAt":167},["ShallowReactive",2],{"drug-semaglutide":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":56,"warnings":66,"renal":74,"monitoring":75,"interactions":76,"review":77,"examples":80,"atc":81,"iran":83,"links":99,"populations":120,"usApproval":162},"semaglutide",1,{"fa":7,"en":8},"سماگلوتاید (تزریقی هفتگی)","Semaglutide (weekly injection)","alimentary-metabolism",{"fa":11,"en":12},"آگونیست گیرنده GLP-1","GLP-1 receptor agonist",[14],{"name":15,"market":16},"Ozempic","US",[18,19,20],"ozempic","اوزمپیک","سماگلوتاید",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"pen","injection","sc","Pen 0.25\u002F0.5 mg, 1 mg or 2 mg per dose (0.68, 1.34 or 2.68 mg\u002FmL)",{"amount":5,"unit":28,"perUnit":29},"mg","application",[16],[32],{"source":33,"section":34},"fda-ozempic","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":28,"dose":47,"refs":51},"t2d","type-2-diabetes",{"fa":40,"en":41},"دیابت نوع ۲ — هفته‌ای یک بار: ۰٫۲۵ mg × ۴ هفته، سپس ۰٫۵ mg","Type 2 diabetes — once weekly: 0.25 mg × 4 weeks, then 0.5 mg",{"minAge":43},{"value":44,"unit":45},18,"year","notCalculated",{"reason":48},{"fa":49,"en":50},"هفته‌ای یک بار زیرجلدی (نه روزانه). ۴ هفته ۰٫۲۵ mg (فقط برای تحمل)، سپس ۰٫۵ mg. در صورت نیاز پس از دست‌کم ۴ هفته ۱ mg و سپس ۲ mg؛ حداکثر ۲ mg در هفته.","Once WEEKLY subcutaneous (not daily). 0.25 mg for 4 weeks (tolerability only), then 0.5 mg. If needed after at least 4 weeks go to 1 mg, then 2 mg; max 2 mg weekly.",[52,54],{"source":33,"section":53},"2.2",{"source":33,"section":55},"2.1",[57],{"id":58,"severity":59,"text":60,"refs":63},"mtc","block",{"fa":61,"en":62},"سابقه شخصی یا خانوادگی کارسینوم مدولاری تیروئید یا MEN 2؛ حساسیت جدی.","Personal or family history of medullary thyroid carcinoma or MEN 2; serious hypersensitivity.",[64],{"source":33,"section":65},"4",[67],{"text":68,"refs":71},{"fa":69,"en":70},"هشدار جعبه‌ای: تومور سلول C تیروئید در جوندگان؛ در سابقه MTC یا MEN 2 ممنوع.","Boxed warning: thyroid C-cell tumours in rodents; contraindicated with MTC or MEN 2 history.",[72],{"source":33,"section":73},"Boxed Warning",[],[],[],{"status":78,"reviewer":79,"date":79},"unverified",null,[],[82],"A10BJ06",{"status":84,"forms":85,"refs":94},"registered",[86,90],{"code":87,"en":88,"fa":89},"53482","SEMAGLUTIDE INJECTION, SOLUTION PARENTERAL 4 mg\u002F3 mL","محلول تزریقی سماگلوتاید ۴ میلی‌گرم \u002F ۳ میلی‌لیتر",{"code":91,"en":92,"fa":93},"53491","SEMAGLUTIDE INJECTION, SOLUTION PARENTERAL 8 mg\u002F3 mL","محلول تزریقی سماگلوتاید ۸ میلی‌گرم \u002F ۳ میلی‌لیتر",[95],{"source":96,"section":97,"url":98},"darooyab-generic","G-5532\u002FSemaglutide","https:\u002F\u002Fwww.darooyab.ir\u002FG-5532\u002FSemaglutide",[100,104,108,112,115,118],{"kind":101,"url":102,"label":103},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=209637","NDA209637",{"kind":105,"url":106,"label":107},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79","FDA Ozempic",{"kind":109,"url":110,"label":111},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa619057.html","Semaglutide",{"kind":109,"url":113,"label":114},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa618008.html","Semaglutide Injection",{"kind":116,"url":117,"label":82},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=A10BJ06",{"kind":119,"url":98,"label":111},"darooyab",{"pregnancy":121,"lactation":130,"pediatric":138,"geriatric":146,"reproductive":154},{"level":122,"text":123,"quote":126,"refs":127},"caution",{"fa":124,"en":125},"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 limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.",[128],{"source":33,"section":129},"8.1",{"level":122,"text":131,"quote":134,"refs":135},{"fa":132,"en":133},"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 semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production.",[136],{"source":33,"section":137},"8.2",{"level":122,"text":139,"quote":142,"refs":143},{"fa":140,"en":141},"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 efficacy of OZEMPIC have not been established in pediatric patients.",[144],{"source":33,"section":145},"8.4",{"level":122,"text":147,"quote":150,"refs":151},{"fa":148,"en":149},"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 the pool of placebo- and active-controlled glycemic control trials, 744 (23.6%) OZEMPIC-treated patients were 65 years of age and over and 102 OZEMPIC-treated patients (3.2%) patients were 75 years of age and over.",[152],{"source":33,"section":153},"8.5",{"level":122,"text":155,"quote":158,"refs":159},{"fa":156,"en":157},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Discontinue OZEMPIC in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide [see Use in Specific Populations ( 8.1 )] .",[160],{"source":33,"section":161},"8.3",{"kind":163,"refs":164,"id":103},"NDA",[165],{"source":33,"section":166},"SPL approval \u002F marketing category",1792111467808]