[{"data":1,"prerenderedAt":127},["ShallowReactive",2],{"drug-berdazimer":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":32,"contraindications":51,"warnings":52,"renal":60,"monitoring":61,"interactions":62,"review":63,"examples":66,"atc":67,"iran":69,"usApproval":76,"links":82,"populations":93},"berdazimer",1,{"fa":7,"en":8},"ژل بردازیمر (مولوسکوم)","Berdazimer gel","dermatology",{"fa":11,"en":12},"آزادکننده نیتریک اکسید موضعی","Topical nitric oxide releaser",[14],{"name":15,"market":16},"Zelsuvmi","US",[18,19],"zelsuvmi","بردازیمر",[21],{"id":22,"form":22,"route":23,"label":24,"concentration":25,"markets":27,"refs":28},"gel","topical","Berdazimer 10.3% gel (two tubes, mixed before use)",{"amount":5,"unit":26,"perUnit":26},"application",[16],[29],{"source":30,"section":31},"fda-zelsuvmi","3",[33],{"id":34,"disease":35,"label":36,"population":39,"type":42,"unit":43,"dose":44,"refs":48},"mc","molluscum",{"fa":37,"en":38},"مولوسکوم (۱ سال به بالا) — روزانه روی هر ضایعه تا ۱۲ هفته","Molluscum (≥1 y) — once daily to each lesion up to 12 weeks",{"minAge":40},{"value":5,"unit":41},"year","notCalculated","mg",{"reason":45},{"fa":46,"en":47},"مقدار مساوی از لوله A و B طبق راهنما مخلوط و فوراً لایه نازک روی هر ضایعه، روزانه تا ۱۲ هفته. نه برای چشم، دهان یا واژن.","Mix equal amounts of tube A and B per the dosing guide and immediately apply a thin layer to each lesion, once daily for up to 12 weeks. Not for eye, mouth or vagina.",[49],{"source":30,"section":50},"2",[],[53],{"text":54,"refs":57},{"fa":55,"en":56},"واکنش محل مصرف از جمله درماتیت تماسی آلرژیک.","Application site reactions including allergic contact dermatitis.",[58],{"source":30,"section":59},"5.1",[],[],[],{"status":64,"reviewer":65,"date":65},"unverified",null,[],[68],"D06BB13",{"status":70,"refs":71},"not-found",[72],{"source":73,"section":74,"url":75},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Berdazimer%20gel",{"kind":77,"refs":78,"id":81},"NDA",[79],{"source":30,"section":80},"SPL approval \u002F marketing category","NDA217424",[83,86,90],{"kind":84,"url":85,"label":81},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=217424",{"kind":87,"url":88,"label":89},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=76b17622-bdb9-41ea-b962-c2acc0df71f7","FDA Zelsuvmi",{"kind":91,"url":92,"label":68},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=D06BB13",{"pregnancy":94,"lactation":103,"pediatric":111,"geriatric":119},{"level":95,"text":96,"quote":99,"refs":100},"caution",{"fa":97,"en":98},"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 no available data on ZELSUVMI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.",[101],{"source":30,"section":102},"8.1",{"level":95,"text":104,"quote":107,"refs":108},{"fa":105,"en":106},"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 berdazimer or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.",[109],{"source":30,"section":110},"8.2",{"level":95,"text":112,"quote":115,"refs":116},{"fa":113,"en":114},"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 ZELSUVMI for the topical treatment of MC have been established in pediatric patients 1 year of age and older.",[117],{"source":30,"section":118},"8.4",{"level":95,"text":120,"quote":123,"refs":124},{"fa":121,"en":122},"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.","Of the total number of ZELSUVMI-treated subjects in clinical studies for MC, none were 65 to 74 years of age, and one was 75 years of age and older [see Clinical Studies (14) ] .",[125],{"source":30,"section":126},"8.5",1792115169462]