[{"data":1,"prerenderedAt":153},["ShallowReactive",2],{"drug-dornase-alfa":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":35,"contraindications":58,"warnings":68,"renal":69,"monitoring":70,"interactions":71,"review":72,"examples":75,"atc":81,"iran":83,"usApproval":95,"links":101,"populations":119},"dornase-alfa",1,{"fa":7,"en":8},"دورناز آلفا","Dornase alfa","respiratory",{"fa":11,"en":12},"آنزیم موکولیتیک (DNase)","Mucolytic enzyme (DNase)",[14],{"name":15,"market":16},"Pulmozyme","US",[18,19,20,21],"pulmozyme","پالموزایم","dornase","دورناز",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":30,"refs":31},"amp-2-5","solution","inhaled","2.5 mg\u002F2.5 mL ampule for nebulizer",{"amount":5,"unit":29,"perVolumeMl":5},"mg",[16],[32],{"source":33,"section":34},"fda-pulmozyme","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":43,"unit":29,"dose":44,"refs":46,"notes":49},"cf","cystic-fibrosis",{"fa":40,"en":41},"فیبروز کیستیک — ۲٫۵ mg (یک آمپول) یک بار در روز با نبولایزر توصیه‌شده","Cystic fibrosis — 2.5 mg (one ampule) once daily via a recommended nebulizer",{},"fixed",{"perDose":45,"dosesPerDay":5},2.5,[47],{"source":33,"section":48},"2.1",[50],{"text":51,"refs":54},{"fa":52,"en":53},"برخی بیماران از دو بار در روز سود می‌برند. با سایر داروها در نبولایزر مخلوط نشود.","Some patients may benefit from twice daily. Do not mix with other drugs in the nebulizer.",[55,56],{"source":33,"section":48},{"source":33,"section":57},"2.2",[59],{"id":60,"severity":61,"text":62,"refs":65},"hyper","block",{"fa":63,"en":64},"حساسیت به دورناز آلفا یا فرآورده‌های سلول تخمدان همستر چینی.","Hypersensitivity to dornase alfa or Chinese hamster ovary cell products.",[66],{"source":33,"section":67},"4",[],[],[],[],{"status":73,"reviewer":74,"date":74},"unverified",null,[76],{"regimen":37,"formulation":24,"input":77,"expect":80},{"ageYears":78,"weightKg":79},10,30,{"perDose":45,"mlPerDose":45},[82],"R05CB13",{"status":84,"forms":85,"refs":90},"registered",[86],{"code":87,"en":88,"fa":89},"08081","DORNASE ALFA 2500IU AMP","آمپول دورناس آلفا ۲۵۰۰ واحد بین‌المللی",[91],{"source":92,"section":93,"url":94},"darooyab-generic","G-2162\u002FDornase-Alfa","https:\u002F\u002Fwww.darooyab.ir\u002FG-2162\u002FDornase-Alfa",{"kind":96,"refs":97,"id":100},"BLA",[98],{"source":33,"section":99},"SPL approval \u002F marketing category","BLA103532",[102,105,109,113,116],{"kind":103,"url":104,"label":100},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103532",{"kind":106,"url":107,"label":108},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=d8c78a7e-ff99-48f3-8952-643ec2ea0f86","FDA Pulmozyme",{"kind":110,"url":111,"label":112},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa694002.html","Dornase Alfa",{"kind":114,"url":115,"label":82},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=R05CB13",{"kind":117,"url":94,"label":118},"darooyab","Dornase-Alfa",{"pregnancy":120,"lactation":129,"pediatric":137,"geriatric":145},{"level":121,"text":122,"quote":125,"refs":126},"caution",{"fa":123,"en":124},"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 adequate and well-controlled studies with PULMOZYME in pregnant women.",[127],{"source":33,"section":128},"8.1",{"level":121,"text":130,"quote":133,"refs":134},{"fa":131,"en":132},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","In a pharmacokinetic study in Cynomolgus monkeys, levels of dornase alfa detected in milk were less than 0.1% of the maternal serum concentration at 24 hours after dosing [intravenous bolus dose (0.1 mg\u002Fkg) of dornase alfa followed by an intravenous infusion (0.080 mg\u002Fkg\u002Fhr) over a 6-hour period] on post-partum day 14.",[135],{"source":33,"section":136},"8.2",{"level":121,"text":138,"quote":141,"refs":142},{"fa":139,"en":140},"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 PULMOZYME in conjunction with standard therapies for cystic fibrosis have been established in pediatric patients.",[143],{"source":33,"section":144},"8.4",{"level":121,"text":146,"quote":149,"refs":150},{"fa":147,"en":148},"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.","Cystic fibrosis is primarily a disease of children and young adults.",[151],{"source":33,"section":152},"8.5",1792191539276]