[{"data":1,"prerenderedAt":181},["ShallowReactive",2],{"drug-cyclosporine-eye":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":34,"contraindications":61,"warnings":71,"renal":72,"monitoring":73,"interactions":74,"review":75,"examples":78,"atc":84,"iran":86,"links":126,"populations":141,"usApproval":176},"cyclosporine-eye",1,{"fa":7,"en":8},"قطره چشمی سیکلوسپورین","Cyclosporine eye emulsion","sensory-organs",{"fa":11,"en":12},"تعدیل‌کننده ایمنی چشمی","Ophthalmic immunomodulator",[14],{"name":15,"market":16},"Restasis","US",[18,19,20],"restasis","رستاسیس","سیکلوسپورین چشمی",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":29,"refs":30},"em-005","eye-drops","ophthalmic","Cyclosporine 0.05% ophthalmic emulsion",{"amount":5,"unit":28,"perUnit":28},"drop",[16],[31],{"source":32,"section":33},"fda-restasis","3",[35],{"id":36,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":48,"notes":51},"dry","dry-eye",{"fa":39,"en":40},"خشکی چشم (افزایش تولید اشک) — یک قطره دو بار در روز در هر چشم","Dry eye (to increase tear production) — 1 drop twice daily in each eye",{"minAge":42},{"value":43,"unit":44},16,"year","fixed",{"perDose":5,"dosesPerDay":47},2,[49],{"source":32,"section":50},"2.2",[52],{"text":53,"refs":56},{"fa":54,"en":55},"حدود ۱۲ ساعت فاصله؛ با اشک مصنوعی ۱۵ دقیقه فاصله. نوک بطری به چشم نخورد.","About 12 h apart; 15 min apart from artificial tears. Do not touch the bottle tip to the eye.",[57,59],{"source":32,"section":58},"2.1",{"source":32,"section":60},"5.1",[62],{"id":63,"severity":64,"text":65,"refs":68},"hyper","block",{"fa":66,"en":67},"حساسیت شناخته‌شده یا مشکوک به اجزا.","Known or suspected hypersensitivity to any ingredient.",[69],{"source":32,"section":70},"4",[],[],[],[],{"status":76,"reviewer":77,"date":77},"unverified",null,[79],{"regimen":36,"formulation":23,"input":80,"expect":83},{"ageYears":81,"weightKg":82},50,65,{"perDose":5,"dosesPerDay":47},[85],"S01XA18",{"status":87,"forms":88,"refs":121},"registered",[89,93,97,101,105,109,113,117],{"code":90,"en":91,"fa":92},"06815","CICLOSPORIN 0.05% OPH DROP","قطره چشمی سیکلوسپورین ۰٫۰۵ درصد",{"code":94,"en":95,"fa":96},"00287","CICLOSPORIN 100MG CAP","کپسول سیکلوسپورین ۱۰۰ میلی‌گرم",{"code":98,"en":99,"fa":100},"06685","CICLOSPORIN 250MG\u002F5ML AMP","آمپول سیکلوسپورین ۲۵۰ میلی‌گرم \u002F ۵ میلی‌لیتر",{"code":102,"en":103,"fa":104},"00288","CICLOSPORIN 25MG CAP","کپسول سیکلوسپورین ۲۵ میلی‌گرم",{"code":106,"en":107,"fa":108},"01758","CICLOSPORIN 50MG CAP","کپسول سیکلوسپورین ۵۰ میلی‌گرم",{"code":110,"en":111,"fa":112},"01452","CICLOSPORIN 50MG\u002F1ML AMP","آمپول سیکلوسپورین ۵۰ میلی‌گرم \u002F ۱ میلی‌لیتر",{"code":114,"en":115,"fa":116},"00289","CICLOSPORIN I00MG\u002FML 50ML ORAL SOL","محلول سیکلوسپورین ید ۰۰ میلی‌گرم \u002F میلی‌لیتر ۵۰ میلی‌لیتر",{"code":118,"en":119,"fa":120},"52168","CYCLOSPORIN SOLUTION, DROPS OPHTHALMIC 0.05 % 0.4 mL","قطره چشمی سیکلوسپورین ۰٫۰۵ درصد ۰٫۴ میلی‌لیتر",[122],{"source":123,"section":124,"url":125},"darooyab-generic","G-2733\u002FCiclosporin","https:\u002F\u002Fwww.darooyab.ir\u002FG-2733\u002FCiclosporin",[127,131,135,138],{"kind":128,"url":129,"label":130},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=050790","NDA050790",{"kind":132,"url":133,"label":134},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=7224d810-bb96-4682-a942-3355e6e8061a","FDA Restasis",{"kind":136,"url":137,"label":85},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=S01XA18",{"kind":139,"url":125,"label":140},"darooyab","Ciclosporin",{"pregnancy":142,"lactation":151,"pediatric":160,"geriatric":168},{"level":143,"text":144,"quote":147,"refs":148},"ok",{"fa":145,"en":146},"برچسب: جذب سیستمیک ناچیز؛ مواجهه جنین انتظار نمی‌رود.","Label: minimal systemic absorption; fetal exposure not expected.","… detected systemically following topical ocular administration [see Clinical Pharmacology (12.3) ] , and maternal use is not expected to result in fetal exposure to the drug.",[149],{"source":32,"section":150},"8.1",{"level":152,"text":153,"quote":156,"refs":157},"caution",{"fa":154,"en":155},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Although blood concentrations are undetectable following topical administration of cyclosporine ophthalmic emulsion 0.05% [see Clinical Pharmacology (12.3) ] , caution should be exercised when RESTASIS MULTIDOSE is administered to a nursing woman.",[158],{"source":32,"section":159},"8.2",{"level":152,"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.","Safety and efficacy have not been established in pediatric patients below the age of 16.",[166],{"source":32,"section":167},"8.4",{"level":152,"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.","No overall difference in safety or effectiveness has been observed between elderly and younger patients.",[174],{"source":32,"section":175},"8.5",{"kind":177,"refs":178,"id":130},"NDA",[179],{"source":32,"section":180},"SPL approval \u002F marketing category",1792115175447]