[{"data":1,"prerenderedAt":198},["ShallowReactive",2],{"drug-glatiramer":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":44,"contraindications":82,"warnings":92,"renal":107,"monitoring":108,"interactions":109,"review":110,"examples":113,"atc":122,"iran":124,"usApproval":140,"links":146,"populations":164},"glatiramer",1,{"fa":7,"en":8},"گلاتیرامر استات","Glatiramer acetate","antineoplastic-immunomodulating",{"fa":11,"en":12},"تعدیل‌کننده ایمنی ام‌اس","MS immunomodulator",[14],{"name":15,"market":16},"Copaxone","US",[18,19,20,21],"copaxone","کوپاکسون","گلاتیرامر","سیناژن کوپاکسون",[23,36],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":31,"refs":32},"pfs-20","injection","sc","20 mg\u002FmL prefilled syringe (white plunger)",{"amount":29,"unit":30,"perVolumeMl":5},20,"mg",[16],[33],{"source":34,"section":35},"fda-copaxone","3",{"id":37,"form":25,"route":26,"label":38,"concentration":39,"markets":41,"refs":42},"pfs-40","40 mg\u002FmL prefilled syringe (blue plunger)",{"amount":40,"unit":30,"perVolumeMl":5},40,[16],[43],{"source":34,"section":35},[45,70],{"id":46,"disease":47,"label":48,"population":51,"type":55,"unit":30,"dose":56,"refs":57,"allowedFormulations":60,"notes":61},"d20","multiple-sclerosis",{"fa":49,"en":50},"ام‌اس عودکننده بزرگسال — ۲۰ mg زیرجلدی روزانه","Relapsing MS, adults — 20 mg SC daily",{"minAge":52},{"value":53,"unit":54},18,"year","fixed",{"perDose":29,"dosesPerDay":5},[58],{"source":34,"section":59},"2.1",[24],[62],{"text":63,"refs":66},{"fa":64,"en":65},"۲۰ mg و ۴۰ mg جایگزین هم نیستند. وریدی نه. پیش از تزریق به دمای اتاق برسد.","20 mg and 40 mg are not interchangeable. Never IV. Warm to room temperature first.",[67,68],{"source":34,"section":59},{"source":34,"section":69},"2",{"id":71,"disease":47,"label":72,"population":75,"type":55,"unit":30,"dose":77,"refs":78,"durationDays":80,"allowedFormulations":81},"w40",{"fa":73,"en":74},"ام‌اس عودکننده بزرگسال — ۴۰ mg زیرجلدی سه بار در هفته (دست‌کم ۴۸ ساعت فاصله)","Relapsing MS, adults — 40 mg SC three times a week (at least 48 h apart)",{"minAge":76},{"value":53,"unit":54},{"perDose":40,"dosesPerDay":5},[79],{"source":34,"section":59},{"min":5,"max":5},[37],[83],{"id":84,"severity":85,"text":86,"refs":89},"hyper","block",{"fa":87,"en":88},"حساسیت به گلاتیرامر یا مانیتول.","Hypersensitivity to glatiramer acetate or mannitol.",[90],{"source":34,"section":91},"4",[93,100],{"text":94,"refs":97},{"fa":95,"en":96},"هشدار جعبه‌ای: آنافیلاکسی تهدیدکننده حیات، از اولین دوز تا سال‌ها بعد.","Boxed warning: life-threatening anaphylaxis, from the first dose up to years later.",[98],{"source":34,"section":99},"Boxed Warning",{"text":101,"refs":104},{"fa":102,"en":103},"واکنش فوری پس از تزریق؛ درد قفسه سینه؛ لیپوآتروفی و نکروز پوست؛ آسیب کبد.","Immediate post-injection reaction; chest pain; lipoatrophy and skin necrosis; liver injury.",[105],{"source":34,"section":106},"5",[],[],[],{"status":111,"reviewer":112,"date":112},"unverified",null,[114,119],{"regimen":46,"formulation":24,"input":115,"expect":118},{"ageYears":116,"weightKg":117},35,65,{"perDose":29,"mlPerDose":5},{"regimen":71,"formulation":37,"input":120,"expect":121},{"ageYears":116,"weightKg":117},{"perDose":40,"mlPerDose":5},[123],"L03AX13",{"status":125,"forms":126,"refs":135},"registered",[127,131],{"code":128,"en":129,"fa":130},"10683","GLATIRAMER ACETATE 20MG\u002FML PREFILLED SYRINGE","سرنگ از پیش پرشده گلاتیرامر استات ۲۰ میلی‌گرم \u002F میلی‌لیتر",{"code":132,"en":133,"fa":134},"23125","GLATIRAMER ACETATE 40MG\u002FML PREFILLED SYRINGE","سرنگ از پیش پرشده گلاتیرامر استات ۴۰ میلی‌گرم \u002F میلی‌لیتر",[136],{"source":137,"section":138,"url":139},"darooyab-generic","G-3869\u002FGlatiramer-Acetate","https:\u002F\u002Fwww.darooyab.ir\u002FG-3869\u002FGlatiramer-Acetate",{"kind":141,"refs":142,"id":145},"NDA",[143],{"source":34,"section":144},"SPL approval \u002F marketing category","NDA020622",[147,150,154,158,161],{"kind":148,"url":149,"label":145},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=020622",{"kind":151,"url":152,"label":153},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=aa88f583-4f5f-433b-80b4-1f4c9fb28357","FDA Copaxone",{"kind":155,"url":156,"label":157},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa603016.html","Glatiramer Injection",{"kind":159,"url":160,"label":123},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L03AX13",{"kind":162,"url":139,"label":163},"darooyab","Glatiramer-Acetate",{"pregnancy":165,"lactation":174,"pediatric":182,"geriatric":190},{"level":166,"text":167,"quote":170,"refs":171},"caution",{"fa":168,"en":169},"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 pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data) .",[172],{"source":34,"section":173},"8.1",{"level":166,"text":175,"quote":178,"refs":179},{"fa":176,"en":177},"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 glatiramer acetate in human milk.",[180],{"source":34,"section":181},"8.2",{"level":166,"text":183,"quote":186,"refs":187},{"fa":184,"en":185},"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 COPAXONE have not been established in patients under 18 years of age.",[188],{"source":34,"section":189},"8.4",{"level":166,"text":191,"quote":194,"refs":195},{"fa":192,"en":193},"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.","COPAXONE has not been studied in elderly patients.",[196],{"source":34,"section":197},"8.5",1792191546642]