[{"data":1,"prerenderedAt":226},["ShallowReactive",2],{"drug-somatropin":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":23,"regimens":46,"contraindications":81,"warnings":91,"renal":99,"monitoring":100,"interactions":101,"review":102,"examples":105,"atc":106,"iran":108,"links":168,"populations":187,"usApproval":221},"somatropin",1,{"fa":7,"en":8},"سوماتروپین (هورمون رشد)","Somatropin","systemic-hormones",{"fa":11,"en":12},"هورمون رشد نوترکیب","Recombinant growth hormone",[14],{"name":15,"market":16},"Genotropin","US",[18,19,20,21,22],"genotropin","ژنوتروپین","growth hormone","هورمون رشد","GH",[24,38],{"id":25,"form":26,"route":27,"label":28,"concentration":29,"markets":33,"refs":34},"cart-5","powder-for-injection","sc","5 mg two-chamber cartridge",{"amount":30,"unit":31,"perUnit":32},5,"mg","vial",[16],[35],{"source":36,"section":37},"fda-genotropin","3",{"id":39,"form":26,"route":27,"label":40,"concentration":41,"markets":43,"refs":44},"cart-12","12 mg two-chamber cartridge",{"amount":42,"unit":31,"perUnit":32},12,[16],[45],{"source":36,"section":37},[47,67],{"id":48,"disease":49,"label":50,"population":53,"type":57,"unit":31,"dose":58,"refs":62},"peds","growth-hormone-deficiency",{"fa":51,"en":52},"کودکان — دوز هفتگی mg\u002Fkg، تقسیم به ۶ یا ۷ تزریق زیرجلدی","Children — weekly mg\u002Fkg dose divided into 6 or 7 subcutaneous injections",{"maxAge":54},{"value":55,"unit":56},18,"year","notCalculated",{"reason":59},{"fa":60,"en":61},"کمبود GH: ۰٫۱۶ تا ۰٫۲۴ mg\u002Fkg\u002Fهفته؛ پرادر-ویلی: ۰٫۲۴؛ SGA: تا ۰٫۴۸؛ ترنر: ۰٫۳۳؛ کوتاهی قد ایدیوپاتیک: تا ۰٫۴۷ mg\u002Fkg\u002Fهفته. دوز هفتگی بر ۶ یا ۷ تقسیم می‌شود؛ هرگز وریدی نه. زیر نظر متخصص غدد کودکان.","GHD: 0.16–0.24 mg\u002Fkg\u002Fweek; Prader-Willi: 0.24; SGA: up to 0.48; Turner: 0.33; idiopathic short stature: up to 0.47 mg\u002Fkg\u002Fweek. Weekly dose split into 6 or 7 injections; never IV. Under a paediatric endocrinologist.",[63,65],{"source":36,"section":64},"2",{"source":36,"section":66},"2.1",{"id":68,"disease":49,"label":69,"population":72,"type":57,"unit":31,"dose":74,"refs":78},"adult",{"fa":70,"en":71},"کمبود GH بزرگسال — حدود ۰٫۲ mg\u002Fروز (۰٫۱۵ تا ۰٫۳۰) یا حداکثر ۰٫۰۴ mg\u002Fkg\u002Fهفته در شروع","Adult GHD — about 0.2 mg\u002Fday (0.15–0.30) or not more than 0.04 mg\u002Fkg\u002Fweek to start",{"minAge":73},{"value":55,"unit":56},{"reason":75},{"fa":76,"en":77},"بدون وزن: شروع ۰٫۲ mg\u002Fروز و هر ۱ تا ۲ ماه ۰٫۱ تا ۰٫۲ mg\u002Fروز افزایش. با وزن: شروع حداکثر ۰٫۰۴ و تا ۰٫۰۸ mg\u002Fkg\u002Fهفته طی ۴ تا ۸ هفته. تنظیم با پاسخ و IGF-I.","Non-weight-based: start 0.2 mg\u002Fday, increase by 0.1–0.2 mg\u002Fday every 1–2 months. Weight-based: start ≤0.04, up to ≤0.08 mg\u002Fkg\u002Fweek at 4–8-week intervals. Adjust to response and IGF-I.",[79],{"source":36,"section":80},"2.2",[82],{"id":83,"severity":84,"text":85,"refs":88},"ci","block",{"fa":86,"en":87},"بیماری حاد بحرانی؛ کودک پرادر-ویلی با چاقی شدید یا اختلال تنفسی شدید (مرگ ناگهانی)؛ بدخیمی فعال؛ حساسیت؛ رتینوپاتی دیابتی پرولیفراتیو فعال یا غیرپرولیفراتیو شدید؛ کودک با اپی‌فیز بسته.","Acute critical illness; children with Prader-Willi who are severely obese or have severe respiratory impairment (sudden death); active malignancy; hypersensitivity; active proliferative or severe non-proliferative diabetic retinopathy; children with closed epiphyses.",[89],{"source":36,"section":90},"4",[92],{"text":93,"refs":96},{"fa":94,"en":95},"نئوپلاسم؛ اختلال تحمل گلوکز و دیابت؛ فشار داخل جمجمه؛ احتباس مایع؛ کم‌کاری آدرنال و تیروئید؛ لغزش اپی‌فیز سر فمور و پیشرفت اسکولیوز در کودک؛ پانکراتیت.","Neoplasms; impaired glucose tolerance and diabetes; intracranial hypertension; fluid retention; hypoadrenalism and hypothyroidism; slipped capital femoral epiphysis and scoliosis progression in children; pancreatitis.",[97],{"source":36,"section":98},"5",[],[],[],{"status":103,"reviewer":104,"date":104},"unverified",null,[],[107],"H01AC01",{"status":109,"forms":110,"refs":163},"registered",[111,115,119,123,127,131,135,139,143,147,151,155,159],{"code":112,"en":113,"fa":114},"17791","SOMATROPIN 10MG 1.5ML PEN","قلم تزریقی سوماتروپین ۱۰ میلی‌گرم ۱٫۵ میلی‌لیتر",{"code":116,"en":117,"fa":118},"01981","SOMATROPIN 12U AMP","آمپول سوماتروپین ۱۲ واحد",{"code":120,"en":121,"fa":122},"20878","SOMATROPIN 16U INJ","فرآورده تزریقی سوماتروپین ۱۶ واحد",{"code":124,"en":125,"fa":126},"01161","SOMATROPIN 4U AMP","آمپول سوماتروپین ۴ واحد",{"code":128,"en":129,"fa":130},"09808","SOMATROPIN 5MG 1.5ML PEN","قلم تزریقی سوماتروپین ۵ میلی‌گرم ۱٫۵ میلی‌لیتر",{"code":132,"en":133,"fa":134},"50071","SOMATROPIN INJECTION PARENTERAL 10 [iU]\u002F1mL 1.5 mL","فرآورده تزریقی سوماتروپین ۱۰ واحد بین‌المللی \u002F ۱ میلی‌لیتر ۱٫۵ میلی‌لیتر",{"code":136,"en":137,"fa":138},"50423","SOMATROPIN INJECTION PARENTERAL 20 [iU]\u002F1mL 1.5 mL","فرآورده تزریقی سوماتروپین ۲۰ واحد بین‌المللی \u002F ۱ میلی‌لیتر ۱٫۵ میلی‌لیتر",{"code":140,"en":141,"fa":142},"24054","SOMATROPIN INJECTION, SOLUTION PARENTERAL 30 [iU]\u002F2.7mL","محلول تزریقی سوماتروپین ۳۰ واحد بین‌المللی \u002F ۲٫۷ میلی‌لیتر",{"code":144,"en":145,"fa":146},"52346","SOMATROPIN INJECTION, SOLUTION PARENTERAL 4 [iU]\u002F0.5mL","محلول تزریقی سوماتروپین ۴ واحد بین‌المللی \u002F ۰٫۵ میلی‌لیتر",{"code":148,"en":149,"fa":150},"50024","SOMATROPIN INJECTION, SOLUTION PARENTERAL 15 [iU]\u002F1mL 1.5 mL","محلول تزریقی سوماتروپین ۱۵ واحد بین‌المللی \u002F ۱ میلی‌لیتر ۱٫۵ میلی‌لیتر",{"code":152,"en":153,"fa":154},"52212","SOMATROPIN INJECTION, SOLUTION PARENTERAL 6 mg\u002F1.03 mL","محلول تزریقی سوماتروپین ۶ میلی‌گرم \u002F ۱٫۰۳ میلی‌لیتر",{"code":156,"en":157,"fa":158},"52210","SOMATROPIN INJECTION, SOLUTION PARENTERAL 8 mg\u002F1mL 1.5 mL","محلول تزریقی سوماتروپین ۸ میلی‌گرم \u002F ۱ میلی‌لیتر ۱٫۵ میلی‌لیتر",{"code":160,"en":161,"fa":162},"52211","SOMATROPIN INJECTION, SOLUTION PARENTERAL 8 mg\u002F1mL 2.5 mL","محلول تزریقی سوماتروپین ۸ میلی‌گرم \u002F ۱ میلی‌لیتر ۲٫۵ میلی‌لیتر",[164],{"source":165,"section":166,"url":167},"darooyab-generic","G-2700\u002FSomatotropin","https:\u002F\u002Fwww.darooyab.ir\u002FG-2700\u002FSomatotropin",[169,173,177,181,184],{"kind":170,"url":171,"label":172},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=020280","BLA020280",{"kind":174,"url":175,"label":176},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=ffebf88b-d257-4542-9808-74d9b7167765","FDA Genotropin",{"kind":178,"url":179,"label":180},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa622022.html","Somatropin Injection",{"kind":182,"url":183,"label":107},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=H01AC01",{"kind":185,"url":167,"label":186},"darooyab","Somatotropin",{"pregnancy":188,"lactation":197,"pediatric":205,"geriatric":213},{"level":189,"text":190,"quote":193,"refs":194},"caution",{"fa":191,"en":192},"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 Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes.",[195],{"source":36,"section":196},"8.1",{"level":189,"text":198,"quote":201,"refs":202},{"fa":199,"en":200},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information regarding the presence of somatropin in human milk.",[203],{"source":36,"section":204},"8.2",{"level":189,"text":206,"quote":209,"refs":210},{"fa":207,"en":208},"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 effectiveness of GENOTROPIN in pediatric patients have been established in growth failure due to Prader-Willi syndrome (PWS), growth failure in children born small for gestational age (SGA) with no catch-up growth by age 2 years, growth failure associated with Turner syndrome, idiopathic short stature (ISS) …",[211],{"source":36,"section":212},"8.4",{"level":189,"text":214,"quote":217,"refs":218},{"fa":215,"en":216},"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.","A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.2) ].",[219],{"source":36,"section":220},"8.5",{"kind":222,"refs":223,"id":172},"BLA",[224],{"source":36,"section":225},"SPL approval \u002F marketing category",1792191567158]