[{"data":1,"prerenderedAt":286},["ShallowReactive",2],{"drug-gemcitabine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":108,"warnings":118,"renal":126,"monitoring":127,"interactions":128,"review":129,"examples":132,"atc":150,"iran":152,"usApproval":216,"links":222,"populations":242},"gemcitabine",1,{"fa":7,"en":8},"جمسیتابین","Gemcitabine","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌متابولیت نوکلئوزید","Nucleoside antimetabolite",[14],{"name":15,"market":16},"Gemzar","US",[18,19,7,4],"gemzar","جمزار",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"vial-1g","powder-for-injection","iv","1 g vial",{"amount":27,"unit":28,"perUnit":29},1000,"mg","vial",[16],[32],{"source":33,"section":34},"fda-gemcitabine","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"vial-200","200 mg vial",{"amount":39,"unit":28,"perUnit":29},200,[16],[42],{"source":33,"section":34},[44,68,81,94],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":56,"durationDays":59,"notes":60},"pancreas","pancreatic-cancer",{"fa":48,"en":49},"سرطان پانکراس — ۱۰۰۰ mg\u002Fm² طی ۳۰ دقیقه هفتگی ۷ هفته، یک هفته استراحت، سپس ۳ هفته از هر ۴","Pancreatic cancer — 1000 mg\u002Fm² over 30 min weekly for 7 weeks, 1 week rest, then 3 of every 4 weeks",{"minAge":51},{"value":52,"unit":53},18,"year","bsa",{"perM2PerDay":27,"dividedDoses":5},[57],{"source":33,"section":58},"2.4",{"min":5,"max":5},[61],{"text":62,"refs":65},{"fa":63,"en":64},"فقط زیر نظر پزشک متخصص شیمی‌درمانی و در مرکز مجهز. عدد ماشین‌حساب = mg\u002Fm² برچسب × سطح بدن (Mosteller)؛ پروتکل، فاصله دوره‌ها، تنظیم بر اساس CBC و عملکرد کلیه\u002Fکبد با تیم انکولوژی.","Only under an oncologist in an equipped centre. Calculator = label mg\u002Fm² × BSA (Mosteller); protocol, cycle interval and adjustment for CBC and renal\u002Fhepatic function rest with the oncology team.",[66],{"source":33,"section":67},"2",{"id":69,"disease":70,"label":71,"population":74,"type":54,"unit":28,"dose":76,"refs":77,"durationDays":80},"nsclc","lung-cancer",{"fa":72,"en":73},"NSCLC — ۱۰۰۰ mg\u002Fm² روزهای ۱، ۸ و ۱۵ هر ۲۸ روز (یا ۱۲۵۰ mg\u002Fm² روز ۱ و ۸ هر ۲۱ روز)","NSCLC — 1000 mg\u002Fm² on days 1, 8 and 15 every 28 days (or 1250 mg\u002Fm² days 1 and 8 every 21 days)",{"minAge":75},{"value":52,"unit":53},{"perM2PerDay":27,"dividedDoses":5},[78],{"source":33,"section":79},"2.3",{"min":5,"max":5},{"id":82,"disease":83,"label":84,"population":87,"type":54,"unit":28,"dose":89,"refs":90,"durationDays":93},"ovary","ovarian-cancer",{"fa":85,"en":86},"سرطان تخمدان — ۱۰۰۰ mg\u002Fm² روز ۱ و ۸ هر ۲۱ روز","Ovarian cancer — 1000 mg\u002Fm² on days 1 and 8 every 21 days",{"minAge":88},{"value":52,"unit":53},{"perM2PerDay":27,"dividedDoses":5},[91],{"source":33,"section":92},"2.1",{"min":5,"max":5},{"id":95,"disease":96,"label":97,"population":100,"type":54,"unit":28,"dose":102,"refs":104,"durationDays":107},"breast","breast-cancer",{"fa":98,"en":99},"سرطان پستان — ۱۲۵۰ mg\u002Fm² روز ۱ و ۸ هر ۲۱ روز","Breast cancer — 1250 mg\u002Fm² on days 1 and 8 every 21 days",{"minAge":101},{"value":52,"unit":53},{"perM2PerDay":103,"dividedDoses":5},1250,[105],{"source":33,"section":106},"2.2",{"min":5,"max":5},[109],{"id":110,"severity":111,"text":112,"refs":115},"hyper","block",{"fa":113,"en":114},"حساسیت به جمسیتابین.","Hypersensitivity to gemcitabine.",[116],{"source":33,"section":117},"4",[119],{"text":120,"refs":123},{"fa":121,"en":122},"سمیت وابسته به برنامه (انفوزیون طولانی‌تر از ۶۰ دقیقه یا بیش از هفتگی سمیت بیشتر)؛ سرکوب مغز استخوان؛ واکنش پوستی شدید؛ سمیت ریوی؛ HUS؛ سمیت کبد؛ نشت مویرگی؛ PRES.","Schedule-dependent toxicity (infusion >60 min or more than weekly is more toxic); myelosuppression; severe skin reactions; pulmonary toxicity; HUS; hepatotoxicity; capillary leak; PRES.",[124],{"source":33,"section":125},"5",[],[],[],{"status":130,"reviewer":131,"date":131},"unverified",null,[133,140,143,146],{"regimen":45,"formulation":22,"input":134,"expect":138},{"ageYears":135,"weightKg":136,"heightCm":137},55,80,180,{"perDose":139},2000,{"regimen":69,"formulation":22,"input":141,"expect":142},{"ageYears":135,"weightKg":136,"heightCm":137},{"perDose":139},{"regimen":82,"formulation":22,"input":144,"expect":145},{"ageYears":135,"weightKg":136,"heightCm":137},{"perDose":139},{"regimen":95,"formulation":22,"input":147,"expect":148},{"ageYears":135,"weightKg":136,"heightCm":137},{"perDose":149},2500,[151],"L01BC05",{"status":153,"forms":154,"refs":211},"registered",[155,159,163,167,171,175,179,183,187,191,195,199,203,207],{"code":156,"en":157,"fa":158},"18664","GEMCITABINE 1G\u002F100ML VIAL","ویال جم‌سیتابین ۱ گرم \u002F ۱۰۰ میلی‌لیتر",{"code":160,"en":161,"fa":162},"21887","GEMCITABINE 1G\u002F10ML VIAL","ویال جم‌سیتابین ۱ گرم \u002F ۱۰ میلی‌لیتر",{"code":164,"en":165,"fa":166},"18665","GEMCITABINE 200MG\u002F20ML VIAL","ویال جم‌سیتابین ۲۰۰ میلی‌گرم \u002F ۲۰ میلی‌لیتر",{"code":168,"en":169,"fa":170},"21888","GEMCITABINE 200MG\u002F2ML VIAL","ویال جم‌سیتابین ۲۰۰ میلی‌گرم \u002F ۲ میلی‌لیتر",{"code":172,"en":173,"fa":174},"20488","GEMCITABINE 2G SOLUTION FOR INJ","فرآورده تزریقی جم‌سیتابین ۲ گرم",{"code":176,"en":177,"fa":178},"02135","GEMCITABINE HCl 1 G VIAL","ویال جم‌سیتابین هیدروکلراید ۱ گرم",{"code":180,"en":181,"fa":182},"02136","GEMCITABINE HCl 200MG VIAL","ویال جم‌سیتابین هیدروکلراید ۲۰۰ میلی‌گرم",{"code":184,"en":185,"fa":186},"52335","GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE PARENTERAL 10 mg\u002F1mL 100 mL","کنسانتره محلول تزریقی جم‌سیتابین هیدروکلراید ۱۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۱۰۰ میلی‌لیتر",{"code":188,"en":189,"fa":190},"52338","GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE PARENTERAL 100 mg\u002F1mL 10 mL","کنسانتره محلول تزریقی جم‌سیتابین هیدروکلراید ۱۰۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۱۰ میلی‌لیتر",{"code":192,"en":193,"fa":194},"52336","GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE PARENTERAL 100 mg\u002F1mL 2 mL","کنسانتره محلول تزریقی جم‌سیتابین هیدروکلراید ۱۰۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۲ میلی‌لیتر",{"code":196,"en":197,"fa":198},"52337","GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE PARENTERAL 10 mg\u002F1mL 20 mL","کنسانتره محلول تزریقی جم‌سیتابین هیدروکلراید ۱۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۲۰ میلی‌لیتر",{"code":200,"en":201,"fa":202},"50294","GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE PARENTERAL 38 mg\u002F1 mL 5.26 mL","کنسانتره محلول تزریقی جم‌سیتابین هیدروکلراید ۳۸ میلی‌گرم \u002F ۱ میلی‌لیتر ۵٫۲۶ میلی‌لیتر",{"code":204,"en":205,"fa":206},"50295","GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE PARENTERAL 38 mg\u002F1 mL 26.3 mL","کنسانتره محلول تزریقی جم‌سیتابین هیدروکلراید ۳۸ میلی‌گرم \u002F ۱ میلی‌لیتر ۲۶٫۳ میلی‌لیتر",{"code":208,"en":209,"fa":210},"50296","GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE PARENTERAL 38 mg\u002F1 mL 52.6 mL","کنسانتره محلول تزریقی جم‌سیتابین هیدروکلراید ۳۸ میلی‌گرم \u002F ۱ میلی‌لیتر ۵۲٫۶ میلی‌لیتر",[212],{"source":213,"section":214,"url":215},"darooyab-generic","G-1009\u002FGemcitabine","https:\u002F\u002Fwww.darooyab.ir\u002FG-1009\u002FGemcitabine",{"kind":217,"refs":218,"id":221},"ANDA",[219],{"source":33,"section":220},"SPL approval \u002F marketing category","ANDA202485",[223,226,230,234,237,240],{"kind":224,"url":225,"label":221},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=202485",{"kind":227,"url":228,"label":229},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=44bcc16c-341d-49e8-a1c6-95d084667aca","FDA Gemcitabine",{"kind":231,"url":232,"label":233},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa696019.html","Gemcitabine Injection",{"kind":231,"url":235,"label":236},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa625100.html","Gemcitabine Intravesical System",{"kind":238,"url":239,"label":151},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01BC05",{"kind":241,"url":215,"label":8},"darooyab",{"pregnancy":243,"lactation":252,"pediatric":260,"geriatric":269,"reproductive":278},{"level":244,"text":245,"quote":248,"refs":249},"avoid",{"fa":246,"en":247},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on animal data and its mechanism of action, Gemcitabine for Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] .",[250],{"source":33,"section":251},"8.1",{"level":244,"text":253,"quote":256,"refs":257},{"fa":254,"en":255},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Due to the potential for serious adverse reactions in breastfed infants from Gemcitabine for Injection, advise women not to breastfeed during treatment with Gemcitabine for Injection and for at least one week following the last dose.",[258],{"source":33,"section":259},"8.2",{"level":261,"text":262,"quote":265,"refs":266},"caution",{"fa":263,"en":264},"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 Gemcitabine for Injection have not been established in pediatric patients.",[267],{"source":33,"section":268},"8.4",{"level":270,"text":271,"quote":274,"refs":275},"ok",{"fa":272,"en":273},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","In clinical studies which enrolled 979 patients with various malignancies who received single agent Gemcitabine for Injection, no overall differences in safety were observed between patients aged 65 and older and younger patients, with the exception of a higher rate of Grade 3 or 4 thrombocytopenia in older patients …",[276],{"source":33,"section":277},"8.5",{"level":261,"text":279,"quote":282,"refs":283},{"fa":280,"en":281},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Gemcitabine for Injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )].",[284],{"source":33,"section":285},"8.3",1792444707430]