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Better tolerated with food.",[63,65],{"source":33,"section":64},"2.2",{"source":33,"section":66},"2.1",{"id":68,"disease":38,"label":69,"population":72,"type":76,"unit":29,"dose":77,"refs":92,"durationDays":94,"notes":95},"treat-child",{"fa":70,"en":71},"درمان — ۱ تا ۱۲ سال: بر اساس وزن، دو بار در روز","Treatment — 1 to 12 years: by weight, twice daily",{"minAge":73,"maxAge":74},{"value":5,"unit":47},{"value":75,"unit":47},13,"weightBand",{"weightBands":78},[79,83,86,89],{"minWeightKg":80,"maxWeightKg":81,"perDose":82,"dosesPerDay":44},0,15,30,{"minWeightKg":81,"maxWeightKg":84,"perDose":85,"dosesPerDay":44},23,45,{"minWeightKg":84,"maxWeightKg":87,"perDose":88,"dosesPerDay":44},40,60,{"minWeightKg":87,"maxWeightKg":90,"perDose":91,"dosesPerDay":44},null,75,[93],{"source":33,"section":54},{"min":56,"max":56},[96],{"text":97,"refs":98},{"fa":60,"en":61},[99,100],{"source":33,"section":64},{"source":33,"section":66},{"id":102,"disease":38,"label":103,"population":106,"type":108,"unit":29,"dose":109,"refs":110,"durationDays":112,"notes":113},"treat-13plus",{"fa":104,"en":105},"درمان — ۱۳ سال و بزرگسال: ۷۵ mg دو بار در روز","Treatment — 13 years and adults: 75 mg twice daily",{"minAge":107},{"value":75,"unit":47},"fixed",{"perDose":91,"dosesPerDay":44},[111],{"source":33,"section":64},{"min":56,"max":56},[114],{"text":115,"refs":116},{"fa":60,"en":61},[117,118],{"source":33,"section":64},{"source":33,"section":66},{"id":120,"disease":121,"label":122,"population":125,"type":76,"unit":29,"dose":128,"refs":134,"durationDays":138,"notes":140},"proph-child","influenza-prophylaxis",{"fa":123,"en":124},"پیشگیری — ۱ تا ۱۲ سال: بر اساس وزن، یک‌بار در روز","Prophylaxis — 1 to 12 years: by weight, once daily",{"minAge":126,"maxAge":127},{"value":5,"unit":47},{"value":75,"unit":47},{"weightBands":129},[130,131,132,133],{"minWeightKg":80,"maxWeightKg":81,"perDose":82,"dosesPerDay":5},{"minWeightKg":81,"maxWeightKg":84,"perDose":85,"dosesPerDay":5},{"minWeightKg":84,"maxWeightKg":87,"perDose":88,"dosesPerDay":5},{"minWeightKg":87,"maxWeightKg":90,"perDose":91,"dosesPerDay":5},[135,136],{"source":33,"section":54},{"source":33,"section":137},"2.3",{"min":139,"max":139},10,[141],{"text":142,"refs":145},{"fa":143,"en":144},"ظرف ۴۸ ساعت پس از تماس نزدیک؛ ۱۰ روز. در شیوع جامعه تا ۶ هفته.","Within 48 h of close contact; 10 days. During a community outbreak up to 6 weeks.",[146],{"source":33,"section":137},{"id":148,"disease":121,"label":149,"population":152,"type":108,"unit":29,"dose":154,"refs":155,"durationDays":157},"proph-13plus",{"fa":150,"en":151},"پیشگیری — ۱۳ سال و بزرگسال: ۷۵ mg یک‌بار در روز","Prophylaxis — 13 years and adults: 75 mg once daily",{"minAge":153},{"value":75,"unit":47},{"perDose":91,"dosesPerDay":5},[156],{"source":33,"section":137},{"min":139,"max":158},42,[160],{"id":161,"severity":162,"text":163,"refs":166},"hypersensitivity","block",{"fa":164,"en":165},"حساسیت جدی شناخته‌شده به اسلتامیویر.","Known serious hypersensitivity to oseltamivir.",[167],{"source":33,"section":168},"4",[170,177],{"text":171,"refs":174},{"fa":172,"en":173},"واکنش‌های جدی پوستی\u002Fحساسیتی","Serious skin\u002Fhypersensitivity reactions",[175],{"source":33,"section":176},"5.1",{"text":178,"refs":181},{"fa":179,"en":180},"رویدادهای عصبی‌روانی (به‌ویژه کودکان)؛ بیمار پایش شود.","Neuropsychiatric events; monitor the patient.",[182],{"source":33,"section":183},"5.2",[185],{"egfrBelow":88,"severity":186,"text":187,"refs":190},"warn",{"fa":188,"en":189},"کلیرانس ۶۰ یا کمتر: کاهش دوز طبق جدول ۲ (بزرگسالان).","CrCl ≤60 mL\u002Fmin: reduce dose per Table 2 (adults).",[191],{"source":33,"section":192},"2.4",[],[],{"status":196,"reviewer":90,"date":90},"unverified",[198,202,205,209,213,217,221,224],{"regimen":37,"formulation":23,"input":199,"expect":200},{"ageMonths":28,"weightKg":28},{"perDose":201,"mlPerDose":50},18,{"regimen":68,"formulation":23,"input":203,"expect":204},{"ageYears":44,"weightKg":51},{"perDose":82,"mlPerDose":56},{"regimen":68,"formulation":23,"input":206,"expect":207},{"ageYears":56,"weightKg":201},{"perDose":85,"mlPerDose":208},7.5,{"regimen":68,"formulation":23,"input":210,"expect":212},{"ageYears":211,"weightKg":82},8,{"perDose":88,"mlPerDose":139},{"regimen":68,"formulation":23,"input":214,"expect":215},{"ageYears":51,"weightKg":85},{"perDose":91,"mlPerDose":216},12.5,{"regimen":102,"formulation":23,"input":218,"expect":220},{"ageYears":82,"weightKg":219},70,{"perDose":91},{"regimen":120,"formulation":23,"input":222,"expect":223},{"ageYears":56,"weightKg":201},{"perDose":85,"perDay":85},{"regimen":148,"formulation":23,"input":225,"expect":226},{"ageYears":82,"weightKg":219},{"perDose":91},[228],"J05AH02",{"status":230,"forms":231,"refs":264},"registered",[232,236,240,244,248,252,256,260],{"code":233,"en":234,"fa":235},"17745","OSELTAMIVIR 30MG CAP","کپسول اسلتامیویر ۳۰ میلی‌گرم",{"code":237,"en":238,"fa":239},"17746","OSELTAMIVIR 45MG CAP","کپسول اسلتامیویر ۴۵ میلی‌گرم",{"code":241,"en":242,"fa":243},"21674","OSELTAMIVIR 60MG\u002F5ML POWDER FOR SUSP","پودر برای تهیه سوسپانسیون خوراکی اسلتامیویر ۶۰ میلی‌گرم \u002F ۵ میلی‌لیتر",{"code":245,"en":246,"fa":247},"07721","OSELTAMIVIR 60MG\u002F5ML SYRUP","شربت اسلتامیویر ۶۰ میلی‌گرم \u002F ۵ میلی‌لیتر",{"code":249,"en":250,"fa":251},"05437","OSELTAMIVIR 75MG CAP","کپسول اسلتامیویر ۷۵ میلی‌گرم",{"code":253,"en":254,"fa":255},"50332","OSELTAMIVIR (AS PHOSPHATE) POWDER, FOR SOLUTION ORAL 30 mg\u002F5mL 100 mL","محلول خوراکی اسلتامیویر (معادل فسفات) ۳۰ میلی‌گرم \u002F ۵ میلی‌لیتر ۱۰۰ میلی‌لیتر",{"code":257,"en":258,"fa":259},"52806","OSELTAMIVIR (AS PHOSPHATE) POWDER, FOR SOLUTION ORAL 30 mg\u002F5mL 60 mL","محلول خوراکی اسلتامیویر (معادل فسفات) ۳۰ میلی‌گرم \u002F ۵ میلی‌لیتر ۶۰ میلی‌لیتر",{"code":261,"en":262,"fa":263},"51520","OSELTAMIVIR (AS PHOSPHATE) POWDER, FOR SUSPENSION ORAL 60 mg\u002F5mL 75 mL","سوسپانسیون خوراکی اسلتامیویر (معادل فسفات) ۶۰ میلی‌گرم \u002F ۵ میلی‌لیتر ۷۵ میلی‌لیتر",[265],{"source":266,"section":267,"url":268},"darooyab-generic","G-1192\u002FOseltamivir","https:\u002F\u002Fwww.darooyab.ir\u002FG-1192\u002FOseltamivir",[270,274,278,281,284],{"kind":271,"url":272,"label":273},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=208823","ANDA208823",{"kind":275,"url":276,"label":277},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=82df3237-636b-7bf9-3ba0-2b476e74bf4c","FDA Oseltamivir susp",{"kind":279,"url":280,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa699040.html",{"kind":282,"url":283,"label":228},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AH02",{"kind":285,"url":268,"label":8},"darooyab",{"pregnancy":287,"lactation":296,"pediatric":304,"geriatric":312},{"level":288,"text":289,"quote":292,"refs":293},"caution",{"fa":290,"en":291},"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 oseltamivir phosphate for oral suspension in pregnant women to inform a drug‐associated risk of adverse developmental outcomes.",[294],{"source":33,"section":295},"8.1",{"level":288,"text":297,"quote":300,"refs":301},{"fa":298,"en":299},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Based on limited published data, oseltamivir and oseltamivir carboxylate have been shown to be present in human milk at low levels considered unlikely to lead to toxicity in the breastfed infant.",[302],{"source":33,"section":303},"8.2",{"level":288,"text":305,"quote":308,"refs":309},{"fa":306,"en":307},"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.","Treatment of Influenza The safety and efficacy of oseltamivir phosphate for the treatment of influenza in pediatric patients 2 weeks old to 17 years of age has been established [see Dosage and Administration ( 2.2 ), Clinical Pharmacology (12.3), and Clinical Studies ( 14.1 )] and is based on: 13 to 17 years of age: …",[310],{"source":33,"section":311},"8.4",{"level":313,"text":314,"quote":317,"refs":318},"ok",{"fa":315,"en":316},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","… tients at least 65 years old, that enrolled 741 subjects (374 received placebo and 362 received oseltamivir phosphate), no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses …",[319],{"source":33,"section":320},"8.5",{"kind":322,"refs":323,"id":273},"ANDA",[324],{"source":33,"section":325},"SPL approval \u002F marketing category",1792440732845]