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Do not give tablets at 11 years or younger (one tablet exceeds the dose).",[85,86],{"source":33,"section":74},{"source":33,"section":87},"2.1",{"id":89,"disease":90,"label":91,"population":94,"type":56,"unit":28,"dose":96,"refs":106,"durationDays":109,"notes":110},"crypto","cryptosporidiosis",{"fa":92,"en":93},"اسهال کریپتوسپوریدیومی","Cryptosporidium diarrhea",{"minAge":95},{"value":5,"unit":55},{"bands":97},[98,101,104],{"minAge":99,"maxAge":100,"perDose":27,"dosesPerDay":63},{"value":5,"unit":55},{"value":62,"unit":55},{"minAge":102,"maxAge":103,"perDose":68,"dosesPerDay":63},{"value":62,"unit":55},{"value":67,"unit":55},{"minAge":105,"maxAge":71,"perDose":40,"dosesPerDay":63},{"value":67,"unit":55},[107,108],{"source":33,"section":74},{"source":33,"section":76},{"min":78,"max":78},[111,116],{"text":112,"refs":113},{"fa":82,"en":83},[114,115],{"source":33,"section":74},{"source":33,"section":87},{"text":117,"refs":120},{"fa":118,"en":119},"در بیماران HIV مثبت یا دچار نقص ایمنی اثربخشی برای کریپتوسپوریدیوم نشان داده نشده است.","Not shown effective for Cryptosporidium in HIV-infected or immunodeficient patients.",[121],{"source":33,"section":76},[123],{"id":124,"severity":125,"text":126,"refs":129},"hypersensitivity","block",{"fa":127,"en":128},"حساسیت قبلی به نیتازوکسانید یا اجزای فرآورده.","Prior hypersensitivity to nitazoxanide or any ingredient.",[130],{"source":33,"section":131},"4.1",[],[],[],[],{"status":137,"reviewer":71,"date":71},"unverified",[139,142,148,153,157],{"regimen":48,"formulation":22,"input":140,"expect":141},{"ageYears":63,"weightKg":67},{"perDose":27,"mlPerDose":29},{"regimen":48,"formulation":22,"input":143,"expect":146},{"ageYears":144,"weightKg":145},6,20,{"perDose":68,"mlPerDose":147},10,{"regimen":89,"formulation":36,"input":149,"expect":152},{"ageYears":150,"weightKg":151},14,50,{"tabletsPerDoseRounded":5},{"regimen":48,"formulation":36,"input":154,"expect":155},{"ageYears":144,"weightKg":145},{"status":156},"blocked",{"regimen":48,"formulation":22,"input":158,"expect":160},{"ageMonths":159,"weightKg":159},8,{"status":156},[162],"P01AX11",{"status":164,"refs":165},"not-found",[166],{"source":167,"section":168,"url":169},"darooyab-generic","G-1139\u002FNitazoxanide","https:\u002F\u002Fwww.darooyab.ir\u002FG-1139\u002FNitazoxanide",[171,175,179,182,185],{"kind":172,"url":173,"label":174},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021498","NDA021498",{"kind":176,"url":177,"label":178},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=e90f98d9-3c9b-4e75-ba18-5517283eadf0","FDA Alinia",{"kind":180,"url":181,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa603017.html",{"kind":183,"url":184,"label":162},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=P01AX11",{"kind":186,"url":169,"label":8},"darooyab",{"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 There are no data with ALINIA in pregnant women to inform a drug-associated risk.",[195],{"source":33,"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 No information regarding the presence of nitazoxanide in human milk, the effects on the breastfed infant, or the effects on milk production is available.",[203],{"source":33,"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.","The safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with ALINIA for Oral Suspension 100 mg\u002F5 mL.",[211],{"source":33,"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.","Clinical studies of ALINIA Tablets and ALINIA for Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.",[219],{"source":33,"section":220},"8.5",{"kind":222,"refs":223,"id":174},"NDA",[224],{"source":33,"section":225},"SPL approval \u002F marketing category",1792191881425]