[{"data":1,"prerenderedAt":205},["ShallowReactive",2],{"drug-valganciclovir":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":77,"warnings":87,"renal":95,"monitoring":105,"interactions":106,"review":107,"examples":110,"atc":119,"iran":121,"usApproval":141,"links":147,"populations":163},"valganciclovir",1,{"fa":7,"en":8},"والگان‌سیکلوویر","Valganciclovir","anti-infectives",{"fa":11,"en":12},"ضدویروس CMV (خوراکی)","Oral anti-CMV antiviral",[14],{"name":15,"market":16},"Valcyte","US",[18,19,20],"valcyte","والسایت","والگانسیکلوویر",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"tab-450","tablet","oral","450 mg tablet",{"amount":28,"unit":29,"perUnit":24,"scored":30},450,"mg",false,[16],[33],{"source":34,"section":35},"fda-valcyte","3",[37,56],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":51,"durationDays":54},"ind","cmv-infection",{"fa":41,"en":42},"رتینیت CMV — القا ۹۰۰ mg دو بار در روز، ۲۱ روز","CMV retinitis — induction 900 mg twice daily for 21 days",{"minAge":44},{"value":45,"unit":46},18,"year","fixed",{"perDose":49,"dosesPerDay":50},900,2,[52],{"source":34,"section":53},"2.2",{"min":55,"max":55},21,{"id":57,"disease":39,"label":58,"population":61,"type":47,"unit":29,"dose":63,"refs":64,"notes":66},"maint",{"fa":59,"en":60},"رتینیت نگهدارنده یا پیشگیری در پیوند — ۹۰۰ mg یک بار در روز","Retinitis maintenance or transplant prevention — 900 mg once daily",{"minAge":62},{"value":45,"unit":46},{"perDose":49,"dosesPerDay":5},[65],{"source":34,"section":53},[67],{"text":68,"refs":71},{"fa":69,"en":70},"پیشگیری: ظرف ۱۰ روز پس از پیوند تا روز ۱۰۰ (قلب، کلیه-پانکراس) یا ۲۰۰ (کلیه). با غذا. کودک طبق الگوریتم BSA و ClCr برچسب.","Prevention: within 10 days of transplant until day 100 (heart, kidney-pancreas) or 200 (kidney). With food. Children per label BSA\u002FCrCl algorithm.",[72,73,75],{"source":34,"section":53},{"source":34,"section":74},"2.1",{"source":34,"section":76},"2.3",[78],{"id":79,"severity":80,"text":81,"refs":84},"hyper","block",{"fa":82,"en":83},"حساسیت به والگان‌سیکلوویر یا گان‌سیکلوویر.","Hypersensitivity to valganciclovir or ganciclovir.",[85],{"source":34,"section":86},"4",[88],{"text":89,"refs":92},{"fa":90,"en":91},"هشدار جعبه‌ای: سمیت خونی (نوتروپنی، کم‌خونی، ترومبوسیتوپنی)، کاهش باروری، سمیت جنینی و سرطان‌زایی.","Boxed warning: haematological toxicity, impaired fertility, fetal toxicity, mutagenesis and carcinogenesis.",[93],{"source":34,"section":94},"Boxed Warning",[96],{"egfrBelow":97,"severity":98,"text":99,"refs":102},60,"warn",{"fa":100,"en":101},"ClCr زیر ۶۰: کاهش دوز طبق جدول ۲؛ همودیالیز: توصیه دوز ندارد.","CrCl \u003C60: reduce per Table 2; haemodialysis: no recommendation.",[103],{"source":34,"section":104},"2.5",[],[],{"status":108,"reviewer":109,"date":109},"unverified",null,[111,116],{"regimen":38,"formulation":23,"input":112,"expect":115},{"ageYears":113,"weightKg":114},45,70,{"perDose":49,"tabletsPerDoseRounded":50},{"regimen":57,"formulation":23,"input":117,"expect":118},{"ageYears":113,"weightKg":114},{"perDose":49,"tabletsPerDoseRounded":50},[120],"J05AB14",{"status":122,"forms":123,"refs":136},"registered",[124,128,132],{"code":125,"en":126,"fa":127},"19085","VALGANCICLOVIR 250MG\u002F5ML SYRUP","شربت وال‌گان‌سیکلوویر ۲۵۰ میلی‌گرم \u002F ۵ میلی‌لیتر",{"code":129,"en":130,"fa":131},"04768","VALGANCICLOVIR 450MG TAB","قرص وال‌گان‌سیکلوویر ۴۵۰ میلی‌گرم",{"code":133,"en":134,"fa":135},"50776","VALGANCICLOVIR (AS HYDROCHLORIDE) POWDER, FOR SOLUTION ORAL 50 mg\u002F1mL 12 g","محلول خوراکی وال‌گان‌سیکلوویر (معادل هیدروکلراید) ۵۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۱۲ گرم",[137],{"source":138,"section":139,"url":140},"darooyab-generic","G-1212\u002FValganciclovir","https:\u002F\u002Fwww.darooyab.ir\u002FG-1212\u002FValganciclovir",{"kind":142,"refs":143,"id":146},"NDA",[144],{"source":34,"section":145},"SPL approval \u002F marketing category","NDA021304",[148,151,155,158,161],{"kind":149,"url":150,"label":146},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021304",{"kind":152,"url":153,"label":154},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=4c517a39-2ded-4c5a-8d56-276853414b31","FDA Valcyte",{"kind":156,"url":157,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa605021.html",{"kind":159,"url":160,"label":120},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AB14",{"kind":162,"url":140,"label":8},"darooyab",{"pregnancy":164,"lactation":172,"pediatric":180,"geriatric":189,"reproductive":197},{"level":165,"text":166,"quote":169,"refs":170},"avoid",{"fa":167,"en":168},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Fetal Toxicity: Based on animal data, VALCYTE has the potential to cause birth defects in humans [see Warnings and Precautions (5.4) ].",[171],{"source":34,"section":94},{"level":165,"text":173,"quote":176,"refs":177},{"fa":174,"en":175},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Advise nursing mothers that breastfeeding is not recommended during treatment with VALCYTE because of the potential for serious adverse events in nursing infants and because of the potential for transmission of HIV [see Boxed Warning , Warnings and Precautions (5.1 , 5.3 , 5.4 , 5.5) , Nonclinical Toxicology (13.1) ] .",[178],{"source":34,"section":179},"8.2",{"level":181,"text":182,"quote":185,"refs":186},"caution",{"fa":183,"en":184},"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 VALCYTE for oral solution and tablets have not been established in children for prevention of CMV disease in pediatric liver transplant patients, in kidney transplant patients less than 4 months of age, in heart transplant patients less than 1 month of age, in pediatric AIDS patients with …",[187],{"source":34,"section":188},"8.4",{"level":181,"text":190,"quote":193,"refs":194},{"fa":191,"en":192},"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.","In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.",[195],{"source":34,"section":196},"8.5",{"level":181,"text":198,"quote":201,"refs":202},{"fa":199,"en":200},"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 Females Because of the mutagenic and teratogenic potential of VALCYTE, females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment with VALCYTE [see Dosage and Administration (2.6) , Warnings and Precautions (5.4 , 5.5) …",[203],{"source":34,"section":204},"8.3",1792191571744]