[{"data":1,"prerenderedAt":140},["ShallowReactive",2],{"drug-bcg-vaccine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":35,"contraindications":56,"warnings":66,"renal":73,"monitoring":74,"interactions":75,"review":76,"examples":79,"atc":80,"iran":82,"usApproval":89,"links":95,"populations":106},"bcg-vaccine",1,{"fa":7,"en":8},"واکسن ب‌ث‌ژ (BCG)","BCG vaccine","anti-infectives",{"fa":11,"en":12},"واکسن زنده ضعیف‌شده","Live attenuated vaccine",[14],{"name":15,"market":16},"BCG Vaccine (Tice)","US",[18,19,20,21],"BCG","ب ث ژ","واکسن سل","بی سی جی",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":30,"refs":31},"vial","powder-for-injection","percutaneous","Lyophilised vial (percutaneous use with multiple-puncture device)",{"amount":5,"unit":29,"perUnit":29},"application",[16],[32],{"source":33,"section":34},"fda-bcg-vaccine","How Supplied",[36],{"id":37,"disease":38,"label":39,"population":42,"type":43,"unit":44,"dose":45,"refs":49},"std","tuberculosis",{"fa":40,"en":41},"پیشگیری از سل — فرآورده آمریکایی Tice با دستگاه چندسوزنی (پوستی)","TB prevention — US Tice product, percutaneous multiple-puncture device",{},"notCalculated","mg",{"reason":46},{"fa":47,"en":48},"این فرآورده آمریکایی فقط از راه پوستی با دستگاه چندسوزنی زده می‌شود و داخل جلدی، زیرجلدی یا عضلانی نیست؛ با واکسن داخل‌جلدی ب‌ث‌ژ برنامه کشوری ایران فرق دارد — برای آن دستورالعمل وزارت بهداشت را دنبال کنید. ویال با ۱ mL آب استریل؛ شیرخوار زیر ۱ ماه نصف دوز (با ۲ mL آب). فقط افراد منفی به تست توبرکولین.","This US product is given only percutaneously with a multiple-puncture device — NOT intradermal, SC or IM; it differs from the intradermal BCG used in Iran’s national schedule (follow Ministry of Health guidance for that). Reconstitute with 1 mL sterile water; infants \u003C1 month half dose (2 mL water). Tuberculin-negative persons only.",[50,52,54],{"source":33,"section":51},"Dosage and Administration",{"source":33,"section":53},"Warnings",{"source":33,"section":55},"Indications and Usage",[57],{"id":58,"severity":59,"text":60,"refs":63},"immuno","block",{"fa":61,"en":62},"نقص ایمنی (HIV، نقص مادرزادی، لوسمی، لنفوم، بدخیمی گسترده) یا سرکوب ایمنی با استروئید، داروهای آلکیله‌کننده، آنتی‌متابولیت یا پرتو؛ بارداری.","Impaired immunity (HIV, congenital immunodeficiency, leukaemia, lymphoma, generalised malignancy) or suppression by steroids, alkylating agents, antimetabolites or radiation; pregnancy.",[64],{"source":33,"section":65},"Contraindications",[67],{"text":68,"refs":71},{"fa":69,"en":70},"لنفادنوپاتی و زخم محل؛ عفونت منتشر BCG در نقص ایمنی؛ هرگز وریدی، زیرجلدی، عضلانی یا داخل جلدی (این فرآورده).","Lymphadenopathy and local ulceration; disseminated BCG infection in immunodeficiency; never IV, SC, IM or intradermal (this product).",[72],{"source":33,"section":53},[],[],[],{"status":77,"reviewer":78,"date":78},"unverified",null,[],[81],"J07AN01",{"status":83,"refs":84},"not-found",[85],{"source":86,"section":87,"url":88},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=BCG%20vaccine",{"kind":90,"refs":91,"id":94},"BLA",[92],{"source":33,"section":93},"SPL approval \u002F marketing category","BLA103050",[96,99,103],{"kind":97,"url":98,"label":94},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103050",{"kind":100,"url":101,"label":102},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=a83f0b99-9038-4c5a-aaac-8792b32838fe","FDA BCG vaccine",{"kind":104,"url":105,"label":81},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J07AN01",{"pregnancy":107,"lactation":116,"pediatric":124,"geriatric":132},{"level":108,"text":109,"quote":112,"refs":113},"caution",{"fa":110,"en":111},"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.","Animal reproduction studies have not been conducted with BCG VACCINE.",[114],{"source":33,"section":115},"Pregnancy",{"level":108,"text":117,"quote":120,"refs":121},{"fa":118,"en":119},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from BCG in nursing infants, a decision should be made whether to discontinue nursing or not to vaccinate, taking into account the importance of tuberculosis vaccination to the mother.",[122],{"source":33,"section":123},"Nursing Mothers",{"level":108,"text":125,"quote":128,"refs":129},{"fa":126,"en":127},"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.","See Treatment and Schedule under DOSAGE AND ADMINISTRATION section.",[130],{"source":33,"section":131},"Pediatric Use",{"level":108,"text":133,"quote":136,"refs":137},{"fa":134,"en":135},"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 BCG VACCINE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.",[138],{"source":33,"section":139},"Geriatric Use",1792156164028]