{ "id": "xifaxan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "XIFAXAN", "generic": "利福昔明", "aliases": [ "XIFAXAN", "rifaximin", "利福昔明", "昔发明", "xifaxan 200 mg", "xifaxan 550 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国：DailyMed 公开处方药标签（页面显示 2025-06-25 更新）。本页只建立所引文件的阅读入口，不从这一美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格或可替代性。", "dosageFormClass": "利福昔明口服片：200 mg、550 mg（美国公开标签所列；本页精确展示 200 mg、30 片瓶装及 550 mg、60 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004（DailyMed 标签所列美国初始批准年份）", "archiveSponsorText": "Salix Pharmaceuticals, Inc. / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "rifaximin generic tablet", "rifamycin antibiotic", "利福昔明仿制片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-xifaxan-rifaximin-tablet-200mg-30-bottle-ndc-65649-301-03", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面更新 2025-06-25", "en": "DailyMed page updated 25 Jun 2025" }, "dosageForm": { "zh": "XIFAXAN 利福昔明口服片", "en": "XIFAXAN rifaximin oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 65649-301-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；30 片瓶装（美国标签）", "en": "200 mg labelled per tablet; 30-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利福昔明", "en": "rifaximin" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "200 mg 每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "200 mg labelled per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸片；一面有 Sx 压印，另一面为空白", "en": "round, biconvex tablet; Sx debossed on one side and plain on the other" }, "imprint": "Sx", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xifaxan-rifaximin-tablet-550mg-60-bottle-ndc-65649-303-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面更新 2025-06-25", "en": "DailyMed page updated 25 Jun 2025" }, "dosageForm": { "zh": "XIFAXAN 利福昔明口服片", "en": "XIFAXAN rifaximin oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 65649-303-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 550 mg；60 片瓶装（美国标签）", "en": "550 mg labelled per tablet; 60-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利福昔明", "en": "rifaximin" }, "value": 550, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "550 mg 每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "550 mg labelled per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形、双凸片；一面有 rfx 压印，另一面为空白", "en": "oval, biconvex tablet; rfx debossed on one side and plain on the other" }, "imprint": "rfx", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1&type=img", "alt": "XIFAXAN 利福昔明 550 mg、60 片瓶装在美国 DailyMed 公开标签中的主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 页面更新 2025-06-25", "presentation": "XIFAXAN 550 mg、60 片瓶装主展示面（DailyMed 标签明确对应 NDC 65649-303-02）", "notice": "此为 DailyMed 标签中明确对应的美国 550 mg、60 片瓶装展示面，仅用于核对品牌、通用名、每片标示量、包装数量和来源；不用于鉴定真伪，也不证明其他规格、其他包装、其他市场、当前供应、原研身份或可替代性。", "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "XIFAXAN 说明书放大阅读：200 mg 与 550 mg 先是不同的准确产品身份，不是“换算几片”的答案", "en": "XIFAXAN label reading: 200 mg and 550 mg first identify different exact products, not a tablet-conversion answer" }, "summary": { "zh": "本模块以 Salix 的 DailyMed 美国公开标签为阅读入口，帮助核对 XIFAXAN、利福昔明、准确片剂、每片 mg、包装和目标市场。它不提供个人片数、疗程、替换、联用或停药方案。", "en": "This module uses Salix's U.S. DailyMed public label to check XIFAXAN, rifaximin, the exact tablet, milligrams per tablet, package and target market. It does not provide an individual's tablet count, course, substitution, combination or stopping plan." }, "checks": [ { "zh": "先分清 200 mg 圆片与 550 mg 椭圆片，以及手中实际药盒的用途。mg 是每一准确片剂的标示量；两种规格、瓶装数量、药片形状或同属抗菌药，都不是网页能据此推导“应吃几片”“能不能换”“能否补一片”或疗程的答案。", "en": "First distinguish the 200 mg round tablet from the 550 mg oval tablet and check the use on the actual pack. mg is the labelled amount in each exact tablet; the two strengths, bottle counts, shape or antibacterial class do not let a webpage derive a tablet count, substitution, make-up use or course." }, { "zh": "标签将 XIFAXAN 用于特定的细菌相关适应症，并明确其不适合用于全身性细菌感染。感冒等病毒性疾病、发热或便血性腹泻、症状持续或加重，都不能靠网页或旧药盒自行决定是否开始、重复、加量、停用或换用另一种抗菌药。", "en": "The label uses XIFAXAN for specific bacteria-related indications and says it is not suitable for systemic bacterial infections. A viral illness such as a cold, fever or bloody diarrhoea, or persistent/worsening symptoms cannot be used to self-decide whether to start, repeat, increase, stop or change to another antibacterial from a webpage or an old pack." }, { "zh": "标签提示严重肝功能受损及与 P-gp 抑制剂（如环孢素）同用需要谨慎。家中有肝病、移植/免疫相关药、抗感染药、草本、营养补充剂或多种慢病药时，应把每一盒实际包装和完整药单交给药师或开方团队；不要按“肠道药”“不怎么吸收”或名称相似自行叠加、轮换或替代。", "en": "The label calls for caution with severe hepatic impairment and concomitant P-gp inhibitors such as cyclosporine. With liver disease, transplant/immune medicines, anti-infectives, herbs, supplements or multiple chronic medicines at home, have a pharmacist or prescriber review every actual pack and the complete medicine list; do not self-combine, alternate or substitute based on “gut medicine,” limited absorption or a similar name." }, { "zh": "出现呼吸困难、面部/口唇/咽喉肿胀、严重或持续腹泻、便血、发热、明显腹痛、意识改变或其他急性严重不适，应及时使用当地紧急医疗或既有照护渠道；不要等待网页或自行尝试不同规格、不同抗菌药或剩余药。", "en": "With difficult breathing, face/lip/throat swelling, severe or persistent diarrhoea, bloody stool, fever, marked abdominal pain, altered consciousness or another acute serious concern, use local urgent or established care promptly; do not wait for a webpage or self-try another strength, antibacterial or leftovers." } ], "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利福昔明怎样起作用：标签描述其抑制细菌 DNA 依赖 RNA 聚合酶", "en": "How rifaximin works: the label describes inhibition of bacterial DNA-dependent RNA polymerase" }, "summary": { "zh": "标签将利福昔明描述为利福霉素 SV 衍生的半合成、非全身性抗菌药，并说明其通过抑制细菌 DNA 依赖 RNA 聚合酶发挥抗菌活性。这个机制用于理解标签，不能判断个人感染原因、是否需要抗菌药、是否存在耐药、应使用何种方案或能否与其他药同用。", "en": "The label describes rifaximin as a semisynthetic, nonsystemic antibacterial derived from rifamycin SV and says it acts by inhibiting bacterial DNA-dependent RNA polymerase. This mechanism helps read the label; it cannot determine an individual's cause of infection, need for an antibacterial, resistance, regimen or suitability with another medicine." }, "checks": [ { "zh": "“肠道内作用”“非全身性”或“RNA 聚合酶”不是自我诊断工具，也不说明任何腹泻、腹痛、肝病相关症状或旅行后不适都应使用此药。是否为细菌感染、哪一种病原体、是否需要其他检查或治疗，需要专业评估。", "en": "“Acts in the gut,” “nonsystemic” or “RNA polymerase” is not a self-diagnostic tool and does not mean every diarrhoea, abdominal pain, liver-related symptom or post-travel concern should use this medicine. Whether there is a bacterial infection, which pathogen is involved, and whether another test or treatment is needed require professional assessment." }, { "zh": "抗菌药机制不能授权把同一类、不同类或余下的抗菌药自行叠加、轮换、分半、缩短或延长疗程。名称相似、药盒颜色、每片 mg 或包装余量都不足以建立可替代性。", "en": "An antibacterial mechanism does not authorise self-combination, alternation, splitting, shortening or extension with a same-class, different-class or leftover antibacterial. Similar names, pack colour, milligrams per tablet or tablets remaining do not establish interchangeability." }, { "zh": "若症状恶化、持续，或出现发热、便血、过敏样症状、意识改变或其他急性问题，应优先使用当地医疗支持；机制页面不替代检验、处方审核或现场评估。", "en": "If symptoms worsen or persist, or there is fever, bloody stool, an allergy-like symptom, altered consciousness or another acute concern, prioritise local medical support; a mechanism page does not replace testing, prescription review or in-person assessment." } ], "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "XIFAXAN", "generic": "利福昔明", "dosageFormClass": "利福昔明口服片：200 mg、550 mg（美国公开标签所列；本页精确展示 200 mg、30 片瓶装及 550 mg、60 片瓶装）" }, "labelSource": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "XIFAXAN 是利福昔明口服片。所引标签列有 200 mg 和 550 mg 两种片剂；mg 是每一准确片剂的标示量，而不是网页能据此算出个人应吃几片、应使用多久或能否把两种规格互换的答案。该标签针对不同病情列出不同专业用药方案，因此先核对手中药盒、处方用途和当前标签比只看数字更重要。", "history": "所引 DailyMed 美国公开标签列示 Initial U.S. Approval: 2004、Salix Pharmaceuticals, Inc. 为包装方，并显示页面更新日期为 2025-06-25。标签将 XIFAXAN 定义为利福霉素类抗菌药，明确其不适合用于全身性细菌感染，并列有发热、便血性腹泻、肝功能严重受损及与 P-gp 抑制剂同用等需要专业判断的警示线索。来源日期和历史节点只定位所引文件，不能替代实际产品的现行说明书、诊断、处方或目标市场记录。", "sourceDocuments": [ { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "DailyMed 公开标签所列 New Drug Application 记录（本档案不另行断言具体申请号）", "approvalTimeline": [ { "date": "2004", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2004。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2004. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed: XIFAXAN rifaximin tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-06-25", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-06-25 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-06-25 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed: XIFAXAN rifaximin tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/xifaxan/", "en": "https://origindrug.com/en/drugs/xifaxan/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }