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100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 7.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 7-1/2（一面）；另一面空白", "en": "COUMADIN / 7-1/2 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-tablet-10mg-ndc-0056-0174-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0174-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 10 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 10 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色（无色素）", "en": "white (dye-free)" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 10（一面）；另一面空白", "en": "COUMADIN / 10 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-injection-5mg-vial-carton6-ndc-0590-0324-35", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠静脉注射用冻干粉（历史标签）", "en": "warfarin sodium lyophilized powder for intravenous injection (historical label)" }, "route": { "zh": "静脉注射（仅作标签身份字段）", "en": "intravenous injection (label identity only)" }, "routeCodes": [ "intravenous" ], "productCode": "NDC 0590-0324-35", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_vial", "primaryDisplay": { "zh": "每瓶华法林钠 5 mg；6 瓶纸盒（历史标签文字）", "en": "Warfarin sodium 5 mg per vial; carton of 6 vials (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 5, "unit": "mg", "basisCode": "per_vial", "basisLabel": { "zh": "每瓶历史标签标示量；不是个人注射量、复溶、给药速度、调整或转换指令", "en": "historical labelled amount per vial; not an individual injection amount, reconstitution, administration-rate, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "vial_carton", "typeLabel": { "zh": "小瓶纸盒", "en": "vial carton" }, "fill": null, "countPerPackage": 6, "countUnit": { "zh": "瓶/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 6, "unit": { "zh": "瓶/盒", "en": "vials per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "小瓶（历史标签文字）", "en": "vial (historical label text)" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；静脉注射用制剂包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验到再包装历史标签，故不展示为原品牌包装", "en": "A repackaged historical label was located, so it is not shown as an original-brand package" }, "summary": { "zh": "DailyMed 可检索到的 COUMADIN 历史记录标示为再包装标签。它可用于追溯商品名、华法林钠、1 mg、90 片和历史 NDC 54868-2128-3，却不能作为本页的准确原品牌包装图。为避免把再包装标签误读为原品牌外观，本档案不展示该图，只保留公开标签作为文字核验入口。", "en": "The searchable historical DailyMed COUMADIN record is identified as repackaged. It can trace the trade name, warfarin sodium, 1 mg, 90 tablets and historical NDC 54868-2128-3, but cannot be presented as this record's exact original-brand package image. To avoid treating a repackaged label as original-brand appearance, this dossier withholds the image and retains the public label as a text-verification entry." }, "source": { "id": "src_a59adb986c93b6ac", "label": "DailyMed（NLM）：COUMADIN 再包装历史标签说明", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=91fa852c-b43d-4a55-983b-74aa6827125d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "COUMADIN 说明书放大阅读：mg、INR 与完整药单要一起看", "en": "COUMADIN label reading: mg, INR and the full medicine list belong together" }, "summary": { "zh": "本模块只解释 FDA 2015 美国标签档案中的产品识别和风险阅读线索。它不推算华法林剂量、INR 目标、漏服处理、饮食调整或转换方案。", "en": "This module explains product-identity and risk-reading clues in the 2015 U.S. FDA label archive only. It does not calculate warfarin dosage, INR targets, missed-dose handling, diet changes or conversion plans." }, "checks": [ { "zh": "该美国标签列出 1、2、2.5、3、4、5、6、7.5、10 mg 等不同刻痕片剂强度，以及注射用制剂。mg 是具体产品单位的身份线索，不是个人每天应服几片的答案，也不能只按颜色、刻痕或数字自行调节。", "en": "This U.S. label lists scored tablet strengths including 1, 2, 2.5, 3, 4, 5, 6, 7.5 and 10 mg, as well as an injectable presentation. mg identifies a specific product unit; it is not an answer to a person's daily tablet count and cannot be self-adjusted from colour, score marks or a number alone." }, { "zh": "标签将 INR 监测作为治疗中的重要信息，并说明药物、饮食改变和其他因素会影响 INR。任何新的处方药、非处方药、草本/保健品、抗菌药或饮食显著变化，都应按负责团队的既定流程复核，不要因网页或他人经验自行改量。", "en": "The label identifies INR monitoring as important and notes that medicines, dietary changes and other factors can affect INR. Any new prescription, OTC product, herb/supplement, antibiotic or major diet change should be reviewed through the responsible team's established process, not self-adjusted from a webpage or someone else's experience." }, { "zh": "标签提到基因型信息可为初始剂量选择提供信息，但这不表示每个人都应自行做“全基因筛查”，更不表示可据报告自行开始、停止或改变抗凝药。基因结果如已存在，应与完整病史、监测记录和全部用药由专业人员解释。", "en": "The label says genotype information can inform initial dose selection, but that does not mean everyone should independently obtain broad genetic screening or use a report to start, stop or change an anticoagulant. If a result already exists, a professional should interpret it with the full history, monitoring record and medicine list." }, { "zh": "异常出血、黑便、呕血、跌倒或头部受伤、计划手术/牙科操作等情况不适合只依靠网页处理；应尽快联系当地负责团队或紧急医疗服务。", "en": "Unexpected bleeding, black stools, vomiting blood, a fall or head injury, or a planned surgical/dental procedure are not situations to manage from a webpage alone; contact the responsible local team or emergency medical services promptly." } ], "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（NDA 009218）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "华法林怎样起作用：它影响维生素 K 依赖性凝血因子的合成", "en": "How warfarin works: it affects synthesis of vitamin K-dependent clotting factors" }, "summary": { "zh": "FDA 公开标签说明华法林会影响维生素 K 依赖性凝血因子 II、VII、IX、X，以及抗凝蛋白 C 和 S 的合成；标签认为其与抑制 VKORC1 酶复合体有关。这解释了为什么监测、药物清单和饮食变化需要一起讨论，但不推导个人剂量、INR 目标、饮食调整或转换方案。", "en": "The FDA public label explains that warfarin affects synthesis of vitamin K-dependent clotting factors II, VII, IX and X, as well as anticoagulant proteins C and S; it describes interference with the VKORC1 enzyme complex. This helps explain why monitoring, the medicine list and dietary changes need to be discussed together, but it does not derive an individual's dose, INR target, diet adjustment or conversion plan." }, "checks": [ { "zh": "这条机制不代表“少吃或多吃某种食物”即可自行校正。任何明显饮食变化、抗菌药、草本/保健品、非处方药或新的处方药，都应按负责团队的既定 INR 监测流程复核。", "en": "This mechanism does not mean that eating less or more of one food can be used for self-correction. Any meaningful dietary change, antibiotic, herb/supplement, OTC product or new prescription needs review through the responsible team's established INR-monitoring process." }, { "zh": "“影响维生素 K 通路”不是广泛基因筛查或自行按基因报告改量的理由。标签中的基因组信息只应由专业人员与病史、监测结果和完整药单共同解释。", "en": "“Affecting the vitamin K pathway” is not a reason for broad genetic screening or self-adjustment from a genetic report. Genomic information in the label should be interpreted by a professional together with history, monitoring results and the complete medicine list." }, { "zh": "机制不能决定是否与其他抗凝/抗血小板药同用、漏服后如何处理或何时停药。异常出血、黑便、呕血、跌倒或头部受伤，应联系当地负责团队或紧急医疗服务。", "en": "Mechanism cannot decide whether to use another anticoagulant or antiplatelet medicine together, how to handle missed use or when to interrupt treatment. For unexpected bleeding, black stools, vomiting blood, a fall or head injury, contact the responsible local team or emergency medical services." } ], "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Coumadin", "generic": "华法林钠", "dosageFormClass": "多种剂型（口服片剂及静脉注射用制剂；FDA 2015 历史标签所列；本页精确展示 9 个口服片 100 片瓶装身份及 1 个注射用 6 瓶纸盒身份）" }, "labelSource": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（NDA 009218）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（NDA 009218）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "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": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "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": [ { "id": "fda-pharmacogenomic-label-record-warfarin", "issuedAt": "2025-12", "status": "fda_pharmacogenomic_label_record", "title": { "zh": "FDA 药物基因组标签记录：warfarin 与 CYP2C9 / VKORC1", "en": "FDA pharmacogenomic label record: warfarin and CYP2C9 / VKORC1" }, "summary": { "zh": "FDA 的药物基因组标签表将 warfarin（Coumadin）列入与 CYP2C9 / VKORC1 相关的标签信息项目。该表是美国监管机构对标签中基因组信息位置的索引，不等于每位使用者都需要筛查、已检测者就应自行改剂量，或可自行换成另一种药。是否检测、怎样解释结果及与其他药同用的问题，必须连同准确产品、适应症、现行标签和完整用药清单由开方团队或药师核对。", "en": "FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling lists warfarin (Coumadin) with CYP2C9 / VKORC1-related labeling information. The table is a U.S. regulator index to where genomic information appears in labeling; it does not mean every user needs screening, that a tested person should self-change a dose, or that another medicine may be substituted independently. Whether to test, how to interpret a result and how it relates to other medicines must be reviewed with the exact product, indication, current label and complete medicine list by the prescribing team or pharmacist." }, "source": { "id": "src_9f4d37bf0406cd2b", "label": "FDA：药品标签中的药物基因组生物标志物表", "url": "https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "pharmacogenomic_label_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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": "FDA 的 COUMADIN（warfarin sodium）2015 美国标签档案列有口服片剂和静脉用制剂，并列出美国初始批准年份为 1954。为防止把颜色、刻痕、mg、每瓶标示量或注射剂混在一起，本页分别建立该历史标签中 1、2、2.5、3、4、5、6、7.5、10 mg 九种口服单刻痕片的 100 片瓶装身份，以及 5 mg、6 瓶纸盒的独立静脉注射用制剂身份；它们不提供个人片数、个人注射量、INR 调整、漏服、饮食改变、转换或停药方案。该标签包含出血风险的加框警告和 INR 监测信息；本页只帮助读者回到一手文件，不能据此生成个人抗凝方案。", "history": "FDA 的 2015 文件明确提示其可能不是最新获批标签。其口服片为单刻痕：一面带 COUMADIN 与数字、另一面空白；该外观事实只帮助阅读历史标签，刻痕本身不等于可以自行掰开、减量或改变产品。抗凝药的产品身份、监测安排、相互作用和围手术期处理都不能只按药名或照片判断。任何转换、漏服、停用或联用问题须回到所在市场的当前标签与负责团队。", "sourceDocuments": [ { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（NDA 009218）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 009218", "approvalTimeline": [ { "date": "1954", "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: 1954。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: 1954. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_acac1255f20ea439", "label": "FDA: COUMADIN label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2015-10", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2015-10 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 2015-10 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_acac1255f20ea439", "label": "FDA: COUMADIN label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "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": [ { "target": { "id": "tylenol-extra-strength", "brand": "Tylenol Extra Strength", "generic": "对乙酰氨基酚", "canonicalUrls": { "zh": "https://origindrug.com/drugs/tylenol-extra-strength/", "en": "https://origindrug.com/en/drugs/tylenol-extra-strength/" } }, "title": { "zh": "与 TYLENOL Extra Strength 同在药单上时：止痛退热药也要先核对", "en": "When TYLENOL Extra Strength is on the same list: an analgesic or fever medicine also needs review first" }, "summary": { "zh": "TYLENOL Extra Strength 的美国公开 Drug Facts 提示，正在使用华法林时应先咨询医生或药师。本卡片只提示把实际 TYLENOL 包装、华法林包装、其他止痛/感冒药、处方药、非处方药和补充剂交给负责团队核对；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. public Drug Facts for TYLENOL Extra Strength says to ask a doctor or pharmacist before use when taking warfarin. This card only signals that the actual TYLENOL pack, warfarin pack, other pain/cold products, prescription medicines, OTC products and supplements need review by the responsible team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "advil-tablets", "brand": "Advil", "generic": "布洛芬", "canonicalUrls": { "zh": "https://origindrug.com/drugs/advil-tablets/", "en": "https://origindrug.com/en/drugs/advil-tablets/" } }, "title": { "zh": "与 ADVIL／布洛芬同在药单上时：抗凝药提示应先核对完整药单", "en": "When ADVIL / ibuprofen is on the same list: an anticoagulant calls for a complete medicine-list review first" }, "summary": { "zh": "ADVIL 当前美国公开 Drug Facts 将正在使用抗凝药列为胃出血警示中需要留意的风险线索。本卡片只提示把实际 Advil 包装、华法林包装、其他止痛/感冒药、处方药、非处方药和补充剂交给负责团队核对；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. public Drug Facts for ADVIL lists use of a blood-thinning anticoagulant as a risk cue in its stomach-bleeding warning. This card only signals that the actual Advil pack, warfarin pack, other pain/cold products, prescription medicines, OTC products and supplements need review by the responsible team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "trulicity", "brand": "Trulicity", "generic": "度拉糖肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/trulicity/", "en": "https://origindrug.com/en/drugs/trulicity/" } }, "title": { "zh": "与 TRULICITY／度拉糖肽同在药单上时：治疗窗较窄的口服药先做完整核对", "en": "When TRULICITY / dulaglutide is on the same list: review a narrow-therapeutic-index oral medicine first" }, "summary": { "zh": "FDA 的 2025 TRULICITY 标签说明其可延缓胃排空，可能降低同用口服药的吸收速率；并明确将华法林列为治疗窗较窄、需要由专业人员监测药物水平的口服药示例。这张卡只提示把华法林、TRULICITY、所有实际药盒、非处方药和补充剂交给药师或开方团队核对；它不提供个人监测目标、给药间隔或调整方案，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The FDA's 2025 TRULICITY label says it delays gastric emptying and may reduce the rate of absorption of concomitant oral medicines; it names warfarin as an example of an oral medicine with a narrow therapeutic index for which professionals monitor drug levels. This card only signals that warfarin, TRULICITY, every actual pack, OTC product and supplement should be reviewed by a pharmacist or prescriber; it provides no individual monitoring target, timing interval or adjustment plan and does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025 美国处方信息（7.1 Oral Medications：华法林为治疗窗较窄口服药示例）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "bayer-low-dose-aspirin", "brand": "BAYER LOW DOSE ASPIRIN", "generic": "阿司匹林", "canonicalUrls": { "zh": "https://origindrug.com/drugs/bayer-low-dose-aspirin/", "en": "https://origindrug.com/en/drugs/bayer-low-dose-aspirin/" } }, "title": { "zh": "与 BAYER LOW DOSE ASPIRIN／阿司匹林 81 mg 同在药单上时：先核对完整药单", "en": "When BAYER LOW DOSE ASPIRIN / aspirin 81 mg is on the same list: review the complete medicine list first" }, "summary": { "zh": "BAYER LOW DOSE ASPIRIN 的当前美国公开 Drug Facts 将正在使用抗凝药列为胃出血警示中需要先核对的线索。本卡片只提示把实际阿司匹林包装、华法林包装、其他止痛/感冒药、处方药、非处方药、草本和补充剂交给药师或医生核对；它不判断任何人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。开始使用或其他变动同样需要先由药师或医生核对。", "en": "The current U.S. public Drug Facts for BAYER LOW DOSE ASPIRIN lists use of an anticoagulant as a cue that needs review in its stomach-bleeding warning. This card only signals that the actual aspirin pack, warfarin pack, other pain/cold products, prescriptions, OTC products, herbs and supplements need review by a pharmacist or clinician; it does not decide whether anyone can use them together or advise self-stopping, time-separation, replacement or adjustment of either medicine. Starting a medicine or making another change also needs pharmacist or clinician review." }, "source": { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 当前美国公开标签（Bayer HealthCare；SPL v8，抗凝药警示）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "amiodarone-cordarone", "brand": "CORDARONE", "generic": "胺碘酮", "canonicalUrls": { "zh": "https://origindrug.com/drugs/amiodarone-cordarone/", "en": "https://origindrug.com/en/drugs/amiodarone-cordarone/" } }, "title": { "zh": "与 CORDARONE／胺碘酮同在药单上时：这是需要专业监测的高风险核对项", "en": "When CORDARONE / amiodarone is on the same list: this is a high-risk professional-monitoring check" }, "summary": { "zh": "当前美国华法林通用名标签将胺碘酮列入需要核对的相互作用药物；当前胺碘酮通用名标签还提示其停用后相互作用仍可能持续数周至数月。本卡片只提示尽快把两种实际药盒、当前说明书、监测记录和完整药单交给开方团队、药师或抗凝管理团队核对；它不判断能否同用，不提供 INR 目标、剂量、给药间隔或停换药方案，也不建议自行停用、错开时间、替换或调整任何一种药。COUMADIN 与 CORDARONE 页面均含历史品牌档案，当前通用名标签不证明这些品牌当前供应或市场状态。", "en": "A current U.S. generic warfarin label lists amiodarone among medicines requiring interaction review, while a current generic amiodarone label also notes that interactions can persist for weeks to months after amiodarone is stopped. This card only signals that both actual packs, current labels, monitoring records and the complete medicine list need prompt review by the prescribing team, pharmacist or anticoagulation service; it does not decide co-use, provide an INR target, dose, timing interval or stop/switch plan, or advise self-stopping, time-separation, replacement or adjustment of either medicine. The COUMADIN and CORDARONE pages include historical brand archives; current generic labels do not establish current brand supply or market status." }, "source": { "id": "src_3490da81ff5c9135", "label": "DailyMed（NLM）：华法林当前美国通用名标签（列示胺碘酮；仅作成分层核对，不代表 COUMADIN 当前市场状态）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4cf3107-5646-4b91-8aae-94548e4409ef", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "levaquin", "brand": "Levaquin", "generic": "左氧氟沙星", "canonicalUrls": { "zh": "https://origindrug.com/drugs/levaquin/", "en": "https://origindrug.com/en/drugs/levaquin/" } }, "title": { "zh": "与 CRAVIT／可乐必妥／LEVAQUIN 同在药单上时：先核对 INR 与出血监测记录", "en": "When CRAVIT / LEVAQUIN is on the same list: review INR and bleeding-monitoring records first" }, "summary": { "zh": "FDA 的 2019 年 LEVAQUIN 美国历史口服片标签将华法林列为需要核对的药物，并提示上市后报告中出现华法林作用增强、凝血酶原时间或 INR 升高及出血事件。该文件同时明确可能不是 FDA 最新批准标签，因此这张卡只作有日期、美国、成分层面的优先核对提示：请把两种实际药盒、目标市场现行说明书、最近的监测记录以及所有处方药、非处方药和补充剂尽快交给开方团队、药师或抗凝管理团队复核。它不判断个人能否同用，不提供 INR 目标、片数、给药间隔或停换药方案，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The FDA's 2019 historical U.S. oral-tablet label for LEVAQUIN lists warfarin as a medicine requiring review and describes postmarketing reports of enhanced warfarin effect, increased prothrombin time or INR, and bleeding episodes. The document also states that it may not be FDA's latest approved label. This card is therefore only a dated, U.S., ingredient-level priority-review cue: promptly take both actual packs, current target-market labels, recent monitoring records, and every prescription, OTC product and supplement to the prescribing team, pharmacist or anticoagulation service. It does not decide individual co-use, provide an INR target, tablet count, timing interval or stop/switch plan, or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国历史口服片标签（7.2 Warfarin；文件明确可能不是最新批准标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" }, "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." ] }