{ "id": "lanoxin-injection", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "LANOXIN Injection", "generic": "地高辛注射液", "aliases": [ "LANOXIN Injection", "LANOXIN Pediatric Injection", "digoxin injection", "地高辛注射液" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 LANOXIN 地高辛注射液公开标签（2025-10 修订；DailyMed SPL v10 于 2025-11-17 发布）", "dosageFormClass": "地高辛注射液：500 mcg/2 mL（250 mcg/mL）单剂量瓶；LANOXIN Injection Pediatric 100 mcg/mL 单剂量瓶（当前美国标签所列）", "dosageFormClassCode": "intravenous_infusion", "route": "肌内 / 静脉注射", "routeCode": "intravenous", "historicalApprovalEntry": "1954（当前美国注射剂标签所列 Initial U.S. Approval）", "archiveSponsorText": "Covis Pharma US, Inc. / DailyMed（NLM）当前注射剂公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "LANOXIN tablet", "LANOXIN oral solution", "digoxin oral solution", "LANOXIN 62.5 mcg tablet", "LANOXIN 125 mcg tablet", "LANOXIN 250 mcg tablet" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lanoxin-injection-adult-500mcg-2ml-vial-ndc-70515-261-10", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-10 修订；DailyMed SPL v10 于 2025-11-17 发布", "en": "Prescribing information revised Oct 2025; DailyMed SPL v10 published 17 Nov 2025" }, "dosageForm": { "zh": "地高辛单剂量注射液瓶", "en": "digoxin single-dose injection vial" }, "route": { "zh": "肌内／静脉注射（只作标签身份字段）", "en": "intramuscular / intravenous injection (label identity only)" }, "routeCodes": [ "intramuscular", "intravenous" ], "productCode": "NDC 70515-261-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_vial", "primaryDisplay": { "zh": "500 mcg/2 mL（250 mcg/mL）；10 支单剂量瓶装", "en": "500 mcg/2 mL (250 mcg/mL); 10 single-dose vials" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 500, "unit": "mcg", "basisCode": "per_vial", "basisLabel": { "zh": "每支单剂量瓶标签总量；不是个人注射量", "en": "labelled total per single-dose vial; not an individual's injection amount" } } ], "concentration": { "basisCode": "micrograms_per_mL", "notation": null, "numerator": { "value": 250, "unit": "mcg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "250 mcg/mL", "en": "250 mcg/mL" } }, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶", "en": "single-dose vial" }, "fill": { "value": 2, "unit": "mL" }, "countPerPackage": 10, "countUnit": { "zh": "支/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "支单剂量瓶/盒", "en": "single-dose vials per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lanoxin-injection-pediatric-100mcg-1ml-vial-ndc-70515-263-10", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-10 修订；DailyMed SPL v10 于 2025-11-17 发布", "en": "Prescribing information revised Oct 2025; DailyMed SPL v10 published 17 Nov 2025" }, "dosageForm": { "zh": "LANOXIN Injection Pediatric 地高辛单剂量注射液瓶", "en": "LANOXIN Injection Pediatric digoxin single-dose injection vial" }, "route": { "zh": "肌内／静脉注射（只作标签身份字段）", "en": "intramuscular / intravenous injection (label identity only)" }, "routeCodes": [ "intramuscular", "intravenous" ], "productCode": "NDC 70515-263-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_vial", "primaryDisplay": { "zh": "100 mcg/mL；1 mL；10 支单剂量瓶装", "en": "100 mcg/mL; 1 mL; 10 single-dose vials" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 100, "unit": "mcg", "basisCode": "per_vial", "basisLabel": { "zh": "每支 1 mL 单剂量瓶标签量；不是个人注射量", "en": "labelled amount in the 1 mL single-dose vial; not an individual's injection amount" } } ], "concentration": { "basisCode": "micrograms_per_mL", "notation": null, "numerator": { "value": 100, "unit": "mcg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 mcg/mL", "en": "100 mcg/mL" } }, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶", "en": "single-dose vial" }, "fill": { "value": 1, "unit": "mL" }, "countPerPackage": 10, "countUnit": { "zh": "支/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "支单剂量瓶/盒", "en": "single-dose vials per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lanoxin-injection-adult-500mcg-2ml-vial-ndc-70515-261-10", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707&type=img", "alt": "LANOXIN 地高辛注射液当前美国 DailyMed 标签中的 500 mcg/2 mL、NDC 70515-261-10、十支单剂量瓶包装面板", "archiveMarket": "美国", "labelVersion": "处方信息 2025-10 修订；DailyMed SPL v10 于 2025-11-17 发布", "presentation": "LANOXIN 地高辛注射液 500 mcg/2 mL（250 mcg/mL），NDC 70515-261-10，10 支单剂量瓶装", "notice": "此图只对应当前美国标签中的成人 500 mcg/2 mL 单剂量瓶。它不代表 Pediatric 100 mcg/mL、已列营销结束日的安瓿、LANOXIN 片剂、generic 地高辛口服液或其他市场；不用于鉴定真伪，也不生成个人注射、输注、换算或换药方案。", "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LANOXIN 注射液说明书放大阅读：先核对浓度、NDC 与单剂量瓶，不做换算", "en": "LANOXIN Injection label reading: check concentration, NDC and single-dose vial first; do not self-convert" }, "summary": { "zh": "本模块只帮助区分当前美国标签中的两个单剂量瓶、浓度与 NDC；不生成个人注射量、频率、途径转换、输注操作、片剂/口服液换算、漏用或停用方案。", "en": "This module only distinguishes the two single-dose vials, concentrations and NDCs in the current U.S. label; it does not generate individual injection amounts, frequency, route conversion, infusion steps, tablet/oral-solution conversion, missed-use or stopping plans." }, "checks": [ { "zh": "成人瓶为 500 mcg/2 mL（250 mcg/mL），Pediatric 瓶为 100 mcg/mL、1 mL。它们是不同标签 identity；页面不把浓度、瓶内总量或 mL 变成个人注射量或换算器。", "en": "The adult vial is 500 mcg/2 mL (250 mcg/mL); the Pediatric vial is 100 mcg/mL and 1 mL. They are different label identities; this page does not turn concentration, vial total or mL into an individual injection amount or converter." }, { "zh": "必须继续核对 NDC：成人单剂量瓶为 70515-261-10，Pediatric 单剂量瓶为 70515-263-10。相同品牌、通用名或“注射液”文字不足以互换两种瓶。", "en": "Continue by checking the NDC: the adult single-dose vial is 70515-261-10 and the Pediatric single-dose vial is 70515-263-10. A shared brand, generic name or the word “injection” is not enough to exchange the two vials." }, { "zh": "当前标签还列有已标明营销结束日的成人及儿科安瓿；本页不把它们当作当前包装，也不据此判断任何实际供应或可获得性。", "en": "The current label also lists adult and pediatric ampules with a stated marketing-end date. This page does not present them as current packages or infer any real-world supply or availability." }, { "zh": "LANOXIN 片剂、generic 地高辛口服液和本注射剂属于不同的剂型、NDA 或标签链路。不要按 mcg、mL、途径或品牌名称自行换算、替换、叠加或改变使用方式。", "en": "LANOXIN tablets, generic digoxin oral solution and this injection belong to different form, NDA or label chains. Do not self-convert, substitute, combine or change use by mcg, mL, route or brand name." }, { "zh": "若出现明显心悸、晕厥、意识改变、严重恶心呕吐、视觉异常或疑似误用，应尽快联系当地医生、药师、毒物咨询或紧急医疗支持；不要依据网页自行继续、补用、停用或改量。", "en": "With marked palpitations, fainting, confusion, severe nausea/vomiting, visual disturbance or suspected misuse, promptly contact local clinicians, pharmacists, poison-control or emergency support; do not self-continue, make up, stop or change an amount from this page." } ], "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地高辛怎样起作用：同一机制不等于不同剂型可以自行换算", "en": "How digoxin works: a shared mechanism does not make different forms self-convertible" }, "summary": { "zh": "当前注射剂标签描述地高辛对 Na+/K+-ATPase 的抑制及其心脏效应。机制帮助理解为什么准确剂型、浓度、途径、肾功能、相互作用与监测需要专业核对；不预测个人效果或注射量。", "en": "The current injection label describes digoxin inhibition of Na+/K+-ATPase and cardiac effects. Mechanism helps explain why exact form, concentration, route, kidney function, interactions and monitoring need professional review; it does not predict an individual's effect or injection amount." }, "checks": [ { "zh": "机制不能从症状或设备读数判断某个人是否应使用地高辛注射剂，也不能决定何时注射、通过何种途径或是否转回口服。", "en": "Mechanism cannot determine from symptoms or device readings whether someone should use digoxin injection, when it should be given, by which route, or whether to change back to oral use." }, { "zh": "作用于心率/传导不使本注射剂与片剂、口服液或其他心律、心衰、血压产品可自行叠加、轮换、替代或按单位换算。", "en": "Effects on rate/conduction do not make this injection self-combinable, alternatable, substitutable or unit-convertible with tablets, oral solution or another rhythm, heart-failure or blood-pressure product." }, { "zh": "机制不能处理疑似中毒、明显心悸、晕厥、意识改变或严重胃肠道/视觉症状；有急性严重担忧时应优先使用当地紧急医疗支持。", "en": "Mechanism cannot manage suspected toxicity, marked palpitations, fainting, confusion or severe gastrointestinal/visual symptoms; prioritise local urgent medical support for an acute serious concern." } ], "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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": "LANOXIN Injection", "generic": "地高辛注射液", "dosageFormClass": "地高辛注射液：500 mcg/2 mL（250 mcg/mL）单剂量瓶；LANOXIN Injection Pediatric 100 mcg/mL 单剂量瓶（当前美国标签所列）" }, "labelSource": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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": "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": "2026-08-20", "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": [], "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": "DailyMed 的 LANOXIN 地高辛注射液当前美国标签列出成人 500 mcg/2 mL（250 mcg/mL）与 Pediatric 100 mcg/mL 两个单剂量瓶。页面把 NDC、浓度、单剂量瓶与标签所列肌内／静脉途径分开呈现；不生成任何个人注射量、频率、输注安排、途径转换、片剂／口服液换算、漏用或停用方案。", "history": "当前注射剂标签对应 NDA 009330，并与 LANOXIN 片剂的 NDA 020405 分开。页面仅展示截至 2026-08-21 在当前标签中列示、且未列出营销结束日的两个小瓶；已列营销结束日的成人与儿科安瓿不作为当前公开 presentation。", "sourceDocuments": [ { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 009330", "approvalTimeline": [ { "date": "1954", "title": { "zh": "当前注射剂标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current injection label" }, "detail": { "zh": "当前 LANOXIN 注射剂标签列示 Initial U.S. Approval: 1954；该年份不把片剂、口服液或其他市场并入本档案。", "en": "The current LANOXIN injection label lists Initial U.S. Approval: 1954; that year does not merge tablets, oral solution or another market into this dossier." }, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed: current U.S. LANOXIN digoxin-injection public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-10-17", "title": { "zh": "当前标签页面更新/处方信息修订", "en": "Current label-page update / prescribing-information revision" }, "detail": { "zh": "DailyMed 页面将 Drug Label Information Updated 标为 2025-10-17，正文列示 Revised 10/2025；它与后续 SPL 公开日期分开记录。", "en": "DailyMed lists Drug Label Information Updated as 17 Oct 2025 and the text as Revised 10/2025; these remain separate from the subsequent SPL publication date." }, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed: current U.S. LANOXIN digoxin-injection public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-11-17", "title": { "zh": "DailyMed SPL v10 公开", "en": "DailyMed SPL v10 published" }, "detail": { "zh": "DailyMed 当前版本列表将 v10 标为 current，并列示 2025-11-17 Published。", "en": "DailyMed marks v10 as current and lists Published 17 Nov 2025." }, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed: current U.S. LANOXIN digoxin-injection public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国注射剂", "en": "United States injection" }, "status": { "zh": "已链接 NDA 009330 当前公开标签与两个现行标签所列单剂量瓶", "en": "Current NDA 009330 public label and two label-listed single-dose vials linked" }, "detail": { "zh": "本档案仅展示 NDC 70515-261-10 成人 500 mcg/2 mL 单剂量瓶与 NDC 70515-263-10 Pediatric 100 mcg/mL 单剂量瓶。它不证明实际在售、库存、可获得性，亦不纳入已列营销结束日的安瓿。", "en": "This dossier displays only the adult 500 mcg/2 mL single-dose vial, NDC 70515-261-10, and the Pediatric 100 mcg/mL single-dose vial, NDC 70515-263-10. It does not establish actual marketing, stock or availability, and does not include ampules with a stated marketing-end date." } }, { "market": { "zh": "LANOXIN 片剂、generic 地高辛口服液及其他市场", "en": "LANOXIN tablets, generic digoxin oral solution and other markets" }, "status": { "zh": "明确分开或待建立", "en": "Explicitly separate or not established" }, "detail": { "zh": "不同 NDA、SPL、剂型、浓度、途径或品牌状态不得并入本注射剂档案。", "en": "A different NDA, SPL, form, concentration, route or brand status is not merged into this injection dossier." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "500 mcg/2 mL（250 mcg/mL）和 100 mcg/mL 能自己按 mL 换算或替换吗？", "en": "Can 500 mcg/2 mL (250 mcg/mL) and 100 mcg/mL be self-converted or substituted by mL?" }, "answer": { "zh": "不能。它们是不同的标签包装身份。本页不提供注射或浓度换算器；应带上实际 NDC、单剂量瓶和完整药单，由药师或处方团队核对。", "en": "No. They are different labelled package identities. This page provides no injection or concentration converter; take the actual NDC, single-dose vial and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "LANOXIN 注射剂能按同品牌或同通用名转成片剂或口服液吗？", "en": "Can LANOXIN Injection be changed to tablets or oral solution because the brand or generic name is shared?" }, "answer": { "zh": "不能。片剂、口服液和注射剂的标签链路、剂型、浓度或途径不同。本页不提供任何转换、替换、加减量或联合使用结论。", "en": "No. Tablets, oral solution and injection have different label chains, forms, concentrations or routes. This page provides no conversion, substitution, adjustment or combination conclusion." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lanoxin-injection/", "en": "https://origindrug.com/en/drugs/lanoxin-injection/" }, "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." ] }