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updated 16 Jun 2026 and published 10 Aug 2026" }, "dosageForm": { "zh": "赖脯胰岛素注射液", "en": "insulin lispro injection solution" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-8213-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "U-100：100 单位/mL；5 支 3 mL Tempo Pen", "en": "U-100: 100 units/mL; five 3 mL Tempo Pens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-u100-tpen-047-01.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖脯胰岛素", "en": "insulin lispro" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位", "en": "labelled concentration; not an individual's injection units" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 单位/mL（U-100）", "en": "100 units/mL (U-100)" } }, "container": { "typeCode": "prefilled_pen", "typeLabel": { "zh": "3 mL 单人使用预充笔", "en": "3 mL single-patient-use prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 5, "countUnit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "deliveryDevice": { "typeCode": "tempo_pen", "name": { "zh": "Tempo Pen", "en": "Tempo Pen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 5, "unit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-humalog-u200-kwikpen-ndc-0002-7712-27", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v87；2026-06-16 更新，2026-08-10 发布", "en": "DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026" }, "dosageForm": { "zh": "赖脯胰岛素注射液", "en": "insulin lispro injection solution" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-7712-27", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "U-200：200 单位/mL；2 支 3 mL KwikPen", "en": "U-200: 200 units/mL; two 3 mL KwikPens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-u200-kpen-014-03.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖脯胰岛素", "en": "insulin lispro" }, "value": 200, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位", "en": "labelled concentration; not an individual's injection units" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-200", "numerator": { "value": 200, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "200 单位/mL（U-200）", "en": "200 units/mL (U-200)" } }, "container": { "typeCode": "prefilled_pen", "typeLabel": { "zh": "3 mL 单人使用预充笔", "en": "3 mL single-patient-use prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 2, "countUnit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "deliveryDevice": { "typeCode": "kwikpen", "name": { "zh": "KwikPen", "en": "KwikPen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-humalog-u200-kwikpen-ndc-0002-7712-27", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-u200-kpen-014-03.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "alt": "HUMALOG U-200 赖脯胰岛素美国 DailyMed 当前标签中的 200 units/mL、两支 3 mL KwikPen 包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v87（2026-06-16 更新；2026-08-10 发布）", "presentation": "HUMALOG U-200，200 units/mL，2 支 3 mL KwikPen，NDC 0002-7712-27", "notice": "此图只对应美国当前标签中的 U-200 KwikPen 两支装。它不代表 U-100、药瓶、药筒、Junior KwikPen、Tempo Pen、HUMALOG MIX 或其他市场；不用于鉴定真伪，也不生成个人注射单位、浓度换算、泵/静脉使用或装置转换。", "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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": "HUMALOG 说明书放大阅读：U-100/U-200、容器与装置必须同时核对", "en": "HUMALOG label reading: U-100/U-200, container and device must be checked together" }, "summary": { "zh": "本模块只帮助阅读当前美国标签中的浓度、容器、NDC、体积与装置；不生成个人注射单位、餐时、泵设置、补用、混合或转换。", "en": "This module only helps read concentration, container, NDC, volume and device in the current U.S. label; it does not generate personal injection units, meal timing, pump settings, make-up use, mixing or conversion." }, "checks": [ { "zh": "U-100 与 U-200 是不同浓度：100 units/mL 与 200 units/mL 不能只看“HUMALOG”或相同 3 mL 外观就当作同一产品。网页不提供二者的单位换算。", "en": "U-100 and U-200 are different concentrations: 100 units/mL and 200 units/mL cannot be treated as the same product from “HUMALOG” or a shared 3 mL appearance. This page provides no unit conversion between them." }, { "zh": "U-200 当前核验的 presentation 只有 KwikPen，不是药瓶或药筒；标签明确不得把 U-200 从笔中抽入注射器，也不得用于泵或静脉。出现装置或浓度不一致时，先停止网页推断并联系药师或开方团队。", "en": "The current reviewed U-200 presentation is KwikPen only, not a vial or cartridge. The label states not to transfer U-200 from the pen into a syringe and not to use it in a pump or intravenously. If device or concentration differs, stop web inference and contact a pharmacist or prescribing team." }, { "zh": "药瓶、药筒、KwikPen、Junior KwikPen 与 Tempo Pen 是不同容器/装置身份；不能因都写 3 mL 或 U-100 就自行转移、分装、共享、拼用或更换装置。", "en": "Vial, cartridge, KwikPen, Junior KwikPen and Tempo Pen are different container/device identities. A shared 3 mL or U-100 marking does not permit self-transfer, division, sharing, combining or device switching." }, { "zh": "HUMALOG MIX75/25 与 MIX50/50 是混悬型复方产品，不是本页的 HUMALOG 注射液。拍照或搜索出现 MIX、protamine/精蛋白或混悬液时，不应把本页当作同一档案。", "en": "HUMALOG MIX75/25 and MIX50/50 are suspension combination products, not the HUMALOG solution in this record. If a photo or search shows MIX, protamine or suspension, do not treat this as the same dossier." }, { "zh": "低血糖、意识改变、抽搐、无法安全吞咽或其他急性严重情况，应立即使用当地紧急医疗支持；网页不能用包装数字替代急救处理或个体化方案。", "en": "Hypoglycaemia with altered awareness, seizure, inability to swallow safely or another acute severe concern requires immediate local emergency support; package numbers on a webpage cannot replace emergency care or an individual plan." } ], "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "赖脯胰岛素怎样起作用：帮助葡萄糖进入组织并影响肝脏葡萄糖输出", "en": "How insulin lispro works: supporting glucose uptake and affecting hepatic glucose output" }, "summary": { "zh": "当前标签把赖脯胰岛素的主要作用描述为调节葡萄糖代谢。机制只用于理解类别，不能预测个人血糖、给出单位、注射时间、餐时或泵设置。", "en": "The current label describes regulation of glucose metabolism as insulin lispro's primary activity. Mechanism only supports class understanding; it cannot predict individual glucose, provide units, injection timing, meal timing or pump settings." }, "checks": [ { "zh": "作用较快不等于网页能决定何时注射、注射多少或漏用后如何处理；这些问题必须回到准确浓度、装置、处方、监测记录与专业人员。", "en": "Rapid action does not let a webpage decide when or how much to inject or what to do after a missed use; those questions require the exact concentration, device, prescription, monitoring record and professionals." }, { "zh": "同属胰岛素或都标单位，不表示不同胰岛素、浓度、泵、药瓶、药筒或预充笔可自行等量替换、叠加或混合。", "en": "Sharing an insulin class or unit notation does not make different insulins, concentrations, pumps, vials, cartridges or pens self-equivalent, combinable or mixable." }, { "zh": "机制不能替代对低血糖、过敏、装置故障或血糖急剧变化的现场评估；有急性严重担忧时应优先使用当地紧急医疗支持。", "en": "Mechanism cannot replace in-person assessment of hypoglycaemia, allergy, device failure or a sharp glucose change; prioritise local urgent medical support for an acute serious concern." } ], "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 当前美国公开标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Humalog", "generic": "赖脯胰岛素", "dosageFormClass": "赖脯胰岛素注射液：U-100 多剂量瓶、药筒与预充笔；U-200 KwikPen 预充笔（当前美国标签/NDC 记录所列）" }, "labelSource": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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" }, "productRoutes": [ { "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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" }, "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 HUMALOG（insulin lispro）当前美国公开标签把 U-100 与 U-200、10 mL 多剂量瓶、3 mL 药筒以及不同预充笔分别列示。截至 2026-08-19，本页按浓度、NDC、容器、装置、体积与包装数量核对现行标签展示且 FDA NDC 目录仍列出的六个 presentation；这不等于已证实在售、有库存或适用于任何个人，也不生成胰岛素单位、注射时间、餐时、泵设置、补用、混合、装置转换或浓度换算。", "history": "HUMALOG 当前标签列示美国初始批准年份为 1996。当前 presentation 以 2026-08-19 的 DailyMed v87 与 FDA NDC 记录为核验边界：已结束的 3 mL vial 和 U-200 Tempo Pen 不作为当前产品呈现；HUMALOG MIX75/25、MIX50/50 也不是本页同一注射液档案。", "sourceDocuments": [ { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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" } ], "applicationNumber": "BLA 020563（U-100）/ BLA 205747（U-200）", "approvalTimeline": [ { "date": "1996-06-14", "title": { "zh": "U-100 美国批准节点", "en": "U-100 U.S. approval node" }, "detail": { "zh": "当前 DailyMed 数据元素将 U-100 产品列在 BLA 020563，并显示 1996-06-14 的营销/批准历史节点；标签列示 Initial U.S. Approval: 1996。", "en": "Current DailyMed data elements list U-100 under BLA 020563 and show a 14 Jun 1996 marketing/approval-history node; the label lists Initial U.S. Approval: 1996." }, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed: current HUMALOG public label and data elements", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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" } }, { "date": "2015-05-26", "title": { "zh": "U-200 BLA 205747 节点", "en": "U-200 BLA 205747 node" }, "detail": { "zh": "当前 DailyMed 数据元素将 U-200 KwikPen 列在 BLA 205747，并显示 2015-05-26 的节点。该日期不把 U-100 与 U-200 合并为一个浓度。", "en": "Current DailyMed data elements list U-200 KwikPen under BLA 205747 and show a 26 May 2015 node. This does not collapse U-100 and U-200 into one concentration." }, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed: current HUMALOG public label and data elements", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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" } }, { "date": "2026-01", "title": { "zh": "当前处方信息修订月份", "en": "Current prescribing-information revision month" }, "detail": { "zh": "当前正文页脚列示 Revised 01/2026；它与 SPL effective/Updated 和 DailyMed Published 日期分开记录。", "en": "The current prescribing-information footer lists Revised 01/2026; it remains distinct from SPL effective/updated and DailyMed published dates." }, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed: current HUMALOG public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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" } }, { "date": "2026-06-16 / 2026-08-10", "title": { "zh": "SPL v87 更新与发布时间", "en": "SPL v87 update and publication dates" }, "detail": { "zh": "DailyMed 将当前 v87 的 Updated/Effective 标为 2026-06-16，并于 2026-08-10 发布；页面不把这两个日期都称为临床修订日。", "en": "DailyMed marks the current v87 as updated/effective on 16 Jun 2026 and published on 10 Aug 2026; this page does not call both dates clinical revision dates." }, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed: current HUMALOG public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接现行标签展示且 NDC 目录仍列出的六个 presentation", "en": "Six presentations shown in the current label and still listed in the NDC Directory are linked" }, "detail": { "zh": "核验截至 2026-08-19；U-100 与 U-200 的 BLA、浓度、容器和装置分别保留。这不证明实际在售、库存或可获得性；药筒记录还存在 NDC 列示与 Purple Book presentation 状态不一致，须单独人工复核。", "en": "Reviewed through 19 Aug 2026; the U-100 and U-200 BLA, concentration, container and device identities remain separate. This does not establish actual marketing, stock or availability; the cartridge record also has an NDC-listing versus Purple Book presentation-status discrepancy requiring separate manual review." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、装置、供应或可替代性。", "en": "No local trade name, approval, device, supply or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "U-100 和 U-200 可以按体积或单位自行换算吗？", "en": "Can U-100 and U-200 be self-converted by volume or units?" }, "answer": { "zh": "不能。本页只显示产品身份，不提供换算器。应核对处方、浓度、NDC、准确装置并联系药师或开方团队。", "en": "No. This page displays product identity and provides no converter. Check the prescription, concentration, NDC and exact device with a pharmacist or prescribing team." } } ], "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/humalog/", "en": "https://origindrug.com/en/drugs/humalog/" }, "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." ] }