{ "id": "janumet", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Janumet", "generic": "西格列汀/二甲双胍", "aliases": [ "sitagliptin metformin", "sitagliptin/metformin", "捷诺达", "sitagliptin / metformin hydrochloride" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（Merck；页面 2025-03-25 更新）。本页只展示两种准确 60 片瓶装：50 mg/500 mg（NDC 0006-0575-61）与 50 mg/1000 mg（NDC 0006-0577-61）；JANUMET XR、其他包装和其他市场必须分别核对。", "dosageFormClass": "西格列汀/盐酸二甲双胍复方薄膜衣口服片：每片 50 mg/500 mg 或 50 mg/1000 mg（本页分别展示两个 60 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007（FDA 2022 标签所列美国初始批准）", "archiveSponsorText": "Merck / DailyMed（NLM）有日期美国公开标签；FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-janumet-sitagliptin-50mg-metformin-500mg-60-count-bottle-ndc-0006057561", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（Merck；页面 2025-03-25 更新）；仅为所引包装展示面，不代表供应", "en": "Dated U.S. DailyMed public label (Merck; page updated 25 Mar 2025); cited package panel only, not availability" }, "dosageForm": { "zh": "JANUMET 西格列汀/盐酸二甲双胍薄膜衣口服片", "en": "JANUMET sitagliptin/metformin hydrochloride film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0575-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西格列汀 50 mg / 盐酸二甲双胍 500 mg；60 片瓶装", "en": "Sitagliptin 50 mg / metformin HCl 500 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumet-05.jpg&setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片复方中西格列汀的标签量；不是个人片数或换药规则", "en": "labelled sitagliptin amount in one combination tablet; not an individual's tablet count or switching rule" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片复方中盐酸二甲双胍的标签量；不是个人片数或换药规则", "en": "labelled metformin HCl amount in one combination tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "胶囊形薄膜衣片；无刻痕", "en": "capsule-shaped film-coated tablet; unscored" }, "imprint": "575", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-janumet-sitagliptin-50mg-metformin-1000mg-60-count-bottle-ndc-0006057761", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（Merck；页面 2025-03-25 更新）；仅为所引包装展示面，不代表供应", "en": "Dated U.S. DailyMed public label (Merck; page updated 25 Mar 2025); cited package panel only, not availability" }, "dosageForm": { "zh": "JANUMET 西格列汀/盐酸二甲双胍薄膜衣口服片", "en": "JANUMET sitagliptin/metformin hydrochloride film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0577-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西格列汀 50 mg / 盐酸二甲双胍 1000 mg；60 片瓶装", "en": "Sitagliptin 50 mg / metformin HCl 1000 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumet-06.jpg&setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片复方中西格列汀的标签量；不是个人片数或换药规则", "en": "labelled sitagliptin amount in one combination tablet; not an individual's tablet count or switching rule" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片复方中盐酸二甲双胍的标签量；不是个人片数或换药规则", "en": "labelled metformin HCl amount in one combination tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "胶囊形薄膜衣片；无刻痕", "en": "capsule-shaped film-coated tablet; unscored" }, "imprint": "577", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-janumet-sitagliptin-50mg-metformin-500mg-60-count-bottle-ndc-0006057561", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumet-05.jpg&setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "alt": "JANUMET 西格列汀/盐酸二甲双胍美国 DailyMed 有日期公开标签中的 50 mg/500 mg、NDC 0006-0575-61、60 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "页面 2025-03-25 更新；本图只对应所引有日期公开标签中的准确瓶装", "presentation": "JANUMET：每片西格列汀 50 mg / 盐酸二甲双胍 500 mg，NDC 0006-0575-61，60 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 有日期公开标签中的 JANUMET、西格列汀 50 mg / 盐酸二甲双胍 500 mg、NDC 0006-0575-61 与 60 片瓶装。它只帮助核对两种成分、每片两组标签量、包装、外形线索和来源；不用于鉴定真伪，也不证明 50 mg/1000 mg、JANUMET XR、单方西格列汀/二甲双胍、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人使用方案。", "source": { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "JANUMET 说明书放大阅读：一片里的两个成分，要分开核对", "en": "JANUMET label reading: two components in one tablet need separate checks" }, "summary": { "zh": "本模块用 FDA 2022 美国标签解释“50 mg/500 mg”“50 mg/1000 mg”这类复方标示的阅读方式；不把包装数字转化为个人服用数量或治疗方案。", "en": "This module uses the 2022 U.S. FDA label to explain combination labels such as “50 mg/500 mg” and “50 mg/1000 mg”; it does not turn package numbers into an individual's tablet count or treatment plan." }, "checks": [ { "zh": "复方片上的两个 mg 分别对应西格列汀和盐酸二甲双胍等不同成分的标示强度；不能把它读成一个总毫克数，也不能据此自行与单方二甲双胍或其他降糖药叠加。", "en": "The two mg values on a combination tablet identify stated strengths for different components such as sitagliptin and metformin HCl. Do not read them as one total milligram value or use them to self-add a separate metformin or other glucose-lowering medicine." }, { "zh": "该标签说明起始安排需要结合既往方案，并提到肾功能、脱水、感染、饮酒和含碘造影等情形需要专业人员评估。出现这些变化时，应联系负责团队核对实际产品，而不是临时自行加减或停药。", "en": "The label says starting use is based on the prior regimen and identifies kidney function, dehydration, infection, alcohol and iodinated contrast as situations needing professional assessment. With such changes, contact the responsible team to review the actual product rather than self-adjusting or stopping." }, { "zh": "如果同时使用胰岛素或促胰岛素分泌药，标签提示低血糖风险可能需要额外处理；这不是网络上可以统一规定的加减法。请记录所有药品名称、强度和实际服用时间，由医生或药师核对。", "en": "When insulin or an insulin secretagogue is also used, the label notes that hypoglycaemia risk may need extra management; this is not a universal online adjustment rule. Record every medicine name, strength and actual timing for a clinician or pharmacist to review." }, { "zh": "药盒颜色、片剂外观与两个数字只帮助定位待核对的产品，不能证明真伪、当前批准、是否为同一版本或是否适合另一位家人。每次应把商品名、两种成分、规格、剂型、目标市场和完整药单一起核对。", "en": "Package colour, tablet appearance and the two numbers only help locate a product for checking. They cannot authenticate it, establish current approval, show it is the same version or prove it suits another family member. Check brand name, both ingredients, strength, dosage form, target market and the complete medicine list together." }, { "zh": "JANUMET XR 是需单独核对的另一种剂型；本页的两款 JANUMET 60 片瓶装面板不能用来判定 XR、其他包装或其他市场产品。任何产品变化都应由医生或药师把实际药盒和处方逐项核对。", "en": "JANUMET XR is a separate dosage form that requires its own verification. The two JANUMET 60-tablet bottle panels on this page cannot establish the identity of XR, another package or a product in another market. Have a clinician or pharmacist review the actual pack and prescription item by item for any product change." } ], "source": { "id": "src_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（NDA 022044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.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": "西格列汀/二甲双胍怎样起作用：一部分减慢肠促胰岛素失活，另一部分影响肝脏和外周葡萄糖利用", "en": "How sitagliptin/metformin works: one part slows incretin inactivation and the other affects hepatic and peripheral glucose handling" }, "summary": { "zh": "FDA 标签将 JANUMET 描述为两种作用机制互补的降糖成分：西格列汀是 DPP-4 抑制剂，减慢肠促胰岛素激素失活；二甲双胍可减少肝脏葡萄糖生成、减少肠道葡萄糖吸收并提高外周胰岛素敏感性。它解释复方为何需要把两种成分一起核对，不决定个人血糖、肾功能、用量或是否应增减单方药。", "en": "The FDA label describes JANUMET as two glucose-lowering ingredients with complementary mechanisms: sitagliptin is a DPP-4 inhibitor that slows incretin-hormone inactivation; metformin can decrease hepatic glucose production and intestinal glucose absorption while improving peripheral insulin sensitivity. This explains why both components must be checked together; it does not decide an individual's glucose, kidney function, dose or whether to add or remove a single-ingredient medicine." }, "checks": [ { "zh": "“一片含两种成分”不表示可以把 JANUMET 与 JANUVIA、二甲双胍单方、其他 DPP-4、GLP-1、胰岛素或其他降糖产品自行叠加、轮换或替换。任何组合都需先把完整药单、实际包装和开方目的交由专业人员核对。", "en": "“Two components in one tablet” does not make JANUMET self-combinable, alternatable or substitutable with JANUVIA, single-ingredient metformin, another DPP-4 product, GLP-1, insulin or another glucose-lowering product. Any combination needs the complete medicine list, actual packs and prescribing purpose reviewed by professionals first." }, { "zh": "机制不能把 50 mg/500 mg、50 mg/1000 mg 或其他包装数字变成自行加减、掰分或从两种单方药拼凑复方的公式。两个数字分别属于两种成分，任何规格或产品变化都要回到现行标签与个人处方。", "en": "Mechanism cannot turn 50 mg/500 mg, 50 mg/1000 mg or numbers on another pack into a formula for self-adjustment, splitting or constructing a combination from two single-ingredient products. The two numbers belong to two components; any strength or product change must return to the current label and individual prescription." }, { "zh": "脱水、肾功能变化、感染、饮酒、含碘造影检查或低血糖相关不适等问题，不能从机制页面判断该如何处理。请带完整药单与实际包装联系当地医生、药师或需要时的紧急支持。", "en": "Dehydration, kidney-function changes, infection, alcohol, iodinated-contrast studies or symptoms related to low glucose cannot be managed from a mechanism page. Contact a local clinician, pharmacist or, when needed, urgent support with the complete medicine list and actual packs." } ], "source": { "id": "src_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.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": "Janumet", "generic": "西格列汀/二甲双胍", "dosageFormClass": "西格列汀/盐酸二甲双胍复方薄膜衣口服片：每片 50 mg/500 mg 或 50 mg/1000 mg（本页分别展示两个 60 片瓶装）" }, "labelSource": { "id": "src_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（NDA 022044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.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_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（NDA 022044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.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." } }, { "source": { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "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": [], "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": "美国 DailyMed 的 JANUMET 有日期公开标签列示西格列汀/盐酸二甲双胍复方薄膜衣口服片。本页将 50 mg/500 mg 与 50 mg/1000 mg 两种准确 60 片瓶装分开，帮助读者把两种成分、两组标签量、NDC、片剂外观和原始说明书一起核对；它不把包装数字转成个人片数、单方叠加、停用、换药或购买建议。", "history": "同一人拿到单方二甲双胍、单方西格列汀、JANUMET 或 JANUMET XR 时，不能仅凭“都治糖尿病”、品牌相似或看见相同的一个 mg 数字自行叠加、互换或按片数计算。应把所有实际药盒、处方、非处方药和补充剂交给药师或开方团队核对。", "sourceDocuments": [ { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（NDA 022044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.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 022044", "approvalTimeline": [ { "date": "2007", "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: 2007。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: 2007. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_98492b07cb5b1b93", "label": "FDA: JANUMET prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.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": "2022", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2022 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 2022 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_98492b07cb5b1b93", "label": "FDA: JANUMET prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.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": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/janumet/", "en": "https://origindrug.com/en/drugs/janumet/" }, "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." ] }