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representative package panel, not a current-label or availability conclusion)" }, "dosageForm": { "zh": "GLUCOPHAGE 盐酸二甲双胍口服薄膜衣片（历史归档包装）", "en": "GLUCOPHAGE metformin hydrochloride oral film-coated tablet (archived package)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-6071-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 1000 mg；100 片瓶装；普通片历史归档面板", "en": "1000 mg per tablet; 100-tablet bottle; immediate-release historical package panel" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucophage-1000mg-btl-lbl.jpg&archiveid=453104", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、普通片/缓释片换算、掰开或调药规则", "en": "amount stated per tablet in the historical label; 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not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装（历史归档）", "en": "100-tablet bottle (historical archive)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、双凸缓释片", "en": "capsule-shaped biconvex extended-release tablet" }, "imprint": "BMS 6063 / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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-glucophage-xr-750mg-100-tablet-bottle-ndc-0087-6064-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开历史归档（Bristol-Myers Squibb；代表性包装面板，非现行标签或供应结论）", "en": "DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)" }, "dosageForm": { "zh": "GLUCOPHAGE XR 盐酸二甲双胍缓释片（历史归档包装）", "en": "GLUCOPHAGE XR metformin hydrochloride extended-release tablet (archived package)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-6064-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 750 mg；100 片瓶装；缓释片历史归档面板", "en": "750 mg per tablet; 100-tablet bottle; extended-release historical package panel" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucophagexr-750mg-btl-lbl.jpg&archiveid=453104", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 750, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、普通片/缓释片换算、掰开或调药规则", "en": "amount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装（历史归档）", "en": "100-tablet bottle (historical archive)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅红色，可呈斑驳外观", "en": "pale red, possibly mottled" }, "shape": { "zh": "胶囊形、双凸缓释片", "en": "capsule-shaped biconvex extended-release tablet" }, "imprint": "BMS 6064 / 750", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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-glucophage-immediate-release-500mg-100-tablet-bottle-ndc-0087-6060-05", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucophage-500mg-btl-lbl+.jpg&archiveid=453104", "alt": "GLUCOPHAGE 二甲双胍在美国 DailyMed Bristol-Myers Squibb 归档标签中的 500 mg、100 片装瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 归档公开标签（Bristol-Myers Squibb，历史归档）", "presentation": "GLUCOPHAGE 片剂：每片盐酸二甲双胍 500 mg、100 片装瓶装标签图（DailyMed Bristol-Myers Squibb 归档标签所列）。", "notice": "此为美国 DailyMed 所存 Bristol-Myers Squibb GLUCOPHAGE 归档标签中明确对应二甲双胍 500 mg、100 片装的瓶装标签图，只帮助核对品牌、通用名、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明该历史标签所涉产品目前仍在任何市场可得，亦不证明 GLUCOPHAGE XR、其他规格、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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": "GLUCOPHAGE XR 说明书放大阅读：缓释片不能当作普通片掰开", "en": "GLUCOPHAGE XR label reading: an extended-release tablet is not an ordinary tablet to split" }, "summary": { "zh": "本模块以 FDA 2018-05 美国历史标签为阅读入口，解释 GLUCOPHAGE 与 GLUCOPHAGE XR 的即时释放/缓释区别及“整片吞服”要求；它不制定个人降糖方案。", "en": "This module uses the May 2018 U.S. FDA historical label as a reading entry point, explaining the immediate-release/extended-release distinction and the “swallow whole” requirement for GLUCOPHAGE and GLUCOPHAGE XR; it does not create an individual glucose-lowering plan." }, "checks": [ { "zh": "该历史标签分别列出 GLUCOPHAGE 500、850、1000 mg 片剂，及 GLUCOPHAGE XR 500、750 mg 缓释片。相同通用名不代表这些不同剂型、规格和给药节奏能由自己按数字换算或替代。", "en": "This historical label separately lists GLUCOPHAGE 500, 850 and 1000 mg tablets and GLUCOPHAGE XR 500 and 750 mg extended-release tablets. A shared generic name does not make those different forms, strengths and dosing schedules self-convertible or interchangeable." }, { "zh": "FDA 标签对 GLUCOPHAGE XR 明确写明整片吞服，不能压碎、切开或咀嚼。因此“掰一半就等于减半”不能用于该缓释片；若吞咽困难、想减量或需改剂型，应先请开方团队或药师确认。", "en": "The FDA label explicitly says to swallow GLUCOPHAGE XR whole and never crush, cut or chew it. Therefore, “half a tablet equals half a dose” cannot be applied to this extended-release tablet; swallowing difficulty, a desired reduction or a form change should first be reviewed by the prescribing team or pharmacist." }, { "zh": "该标签把肾功能、碘造影检查、饮酒和部分联用药物列为需要专业评估的情境；高龄或多病共存时尤其不能只凭通用名、血糖读数或包装规格自行停用、换为缓释/普通片或临时加量。", "en": "The label identifies kidney function, iodinated contrast procedures, alcohol and some co-medications as situations requiring professional assessment. Especially with older age or multiple conditions, do not self-stop, change between extended-release and ordinary tablets, or temporarily increase use from a generic name, glucose reading or package strength alone." }, { "zh": "长期使用时，维生素 B12 与血液指标是说明书列出的复核线索；不要自行用补充剂替代检查，也不要因一次结果自行停药。应把近期检验、饮食/吸收问题及全部药物交给专业人员共同判断。", "en": "With long-term use, vitamin B12 and haematologic measures are label-listed review cues. Do not replace testing with self-selected supplements or stop from one result. Recent tests, diet or absorption concerns and the complete medicine list need professional review together." }, { "zh": "腹泻、恶心等不适不等于乳酸性酸中毒，网页也不能诊断原因；但若出现迅速加重的极度乏力、呼吸困难、明显嗜睡/意识改变、持续严重腹痛或循环不稳，应立即使用当地急救或紧急医疗服务，并带上准确药盒与完整药单。", "en": "Diarrhoea or nausea does not by itself mean lactic acidosis, and a webpage cannot diagnose the cause. Rapidly worsening extreme weakness, breathing difficulty, marked drowsiness or altered consciousness, persistent severe abdominal pain or circulatory instability requires local emergency care with the exact pack and complete medicine list." } ], "source": { "id": "src_8bffc6c29d4c394e", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2018-05 处方信息（缓释片整片吞服要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034%2C021202s018lbl.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": "二甲双胍怎样起作用：它同时涉及肝脏、肠道和身体对胰岛素的反应", "en": "How metformin works: it involves the liver, intestine and the body's response to insulin" }, "summary": { "zh": "FDA 的 GLUCOPHAGE / GLUCOPHAGE XR 公开标签描述：二甲双胍可减少肝脏葡萄糖生成、减少肠道葡萄糖吸收，并通过增加外周组织对葡萄糖的摄取和利用来改善胰岛素敏感性。这些是药理路径的概述，不是个人的剂量、联用、换药或停药方案。", "en": "The FDA public GLUCOPHAGE / GLUCOPHAGE XR label describes metformin as decreasing hepatic glucose production and intestinal glucose absorption, and improving insulin sensitivity by increasing peripheral glucose uptake and use. These are an overview of pharmacologic pathways, not an individual dose, combination, switch or stopping plan." }, "checks": [ { "zh": "不要把它简化为“只作用于一个器官”或“只要血糖高就能自己加用”。机制帮助理解标签语言，但不能替代诊断、近期检验、实际产品身份和个人处方的共同判断。", "en": "Do not simplify this into “it works on only one organ” or “a high glucose result means it can be self-added.” A mechanism helps read label language, but cannot replace the combined assessment of diagnosis, recent tests, actual product identity and an individual prescription." }, { "zh": "普通片与 GLUCOPHAGE XR 缓释片可有同一活性成分，但“同一机制”不使它们的剂型、强度、整片吞服要求或使用节奏可以自行换算。任何改为缓释/普通片、掰开或更改频率的想法都需先核对具体标签和药师/开方团队意见。", "en": "Ordinary tablets and GLUCOPHAGE XR extended-release tablets can share the active ingredient, but “the same mechanism” does not make their form, strength, swallow-whole requirement or schedule self-convertible. Any thought of changing between immediate- and extended-release forms, splitting, or changing frequency needs the exact label and pharmacist or prescribing-team review first." }, { "zh": "与其他降糖药、胰岛素、利尿剂或可能影响肾功能的产品同用时，机制只提示需要把完整药单和实际包装放在一起复核；它不能回答某个人应否叠加、替换、暂时停用或如何处理漏用。", "en": "When other glucose-lowering medicines, insulin, diuretics or products that may affect kidney function are also used, the mechanism only signals that the complete medicine list and actual packages need joint review; it cannot answer whether a person should add, substitute, temporarily stop or manage a missed use." } ], "source": { "id": "src_8bffc6c29d4c394e", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2018-05 处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034%2C021202s018lbl.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": "Glucophage", "generic": "二甲双胍", "dosageFormClass": "盐酸二甲双胍口服普通片与缓释片；品牌、剂型、每片毫克数和市场必须同时核对" }, "labelSource": { "id": "src_8bffc6c29d4c394e", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2018-05 处方信息（缓释片整片吞服要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034%2C021202s018lbl.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_8bffc6c29d4c394e", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2018-05 处方信息（缓释片整片吞服要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034%2C021202s018lbl.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_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_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." } }, { "source": { "id": "src_f7d2efc712cefcdb", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2017 美国历史标签（NDA 020357 / 021202）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039%2C021202s021s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2016-metformin-reduced-kidney-function-labelling-change", "issuedAt": "2016-04-08", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：含二甲双胍产品在肾功能减退人群中的标签更新", "en": "FDA Drug Safety Communication: labelling update for metformin-containing medicines in reduced kidney function" }, "summary": { "zh": "FDA 于 2016-04-08 发布对所有含二甲双胍药物的美国标签更新，说明其审查后将肾功能评价口径调整为 eGFR，并扩展了部分轻度及中度肾功能减退者的标签使用范围。该记录适用于二甲双胍成分层面的美国监管标签变更，不等于 GLUCOPHAGE、其缓释剂型、其他市场产品或任何个人都适合／不适合使用，也不提供自行开始、停止、减量、加量或将普通片换成缓释片的结论。肾功能、剂型和联用药物问题应以手中准确产品、目标市场现行说明书及开方团队或药师核对为准。", "en": "On 2016-04-08, FDA issued a U.S. labelling update for all metformin-containing medicines. After its review, FDA changed the kidney-function measure used in labelling to eGFR and expanded labelled use for some people with mild or moderate renal impairment. This is a U.S. ingredient-level regulatory labelling change. It does not determine whether GLUCOPHAGE, an extended-release form, a product in another market, or any individual is suitable or unsuitable, and it does not support self-starting, stopping, reducing, increasing, or exchanging immediate-release and extended-release products. Kidney function, dosage form and co-medication questions require the exact product, current target-market label and review by the prescribing team or pharmacist." }, "source": { "id": "src_c0757f8de2a30ee1", "label": "美国国家医学图书馆 Bookshelf：FDA 二甲双胍安全公告历史档案（含 2016-04-08 肾功能标签更新）", "url": "https://www.ncbi.nlm.nih.gov/books/NBK409379/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 GLUCOPHAGE / GLUCOPHAGE XR（metformin hydrochloride）2018-05 美国标签档案覆盖口服片剂与缓释片，并列出美国初始批准年份为 1995。DailyMed 所存 Bristol-Myers Squibb 归档标签保留五个可逐项核对的 100 片瓶装面板：GLUCOPHAGE 普通片 500/850/1000 mg，以及 GLUCOPHAGE XR 缓释片 500/750 mg。它们都是历史归档身份线索，不推定现行标签、当前包装、其他市场批准、持有人、原研关系、供应或可售资格。", "history": "本页五张瓶装标签图只分别对应美国 DailyMed 所存 Bristol-Myers Squibb 历史归档中的特定 NDC、强度、普通片或缓释片与 100 片瓶装；归档内各 NDC 均列有营销结束日期。它们不确认当前包装、产品真伪、其他市场或实际可得性。相同通用名及同一品牌家族下的普通片与缓释产品不能自动视为同一完整产品身份。", "sourceDocuments": [ { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_f7d2efc712cefcdb", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2017 美国历史标签（NDA 020357 / 021202）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039%2C021202s021s023lbl.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_ae71b241c29fe815", "label": "FDA：2025 临床审评中的 metformin / metformin XR 美国监管历史", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216778Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d3223f16818206ea", "label": "DailyMed（NLM）：当前通用名 metformin hydrochloride 普通片标签（仅作当前剂型与安全阅读背景）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0f251f2c-97f3-4048-84f2-81fea03685aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "generic_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_8978b60669978d12", "label": "DailyMed（NLM）：当前通用名 metformin hydrochloride 缓释片标签（仅作当前剂型与安全阅读背景）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d0b74de-ef4c-4dd2-8019-2ddb409c60b4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "generic_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_ee8d8ba271a3603e", "label": "EMA：metformin 与含 metformin 药品转介及成员国授权背景", "url": "https://www.ema.europa.eu/en/medicines/human/referrals/metformin-metformin-containing-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_reference", "market": "EU", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "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": "FDA NDA 020357（GLUCOPHAGE）／NDA 021202（GLUCOPHAGE XR）", "approvalTimeline": [ { "date": "1995-03-03", "title": { "zh": "FDA 批准 GLUCOPHAGE", "en": "FDA approved GLUCOPHAGE" }, "detail": { "zh": "FDA 2025 临床审评的监管历史表将 NDA 020357 与该日期及 Glucophage 相连；这是美国历史批准节点，不是当前供应证明。", "en": "The regulatory-history table in a 2025 FDA clinical review links NDA 020357, this date and Glucophage; it is a U.S. historical approval node, not evidence of current supply." }, "source": { "id": "src_ae71b241c29fe815", "label": "FDA：2025 临床审评中的 metformin 美国监管历史表", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216778Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2000-10-13", "title": { "zh": "FDA 批准 GLUCOPHAGE XR", "en": "FDA approved GLUCOPHAGE XR" }, "detail": { "zh": "同一 FDA 监管历史表将 NDA 021202 与 Glucophage XR 相连；普通片和缓释片必须按完整产品身份分别阅读。", "en": "The same FDA regulatory-history table links NDA 021202 to Glucophage XR; immediate-release and extended-release products must be read as distinct complete identities." }, "source": { "id": "src_ae71b241c29fe815", "label": "FDA：2025 临床审评中的 metformin XR 美国监管历史表", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216778Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2017-04", "title": { "zh": "美国历史品牌标签更新节点", "en": "U.S. historical brand-label update node" }, "detail": { "zh": "该标签列出 GLUCOPHAGE 500/850/1000 mg 与 GLUCOPHAGE XR 500/750 mg，并明确文件可能不是 FDA 最新标签。", "en": "This label lists GLUCOPHAGE 500/850/1000 mg and GLUCOPHAGE XR 500/750 mg and explicitly warns that it may not be the latest FDA-approved label." }, "source": { "id": "src_f7d2efc712cefcdb", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2017 美国历史标签（Reference ID 4079189）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039%2C021202s021s023lbl.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": "美国历史品牌档案", "en": "U.S. historical brand archive" }, "status": { "zh": "五个历史品牌包装已逐项建档；不宣称当前品牌供应", "en": "Five historical brand packages are itemised; current brand supply is not claimed" }, "detail": { "zh": "页面保留 NDC、每片毫克数、普通片/缓释片、片面刻字与历史标签来源。当前通用名标签只能补充安全阅读背景，不能冒充当前 GLUCOPHAGE 品牌标签。", "en": "The page preserves NDC, per-tablet milligrams, immediate/extended-release form, tablet imprint and historical-label source. Current generic labels may add safety-reading context but must not be presented as current GLUCOPHAGE brand labels." } }, { "market": { "zh": "欧盟及成员国", "en": "EU and member states" }, "status": { "zh": "metformin 产品为成员国层面授权；品牌与现行说明书须逐国核对", "en": "Metformin products are nationally authorised; brand and current leaflet require country-by-country checking" }, "detail": { "zh": "EMA 的转介页面说明相关产品包含 Glucophage 等名称，但不由此推定任一国家的当前包装、供应、原研关系或可替代性。", "en": "The EMA referral page notes products including the name Glucophage, but this does not establish current pack, supply, originator status or interchangeability in any country." } }, { "market": { "zh": "中国大陆、日本及其他市场", "en": "Mainland China, Japan and other markets" }, "status": { "zh": "现行市场记录待逐项建立", "en": "Current market record not yet established" }, "detail": { "zh": "不从美国历史品牌或通用名推定当地商品名、批准、包装、供应或换药关系。", "en": "No local trade name, approval, pack, supply or switching relationship is inferred from the U.S. historical brand or generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "500 mg 是一盒有 500 片吗？", "en": "Does 500 mg mean there are 500 tablets in the pack?" }, "answer": { "zh": "不是。这里的 500 mg 是每片标签标示的盐酸二甲双胍量；包装片数是另一个字段。个人一次吃几片、一天几次必须看准确处方，不能从 mg 自行推算。", "en": "No. Here, 500 mg is the labelled metformin hydrochloride amount per tablet; pack count is a separate field. Tablets per use and uses per day require the exact prescription and cannot be inferred from mg alone." } }, { "question": { "zh": "GLUCOPHAGE XR 能掰一半吗？", "en": "Can GLUCOPHAGE XR be split in half?" }, "answer": { "zh": "历史品牌标签要求 GLUCOPHAGE XR 整片吞服，不得压碎或咀嚼；当前通用名缓释标签进一步明确不得切开。不要自行掰片；吞咽困难或需调整时请带准确包装咨询药师或开方团队。", "en": "The historical brand label requires GLUCOPHAGE XR to be swallowed whole and not crushed or chewed; current generic extended-release labels further say not to cut it. Do not split it yourself; take the exact pack to a pharmacist or prescriber if swallowing is difficult or a change is needed." } }, { "question": { "zh": "做增强 CT 或血管造影前需要停药吗？", "en": "Must it be stopped before contrast CT or angiography?" }, "answer": { "zh": "不能只凭“要做造影”自行停药。标签把造影剂类型、给药途径、肾功能、肝病、心衰与饮酒史等列为共同判断因素；应提前把检查通知和近期肾功能结果交给开方团队/检查机构，按其具体指示处理。", "en": "Do not stop it yourself merely because contrast imaging is planned. The label considers contrast type and route, kidney function, liver disease, heart failure and alcohol history together. Give the imaging notice and recent kidney results to the prescriber and imaging service in advance and follow their specific instructions." } } ], "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/glucophage/", "en": "https://origindrug.com/en/drugs/glucophage/" }, "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." ] }