{ "id": "flagyl-metronidazole", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "FLAGYL", "generic": "甲硝唑", "aliases": [ "FLAGYL", "甲硝唑", "metronidazole", "Flagyl 375" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国：DailyMed 公开标签（SPL v25，2026-05-25 发布）仅对应 FLAGYL（metronidazole）375 mg 口服胶囊、NDC 0025-1942-50、50 粒瓶装。它不建立中国大陆、欧盟、日本或其他市场的当前批准、供应、原研/仿制关系、包装、可得性或可售资格。", "dosageFormClass": "甲硝唑口服胶囊：每粒 375 mg（美国公开标签所列；NDC 0025-1942-50，50 粒瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "本页不由单一公开标签推定首次批准年份；应按目标市场官方批准档案核验", "archiveSponsorText": "Pfizer Laboratories, Division of Pfizer Inc.（美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "metronidazole injection", "甲硝唑注射液", "metronidazole vaginal", "甲硝唑阴道制剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-flagyl-metronidazole-capsule-375mg-50-bottle-ndc-0025-1942-50", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "en": "U.S. DailyMed public label (Pfizer; SPL v25, published 25 May 2026)" }, "dosageForm": { "zh": "FLAGYL 甲硝唑口服胶囊", "en": "FLAGYL metronidazole oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0025-1942-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 375 mg；50 粒瓶装", "en": "375 mg per capsule; 50-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384&name=flagyl-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲硝唑", "en": "metronidazole" }, "value": 375, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、疗程或换算", "en": "labelled amount per capsule; not an individual's capsule count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "铁灰色不透明胶囊体、浅绿色不透明胶囊帽", "en": "iron-gray opaque body and light-green opaque cap" }, "shape": null, "imprint": "375 mg / FLAGYL", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg、50 粒瓶装美国公开标签面板（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-flagyl-metronidazole-capsule-375mg-50-bottle-ndc-0025-1942-50", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384&name=flagyl-03.jpg", "alt": "FLAGYL 甲硝唑 375 mg 口服胶囊在美国 DailyMed Pfizer 公开标签中的 50 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v25（2026-05-25 发布）", "presentation": "FLAGYL 甲硝唑：每粒 375 mg、NDC 0025-1942-50、50 粒瓶装标签图（DailyMed Pfizer 公开标签所列）。", "notice": "此图只对应美国 DailyMed 公开标签中的 FLAGYL、甲硝唑 375 mg 口服胶囊、NDC 0025-1942-50 与 50 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、胶囊、包装数量和来源；不用于鉴定真伪，也不证明片剂、注射液、阴道制剂、其他强度、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或任何个人的粒数、疗程、联用、停用或换药方案。", "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg、50 粒瓶装美国公开标签面板（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FLAGYL／甲硝唑说明书放大阅读：375 mg 是每粒胶囊的身份，不是个人粒数公式", "en": "FLAGYL label reading: 375 mg identifies each capsule; it is not an individual capsule-count formula" }, "summary": { "zh": "本模块以 Pfizer 的美国 DailyMed 公开标签为阅读入口，帮助核对 FLAGYL、甲硝唑、每粒 375 mg、口服胶囊、NDC 0025-1942-50、50 粒瓶装与标签警示。它不决定个人是否需要抗感染治疗、每次或每天几粒、疗程、是否饮酒、与华法林或其他药物同服、停用或换药。", "en": "This module uses Pfizer's U.S. DailyMed public label to check FLAGYL, metronidazole, 375 mg per capsule, oral capsule, NDC 0025-1942-50, the 50-capsule bottle and label warnings. It does not decide an individual's need for anti-infective treatment, capsule count, course, alcohol use, co-use with warfarin or another medicine, stopping or switching." }, "checks": [ { "zh": "先同时核对 FLAGYL、甲硝唑、每粒 375 mg、口服胶囊、NDC 0025-1942-50、50 粒瓶装和目标市场。375 mg 是这一准确胶囊每一粒的标签标示量，50 粒是包装数量；它们不是网页给任何人计算用量、疗程或与另一种甲硝唑产品换算的答案。", "en": "Check FLAGYL, metronidazole, 375 mg per capsule, oral-capsule form, NDC 0025-1942-50, the 50-capsule bottle and target market together. 375 mg is the labelled amount in each exact capsule and 50 is the pack count; neither is a web answer for personal use, course length or conversion to another metronidazole product." }, { "zh": "该标签把胶囊、片剂、注射制剂、阴道制剂和其他抗感染药视为不同产品问题。相同通用名、相近包装、同写 mg 或“抗菌药”都不能证明可以自行改剂型、叠加、轮换、用余药续用或因症状相似就开始使用。", "en": "The label context treats capsules, tablets, injections, vaginal products and other anti-infectives as different product questions. A matching generic name, similar package, shared mg wording or the label 'antibacterial' does not establish self-directed form changes, combination, alternation, leftover use or starting treatment for a similar symptom." }, { "zh": "标签列出与酒精或含丙二醇产品、华法林及其他口服香豆素抗凝药等相关的核对事项，并提示严重皮肤反应等风险。请把所有处方药、非处方药、补充剂和实际药盒交给药师或开方团队逐项核对；网页不能把这些警示变成个人的“能用/不能用”或停药安排。", "en": "The label identifies matters to check involving alcohol or propylene-glycol-containing products, warfarin and other oral coumarin anticoagulants, and flags serious skin reactions among other risks. Give all prescription medicines, OTC products, supplements and actual packs to a pharmacist or prescriber for item-by-item review; a webpage cannot turn these warnings into an individual's 'can/cannot use' or stopping plan." }, { "zh": "出现广泛皮疹、水疱、发热、黏膜异常、严重腹痛、昏厥、呼吸困难或其他急性严重不适时，应优先使用当地医疗支持；不要等待网页答复，也不要用同时停换多种药来试探原因。", "en": "With widespread rash, blisters, fever, mucosal changes, severe abdominal pain, fainting, breathing difficulty or another acute serious concern, prioritise local medical support; do not wait for a web response or test the cause by stopping and changing several medicines at once." } ], "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑美国公开标签（Pfizer；产品身份、警示与相互作用阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甲硝唑怎样起作用：它在敏感厌氧菌内经还原后影响 DNA 合成", "en": "How metronidazole works: in susceptible anaerobic bacteria, reduction can affect DNA synthesis" }, "summary": { "zh": "DailyMed 的 FLAGYL 标签将甲硝唑描述为硝基咪唑类抗菌药：在敏感厌氧菌内被还原后，可形成与 DNA 相互作用的产物，抑制 DNA 合成并导致 DNA 降解。标签同时说明其精确机制并不完全清楚。此处只解释药理路径，不诊断感染、不决定是否需要抗菌药、产品选择、粒数、疗程、联用或换药。", "en": "The FLAGYL DailyMed label describes metronidazole as a nitroimidazole antibacterial: after reduction in susceptible anaerobic bacteria, products can interact with DNA, inhibit DNA synthesis and lead to DNA degradation. The label also says its precise mechanism is not fully understood. This explains a pharmacologic pathway only; it does not diagnose infection or decide whether an antibacterial is needed, product selection, capsule count, course, combination or switching." }, "checks": [ { "zh": "“影响 DNA”或“厌氧菌”是标签机制线索，不是从网页判断腹痛、腹泻、阴道不适、口腔问题、发热或其他症状病因的工具，也不代表每一种感染都适合甲硝唑。", "en": "“Affecting DNA” or “anaerobic bacteria” is a label mechanism clue, not a website tool for diagnosing abdominal pain, diarrhoea, vaginal discomfort, oral concerns, fever or another symptom, and it does not mean every infection is suitable for metronidazole." }, { "zh": "与其他抗菌药的机制相似或不同，都不表示能自行把多种抗感染药拼在一起、交替、按 mg 换算或用余药续用。准确产品、病因评估、目标市场标签、完整药单和专业判断必须一起核对。", "en": "A related or different mechanism from another antibacterial does not permit self-combining, alternating, milligram conversion or leftover use. The exact product, cause assessment, target-market label, complete medicine list and professional judgment need review together." }, { "zh": "机制不能替代对过敏、严重皮肤反应、神经系统不适、肝脏情况、抗凝药联用或其他风险的产品级核对。出现新发或严重不适时，应联系当地药师、医生或紧急医疗支持。", "en": "Mechanism cannot replace product-level checking for allergy, serious skin reactions, neurologic symptoms, liver context, anticoagulant co-use or other risks. With a new or serious concern, contact local pharmacist, clinician or emergency support." } ], "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑美国公开标签（Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "FLAGYL", "generic": "甲硝唑", "dosageFormClass": "甲硝唑口服胶囊：每粒 375 mg（美国公开标签所列；NDC 0025-1942-50，50 粒瓶装）" }, "labelSource": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg 口服胶囊美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "productRoutes": [ { "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg 口服胶囊美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "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": "2026-08-24", "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": "2026-08-24", "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 Pfizer FLAGYL（metronidazole）美国公开标签列示 375 mg 口服胶囊、NDC 0025-1942-50、50 粒瓶装，以及相应的成分、警示与来源文件。本页帮助把商品名、通用名、每粒标示量、胶囊、包装与目标市场放在一起阅读；不把 375 mg 或 50 粒包装换算为个人该服几粒、疗程、能否与其他抗感染药同服、停用、换药或购买结论。", "history": "FLAGYL 375 这份美国公开标签中，375 mg 表示这一准确胶囊每粒的标示量，50 粒表示这一准确瓶装的包装数量。它不等于任何人的处方片数或疗程，也不能与甲硝唑片剂、注射液、阴道制剂、其他强度、其他厂家或其他市场的产品按数字自行换算、替换或叠加。", "sourceDocuments": [ { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg 口服胶囊美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（FLAGYL）", "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": "DailyMed SPL setid a2883ca1-5a9a-4259-9d80-46ab67274384（v25；美国公开标签记录，不据此推定其他市场状态）", "approvalTimeline": [ { "date": "2026-05-25（SPL v25 发布）", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 2026-05-25（SPL v25 发布） 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated 2026-05-25（SPL v25 发布） as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg 美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "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": "不从美国公开标签推定当地批准、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. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "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/flagyl-metronidazole/", "en": "https://origindrug.com/en/drugs/flagyl-metronidazole/" }, "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." ] }