{ "id": "ceftin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "CEFTIN", "generic": "头孢呋辛酯", "aliases": [ "Ceftin", "cefuroxime axetil", "cefuroxime", "头孢呋辛酯", "头孢呋辛酯片", "头孢呋辛酯混悬剂", "头孢呋辛", "NDA 050605", "NDA 050672", "DIN 02212307", "125 mg/5 mL" ], "marketBrandNames": [ { "name": "CEFTIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "FDA Orange Book 历史 RLD；片剂与混悬剂当前均列为 Discontinued。", "en": "Historical FDA Orange Book RLD; tablets and suspension are currently listed as discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "CEFTIN", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Health Canada 当前 DIN 02212307：125 mg/5 mL 混悬剂颗粒，Sandoz Canada。", "en": "Current Health Canada DIN 02212307: 125 mg/5 mL granules for suspension, Sandoz Canada." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA Orange Book：NDA 050605 三个片剂强度与 NDA 050672 两个混悬剂浓度均为历史 RLD、当前列为 Discontinued；加拿大 Health Canada：DIN 02212307 的 125 mg/5 mL 混悬剂颗粒当前列为 Marketed", "dosageFormClass": "头孢呋辛酯口服片与复溶后口服混悬剂；每片 mg 与每 5 mL 的 mg/5 mL 是不同计量基础，不能按数字直接互换", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（美国片剂）；1994（美国混悬剂）；加拿大当前记录另行列示", "archiveSponsorText": "美国历史 NDA：GlaxoSmithKline；加拿大当前 DIN：Sandoz Canada Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "cefuroxime sodium injection", "头孢呋辛钠注射剂", "generic cefuroxime axetil tablet", "其他厂牌头孢呋辛酯" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ceftin-cefuroxime-axetil-tablet-125-nda-050605-product-001-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服片（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050605 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于头孢呋辛 125；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 125 per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或疗程", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ceftin-cefuroxime-axetil-tablet-250-nda-050605-product-002-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服片（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050605 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于头孢呋辛 250；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 250 per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或疗程", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ceftin-cefuroxime-axetil-tablet-500-nda-050605-product-003-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服片（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050605 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于头孢呋辛 500；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 500 per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或疗程", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ceftin-cefuroxime-axetil-suspension-125-nda-050672-product-001-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服混悬剂用粉末（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil powder for oral suspension (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050672 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 相当于头孢呋辛 125；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 125 per 5 mL after reconstitution; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 125, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 的历史监管浓度；不是个人毫升数、频率或疗程", "en": "historical regulatory concentration per 5 mL after reconstitution; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ceftin-cefuroxime-axetil-suspension-250-nda-050672-product-002-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服混悬剂用粉末（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil powder for oral suspension (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050672 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 相当于头孢呋辛 250；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 250 per 5 mL after reconstitution; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 250, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 的历史监管浓度；不是个人毫升数、频率或疗程", "en": "historical regulatory concentration per 5 mL after reconstitution; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-ceftin-cefuroxime-axetil-granules-for-suspension-125mg-5ml-din-02212307", "marketCode": "CA", "labelVersion": { "zh": "Health Canada 当前产品专论（2025-10-03）", "en": "Current Health Canada product monograph (3 Oct 2025)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服混悬剂用颗粒", "en": "CEFTIN cefuroxime axetil granules for oral suspension" }, "route": { "zh": "口服（加拿大当前市场记录）", "en": "oral (current Canadian market record)" }, "routeCodes": [ "oral" ], "productCode": "DIN 02212307", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 相当于头孢呋辛 125 mg；当前公开记录未据此建立个人毫升数", "en": "Equivalent to cefuroxime 125 mg per 5 mL after reconstitution; the public record does not establish an individual's millilitres" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 125, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 的标签浓度；不是个人毫升数、频率或疗程", "en": "labelled concentration per 5 mL after reconstitution; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "marketed_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已建立六个官方文字产品身份；没有用仿制药、零售图或历史图冒充原品牌包装", "en": "Six official text product identities are established; no generic, retail or historical image is presented as an originator-brand pack" }, "summary": { "zh": "FDA 数据可核实美国五个历史产品的剂型、强度、NDA、产品号、RLD 与停止销售状态；Health Canada 可核实当前加拿大 DIN、剂型与浓度。现有官方来源没有提供与这六个身份一一对应、可安全公开展示的原品牌包装主展示面，因此页面显示来源可追溯文字卡与可放大说明书，并明确暂无准确包装图。", "en": "FDA data verify dosage form, strength, NDA, product number, RLD and discontinued status for five historical U.S. products; Health Canada verifies the current Canadian DIN, form and concentration. The reviewed official sources do not provide an originator-brand principal display panel safely matched one-to-one to all six identities, so the page shows traceable text cards and an enlarged label while explicitly disclosing the image gap." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CEFTIN 说明书放大阅读：先分清每片 mg、复溶后 mg/5 mL 和个人毫升数", "en": "CEFTIN label reading: separate mg per tablet, mg/5 mL after reconstitution and an individual's millilitres" }, "summary": { "zh": "加拿大当前产品专论把 CEFTIN 写为复溶后 125 mg/5 mL 的口服混悬剂。125 mg/5 mL 是浓度，不是每次 5 mL，也不是任何人的剂量；实际毫升数、频率和疗程必须回到准确处方、年龄/体重、感染情况、肾功能和给药器。", "en": "The current Canadian monograph identifies CEFTIN as an oral suspension containing 125 mg/5 mL after reconstitution. 125 mg/5 mL is a concentration, not an instruction to take 5 mL and not anyone's dose. Actual millilitres, frequency and course must return to the exact prescription, age/weight, infection context, kidney function and dosing device." }, "checks": [ { "zh": "片剂的 125、250、500 mg 是每片标签量；混悬剂的 125 或 250 mg/5 mL 是复溶后每 5 mL 的浓度。不能只让数字相同就把片剂与混悬剂按毫克对毫升自行替代；FDA 标签资料还指出两种剂型并非生物等效，不能按毫克对毫克直接替换。", "en": "Tablet 125, 250 and 500 mg values are per tablet; suspension 125 or 250 mg/5 mL values are concentrations per 5 mL after reconstitution. Matching numbers do not permit self-substitution between tablets and suspension, and FDA label material states that the forms are not bioequivalent and are not directly substitutable milligram for milligram." }, { "zh": "加拿大当前混悬剂应按药房配制后的标签与口服给药器量取；普通厨房勺不是准确给药器。产品专论要求冷藏 2–8°C，并在 10 天后丢弃剩余复溶液。网页不会把浓度转换为个人毫升数。", "en": "Use the pharmacy label and an oral dosing device for the reconstituted Canadian suspension; an ordinary kitchen spoon is not an accurate dosing device. The monograph requires refrigeration at 2–8°C and disposal of the remaining reconstituted suspension after 10 days. The site does not convert the concentration into individual millilitres." }, { "zh": "加拿大专论建议与食物同用以获得最佳吸收；但页面不决定个人时刻，也不把该说明外推到美国历史片剂、其他厂牌或不同市场产品。先核对手中准确药盒和当地现行说明书。", "en": "The Canadian monograph recommends use with food for optimal absorption, but this page does not decide personal timing or extend that statement to historical U.S. tablets, another brand or another market. Check the exact pack and current local label first." }, { "zh": "使用前应告知头孢菌素、青霉素或其他药物过敏史，以及肾功能问题和完整药单。呼吸困难、面唇舌喉肿胀、晕厥、严重皮肤反应或胸部不适伴过敏表现需要立即使用当地急救服务；严重、持续或带血腹泻需要尽快医疗评估。", "en": "Before use, disclose cephalosporin, penicillin or other drug allergies, kidney problems and the complete medicine list. Breathing difficulty, swelling of the face/lips/tongue/throat, fainting, a severe skin reaction or chest discomfort with allergic features requires immediate local emergency care. Severe, persistent or bloody diarrhoea needs prompt medical assessment." }, { "zh": "减酸药、氨基糖苷类、利尿药以及其他处方药、非处方药和补充剂都应放入完整药单交给药师或开方团队核对。网页不会仅凭两个药名自动判定可以同服、需要错开或怎样调整。", "en": "Acid-reducing medicines, aminoglycosides, diuretics and all other prescription, OTC and supplement products belong on the complete medicine list for pharmacist or prescriber review. The site does not decide co-use, separation or adjustment from two medicine names alone." } ], "source": { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "头孢呋辛怎样起作用：抑制细菌细胞壁合成，不表示对所有发热或咳嗽都有效", "en": "How cefuroxime works: inhibiting bacterial cell-wall synthesis does not mean it treats every fever or cough" }, "summary": { "zh": "头孢呋辛酯口服后转化为头孢呋辛，通过与细菌青霉素结合蛋白相互作用、抑制细胞壁合成发挥抗菌作用。机制只帮助理解药物类别，不能仅凭症状判断病原、敏感性、是否需要抗菌药或疗程。", "en": "After oral administration, cefuroxime axetil is converted to cefuroxime, which acts through bacterial penicillin-binding proteins and inhibition of cell-wall synthesis. The mechanism explains the class but cannot establish the organism, susceptibility, need for an antibacterial or course from symptoms alone." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。不要拿剩药、与家人共用、因症状相似自行开始，或在感觉好转后自行缩短处方疗程。", "en": "Antibacterials do not treat an ordinary viral cold. Do not use leftovers, share, self-start because symptoms seem similar or shorten a prescribed course because you feel better." }, { "zh": "CEFTIN、KEFLEX、阿莫西林、AUGMENTIN、ZITHROMAX、LEVAQUIN 等不是按毫克数字自行替换、轮换或叠加的一种药。药物类别、病原与药敏、感染部位、过敏史、肾功能和完整药单都会影响专业判断。", "en": "CEFTIN, KEFLEX, amoxicillin, AUGMENTIN, ZITHROMAX and LEVAQUIN are not one medicine that can be self-switched, alternated or combined from milligram numbers. Class, organism and susceptibility, infection site, allergy history, kidney function and the complete medicine list all affect professional judgement." }, { "zh": "网页只解释准确产品与官方说明书，不替个人选择抗菌药、计算片数或毫升数，也不判断是否需要培养、药敏或复诊。", "en": "The site explains the exact product and official label. It does not select an antibacterial, calculate tablets or millilitres, or decide whether culture, susceptibility testing or follow-up is needed for an individual." } ], "source": { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CEFTIN", "generic": "头孢呋辛酯", "dosageFormClass": "头孢呋辛酯口服片与复溶后口服混悬剂；每片 mg 与每 5 mL 的 mg/5 mL 是不同计量基础，不能按数字直接互换" }, "labelSource": { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-29", "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_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-29", "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": "CEFTIN 是头孢呋辛酯品牌档案。美国历史记录包含 125、250、500 mg 片剂和 125、250 mg/5 mL 混悬剂，当前均列为停止销售；加拿大当前记录是 125 mg/5 mL 混悬剂颗粒。最重要的是先看剂型和计量单位：片剂写的是每片 mg，混悬剂写的是复溶后每 5 mL 含多少 mg，两个数字不能直接当成个人片数或毫升数。", "history": "FDA Orange Book 记录 CEFTIN 片剂于 1987-12-28 获批，125 mg/5 mL 与 250 mg/5 mL 混悬剂分别于 1994-06-30 与 1997-04-29 获批；当前均为停止销售的历史 RLD 记录。Health Canada 当前产品数据库另列 DIN 02212307、125 mg/5 mL 混悬剂颗粒为 Marketed，产品专论日期为 2025-10-03。", "sourceDocuments": [ { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_3fe7f0d27d7c8b9e", "label": "FDA：CEFTIN NDA 050605/S-051 与 NDA 050672/S-037 补充批准信（2019-04-25）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/50605Orig1s051;%2050672Orig1s037ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 050605（CEFTIN 片剂）／NDA 050672（CEFTIN 混悬剂）；Health Canada DIN 02212307（当前 125 mg/5 mL 混悬剂）", "approvalTimeline": [ { "date": "1987-12-28", "title": { "zh": "FDA 批准 CEFTIN 口服片", "en": "FDA approved CEFTIN oral tablets" }, "detail": { "zh": "Orange Book 当前数据将 125、250、500 mg 片剂与 NDA 050605、RLD 身份和现行 Discontinued 状态相连。", "en": "The current Orange Book dataset links 125, 250 and 500 mg tablets to NDA 050605, RLD identity and current discontinued status." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1994-06-30", "title": { "zh": "FDA 批准 125 mg/5 mL 混悬剂", "en": "FDA approved the 125 mg/5 mL suspension" }, "detail": { "zh": "该产品属于 NDA 050672；250 mg/5 mL 产品后来于 1997-04-29 获批。两者当前均列为 Discontinued。", "en": "This product belongs to NDA 050672; the 250 mg/5 mL product was later approved on 29 Apr 1997. Both are currently listed as discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2019-04-25", "title": { "zh": "FDA 批准 CEFTIN 标签补充申请", "en": "FDA approved CEFTIN labelling supplements" }, "detail": { "zh": "批准信同时连接 NDA 050605 片剂与 NDA 050672 混悬剂，是有日期的历史监管节点；它不是当前库存或重新上市结论。", "en": "The approval letter links the tablet and suspension NDAs as a dated regulatory node; it is not a finding of current stock or relaunch." }, "source": { "id": "src_3fe7f0d27d7c8b9e", "label": "FDA：CEFTIN NDA 050605/S-051 与 NDA 050672/S-037 补充批准信（2019-04-25）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/50605Orig1s051;%2050672Orig1s037ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-10-03", "title": { "zh": "Health Canada 当前产品专论日期", "en": "Current Health Canada monograph date" }, "detail": { "zh": "DIN 02212307 当前列为 Marketed，剂型为混悬剂颗粒、浓度 125 mg/5 mL，持有人为 Sandoz Canada Inc.。", "en": "DIN 02212307 is currently listed as marketed: granules for suspension, 125 mg/5 mL, held by Sandoz Canada Inc." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "五个历史 RLD 产品当前均列为 Discontinued", "en": "Five historical RLD products are currently listed as discontinued" }, "detail": { "zh": "保留 FDA 监管身份用于历史追溯，不表示有库存、可购买、适合个人或可与当前仿制药直接互换。", "en": "The FDA identities are retained for historical traceability and do not establish stock, purchasing availability, individual suitability or direct interchangeability with a current generic." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "DIN 02212307 的 125 mg/5 mL 混悬剂颗粒当前列为 Marketed", "en": "DIN 02212307 125 mg/5 mL granules for suspension are currently listed as marketed" }, "detail": { "zh": "“Marketed”是监管数据库状态，不表示任何具体药店有库存，也不是个人购买或使用建议。", "en": "‘Marketed’ is a regulatory-database status, not proof of stock at a particular pharmacy or an individual purchasing or use recommendation." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国或加拿大品牌记录推定当地商品名、批准、持有人、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, holder, pack, supply, originator/generic relationship or interchangeability is inferred from U.S. or Canadian brand records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "瓶上写 125 mg/5 mL，是不是每次都喝 5 mL？", "en": "Does 125 mg/5 mL mean taking 5 mL every time?" }, "answer": { "zh": "不是。它表示复溶后每 5 mL 中含 125 mg，是浓度。个人毫升数、频率和疗程必须来自准确处方与药房标签，并用合适的口服给药器量取。", "en": "No. It is the concentration: 125 mg in each 5 mL after reconstitution. Individual millilitres, frequency and course must come from the exact prescription and pharmacy label and be measured with an appropriate oral dosing device." } }, { "question": { "zh": "同样写 250 mg，片剂和 250 mg/5 mL 混悬剂可以直接换吗？", "en": "Can a 250 mg tablet and 250 mg/5 mL suspension be directly exchanged?" }, "answer": { "zh": "不能仅按数字自行换。前者是每片量，后者是复溶后浓度；剂型、吸收和配制方式不同，FDA 资料还明确两种剂型并非生物等效、不能按毫克对毫克直接替换。请让药师或开方团队核对准确产品和处方。", "en": "Do not self-exchange them from the number alone. One is an amount per tablet and the other is a concentration after reconstitution. Their forms, absorption and preparation differ, and FDA material states that the forms are not bioequivalent or directly substitutable milligram for milligram. Ask the pharmacist or prescriber to check the exact product and prescription." } }, { "question": { "zh": "美国 CEFTIN 停止销售，是否表示因为不安全？", "en": "Does discontinued U.S. CEFTIN mean it was unsafe?" }, "answer": { "zh": "不能这样推断。FDA Orange Book 对 NDA 050605 片剂记录了“并非因安全性或有效性原因撤市”的联邦公报判定；网页仍不据此判断具体停产原因、当前库存或其他市场状态。", "en": "That inference is not justified. The FDA Orange Book records a Federal Register determination that the NDA 050605 tablets were not discontinued or withdrawn for safety or effectiveness reasons. The site still does not infer a particular commercial reason, current stock or another market's status." } } ], "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/ceftin/", "en": "https://origindrug.com/en/drugs/ceftin/" }, "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." ] }