{ "id": "cipro", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Cipro", "generic": "环丙沙星", "aliases": [ "ciprofloxacin" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服片剂：250 mg、500 mg；口服混悬液：250 mg/5 mL、500 mg/5 mL（DailyMed 2026 标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（DailyMed 2026 标签所列美国初始批准）", "archiveSponsorText": "Bayer / DailyMed 公开标签与 FDA 历史监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cipro-tablet-500mg-100-tablet-bottle-ndc-50419-754-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32，2026-03-04 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v32, published 4 Mar 2026; cited public label panel only, not availability" }, "dosageForm": { "zh": "CIPRO 环丙沙星口服薄膜衣片", "en": "CIPRO ciprofloxacin oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-754-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；100 片瓶装", "en": "500 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-08.jpg&setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "环丙沙星", "en": "ciprofloxacin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、疗程或自行换算", "en": "labelled amount per tablet; not an individual tablet count, course or self-conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "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": "略带黄色", "en": "slightly yellowish" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "BAYER / CIP 500", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 当前公开标签（Bayer；SPL v32，2026-03-04 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cipro-oral-suspension-250mg-per-5ml-100ml-kit-ndc-50419-777-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32，2026-03-04 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v32, published 4 Mar 2026; cited public label panel only, not availability" }, "dosageForm": { "zh": "CIPRO 环丙沙星口服混悬液套件（5%）", "en": "CIPRO ciprofloxacin oral suspension kit (5%)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-777-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含 250 mg；100 mL 复溶后口服混悬液套件", "en": "250 mg per 5 mL; 100 mL reconstituted oral-suspension kit" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-09.jpg&setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "环丙沙星", "en": "ciprofloxacin" }, "value": 250, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标签浓度；不是个人毫升数、疗程或与片剂自行换算", "en": "labelled concentration per 5 mL; not an individual's millilitres, course or self-conversion to tablets" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "250 mg/5 mL", "numerator": { "value": 250, "unit": "mg" }, "denominator": { "value": 5, "unit": "mL" }, "display": { "zh": "250 mg/5 mL（标签浓度；不是个人毫升数）", "en": "250 mg/5 mL (labelled concentration; not an individual's millilitres)" } }, "container": { "typeCode": "reconstitution_kit", "typeLabel": { "zh": "复溶口服混悬液套件", "en": "oral-suspension reconstitution kit" }, "fill": { "value": 100, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "套件/盒", "en": "kit per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "套件/盒", "en": "kit per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 当前公开标签（Bayer；SPL v32，2026-03-04 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cipro-tablet-500mg-100-tablet-bottle-ndc-50419-754-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-08.jpg&setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&type=img", "alt": "CIPRO 500 mg 环丙沙星片在美国 DailyMed 公开标签中的 Bayer 100 片装包装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2026-03 更新；图稿标注 2014）", "presentation": "CIPRO 500 mg、100 片装包装标签图（DailyMed 公开标签所列；Bayer 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 CIPRO 500 mg、100 片装的 Bayer 包装标签图，只帮助核对品牌、通用名、标示强度、片剂和来源；不用于鉴定真伪，也不证明 250 mg、口服混悬剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_607506de7ddf2b92", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CIPRO 说明书放大阅读：片剂、口服混悬液与同类抗菌药不能按经验互换", "en": "CIPRO label reading: tablets, oral suspension and related antibacterials are not interchangeable by experience" }, "summary": { "zh": "本模块以 Bayer 的 DailyMed 2026 美国公开标签为阅读入口，帮助核对 CIPRO、环丙沙星、口服片剂或口服混悬液、每一单位标示强度/浓度和目标市场；它不诊断感染，也不提供个人片数、毫升数、疗程、补用或换药方案。", "en": "This module uses Bayer's 2026 U.S. DailyMed public label as a reading entry point. It helps check CIPRO, ciprofloxacin, oral tablet or oral suspension, stated strength/concentration per unit and target market; it does not diagnose infection or provide an individual's tablet count, millilitres, duration, make-up or switching plan." }, "checks": [ { "zh": "先同时核对 CIPRO、环丙沙星、准确剂型和规格。片剂上的 mg 与口服混悬液的浓度、量具和体积不是同一种信息；相同通用名或相近数字，不能支持自行从“几片”换成“几毫升”，也不能支持把不同制剂拼成一个方案。", "en": "Check CIPRO, ciprofloxacin, exact dosage form and strength together. Milligrams on a tablet and the concentration, measuring device and volume of an oral suspension are not the same information; a shared generic name or nearby number does not support self-conversion from “tablets” to “millilitres” or assembling different forms into one plan." }, { "zh": "FDA 标签对氟喹诺酮类的重要严重不良反应、神经系统及肌腱等问题有专门警示。高龄、既往不适、多药并用或出现新疼痛、感觉异常、精神/神经系统症状时，应带实际包装和完整药单及时请专业人员判断，不要从网页决定继续、加量、停用或改药。", "en": "The FDA label carries dedicated warnings about important serious fluoroquinolone adverse reactions, including nervous-system and tendon-related concerns. With older age, prior reactions, multiple medicines, or new pain, sensory, mental or neurologic symptoms, take the actual package and complete medicine list for timely professional assessment; do not use this page to decide continuation, increase, stopping or a change." }, { "zh": "“都是抗菌药”“都是治疗尿路/呼吸道感染”并不说明可以同时服用、轮换、借给家人或替代另一种药。感染部位、检测、既往用药、肾功能、其他药物和现行标签都需由开方团队逐项核对。", "en": "“Both antibacterials” or “both used for urinary/respiratory infection” does not establish that products can be taken together, alternated, shared with family or substituted. Infection site, testing, prior treatment, kidney function, other medicines and the current label all need item-by-item review by the prescribing team." }, { "zh": "药盒照片、颜色和本页来源链接只帮助核对阅读对象，不能鉴定真伪、决定是否需要抗菌药或取代急性病情评估。出现严重或迅速恶化的不适、过敏相关症状或不确定如何使用时，应走当地医疗支持渠道。", "en": "Package photos, colours and this page’s source link only help identify what is being read; they cannot authenticate a medicine, decide whether an antibacterial is needed or replace assessment of acute illness. With severe or rapidly worsening illness, allergy-related symptoms or uncertainty about use, use local medical-support pathways." } ], "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "环丙沙星怎样起作用：它抑制细菌 DNA 复制所需的两种拓扑异构酶", "en": "How ciprofloxacin works: it inhibits two topoisomerases required for bacterial DNA replication" }, "summary": { "zh": "Bayer 的 DailyMed 2026 公开标签说明环丙沙星的杀菌作用来自抑制细菌拓扑异构酶 II（DNA 旋转酶）和拓扑异构酶 IV；这些酶与细菌 DNA 的复制、转录、修复和重组有关。机制帮助理解它是抗菌药，而不诊断感染、不决定个人剂量、疗程或是否应使用。", "en": "Bayer's 2026 DailyMed public label states that ciprofloxacin's bactericidal action results from inhibition of bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, enzymes involved in bacterial DNA replication, transcription, repair and recombination. This explains an antibacterial mechanism; it does not diagnose infection or decide an individual's dose, duration or need for treatment." }, "checks": [ { "zh": "机制与“抗菌”二字都不能区分病毒、细菌或其他原因造成的症状，更不能把任一发热、咳嗽、腹泻或尿路不适变成自行开始抗菌药的依据。适用性需要临床判断、检查资料与准确产品的现行标签。", "en": "Neither mechanism nor the word “antibacterial” distinguishes viral, bacterial or other causes of symptoms, and neither turns any fever, cough, diarrhoea or urinary symptom into a basis for self-starting an antibacterial. Suitability needs clinical judgment, testing information and the current label for the exact product." }, { "zh": "与其他抗菌药类别不同的机制，不表示可以自行联用、轮换或在一个疗程中替换。抗菌药选择、转换与复核必须依据具体感染、培养/敏感性等资料、完整药单和开方团队。", "en": "A mechanism that differs from other antibacterial classes does not permit self-combination, alternation or substitution during a course. Antibacterial selection, conversion and review must use the specific infection, information such as culture/susceptibility when relevant, the complete medicine list and the prescribing team." }, { "zh": "片剂与口服混悬液具有相同的活性成分并不使其可由机制自行换算。每种具体包装的浓度、强度、量具、标签版本与处方都必须单独核对。", "en": "A shared active ingredient in a tablet and oral suspension does not make them convertible from mechanism alone. Concentration, strength, measuring device, label version and prescription for each exact package must be checked separately." } ], "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Cipro", "generic": "环丙沙星", "dosageFormClass": "口服片剂：250 mg、500 mg；口服混悬液：250 mg/5 mL、500 mg/5 mL（DailyMed 2026 标签所列）" }, "labelSource": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_949a8bafda6a536b", "label": "FDA：CIPRO 2016 美国历史标签（NDA 020780）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.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": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2013-systemic-fluoroquinolone-peripheral-neuropathy-label-change", "issuedAt": "2013-08-15", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：全身用氟喹诺酮类的周围神经病变标签更新", "en": "FDA Drug Safety Communication: peripheral-neuropathy label updates for systemic fluoroquinolones" }, "summary": { "zh": "FDA 于 2013-08-15 发布药物安全通讯，要求全身用（口服或注射）氟喹诺酮类的说明书和患者用药指南更清楚说明周围神经病变风险；公告明确列出 Levaquin、Cipro 和 Avelox，并说明该风险可在开始用药后不久出现且可能持续。本记录是特定日期的美国类别监管通讯，不把同类关系变成任何个人的停药、改药、剂型转换或症状归因结论；出现疼痛、灼热、麻刺、麻木、无力或感觉异常等急性或令人担忧的不适，应使用当地医疗支持并由专业人员核对实际产品与完整药单。", "en": "On 2013-08-15, FDA issued a Drug Safety Communication requiring clearer peripheral-neuropathy information in labels and Medication Guides for systemic (oral or injectable) fluoroquinolones. The notice explicitly lists Levaquin, Cipro and Avelox, and says this risk may occur soon after treatment starts and may persist. This is a dated U.S. class communication; it does not turn class membership into an individual stop, switch, dosage-form conversion or symptom-attribution conclusion. With acute or concerning pain, burning, tingling, numbness, weakness or altered sensation, use local medical support and have a professional check the actual product and complete medicine list." }, "source": { "id": "src_15292a025a5f8cfe", "label": "FDA：2013-08-15 全身用氟喹诺酮类周围神经病变标签更新药物安全通讯", "url": "https://www.fda.gov/media/86575/download", "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": "Bayer 的 DailyMed CIPRO（ciprofloxacin hydrochloride）2026 美国公开标签列示 250 mg、500 mg 口服片，以及 250 mg/5 mL、500 mg/5 mL 口服混悬液，并列出美国初始批准年份为 1987。本页把当前公开标签与 FDA 2016 历史文件分开保留，用于核对品牌、通用名、剂型、强度/浓度、包装图和版本；不据此推定其他市场批准、持有人、原研关系、供应或可售资格。", "history": "片剂上的 mg 与口服混悬液的 mg/5 mL 是不同的身份字段，不能仅按通用名或相近数字互相换算。页面所示 Bayer 500 mg 包装图只对应该标签列示的一个口服片包装；历史 FDA 文件不能替代现行标签，现行标签也不构成个人使用、换药或购买结论。", "sourceDocuments": [ { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_949a8bafda6a536b", "label": "FDA：CIPRO 2016 美国历史标签（NDA 020780）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020780", "approvalTimeline": [ { "date": "1987", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1987。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1987. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_949a8bafda6a536b", "label": "FDA: CIPRO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2016-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2016-07 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2016-07 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_949a8bafda6a536b", "label": "FDA: CIPRO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cipro/", "en": "https://origindrug.com/en/drugs/cipro/" }, "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." ] }