{ "id": "spiriva-respimat", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Spiriva Respimat", "generic": "噻托溴铵", "aliases": [ "SPIRIVA RESPIMAT", "Spiriva Respimat", "tiotropium bromide inhalation spray" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 SPIRIVA RESPIMAT 当前公开标签（DailyMed SPL v16，2026-08-19 发布）", "dosageFormClass": "SPIRIVA RESPIMAT 定量吸入喷雾剂：每次按压 1.25 mcg 或 2.5 mcg；专用吸入器与药筒系统（DailyMed SPL v16 所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "2004（当前 DailyMed 标签所列美国初始批准）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc. / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SPIRIVA HANDIHALER", "HANDIHALER", "18 mcg capsule", "18 mcg inhalation powder", "STIOLTO RESPIMAT", "COMBIVENT RESPIMAT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-spiriva-respimat-tiotropium-1-25mcg-60-actuations-ndc-0597-0160-61", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v16（2026-08-19 发布）", "en": "DailyMed SPL v16 (published 19 Aug 2026)" }, "dosageForm": { "zh": "SPIRIVA RESPIMAT 定量吸入喷雾剂；专用吸入器与药筒系统", "en": "SPIRIVA RESPIMAT metered inhalation spray; dedicated inhaler-and-cartridge system" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0597-0160-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_actuation", "primaryDisplay": { "zh": "每次按压标签标示噻托溴铵 1.25 mcg；1 个 RESPIMAT 吸入器＋1 个专用药筒（60 次标签按压）", "en": "Tiotropium 1.25 mcg per labelled actuation; one RESPIMAT inhaler plus one dedicated cartridge (60 labelled actuations)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02&name=spiriva-16.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "噻托溴铵", "en": "tiotropium" }, "value": 1.25, "unit": "mcg", "basisCode": "per_actuation", "basisLabel": { "zh": "每次按压的标签成分标示；不是个人使用次数或方案", "en": "labelled ingredient amount per actuation; not an individual's use count or regimen" } } ], "concentration": null, "container": { "typeCode": "metered_inhaler_with_cartridge", "typeLabel": { "zh": "RESPIMAT 吸入器与专用铝制药筒系统", "en": "RESPIMAT inhaler with dedicated aluminium cartridge system" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "系统/纸盒", "en": "system per carton" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "次标签按压", "en": "labelled actuations" } } }, "deliveryDevice": { "typeCode": "respimat_metered_inhaler", "name": { "zh": "RESPIMAT 吸入器", "en": "RESPIMAT inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器＋药筒/纸盒（60 次标签按压）", "en": "inhaler plus cartridge per carton (60 labelled actuations)" } }, "physicalClues": { "color": { "zh": "蓝色 帽与对应标签面板", "en": "blue cap and corresponding label panel" }, "shape": { "zh": "灰色圆柱形装置、透明底座；专用药筒", "en": "grey cylindrical device with clear base; dedicated cartridge" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-spiriva-respimat-tiotropium-2-5mcg-60-actuations-ndc-0597-0100-61", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v16（2026-08-19 发布）", "en": "DailyMed SPL v16 (published 19 Aug 2026)" }, "dosageForm": { "zh": "SPIRIVA RESPIMAT 定量吸入喷雾剂；专用吸入器与药筒系统", "en": "SPIRIVA RESPIMAT metered inhalation spray; dedicated inhaler-and-cartridge system" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0597-0100-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_actuation", "primaryDisplay": { "zh": "每次按压标签标示噻托溴铵 2.5 mcg；1 个 RESPIMAT 吸入器＋1 个专用药筒（60 次标签按压）", "en": "Tiotropium 2.5 mcg per labelled actuation; one RESPIMAT inhaler plus one dedicated cartridge (60 labelled actuations)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02&name=spiriva-17.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "噻托溴铵", "en": "tiotropium" }, "value": 2.5, "unit": "mcg", "basisCode": "per_actuation", "basisLabel": { "zh": "每次按压的标签成分标示；不是个人使用次数或方案", "en": "labelled ingredient amount per actuation; not an individual's use count or regimen" } } ], "concentration": null, "container": { "typeCode": "metered_inhaler_with_cartridge", "typeLabel": { "zh": "RESPIMAT 吸入器与专用铝制药筒系统", "en": "RESPIMAT inhaler with dedicated aluminium cartridge system" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "系统/纸盒", "en": "system per carton" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "次标签按压", "en": "labelled actuations" } } }, "deliveryDevice": { "typeCode": "respimat_metered_inhaler", "name": { "zh": "RESPIMAT 吸入器", "en": "RESPIMAT inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器＋药筒/纸盒（60 次标签按压）", "en": "inhaler plus cartridge per carton (60 labelled actuations)" } }, "physicalClues": { "color": { "zh": "水蓝色 帽与对应标签面板", "en": "aqua cap and corresponding label panel" }, "shape": { "zh": "灰色圆柱形装置、透明底座；专用药筒", "en": "grey cylindrical device with clear base; dedicated cartridge" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-spiriva-respimat-tiotropium-2-5mcg-60-actuations-ndc-0597-0100-61", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02&name=spiriva-17.jpg", "alt": "SPIRIVA RESPIMAT 噻托溴铵 2.5 mcg 每次按压、60 次标签按压、NDC 0597-0100-61 在美国 DailyMed 当前公开标签中的纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v16（2026-08-19 发布）", "presentation": "SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂：每次按压 2.5 mcg；1 个 RESPIMAT 吸入器＋1 个专用药筒；60 次标签按压；NDC 0597-0100-61。", "notice": "此图只对应美国 DailyMed SPL v16 中 SPIRIVA RESPIMAT 2.5 mcg 每次按压、NDC 0597-0100-61、60 次标签按压的专用吸入器＋药筒纸盒。它只帮助核对品牌、成分、按压标示量、装置、药筒、包装和来源；不用于鉴定真伪，也不证明 1.25 mcg、HandiHaler 胶囊、其他 RESPIMAT 产品、其他市场标签、原研身份、目标市场批准、供应或可售资格。", "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SPIRIVA RESPIMAT 说明书放大阅读：先核对喷雾装置与药筒，再看每次按压的标示量", "en": "SPIRIVA RESPIMAT label reading: check the spray device and cartridge before the per-actuation label amount" }, "summary": { "zh": "本模块以美国 DailyMed SPL v16 当前公开标签为入口，帮助分辨 SPIRIVA RESPIMAT、噻托溴铵、每次按压标示量、60 次标签按压、专用吸入器和专用药筒。它不复述任何人的操作步骤、按压次数、间隔、漏用处理、加用、替换或急性呼吸处理方案。", "en": "This module uses the current U.S. DailyMed SPL v16 label to distinguish SPIRIVA RESPIMAT, tiotropium, the labelled amount per actuation, 60 labelled actuations, the dedicated inhaler and its dedicated cartridge. It does not reproduce anyone's device steps, actuation count, interval, missed-use action, escalation, substitution or acute-breathing plan." }, "checks": [ { "zh": "“1.25 mcg／2.5 mcg 每次按压”是喷雾装置中一次按压的标签身份字段，不是网页给任何人计算全天应按几次的答案。应同时核对准确产品名、帽色、NDC、吸入器、药筒、目标市场和处方标签。", "en": "“1.25 mcg / 2.5 mcg per actuation” is a label-identity field for one actuation from this spray device, not a webpage answer to how many times anyone should use it in a day. Check the exact product name, cap colour, NDC, inhaler, cartridge, target market and prescription label together." }, { "zh": "标签明确药筒只供 SPIRIVA RESPIMAT 吸入器使用，不应和其他 RESPIMAT 装置产品混用。相近的装置名、共同成分、都写“吸入”或都属于同一品牌家族，都不能证明装置、药筒或规格可自行替换。", "en": "The label says the cartridge is only for the SPIRIVA RESPIMAT inhaler and is not to be interchanged with another RESPIMAT device product. Similar device names, a shared ingredient, both saying “inhalation,” or the same brand family do not establish self-interchangeability of a device, cartridge or strength." }, { "zh": "SPIRIVA HANDIHALER 是粉雾剂胶囊配 HandiHaler 装置；RESPIMAT 是喷雾吸入器配药筒。HandiHaler 的“18 mcg 胶囊”不是 RESPIMAT 的药筒，也不是口服胶囊；看到相同通用名或微克数字不能推导换用。", "en": "SPIRIVA HANDIHALER is an inhalation-powder capsule with a HandiHaler device; RESPIMAT is a spray inhaler with a cartridge. A HandiHaler “18 mcg capsule” is neither a RESPIMAT cartridge nor a swallowed capsule, and a shared generic name or microgram number does not establish a switch." }, { "zh": "标签将本产品与急性支气管痉挛的即时缓解区分开来。突然或加重的气促、喘鸣、胸闷或不确定如何使用装置时，应按当地紧急医疗渠道和既有照护计划处理，并携带实际装置与完整药单请药师或临床人员核对。", "en": "The label distinguishes this product from immediate relief of acute bronchospasm. Sudden or worsening breathlessness, wheeze, chest tightness or uncertainty about the device needs local urgent-care pathways and an existing care plan, with the actual device and full medicine list reviewed by a pharmacist or clinician." } ], "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "噻托溴铵怎样起作用：它是长效抗毒蕈碱药，作用于气道平滑肌的 M3 受体", "en": "How tiotropium works: it is a long-acting antimuscarinic medicine acting at M3 receptors in airway smooth muscle" }, "summary": { "zh": "当前标签将噻托溴铵描述为抗胆碱能支气管扩张剂；在气道中，它通过抑制平滑肌上的 M3 受体产生支气管扩张相关作用。机制解释的是作用路径，不判断某个人是否适合、需要何种装置、是否应联用其他吸入药，或出现症状时应如何自行处理。", "en": "The current label describes tiotropium as an anticholinergic bronchodilator; in the airways it has bronchodilation-related effects through inhibition of M3 receptors on smooth muscle. Mechanism explains an action pathway, not whether an individual is suitable, which device is needed, whether another inhaler should be combined, or how to self-manage symptoms." }, "checks": [ { "zh": "“抗胆碱能”是核对同类药和完整药单时的一个线索，不表示可以把 RESPIMAT 与其他抗胆碱能吸入药、口服药、贴剂或眼用药自行叠加、轮换或换算。请把所有实际药品和装置交由药师或医生逐项复核。", "en": "“Anticholinergic” is one clue for reviewing related medicines and the complete medicine list; it does not permit self-combining, alternating or converting RESPIMAT with another anticholinergic inhaler, oral medicine, patch or eye medicine. Have a pharmacist or clinician review every actual medicine and device." }, { "zh": "M3 受体机制不能让相同成分的 HandiHaler 胶囊、RESPIMAT 药筒、其他喷雾装置或其他市场产品变成同一身份。产品形态、药筒与装置配对、标签版本、市场和处方目的都需要一起核对。", "en": "An M3-receptor mechanism does not make a same-ingredient HandiHaler capsule, RESPIMAT cartridge, another spray device or another-market product the same identity. Product form, cartridge-device pairing, label version, market and prescribing purpose all need to be checked together." }, { "zh": "眼痛、视物模糊、排尿困难、严重过敏样反应或呼吸症状变化等情况，不能从机制页面推断自行增减、停用或换装置。请依据当地紧急医疗渠道和专业人员建议处理。", "en": "Eye pain, blurred vision, difficulty passing urine, a serious allergy-like reaction or changing breathing symptoms cannot be used with a mechanism page to decide self-escalation, stopping or changing devices. Use local urgent-care pathways and professional advice." } ], "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Spiriva Respimat", "generic": "噻托溴铵", "dosageFormClass": "SPIRIVA RESPIMAT 定量吸入喷雾剂：每次按压 1.25 mcg 或 2.5 mcg；专用吸入器与药筒系统（DailyMed SPL v16 所列）" }, "labelSource": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "productRoutes": [ { "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "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": "2026-08-22", "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": "2026-08-22", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 SPIRIVA RESPIMAT（tiotropium bromide inhalation spray）当前公开标签将其定义为专用 RESPIMAT 吸入器与铝制药筒组成的定量吸入喷雾系统。本页分别记录 1.25 mcg 与 2.5 mcg 每次按压、各自 NDC、60 次标签按压的两张准确包装面板；不把任何包装数字转成个人应按几次、何时按、能否加用或换用的结论。", "history": "SPIRIVA RESPIMAT 与 SPIRIVA HANDIHALER 都含噻托溴铵，但标签产品形态不同：前者是定量喷雾吸入器＋专用药筒，后者是粉雾剂胶囊＋HandiHaler 装置。相同品牌家族、成分或微克数字不建立自行转换、叠加或替代关系。", "sourceDocuments": [ { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, { "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": "DailyMed SPL setid 7b656b14-fcaa-2741-f6f0-e0be48971c02（SPL v16）", "approvalTimeline": [ { "date": "2004", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 SPIRIVA RESPIMAT 标签列示 Initial U.S. Approval: 2004。该年份只定位这份美国公开标签，不推定其他市场批准、供应、可售资格、原研/仿制关系或任何个人适用性。", "en": "The current SPIRIVA RESPIMAT label lists Initial U.S. Approval: 2004. This year only locates this U.S. public label; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "date": "2026-08-19", "title": { "zh": "DailyMed 发布当前 SPL v16", "en": "DailyMed published current SPL v16" }, "detail": { "zh": "DailyMed 媒体目录将这份 SPIRIVA RESPIMAT 标签标示为 SPL v16，并列示 2026-08-19 发布。本页只用其核对两个专用吸入器＋药筒、每次按压标示量、各自 NDC 和 60 次标签按压；不据此判断实际在售、库存、购买或个人操作。", "en": "The DailyMed media catalogue identifies this SPIRIVA RESPIMAT label as SPL v16 and lists publication on 19 Aug 2026. This page uses it only to check the two inhaler-and-cartridge systems, labelled amount per actuation, their NDCs and 60 labelled actuations; it does not establish actual marketing, stock, purchase or individual operation." }, "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与两个准确包装面板", "en": "Current public label and two exact package panels linked" }, "detail": { "zh": "本页分别展示 1.25 mcg 和 2.5 mcg 每次按压、各一个 RESPIMAT 吸入器＋专用药筒、各 60 次标签按压的纸盒（NDC 0597-0160-61 与 NDC 0597-0100-61）。它们不用于鉴定真伪，也不建立实际在售、库存、购买、个人使用次数、换药、装置互换或可替代性。", "en": "This page separately displays the 1.25 mcg and 2.5 mcg per-actuation cartons, each with one RESPIMAT inhaler plus its dedicated cartridge and 60 labelled actuations (NDC 0597-0160-61 and NDC 0597-0100-61). They do not authenticate a product or establish actual marketing, stock, purchase, individual use count, switching, device interchangeability or substitutability." } }, { "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": "不从美国标签、英文品牌、NDC、药筒、帽色或包装图推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, English brand, NDC, cartridge, cap colour or package image; every market requires separate review against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "同为噻托溴铵，SPIRIVA RESPIMAT 与 SPIRIVA HANDIHALER 能否按微克数、装置名或“都是吸入药”自行换用？", "en": "Both name tiotropium. Can SPIRIVA RESPIMAT and SPIRIVA HANDIHALER be self-switched by microgram number, device name or because both are inhalers?" }, "answer": { "zh": "不能。RESPIMAT 是定量喷雾吸入器与专用药筒，HANDIHALER 是粉雾剂胶囊与专用装置；共同成分、品牌家族或微克数不建立转换公式或替代关系。请把两种实际包装、装置和完整药单交给药师或开方团队核对。", "en": "No. RESPIMAT is a metered spray inhaler with a dedicated cartridge, while HANDIHALER is an inhalation-powder capsule with its dedicated device; a shared ingredient, brand family or microgram number does not establish a conversion or substitution. Take both actual packs, devices and the full medicine list to a pharmacist or prescribing team." } }, { "question": { "zh": "包装写 1.25 mcg、2.5 mcg 或 60 次标签按压，是否表示可以自己计算或改变使用次数？", "en": "Do 1.25 mcg, 2.5 mcg or 60 labelled actuations on the carton mean someone can calculate or change their own use count?" }, "answer": { "zh": "不是。这些是这个准确美国标签产品的按压标示量与包装身份。页面不提供个人次数、时间表、漏用处理、加用、装置步骤或购买建议；请按手上准确标签，并向药师或医生核对。", "en": "No. These are the labelled per-actuation amount and package identity for this exact U.S.-labelled product. This page provides no personal use count, schedule, missed-use action, escalation, device steps or purchase advice; use the exact label in hand and check with a pharmacist or clinician." } } ], "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/spiriva-respimat/", "en": "https://origindrug.com/en/drugs/spiriva-respimat/" }, "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." ] }