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100, 500 and 1000 Tablets are bottle counts. A score does not permit self-splitting. Use and whether gradual adjustment is needed depend on the exact prescription, duration, disease, infection risk and other medicines; the site does not generate an individual plan." }, "checks": [ { "zh": "糖皮质激素会抑制免疫并增加病毒、细菌、真菌、寄生虫等感染风险，也可能掩盖部分感染表现。发热、气促、意识变化、明显虚弱、带状疱疹/水痘/麻疹暴露或快速恶化，应及时联系治疗团队，严重时使用当地急救。", "en": "Corticosteroids suppress immune function and increase viral, bacterial, fungal and parasitic infection risk, and may mask some infection signs. Fever, breathing difficulty, altered awareness, marked weakness, shingles/chickenpox/measles exposure or rapid deterioration needs prompt treating-team review and emergency care when severe." }, { "zh": "连续或较长时间使用后，突然停用可能出现肾上腺功能不足或撤药问题。不要因为感觉好转、血糖/血压变化或药盒快用完，就自行骤停、隔天轮换或照搬网上减量表；漏服、多服或断药应核对准确处方。", "en": "After continuous or longer use, abrupt withdrawal can cause adrenal insufficiency or withdrawal problems. Do not abruptly stop, alternate days or copy an online taper because symptoms improve, glucose or pressure changes, or the pack is nearly empty. Missed, extra or interrupted use requires review of the exact prescription." }, { "zh": "老人和多药使用者应优先核对血糖、血压、水肿/钠钾、骨质疏松与骨折、肌无力、胃肠道出血、眼压/白内障、情绪睡眠或意识变化和跌倒；网页不能凭一个化验值或症状决定继续、减量或停药。", "en": "Older adults and people with several medicines require priority review of glucose, blood pressure, oedema/sodium/potassium, osteoporosis/fracture, muscle weakness, gastrointestinal bleeding, eye pressure/cataract, mood/sleep or awareness changes and falls. One laboratory value or symptom cannot let the site decide continuation, reduction or stopping." }, { "zh": "NSAID 止痛药、抗凝/抗血小板药、利尿剂、地高辛、降糖药、环孢素、某些抗感染药和疫苗同处药单时需要专业核对。免疫抑制剂量下活疫苗存在重要边界；不要自行安排错开时间、加胃药或停掉其中一盒。", "en": "An NSAID pain medicine, anticoagulant/antiplatelet, diuretic, digoxin, glucose-lowering medicine, ciclosporin, selected anti-infectives or a vaccine on the same list requires professional review. Live vaccines have an important boundary during immunosuppressive dosing; do not invent spacing, add a stomach medicine or remove a pack yourself." } ], "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "泼尼松为何能减轻炎症：广泛改变炎症、代谢与免疫反应，不是单一止痛开关", "en": "Why prednisone can reduce inflammation: broad inflammatory, metabolic and immune effects, not a single pain switch" }, "summary": { "zh": "当前标签把泼尼松归为合成糖皮质激素，说明其具有强效抗炎作用、广泛代谢影响并改变机体对多种刺激的免疫反应。这可以解释多系统疗效和风险同时存在，但不能由机制推导个人适应证、片数、疗程或减量速度。", "en": "The current label identifies prednisone as a synthetic glucocorticoid with potent anti-inflammatory effects, broad metabolic effects and modification of immune responses to diverse stimuli. This helps explain simultaneous multisystem benefit and risk, but cannot derive an individual's indication, tablet count, course or taper speed." }, "checks": [ { "zh": "泼尼松普通片、RAYOS 延迟释放泼尼松、泼尼松龙、甲泼尼龙、地塞米松和氢化可的松不是可以按 mg 一比一换算的同一种药；也不能按共同“激素”名称自行叠加或轮换。", "en": "Immediate-release prednisone, RAYOS delayed-release prednisone, prednisolone, methylprednisolone, dexamethasone and hydrocortisone are not one medicine that can be converted one-to-one by milligrams, or self-combined or alternated from a shared corticosteroid label." }, { "zh": "抗炎作用可能让疼痛、皮疹或发热暂时减轻，但不等于病因已经消失，也不等于可以自行停抗感染药、增加激素或延长疗程。", "en": "Anti-inflammatory effects may temporarily reduce pain, rash or fever, but do not prove the cause has resolved or permit self-stopping an anti-infective, increasing the corticosteroid or extending a course." }, { "zh": "同样的每片 mg 在不同疾病、使用时间、年龄、肝肾情况和并用药下意义不同。网页只帮助识别准确产品和说明书边界，不计算“等效激素剂量”。", "en": "The same per-tablet milligram figure has different context across diseases, duration, age, liver/kidney status and co-medication. The site identifies the exact product and label boundary and does not calculate an equivalent corticosteroid dose." } ], "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DELTASONE / prednisone", "generic": "泼尼松普通片", "dosageFormClass": "泼尼松普通口服片。DELTASONE 历史原研、当前通用药、RAYOS 延迟释放片、泼尼松龙、甲泼尼龙及其他糖皮质激素是不同产品或成分；共同“激素”用途和 mg 数字不建立剂量换算、分片、减量或替换结论。" }, "labelSource": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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_9bee8c0c74da02f8", "label": "FDA Drugs@FDA：DELTASONE／prednisone NDA 009986 五个历史 RLD 规格与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=009986", "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": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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": "2026-09-02", "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": "DELTASONE 是泼尼松普通片的美国历史原研/RLD；本页可见九个面板是当前通用药，不是原品牌包装。5/10/20 mg 是每片含量，100/500/1000 Tablets 是整瓶片数。泼尼松可能抑制免疫并影响血糖、情绪/睡眠、骨骼、胃肠、水盐和眼睛；连续或较长时间使用后突然停药可能有风险。网页不生成个人疗程、片数、减量表、隔天方案或与其他激素的换算。", "history": "FDA 审评记录 prednisone 于 1955 年以 DELTASONE 和 METICORTEN 在美国首次获批。当前 DELTASONE 五个历史 RLD 规格均为 DISCN；DailyMed 当前通用药标签修订于 2025-08-15。RAYOS 是另一个 NDA 下的延迟释放泼尼松产品，不能把普通片历史或标签直接套用到延迟释放片。", "sourceDocuments": [ { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_9bee8c0c74da02f8", "label": "FDA Drugs@FDA：DELTASONE／prednisone NDA 009986 五个历史 RLD 规格与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=009986", "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": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_a017eea207be0826", "label": "FDA：泼尼松普通片 1955 年 DELTASONE／METICORTEN 初始批准历史及 RAYOS 延迟释放剂型审评背景", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "DELTASONE NDA 009986（历史原研/RLD）；prednisone ANDA 212629（当前通用药标签）", "approvalTimeline": [ { "date": "1955", "title": { "zh": "DELTASONE 与 METICORTEN 在美国初始批准", "en": "Initial U.S. approval of DELTASONE and METICORTEN" }, "detail": { "zh": "FDA 临床药理审评记录 prednisone 于 1955 年以 DELTASONE NDA 009986 和 METICORTEN NDA 009766 首次获批。", "en": "FDA clinical-pharmacology review records initial U.S. prednisone approval in 1955 as DELTASONE NDA 009986 and METICORTEN NDA 009766." }, "source": { "id": "src_a017eea207be0826", "label": "FDA：泼尼松普通片 1955 年 DELTASONE／METICORTEN 初始批准历史及 RAYOS 延迟释放剂型审评背景", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-09-02", "title": { "zh": "当前 Drugs@FDA 历史品牌状态核验", "en": "Current Drugs@FDA historical-brand status verification" }, "detail": { "zh": "五个 DELTASONE 规格均为 RLD、DISCN，并逐行标明并非因安全性或有效性撤回。", "en": "All five DELTASONE strengths are RLD and DISCN, with each row marked as not withdrawn for safety or effectiveness." }, "source": { "id": "src_9bee8c0c74da02f8", "label": "FDA Drugs@FDA：DELTASONE／prednisone NDA 009986 五个历史 RLD 规格与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=009986", "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": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2025-08-15", "title": { "zh": "当前通用药标签修订", "en": "Current generic label revision" }, "detail": { "zh": "ANDA 212629 的 5/10/20 mg、九个瓶装 NDC 与包装面板可公开阅读。", "en": "The 5/10/20 mg, nine bottle NDCs and package panels under ANDA 212629 are publicly readable." }, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 DELTASONE", "en": "United States — DELTASONE" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 009986；2.5、5、10、20、50 mg 当前均为 DISCN，且并非因安全性或有效性撤回。", "en": "NDA 009986; the 2.5, 5, 10, 20 and 50 mg rows are DISCN and not withdrawn for safety or effectiveness." } }, { "market": { "zh": "美国当前通用药", "en": "United States — current generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 212629；5、10、20 mg，各有 100、500、1000 片瓶装。", "en": "ANDA 212629; 5, 10 and 20 mg in 100-, 500- and 1000-tablet bottles." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Check the local regulator, current label and pack in hand item by item." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 DELTASONE 原研药盒吗？", "en": "Is the pictured pack the original DELTASONE pack?" }, "answer": { "zh": "不是。九个图片都是当前 ANDA 212629 通用药包装面板；DELTASONE 只作为历史原研/RLD 身份展示，本页没有把通用药图片冒充原品牌。", "en": "No. All nine images are current generic package panels under ANDA 212629. DELTASONE is shown only as the historical originator/RLD identity, and no generic image is presented as the original brand." } }, { "question": { "zh": "20 mg 有刻痕，能不能掰成两片 10 mg？", "en": "The 20 mg tablet is scored. Can it be split into two 10 mg halves?" }, "answer": { "zh": "不能由刻痕和算术自行决定。20 mg 与 10 mg 是不同准确产品；分片还涉及处方、产品标签、均一性、疗程和药师确认。网页只记录刻痕，不生成掰片或减量许可。", "en": "Not from a score and arithmetic alone. The 20 mg and 10 mg are distinct exact products, and splitting also depends on the prescription, product label, uniformity, course and pharmacist review. The site records the score but does not issue splitting or taper permission." } }, { "question": { "zh": "泼尼松、RAYOS 和甲泼尼龙可以按 mg 换着吃吗？", "en": "Can prednisone, RAYOS and methylprednisolone be alternated by milligrams?" }, "answer": { "zh": "不能。RAYOS 是延迟释放泼尼松，MEDROL 是甲泼尼龙；释放方式、成分、作用时程和处方安排不同，网页不提供换算或替换方案。", "en": "No. RAYOS is delayed-release prednisone and MEDROL is methylprednisolone. Release, ingredient, duration and prescription arrangements differ, and the site provides no conversion or substitution plan." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/deltasone-prednisone/", "en": "https://origindrug.com/en/drugs/deltasone-prednisone/" }, "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." ] }