{ "id": "rayos", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "RAYOS", "generic": "泼尼松（延迟释放）", "aliases": [ "Rayos", "prednisone delayed-release", "delayed-release prednisone", "泼尼松延迟释放片", "泼尼松缓释片", "prednisone", "泼尼松", "NDA 202020", "75987-020-01", "75987-020-02", "75987-021-01", "75987-021-02", "75987-022-01", "75987-022-02", "NP 1", "NP 2", "NP 5" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 FDA NDA 202020 历史与当前申请状态：RAYOS 1 mg、2 mg、5 mg 延迟释放片均列为 Discontinued；RLD 为 Yes；本页使用 2024-06 标签作为最近核验的有日期说明书", "dosageFormClass": "泼尼松延迟释放片：每片 1 mg、2 mg 或 5 mg；六个历史瓶装身份；不是普通即释泼尼松片，也不是持续整天匀速释放的同义词", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2012", "archiveSponsorText": "Horizon Pharma USA, Inc.（FDA 2024 有日期标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "immediate-release prednisone", "prednisone regular tablet", "泼尼松普通片", "prednisolone", "泼尼松龙", "methylprednisolone", "甲泼尼龙" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-rayos-prednisone-delayed-release-1mg-30-tablet-bottle-ndc-7598702001", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-020-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 1 mg；30 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 1 mg per tablet; 30-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "淡黄白色", "en": "pale yellowish-white" }, "shape": { "zh": "淡黄白色、圆形、无刻痕；一面压印 NP，另一面压印 1；延迟释放包衣必须保持完整", "en": "pale yellowish-white, round and unscored; debossed NP on one side and 1 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 1", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-1mg-100-tablet-bottle-ndc-7598702002", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-020-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 1 mg；100 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 1 mg per tablet; 100-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "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": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "淡黄白色", "en": "pale yellowish-white" }, "shape": { "zh": "淡黄白色、圆形、无刻痕；一面压印 NP，另一面压印 1；延迟释放包衣必须保持完整", "en": "pale yellowish-white, round and unscored; debossed NP on one side and 1 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 1", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-2mg-30-tablet-bottle-ndc-7598702101", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-021-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 2 mg；30 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 2 mg per tablet; 30-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄白色", "en": "yellowish-white" }, "shape": { "zh": "黄白色、圆形、无刻痕；一面压印 NP，另一面压印 2；延迟释放包衣必须保持完整", "en": "yellowish-white, round and unscored; debossed NP on one side and 2 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 2", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-2mg-100-tablet-bottle-ndc-7598702102", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-021-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 2 mg；100 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 2 mg per tablet; 100-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "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": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄白色", "en": "yellowish-white" }, "shape": { "zh": "黄白色、圆形、无刻痕；一面压印 NP，另一面压印 2；延迟释放包衣必须保持完整", "en": "yellowish-white, round and unscored; debossed NP on one side and 2 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 2", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-5mg-30-tablet-bottle-ndc-7598702201", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-022-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 5 mg；30 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 5 mg per tablet; 30-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "浅黄色、圆形、无刻痕；一面压印 NP，另一面压印 5；延迟释放包衣必须保持完整", "en": "light yellow, round and unscored; debossed NP on one side and 5 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 5", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-5mg-100-tablet-bottle-ndc-7598702202", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-022-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 5 mg；100 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 5 mg per tablet; 100-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "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": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "浅黄色、圆形、无刻痕；一面压印 NP，另一面压印 5；延迟释放包衣必须保持完整", "en": "light yellow, round and unscored; debossed NP on one side and 5 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 5", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验历史标签中的颜色、刻字、强度、NDC 与瓶装数量；没有把文字外观冒充为当前包装图片", "en": "Historical label text verifies colour, imprint, strength, NDC and bottle count; text-only appearance is not presented as a current package image" }, "summary": { "zh": "FDA 2024 标签列出三种无刻痕圆片和六个历史瓶装 NDC，但本次没有取得与每个包装一一对应、可安全公开展示的官方主展示面。由于 Drugs@FDA 当前状态为 Discontinued，页面只展示可追溯文字身份和可放大说明书，不使用零售图、二手交易图或其他泼尼松产品图片代替。", "en": "The 2024 FDA label lists three round unscored tablets and six historical bottle NDCs, but this review did not obtain an official principal display panel safely matched one-to-one to every pack. Because Drugs@FDA now lists the products as discontinued, the page shows traceable text identity and an enlarged label without substituting retail, resale or another prednisone product image." }, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RAYOS 说明书放大阅读：延迟释放不是普通片，包衣必须保持完整", "en": "RAYOS label reading: delayed release is not a regular tablet, and the coating must remain intact" }, "summary": { "zh": "FDA 有日期说明书要求随食物整片吞服，并明确不得掰开、分割或咀嚼。标签体外试验显示包衣使药物约延迟 4 小时才开始释放；这解释剂型差异，不是任何人的服药时刻、补服或换药指令。", "en": "The dated FDA label requires the tablet to be swallowed whole with food and says not to break, divide or chew it. Label in-vitro testing describes an approximately four-hour delay before release begins; this explains dosage-form identity and is not anyone's timing, make-up-dose or switching instruction." }, "checks": [ { "zh": "1、2、5 mg 是每片延迟释放片的标签标示量，不是一次吃几片。两个 1 mg 片在算术上虽合计 2 mg，也不能据此自行替代一片 2 mg、拼接处方或改变递减安排。", "en": "1, 2 and 5 mg are labelled amounts per delayed-release tablet, not tablets per dose. Although two 1 mg numbers add arithmetically to 2 mg, that does not permit self-substitution for one 2 mg tablet, prescription assembly or a change to a taper." }, { "zh": "不要自行掰、切、压碎或咀嚼 RAYOS。它没有刻痕，且标签说明延迟释放依赖完整包衣；若吞咽困难或处方需要更小强度，应让药师或开方团队核对准确产品和可行方案。", "en": "Do not self-break, cut, crush or chew RAYOS. It is unscored and the label explains that delayed release depends on an intact coating. If swallowing is difficult or the prescription needs a lower strength, ask the pharmacist or prescriber to review the exact product and feasible options." }, { "zh": "不要突然停用、照抄他人的递减表，或与 MEDROL、地塞米松、普通泼尼松等按毫克数自行换算。激素种类、释放方式、使用时间和个体情况不同；停用或转换需要负责治疗的专业人员决定。", "en": "Do not abruptly stop, copy another person's taper, or self-convert milligrams with MEDROL, dexamethasone or regular prednisone. Corticosteroid, release pattern, duration and individual circumstances differ; stopping or conversion requires the treating professional." }, { "zh": "感染暴露或发热、视力变化、明显情绪或行为改变、黑便/呕血、严重腹痛、显著水肿或气促等需要及时联系医疗人员；呼吸困难、面唇舌喉肿胀、晕厥或其他危重表现应立即使用当地急救服务。", "en": "Infection exposure or fever, vision change, marked mood or behaviour change, black stools or vomiting blood, severe abdominal pain, marked swelling or breathlessness need prompt medical contact. Breathing difficulty, swelling of the face/lips/tongue/throat, fainting or another critical feature requires immediate local emergency care." }, { "zh": "老年人、糖尿病、高血压、骨质疏松、胃肠道问题、肾肝功能异常或感染风险较高者，应把这些情况与完整药单交给专业人员核对。华法林、阿司匹林/NSAIDs、利尿药、地高辛、抗糖尿病药、利福平、苯妥英、酮康唑、环孢素、雌激素以及补充剂/草药都应列入药单。", "en": "Older adults and people with diabetes, hypertension, osteoporosis, gastrointestinal disease, kidney or liver impairment or higher infection risk should have these factors and the complete medicine list reviewed. Warfarin, aspirin/NSAIDs, diuretics, digoxin, diabetes medicines, rifampin, phenytoin, ketoconazole, cyclosporine, oestrogens, supplements and herbal products all belong on that list." } ], "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "RAYOS 怎样起作用：泼尼松经体内转化后产生糖皮质激素作用，延迟释放改变的是释放时点", "en": "How RAYOS works: prednisone is converted in the body for glucocorticoid effects, while delayed release changes the release timing" }, "summary": { "zh": "泼尼松在体内转化为具有活性的泼尼松龙，通过糖皮质激素相关通路产生广泛的抗炎和免疫作用。RAYOS 的核心产品差异是完整包衣造成的延迟释放；这不表示它整天匀速释放，也不证明比即释泼尼松更强、更安全或适合某个个人。", "en": "Prednisone is converted in the body to active prednisolone and produces broad anti-inflammatory and immune effects through glucocorticoid-related pathways. RAYOS's key product difference is delayed release from the intact coating. That does not mean constant all-day release or prove that it is stronger, safer or suitable for an individual compared with immediate-release prednisone." }, "checks": [ { "zh": "“延迟释放”表示释放开始时间被推后，不等于“持续释放”“缓慢整天释放”或所有写有 ER/XR/SR/MR 的产品。必须按准确商品名、剂型和说明书核对。", "en": "Delayed release means that release onset is postponed; it does not mean sustained release, constant all-day release or every product labelled ER/XR/SR/MR. Check the exact brand, dosage form and label." }, { "zh": "FDA 原始审评记录了 RAYOS 与即释泼尼松的药代和食物影响差异，但不能把这种剂型差异改写成疗效优越、可自行换算或可绕过处方的结论。", "en": "The FDA original review records pharmacokinetic and food-effect differences from immediate-release prednisone, but that dosage-form difference must not be rewritten as superior efficacy, self-convertibility or a way around a prescription." }, { "zh": "网页只解释产品身份和官方说明书。具体适应症、服用时间、剂量、疗程、递减和停药必须回到准确处方，并结合疾病、使用时长、既往反应和全部用药由专业人员核对。", "en": "The site explains product identity and the official label only. Indication, timing, amount, duration, taper and stopping must return to the exact prescription and professional review of the condition, duration of use, prior reactions and all medicines." } ], "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RAYOS", "generic": "泼尼松（延迟释放）", "dosageFormClass": "泼尼松延迟释放片：每片 1 mg、2 mg 或 5 mg；六个历史瓶装身份；不是普通即释泼尼松片，也不是持续整天匀速释放的同义词" }, "labelSource": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_025e5f7a177cb85e", "label": "FDA Drugs@FDA：RAYOS（prednisone）NDA 202020 当前申请记录；1 mg、2 mg、5 mg 均列为 Discontinued，RLD 为 Yes", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202020", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "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": "RAYOS 是一种已经在美国停止销售的泼尼松延迟释放品牌档案。它的完整包衣使药物不是吞下后立即释放；FDA 标签要求随食物整片吞服，不能掰开、分割或咀嚼。本页帮助辨认 1、2、5 mg 的每片强度、六个历史 NDC、外观文字和重要安全问题；不会把历史档案写成当前库存，也不会生成个人片数、服用时间、递减或停药方案。", "history": "FDA 于 2012 年通过 505(b)(2) 路径批准 RAYOS。原始审评把它与即释泼尼松分开评价，记录延迟释放和食物影响；这不构成疗效优于普通泼尼松的结论。FDA 2024 标签和 SUPPL-013 批准信保留了最新有日期的说明书节点，而当前 Drugs@FDA 申请页已将三个强度全部列为 Discontinued。", "sourceDocuments": [ { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_025e5f7a177cb85e", "label": "FDA Drugs@FDA：RAYOS（prednisone）NDA 202020 当前申请记录；1 mg、2 mg、5 mg 均列为 Discontinued，RLD 为 Yes", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202020", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_5f240b25f31e1431", "label": "FDA：RAYOS NDA 202020 原始审评总结（2012；505(b)(2) 延迟释放泼尼松）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000SumR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_d4bb0a4137680005", "label": "FDA：RAYOS NDA 202020/S-013 补充批准信（2024-06-05）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202020Orig1s013ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 202020（RAYOS / prednisone delayed-release tablets；美国 RLD，当前三种强度均为 Discontinued）", "approvalTimeline": [ { "date": "2012-07-26", "title": { "zh": "FDA 批准 RAYOS 延迟释放片", "en": "FDA approved RAYOS delayed-release tablets" }, "detail": { "zh": "FDA 原始审评将该 505(b)(2) NDA 与即释泼尼松参考药分开评价，记录延迟释放与食物影响。此节点用于追溯产品设计与批准，不是当前供应或相对疗效结论。", "en": "The FDA original review evaluated this 505(b)(2) NDA against an immediate-release prednisone reference and recorded delayed-release and food effects. This node traces product design and approval; it is not a current-supply or comparative-efficacy conclusion." }, "source": { "id": "src_5f240b25f31e1431", "label": "FDA：RAYOS NDA 202020 原始审评总结（2012；505(b)(2) 延迟释放泼尼松）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000SumR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2024-06-05", "title": { "zh": "FDA 批准 SUPPL-013 标签更新", "en": "FDA approved the SUPPL-013 label update" }, "detail": { "zh": "FDA 批准信和 2024-06 处方信息构成本页最近核验的有日期说明书节点。文件日期不是产品仍有库存或已重新上市的证据。", "en": "The FDA approval letter and Jun 2024 prescribing information are the most recent dated label node reviewed here. A document date is not evidence of stock or relaunch." }, "source": { "id": "src_d4bb0a4137680005", "label": "FDA：RAYOS NDA 202020/S-013 补充批准信（2024-06-05）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202020Orig1s013ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "复核 Drugs@FDA 当前申请状态", "en": "Current Drugs@FDA application status reviewed" }, "detail": { "zh": "NDA 202020 当前申请页将 1、2、5 mg 三种延迟释放片均列为 Discontinued，并将 RLD 列为 Yes。该日期是本站核验日，不是监管决定日期。", "en": "The current NDA 202020 application page lists all 1, 2 and 5 mg delayed-release tablets as Discontinued and RLD as Yes. This is the site's review date, not a regulatory-decision date." }, "source": { "id": "src_025e5f7a177cb85e", "label": "FDA Drugs@FDA：RAYOS（prednisone）NDA 202020 当前申请记录；1 mg、2 mg、5 mg 均列为 Discontinued，RLD 为 Yes", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202020", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "RLD 历史档案；1 mg、2 mg、5 mg 当前均列为 Discontinued", "en": "Historical RLD archive; 1 mg, 2 mg and 5 mg are currently listed as Discontinued" }, "detail": { "zh": "页面保留最近有日期的 FDA 标签、六个历史瓶装身份和当前申请状态。它不是库存、购买渠道、重新上市或个人适用性结论。", "en": "The page retains the most recent dated FDA label, six historical bottle identities and current application status. It is not a finding of stock, purchasing route, relaunch or individual suitability." } }, { "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 RAYOS 品牌、NDA、RLD 身份、通用名或外观推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, originator/generic relationship or interchangeability is inferred from the U.S. RAYOS brand, NDA, RLD identity, generic name or appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "RAYOS 是缓释片吗？是不是整天慢慢释放？", "en": "Is RAYOS an extended-release tablet that releases all day?" }, "answer": { "zh": "准确说它是延迟释放片：完整包衣让释放开始时间推后。它不等于所有“缓释/控释/长效”制剂，也不能据此推断整天匀速释放。核对时应使用完整商品名、剂型和官方说明书。", "en": "Its exact form is delayed release: the intact coating postpones the start of release. It is not equivalent to every sustained-, controlled- or extended-release product, and constant all-day release cannot be inferred. Use the full brand, dosage form and official label when checking it." } }, { "question": { "zh": "1 mg 片可以掰一半当 0.5 mg 吗？", "en": "Can a 1 mg tablet be split in half to make 0.5 mg?" }, "answer": { "zh": "不能自行这样做。RAYOS 标签把片剂列为无刻痕，并明确要求整片吞服、不得掰开、分割或咀嚼，因为延迟释放依赖完整包衣。需要更小强度或调整方案时，应让药师或开方团队核对准确处方和可用产品。", "en": "Do not do this yourself. The RAYOS label describes an unscored tablet and requires swallowing whole without breaking, dividing or chewing because delayed release depends on the intact coating. If a lower strength or change is needed, ask the pharmacist or prescriber to review the exact prescription and available product." } }, { "question": { "zh": "FDA 还有说明书，是否表示现在还能买到？", "en": "If FDA still has a label, is RAYOS still available?" }, "answer": { "zh": "不是。当前 Drugs@FDA 申请页将三个强度都列为 Discontinued。保留说明书和 NDA 是监管档案事实，不是库存、购买资格或重新上市结论。", "en": "No. The current Drugs@FDA application page lists all three strengths as Discontinued. A retained label and NDA are regulatory-record facts, not stock, purchasing eligibility or relaunch conclusions." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/rayos/", "en": "https://origindrug.com/en/drugs/rayos/" }, "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." ] }