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not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 240, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 240, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、蓝色胶囊体", "en": "blue cap and blue body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 245", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 61.25/245 mg、NDC 64896-664-43、240 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-rytary-carbidopa-23-75mg-levodopa-95mg-100-capsule-bottle-ndc-6489666101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rytary-extended-release-capsules-3.jpg&setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "alt": "DailyMed 当前 RYTARY 23.75/95 mg、NDC 64896-661-01、100 粒瓶装标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（SPL v26，2026-03-26 更新）", "presentation": "RYTARY 每粒卡比多巴 23.75 mg / 左旋多巴 95 mg，NDC 64896-661-01，100 粒瓶装。", "notice": "此图只对应 RYTARY 23.75/95 mg、NDC 64896-661-01、100 粒瓶装；不能代表另三个 100 粒包装、240 粒或 25 粒包装、另一个 100 粒 NDC、其他卡比多巴/左旋多巴制剂、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存或可替代性。", "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 23.75/95 mg、NDC 64896-661-01、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": { "status": "partial_exact_visual_coverage", "title": { "zh": "十四个包装身份中只有四个有精确官方展示面板", "en": "Only four of fourteen package identities have exact official display panels" }, "summary": { "zh": "当前 SPL 为四种 100 粒、NDC -01 瓶装提供准确展示面板；其余十个活跃结构化包装 NDC 只有来源文字身份。网页为这些包装保留文字卡，不借用相同规格或相同片数的图片。", "en": "The current SPL provides exact display panels for the four 100-capsule NDC -01 bottles. The other ten active structured package NDCs have source-text identity only. The site keeps text cards for them and does not borrow an image from the same strength or pack count." }, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RYTARY 说明书放大阅读：缓释胶囊不能分半；吞咽困难时必须使用全部内容物", "en": "RYTARY label reading: the extended-release capsule cannot be halved; swallowing difficulty requires the entire contents" }, "summary": { "zh": "四组双数字都是每粒胶囊内卡比多巴和左旋多巴的标示量。打开胶囊撒在苹果酱上，是现行标签针对吞咽困难给出的整粒内容物给药方式，不是减半、按颗粒估算剂量或改变缓释结构的通用许可。RYTARY 与 SINEMET、STALEVO、CREXONT 等产品不能按共同成分或毫克数自行换算。", "en": "Each paired strength states carbidopa and levodopa in one capsule. Opening the capsule onto applesauce is a current-label administration option for swallowing difficulty using the entire contents; it is not permission to halve a dose, estimate pellets or alter extended release generally. RYTARY cannot be self-converted with SINEMET, STALEVO, CREXONT or another product from shared ingredients or milligrams." }, "checks": [ { "zh": "标签要求整粒吞服；不要咀嚼、分开当两次、压碎或把颗粒研碎。吞咽困难时，可按标签小心旋开胶囊两半，把两半的全部内容物撒在 1–2 汤匙苹果酱上立即全部吃完；不能保存，也不能只取一半。若实际产品、食物要求或吞咽能力不同，应让药师或开方团队核对。", "en": "The label says to swallow the capsule whole and not chew, divide or crush it or grind the pellets. For swallowing difficulty, the label allows carefully opening both halves, sprinkling the entire contents on 1–2 tablespoons of applesauce and consuming it immediately. Do not store it or take only part. Have a pharmacist or prescriber review a different actual product, food requirement or swallowing limitation." }, { "zh": "RYTARY 与其他卡比多巴/左旋多巴产品不可互换。SINEMET 是即释片；STALEVO 还含恩他卡朋；CREXONT、DHIVY、DUOPA、VYALEV 等还有不同剂型或给药系统。不要根据总左旋多巴毫克、双数字、外观或旧处方自行叠加、隔天轮换、换算或替换。", "en": "RYTARY is not interchangeable with other carbidopa/levodopa products. SINEMET is an immediate-release tablet; STALEVO also contains entacapone; CREXONT, DHIVY, DUOPA and VYALEV have different forms or delivery systems. Do not self-combine, alternate by day, convert or substitute from total levodopa milligrams, paired numbers, appearance or an old prescription." }, { "zh": "不要突然停用或快速减量。标签描述快速减量、停药或改变多巴胺能治疗后可能出现高热、肌肉僵硬、意识改变和自主神经不稳定。若出现高热、明显僵硬、意识异常、呼吸或循环不稳等急性严重表现，立即使用当地急救服务，并携带药盒与完整药单。", "en": "Do not suddenly stop or rapidly reduce RYTARY. The label describes hyperpyrexia, muscular rigidity, altered consciousness and autonomic instability after rapid reduction, withdrawal or changes in dopaminergic therapy. Use local emergency services immediately for high fever, marked rigidity, altered consciousness, breathing or circulatory instability, and take the pack and complete medicine list." }, { "zh": "日常活动中突然入睡、明显嗜睡或头晕可能影响驾驶和操作机器；幻觉、精神症状、异常冲动（赌博、消费、性冲动、暴食等）或新的不自主动作也需要尽快联系治疗团队。家属和照护者常比本人更早注意到这些变化。网页不据此替个人调药。", "en": "Sudden sleep during daily activities, marked somnolence or dizziness may impair driving or machinery use. Hallucinations, psychotic symptoms, intense urges involving gambling, spending, sex or eating, and new involuntary movements also require prompt contact with the care team. Family or carers may notice these changes first. The site does not adjust treatment from these symptoms." }, { "zh": "2026 年标签加入维生素 B6 缺乏与相关癫痫发作警告。抑郁、意识混乱、口角炎、舌炎、皮炎、贫血、神经病变或癫痫发作需要医疗评估；癫痫发作、意识丧失或持续抽搐时立即使用当地急救服务。不要依据网页自行检测、补充大剂量 B6 或停换药。", "en": "The 2026 label added a warning about vitamin B6 deficiency and associated seizures. Depression, confusion, cheilosis, glossitis, dermatitis, anaemia, neuropathy or seizures needs clinical assessment; use local emergency services for a seizure, loss of consciousness or ongoing convulsions. Do not use the site to arrange testing, high-dose B6 supplementation, stopping or switching." }, { "zh": "非选择性 MAO 抑制剂（如苯乙肼、反苯环丙胺）及停药不足两周属于标签禁忌边界。铁盐或含铁复合维生素可能降低生物利用度；高脂高热量餐可能延迟吸收，高蛋白餐也可能影响左旋多巴吸收。不要自行停药、改餐、错开时间或删掉补充剂，让药师按完整药单和日常饮食核对。", "en": "Nonselective MAO inhibitors such as phenelzine or tranylcypromine, including use within the past two weeks, form a labelled contraindication boundary. Iron salts or iron-containing multivitamins may reduce bioavailability; high-fat, high-calorie meals may delay absorption, and high-protein meals may also affect levodopa absorption. Do not self-stop medicines, change meals, schedule separation or remove supplements; have a pharmacist review the full list and usual diet." }, { "zh": "标签还提醒心血管缺血事件、既往消化性溃疡出血风险和青光眼眼压监测。胸痛、严重气促、昏厥、呕血或黑便、急性视力变化等严重表现应使用当地紧急医疗渠道；网页不根据症状替个人继续、暂停或改变规格。", "en": "The label also addresses cardiovascular ischaemic events, upper gastrointestinal bleeding risk with prior peptic ulcer and intraocular-pressure monitoring in glaucoma. Use local urgent or emergency care for chest pain, severe breathlessness, fainting, vomiting blood or black stools, acute visual change or another serious presentation; the site does not continue, pause or change a strength for an individual." } ], "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样配合：左旋多巴进入脑内形成多巴胺，卡比多巴主要减少外周分解", "en": "How the two ingredients work together: levodopa reaches the brain to form dopamine while carbidopa mainly reduces peripheral breakdown" }, "summary": { "zh": "当前标签说明，左旋多巴可通过血脑屏障并在脑内转化为多巴胺；卡比多巴不易通过血脑屏障，主要抑制外周左旋多巴脱羧，使更多左旋多巴可供进入脑内。RYTARY 还通过即释与缓释成分组合形成特定释放曲线。机制能解释为什么同一粒有两种成分和缓释设计，但不能产生个人转换表、适合性或胶囊数。", "en": "The current label explains that levodopa crosses the blood-brain barrier and is converted to dopamine in the brain, while carbidopa does not readily cross and mainly inhibits peripheral levodopa decarboxylation, leaving more levodopa available to reach the brain. RYTARY also combines immediate- and extended-release components for a specific release profile. This explains two ingredients and the extended-release design but cannot produce an individual conversion table, suitability decision or capsule count." }, "checks": [ { "zh": "同一通用成分不等于相同释放曲线。RYTARY、SINEMET、Sinemet CR 与 CREXONT 的剂型结构不同，不能把每粒或每片 mg 直接相加后认定等效。", "en": "Shared generic ingredients do not create the same release profile. RYTARY, SINEMET, Sinemet CR and CREXONT have different dosage-form designs; per-capsule or per-tablet milligrams cannot simply be added and treated as equivalent." }, { "zh": "打开胶囊把全部颗粒撒在苹果酱上，不等于破坏缓释颗粒；咀嚼、压碎、研磨、只取部分或存放混合物会越过标签边界。", "en": "Opening the capsule and sprinkling all pellets on applesauce does not mean destroying the extended-release pellets. Chewing, crushing, grinding, taking only part or storing the mixture crosses the label boundary." }, { "zh": "作用机理不会判断某个人何时出现“开”“关”、是否需要换制剂、如何处理漏服或是否适合基因筛查。帕金森病治疗和多药联用应由熟悉病情的团队结合实际产品、症状日记和完整药单评估。", "en": "Mechanism cannot determine an individual's on/off timing, need for a formulation change, missed-use response or suitability for genetic screening. Parkinson treatment and polypharmacy require the treating team to review the actual product, symptom record and complete medicine list." } ], "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "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": "RYTARY", "generic": "卡比多巴/左旋多巴缓释胶囊", "dosageFormClass": "卡比多巴/左旋多巴固定两成分缓释口服胶囊：23.75/95、36.25/145、48.75/195、61.25/245 mg；每组两个数字属于同一粒胶囊内两种成分；不是 SINEMET 即释片或其他缓释产品的毫克换算表" }, "labelSource": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：RYTARY，NDA 203312，四个缓释胶囊规格均列为处方 RLD；61.25/245 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：RYTARY NDA 203312 申请、标签与补充申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "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": "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": "2026-08-29", "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": [ { "id": "fda-2026-rytary-carbidopa-levodopa-vitamin-b6-seizure-safety-communication", "issuedAt": "2026-03-20", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：RYTARY 等含卡比多巴/左旋多巴产品的维生素 B6 缺乏与癫痫发作警告", "en": "FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for RYTARY and other carbidopa/levodopa products" }, "summary": { "zh": "FDA 于 2026-03-20 发布安全通讯，要求所有含卡比多巴/左旋多巴产品加入维生素 B6 缺乏及相关癫痫发作警告；RYTARY 当前标签已经纳入这项警示。该通讯不能判断个人是否缺乏维生素 B6、是否需要检测或补充，也不能支持自行停药、换成 SINEMET／STALEVO、改变胶囊数或调整给药时间。出现癫痫发作、意识丧失或持续抽搐时使用当地急救服务；其他疑似表现请让开方团队结合准确产品和完整药单评估。", "en": "On 20 Mar 2026, FDA issued a Drug Safety Communication requiring every carbidopa/levodopa product to add a warning about vitamin B6 deficiency and associated seizures; the current RYTARY label includes this warning. The communication cannot determine an individual's vitamin B6 status, need for testing or supplementation, and does not support self-stopping, switching to SINEMET or STALEVO, changing capsule counts or altering timing. Use local emergency services for a seizure, loss of consciousness or ongoing convulsions; have the prescribing team assess other suspected symptoms using the exact product and complete medicine list." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "RYTARY 是卡比多巴/左旋多巴缓释胶囊，不是 SINEMET 即释片的另一种包装。标签明确说 RYTARY 与其他卡比多巴/左旋多巴产品的剂量不可互换。整粒能吞咽时应整粒吞服；吞咽困难者，标签允许把胶囊两半全部内容物撒在少量苹果酱上立即吃完，但不能咀嚼、分成半粒、压碎、只吃一部分或留到以后。网页只解释产品和说明书，不计算个人胶囊数、转换表、间隔、漏服或停药方案。", "history": "FDA 于 2015-01-07 批准 RYTARY NDA 203312 的四个缓释胶囊规格；当前 Orange Book 仍将四个规格列为处方 RLD。2026 年补充申请及 FDA 安全通讯把维生素 B6 缺乏与相关癫痫发作信息纳入含卡比多巴/左旋多巴产品的标签更新。DailyMed 当前页面于 2026-03-26 更新。标签所写 Initial U.S. Approval: 1975 指卡比多巴/左旋多巴组合的历史，不是 RYTARY 品牌在 1975 年获批。", "sourceDocuments": [ { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：RYTARY，NDA 203312，四个缓释胶囊规格均列为处方 RLD；61.25/245 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：RYTARY NDA 203312 申请、标签与补充申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_cbd3cd0c28d32a40", "label": "FDA：RYTARY NDA 203312 原始批准函（2015-01-07）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203312Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_fa67960e7b1a5aba", "label": "FDA：RYTARY NDA 203312/S-026 维生素 B6 缺乏与癫痫发作标签补充批准函（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/203312Orig1s026ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } ], "applicationNumber": "FDA NDA 203312（RYTARY / carbidopa and levodopa extended-release capsules）", "approvalTimeline": [ { "date": "2015-01-07", "title": { "zh": "RYTARY 四个缓释胶囊规格获批", "en": "Four RYTARY extended-release capsule strengths approved" }, "detail": { "zh": "FDA 原始批准函确认 NDA 203312 的 23.75/95、36.25/145、48.75/195 与 61.25/245 mg 四个规格获批；Orange Book 当前数据仍列四个处方 RLD。", "en": "The FDA original approval letter confirms approval of NDA 203312 strengths 23.75/95, 36.25/145, 48.75/195 and 61.25/245 mg; current Orange Book data still list four prescription RLD products." }, "source": { "id": "src_cbd3cd0c28d32a40", "label": "FDA：RYTARY NDA 203312 原始批准函（2015-01-07）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203312Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-03-20", "title": { "zh": "FDA 发布维生素 B6 缺乏与癫痫发作安全通讯", "en": "FDA issued vitamin B6 deficiency and seizure safety communication" }, "detail": { "zh": "该通讯覆盖含卡比多巴/左旋多巴产品，并要求相应标签更新；它不判断任何个人是否缺乏、是否需要补充或是否应停药。", "en": "The communication covers carbidopa/levodopa products and requires corresponding label updates; it does not determine an individual's deficiency, supplementation need or whether treatment should be stopped." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "date": "2026-03-26", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "SPL v26 列四个规格、十四个活跃结构化包装 NDC、四个精确 100 粒瓶装面板、胶囊打开/苹果酱规则和扩展安全信息。", "en": "SPL v26 lists four strengths, fourteen active structured package NDCs, four exact 100-capsule bottle panels, capsule-opening/applesauce instructions and expanded safety information." }, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "Orange Book 身份核验", "en": "Orange Book identity reviewed" }, "detail": { "zh": "当前数据列四个处方 RLD 规格，并将 61.25/245 mg 列为 RS。", "en": "Current data list four prescription RLD strengths and identify 61.25/245 mg as the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：RYTARY，NDA 203312，四个缓释胶囊规格均列为处方 RLD；61.25/245 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD；61.25/245 mg 同时为 RS；当前 SPL 列十四个活跃包装 NDC", "en": "Four prescription RLD products; 61.25/245 mg is also RS; current SPL lists fourteen active package NDCs" }, "detail": { "zh": "四种 100 粒、NDC -01 瓶装有精确展示面板；其余包装保持文字身份。任何记录都不等于药房实时库存、购买资格、个人适用性或与其他卡比多巴/左旋多巴产品可互换。", "en": "Four 100-capsule NDC -01 bottles have exact display panels; the remaining packs retain text identity. No record establishes real-time stock, purchasing eligibility, individual suitability or interchangeability with another carbidopa/levodopa product." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分、颜色或双数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients, colours or paired numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "RYTARY 胶囊可以打开吃一半吗？", "en": "Can a RYTARY capsule be opened and half taken?" }, "answer": { "zh": "不能。现行标签针对吞咽困难允许打开胶囊，但必须把两半的全部内容物撒在少量苹果酱上立即全部吃完；不能分半、估算颗粒、压碎、咀嚼或留到以后。任何个人调整必须由开方团队决定。", "en": "No. The current label allows opening for swallowing difficulty only when the entire contents of both halves are sprinkled on a small amount of applesauce and consumed immediately. Do not halve, estimate pellets, crush, chew or save them. Any individual adjustment belongs with the prescribing team." } }, { "question": { "zh": "RYTARY 和 SINEMET 的毫克数能直接换算吗？", "en": "Can RYTARY and SINEMET milligrams be converted directly?" }, "answer": { "zh": "不能。标签明确说明 RYTARY 与其他卡比多巴/左旋多巴产品不可互换；两者的释放结构和处方转换规则不同。网页不提供个人转换表，应把两盒药、处方时间表和症状记录交给治疗团队核对。", "en": "No. The label states that RYTARY is not interchangeable with other carbidopa/levodopa products; release design and prescribed conversion rules differ. The site provides no individual conversion table. Take both packs, prescribed schedule and symptom record to the treating team." } }, { "question": { "zh": "为什么同一规格会出现多个瓶装 NDC，却只有一张图？", "en": "Why can one strength have several bottle NDCs but only one image?" }, "answer": { "zh": "当前 SPL 的结构化包装数据列多个活跃 NDC，但官方展示面板只对应四个 100 粒、NDC -01 瓶装。网页因此为其他 NDC 保留文字身份卡，不重复使用可能造成误认的图片。", "en": "The current SPL structured package data list several active NDCs per strength, while official display panels correspond only to four 100-capsule NDC -01 bottles. The site therefore keeps text-only identity cards for the other NDCs rather than reusing a potentially misleading image." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/rytary/", "en": "https://origindrug.com/en/drugs/rytary/" }, "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." ] }