{
  "id": "stalevo",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-27",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "STALEVO",
    "generic": "卡比多巴/左旋多巴/恩他卡朋（复方）",
    "aliases": [
      "Stalevo",
      "carbidopa levodopa entacapone",
      "carbidopa/levodopa/entacapone",
      "卡比多巴 左旋多巴 恩他卡朋",
      "卡比多巴/左旋多巴/恩他卡朋",
      "息宁 恩他卡朋",
      "STALEVO 50",
      "STALEVO 75",
      "STALEVO 100",
      "STALEVO 125",
      "STALEVO 150",
      "STALEVO 200",
      "52427-805-01",
      "52427-809-01",
      "52427-816-01",
      "52427-827-01",
      "52427-834-01",
      "52427-842-01",
      "LCE 50",
      "LCE 75",
      "LCE 100",
      "LCE 125",
      "LCE 150",
      "LCE 200"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "神经与认知",
    "sourceArchiveMarket": "美国：DailyMed 当前 STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片标签（SPL v8，2026-03-27 生效；NDA 021485）。本页不从美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、包装、可售资格或可替代性。",
    "dosageFormClass": "STALEVO 固定三成分薄膜衣口服片：50、75、100、125、150、200 六种名称强度；每片分别含卡比多巴/左旋多巴，并固定含恩他卡朋 200 mg；美国标签所列均为 100 片瓶装",
    "dosageFormClassCode": "oral_solid",
    "route": "口服（高风险固定三成分产品身份字段）",
    "routeCode": "oral",
    "historicalApprovalEntry": "2003-06-11（FDA NDA 021485 原始申请批准记录）",
    "archiveSponsorText": "Almatica Pharma LLC（DailyMed 当前美国公开标签所列经销方；Orion Corporation 为产品来源方）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [
      "SINEMET",
      "carbidopa and levodopa only",
      "卡比多巴/左旋多巴二成分片",
      "entacapone tablet",
      "恩他卡朋单方片",
      "extended-release carbidopa/levodopa",
      "卡比多巴左旋多巴缓释片",
      "another-market STALEVO pack",
      "其他市场 STALEVO 包装"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-stalevo-50-carbidopa-12-5mg-levodopa-50mg-entacapone-200mg-100-bottle-ndc-52427-805-01",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）",
        "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)"
      },
      "dosageForm": {
        "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片",
        "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 52427-805-01",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "STALEVO 50：每片卡比多巴 12.5 mg / 左旋多巴 50 mg / 恩他卡朋 200 mg；100 片瓶装",
        "en": "STALEVO 50: carbidopa 12.5 mg / levodopa 50 mg / entacapone 200 mg per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo50.jpg&archiveid=955349",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "卡比多巴",
            "en": "carbidopa"
          },
          "value": 12.5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种标签成分；不是个人剂量或换算指令",
            "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "左旋多巴",
            "en": "levodopa"
          },
          "value": 50,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种标签成分；不是个人剂量或换算指令",
            "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "恩他卡朋",
            "en": "entacapone"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数",
            "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "HDPE 瓶",
          "en": "HDPE bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-27",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "棕红色或灰红色",
          "en": "brownish-red or greyish-red"
        },
        "shape": {
          "zh": "圆形、双凸、无刻痕薄膜衣片",
          "en": "round, biconvex, unscored film-coated tablet"
        },
        "imprint": "LCE 50",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_b7f41b68bad71874",
        "label": "DailyMed（NLM）：STALEVO 50，12.5/50/200 mg、100 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-27",
        "reviewedAt": "2026-08-27"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-stalevo-75-carbidopa-18-75mg-levodopa-75mg-entacapone-200mg-100-bottle-ndc-52427-809-01",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）",
        "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)"
      },
      "dosageForm": {
        "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片",
        "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 52427-809-01",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "STALEVO 75：每片卡比多巴 18.75 mg / 左旋多巴 75 mg / 恩他卡朋 200 mg；100 片瓶装",
        "en": "STALEVO 75: carbidopa 18.75 mg / levodopa 75 mg / entacapone 200 mg per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo75.jpg&archiveid=955349",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "卡比多巴",
            "en": "carbidopa"
          },
          "value": 18.75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种标签成分；不是个人剂量或换算指令",
            "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "左旋多巴",
            "en": "levodopa"
          },
          "value": 75,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种标签成分；不是个人剂量或换算指令",
            "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "恩他卡朋",
            "en": "entacapone"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数",
            "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "HDPE 瓶",
          "en": "HDPE bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-27",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅棕红色",
          "en": "light brownish-red"
        },
        "shape": {
          "zh": "椭圆形、无刻痕薄膜衣片",
          "en": "oval, unscored film-coated tablet"
        },
        "imprint": "LCE 75",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_b7f41b68bad71874",
        "label": "DailyMed（NLM）：STALEVO 75，18.75/75/200 mg、100 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-27",
        "reviewedAt": "2026-08-27"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-stalevo-100-carbidopa-25mg-levodopa-100mg-entacapone-200mg-100-bottle-ndc-52427-816-01",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）",
        "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)"
      },
      "dosageForm": {
        "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片",
        "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 52427-816-01",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "STALEVO 100：每片卡比多巴 25 mg / 左旋多巴 100 mg / 恩他卡朋 200 mg；100 片瓶装",
        "en": "STALEVO 100: carbidopa 25 mg / levodopa 100 mg / entacapone 200 mg per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo100.jpg&archiveid=955349",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "卡比多巴",
            "en": "carbidopa"
          },
          "value": 25,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种标签成分；不是个人剂量或换算指令",
            "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "左旋多巴",
            "en": "levodopa"
          },
          "value": 100,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种标签成分；不是个人剂量或换算指令",
            "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "恩他卡朋",
            "en": "entacapone"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数",
            "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "HDPE 瓶",
          "en": "HDPE bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-27",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "棕红色或灰红色",
          "en": "brownish-red or greyish-red"
        },
        "shape": {
          "zh": "椭圆形、无刻痕薄膜衣片",
          "en": "oval, unscored film-coated tablet"
        },
        "imprint": "LCE 100",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_b7f41b68bad71874",
        "label": "DailyMed（NLM）：STALEVO 100，25/100/200 mg、100 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-27",
        "reviewedAt": "2026-08-27"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-stalevo-125-carbidopa-31-25mg-levodopa-125mg-entacapone-200mg-100-bottle-ndc-52427-827-01",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）",
        "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)"
      },
      "dosageForm": {
        "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片",
        "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 52427-827-01",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "STALEVO 125：每片卡比多巴 31.25 mg / 左旋多巴 125 mg / 恩他卡朋 200 mg；100 片瓶装",
        "en": "STALEVO 125: carbidopa 31.25 mg / levodopa 125 mg / entacapone 200 mg per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo125.jpg&archiveid=955349",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "卡比多巴",
            "en": "carbidopa"
          },
          "value": 31.25,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种标签成分；不是个人剂量或换算指令",
            "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "左旋多巴",
            "en": "levodopa"
          },
          "value": 125,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种标签成分；不是个人剂量或换算指令",
            "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "恩他卡朋",
            "en": "entacapone"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数",
            "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "HDPE 瓶",
          "en": "HDPE bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-27",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅棕红色",
          "en": "light brownish-red"
        },
        "shape": {
          "zh": "椭圆形、无刻痕薄膜衣片",
          "en": "oval, unscored film-coated tablet"
        },
        "imprint": "LCE 125",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_b7f41b68bad71874",
        "label": "DailyMed（NLM）：STALEVO 125，31.25/125/200 mg、100 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-27",
        "reviewedAt": "2026-08-27"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-stalevo-150-carbidopa-37-5mg-levodopa-150mg-entacapone-200mg-100-bottle-ndc-52427-834-01",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）",
        "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)"
      },
      "dosageForm": {
        "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片",
        "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 52427-834-01",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "STALEVO 150：每片卡比多巴 37.5 mg / 左旋多巴 150 mg / 恩他卡朋 200 mg；100 片瓶装",
        "en": "STALEVO 150: carbidopa 37.5 mg / levodopa 150 mg / entacapone 200 mg per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo150.jpg&archiveid=955349",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "卡比多巴",
            "en": "carbidopa"
          },
          "value": 37.5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种标签成分；不是个人剂量或换算指令",
            "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "左旋多巴",
            "en": "levodopa"
          },
          "value": 150,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种标签成分；不是个人剂量或换算指令",
            "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "恩他卡朋",
            "en": "entacapone"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数",
            "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "HDPE 瓶",
          "en": "HDPE bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-27",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "棕红色或灰红色",
          "en": "brownish-red or greyish-red"
        },
        "shape": {
          "zh": "长椭圆形、无刻痕薄膜衣片",
          "en": "elongated oval, unscored film-coated tablet"
        },
        "imprint": "LCE 150",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_b7f41b68bad71874",
        "label": "DailyMed（NLM）：STALEVO 150，37.5/150/200 mg、100 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-27",
        "reviewedAt": "2026-08-27"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-stalevo-200-carbidopa-50mg-levodopa-200mg-entacapone-200mg-100-bottle-ndc-52427-842-01",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）",
        "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)"
      },
      "dosageForm": {
        "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片",
        "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 52427-842-01",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "STALEVO 200：每片卡比多巴 50 mg / 左旋多巴 200 mg / 恩他卡朋 200 mg；100 片瓶装",
        "en": "STALEVO 200: carbidopa 50 mg / levodopa 200 mg / entacapone 200 mg per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo200.jpg&archiveid=955349",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "卡比多巴",
            "en": "carbidopa"
          },
          "value": 50,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种标签成分；不是个人剂量或换算指令",
            "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "左旋多巴",
            "en": "levodopa"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种标签成分；不是个人剂量或换算指令",
            "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "恩他卡朋",
            "en": "entacapone"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数",
            "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "HDPE 瓶",
          "en": "HDPE bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-27",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "深棕红色",
          "en": "dark brownish-red"
        },
        "shape": {
          "zh": "椭圆形、无刻痕薄膜衣片",
          "en": "oval, unscored film-coated tablet"
        },
        "imprint": "LCE 200",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_b7f41b68bad71874",
        "label": "DailyMed（NLM）：STALEVO 200，50/200/200 mg、100 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-27",
        "reviewedAt": "2026-08-27"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-stalevo-50-carbidopa-12-5mg-levodopa-50mg-entacapone-200mg-100-bottle-ndc-52427-805-01",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo50.jpg&archiveid=955349",
    "alt": "STALEVO 50 卡比多巴 12.5 mg／左旋多巴 50 mg／恩他卡朋 200 mg、NDC 52427-805-01、100 片瓶装的美国 DailyMed 标签展示面",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 当前标签 SPL v8（2026-03-27 生效）；包装面板标注 Rev. 06/2021",
    "presentation": "STALEVO 50：每片卡比多巴 12.5 mg / 左旋多巴 50 mg / 恩他卡朋 200 mg，NDC 52427-805-01，100 片瓶装标签展示面。",
    "notice": "此图只对应所引美国 DailyMed 标签中的 STALEVO 50、三种每片成分量、NDC 52427-805-01 与 100 片瓶装。它不代表 STALEVO 75/100/125/150/200、SINEMET、恩他卡朋单方、其他市场包装或当前可得性；不用于鉴定真伪，也不生成个人片数、间隔、分片、压碎、换药或停药方案。",
    "source": {
      "id": "src_b7f41b68bad71874",
      "label": "DailyMed（NLM）：STALEVO 50，12.5/50/200 mg、NDC 52427-805-01、100 片瓶装标签面板",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-27",
      "reviewedAt": "2026-08-27"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "STALEVO 说明书放大阅读：三个数字属于同一片，六种强度都含恩他卡朋 200 mg",
      "en": "STALEVO label reading: three numbers belong to one tablet, and every strength contains entacapone 200 mg"
    },
    "summary": {
      "zh": "STALEVO 是三成分固定复方，不是单一左旋多巴片。美国当前标签明确要求整片使用，不可掰开、压碎或咀嚼；同一给药间隔只使用一片。六种强度每片都含恩他卡朋 200 mg，靠多片或部分片剂凑更高左旋多巴量可能导致恩他卡朋过量。网页不据此安排个人片数、时间或转换。",
      "en": "STALEVO is a fixed three-ingredient combination, not a levodopa-only tablet. The current U.S. label says tablets must not be split, crushed or chewed and only one tablet is administered at each dosing interval. Every strength contains entacapone 200 mg; combining tablets or tablet portions to obtain more levodopa may cause entacapone overdose. The site does not turn this into an individual tablet count, schedule or conversion."
    },
    "checks": [
      {
        "zh": "先同时核对 STALEVO 名称、卡比多巴/左旋多巴/恩他卡朋三种成分、三组每片 mg、NDC、100 片瓶装、LCE 刻印与目标市场。STALEVO 100 的“100”只对应左旋多巴这一组名称强度；整片仍含卡比多巴 25 mg 和恩他卡朋 200 mg。",
        "en": "Check STALEVO, all three ingredients, all three milligram amounts per tablet, NDC, 100-tablet bottle, LCE imprint and market together. The '100' in STALEVO 100 names the levodopa component only; the same tablet also contains carbidopa 25 mg and entacapone 200 mg."
      },
      {
        "zh": "不要把 STALEVO 当成 SINEMET 的另一种包装。两者可能都写卡比多巴/左旋多巴，但 STALEVO 还含恩他卡朋；共同成分、相近数字或相似用途不能建立自行同服、轮换、替换或叠加关系。请把两盒实际药和完整药单交给药师或开方团队核对。",
        "en": "Do not treat STALEVO as another SINEMET pack. Both may name carbidopa/levodopa, but STALEVO also contains entacapone. Shared ingredients, nearby numbers or a similar purpose do not establish self-co-use, alternation, substitution or stacking. Have a pharmacist or prescriber review both actual packs and the complete medicine list."
      },
      {
        "zh": "当前标签还涉及突然停用后的高热与意识混乱、日常活动中突然入睡、直立性低血压、异动症、幻觉、冲动控制、腹泻及与华法林等药物相互作用。网页只提示把症状、跌倒、嗜睡和完整药单带去核对，不给出自行停用、减量、补服或错开方案。",
        "en": "The current label also addresses hyperpyrexia and confusion after abrupt reduction or withdrawal, falling asleep during daily activities, orthostatic hypotension, dyskinesia, hallucinations, impulse-control problems, diarrhoea and interactions including warfarin. The site only prompts review of symptoms, falls, sleepiness and the complete medicine list; it does not provide self-stopping, reduction, make-up or spacing instructions."
      },
      {
        "zh": "若出现意识丧失、严重跌倒、呼吸困难、明显意识混乱、高热、疑似过量或其他急性严重情况，应立即使用当地急救或毒物咨询渠道，并带上全部药盒；不要等待网页检索或自行用另一种帕金森药抵消。",
        "en": "For loss of consciousness, a serious fall, breathing difficulty, marked confusion, high fever, suspected overdose or another acute serious concern, use local emergency or poison-information services immediately and bring all medicine packs; do not wait for a web search or try to counteract it with another Parkinson medicine."
      }
    ],
    "source": {
      "id": "src_b7f41b68bad71874",
      "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（2.7 重要用法、5 警告与相互作用）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-27",
      "reviewedAt": "2026-08-27"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "三种成分怎样配合：左旋多巴进入脑内转化，多巴脱羧酶与 COMT 通路在外周被抑制",
      "en": "How the three ingredients work together: levodopa reaches the brain while peripheral decarboxylase and COMT pathways are inhibited"
    },
    "summary": {
      "zh": "美国当前标签说明，左旋多巴可通过血脑屏障并在脑内转化为多巴胺；卡比多巴抑制外周左旋多巴脱羧，帮助更多左旋多巴到达脑内；恩他卡朋可逆、选择性抑制 COMT，从另一条外周代谢路径影响左旋多巴暴露。这个机制只解释为什么一片有三种成分，不能推导个人强度、频率、换药或联用。",
      "en": "The current U.S. label explains that levodopa crosses the blood-brain barrier and is converted to dopamine in the brain; carbidopa inhibits peripheral levodopa decarboxylation, allowing more levodopa to reach the brain; and entacapone is a reversible, selective COMT inhibitor that affects another peripheral levodopa pathway. This mechanism explains why one tablet has three ingredients but cannot determine an individual's strength, frequency, switch or combination."
    },
    "checks": [
      {
        "zh": "三条作用路径不表示三组 mg 可以分别拆开计算，也不表示 STALEVO 与单独卡比多巴/左旋多巴、恩他卡朋片或其他帕金森药之间存在网页可算的等效关系。",
        "en": "Three pathways do not make the three milligram values separately calculable and do not create a web-computable equivalence between STALEVO and separate carbidopa/levodopa, entacapone or another Parkinson medicine."
      },
      {
        "zh": "标签把恩他卡朋描述为 COMT 抑制剂，并说明六种强度都含 200 mg。这个恒定数字是固定复方身份的重要线索，也是不能靠多片或分片自行凑左旋多巴量的原因之一。",
        "en": "The label describes entacapone as a COMT inhibitor and states that every strength contains 200 mg. This constant amount is a key fixed-combination identity clue and one reason multiple tablets or tablet portions must not be self-combined to obtain more levodopa."
      },
      {
        "zh": "机制不能解释某次突然嗜睡、头晕、幻觉、腹泻、尿色改变或症状波动的个人原因。最有用的下一步是记录发生时间，带准确药盒和完整药单请专业人员核对；严重或快速加重时优先使用紧急渠道。",
        "en": "A mechanism cannot explain the individual cause of sudden sleepiness, dizziness, hallucinations, diarrhoea, urine-colour change or symptom fluctuation. Record the timing and take the exact pack and complete medicine list for professional review; use urgent services first if severe or rapidly worsening."
      }
    ],
    "source": {
      "id": "src_b7f41b68bad71874",
      "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（12.1 Mechanism of Action）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-27",
      "reviewedAt": "2026-08-27"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "STALEVO",
      "generic": "卡比多巴/左旋多巴/恩他卡朋（复方）",
      "dosageFormClass": "STALEVO 固定三成分薄膜衣口服片：50、75、100、125、150、200 六种名称强度；每片分别含卡比多巴/左旋多巴，并固定含恩他卡朋 200 mg；美国标签所列均为 100 片瓶装"
    },
    "labelSource": {
      "id": "src_b7f41b68bad71874",
      "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（Almatica；SPL v8，2026-03-27 生效）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-27",
      "reviewedAt": "2026-08-27"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_b7f41b68bad71874",
          "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（Almatica；SPL v8，2026-03-27 生效）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-27",
          "reviewedAt": "2026-08-27"
        },
        "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": "2026-08-27",
        "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_7b18431655bfdce2",
          "label": "FDA：STALEVO NDA 021485 行政记录与原始申请批准日期（2003-06-11）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_STALEVO_Admindocs.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-27",
          "reviewedAt": "2026-08-27"
        },
        "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": "2026-08-27",
        "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": "2026-08-27",
      "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": "STALEVO 是美国 NDA 021485 的卡比多巴/左旋多巴/恩他卡朋固定三成分口服片。六种强度名称看起来只是 50 到 200 的变化，但每片都同时含三种成分，且恩他卡朋固定为 200 mg。美国当前标签明确写明：整片使用，不可掰开、压碎或咀嚼；不要靠多片或部分片剂凑更高的左旋多巴量，否则可能造成恩他卡朋过量。网页只帮助读清药盒和说明书，不计算个人片数、间隔、换药、停药或漏服处理。",
    "history": "FDA 行政记录将 STALEVO 原始 NDA 021485 的批准日期列为 2003-06-11；当前 DailyMed 标签列示 Initial U.S. Approval: 2003，并于 2026-03-27 生效修订。包装面板本身标注 Rev. 06/2021；页面将标签修订日与包装面板版本分开显示，不把任一日期解释为当前库存、可获得性或其他市场状态。",
    "sourceDocuments": [
      {
        "id": "src_b7f41b68bad71874",
        "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（Almatica；SPL v8，2026-03-27 生效）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-27",
        "reviewedAt": "2026-08-27"
      },
      {
        "id": "src_7b18431655bfdce2",
        "label": "FDA：STALEVO NDA 021485 行政记录与原始申请批准日期（2003-06-11）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_STALEVO_Admindocs.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "historical_public_record",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-27",
        "reviewedAt": "2026-08-27"
      }
    ],
    "applicationNumber": "NDA 021485（FDA 原始申请行政记录与当前美国标签所列）",
    "approvalTimeline": [
      {
        "date": "2003-06-11",
        "title": {
          "zh": "FDA NDA 021485 原始申请批准",
          "en": "FDA NDA 021485 original application approval"
        },
        "detail": {
          "zh": "FDA 行政记录将 STALEVO、NDA 021485、原始 NDA 与 2003-06-11 批准日期相连，最初包括 STALEVO 50、100 和 150。该美国节点不自动建立其他市场的商品名、批准、供应、参比关系或可替代性。",
          "en": "The FDA administrative record links STALEVO, NDA 021485, an original NDA and the approval date 11 Jun 2003, initially covering STALEVO 50, 100 and 150. This U.S. node does not automatically establish another market's trade name, approval, supply, reference status or interchangeability."
        },
        "source": {
          "id": "src_7b18431655bfdce2",
          "label": "FDA：STALEVO NDA 021485 行政记录与原始申请批准日期（2003-06-11）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_STALEVO_Admindocs.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-27",
          "reviewedAt": "2026-08-27"
        }
      },
      {
        "date": "2026-03-27",
        "title": {
          "zh": "DailyMed 当前 SPL v8 生效",
          "en": "Current DailyMed SPL v8 effective"
        },
        "detail": {
          "zh": "当前美国公开标签列出六种 STALEVO 强度、六个 100 片瓶装 NDC、整片使用边界及三成分机制。包装面板自身标注 Rev. 06/2021；标签生效日与包装面板版本在本页分开。",
          "en": "The current U.S. public label lists six STALEVO strengths, six 100-tablet bottle NDCs, the whole-tablet boundary and the three-ingredient mechanism. The package panels themselves are marked Rev. 06/2021; the label effective date and package-panel version remain separate on this page."
        },
        "source": {
          "id": "src_b7f41b68bad71874",
          "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（SPL v8，2026-03-27 生效）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-27",
          "reviewedAt": "2026-08-27"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "已链接当前 NDA 品牌标签、六种准确三成分强度与六个包装面板",
          "en": "Current NDA brand label, six exact three-ingredient strengths and six package panels linked"
        },
        "detail": {
          "zh": "本页分别记录 STALEVO 50、75、100、125、150、200 的三种每片成分量、NDC、100 片瓶装、LCE 刻印和来源。它用于产品身份与安全阅读，不用于鉴定真伪，也不建立当前库存、购买、个人片数、间隔、转换、停用或联用。",
          "en": "This page separately records all three per-tablet ingredient amounts, NDC, 100-tablet bottle, LCE imprint and source for STALEVO 50, 75, 100, 125, 150 and 200. It supports product identity and safety reading; it does not authenticate a product or establish current stock, purchase, individual tablet count, interval, conversion, stopping or co-use."
        }
      },
      {
        "market": {
          "zh": "中国大陆、欧盟、日本及其他市场",
          "en": "Mainland China, the 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 NDA、DailyMed 名称、NDC、三组 mg、LCE 刻印或包装图推定当地商品名、批准、包装、供应、可售资格、参比/原研关系或可替代性；每个市场均须以当地现行监管资料单独核对。",
          "en": "No local trade name, approval, packaging, supply, sale eligibility, reference/originator relationship or interchangeability is inferred from the U.S. NDA, DailyMed name, NDC, three milligram values, LCE imprint or package image; every market requires separate review against current local regulatory material."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "STALEVO 100 上的 25/100/200，是否能只看中间的 100？",
          "en": "Can I read only the middle 100 in STALEVO 100's 25/100/200?"
        },
        "answer": {
          "zh": "不能。25/100/200 共同识别同一片中的卡比多巴、左旋多巴和恩他卡朋。名称中的“100”只是左旋多巴这一组强度；网页不会把三组数字拆成个人剂量或换算式。",
          "en": "No. 25/100/200 together identify carbidopa, levodopa and entacapone in the same tablet. The '100' in the name identifies only the levodopa component; the site does not split the three numbers into an individual dose or conversion formula."
        }
      },
      {
        "question": {
          "zh": "STALEVO 能否掰半，或用两片较低强度凑成一片较高强度？",
          "en": "Can STALEVO be split, or can two lower-strength tablets be combined to make a higher strength?"
        },
        "answer": {
          "zh": "不能从网页这样操作。当前美国标签写明不要掰开、压碎或咀嚼，并指出六种强度每片都含恩他卡朋 200 mg；用多片或部分片剂凑更高左旋多巴量可能造成恩他卡朋过量。请带实际药盒、处方和完整药单请药师或开方团队核对。",
          "en": "Do not do this from a webpage. The current U.S. label says not to split, crush or chew and states that every strength contains entacapone 200 mg; combining tablets or tablet portions to obtain more levodopa may cause entacapone overdose. Have a pharmacist or prescriber review the actual pack, prescription and complete medicine list."
        }
      },
      {
        "question": {
          "zh": "已经有 SINEMET，又看到 STALEVO，能否一起吃或轮换？",
          "en": "If SINEMET is already on the list, can STALEVO be taken with it or alternated?"
        },
        "answer": {
          "zh": "不能仅凭网页决定。两者都可能含卡比多巴/左旋多巴，但 STALEVO 另外含恩他卡朋；共同成分会带来重复成分与转换风险。应把两盒实际产品、处方时间表和完整药单交给药师或开方团队逐项核对，不要自行叠加、轮换、替代或停用。",
          "en": "A webpage cannot decide this. Both may contain carbidopa/levodopa, while STALEVO additionally contains entacapone; shared ingredients create duplicate-ingredient and conversion risks. Have a pharmacist or prescriber review both actual products, the prescribed schedule and complete medicine list; do not self-stack, alternate, substitute or stop."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dosage-forms-are-part-of-medicine-identity",
      "how-to-read-a-drug-label"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/stalevo/",
    "en": "https://origindrug.com/en/drugs/stalevo/"
  },
  "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."
  ]
}