{
  "id": "xigduo-xr",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-30",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "XIGDUO XR",
    "generic": "达格列净/盐酸二甲双胍缓释片",
    "aliases": [
      "Xigduo XR",
      "dapagliflozin and metformin hydrochloride extended-release",
      "dapagliflozin metformin XR",
      "达格列净二甲双胍缓释片",
      "达格列净/盐酸二甲双胍缓释片",
      "dapagliflozin and metformin hydrochloride",
      "NDA 205649",
      "0310-6225-60",
      "0310-6250-30",
      "0310-6260-60",
      "0310-6270-30",
      "0310-6280-30",
      "1074 2.5/1000",
      "1070 5/500",
      "1071 5/1000",
      "1072 10/500",
      "1073 10/1000"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "代谢",
    "sourceArchiveMarket": "美国 XIGDUO XR 当前 DailyMed 公开品牌标签（SPL v39；2026-08-11 生效；NDA 205649）。本档案只建立该标签中的五种准确瓶装身份，不由美国资料推定中国大陆或其他市场的商品名、批准、包装、供应、可售资格或可替代性。",
    "dosageFormClass": "达格列净/盐酸二甲双胍薄膜衣缓释口服片：2.5 mg/1,000 mg、5 mg/500 mg、5 mg/1,000 mg、10 mg/500 mg、10 mg/1,000 mg；五种产品均须整片吞服，不得压碎、切开或咀嚼",
    "dosageFormClassCode": "oral_modified_release",
    "route": "口服（固定复方缓释片准确产品身份字段）",
    "routeCode": "oral",
    "historicalApprovalEntry": "2014（当前美国公开标签所列 Initial U.S. Approval）",
    "archiveSponsorText": "AstraZeneca Pharmaceuticals LP（当前美国公开品牌标签所列）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [
      "FARXIGA",
      "dapagliflozin tablet",
      "GLUCOPHAGE",
      "metformin tablet",
      "QTERN",
      "dapagliflozin saxagliptin",
      "QTERNMET XR",
      "SYNJARDY",
      "INVOKAMET"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-xigduo-xr-dapagliflozin-2-5mg-metformin-1000mg-0310622560",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）",
        "en": "current U.S. DailyMed public label (effective 11 Aug 2026)"
      },
      "dosageForm": {
        "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片",
        "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet"
      },
      "route": {
        "zh": "口服；缓释片必须整片吞服",
        "en": "oral; extended-release tablet must be swallowed whole"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0310-6225-60",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片达格列净 2.5 mg + 盐酸二甲双胍 1,000 mg；60 片瓶装",
        "en": "2.5 mg dapagliflozin + 1,000 mg metformin HCl per tablet; 60-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "达格列净",
            "en": "dapagliflozin"
          },
          "value": 2.5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "盐酸二甲双胍",
            "en": "metformin hydrochloride"
          },
          "value": 1000,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": null,
      "package": {
        "count": 60,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅棕至棕色",
          "en": "light brown to brown"
        },
        "shape": {
          "zh": "双凸椭圆形",
          "en": "biconvex oval"
        },
        "imprint": "1074 / 2.5/1000",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_32bee81e299db602",
        "label": "DailyMed（NLM）：XIGDUO XR 2.5 mg/1,000 mg、NDC 0310-6225-60、60 片瓶装美国当前标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-30",
        "reviewedAt": "2026-08-30"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-xigduo-xr-dapagliflozin-5mg-metformin-500mg-0310625030",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）",
        "en": "current U.S. DailyMed public label (effective 11 Aug 2026)"
      },
      "dosageForm": {
        "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片",
        "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet"
      },
      "route": {
        "zh": "口服；缓释片必须整片吞服",
        "en": "oral; extended-release tablet must be swallowed whole"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0310-6250-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片达格列净 5 mg + 盐酸二甲双胍 500 mg；30 片瓶装",
        "en": "5 mg dapagliflozin + 500 mg metformin HCl per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "达格列净",
            "en": "dapagliflozin"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "盐酸二甲双胍",
            "en": "metformin hydrochloride"
          },
          "value": 500,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": null,
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "橙色",
          "en": "orange"
        },
        "shape": {
          "zh": "双凸胶囊形",
          "en": "biconvex capsule-shaped"
        },
        "imprint": "1070 / 5/500",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_32bee81e299db602",
        "label": "DailyMed（NLM）：XIGDUO XR 5 mg/500 mg、NDC 0310-6250-30、30 片瓶装美国当前标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-30",
        "reviewedAt": "2026-08-30"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-xigduo-xr-dapagliflozin-5mg-metformin-1000mg-0310626060",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）",
        "en": "current U.S. DailyMed public label (effective 11 Aug 2026)"
      },
      "dosageForm": {
        "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片",
        "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet"
      },
      "route": {
        "zh": "口服；缓释片必须整片吞服",
        "en": "oral; extended-release tablet must be swallowed whole"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0310-6260-60",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片达格列净 5 mg + 盐酸二甲双胍 1,000 mg；60 片瓶装",
        "en": "5 mg dapagliflozin + 1,000 mg metformin HCl per tablet; 60-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-08.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "达格列净",
            "en": "dapagliflozin"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "盐酸二甲双胍",
            "en": "metformin hydrochloride"
          },
          "value": 1000,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": null,
      "package": {
        "count": 60,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "粉红至深粉红色",
          "en": "pink to dark pink"
        },
        "shape": {
          "zh": "双凸椭圆形",
          "en": "biconvex oval"
        },
        "imprint": "1071 / 5/1000",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_32bee81e299db602",
        "label": "DailyMed（NLM）：XIGDUO XR 5 mg/1,000 mg、NDC 0310-6260-60、60 片瓶装美国当前标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-30",
        "reviewedAt": "2026-08-30"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-xigduo-xr-dapagliflozin-10mg-metformin-500mg-0310627030",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）",
        "en": "current U.S. DailyMed public label (effective 11 Aug 2026)"
      },
      "dosageForm": {
        "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片",
        "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet"
      },
      "route": {
        "zh": "口服；缓释片必须整片吞服",
        "en": "oral; extended-release tablet must be swallowed whole"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0310-6270-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片达格列净 10 mg + 盐酸二甲双胍 500 mg；30 片瓶装",
        "en": "10 mg dapagliflozin + 500 mg metformin HCl per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-09.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "达格列净",
            "en": "dapagliflozin"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "盐酸二甲双胍",
            "en": "metformin hydrochloride"
          },
          "value": 500,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": null,
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "粉红色",
          "en": "pink"
        },
        "shape": {
          "zh": "双凸胶囊形",
          "en": "biconvex capsule-shaped"
        },
        "imprint": "1072 / 10/500",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_32bee81e299db602",
        "label": "DailyMed（NLM）：XIGDUO XR 10 mg/500 mg、NDC 0310-6270-30、30 片瓶装美国当前标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-30",
        "reviewedAt": "2026-08-30"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-xigduo-xr-dapagliflozin-10mg-metformin-1000mg-0310628030",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）",
        "en": "current U.S. DailyMed public label (effective 11 Aug 2026)"
      },
      "dosageForm": {
        "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片",
        "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet"
      },
      "route": {
        "zh": "口服；缓释片必须整片吞服",
        "en": "oral; extended-release tablet must be swallowed whole"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0310-6280-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片达格列净 10 mg + 盐酸二甲双胍 1,000 mg；30 片瓶装",
        "en": "10 mg dapagliflozin + 1,000 mg metformin HCl per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-10.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "达格列净",
            "en": "dapagliflozin"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第一种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "盐酸二甲双胍",
            "en": "metformin hydrochloride"
          },
          "value": 1000,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片第二种活性成分标示量；不是个人片数或换算指令",
            "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": null,
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色至深黄色",
          "en": "yellow to dark yellow"
        },
        "shape": {
          "zh": "双凸椭圆形",
          "en": "biconvex oval"
        },
        "imprint": "1073 / 10/1000",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_32bee81e299db602",
        "label": "DailyMed（NLM）：XIGDUO XR 10 mg/1,000 mg、NDC 0310-6280-30、30 片瓶装美国当前标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-30",
        "reviewedAt": "2026-08-30"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-xigduo-xr-dapagliflozin-5mg-metformin-500mg-0310625030",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
    "alt": "XIGDUO XR 达格列净 5 mg/盐酸二甲双胍 500 mg、NDC 0310-6250-30、30 片瓶装的美国 DailyMed 当前标签展示面",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed SPL v39；2026-08-11 生效",
    "presentation": "XIGDUO XR 每片达格列净 5 mg/盐酸二甲双胍 500 mg，NDC 0310-6250-30，30 片瓶装标签展示面。",
    "notice": "此图只对应所引美国标签中的 5 mg/500 mg、NDC 0310-6250-30、30 片瓶装；不代表另四种强度、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、换药或联合用药方案。",
    "source": {
      "id": "src_32bee81e299db602",
      "label": "DailyMed（NLM）：XIGDUO XR 5 mg/500 mg、NDC 0310-6250-30、30 片瓶装美国当前标签面板",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-30",
      "reviewedAt": "2026-08-30"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "XIGDUO XR 说明书放大阅读：一片有两种成分，缓释片不能掰、压碎或咀嚼",
      "en": "XIGDUO XR label reading: two ingredients in one tablet, and the extended-release tablet must not be cut, crushed or chewed"
    },
    "summary": {
      "zh": "当前美国标签把五种强度、两个成分、包装数量和整片吞服要求分别列出。读者首先要确认自己手里是哪一种准确产品：不要把两个 mg 数字相加，不要按照片估算后掰开半片，也不要再自行加用 FARXIGA/达格列净与二甲双胍产品。",
      "en": "The current U.S. label separately lists five strengths, two ingredients, pack count and the whole-tablet requirement. First identify the exact product in hand: do not add the two milligram numbers, estimate and cut a half-tablet from appearance, or self-add FARXIGA/dapagliflozin or metformin products."
    },
    "checks": [
      {
        "zh": "例如“5 mg/500 mg”表示每片含达格列净 5 mg 和盐酸二甲双胍 500 mg；它不是早晚各一个数字，不是 505 mg 的可比强度，也不能与另一种药的 mg 直接比较。",
        "en": "For example, 5 mg/500 mg means 5 mg dapagliflozin and 500 mg metformin HCl in each tablet. The two figures are not morning/evening amounts, not a comparable 505 mg strength and not directly comparable with another medicine's milligrams."
      },
      {
        "zh": "标签明确要求整片吞服，不得压碎、切开或咀嚼；排便中偶尔看到像药片的柔软物可能是非活性成分残留，但网页不能仅凭这一现象判断个人吸收或补服。",
        "en": "The label requires swallowing whole and says not to crush, cut or chew. A soft mass resembling the tablet can occasionally appear in stool from inactive ingredients, but the site cannot use that observation to judge an individual's absorption or make-up use."
      },
      {
        "zh": "一片已经含达格列净和二甲双胍。若药单里还有 FARXIGA、达格列净、GLUCOPHAGE、二甲双胍、JANUMET 或其他复方降糖药，先视为需要核对的共同成分线索；不要自行叠加、轮换或停掉其中一盒。",
        "en": "One tablet already contains dapagliflozin and metformin. FARXIGA, dapagliflozin, GLUCOPHAGE, metformin, JANUMET or another glucose-lowering combination on the same list is a shared-ingredient cue requiring review; do not self-combine, alternate or stop a pack."
      },
      {
        "zh": "标签涉及乳酸性酸中毒、酮症酸中毒、脱水/低血压、肾功能、泌尿生殖感染、手术与含碘造影等重要边界。出现呼吸困难、严重虚弱、持续呕吐、明显意识变化、严重腹痛或其他急性重症时，应立即使用当地急救渠道并带上全部药盒。",
        "en": "The label covers lactic acidosis, ketoacidosis, volume depletion/hypotension, kidney function, genitourinary infection, surgery and iodinated contrast. Breathing difficulty, severe weakness, persistent vomiting, marked altered awareness, severe abdominal pain or another acute serious concern requires local emergency help with every medicine pack."
      }
    ],
    "source": {
      "id": "src_32bee81e299db602",
      "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开标签与 FDA 批准患者用药指南（2026-08 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-30",
      "reviewedAt": "2026-08-30"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "两种成分怎样配合：达格列净影响肾脏葡萄糖重吸收，二甲双胍影响肝糖生成与胰岛素敏感性",
      "en": "How the two ingredients work: dapagliflozin affects renal glucose reabsorption, while metformin affects hepatic glucose production and insulin sensitivity"
    },
    "summary": {
      "zh": "标签将达格列净列为 SGLT2 抑制剂，将二甲双胍列为双胍类。两条作用路径解释为何这是固定复方，但不能推导个人该选哪种强度、是否适合、何时停用或是否需要与其他降糖药联合。",
      "en": "The label identifies dapagliflozin as an SGLT2 inhibitor and metformin as a biguanide. The two pathways explain the fixed combination but cannot determine an individual's strength, suitability, interruption or combination with another glucose-lowering medicine."
    },
    "checks": [
      {
        "zh": "“两种机制互补”不是把 FARXIGA 和二甲双胍自行拼成 XIGDUO XR 的许可；固定复方的缓释结构、成分量、标签和监测边界属于准确产品。",
        "en": "“Complementary mechanisms” does not permit self-assembling XIGDUO XR from FARXIGA and metformin; the fixed combination's extended-release design, ingredient amounts, label and monitoring boundaries belong to the exact product."
      },
      {
        "zh": "肾脏和肝脏相关机制提示为什么肾功能、脱水、饮食减少、感染、饮酒、手术或造影前后需要专业核对，但网页不会据一次血糖、体重或化验值选择强度。",
        "en": "Kidney- and liver-related mechanisms help explain why renal function, dehydration, reduced intake, infection, alcohol, surgery or contrast procedures require professional review, but the site does not select a strength from one glucose, weight or laboratory value."
      },
      {
        "zh": "基因筛查不是网页替个人选择这款药的默认答案。个体适用性要结合诊断、肾肝功能、完整药单、既往反应和目标市场现行说明书，由负责团队判断。",
        "en": "Genetic screening is not the site's default answer for choosing this medicine. Individual suitability requires diagnosis, renal and hepatic function, the complete medicine list, prior response and the current target-market label, reviewed by the treating team."
      }
    ],
    "source": {
      "id": "src_32bee81e299db602",
      "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开标签（12.1 Mechanism of Action）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-30",
      "reviewedAt": "2026-08-30"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "XIGDUO XR",
      "generic": "达格列净/盐酸二甲双胍缓释片",
      "dosageFormClass": "达格列净/盐酸二甲双胍薄膜衣缓释口服片：2.5 mg/1,000 mg、5 mg/500 mg、5 mg/1,000 mg、10 mg/500 mg、10 mg/1,000 mg；五种产品均须整片吞服，不得压碎、切开或咀嚼"
    },
    "labelSource": {
      "id": "src_32bee81e299db602",
      "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开品牌标签、五种包装面板与 Medication Guide（SPL v39；2026-08-11 生效）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-30",
      "reviewedAt": "2026-08-30"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_32bee81e299db602",
          "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开品牌标签、五种包装面板与 Medication Guide（SPL v39；2026-08-11 生效）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-30",
          "reviewedAt": "2026-08-30"
        },
        "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": "2026-08-30",
        "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": "2026-08-30",
      "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": "XIGDUO XR 一片同时含达格列净和盐酸二甲双胍缓释成分。包装上的两个 mg 数字分别属于两种成分，不是早晚片数、相加后的总强度，也不能用来与 FARXIGA、GLUCOPHAGE、其他二甲双胍或其他 SGLT2 产品自行拼接。当前美国标签列五种瓶装产品，并明确缓释片必须整片吞服，不得压碎、切开或咀嚼。网页只帮助认清准确产品、成分、每片标示量和官方说明书，不生成个人片数、换药、补服或停药方案。",
    "history": "FDA/NLM 当前公开标签记录 XIGDUO XR 的美国初始批准年份为 2014，当前 SPL 于 2026-08-11 生效。该固定复方不能并入单方 FARXIGA 或单方二甲双胍档案；同一成分重叠反而是需要带完整药单给药师或开方团队核对的线索。",
    "sourceDocuments": [
      {
        "id": "src_32bee81e299db602",
        "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开品牌标签、五种包装面板与 Medication Guide（SPL v39；2026-08-11 生效）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-30",
        "reviewedAt": "2026-08-30"
      },
      {
        "id": "src_94dd7b6171dec015",
        "label": "FDA：糖尿病药品公众信息页（固定复方 XIGDUO XR 成分核对入口）",
        "url": "https://www.fda.gov/consumers/womens-health-topics/women-and-diabetes-diabetes-medicines",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "official_public_guidance",
        "documentKind": "regulatory_guidance",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-30",
        "reviewedAt": "2026-08-30"
      }
    ],
    "applicationNumber": "FDA NDA 205649（XIGDUO XR；达格列净/盐酸二甲双胍缓释片）",
    "approvalTimeline": [
      {
        "date": "2014-10-29",
        "title": {
          "zh": "美国 XIGDUO XR NDA 205649 产品记录",
          "en": "U.S. XIGDUO XR NDA 205649 product record"
        },
        "detail": {
          "zh": "当前 DailyMed 标签把 XIGDUO XR、NDA 205649、2014 年美国初始批准及 2014-10-29 营销起始记录相连。该节点只建立美国产品史，不推定其他市场批准、包装或供应。",
          "en": "The current DailyMed label links XIGDUO XR, NDA 205649, initial U.S. approval in 2014 and a 29 Oct 2014 marketing-start record. This establishes U.S. product history only and does not infer another market's approval, pack or supply."
        },
        "source": {
          "id": "src_32bee81e299db602",
          "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开标签（NDA 205649 与产品记录）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-30",
          "reviewedAt": "2026-08-30"
        }
      },
      {
        "date": "2026-08-11",
        "title": {
          "zh": "当前 DailyMed SPL v39 生效",
          "en": "Current DailyMed SPL v39 became effective"
        },
        "detail": {
          "zh": "本页放大说明书、患者指南、五种准确瓶装身份、整片吞服及复方成分边界均以该当前公开标签为主要来源；标签日期不是药店库存或个人用药结论。",
          "en": "This page's enlarged label, Medication Guide, five exact bottle identities, whole-tablet rule and fixed-combination boundary use this current public label as the primary source. A label date is not pharmacy stock or an individual-use conclusion."
        },
        "source": {
          "id": "src_32bee81e299db602",
          "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开品牌标签（SPL v39；2026-08-11 生效）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-30",
          "reviewedAt": "2026-08-30"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "当前公开品牌标签与五种准确瓶装身份已建立",
          "en": "Current public brand label and five exact bottle identities established"
        },
        "detail": {
          "zh": "记录五种每片双成分强度、NDC、瓶装数量、颜色、形状、刻印和官方标签面板；不表示任何具体渠道有库存，不用于真伪、购买或个人片数判断。",
          "en": "Records both per-tablet ingredient amounts, NDC, bottle count, colour, shape, imprint and official label panel for five products. It does not establish stock at a particular channel and is not an authenticity, purchase or individual tablet-count decision."
        }
      },
      {
        "market": {
          "zh": "中国大陆、欧盟、日本及其他市场",
          "en": "Mainland China, EU, Japan and other markets"
        },
        "status": {
          "zh": "待逐项建立现行监管产品记录",
          "en": "Current regulatory product records not established"
        },
        "detail": {
          "zh": "不从美国商品名、共同成分、NDA 或包装推定当地商品名、批准、持有人、规格、供应、原研/参比关系或可替代性；须按当地现行监管文件逐产品核对。",
          "en": "No local trade name, approval, holder, strength, supply, originator/reference relationship or interchangeability is inferred from the U.S. brand, shared ingredients, NDA or packs; each product requires current local regulatory review."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "5 mg/500 mg 是 505 mg，还是一天两个时间的用量？",
          "en": "Does 5 mg/500 mg mean 505 mg, or two times of day?"
        },
        "answer": {
          "zh": "都不是。它表示一片里分别有达格列净 5 mg 和盐酸二甲双胍 500 mg。两个数字属于两种成分，不能相加后与别的药比较，也不能推导个人片数或频次。",
          "en": "Neither. It means one tablet contains 5 mg dapagliflozin and 500 mg metformin HCl. The two figures belong to two ingredients and cannot be added for comparison with another medicine or used to derive an individual tablet count or frequency."
        }
      },
      {
        "question": {
          "zh": "药片太大，可以掰一半、压碎或嚼碎吗？",
          "en": "Can a large tablet be halved, crushed or chewed?"
        },
        "answer": {
          "zh": "当前标签明确要求整片吞服，不得压碎、切开或咀嚼。吞咽困难时不要自行破坏缓释结构，应携带准确药盒联系开方团队或药师讨论可行产品。",
          "en": "The current label explicitly requires swallowing whole and says not to crush, cut or chew. If swallowing is difficult, do not damage the extended-release design; take the exact pack to the prescriber or pharmacist to discuss an appropriate product."
        }
      },
      {
        "question": {
          "zh": "已经吃 XIGDUO XR，还能再吃 FARXIGA 或二甲双胍吗？",
          "en": "Can FARXIGA or metformin be added when XIGDUO XR is already used?"
        },
        "answer": {
          "zh": "网页不能决定联用。XIGDUO XR 已含达格列净和盐酸二甲双胍；药单中再出现共同成分必须优先核对，不能自行叠加、轮换或停掉其中一盒。",
          "en": "A webpage cannot decide combination use. XIGDUO XR already contains dapagliflozin and metformin HCl. Another shared ingredient on the medicine list requires priority review, not self-combination, alternation or stopping a pack."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dosage-forms-are-part-of-medicine-identity",
      "how-to-read-a-drug-label",
      "generic-drugs-and-bioequivalence"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/xigduo-xr/",
    "en": "https://origindrug.com/en/drugs/xigduo-xr/"
  },
  "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."
  ]
}