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Narrative

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Source1

{
  "resourceType": "Composition",
  "id": "LantusInjectionLabelComposition",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "identifier": [
    {
      "system": "urn:ietf:rfc:3986",
      "value": "urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6"
    }
  ],
  "version": "11",
  "status": "final",
  "type": {
    "coding": [
      {
        "system": "http://loinc.org",
        "code": "34391-3",
        "display": "HUMAN PRESCRIPTION DRUG LABEL"
      }
    ]
  },
  "date": "2021-01-27",
  "author": [
    {
      "reference": "Organization/SanofiAventisUS"
    }
  ],
  "title": "These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>\n      <br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000",
  "section": [
    {
      "id": "68224803-d32c-4438-9439-9c210668e295",
      "extension": [
        {
          "url": "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime",
          "valueDateTime": "2021-01-27"
        },
        {
          "url": "http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId",
          "valueString": "S1"
        }
      ],
      "title": "1 INDICATIONS AND USAGE",
      "code": {
        "coding": [
          {
            "system": "http://loinc.org",
            "code": "34067-9",
            "display": "INDICATIONS &amp; USAGE SECTION"
          }
        ]
      },
      "text": {
        "status": "additional",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div style=\"highlights\"><p>LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. (<a href=\"#S1\">1</a>)</p><p><span style=\"text-decoration: underline\">Limitations of Use</span></p><p>Not recommended for treating diabetic ketoacidosis. (<a href=\"#S1\">1</a>)</p></div><div style=\"narrative\"><a name=\"S1\"/><p>LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.</p></div></div>"
      },
      "section": [
        {
          "id": "0230cfa8-ff67-4666-ba57-bbad268ac6fe",
          "code": {
            "coding": [
              {
                "system": "http://loinc.org",
                "code": "42229-5",
                "display": "SPL UNCLASSIFIED SECTION"
              }
            ]
          },
          "text": {
            "status": "additional",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div style=\"narrative\"><p><span style=\"text-decoration: underline\">Limitations of Use</span></p><p>LANTUS is not recommended for the treatment of diabetic ketoacidosis.</p></div></div>"
          }
        }
      ]
    },
    {
      "id": "f65bb254-5018-4af5-b02a-38d5d51ed901",
      "extension": [
        {
          "url": "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime",
          "valueDateTime": "2021-01-27"
        }
      ],
      "code": {
        "coding": [
          {
            "system": "http://loinc.org",
            "code": "48780-1",
            "display": "SPL LISTING DATA ELEMENTS SECTION"
          }
        ]
      },
      "entry": [
        {
          "reference": "MedicinalProductDefinition/LantusSyringeDefinition"
        },
        {
          "reference": "MedicinalProductDefinition/LantusVialDefinition"
        }
      ]
    },
    {
      "id": "ff673a31-f676-444c-a009-8d4a2645fd19",
      "extension": [
        {
          "url": "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime",
          "valueDateTime": "2021-01-27"
        }
      ],
      "title": "PRINCIPAL DISPLAY PANEL - 10 mL Vial Package",
      "code": {
        "coding": [
          {
            "system": "http://loinc.org",
            "code": "51945-4",
            "display": "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"
          }
        ]
      },
      "text": {
        "status": "additional",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div style=\"narrative\"><p>NDC 0088-5021-01<br/>Rx only</p><p>Lantus<sup>®</sup><br/>insulin glargine<br/>injection</p><p>100 units/mL<br/>(U-100)<br/>For subcutaneous<br/>injection only</p><p>Do not mix with<br/>other insulins</p><p>Use only if solution<br/>is clear and colorless<br/>with no particles visible</p><p>Use with U-100<br/>syringe only</p><p>One 10 mL multiple-dose vial</p><p>novaplus <sub>™</sub></p><img src=\"lantusnova-20.jpg\" alt=\"PRINCIPAL DISPLAY PANEL - 10 mL Vial Package\"/></div></div>"
      }
    },
    {
      "id": "8ce1b409-6067-4c9d-8e21-bdb6df850c24",
      "extension": [
        {
          "url": "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime",
          "valueDateTime": "2021-01-27"
        }
      ],
      "title": "PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package",
      "code": {
        "coding": [
          {
            "system": "http://loinc.org",
            "code": "51945-4",
            "display": "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"
          }
        ]
      },
      "text": {
        "status": "additional",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div style=\"narrative\"><p>NDC 0088-5020-05<br/>Rx only</p><p>Lantus<sup>®</sup> SoloStar<sup>®</sup><br/>insulin glargine injection<br/>For Single Patient Use Only<br/>100 units/mL (U-100)<br/>Five 3 mL Prefilled Pens</p><p>Solution for injection in a disposable insulin delivery device<br/>Do not mix with other insulins<br/>For subcutaneous injection only<br/>Use only if solution is clear and colorless with no particles visible<br/>Use within 28 days after initial use *Needles not include (see back panel)</p><p>novaplus <sub>™</sub></p><img src=\"lantusnova-21.jpg\" alt=\"PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package\"/></div></div>"
      }
    }
  ]
}