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Packagehl7.fhir.uv.emedicinal-product-info
Resource TypeBundle
IdBundle-bundle-epi-type1-example-paracetamol.json
FHIR VersionR5

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Source1

{
  "resourceType": "Bundle",
  "id": "bundle-epi-type1-example-paracetamol",
  "meta": {
    "versionId": "1.0",
    "lastUpdated": "2024-03-20T10:00:00Z",
    "profile": [
      "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type1"
    ]
  },
  "language": "en",
  "identifier": {
    "system": "http://example.org/identifier",
    "value": "epi-paracetamol-t1"
  },
  "type": "document",
  "timestamp": "2024-03-20T10:00:00Z",
  "entry": [
    {
      "fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-paracetamol-t1",
      "resource": {
        "resourceType": "Composition",
        "id": "composition-paracetamol-t1",
        "meta": {
          "versionId": "1",
          "lastUpdated": "2024-03-20T10:00:00Z",
          "profile": [
            "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
          ]
        },
        "language": "en",
        "text": {
          "status": "generated",
          "div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><a name=\"Composition_composition-paracetamol-t1\"> </a><p>Package Leaflet: Information for the user - Paracetamol 500 mg tablets</p></div>"
        },
        "identifier": [
          {
            "system": "http://example.org/identifier",
            "value": "composition-paracetamol-t1"
          }
        ],
        "version": "1.0",
        "status": "final",
        "type": {
          "coding": [
            {
              "system": "https://spor.ema.europa.eu/rmswi/",
              "code": "100000155538",
              "display": "Package Leaflet"
            }
          ]
        },
        "subject": [
          {
            "display": "Paracetamol"
          }
        ],
        "date": "2024-03-20T10:00:00Z",
        "author": [
          {
            "display": "Acme Pharma Inc."
          }
        ],
        "title": "Package Leaflet: Information for the user - Paracetamol 500 mg tablets",
        "section": [
          {
            "title": "Package Leaflet",
            "code": {
              "coding": [
                {
                  "system": "https://spor.ema.europa.eu/rmswi/",
                  "code": "100000155538",
                  "display": "Package Leaflet"
                }
              ]
            },
            "text": {
              "status": "generated",
              "div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">Package Leaflet</div>"
            },
            "section": [
              {
                "title": "1. What Paracetamol 500 mg tablets is and what it is used for",
                "code": {
                  "coding": [
                    {
                      "system": "https://spor.ema.europa.eu/rmswi/",
                      "code": "100000155538",
                      "display": "1. What Paracetamol 500 mg tablets is and what it is used for"
                    }
                  ]
                },
                "text": {
                  "status": "generated",
                  "div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>1. What Paracetamol 500 mg tablets is and what it is used for</h3><p>Paracetamol belongs to a group of medicines called analgesics (painkillers) and antipyretics (medicines to reduce fever).</p><p>Paracetamol is used to relieve mild to moderate pain and fever.</p></div>"
                }
              },
              {
                "title": "2. What you need to know before you take Paracetamol 500 mg tablets",
                "code": {
                  "coding": [
                    {
                      "system": "https://spor.ema.europa.eu/rmswi/",
                      "code": "100000155538",
                      "display": "2. What you need to know before you take Paracetamol 500 mg tablets"
                    }
                  ]
                },
                "text": {
                  "status": "generated",
                  "div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>2. What you need to know before you take Paracetamol 500 mg tablets</h3><p><strong>Do not take Paracetamol:</strong> if you are allergic to paracetamol or any of the other ingredients of this medicine.</p><p><strong>Warnings and precautions:</strong> Talk to your doctor or pharmacist before taking Paracetamol if you have liver or kidney problems.</p></div>"
                }
              },
              {
                "title": "3. How to take Paracetamol 500 mg tablets",
                "code": {
                  "coding": [
                    {
                      "system": "https://spor.ema.europa.eu/rmswi/",
                      "code": "100000155538",
                      "display": "3. How to take Paracetamol 500 mg tablets"
                    }
                  ]
                },
                "text": {
                  "status": "generated",
                  "div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>3. How to take Paracetamol 500 mg tablets</h3><p>Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.</p><p>The recommended dose is 1 tablet every 4 to 6 hours as needed. Do not take more than 6 tablets in any 24-hour period.</p></div>"
                }
              },
              {
                "title": "4. Possible side effects",
                "code": {
                  "coding": [
                    {
                      "system": "https://spor.ema.europa.eu/rmswi/",
                      "code": "100000155538",
                      "display": "4. Possible side effects"
                    }
                  ]
                },
                "text": {
                  "status": "generated",
                  "div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>4. Possible side effects</h3><p>Like all medicines, this medicine can cause side effects, although not everybody gets them.</p><p>Stop taking the medicine and tell your doctor immediately if you experience allergic reactions such as skin rash or swelling.</p></div>"
                }
              },
              {
                "title": "5. How to store Paracetamol 500 mg tablets",
                "code": {
                  "coding": [
                    {
                      "system": "https://spor.ema.europa.eu/rmswi/",
                      "code": "100000155538",
                      "display": "5. How to store Paracetamol 500 mg tablets"
                    }
                  ]
                },
                "text": {
                  "status": "generated",
                  "div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>5. How to store Paracetamol 500 mg tablets</h3><p>Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton.</p><p>This medicine does not require any special storage conditions.</p></div>"
                }
              },
              {
                "title": "6. Contents of the pack and other information",
                "code": {
                  "coding": [
                    {
                      "system": "https://spor.ema.europa.eu/rmswi/",
                      "code": "100000155538",
                      "display": "6. Contents of the pack and other information"
                    }
                  ]
                },
                "text": {
                  "status": "generated",
                  "div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>6. Contents of the pack and other information</h3><p><strong>What Paracetamol contains:</strong> The active substance is paracetamol. The other ingredients are pregelatinized starch, povidone, stearic acid, talc, magnesium stearate, and hypromellose.</p><p><strong>What Paracetamol looks like and contents of the pack:</strong> Paracetamol tablets are white and round. They are available in blister packs of 30 or 50 tablets.</p></div>"
                }
              }
            ]
          }
        ]
      }
    }
  ]
}