Miscellaneous ePI Test
0.1.0 - CI Build

Miscellaneous ePI Test, published by . This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/epi-test/ and changes regularly. See the Directory of published versions

: TSZ 0818 Bundle UK EN - PIL Talzenna - JSON Representation

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{
  "resourceType" : "Bundle",
  "id" : "0817Bundle",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"
    ]
  },
  "language" : "en",
  "identifier" : {
    "system" : "https://www.mhra.gov.uk/",
    "value" : "0817BundleUniqueIdentifier"
  },
  "type" : "document",
  "timestamp" : "2022-03-04T00:00:00Z",
  "entry" : [
    {
      "fullUrl" : "Composition/0818TestandLearn",
      "resource" : {
        "resourceType" : "Composition",
        "id" : "0818TestandLearn",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"
          ]
        },
        "language" : "en",
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_0818TestandLearn\"> </a><p><b>Generated Narrative: Composition</b><a name=\"0818TestandLearn\"> </a><a name=\"hc0818TestandLearn\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Composition &quot;0818TestandLearn&quot;  (Language &quot;en&quot;) </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.mhra.gov.uk/</code>/c387d81a-3b28-11ee-be56-0242ac120002</p><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000155538)</span></p><p><b>date</b>: 2022-03-04 00:00:00+0000</p><p><b>author</b>: See on this page: Organization/0817Org</p><p><b>title</b>: 0818TestandLearnTitle2 input in code row 18</p></div>"
        },
        "identifier" : [
          {
            "system" : "https://www.mhra.gov.uk/",
            "value" : "c387d81a-3b28-11ee-be56-0242ac120002"
          }
        ],
        "status" : "final",
        "type" : {
          "coding" : [
            {
              "system" : "https://www.mhra.gov.uk/",
              "code" : "100000155538"
            }
          ],
          "text" : "Package Leaflet"
        },
        "date" : "2022-03-04T00:00:00Z",
        "author" : [
          {
            🔗 "reference" : "Organization/0817Org"
          }
        ],
        "title" : "0818TestandLearnTitle2 input in code row 18",
        "section" : [
          {
            "title" : "What is in this leaflet",
            "code" : {
              "coding" : [
                {
                  "system" : "https://www.mhra.gov.uk/",
                  "code" : "100000155538"
                }
              ],
              "text" : "What is in this leaflet"
            },
            "text" : {
              "status" : "additional",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ol><li>What Talzenna is and what it is used for</li><li>What you need to know before you take Talzenna</li><li>How to take Talzenna</li><li>Possible side effects</li><li>How to store Talzenna</li><li>Contents of the pack and other information</li></ol></div>"
            }
          },
          {
            "title" : "1. What Talzenna is and what it is used for",
            "code" : {
              "coding" : [
                {
                  "system" : "https://www.mhra.gov.uk/",
                  "code" : "200000029895"
                }
              ],
              "text" : "1. What Talzenna is and what it is used for"
            },
            "text" : {
              "status" : "additional",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
            },
            "section" : [
              {
                "title" : "What Talzenna is and how it works",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://www.mhra.gov.uk/",
                      "code" : "200000029895"
                    }
                  ],
                  "text" : "What Talzenna is and how it works"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Talzenna contains the active substance talazoparib. It is a type of anticancer medicine known as a ‘PARP (poly-ADP ribose polymerase) inhibitor’.</p><p>Patients with changes (mutations) in genes called BRCA are at risk of developing some forms of cancer. Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in certain cancer cells. As a result, the cancer cells can no longer repair themselves and they die.</p></div>"
                }
              },
              {
                "title" : "What Talzenna is used for",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://www.mhra.gov.uk/",
                      "code" : "200000029895"
                    }
                  ],
                  "text" : "What Talzenna is used for"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene.</p><p>Talzenna is used when the cancer has spread beyond the original tumour or to other parts of the body.</p><p>Your healthcare provider will perform a test to make sure that Talzenna is right for you.</p><p>If you have any questions about how Talzenna works or why this medicine has been prescribed for you, ask your doctor.</p></div>"
                }
              }
            ]
          },
          {
            "title" : "2. What you need to know before you take Talzenna",
            "code" : {
              "coding" : [
                {
                  "system" : "https://www.mhra.gov.uk/",
                  "code" : "200000029896"
                }
              ],
              "text" : "2. What you need to know before you take Talzenna"
            },
            "text" : {
              "status" : "additional",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
            },
            "section" : [
              {
                "title" : "Do not take Talzenna",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://www.mhra.gov.uk/",
                      "code" : "200000029897"
                    }
                  ],
                  "text" : "Do not take Talzenna"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>If you are allergic to talazoparib or any of the other ingredients of this medicine (listed in section 6)</li><li>f you are breast-feeding.</li></ul></div>"
                }
              },
              {
                "title" : "Warnings and precautions",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://www.mhra.gov.uk/",
                      "code" : "200000029898"
                    }
                  ],
                  "text" : "Warnings and precautions"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Talk to your doctor, pharmacist or nurse before taking Talzenna and during your treatment if you experience signs or symptoms described in this section.</p><p><b>Low blood cell counts</b></p><p>Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia). Signs and symptoms you need to look out for include:</p><ul><li><b>Anaemia:</b> Being short of breath, feeling very tired, pale skin, or fast heartbeat – these may be signs of a low red blood cell count</li><li><b>Neutropenia:</b> Infection, developing chills or shivering, or fever – these may be signs of a low white blood cell count</li><li><b>Thrombocytopenia:</b> Bruising or bleeding for longer than usual if you hurt yourself – these may be signs of a low blood platelet count</li></ul><p>Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia). Signs and symptoms you need to look out for include:</p></div>"
                }
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "Organization/0817Org",
      "resource" : {
        "resourceType" : "Organization",
        "id" : "0817Org",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_0817Org\"> </a><p><b>Generated Narrative: Organization</b><a name=\"0817Org\"> </a><a name=\"hc0817Org\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization &quot;0817Org&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/0817org01\u00a0(use:\u00a0official)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#220000000034)</span></p><p><b>name</b>: Willywonka Factory</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>221B Baker Street, London NW1 6XE(work)</td></tr></table></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/omswi",
            "value" : "0817org01"
          }
        ],
        "active" : true,
        "type" : [
          {
            "coding" : [
              {
                "system" : "https://spor.ema.europa.eu/rmswi",
                "code" : "220000000034",
                "display" : "Marketing authorisation holder"
              }
            ],
            "text" : "Marketing authorisation holder"
          }
        ],
        "name" : "Willywonka Factory",
        "contact" : [
          {
            "address" : {
              "use" : "work",
              "type" : "physical",
              "text" : "221B Baker Street, London NW1 6XE",
              "line" : [
                "Baker Street"
              ],
              "city" : "London",
              "country" : "UK"
            }
          }
        ]
      }
    }
  ]
}