Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. 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/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions

: [Preprocessed] ePI document for Flucelvax Package Leaflet in ES - JSON Representation

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{
  "resourceType" : "Bundle",
  "id" : "processedbundleflucelvaxES",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"
    ]
  },
  "language" : "es",
  "identifier" : {
    "system" : "https://www.gravitatehealth.eu/sid/doc",
    "value" : "P/EU/1/97/049/001"
  },
  "type" : "document",
  "timestamp" : "2023-04-25T11:55:27Z",
  "entry" : [
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1",
      "resource" : {
        "resourceType" : "Composition",
        "id" : "composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"
          ]
        },
        "language" : "es",
        "text" : {
          "status" : "extensions",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"es\" lang=\"es\"><a name=\"Composition_composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1\"> </a><p><b>Generated Narrative: Composition</b><a name=\"composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1\"> </a><a name=\"hccomposition-proc-es-e8bd725f64067aeae7994e2b56cd71c1\"> </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\">ResourceComposition &quot;composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1&quot;  (Language &quot;es&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><blockquote><p><b>HtmlElementLink</b></p><blockquote><p><b>url</b></p><code>elementClass</code></blockquote><p><b>value</b>: indication</p><blockquote><p><b>url</b></p><code>concept</code></blockquote><p><b>value</b>: HIV-infection/AIDS <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#B90)</span></p></blockquote><blockquote><p><b>HtmlElementLink</b></p><blockquote><p><b>url</b></p><code>elementClass</code></blockquote><p><b>value</b>: pregnancyCategory</p><blockquote><p><b>url</b></p><code>concept</code></blockquote><p><b>value</b>: Pregnancy <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#W78)</span></p></blockquote><blockquote><p><b>HtmlElementLink</b></p><blockquote><p><b>url</b></p><code>elementClass</code></blockquote><p><b>value</b>: breastfeedingCategory</p><blockquote><p><b>url</b></p><code>concept</code></blockquote><p><b>value</b>: Normal breast feeding (finding) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOWMED CT</a>#69840006)</span></p></blockquote><p><b>identifier</b>: <code>https://spor.ema.europa.eu/rmswi/</code>/ESprocessed163dd4e7fa7eed938c8bb01cecedf200</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>category</b>: Processed <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-epicategory-cs.html\">Category of EPI</a>#P)</span></p><p><b>date</b>: 2023-10-26 15:15:46+0000</p><p><b>author</b>: See on this page: Organization/mah-45fe50eae508b5755dd140ab2093eb5e</p><p><b>title</b>: TEST PURPOSES ONLY - Flucelvax</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td>Official <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-composition-attestation-mode.html\">Composition Attestation Mode</a>#official)</span></td><td>2023-10-26 15:15:46+0000</td></tr></table></div>"
        },
        "extension" : [
          {
            "extension" : [
              {
                "url" : "elementClass",
                "valueString" : "indication"
              },
              {
                "url" : "concept",
                "valueCodeableReference" : {
                  "concept" : {
                    "coding" : [
                      {
                        "system" : "https://icpc2.icd.com/",
                        "code" : "B90",
                        "display" : "HIV-infection/AIDS"
                      }
                    ]
                  }
                }
              }
            ],
            "url" : "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink"
          },
          {
            "extension" : [
              {
                "url" : "elementClass",
                "valueString" : "pregnancyCategory"
              },
              {
                "url" : "concept",
                "valueCodeableReference" : {
                  "concept" : {
                    "coding" : [
                      {
                        "system" : "https://icpc2.icd.com/",
                        "code" : "W78",
                        "display" : "Pregnancy"
                      }
                    ]
                  }
                }
              }
            ],
            "url" : "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink"
          },
          {
            "extension" : [
              {
                "url" : "elementClass",
                "valueString" : "breastfeedingCategory"
              },
              {
                "url" : "concept",
                "valueCodeableReference" : {
                  "concept" : {
                    "coding" : [
                      {
                        "system" : "http://snomed.info/sct",
                        "code" : "69840006",
                        "display" : "Normal breast feeding (finding)"
                      }
                    ]
                  }
                }
              }
            ],
            "url" : "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink"
          }
        ],
        "identifier" : [
          {
            "system" : "https://spor.ema.europa.eu/rmswi/",
            "value" : "ESprocessed163dd4e7fa7eed938c8bb01cecedf200"
          }
        ],
        "status" : "final",
        "type" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000155538"
            }
          ],
          "text" : "Package Leaflet"
        },
        "category" : [
          {
            "coding" : [
              {
                "system" : "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs",
                "code" : "P",
                "display" : "Processed"
              }
            ]
          }
        ],
        "subject" : [
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          }
        ],
        "date" : "2023-10-26T15:15:46Z",
        "author" : [
          {
            "reference" : "Organization/mah-45fe50eae508b5755dd140ab2093eb5e"
          }
        ],
        "title" : "TEST PURPOSES ONLY - Flucelvax",
        "attester" : [
          {
            "mode" : {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/composition-attestation-mode",
                  "code" : "official"
                }
              ]
            },
            "time" : "2023-10-26T15:15:46Z"
          }
        ],
        "section" : [
          {
            "title" : "B. Package Leaflet",
            "code" : {
              "coding" : [
                {
                  "system" : "https://spor.ema.europa.eu/rmswi/",
                  "code" : "100000155538"
                }
              ],
              "text" : "B. PACKAGE LEAFLET"
            },
            "text" : {
              "status" : "additional",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
            },
            "emptyReason" : {
              "coding" : [
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
                  "code" : "unavailable"
                }
              ]
            },
            "section" : [
              {
                "title" : "Package leaflet: Information for the user",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
                    }
                  ],
                  "text" : "Prospecto: información para el usuario"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><strong><span>Prospecto: informaci&#243;n para el usuario</span></strong></p><p><strong><span>Flucelvax Tetra - suspensi&#243;n inyectable en jeringa precargada</span></strong></p><p><span>Vacuna contra la gripe (ant&#237;geno de superficie, inactivado, preparada en cultivos celulares)</span></p><p><strong><span>Lea todo el prospecto detenidamente antes de empezar a recibir este medicamento, porque contiene</span></strong> <strong><span>informaci&#243;n importante para usted.</span></strong></p><p><span>- Conserve este prospecto, ya que puede tener que volver a leerlo.</span></p><p><span>- Si tiene alguna duda, consulte a su m&#233;dico, farmac&#233;utico o enfermero.</span></p><p><span>- Si experimenta efectos adversos, consulte a su m&#233;dico, farmac&#233;utico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver secci&#243;n 4.</span></p></div>"
                }
              },
              {
                "title" : "What is in this leaflet",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
                    }
                  ],
                  "text" : "Contenido del prospecto"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><strong><span>Contenido del prospecto</span></strong></p><p><span>1.&#160;&#160;&#160; Qu&#233; es Flucelvax Tetra y para qu&#233; se utiliza</span></p><p><span>2.&#160;&#160;&#160; Qu&#233; necesita saber antes de empezar a recibir Flucelvax Tetra</span></p><p><span>3.&#160;&#160;&#160; C&#243;mo se administra Flucelvax Tetra</span></p><p><span>4.&#160;&#160;&#160; Posibles efectos adversos</span></p><p><span>5.&#160;&#160;&#160; Conservaci&#243;n de Flucelvax Tetra</span></p><p><span>6.&#160;&#160;&#160; Contenido del envase e informaci&#243;n adicional</span></p></div>"
                }
              },
              {
                "title" : "1. What Flucelvax is and what it is used for",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
                    }
                  ],
                  "text" : "1. Qué es Flucelvax Tetra y para qué se utiliza"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"indication\"><span>Flucelvax Tetra es una vacuna contra la gripe. Flucelvax Tetra se prepara en cultivos celulares y, por lo tanto, no contiene huevo.</span></p><p><span>Cuando una persona recibe la vacuna, el sistema inmunitario (el sistema de defensa natural del organismo) producir&#225; su propia protecci&#243;n frente al virus de la gripe. Ninguno de los componentes de la vacuna puede causar la gripe.</span></p><p><span>Flucelvax Tetra se usa para prevenir la gripe en adultos y ni&#241;os a partir de los 2 a&#241;os de edad.</span></p><p><span>La vacuna va dirigida a cuatro cepas del virus de la gripe siguiendo las recomendaciones de la</span> <span>Organizaci&#243;n Mundial de la Salud para la campa&#241;a</span> <span>2023/2024.</span></p></div>"
                }
              },
              {
                "title" : "2. What you need to know before you take Flucelvax",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
                    }
                  ],
                  "text" : "2. Qué necesita saber antes de empezar a recibir Flucelvax Tetra"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><strong><span>No debe recibir Flucelvax Tetra:</span></strong></p><p><span>Si es al&#233;rgico a:</span></p><ul><li><span>los principios activos o alguno de los dem&#225;s componentes de esta vacuna (incluidos en la secci&#243;n 6).</span></li><li><span>la beta-propiolactona, al bromuro de cetiltrimetilamonio o al polisorbato 80, que son residuos del proceso de fabricaci&#243;n que pueden estar presentes en cantidades m&#237;nimas.</span></li></ul><p><strong><span>Advertencias y precauciones</span></strong></p><p><span>Consulte a su m&#233;dico, farmac&#233;utico o enfermero antes de empezar a recibir Flucelvax Tetra.</span></p><p><span>ANTES DE vacunarse</span></p><ul><li><span>su m&#233;dico o enfermero comprobar&#225; la f&#225;cil disponibilidad de tratamiento m&#233;dico y supervisi&#243;n adecuados en el caso raro de que se produjera una reacci&#243;n anafil&#225;ctica (una reacci&#243;n al&#233;rgica muy grave con s&#237;ntomas como dificultad para respirar, mareos, pulso d&#233;bil y r&#225;pido y erupci&#243;n cut&#225;nea) despu&#233;s de la administraci&#243;n. Esta reacci&#243;n puede presentarse con Flucelvax Tetra, al igual que con todas las vacunas que se inyectan.</span></li><li><span>debe informar a su m&#233;dico si tiene una enfermedad aguda que cursa con fiebre. Su m&#233;dico puede decidir retrasar su vacunaci&#243;n hasta que la fiebre haya desaparecido.</span></li><ul><li><span>debe informar a su m&#233;dico si su sistema inmunitario est&#225; comprometido o si est&#225; recibiendo un tratamiento que afecte al mismo, por ejemplo, medicamento contra el c&#225;ncer (quimioterapia) o corticoides (ver secci&#243;n &#8220;Otros medicamentos y Flucelvax Tetra&#8221;).</span></li></ul><li><span>debe informar a su m&#233;dico si tiene un problema de sangrado o le salen moretones&#160;&#160;&#160;&#160; f&#225;cilmente.</span></li><li><span>puede desmayarse despu&#233;s de la inyecci&#243;n con una aguja, o incluso antes, por lo tanto, informe a su m&#233;dico o enfermero si se ha desmayado anteriormente con alguna inyecci&#243;n.</span></li></ul><p><span>Como ocurre con todas las vacunas, Flucelvax Tetra puede no proteger completamente a todas las personas que son vacunadas.</span></p><p><strong><span>Otros medicamentos y Flucelvax Tetra</span></strong></p><p><span>Informe a su m&#233;dico o enfermero si est&#225; utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento, incluso los adquiridos sin receta, o si ha recibido recientemente alguna otra vacuna.</span></p><p><span>Flucelvax Tetra se puede administrar al mismo tiempo que otras vacunas.</span></p><div class=\"pregnancyCategory\"><p><strong><span>Embarazo y lactancia</span></strong></p><p><span>Embarazo:</span></p><p><span>Si est&#225; embarazada, cree que podr&#237;a estar embarazada o tiene intenci&#243;n de quedarse embarazada, consulte a su m&#233;dico. Las vacunas antigripales se pueden administrar en cualquier trimestre del embarazo.</span></p></div><div class=\"breastfeedingCategory\"><p><span>Lactancia:</span></p><p><span>El uso de Flucelvax Tetra durante la lactancia no ha sido estudiado. Flucelvax Tetra se puede administrar durante la lactancia.</span></p></div><p><strong><span>Conducci&#243;n y uso de m&#225;quinas</span></strong></p><p><span>La influencia de Flucelvax Tetra sobre la capacidad para conducir y utilizar m&#225;quinas es nula o insignificante.</span></p><p><strong><span>Flucelvax Tetra contiene cloruro de sodio y cloruro de potasio</span></strong></p><p><span>Esta vacuna contiene menos de 1 mmol de sodio (23 mg) por dosis; esto es, esencialmente &#8220;exento de sodio&#8221;.</span></p><p><span>Esta vacuna contiene potasio, menos de 1 mmol (39 mg) por dosis; esto es, esencialmente &#8220;exento de potasio&#8221;.</span></p></div>"
                }
              },
              {
                "title" : "3. How to take Flucelvax",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
                    }
                  ],
                  "text" : "3. Cómo se administra Flucelvax Tetra"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span>Su m&#233;dico o enfermero le administrar&#225; Flucelvax Tetra en forma de inyecci&#243;n en el m&#250;sculo de la parte superior del brazo (m&#250;sculo deltoides).</span></p><p><span>Adultos y ni&#241;os a partir de 2 a&#241;os de edad:</span></p><p><span>Una dosis de 0,5 ml</span></p><p><span>Si su hijo es menor de 9 a&#241;os y nunca ha sido vacunado contra la gripe, se le debe administrar una segunda dosis despu&#233;s, de al menos, 4 semanas.</span></p></div>"
                }
              },
              {
                "title" : "4. Possible side effects",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
                    }
                  ],
                  "text" : "4. Posibles efectos adversos"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span>Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.</span></p><p><span>Los siguientes efectos adversos se han notificado durante los ensayos cl&#237;nicos y durante el uso general:</span></p><p><strong><span>Efectos adversos muy graves</span></strong></p><p><span>Consulte inmediatamente con su m&#233;dico o acuda al servicio de urgencias del hospital m&#225;s cercano si presenta el siguiente efecto adverso &#8211; puede necesitar urgentemente atenci&#243;n m&#233;dica u hospitalizaci&#243;n:</span></p><p><span>Dificultad para respirar, mareos, pulso d&#233;bil y r&#225;pido junto con erupci&#243;n cut&#225;nea, que son los s&#237;ntomas de una reacci&#243;n anafil&#225;ctica (una reacci&#243;n al&#233;rgica muy grave)</span></p><p><strong><span>Efectos adversos graves</span></strong></p><p><span>Informe inmediatamente a su m&#233;dico si presenta cualquiera de los efectos adversos siguientes &#8211; puede necesitar atenci&#243;n m&#233;dica:</span></p><ul><li><span>Se siente d&#233;bil, tiene dificultades para moverse o presenta entumecimiento u hormigueo en las extremidades. Estos pueden ser s&#237;ntomas del s&#237;ndrome de Guillain-Barr&#233; (SGB), una enfermedad autoinmune causada por el propio sistema inmunitario del organismo</span></li><li><span>Hinchaz&#243;n extensa del miembro en el que se ha inyectado</span></li></ul><p><strong><span>Efectos adversos leves</span></strong></p><p><span>Muy frecuentes</span> <span>(pueden afectar a m&#225;s de 1 de cada 10 personas):</span></p><ul><li><span>Dolor en la zona de inyecci&#243;n, cardenales, enrojecimiento y endurecimiento o hinchaz&#243;n en la zona de inyecci&#243;n</span></li><li><span>Dolor de cabeza</span></li><li><span>Dolor muscular</span></li><li><span>Cansancio</span></li><li><span>P&#233;rdida de apetito</span></li><li><span>Irritabilidad (notificada solo en ni&#241;os de 2 a &#60; 6 a&#241;os)</span></li><li><span>Somnolencia (notificada solo en ni&#241;os de 2 a &#60; 6 a&#241;os)</span></li></ul><p><span>En los pacientes de edad avanzada fueron frecuentes el endurecimiento o la hinchaz&#243;n en el lugar de la inyecci&#243;n, el dolor de cabeza, el dolor muscular y la fatiga.</span></p><p><span>Los cardenales en el lugar de la inyecci&#243;n fueron frecuentes en adultos, ancianos y ni&#241;os de 9 a &#60; 18 a&#241;os.</span></p><p><span>El dolor de cabeza fue frecuente en ancianos.</span></p><p><span>La p&#233;rdida de apetito fue frecuente en adultos, ancianos y ni&#241;os de 9 a &#60; 18 a&#241;os.</span></p><p><span>Frecuentes</span> <span>(pueden afectar hasta 1 de cada 10 personas):</span></p><ul><li><span>N&#225;useas, v&#243;mitos, diarrea</span></li><li><span>Dolor articular</span></li><li><span>Tiritona</span></li><li><span>Cambios en los h&#225;bitos alimenticios (notificados solo en ni&#241;os de 2 a &#60; 6 a&#241;os)</span></li><li><span>Fiebre (&#62; 38 &#176;C)</span></li></ul><p><span>Los v&#243;mitos fueron poco frecuentes en los pacientes de edad avanzada</span></p><p><span>La fiebre fue infrecuente en adultos y ancianos</span></p><p><span>Frecuencia no conocida</span> <span>(no puede estimarse a partir de los datos disponibles):</span></p><ul><li><span>Sensaci&#243;n de hormigueo y</span> <span>entumecimiento (parestesia)</span></li><li><span>Reacciones cut&#225;neas generalizadas incluyendo picor, ampollas en la piel (prurito, urticaria) o erupci&#243;n cut&#225;nea inespec&#237;fica</span></li></ul><p><strong><span>Comunicaci&#243;n de efectos adversos</span></strong></p><p><span>Si experimenta cualquier tipo de efecto adverso, consulte a su profesional sanitario, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto.</span> <span>Tambi&#233;n puede comunicarlos directamente a trav&#233;s del Sistema Espa&#241;ol de Farmacovigilancia de Medicamentos de Uso Humano en</span> <a href=\"http://www.notificaRAM.es\"><span>www.notificaRAM.es</span></a><span>.</span> <span>M</span><span>ediante la comunicaci&#243;n de efectos adversos usted puede contribuir a proporcionar m&#225;s informaci&#243;n sobre la seguridad de este medicamento.</span></p></div>"
                }
              },
              {
                "title" : "5. How to store Flucelvax",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
                    }
                  ],
                  "text" : "5. Conservación de Flucelvax Tetra"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span>Mantener este medicamento fuera de la vista y del alcance de los ni&#241;os.</span></p><p><span>Conservar en nevera (entre 2 &#176;C y 8 &#176;C). No congelar.</span></p><p><span>Mantener la jeringa precargada en el embalaje exterior para protegerla de la luz.</span></p><p><span>No utilice esta vacuna despu&#233;s de la fecha de caducidad que aparece en la etiqueta y en la caja despu&#233;s de EXP/CAD. La fecha de caducidad es el &#250;ltimo d&#237;a del mes que se indica.</span></p><p><span>Los medicamentos no se deben tirar por los desag&#252;es ni a la basura. Pregunte a su farmac&#233;utico c&#243;mo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudar&#225; a proteger el medio ambiente.</span></p></div>"
                }
              },
              {
                "title" : "6. Contents of the pack and other information",
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                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
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                  ],
                  "text" : "6. Contenido del envase e información adicional"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span>&#xa0;</span></p><p><strong><span>Composici&#243;n de Flucelvax Tetra</span></strong></p><ul><li><span>Los principios activos son ant&#237;genos de superficie del virus de la gripe (hemaglutinina y neuraminidasa), inactivados, de las siguientes cepas*:</span></li></ul><p><a name=\"_Hlk66283421\"></a><a name=\"_Hlk66283267\"><span>Cepa similar a</span> <span>A/Wisconsin/67/2022 (H1N1)pdm09</span> <span>(A/Georgia/12/2022 CVR-167)</span></a></p><p><span>15 microgramos HA**</span></p><p><a name=\"_Hlk66283440\"></a><a name=\"_Hlk66283292\"><span>Cepa similar a</span> <span>A/Darwin/6/2021 (H3N2)</span> <span>(A/Darwin/11/2021, wild type)</span></a></p><p><span>15 microgramos HA**</span></p><p><span>Cepa similar a B/Austria/1359417/2021</span> <span>(</span><span>Singapore/WUH4618/2021</span><span>, wild type</span><span>)</span> <span>15 microgramos HA**</span></p><p><span>Cepa similar a B/Phuket/3073/2013 (B/Singapore/INFTT-16-0610/2016, wild type)</span></p><p><span>15 microgramos HA**</span></p><p><span>por dosis de 0,5 ml</span></p><p><span>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.</span></p><p><span>*</span><span>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</span> <span>propagadas en c&#233;lulas Madin Darby Canine Kidney (MDCK) (se trata de un cultivo celular especial en el que crece el virus de la gripe)</span></p><p><span>** hemaglutinina</span></p><p><span>Esta vacuna cumple con la recomendaci&#243;n de la Organizaci&#243;n Mundial de la Salud (OMS) (hemisferio norte) y con la recomendaci&#243;n de la UE para la CAMPA&#209;A 2023/2024.</span></p><ul><li><span>Los dem&#225;s componentes son: cloruro de sodio, cloruro de potasio, cloruro de magnesio hexahidrato, fosfato dis&#243;dico dihidrato, dihidrogenofosfato de potasio y agua para preparaciones inyectables.</span></li></ul><p><strong><span>Aspecto del producto y contenido del envase</span></strong></p><p><span>Flucelvax Tetra es una suspensi&#243;n inyectable en jeringa precargada (jeringa lista para usar). Flucelvax Tetra es una suspensi&#243;n de transparente a ligeramente opalescente.</span></p><p><span>Cada jeringa individual contiene 0,5 ml de suspensi&#243;n inyectable.</span></p><p><span>Flucelvax Tetra est&#225; disponible en envases de 1 jeringa precargada con o sin aguja o 10 jeringas</span></p><p><span>precargadas con o sin agujas.</span></p><p><span>Puede que solamente est&#233;n comercializados algunos tama&#241;os de envases.</span></p><p><strong><span>Titular de la autorizaci&#243;n de comercializaci&#243;n y responsable de la fabricaci&#243;n</span></strong></p><p><span>Seqirus Netherlands B.V.</span></p><p><span>Paasheuvelweg 28</span></p><p><span>1105BJ Amsterdam</span></p><p><span>Pa&#237;ses Bajos</span></p><p><span>Pueden solicitar m&#225;s informaci&#243;n respecto a este medicamento dirigi&#233;ndose al representante local del titular de la autorizaci&#243;n de comercializaci&#243;n:</span></p><p><span>Seqirus Spain, S.L., Barcelona</span></p><p><span>Tel: 937 817 884</span></p><p><strong><span>Fecha de la &#250;ltima revisi&#243;n de este prospecto: 07/2023</span></strong></p><p><strong><span>Otras fuentes de informaci&#243;n</span></strong></p><p><span>La informaci&#243;n detallada de este medicamento est&#225; disponible en la p&#225;gina web de la Agencia Europea de Medicamentos:</span> <a href=\"http://www.ema.europa.eu/\"><span>http://www.ema.europa.eu/.</span></a></p><p><span>------------------------------------------------------------------------------------------------------------- Esta informaci&#243;n est&#225; destinada &#250;nicamente a profesionales del sector sanitario:</span></p><p><span>Debe estar siempre f&#225;cilmente disponible el tratamiento m&#233;dico y la supervisi&#243;n apropiados en caso de un episodio anafil&#225;ctico, que puede aparecer raramente despu&#233;s de administrar la vacuna.</span></p><p><span>Agitar antes de usar. Despu&#233;s de agitar, el aspecto normal de la vacuna es una suspensi&#243;n de transparente a ligeramente opalescente.</span></p><p><span>Se debe inspeccionar visualmente la vacuna en busca de part&#237;culas extra&#241;as o cambios de color antes de la administraci&#243;n. Si se observan part&#237;culas extra&#241;as y/o cualquier variaci&#243;n del aspecto f&#237;sico, no administre la vacuna.</span></p></div>"
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          "value" : "9V4SVN4JQV"
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        "meta" : {
          "profile" : [
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          "status" : "generated",
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            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
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            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
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        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-2c0c197a41a706fb2549601e635da1f3\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-2c0c197a41a706fb2549601e635da1f3\"> </a><a name=\"hcingredient-for-2c0c197a41a706fb2549601e635da1f3\"> </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\">ResourceIngredient &quot;ingredient-for-2c0c197a41a706fb2549601e635da1f3&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/B3EV5T8SUF\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1</li><li>See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</li><li>See on this page: AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1</li></ul><p><b>role</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#B3EV5T8SUF)</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style=\"display: none\">*</td><td>15 ug<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code ug = 'ug')</span></td><td>active ingredient - basis of strength <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html\">RoleClass</a>#ACTIB)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "B3EV5T8SUF"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"
          },
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "active"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "B3EV5T8SUF",
                  "display" : "INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE"
                }
              ]
            }
          },
          "strength" : [
            {
              "presentationQuantity" : {
                "value" : 15,
                "system" : "http://unitsofmeasure.org",
                "code" : "ug"
              },
              "basis" : {
                "coding" : [
                  {
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
                    "code" : "ACTIB",
                    "display" : "active ingredient - basis of strength"
                  }
                ]
              }
            }
          ]
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-sodiumchloride",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-flucelvax-sodiumchloride",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-flucelvax-sodiumchloride\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-flucelvax-sodiumchloride\"> </a><a name=\"hcingredient-for-flucelvax-sodiumchloride\"> </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\">ResourceIngredient &quot;ingredient-for-flucelvax-sodiumchloride&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/451W47IQ8X\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1</li><li>See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</li><li>See on this page: AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>Sodium chloride <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#451W47IQ8X)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "451W47IQ8X"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"
          },
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "451W47IQ8X",
                  "display" : "Sodium chloride"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-potassiumchloride",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-flucelvax-potassiumchloride",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-flucelvax-potassiumchloride\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-flucelvax-potassiumchloride\"> </a><a name=\"hcingredient-for-flucelvax-potassiumchloride\"> </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\">ResourceIngredient &quot;ingredient-for-flucelvax-potassiumchloride&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/660YQ98I10\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1</li><li>See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</li><li>See on this page: AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>Potassium chloride <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#660YQ98I10)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "660YQ98I10"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"
          },
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "660YQ98I10",
                  "display" : "Potassium chloride"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-magnesiumchloride",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-flucelvax-magnesiumchloride",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-flucelvax-magnesiumchloride\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-flucelvax-magnesiumchloride\"> </a><a name=\"hcingredient-for-flucelvax-magnesiumchloride\"> </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\">ResourceIngredient &quot;ingredient-for-flucelvax-magnesiumchloride&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/02F3473H9O\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1</li><li>See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</li><li>See on this page: AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>MAGNESIUM CHLORIDE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#02F3473H9O)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "02F3473H9O"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"
          },
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "02F3473H9O",
                  "display" : "MAGNESIUM CHLORIDE"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate\"> </a><a name=\"hcingredient-for-flucelvax-sodiumphosphatedibasicdihydrate\"> </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\">ResourceIngredient &quot;ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/94255I6E2T\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1</li><li>See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</li><li>See on this page: AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>SODIUM PHOSPHATE, DIBASIC, DIHYDRATE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#94255I6E2T)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "94255I6E2T"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"
          },
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "94255I6E2T",
                  "display" : "SODIUM PHOSPHATE, DIBASIC, DIHYDRATE"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-potassiumdihydrogenphosphate",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-flucelvax-potassiumdihydrogenphosphate",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-flucelvax-potassiumdihydrogenphosphate\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-flucelvax-potassiumdihydrogenphosphate\"> </a><a name=\"hcingredient-for-flucelvax-potassiumdihydrogenphosphate\"> </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\">ResourceIngredient &quot;ingredient-for-flucelvax-potassiumdihydrogenphosphate&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/4J9FJ0HL51\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1</li><li>See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</li><li>See on this page: AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>Potassium dihydrogen phosphate <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#4J9FJ0HL51)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "4J9FJ0HL51"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"
          },
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "4J9FJ0HL51",
                  "display" : "Potassium dihydrogen phosphate"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-waterforinjections",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-flucelvax-waterforinjections",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-flucelvax-waterforinjections\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-flucelvax-waterforinjections\"> </a><a name=\"hcingredient-for-flucelvax-waterforinjections\"> </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\">ResourceIngredient &quot;ingredient-for-flucelvax-waterforinjections&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/059QF0KO0R\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1</li><li>See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</li><li>See on this page: AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td>Water for injections <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#059QF0KO0R)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "059QF0KO0R"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"
          },
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "059QF0KO0R",
                  "display" : "Water for injections"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadelaware552019cvr45h1n1whole",
      "resource" : {
        "resourceType" : "SubstanceDefinition",
        "id" : "substance-influenzaavirusadelaware552019cvr45h1n1whole",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_substance-influenzaavirusadelaware552019cvr45h1n1whole\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"substance-influenzaavirusadelaware552019cvr45h1n1whole\"> </a><a name=\"hcsubstance-influenzaavirusadelaware552019cvr45h1n1whole\"> </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\">ResourceSubstanceDefinition &quot;substance-influenzaavirusadelaware552019cvr45h1n1whole&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/9V4SVN4JQV\u00a0(use:\u00a0official)</p><p><b>version</b>: 1.0</p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>manufacturer</b>: See on this page: Organization/mah-45fe50eae508b5755dd140ab2093eb5e</p></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
            "value" : "9V4SVN4JQV"
          }
        ],
        "version" : "1.0",
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active"
            }
          ]
        },
        "manufacturer" : [
          {
            "reference" : "Organization/mah-45fe50eae508b5755dd140ab2093eb5e"
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadarwin112021h3n2whole",
      "resource" : {
        "resourceType" : "SubstanceDefinition",
        "id" : "substance-influenzaavirusadarwin112021h3n2whole",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_substance-influenzaavirusadarwin112021h3n2whole\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"substance-influenzaavirusadarwin112021h3n2whole\"> </a><a name=\"hcsubstance-influenzaavirusadarwin112021h3n2whole\"> </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\">ResourceSubstanceDefinition &quot;substance-influenzaavirusadarwin112021h3n2whole&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/JS7E5ZZ3AC\u00a0(use:\u00a0official)</p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>manufacturer</b>: See on this page: Organization/mah-45fe50eae508b5755dd140ab2093eb5e</p></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
            "value" : "JS7E5ZZ3AC"
          }
        ],
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active"
            }
          ]
        },
        "manufacturer" : [
          {
            "reference" : "Organization/mah-45fe50eae508b5755dd140ab2093eb5e"
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporewuh46182021whole",
      "resource" : {
        "resourceType" : "SubstanceDefinition",
        "id" : "substance-influenzabvirusbsingaporewuh46182021whole",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_substance-influenzabvirusbsingaporewuh46182021whole\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"substance-influenzabvirusbsingaporewuh46182021whole\"> </a><a name=\"hcsubstance-influenzabvirusbsingaporewuh46182021whole\"> </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\">ResourceSubstanceDefinition &quot;substance-influenzabvirusbsingaporewuh46182021whole&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/BFA4LSE5QQ\u00a0(use:\u00a0official)</p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>manufacturer</b>: See on this page: Organization/mah-45fe50eae508b5755dd140ab2093eb5e</p></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
            "value" : "BFA4LSE5QQ"
          }
        ],
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active"
            }
          ]
        },
        "manufacturer" : [
          {
            "reference" : "Organization/mah-45fe50eae508b5755dd140ab2093eb5e"
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporeinftt1606102016whole",
      "resource" : {
        "resourceType" : "SubstanceDefinition",
        "id" : "substance-influenzabvirusbsingaporeinftt1606102016whole",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_substance-influenzabvirusbsingaporeinftt1606102016whole\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"substance-influenzabvirusbsingaporeinftt1606102016whole\"> </a><a name=\"hcsubstance-influenzabvirusbsingaporeinftt1606102016whole\"> </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\">ResourceSubstanceDefinition &quot;substance-influenzabvirusbsingaporeinftt1606102016whole&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/B3EV5T8SUF\u00a0(use:\u00a0official)</p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>manufacturer</b>: See on this page: Organization/mah-45fe50eae508b5755dd140ab2093eb5e</p></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
            "value" : "B3EV5T8SUF"
          }
        ],
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active"
            }
          ]
        },
        "manufacturer" : [
          {
            "reference" : "Organization/mah-45fe50eae508b5755dd140ab2093eb5e"
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1",
      "resource" : {
        "resourceType" : "AdministrableProductDefinition",
        "id" : "ap-04c9bd6fb89d38b2d83eced2460c4dc1",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1\"> </a><p><b>Generated Narrative: AdministrableProductDefinition</b><a name=\"ap-04c9bd6fb89d38b2d83eced2460c4dc1\"> </a><a name=\"hcap-04c9bd6fb89d38b2d83eced2460c4dc1\"> </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\">ResourceAdministrableProductDefinition &quot;ap-04c9bd6fb89d38b2d83eced2460c4dc1&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-AdministrableProductDefinition-uv-epi.html\">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/xx</p><p><b>status</b>: active</p><p><b>formOf</b>: See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</p><p><b>administrableDoseForm</b>: suspension for injection in pre-filled syringe <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000074063)</span></p><p><b>unitOfPresentation</b>: Syringe <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#200000002150)</span></p><p><b>producedFrom</b>: See on this page: ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1</p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: Subcutaneous use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000073633)</span></p><h3>TargetSpecies</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Human <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000109093)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : [
          {
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "xx"
          }
        ],
        "status" : "active",
        "formOf" : [
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          }
        ],
        "administrableDoseForm" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000074063",
              "display" : "suspension for injection in pre-filled syringe"
            }
          ]
        },
        "unitOfPresentation" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "200000002150",
              "display" : "Syringe"
            }
          ]
        },
        "producedFrom" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"
          }
        ],
        "routeOfAdministration" : [
          {
            "code" : {
              "coding" : [
                {
                  "system" : "https://spor.ema.europa.eu/rmswi",
                  "code" : "100000073633",
                  "display" : "Subcutaneous use"
                }
              ]
            },
            "targetSpecies" : [
              {
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi",
                      "code" : "100000109093",
                      "display" : "Human"
                    }
                  ]
                }
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization04c9bd6fb89d38b2d83eced2460c4dc10",
      "resource" : {
        "resourceType" : "RegulatedAuthorization",
        "id" : "authorization04c9bd6fb89d38b2d83eced2460c4dc10",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_authorization04c9bd6fb89d38b2d83eced2460c4dc10\"> </a><p><b>Generated Narrative: RegulatedAuthorization</b><a name=\"authorization04c9bd6fb89d38b2d83eced2460c4dc10\"> </a><a name=\"hcauthorization04c9bd6fb89d38b2d83eced2460c4dc10\"> </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\">ResourceRegulatedAuthorization &quot;authorization04c9bd6fb89d38b2d83eced2460c4dc10&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-RegulatedAuthorization-uv-epi.html\">RegulatedAuthorization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1326/001\u00a0(use:\u00a0official)</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</p><p><b>type</b>: Marketing Authorisation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072062)</span></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2019-01-01</p><p><b>holder</b>: See on this page: Organization/mah-45fe50eae508b5755dd140ab2093eb5e</p></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "EU/1/18/1326/001"
          }
        ],
        "subject" : [
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          }
        ],
        "type" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072062",
              "display" : "Marketing Authorisation"
            }
          ]
        },
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active",
              "display" : "Active"
            }
          ]
        },
        "statusDate" : "2019-01-01",
        "holder" : {
          "reference" : "Organization/mah-45fe50eae508b5755dd140ab2093eb5e"
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-45fe50eae508b5755dd140ab2093eb5e",
      "resource" : {
        "resourceType" : "Organization",
        "id" : "mah-45fe50eae508b5755dd140ab2093eb5e",
        "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_mah-45fe50eae508b5755dd140ab2093eb5e\"> </a><p><b>Generated Narrative: Organization</b><a name=\"mah-45fe50eae508b5755dd140ab2093eb5e\"> </a><a name=\"hcmah-45fe50eae508b5755dd140ab2093eb5e\"> </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\">ResourceOrganization &quot;mah-45fe50eae508b5755dd140ab2093eb5e&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>/ORG-100013715\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>: Seqirus Netherlands B.V.</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>Paasheuvelweg 28 1105BJ Amsterdam Netherlands(work)</td></tr></table></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/omswi",
            "value" : "ORG-100013715"
          }
        ],
        "active" : true,
        "type" : [
          {
            "coding" : [
              {
                "system" : "https://spor.ema.europa.eu/rmswi",
                "code" : "220000000034",
                "display" : "Marketing authorisation holder"
              }
            ]
          }
        ],
        "name" : "Seqirus Netherlands B.V.",
        "contact" : [
          {
            "address" : {
              "use" : "work",
              "type" : "physical",
              "text" : "Paasheuvelweg 28 1105BJ Amsterdam Netherlands",
              "line" : [
                "Paasheuvelweg 28"
              ],
              "city" : "1105BJ Amsterdam",
              "postalCode" : "367061",
              "country" : "Netherlands"
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-a854b6fee6a8536c78c604a4b9f6c395",
      "resource" : {
        "resourceType" : "PackagedProductDefinition",
        "id" : "ppd-a854b6fee6a8536c78c604a4b9f6c395",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_ppd-a854b6fee6a8536c78c604a4b9f6c395\"> </a><p><b>Generated Narrative: PackagedProductDefinition</b><a name=\"ppd-a854b6fee6a8536c78c604a4b9f6c395\"> </a><a name=\"hcppd-a854b6fee6a8536c78c604a4b9f6c395\"> </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\">ResourcePackagedProductDefinition &quot;ppd-a854b6fee6a8536c78c604a4b9f6c395&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-PackagedProductDefinition-uv-epi.html\">PackagedProductDefinition (ePI)</a></p></div><p><b>name</b>: Flucelvax Tetra - suspension for injection in pre-filled syringe\nInfluenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1</p><p><b>type</b>: 100000155527 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000155527)</span></p><p><b>packageFor</b>: See on this page: MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1</p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2019-01-01</p><p><b>containedItemQuantity</b>: 15 ug<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code ug = 'ug')</span></p><p><b>copackagedIndicator</b>: true</p><blockquote><p><b>packaging</b></p><p><b>type</b>: Box <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000073498)</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: Cardboard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#200000003529)</span></p><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/xxxx</p><p><b>type</b>: 100000073498 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000073498)</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: Cardboard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#200000003529)</span></p><blockquote><p><b>containedItem</b></p></blockquote></blockquote></blockquote></div>"
        },
        "name" : "Flucelvax Tetra - suspension for injection in pre-filled syringe\nInfluenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1",
        "type" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000155527"
            }
          ]
        },
        "packageFor" : [
          {
            "reference" : "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"
          }
        ],
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active",
              "display" : "Active"
            }
          ]
        },
        "statusDate" : "2019-01-01",
        "containedItemQuantity" : [
          {
            "value" : 15,
            "system" : "http://unitsofmeasure.org",
            "code" : "ug"
          }
        ],
        "copackagedIndicator" : true,
        "packaging" : {
          "type" : {
            "coding" : [
              {
                "system" : "https://spor.ema.europa.eu/rmswi",
                "code" : "100000073498",
                "display" : "Box"
              }
            ]
          },
          "quantity" : 1,
          "material" : [
            {
              "coding" : [
                {
                  "system" : "https://spor.ema.europa.eu/rmswi",
                  "code" : "200000003529",
                  "display" : "Cardboard"
                }
              ]
            }
          ],
          "packaging" : [
            {
              "identifier" : [
                {
                  "system" : "https://spor.ema.europa.eu/pmswi",
                  "value" : "xxxx"
                }
              ],
              "type" : {
                "coding" : [
                  {
                    "system" : "https://spor.ema.europa.eu/rmswi",
                    "code" : "100000073498",
                    "display" : "100000073498"
                  }
                ]
              },
              "quantity" : 1,
              "material" : [
                {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi",
                      "code" : "200000003529",
                      "display" : "Cardboard"
                    }
                  ]
                }
              ],
              "containedItem" : [
                {
                  "item" : {
                    "reference" : {
                      "reference" : "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"
                    }
                  }
                }
              ]
            }
          ]
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1",
      "resource" : {
        "resourceType" : "MedicinalProductDefinition",
        "id" : "mpb6ced64d25ea2c8da6c6099386f14db1",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1\"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"mpb6ced64d25ea2c8da6c6099386f14db1\"> </a><a name=\"hcmpb6ced64d25ea2c8da6c6099386f14db1\"> </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\">ResourceMedicinalProductDefinition &quot;mpb6ced64d25ea2c8da6c6099386f14db1&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1326/001, <code>https://www.who-umc.org/phpid</code>/0xF79CABF272B6A7EEF104DDDA44E82717</p><p><b>type</b>: Medicinal Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-type.html\">Medicinal Product Type</a>#MedicinalProduct)</span></p><p><b>domain</b>: Human use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-domain.html\">Medicinal Product Domain</a>#Human)</span></p><p><b>status</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>legalStatusOfSupply</b>: Medicinal product subject to medical prescription <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000000000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Flucelvax Tetra - suspension for injection in pre-filled syringe\nInfluenza vaccine (surface antigen, inactivated, prepared in cell cultures)</p><p><b>type</b>: Full name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000001)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Flucelvax Tetra</p><p><b>type</b>: Invented name part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000002)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</p><p><b>type</b>: Scientific name part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000003)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 15 ug</p><p><b>type</b>: Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000004)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Solution for injection</p><p><b>type</b>: Pharmaceutical dose form part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000005)</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td>Spain <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#ES)</span></td><td>Spain <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#ES)</span></td><td>English <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html\">Tags for the Identification of Languages</a>#en)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : [
          {
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "EU/1/18/1326/001"
          },
          {
            "system" : "https://www.who-umc.org/phpid",
            "value" : "0xF79CABF272B6A7EEF104DDDA44E82717"
          }
        ],
        "type" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/medicinal-product-type",
              "code" : "MedicinalProduct",
              "display" : "Medicinal Product"
            }
          ]
        },
        "domain" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/medicinal-product-domain",
              "code" : "Human",
              "display" : "Human use"
            }
          ]
        },
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active",
              "display" : "active"
            }
          ]
        },
        "legalStatusOfSupply" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000000000",
              "display" : "Medicinal product subject to medical prescription"
            }
          ]
        },
        "name" : [
          {
            "productName" : "Flucelvax Tetra - suspension for injection in pre-filled syringe\nInfluenza vaccine (surface antigen, inactivated, prepared in cell cultures)",
            "type" : {
              "coding" : [
                {
                  "system" : "https://spor.ema.europa.eu/lists/220000000000",
                  "code" : "220000000001",
                  "display" : "Full name"
                }
              ]
            },
            "part" : [
              {
                "part" : "Flucelvax Tetra",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000002",
                      "display" : "Invented name part"
                    }
                  ]
                }
              },
              {
                "part" : "Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000003",
                      "display" : "Scientific name part"
                    }
                  ]
                }
              },
              {
                "part" : "15 ug",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000004",
                      "display" : "Strength part"
                    }
                  ]
                }
              },
              {
                "part" : "Solution for injection",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000005",
                      "display" : "Pharmaceutical dose form part"
                    }
                  ]
                }
              }
            ],
            "usage" : [
              {
                "country" : {
                  "coding" : [
                    {
                      "system" : "urn:iso:std:iso:3166",
                      "code" : "ES",
                      "display" : "Spain"
                    }
                  ]
                },
                "jurisdiction" : {
                  "coding" : [
                    {
                      "system" : "urn:iso:std:iso:3166",
                      "code" : "ES",
                      "display" : "Spain"
                    }
                  ]
                },
                "language" : {
                  "coding" : [
                    {
                      "system" : "urn:ietf:bcp:47",
                      "code" : "en",
                      "display" : "English"
                    }
                  ]
                }
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1",
      "resource" : {
        "resourceType" : "ManufacturedItemDefinition",
        "id" : "mid-04c9bd6fb89d38b2d83eced2460c4dc1",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1\"> </a><p><b>Generated Narrative: ManufacturedItemDefinition</b><a name=\"mid-04c9bd6fb89d38b2d83eced2460c4dc1\"> </a><a name=\"hcmid-04c9bd6fb89d38b2d83eced2460c4dc1\"> </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\">ResourceManufacturedItemDefinition &quot;mid-04c9bd6fb89d38b2d83eced2460c4dc1&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-ManufacturedItemDefinition-uv-epi.html\">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1326/001\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: suspension for injection in pre-filled syringe <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000074063)</span></p><p><b>unitOfPresentation</b>: Syringe <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#200000002150)</span></p></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "EU/1/18/1326/001"
          }
        ],
        "status" : "active",
        "manufacturedDoseForm" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000074063",
              "display" : "suspension for injection in pre-filled syringe"
            }
          ]
        },
        "unitOfPresentation" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "200000002150",
              "display" : "Syringe"
            }
          ]
        }
      }
    }
  ]
}