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 - XML Representation

Raw xml | Download


<Bundle xmlns="http://hl7.org/fhir">
  <id value="processedbundleflucelvaxES"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
  </meta>
  <language value="es"/>
  <identifier>
    <system value="https://www.gravitatehealth.eu/sid/doc"/>
    <value value="EU/1/18/1326/001"/>
  </identifier>
  <type value="document"/>
  <timestamp value="2023-04-25T11:55:27Z"/>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1"/>
    <resource>
      <Composition>
        <id value="composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
        </meta>
        <language value="es"/>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="es" lang="es"><a name="Composition_composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1</b></p><a name="composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1"> </a><a name="hccomposition-proc-es-e8bd725f64067aeae7994e2b56cd71c1"> </a><a name="composition-proc-es-e8bd725f64067aeae7994e2b56cd71c1-en-US"> </a><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">Language: es</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><ul><li>elementClass: indication</li><li>concept: <span title="Codes:{https://icpc2.icd.com/ B90}">HIV-infection/AIDS</span></li></ul></blockquote><blockquote><p><b>HtmlElementLink</b></p><ul><li>elementClass: pregnancyCategory</li><li>concept: <span title="Codes:{https://icpc2.icd.com/ W78}">Pregnancy</span></li></ul></blockquote><blockquote><p><b>HtmlElementLink</b></p><ul><li>elementClass: breastfeedingCategory</li><li>concept: <span title="Codes:{http://snomed.info/sct 69840006}">Normal breast feeding (finding)</span></li></ul></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>: <span title="Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}">Package Leaflet</span></p><p><b>category</b>: <span title="Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs P}">Processed</span></p><p><b>date</b>: 2023-10-26 15:15:46+0000</p><p><b>author</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></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><span title="Codes:{http://hl7.org/fhir/composition-attestation-mode official}">Official</span></td><td>2023-10-26 15:15:46+0000</td></tr></table></div>
        </text>
        <extension
                   url="http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink">
          <extension url="elementClass">
            <valueString value="indication"/>
          </extension>
          <extension url="concept">
            <valueCodeableReference>
              <concept>
                <coding>
                  <system value="https://icpc2.icd.com/"/>
                  <code value="B90"/>
                  <display value="HIV-infection/AIDS"/>
                </coding>
              </concept>
            </valueCodeableReference>
          </extension>
        </extension>
        <extension
                   url="http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink">
          <extension url="elementClass">
            <valueString value="pregnancyCategory"/>
          </extension>
          <extension url="concept">
            <valueCodeableReference>
              <concept>
                <coding>
                  <system value="https://icpc2.icd.com/"/>
                  <code value="W78"/>
                  <display value="Pregnancy"/>
                </coding>
              </concept>
            </valueCodeableReference>
          </extension>
        </extension>
        <extension
                   url="http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink">
          <extension url="elementClass">
            <valueString value="breastfeedingCategory"/>
          </extension>
          <extension url="concept">
            <valueCodeableReference>
              <concept>
                <coding>
                  <system value="http://snomed.info/sct"/>
                  <code value="69840006"/>
                  <display value="Normal breast feeding (finding)"/>
                </coding>
              </concept>
            </valueCodeableReference>
          </extension>
        </extension>
        <identifier>
          <system value="https://spor.ema.europa.eu/rmswi/"/>
          <value value="ESprocessed163dd4e7fa7eed938c8bb01cecedf200"/>
        </identifier>
        <status value="final"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="100000155538"/>
          </coding>
          <text value="Package Leaflet"/>
        </type>
        <category>
          <coding>
            <system
                    value="http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"/>
            <code value="P"/>
            <display value="Processed"/>
          </coding>
        </category>
        <subject>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </subject>
        <date value="2023-10-26T15:15:46Z"/>
        <author>
          <reference
                     value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
        </author>
        <title value="TEST PURPOSES ONLY - Flucelvax"/>
        <attester>
          <mode>
            <coding>
              <system
                      value="http://hl7.org/fhir/composition-attestation-mode"/>
              <code value="official"/>
            </coding>
          </mode>
          <time value="2023-10-26T15:15:46Z"/>
        </attester>
        <section>
          <title value="B. Package Leaflet"/>
          <code>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi/"/>
              <code value="100000155538"/>
            </coding>
            <text value="B. PACKAGE LEAFLET"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <emptyReason>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
              <code value="unavailable"/>
            </coding>
          </emptyReason>
          <section>
            <title value="Package leaflet: Information for the user"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text value="Prospecto: información para el usuario"/>
            </code>
            <text>
              <status value="additional"/>
              <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>
            </text>
          </section>
          <section>
            <title value="What is in this leaflet"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text value="Contenido del prospecto"/>
            </code>
            <text>
              <status value="additional"/>
              <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>
            </text>
          </section>
          <section>
            <title value="1. What Flucelvax is and what it is used for"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text value="1. Qué es Flucelvax Tetra y para qué se utiliza"/>
            </code>
            <text>
              <status value="additional"/>
              <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>
            </text>
          </section>
          <section>
            <title
                   value="2. What you need to know before you take Flucelvax"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text
                    value="2. Qué necesita saber antes de empezar a recibir Flucelvax Tetra"/>
            </code>
            <text>
              <status value="additional"/>
              <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>
            </text>
          </section>
          <section>
            <title value="3. How to take Flucelvax"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text value="3. Cómo se administra Flucelvax Tetra"/>
            </code>
            <text>
              <status value="additional"/>
              <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>
            </text>
          </section>
          <section>
            <title value="4. Possible side effects"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text value="4. Posibles efectos adversos"/>
            </code>
            <text>
              <status value="additional"/>
              <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>
            </text>
          </section>
          <section>
            <title value="5. How to store Flucelvax"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text value="5. Conservación de Flucelvax Tetra"/>
            </code>
            <text>
              <status value="additional"/>
              <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>
            </text>
          </section>
          <section>
            <title value="6. Contents of the pack and other information"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text value="6. Contenido del envase e información adicional"/>
            </code>
            <text>
              <status value="additional"/>
              <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>
            </text>
          </section>
        </section>
      </Composition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-2e8cb2387c664fb619f6b8914767d38f"/>
    <resource>
      <Ingredient>
        <id value="ingredient-for-2e8cb2387c664fb619f6b8914767d38f"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-2e8cb2387c664fb619f6b8914767d38f"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-2e8cb2387c664fb619f6b8914767d38f</b></p><a name="ingredient-for-2e8cb2387c664fb619f6b8914767d38f"> </a><a name="hcingredient-for-2e8cb2387c664fb619f6b8914767d38f"> </a><a name="ingredient-for-2e8cb2387c664fb619f6b8914767d38f-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/9V4SVN4JQV (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072072}">active</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 9V4SVN4JQV}">INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE</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  codeug = 'ug')</span></td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="9V4SVN4JQV"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072072"/>
            <display value="active"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="9V4SVN4JQV"/>
                <display
                         value="INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationQuantity>
              <value value="15"/>
              <system value="http://unitsofmeasure.org"/>
              <code value="ug"/>
            </presentationQuantity>
            <basis>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
                <code value="ACTIB"/>
                <display value="active ingredient - basis of strength"/>
              </coding>
            </basis>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"/>
    <resource>
      <Ingredient>
        <id
            value="ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole</b></p><a name="ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"> </a><a name="hcingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"> </a><a name="ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/JS7E5ZZ3AC (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">active</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta JS7E5ZZ3AC}">INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE</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  codeug = 'ug')</span></td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="JS7E5ZZ3AC"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072082"/>
            <display value="active"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="JS7E5ZZ3AC"/>
                <display
                         value="INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationQuantity>
              <value value="15"/>
              <system value="http://unitsofmeasure.org"/>
              <code value="ug"/>
            </presentationQuantity>
            <basis>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
                <code value="ACTIB"/>
                <display value="active ingredient - basis of strength"/>
              </coding>
            </basis>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"/>
    <resource>
      <Ingredient>
        <id value="ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-f4e520e2974f4acb8abe26b607ea5a46</b></p><a name="ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"> </a><a name="hcingredient-for-f4e520e2974f4acb8abe26b607ea5a46"> </a><a name="ingredient-for-f4e520e2974f4acb8abe26b607ea5a46-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/BFA4LSE5QQ (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">active</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta BFA4LSE5QQ}">INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE</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  codeug = 'ug')</span></td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="BFA4LSE5QQ"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072082"/>
            <display value="active"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="BFA4LSE5QQ"/>
                <display
                         value="INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationQuantity>
              <value value="15"/>
              <system value="http://unitsofmeasure.org"/>
              <code value="ug"/>
            </presentationQuantity>
            <basis>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
                <code value="ACTIB"/>
                <display value="active ingredient - basis of strength"/>
              </coding>
            </basis>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-2c0c197a41a706fb2549601e635da1f3"/>
    <resource>
      <Ingredient>
        <id value="ingredient-for-2c0c197a41a706fb2549601e635da1f3"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-2c0c197a41a706fb2549601e635da1f3"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-2c0c197a41a706fb2549601e635da1f3</b></p><a name="ingredient-for-2c0c197a41a706fb2549601e635da1f3"> </a><a name="hcingredient-for-2c0c197a41a706fb2549601e635da1f3"> </a><a name="ingredient-for-2c0c197a41a706fb2549601e635da1f3-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/B3EV5T8SUF (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">active</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta B3EV5T8SUF}">INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE</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  codeug = 'ug')</span></td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="B3EV5T8SUF"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072082"/>
            <display value="active"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="B3EV5T8SUF"/>
                <display
                         value="INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationQuantity>
              <value value="15"/>
              <system value="http://unitsofmeasure.org"/>
              <code value="ug"/>
            </presentationQuantity>
            <basis>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
                <code value="ACTIB"/>
                <display value="active ingredient - basis of strength"/>
              </coding>
            </basis>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-sodiumchloride"/>
    <resource>
      <Ingredient>
        <id value="ingredient-for-flucelvax-sodiumchloride"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-sodiumchloride"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-sodiumchloride</b></p><a name="ingredient-for-flucelvax-sodiumchloride"> </a><a name="hcingredient-for-flucelvax-sodiumchloride"> </a><a name="ingredient-for-flucelvax-sodiumchloride-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/451W47IQ8X (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 451W47IQ8X}">Sodium chloride</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="451W47IQ8X"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072082"/>
            <display value="Excipient"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="451W47IQ8X"/>
                <display value="Sodium chloride"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-potassiumchloride"/>
    <resource>
      <Ingredient>
        <id value="ingredient-for-flucelvax-potassiumchloride"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-potassiumchloride"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-potassiumchloride</b></p><a name="ingredient-for-flucelvax-potassiumchloride"> </a><a name="hcingredient-for-flucelvax-potassiumchloride"> </a><a name="ingredient-for-flucelvax-potassiumchloride-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/660YQ98I10 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 660YQ98I10}">Potassium chloride</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="660YQ98I10"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072082"/>
            <display value="Excipient"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="660YQ98I10"/>
                <display value="Potassium chloride"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-magnesiumchloride"/>
    <resource>
      <Ingredient>
        <id value="ingredient-for-flucelvax-magnesiumchloride"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-magnesiumchloride"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-magnesiumchloride</b></p><a name="ingredient-for-flucelvax-magnesiumchloride"> </a><a name="hcingredient-for-flucelvax-magnesiumchloride"> </a><a name="ingredient-for-flucelvax-magnesiumchloride-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/02F3473H9O (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 02F3473H9O}">MAGNESIUM CHLORIDE</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="02F3473H9O"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072082"/>
            <display value="Excipient"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="02F3473H9O"/>
                <display value="MAGNESIUM CHLORIDE"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"/>
    <resource>
      <Ingredient>
        <id value="ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate</b></p><a name="ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"> </a><a name="hcingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"> </a><a name="ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/94255I6E2T (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 94255I6E2T}">SODIUM PHOSPHATE, DIBASIC, DIHYDRATE</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="94255I6E2T"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072082"/>
            <display value="Excipient"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="94255I6E2T"/>
                <display value="SODIUM PHOSPHATE, DIBASIC, DIHYDRATE"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-potassiumdihydrogenphosphate"/>
    <resource>
      <Ingredient>
        <id value="ingredient-for-flucelvax-potassiumdihydrogenphosphate"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-potassiumdihydrogenphosphate"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-potassiumdihydrogenphosphate</b></p><a name="ingredient-for-flucelvax-potassiumdihydrogenphosphate"> </a><a name="hcingredient-for-flucelvax-potassiumdihydrogenphosphate"> </a><a name="ingredient-for-flucelvax-potassiumdihydrogenphosphate-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/4J9FJ0HL51 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 4J9FJ0HL51}">Potassium dihydrogen phosphate</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="4J9FJ0HL51"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072082"/>
            <display value="Excipient"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="4J9FJ0HL51"/>
                <display value="Potassium dihydrogen phosphate"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-waterforinjections"/>
    <resource>
      <Ingredient>
        <id value="ingredient-for-flucelvax-waterforinjections"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-waterforinjections"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-waterforinjections</b></p><a name="ingredient-for-flucelvax-waterforinjections"> </a><a name="hcingredient-for-flucelvax-waterforinjections"> </a><a name="ingredient-for-flucelvax-waterforinjections-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/059QF0KO0R (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</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><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 059QF0KO0R}">Water for injections</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
          <value value="059QF0KO0R"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <for>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072082"/>
            <display value="Excipient"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="059QF0KO0R"/>
                <display value="Water for injections"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadelaware552019cvr45h1n1whole"/>
    <resource>
      <SubstanceDefinition>
        <id value="substance-influenzaavirusadelaware552019cvr45h1n1whole"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substance-influenzaavirusadelaware552019cvr45h1n1whole"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substance-influenzaavirusadelaware552019cvr45h1n1whole</b></p><a name="substance-influenzaavirusadelaware552019cvr45h1n1whole"> </a><a name="hcsubstance-influenzaavirusadelaware552019cvr45h1n1whole"> </a><a name="substance-influenzaavirusadelaware552019cvr45h1n1whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/9V4SVN4JQV (use: official, )</p><p><b>version</b>: 1.0</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="9V4SVN4JQV"/>
        </identifier>
        <version value="1.0"/>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
          </coding>
        </status>
        <manufacturer>
          <reference
                     value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
        </manufacturer>
      </SubstanceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadarwin112021h3n2whole"/>
    <resource>
      <SubstanceDefinition>
        <id value="substance-influenzaavirusadarwin112021h3n2whole"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substance-influenzaavirusadarwin112021h3n2whole"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substance-influenzaavirusadarwin112021h3n2whole</b></p><a name="substance-influenzaavirusadarwin112021h3n2whole"> </a><a name="hcsubstance-influenzaavirusadarwin112021h3n2whole"> </a><a name="substance-influenzaavirusadarwin112021h3n2whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/JS7E5ZZ3AC (use: official, )</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="JS7E5ZZ3AC"/>
        </identifier>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
          </coding>
        </status>
        <manufacturer>
          <reference
                     value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
        </manufacturer>
      </SubstanceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporewuh46182021whole"/>
    <resource>
      <SubstanceDefinition>
        <id value="substance-influenzabvirusbsingaporewuh46182021whole"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substance-influenzabvirusbsingaporewuh46182021whole"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substance-influenzabvirusbsingaporewuh46182021whole</b></p><a name="substance-influenzabvirusbsingaporewuh46182021whole"> </a><a name="hcsubstance-influenzabvirusbsingaporewuh46182021whole"> </a><a name="substance-influenzabvirusbsingaporewuh46182021whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/BFA4LSE5QQ (use: official, )</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="BFA4LSE5QQ"/>
        </identifier>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
          </coding>
        </status>
        <manufacturer>
          <reference
                     value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
        </manufacturer>
      </SubstanceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporeinftt1606102016whole"/>
    <resource>
      <SubstanceDefinition>
        <id value="substance-influenzabvirusbsingaporeinftt1606102016whole"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substance-influenzabvirusbsingaporeinftt1606102016whole"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substance-influenzabvirusbsingaporeinftt1606102016whole</b></p><a name="substance-influenzabvirusbsingaporeinftt1606102016whole"> </a><a name="hcsubstance-influenzabvirusbsingaporeinftt1606102016whole"> </a><a name="substance-influenzabvirusbsingaporeinftt1606102016whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/B3EV5T8SUF (use: official, )</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="B3EV5T8SUF"/>
        </identifier>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
          </coding>
        </status>
        <manufacturer>
          <reference
                     value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
        </manufacturer>
      </SubstanceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
    <resource>
      <AdministrableProductDefinition>
        <id value="ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition ap-04c9bd6fb89d38b2d83eced2460c4dc1</b></p><a name="ap-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><a name="hcap-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><a name="ap-04c9bd6fb89d38b2d83eced2460c4dc1-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/xx</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000074063}">suspension for injection in pre-filled syringe</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000002150}">Syringe</span></p><p><b>producedFrom</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073633}">Subcutaneous use</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><span title="Codes:{https://spor.ema.europa.eu/rmswi 100000109093}">Human</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="https://spor.ema.europa.eu/pmswi"/>
          <value value="xx"/>
        </identifier>
        <status value="active"/>
        <formOf>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </formOf>
        <administrableDoseForm>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000074063"/>
            <display value="suspension for injection in pre-filled syringe"/>
          </coding>
        </administrableDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="200000002150"/>
            <display value="Syringe"/>
          </coding>
        </unitOfPresentation>
        <producedFrom>
          <reference
                     value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        </producedFrom>
        <routeOfAdministration>
          <code>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="100000073633"/>
              <display value="Subcutaneous use"/>
            </coding>
          </code>
          <targetSpecies>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi"/>
                <code value="100000109093"/>
                <display value="Human"/>
              </coding>
            </code>
          </targetSpecies>
        </routeOfAdministration>
      </AdministrableProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization04c9bd6fb89d38b2d83eced2460c4dc10"/>
    <resource>
      <RegulatedAuthorization>
        <id value="authorization04c9bd6fb89d38b2d83eced2460c4dc10"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_authorization04c9bd6fb89d38b2d83eced2460c4dc10"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization authorization04c9bd6fb89d38b2d83eced2460c4dc10</b></p><a name="authorization04c9bd6fb89d38b2d83eced2460c4dc10"> </a><a name="hcauthorization04c9bd6fb89d38b2d83eced2460c4dc10"> </a><a name="authorization04c9bd6fb89d38b2d83eced2460c4dc10-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1326/001 (use: official, )</p><p><b>subject</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072062}">Marketing Authorisation</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>statusDate</b>: 2019-01-01</p><p><b>holder</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://spor.ema.europa.eu/pmswi"/>
          <value value="EU/1/18/1326/001"/>
        </identifier>
        <subject>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </subject>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072062"/>
            <display value="Marketing Authorisation"/>
          </coding>
        </type>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
            <display value="Active"/>
          </coding>
        </status>
        <statusDate value="2019-01-01"/>
        <holder>
          <reference
                     value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
        </holder>
      </RegulatedAuthorization>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
    <resource>
      <Organization>
        <id value="mah-45fe50eae508b5755dd140ab2093eb5e"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_mah-45fe50eae508b5755dd140ab2093eb5e"> </a><p class="res-header-id"><b>Generated Narrative: Organization mah-45fe50eae508b5755dd140ab2093eb5e</b></p><a name="mah-45fe50eae508b5755dd140ab2093eb5e"> </a><a name="hcmah-45fe50eae508b5755dd140ab2093eb5e"> </a><a name="mah-45fe50eae508b5755dd140ab2093eb5e-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100013715 (use: official, )</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 220000000034}">Marketing authorisation holder</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>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://spor.ema.europa.eu/omswi"/>
          <value value="ORG-100013715"/>
        </identifier>
        <active value="true"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="220000000034"/>
            <display value="Marketing authorisation holder"/>
          </coding>
        </type>
        <name value="Seqirus Netherlands B.V."/>
        <contact>
          <address>
            <use value="work"/>
            <type value="physical"/>
            <text value="Paasheuvelweg 28 1105BJ Amsterdam Netherlands"/>
            <line value="Paasheuvelweg 28"/>
            <city value="1105BJ Amsterdam"/>
            <postalCode value="367061"/>
            <country value="Netherlands"/>
          </address>
        </contact>
      </Organization>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-a854b6fee6a8536c78c604a4b9f6c395"/>
    <resource>
      <PackagedProductDefinition>
        <id value="ppd-a854b6fee6a8536c78c604a4b9f6c395"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_ppd-a854b6fee6a8536c78c604a4b9f6c395"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition ppd-a854b6fee6a8536c78c604a4b9f6c395</b></p><a name="ppd-a854b6fee6a8536c78c604a4b9f6c395"> </a><a name="hcppd-a854b6fee6a8536c78c604a4b9f6c395"> </a><a name="ppd-a854b6fee6a8536c78c604a4b9f6c395-en-US"> </a><p><b>name</b>: Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000155527}">100000155527</span></p><p><b>packageFor</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>statusDate</b>: 2019-01-01</p><p><b>containedItemQuantity</b>: 15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeug = 'ug')</span></p><p><b>copackagedIndicator</b>: true</p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000003529}">Cardboard</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>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">100000073498</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000003529}">Cardboard</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></td></tr></table></blockquote></blockquote></blockquote></div>
        </text>
        <name
              value="Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000155527"/>
          </coding>
        </type>
        <packageFor>
          <reference
                     value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
        </packageFor>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
            <display value="Active"/>
          </coding>
        </status>
        <statusDate value="2019-01-01"/>
        <containedItemQuantity>
          <value value="15"/>
          <system value="http://unitsofmeasure.org"/>
          <code value="ug"/>
        </containedItemQuantity>
        <copackagedIndicator value="true"/>
        <packaging>
          <type>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="100000073498"/>
              <display value="Box"/>
            </coding>
          </type>
          <quantity value="1"/>
          <material>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="200000003529"/>
              <display value="Cardboard"/>
            </coding>
          </material>
          <packaging>
            <identifier>
              <system value="https://spor.ema.europa.eu/pmswi"/>
              <value value="xxxx"/>
            </identifier>
            <type>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi"/>
                <code value="100000073498"/>
                <display value="100000073498"/>
              </coding>
            </type>
            <quantity value="1"/>
            <material>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi"/>
                <code value="200000003529"/>
                <display value="Cardboard"/>
              </coding>
            </material>
            <containedItem>
              <item>
                <reference>
                  <reference
                             value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
                </reference>
              </item>
            </containedItem>
          </packaging>
        </packaging>
      </PackagedProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="mpb6ced64d25ea2c8da6c6099386f14db1"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpb6ced64d25ea2c8da6c6099386f14db1</b></p><a name="mpb6ced64d25ea2c8da6c6099386f14db1"> </a><a name="hcmpb6ced64d25ea2c8da6c6099386f14db1"> </a><a name="mpb6ced64d25ea2c8da6c6099386f14db1-en-US"> </a><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>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}">Medicinal Product</span></p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">active</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000000000}">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Flucelvax Tetra</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}">Invented name part</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>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 15 ug</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Solution for injection</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}">Pharmaceutical dose form part</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><span title="Codes:{urn:iso:std:iso:3166 ES}">Spain</span></td><td><span title="Codes:{urn:iso:std:iso:3166 ES}">Spain</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="https://spor.ema.europa.eu/pmswi"/>
          <value value="EU/1/18/1326/001"/>
        </identifier>
        <identifier>
          <system value="https://www.who-umc.org/phpid"/>
          <value value="0xF79CABF272B6A7EEF104DDDA44E82717"/>
        </identifier>
        <type>
          <coding>
            <system value="http://hl7.org/fhir/medicinal-product-type"/>
            <code value="MedicinalProduct"/>
            <display value="Medicinal Product"/>
          </coding>
        </type>
        <domain>
          <coding>
            <system value="http://hl7.org/fhir/medicinal-product-domain"/>
            <code value="Human"/>
            <display value="Human use"/>
          </coding>
        </domain>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
            <display value="active"/>
          </coding>
        </status>
        <legalStatusOfSupply>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000000000"/>
            <display
                     value="Medicinal product subject to medical prescription"/>
          </coding>
        </legalStatusOfSupply>
        <name>
          <productName
                       value="Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)"/>
          <type>
            <coding>
              <system value="https://spor.ema.europa.eu/lists/220000000000"/>
              <code value="220000000001"/>
              <display value="Full name"/>
            </coding>
          </type>
          <part>
            <part value="Flucelvax Tetra"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000002"/>
                <display value="Invented name part"/>
              </coding>
            </type>
          </part>
          <part>
            <part
                  value="Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000003"/>
                <display value="Scientific name part"/>
              </coding>
            </type>
          </part>
          <part>
            <part value="15 ug"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000004"/>
                <display value="Strength part"/>
              </coding>
            </type>
          </part>
          <part>
            <part value="Solution for injection"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000005"/>
                <display value="Pharmaceutical dose form part"/>
              </coding>
            </type>
          </part>
          <usage>
            <country>
              <coding>
                <system value="urn:iso:std:iso:3166"/>
                <code value="ES"/>
                <display value="Spain"/>
              </coding>
            </country>
            <jurisdiction>
              <coding>
                <system value="urn:iso:std:iso:3166"/>
                <code value="ES"/>
                <display value="Spain"/>
              </coding>
            </jurisdiction>
            <language>
              <coding>
                <system value="urn:ietf:bcp:47"/>
                <code value="en"/>
                <display value="English"/>
              </coding>
            </language>
          </usage>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
    <resource>
      <ManufacturedItemDefinition>
        <id value="mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition mid-04c9bd6fb89d38b2d83eced2460c4dc1</b></p><a name="mid-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><a name="hcmid-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><a name="mid-04c9bd6fb89d38b2d83eced2460c4dc1-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1326/001 (use: official, )</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi/ 100000074063}">suspension for injection in pre-filled syringe</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000002150}">Syringe</span></p></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://spor.ema.europa.eu/pmswi"/>
          <value value="EU/1/18/1326/001"/>
        </identifier>
        <status value="active"/>
        <manufacturedDoseForm>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="100000074063"/>
            <display value="suspension for injection in pre-filled syringe"/>
          </coding>
        </manufacturedDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="200000002150"/>
            <display value="Syringe"/>
          </coding>
        </unitOfPresentation>
      </ManufacturedItemDefinition>
    </resource>
  </entry>
</Bundle>