Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml">Prospecto: información para el paciente Dovato 50 mg/300 mg comprimidos recubiertos con película dolutegravir/lamivudina <b>Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.</b><ul><li>Conserve este prospecto, ya que puede tener que volver a leerlo.</li><li>Si tiene alguna duda, consulte a su médico o farmacéutico.</li><li>Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.</li><li>Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.</li></ul></div>
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<div xmlns="http://www.w3.org/1999/xhtml">Contenido del prospecto<ol><li>Qué es Dovato y para qué se utiliza</li><li>Qué necesita saber antes de empezar a tomar Dovato</li><li>Cómo tomar Dovato</li><li>Posibles efectos adversos</li><li>Conservación de Dovato</li><li>Contenido del envase e información adicional</li></ol></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><b>1. Qué es Dovato y para qué se utiliza</b> Dovato es un medicamento que contiene dos principios activos usados para tratar la infección por el virus de la inmunodeficiencia humana (VIH): dolutegravir y lamivudina. Dolutegravir pertenece al grupo de medicamentos antirretrovirales llamados inhibidores de la integrasa (INI) y lamivudina pertenece a un grupo de medicamentos antirretrovirales denominados inhibidores de la transcriptasa inversa análogos de nucleósido (ITIAN).</div>
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<div xmlns="http://www.w3.org/1999/xhtml"><b>2. Qué necesita saber antes de empezar a tomar Dovato</b> <b>No tome Dovato</b><ul><li>si es <b>alérgico</b> (hipersensible) a dolutegravir o lamivudina o a alguno de los demás componentes de este medicamento (incluidos en la sección 6)</li><li>si está tomando un medicamento llamado <b>fampridina</b> (también conocido como dalfampridina; utilizado para tratar la esclerosis múltiple).</li></ul></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><b>3. Cómo tomar Dovato</b><p>Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico.</p><ul><li>La dosis recomendada de Dovato es <b>un comprimido una vez al día.</b></li></ul><p>Trague el comprimido con un poco de líquido. Dovato se puede tomar con o sin alimentos.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>4. Posibles efectos adversos</b></p><p>Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran, <b>por lo que es muy importante que le comente a su médico cualquier cambio en su estado de salud.</b></p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><b>5. Conservación de Dovato</b><p>Mantener este medicamento fuera de la vista y del alcance de los niños</p><p>No utilice este medicamento después de la fecha de caducidad que aparece en la caja y el frasco después de CAD. La fecha de caducidad es el último día del mes que se indica.</p><p>Este medicamento no requiere ninguna condición especial de conservación.</p><p>Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><b>6. Contenido del envase e información adicional</b> <b>Composición de Dovato</b><ul><li>Los principios activos son dolutegravir y lamivudina. Cada comprimido contiene dolutegravir sódico equivalente a 50 mg de dolutegravir y 300 mg de lamivudina.</li><li>Los demás componentes son celulosa microcristalina, carboximetilalmidón sódico, estearato de magnesio, manitol (E421), povidona (K29/32), fumarato estearilo de sodio, hipromelosa (E464), macrogol, dióxido de titanio (E171).</li><li>Este medicamento contiene menos de 1 mmol de sodio (23 mg) por comprimido; esto es, esencialmente “exento de sodio”.</li></ul></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PackagedProductDefinition</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource PackagedProductDefinition "cfsb1650995718524" </p></div><p><b>identifier</b>: id: EU/1/19/1370/001 (OFFICIAL)</p><p><b>name</b>: Dovato 50 mg/300 mg film-coated tablets</p><p><b>type</b>: Chemical Medicinal Prodcut <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-CodeSystemUvEPIRrmswi.html">Referentials Management Services CodeSystem</a>#100000155527)</span></p><p><b>packageFor</b>: <a href="#MedicinalProductDefinition_cfsb1650904258324">See above (MedicinalProductDefinition/cfsb1650904258324)</a></p><p><b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://build.fhir.org/codesystem-publication-status.html">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2012-02-07 01:28:17+0000</p><p><b>containedItemQuantity</b>: 30 tablets</p><p><b>manufacturer</b>: <a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></p><h3>Packages</h3><table class="grid"><tr><td>-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td>*</td><td>id: 654321</td><td>Child-resistant closure <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-CodeSystemUvEPIRrmswi.html">Referentials Management Services CodeSystem</a>#100000073504)</span></td><td>1</td><td>Cardboard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-CodeSystemUvEPIRrmswi.html">Referentials Management Services CodeSystem</a>#200000003529)</span></td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="$spor-prod"/>
<value value="EU/1/19/1370/001"/>
</identifier>
<name value="Dovato 50 mg/300 mg film-coated tablets"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000155527"/>
</coding>
<text value="Chemical Medicinal Prodcut"/>
</type>
<packageFor>
<reference value="MedicinalProductDefinition/cfsb1650904258324"/>
</packageFor>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<statusDate value="2012-02-07T13:28:17Z"/>
<containedItemQuantity>
<value value="30"/>
<unit value="tablets"/>
</containedItemQuantity>
<manufacturer>
<reference value="Organization/cfsb1650997423990"/>
</manufacturer>
<package>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="654321"/>
</identifier>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073504"/>
<display value="Child-resistant closure"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
</package>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<resource>
<AdministrableProductDefinition>
<id value="cfsb1650999516847"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdministrableProductDefinition</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource AdministrableProductDefinition "cfsb1650999516847" </p></div><p><b>identifier</b>: id: 123456</p><p><b>status</b>: active</p><p><b>formOf</b>: <a href="#MedicinalProductDefinition_cfsb1650904258324">See above (MedicinalProductDefinition/cfsb1650904258324)</a></p><p><b>administrableDoseForm</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#10219000)</span></p><p><b>unitOfPresentation</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#15054000)</span></p><p><b>producedFrom</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: Oral use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#20053000)</span></p><h3>TargetSpecies</h3><table class="grid"><tr><td>-</td><td><b>Code</b></td></tr><tr><td>*</td><td>Human <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000109093)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="https://www.who-umc.org/phpid"/>
<value value="123456"/>
</identifier>
<status value="active"/>
<formOf>
<reference value="MedicinalProductDefinition/cfsb1650904258324"/>
</formOf>
<administrableDoseForm>
<coding>
<system
value="https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/"/>
<code value="10219000"/>
</coding>
<text value="Tablet"/>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system
value="https://standardterms.edqm.eu/browse/get_concepts/UOP/"/>
<code value="15054000"/>
</coding>
<text value="Tablet"/>
</unitOfPresentation>
<producedFrom>
<reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system
value="https://standardterms.edqm.eu/browse/get_concepts/ROA/"/>
<code value="20053000"/>
</coding>
<text value="Oral use"/>
</code>
<targetSpecies>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="/#100000109093"/>
</coding>
<text value="Human"/>
</code>
</targetSpecies>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<resource>
<ManufacturedItemDefinition>
<id value="cfsb1650998521654"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ManufacturedItemDefinition</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ManufacturedItemDefinition "cfsb1650998521654" </p></div><p><b>identifier</b>: id: EU/1/19/1370/001 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Film-coated tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000073665)</span></p><p><b>unitOfPresentation</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-CodeSystemUvEPIRrmswi.html">Referentials Management Services CodeSystem</a>#200000002152)</span></p><p><b>manufacturer</b>: <a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi/#/"/>
<value value="EU/1/19/1370/001"/>
</identifier>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000073665"/>
</coding>
<text value="Film-coated tablet"/>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002152"/>
</coding>
<text value="Tablet"/>
</unitOfPresentation>
<manufacturer>
<reference value="Organization/cfsb1650997423990"/>
</manufacturer>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<resource>
<Ingredient>
<id value="cfsb1651162710491"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651162710491" </p></div><p><b>identifier</b>: id: 1Q1V9V5WYQ (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#00000072072)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Strengths</h3><table class="grid"><tr><td>-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td>*</td><td>50 mg</td><td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (v3-RoleClassIngredientEntity##ACTIB)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="1Q1V9V5WYQ"/>
</identifier>
<status value="active"/>
<for>
<reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="00000072072"/>
</coding>
<text value="active"/>
</role>
<manufacturer>
<manufacturer>
<reference value="Organization/cfsb1650997423990"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="1Q1V9V5WYQ"/>
<display value="DOLUTEGRAVIR SODIUM"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="50"/>
<unit value="mg"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity"/>
<code value="#ACTIB"/>
</coding>
<text value="active ingredient - basis of strength"/>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<resource>
<Ingredient>
<id value="cfsb1651164758053"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651164758053" </p></div><p><b>identifier</b>: id: 2T8Q726O95 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072072)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Strengths</h3><table class="grid"><tr><td>-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td>*</td><td>300 mg</td><td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (v3-RoleClassIngredientEntity##ACTIB)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="2T8Q726O95"/>
</identifier>
<status value="active"/>
<for>
<reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000072072"/>
</coding>
<text value="active"/>
</role>
<manufacturer>
<manufacturer>
<reference value="Organization/cfsb1650997423990"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="2T8Q726O95"/>
<display value="lamivudine"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="300"/>
<unit value="mg"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity"/>
<code value="#ACTIB"/>
</coding>
<text value="active ingredient - basis of strength"/>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<resource>
<Ingredient>
<id value="cfsb1651170791283"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651170791283" </p></div><p><b>identifier</b>: id: OP1R32D61U (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072082)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="OP1R32D61U"/>
</identifier>
<status value="active"/>
<for>
<reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000072082"/>
</coding>
<text value="Excipient"/>
</role>
<manufacturer>
<manufacturer>
<reference value="Organization/cfsb1650997423990"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="OP1R32D61U"/>
<display value="microcrystalline cellulose"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<resource>
<Ingredient>
<id value="cfsb1651229974487"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651229974487" </p></div><p><b>identifier</b>: id: H8AV0SQX4D (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072082)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="H8AV0SQX4D"/>
</identifier>
<status value="active"/>
<for>
<reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000072082"/>
</coding>
<text value="Excipient"/>
</role>
<manufacturer>
<manufacturer>
<reference value="Organization/cfsb1650997423990"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="H8AV0SQX4D"/>
<display value="sodium starch glycolate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<resource>
<Ingredient>
<id value="cfsb1651230170831"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651230170831" </p></div><p><b>identifier</b>: id: 70097M6I30 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072082)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="70097M6I30"/>
</identifier>
<status value="active"/>
<for>
<reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000072082"/>
</coding>
<text value="Excipient"/>
</role>
<manufacturer>
<manufacturer>
<reference value="Organization/cfsb1650997423990"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="70097M6I30"/>
<display value="magnesium stearate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<resource>
<Ingredient>
<id value="cfsb1651230330246"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651230330246" </p></div><p><b>identifier</b>: id: 3OWL53L36A (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072082)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="3OWL53L36A"/>
</identifier>
<status value="active"/>
<for>
<reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000072082"/>
</coding>
<text value="Excipient"/>
</role>
<manufacturer>
<manufacturer>
<reference value="Organization/cfsb1650997423990"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="3OWL53L36A"/>
<display value="mannitol"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
</Bundle>