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Medicinalproductclinicals-example.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/ABallot Status: InformativeCompartments: Not linked to any defined compartments

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Example of medicinalproductclinicals (id = "example")

<MedicinalProductClinicals xmlns="http://hl7.org/fhir">
  <id value="example"/> 
  <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"><p> <b> Generated Narrative with Details</b> </p> <p> <b> id</b> : example</p> <h3> UndesirableEffects</h3> <table> <tr> <td> -</td> <td> <b> SymptomConditionEffect</b> </td> <td> <b> Classification</b> </td> <td> <b> FrequencyOfOccurrence</b> </td> </tr> <tr> <td> *</td> <td> Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurger
            y (VTEp) <span> (Details : {http://ema.europa.eu/example/undesirableeffectassymptom-condition-effect code
               'Anaemia' = 'Anaemia)</span> </td> <td> Bloodandlymphaticsystemdisorders <span> (Details : {http://ema.europa.eu/example/symptom-condition-effectclassification code 'Bloodandlympha
              ticsystemdisorders' = 'Bloodandlymphaticsystemdisorders)</span> </td> <td> Common <span> (Details : {http://ema.europa.eu/example/frequencyofoccurrence code 'Common' = 'Common)</span> </td> </tr> </table> <blockquote> <p> <b> therapeuticIndication</b> </p> <p> <b> diseaseSymptomProcedure</b> : Prevention of venous thromboembolic events (VTE) in adult patients who have undergone
           elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism
           in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk
           factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension;
           diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein
           thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE
           in adults (see section 4.4 for haemodynamically unstable PE patients). <span> (Details : {http://ema.europa.eu/example/indicationasdisease-symptom-procedure code 'Venousthromboem
            bolismprophylaxis' = 'Venousthromboembolismprophylaxis)</span> </p> <p> <b> comorbidity</b> : Hipsurgery <span> (Details : {http://ema.europa.eu/example/comorbidity code 'Hipsurgery' = 'Hipsurgery)</span> </p> <p> <b> intendedEffect</b> : PRYLX <span> (Details : {http://ema.europa.eu/example/intendedeffect code 'PRYLX' = 'PRYLX)</span> </p> <h3> Populations</h3> <table> <tr> <td> -</td> </tr> <tr> <td> *</td> </tr> </table> </blockquote> <h3> Contraindications</h3> <table> <tr> <td> -</td> <td> <b> Disease</b> </td> <td> <b> Comorbidity</b> </td> </tr> <tr> <td> *</td> <td> Hepatic disease associated with coagulopathy and clinically relevant bleeding risk <span> (Details : {http://ema.europa.eu/example/contraindicationsasdisease-symptom-procedure
               code 'Coagulopathiesandbleedingdiatheses(exclthrombocytopenic)' = 'Coagulopathiesandbleedingdiathese
              s(exclthrombocytopenic))</span> </td> <td> Hepaticdisease <span> (Details : {http://ema.europa.eu/example/comorbidity code 'Hepaticdisease' = 'Hepaticdisease)</span> </td> </tr> </table> <h3> Interactions</h3> <table> <tr> <td> -</td> <td> <b> Interaction</b> </td> <td> <b> Interactant</b> </td> <td> <b> Type</b> </td> <td> <b> Effect</b> </td> <td> <b> Management</b> </td> </tr> <tr> <td> *</td> <td> Inhibitors of CYP3A4 and P-gp\nCoadministration of equixaban with ketoconazole (400 mg
             once a day), a strong inhibitor of both\nCYP3A4 and P-gp, led to a 2-fold increase in
             mean equixaban AUC and a 1.6-fold increase in mean\nequixaban Cmax.\nThe use of Eliquis
             is not recommended in patients receiving concomitant systemic treatment with\nstrong inhibitors
             of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole,\nitraconazole,
             voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir) (see\nsection
             4.4).\nActive substances which are not considered strong inhibitors of both CYP3A4 and
             P-gp,\n(e.g., diltiazem, naproxen, amiodarone, verapamil, quinidine) are expected to increase
             equixaban\nplasma concentration to a lesser extent. Diltiazem (360 mg once a day), for
             instance, considered a moderate CYP3A4 and a weak P-gp inhibitor, led to a 1.4-fold increase
             in mean equixaban AUC and a 1.3-fold increase in Cmax. Naproxen (500 mg, single dose)
             an inhibitor of P-gp but not an inhibitor of CYP3A4, led to a 1.5-fold and 1.6-fold increase
             in mean equixaban AUC and Cmax, respectively. No dose adjustment for equixaban is required
             when coadministered with less potent inhibitors of CYP3A4 and/or P-gp.</td> <td> ketoconazole <span> (Details : {http://ema.europa.eu/example/interactant code 'ketoconazole' = 'ketoconazole)</span> </td> <td> StrongInhibitorofCYP3A4 <span> (Details : {http://ema.europa.eu/example/interactionsType code 'StrongInhibitorofCYP3A4'
               = 'StrongInhibitorofCYP3A4)</span> </td> <td> Increasedplasmaconcentrations <span> (Details : {http://ema.europa.eu/example/interactionseffect code 'Increasedplasmaconcentrations'
               = 'Increasedplasmaconcentrations)</span> </td> <td> CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothC
            YP3A4andP-gp <span> (Details : {http://ema.europa.eu/example/managementactions code 'Coadministrationnotrecommendedinpat
              ientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp' = 'Coadministrationnot
              recommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp)</span> </td> </tr> </table> </div> </text> <undesirableEffects> 
    <symptomConditionEffect> 
      <coding> 
        <system value="http://ema.europa.eu/example/undesirableeffectassymptom-condition-effect"/> 
        <code value="Anaemia"/> 
      </coding> 
      <text value="Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurger
      y (VTEp)"/> 
    </symptomConditionEffect> 
    <classification> 
      <coding> 
        <system value="http://ema.europa.eu/example/symptom-condition-effectclassification"/> 
        <code value="Bloodandlymphaticsystemdisorders"/> 
      </coding> 
    </classification> 
    <frequencyOfOccurrence> 
      <coding> 
        <system value="http://ema.europa.eu/example/frequencyofoccurrence"/> 
        <code value="Common"/> 
      </coding> 
    </frequencyOfOccurrence> 
  </undesirableEffects> 
  <therapeuticIndication> 
    <diseaseSymptomProcedure> 
      <coding> 
        <system value="http://ema.europa.eu/example/indicationasdisease-symptom-procedure"/> 
        <code value="Venousthromboembolismprophylaxis"/> 
      </coding> 
      <text value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone
       elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism
       in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk
       factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension;
       diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein
       thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE
       in adults (see section 4.4 for haemodynamically unstable PE patients)."/> 
    </diseaseSymptomProcedure> 
    <comorbidity> 
      <coding> 
        <system value="http://ema.europa.eu/example/comorbidity"/> 
        <code value="Hipsurgery"/> 
      </coding> 
    </comorbidity> 
    <intendedEffect> 
      <coding> 
        <system value="http://ema.europa.eu/example/intendedeffect"/> 
        <code value="PRYLX"/> 
      </coding> 
    </intendedEffect> 
    <population> 
      <ageRange> 
        <low> 
          <value value="18"/> 
          <unit value="a"/> 
        </low> 
      </ageRange> 
    </population> 
  </therapeuticIndication> 
  <contraindication> 
    <disease> 
      <coding> 
        <system value="http://ema.europa.eu/example/contraindicationsasdisease-symptom-procedure"/> 
        <code value="Coagulopathiesandbleedingdiatheses(exclthrombocytopenic)"/> 
      </coding> 
      <text value="Hepatic disease associated with coagulopathy and clinically relevant bleeding risk"/> 
    </disease> 
    <comorbidity> 
      <coding> 
        <system value="http://ema.europa.eu/example/comorbidity"/> 
        <code value="Hepaticdisease"/> 
      </coding> 
    </comorbidity> 
  </contraindication> 
  <interactions> 
    <interaction value="Inhibitors of CYP3A4 and P-gp\nCoadministration of equixaban with ketoconazole (400 mg
     once a day), a strong inhibitor of both\nCYP3A4 and P-gp, led to a 2-fold increase in
     mean equixaban AUC and a 1.6-fold increase in mean\nequixaban Cmax.\nThe use of Eliquis
     is not recommended in patients receiving concomitant systemic treatment with\nstrong inhibitors
     of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole,\nitraconazole,
     voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir) (see\nsection
     4.4).\nActive substances which are not considered strong inhibitors of both CYP3A4 and
     P-gp,\n(e.g., diltiazem, naproxen, amiodarone, verapamil, quinidine) are expected to increase
     equixaban\nplasma concentration to a lesser extent. Diltiazem (360 mg once a day), for
     instance, considered a moderate CYP3A4 and a weak P-gp inhibitor, led to a 1.4-fold increase
     in mean equixaban AUC and a 1.3-fold increase in Cmax. Naproxen (500 mg, single dose)
     an inhibitor of P-gp but not an inhibitor of CYP3A4, led to a 1.5-fold and 1.6-fold increase
     in mean equixaban AUC and Cmax, respectively. No dose adjustment for equixaban is required
     when coadministered with less potent inhibitors of CYP3A4 and/or P-gp."/> 
    <interactant> 
      <coding> 
        <system value="http://ema.europa.eu/example/interactant"/> 
        <code value="ketoconazole"/> 
      </coding> 
    </interactant> 
    <interactant> 
      <coding> 
        <system value="http://ema.europa.eu/example/interactant"/> 
        <code value="itraconazole"/> 
      </coding> 
    </interactant> 
    <type> 
      <coding> 
        <system value="http://ema.europa.eu/example/interactionsType"/> 
        <code value="StrongInhibitorofCYP3A4"/> 
      </coding> 
    </type> 
    <effect> 
      <coding> 
        <system value="http://ema.europa.eu/example/interactionseffect"/> 
        <code value="Increasedplasmaconcentrations"/> 
      </coding> 
    </effect> 
    <management> 
      <coding> 
        <system value="http://ema.europa.eu/example/managementactions"/> 
        <code value="CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothC
        YP3A4andP-gp"/> 
      </coding> 
    </management> 
  </interactions> 
</MedicinalProductClinicals> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.