Medicinalproductinteraction-example.xml

Example of medicinalproductinteraction (id = "example")

<?xml version="1.0" encoding="UTF-8"?>

<MedicinalProductInteraction 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> <p> <b> description</b> : 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.</p> <blockquote> <p> <b> interactant</b> </p> <p> <b> item</b> : ketoconazole <span> (Details : {http://ema.europa.eu/example/interactant code 'ketoconazole' = 'ketoconazole)</span> </p> </blockquote> <blockquote> <p> <b> interactant</b> </p> <p> <b> item</b> : itraconazole <span> (Details : {http://ema.europa.eu/example/interactant code 'itraconazole' = 'itraconazole)</span> </p> </blockquote> <p> <b> type</b> : StrongInhibitorofCYP3A4 <span> (Details : {http://ema.europa.eu/example/interactionsType code 'StrongInhibitorofCYP3A4'
           = 'StrongInhibitorofCYP3A4)</span> </p> <p> <b> effect</b> : Increasedplasmaconcentrations <span> (Details : {http://ema.europa.eu/example/interactionseffect code 'Increasedplasmaconcentrations'
           = 'Increasedplasmaconcentrations)</span> </p> <p> <b> management</b> : Coadministration not recommended in patients receiving concomitant systemic treatment
         strong inhibitors of both CYP3A4 and P-gp <span> (Details )</span> </p> </div> </text> <description 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> 
    <itemCodeableConcept> 
      <coding> 
        <system value="http://ema.europa.eu/example/interactant"/> 
        <code value="ketoconazole"/> 
      </coding> 
    </itemCodeableConcept> 
  </interactant> 
  <interactant> 
    <itemCodeableConcept> 
      <coding> 
        <system value="http://ema.europa.eu/example/interactant"/> 
        <code value="itraconazole"/> 
      </coding> 
    </itemCodeableConcept> 
  </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> 
    <text value="Coadministration not recommended in patients receiving concomitant systemic treatment
     strong inhibitors of both CYP3A4 and P-gp"/> 
  </management> 
</MedicinalProductInteraction>