R4 Ballot #2 (Mixed Normative/Trial use)

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Medicinalproductundesirableeffect-example

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

This is the narrative for the resource. See also the XML, JSON or Turtle format. This example conforms to the profile MedicinalProductUndesirableEffect.

Generated Narrative with Details

id: example

UndesirableEffects

-SymptomConditionEffectClassificationFrequencyOfOccurrence
*Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp) (Details : {http://ema.europa.eu/example/undesirableeffectassymptom-condition-effect code 'Anaemia' = 'Anaemia)Bloodandlymphaticsystemdisorders (Details : {http://ema.europa.eu/example/symptom-condition-effectclassification code 'Bloodandlymphaticsystemdisorders' = 'Bloodandlymphaticsystemdisorders)Common (Details : {http://ema.europa.eu/example/frequencyofoccurrence code 'Common' = 'Common)

therapeuticIndication

diseaseSymptomProcedure: 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). (Details : {http://ema.europa.eu/example/indicationasdisease-symptom-procedure code 'Venousthromboembolismprophylaxis' = 'Venousthromboembolismprophylaxis)

comorbidity: Hipsurgery (Details : {http://ema.europa.eu/example/comorbidity code 'Hipsurgery' = 'Hipsurgery)

intendedEffect: PRYLX (Details : {http://ema.europa.eu/example/intendedeffect code 'PRYLX' = 'PRYLX)

Populations

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*

Contraindications

-DiseaseComorbidity
*Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (Details : {http://ema.europa.eu/example/contraindicationsasdisease-symptom-procedure code 'Coagulopathiesandbleedingdiatheses(exclthrombocytopenic)' = 'Coagulopathiesandbleedingdiatheses(exclthrombocytopenic))Hepaticdisease (Details : {http://ema.europa.eu/example/comorbidity code 'Hepaticdisease' = 'Hepaticdisease)

Interactions

-InteractionInteractantTypeEffectManagement
*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.ketoconazole (Details : {http://ema.europa.eu/example/interactant code 'ketoconazole' = 'ketoconazole)StrongInhibitorofCYP3A4 (Details : {http://ema.europa.eu/example/interactionsType code 'StrongInhibitorofCYP3A4' = 'StrongInhibitorofCYP3A4)Increasedplasmaconcentrations (Details : {http://ema.europa.eu/example/interactionseffect code 'Increasedplasmaconcentrations' = 'Increasedplasmaconcentrations)CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp (Details : {http://ema.europa.eu/example/managementactions code 'CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp' = 'CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp)

 

 

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.