R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: (v3.5.0: R4 Ballot 2). #2). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions

Medicinalproductclinicals-example

Biomedical Research and Regulation Work Group Maturity Level : N/A Ballot Status : Informative Compartments : Not linked to any defined compartments

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

Generated Narrative with Details

id : example

UndesirableEffects

- identifier : 49476534 SymptomConditionEffect actuality : actual Classification event : This was a mild rash on the left forearm FrequencyOfOccurrence
* Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp) (Details : {SNOMED CT {http://ema.europa.eu/example/undesirableeffectassymptom-condition-effect code '304386008' 'Anaemia' = 'O/E - itchy rash', given as 'O/E - itchy rash'}) '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)

subject : Patient/example therapeuticIndication

date diseaseSymptomProcedure : 29/01/2017 12:34:56 PM 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)

seriousness comorbidity : Non-serious Hipsurgery (Details : {http://hl7.org/fhir/adverse-event-seriousness {http://ema.europa.eu/example/comorbidity code 'Non-serious' 'Hipsurgery' = 'Non-serious', given as 'Non-serious'}) 'Hipsurgery)

severity intendedEffect : Mild PRYLX (Details : {http://hl7.org/fhir/adverse-event-severity {http://ema.europa.eu/example/intendedeffect code 'Mild' 'PRYLX' = 'Mild', given as 'Mild'}) 'PRYLX)

Populations

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Contraindications

- recorder : Practitioner/example Disease Comorbidity
* 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)

SuspectEntities Interactions

- Instance Interaction Interactant Type Effect Management
* 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) Medication/example 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.