FrancophonIA/ELRC3.0 huggingface dataset:
English: As the clinical trial experience in patients with advanced hepatic impairment is limited, vernakalant is not recommended in these patients.
Danish: Da erfaring i kliniske undersøgelser med patienter med fremskreden leverinsufficiens er begrænset, bør vernakalant ikke anvendes til disse patienter.
English: • pain in your mouth or throat
Danish: • smerter i munden eller svælget
English: • taste disturbances
Danish: • smagsforstyrrelser
English: • low blood pressure, slow heart beat, feeling dizzy
Danish: • lavt blodtryk, langsom hjerterytme, svimmelhed
English: However, acute intravenous administration of vernakalant is not expected to markedly impact the PK of chronically administered 2D6 substrates, as a consequence of vernakalant's short half-life and the ensuing transient nature of 2D6 inhibition.
Danish: Akut intravenøs administration af vernakalant forventes dog ikke at have markant indvirkning på farmakokinetikken af kronisk administreret 2D6-substrater som følge af vernakalants korte halveringstid og 2D6-hæmningens deraf følgende flygtige natur.
English: • decreased feeling or sensitivity of the mouth
Danish: • nedsat følelse eller følsomhed i munden
English: Uncommon: Lacrimation increased; eye irritation; visual impairment
Danish: Ikke almindelig: Øget tåresekretion; øjenirritation; nedsat syn
English: The solution should be visually re-inspected for particulate matter and discolouration before administering.
Danish: Kontroller igen opløsningen visuelt for partikelindhold og misfarvning før indgivelse.
English: However, blockade of cationic currents, including hERG channels and cardiac voltage-dependent sodium channels, which are present in the ventricles has been documented.
Danish: Der er dog dokumentation for blokering af kationisk strømning, herunder hERG-kanaler og spændingsafhængige natriumkanaler i hjertet, som er til stede i ventriklerne.
English: ACT II examined the effect of vernakalant on patients who developed atrial fibrillation of < 3 days duration after recently undergoing coronary artery bypass graft, (CABG) and/or valvular surgery (atrial fibrillation occurred more than 1 day but less than 7 days after surgery).
Danish: ACT II undersøgte virkningen af vernakalant hos patienter, som udviklede atrieflimren med varighed < 3 dage efter nylig koronar bypasskirurgi (CABG) og/eller valvulær kirurgi (atrieflimren forekom > 1 dag men < 7 dage efter kirurgi).
English: Efficacy in patients who developed atrial fibrillation post cardiac surgery (ACT II) Efficacy was studied in patients with atrial fibrillation after cardiac surgery in ACT II, a phase 3, double-blind, placebo-controlled, parallel group study (ACT II) in 150 patients with sustained atrial fibrillation (3 hours to 72 hours duration) that occurred between 24 hours and 7 days post coronary artery bypass graft and/or valvular surgery.
Danish: Effekt hos patienter som udviklede atrieflimren efter kardiel kirurgi (ACT II) Effekten blev undersøgt hos patienter med atrieflimren efter kardiel kirurgi i ACT II, en fase 3, dobbeltblindet, placebokontrolleret, parallel gruppeundersøgelse (ACT II) hos 150 patienter med vedvarende atrieflimren (3-72 timers varighed), som indtrådte mellem 24 timer og 7 dage efter koronar bypasskirurgi og/eller valvulær kirurgi.
English: • Patients with severe aortic stenosis, patients with systolic blood pressure < 100 mm Hg, and patients with heart failure class NYHA III and NYHA IV. - Alert HCP about BRINAVESS special warnings and precautions in patients with, clinically meaningful valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis, previously documented LVEF ≤ 35 %, advanced hepatic impairment.
Danish: • Patienter med svær aortastenose, patienter med systolisk blodtryk < 100 mm Hg og patienter med hjerteinsufficiens NYHA III og NYHA IV - Læger og sundhedspersonale skal gøres opmærksom på særlige advarsler og forsigtighedsregler for BRINAVESS hos patienter med klinisk betydningsfuld valvulær stenose, hypertrofisk obstruktiv kardiomyopati, restriktiv kardiomyopati eller konstriktiv perikaridit, tidligere dokumenteret venstre ventrikel ejektionsfraktion ≤ 35 %, fremskreden leverinsufficiens.
English: Vernakalant is an antiarrhythmic medicine that acts preferentially in the atria to prolong atrial refractoriness and to rate-dependently slow impulse conduction.
Danish: Vernakalant er et antiarytmisk lægemiddel, som fortrinsvis virker i atrierne til at øge den refraktære periode i atrierne og til frekvensafhængigt at nedsætte impulsoverledningen.
English: • your heart beat (such as a very fast (uncommon) or very slow heart beat (common), a missed beat (uncommon), or a short pause in the normal activity of your heart (uncommon))
Danish: (almindelige), hjertet springer et slag over (ikke almindelige), eller en kort pause i hjertets normale aktivitet (ikke almindelige))
English: Treatment with vernakalant, converted 51.7 % of patients to SR at 90 minutes versus 5.2 % with amiodarone resulting in a significantly faster conversion rate from AF to SR within the first 90 minutes compared to amiodarone (log-rank P-value < 0.0001).
Danish: Efter behandling med vernakalant konverterede 51,7 % af patienterne til sinusrytme efter 90 minutter versus 5,2 % med amiodaron, hvilket resulterede i signifikant højere konverteringshastighed i konvertering fra atrieflimren til sinusrytme inden for 90 minutter sammenlignet med amiodaron (log-rank P-værdi < 0,0001).
English: The checklist should be placed on the infusion container to be read by the healthcare professional who will administer BRINAVESS.
Danish: Tjeklisten skal anbringes på infusionsbeholderen, så den kan læses af den sundhedsperson, der administrerer BRINAVESS.
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Spørg Deres læge, hvis De har yderligere spørgsmål om brugen af denne medicin.
English: Patients should be carefully observed for the entire duration of the infusion and for at least 15 minutes after completion of the infusion with assessment of vital signs and continuous cardiac rhythm monitoring.
Danish: Patienterne skal observeres omhyggeligt under hele infusionen og i mindst 15 minutter efter afsluttet infusion med vurdering af vitale tegn og løbende monitorering af hjerterytmen.
English: A pre-infusion checklist is provided with the medicinal product.
Danish: En tjekliste til anvendelse før infusion følger med lægemidlet.
English: Efficacy was studied in a total of 390 haemodynamically stable adult patients with short duration atrial fibrillation including patients with hypertension (40.5 %), ischaemic heart disease (12.8 %), valvular heart disease (9.2 %) and CHF (10.8 %).
Danish: Effekten blev undersøgt hos i alt 390 hæmodynamisk stabile voksne patienter, som havde haft atrieflimren i kort tid, herunder patienter med hypertension (40,5 %), iskæmisk hjertesygdom (12,8 %), valvulær hjertesygdom (9,2 %) og venstresidig hjerteinsufficiens (10,8 %).
English: In patients with valvular heart disease, there was a higher incidence of ventricular arrhythmia events in vernakalant patients until 24 hours after dosing.
Danish: Hos patienter med valvulær hjertesygdom var der en højere incidens af ventrikulær arytmi hos patienter, der fik vernakalant indtil 24 timer efter dosering.
English: Common: Bradycardia**; atrial flutter** Uncommon: Sinus arrest; ventricular tachycardia; palpitations; bundle branch block left; ventricular extrasystoles; AV block first degree; AV block complete; bundle branch block right; sinus bradycardia; ECG QRS complex prolonged; cardiogenic shock
Danish: Almindelig: Bradykardi**; atrieflagren** Ikke almindelig: Sinusarrest; ventrikulær takykardi; palpitationer; venstresidigt grenblok; ventrikulære ekstrasystoler; 1. grads AVblok; komplet AV-blok; højresidigt grenblok; sinusbradykardi; forlænget QRS-kompleks i EKG'et;kardiogent shock.
English: • certain kinds of heart beat problems, (such as an awareness of your heart beating (palpitations)
Danish: • visse former for problemer med hjerterytmen (såsom hjertebanken (palpitationer) eller et ekstra hjerteslag)
English: This medicinal product contains 32 mg sodium per 200 mg vial, equivalent to 1.6 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 32 mg natrium pr. 200 mg hætteglas, svarende til 1,6 % af den WHOanbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: - Alert HCP for adverse reactions, which may occur after BRINAVESS administration, including hypotension, bradycardia, atrial flutter, or ventricular arrhythmia.
Danish: - Læger og sundhedspersonale skal gøres opmærksom på bivirkninger, der kan forekomme efter administration af BRINAVESS herunder hypotension, bradykardi, atrieflagren eller ventrikulær arytmi.
English: The use in CHF patients corresponding to NYHA III or NYHA IV is contraindicated (see section 4.3).
Danish: Anvendelse til patienter med venstresidig hjerteinsufficiens svarende til NYHA III eller NYHA IV er kontraindiceret (se pkt.
English: Within the first 2 hours, ventricular arrhythmia occurred in 6.4% of patients treated with vernakalant versus none after placebo.
Danish: Inden for de første 2 timer opstod der ventrikulær arytmi hos 6,4 % af de patienter, der blev behandlet med vernakalant versus ingen efter placebo.
English: There is limited experience with the use of intravenous rhythm control antiarrhythmics (class I and class III) in the first 4 hours after vernakalant administration, therefore these agents must not be used within this period (see section 4.3).
Danish: Der er begrænset erfaring med anvendelse af intravenøse antiarytmika til rytmekontrol (klasse I og III) de første 4 timer efter administration af vernakalant, og derfor må disse lægemidler ikke anvendes i denne periode (se pkt.
English: This medicinal product contains 80 mg sodium per 500 mg vial, equivalent to 4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 80 mg natrium pr. 500 mg hætteglas, svarende til 4 % af den WHOanbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: If the patient was in atrial fibrillation or atrial flutter at the end of the 15-minute observation period, a second 10-minute infusion of 2.0 mg/kg BRINAVESS (or matching placebo) was administered.
Danish: Hvis patienten havde atrieflimren eller atrieflagren efter den 15 minutters observationsperiode, blev yderligere en 10 minutters infusion af 2,0 mg/kg BRINAVESS (eller tilsvarende placebo) indgivet.
English: • a change in your sense of smell
Danish: • forandring af lugtesansen
English: Vernakalant was studied in 116 pts with atrial fibrillation (3 hrs to 48 hrs) including patients with hypertension (74.1 %), IHD (19 %), valvular heart disease (3.4 %) and CHF (17.2 %).
Danish: Vernakalant blev undersøgt hos 116 patienter med atrieflimren (3-48 timer) herunder patienter med hypertension (74,1 %), iskæmisk hjertesygdom (19 %), valvulær hjertesygdom (3,4 %) og venstresidig hjerteinsufficiens (17,2 %).
English: Dizziness has been reported within the first 2 hours after receiving it (see section 4.8).
Danish: Der er blevet rapporteret om svimmelhed inden for de første 2 timer efter indgift(se pkt.
English: This medicine contains 80 mg of sodium (main component of cooking/table salt) in each vial of 500 mg.
Danish: Dette lægemiddel indeholder 80 mg natrium (hovedkomponent af madlavnings-/bordsalt) i hvert 500 mg hætteglas.
English: This medicine contains 32 mg sodium (main component of cooking/table salt) in each 200 mg vial.
Danish: Dette lægemiddel indeholder 32 mg natrium (hovedkomponent af madlavnings-/bordsalt) i hvert 200 mg hætteglas.
English: • Continue to monitor the patient for 2 hrs after the start of infusion and until clinical and ECG parameters have stabilised.
Danish: • Fortsæt med at monitorere patienten i 2 timer efter infusionsstart og til de kliniske parametre og EKG er stabile.
English: Efficacy from Post-Marketing Observational Study In the post-approval safety study SPECTRUM that included 1,778 patients with 2,009 BRINAVESS treatment episodes, effectiveness was assessed as the proportion of patients who converted to sinus rhythm for at least one (1) minute within 90 minutes from the start of BRINAVESS infusion, excluding patients who received electrical cardioversion or intravenous Class I/III antiarrhythmics for cardioversion within the 90-minute window.
Danish: I sikkerhedsstudiet efter godkendelse SPECTRUM, der omfattede 1.778 patienter med 2.009 BRINAVESS-behandlingsepisoder, blev effektiviteten vurderet som den andel af patienterne, som konverterede til sinusrytme i mindst ét (1) minut inden for 90 minutter efter start på BRINAVESS-infusion, eksklusive patienter, som fik elektrisk konvertering eller intravenøse klasse I/III-antiarytmika mod konvertering inden for 90-minutters tidsvinduet.
English: • coughing, sore nose
Danish: • hoste, øm næse
English: BRINAVESS is available in pack of 1 vial containing 200 mg or 500 mg of vernakalant hydrochloride.
Danish: BRINAVESS findes i pakninger med 1 hætteglas indeholdende 200 mg eller 500 mg vernakalanthydrochlorid.
English: • Patients with prolonged QT at baseline (uncorrected > 440 msec), or severe bradycardia, sinus node dysfunction or second degree and third degree heart block in the absence of a pacemaker.
Danish: • Patienter med forlænget QT ved baseline (ukorrigeret > 440 ms), svær bradykardi, sinusknudeforstyrrelser eller 2. grads AV-blok og 3. grads AV-blok uden pacemaker.
English: Do NOT give other IV antiarrhythmic medicines (class I and/or class III) for at least 4 hours after infusion of BRINAVESS.
Danish: Der må IKKE gives andre intravenøse antiarytmika (klasse I og/eller III) i mindst 4 timer efter infusion af BRINAVESS.
English: OTHER SPECIAL WARNINGS, IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER UDLØBSDATO
English: If haemodynamically stable atrial flutter is observed after the initial infusion, the second infusion may be administered as patients may convert to sinus rhythm (see sections 4.4 and 4.8).
Danish: Hvis der ses hæmodynamisk stabil atrieflagren efter den initiale infusion, kan 2. infusion gives, da patienterne måske konverterer til sinusrytme (se pkt.
English: Of the patients who did not convert to sinus rhythm, the incidence of bradycardia events in the first 2 hours post-dose was similar in placebo and vernakalant treated groups (4.0% and 3.8%, respectively).
Danish: Hos de patienter, der ikke konverterede til sinusrytme, var incidensen af bradykardi i de første 2 timer efter dosering den samme i de grupper, der fik placebo og vernakalant (henholdsvis 4,0% og 3,8%).
English: Efficacy in patients with sustained atrial fibrillation, (ACT I and ACT III) Primary efficacy endpoint was the proportion of subjects with short duration atrial fibrillation (3 hours to 7 days) who had a treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of one minute within 90 minutes of first exposure to study drug.
Danish: Effekt hos patienter med vedvarende atrieflimren (ACT I og ACT III) Det primære effekt-endepunkt var andelen af patienter med atrieflimren af kort varighed (3 timer til 7 dage), som fik behandlingsinduceret konvertering af atrieflimren til sinusrytme i minimum 1 minut inden for 90 minutter efter første eksponering til lægemidlet.
English: No dose adjustment of vernakalant is required on the basis of CYP2D6 metaboliser status, or when vernakalant is administered concurrently with 2D6 inhibitors.
Danish: Dosisjustering af vernakalant er ikke nødvendig på basis af CYP2D6 metaboliseringsstatus, eller når vernakalant administreres samtidigt med 2D6-hæmmere.
English: In addition, acute exposure of vernakalant in poor metabolisers of CYP2D6 is only minimally different when compared to that of extensive metabolisers.
Danish: Desuden er akut eksponering af vernakalant hos patienter med dårlig metaboliseringsgrad af CYP2D6 kun minimalt forskellig i sammenligning med patienter med ekstensiv metaboliseringsgrad .
English: Vernakalant given by infusion is not expected to perpetrate meaningful drug interactions due to the rapid distribution and transient exposure, low protein binding, lack of inhibition of other CYP P450 enzymes tested (CYP3A4, 1A2, 2C9, 2C19 or 2E1) and lack of P-glycoprotein inhibition in a digoxin transport assay.
Danish: Vernakalant givet ved infusion forventes ikke at medføre lægemiddelinteraktion af betydning på grund af den hurtige fordeling og flygtige eksponering samt lave proteinbinding, og på grund af at andre testede CYP P450-enzymer (CYP3A4, 1A2, 2C9, 2C19 eller 2E1) ikke hæmmes, samt at p-glycoprotein ikke hæmmes i digoxintransport.
English: Contents of the pack and other information What BRINAVESS contains
Danish: Pakningsstørrelser og yderligere oplysninger BRINAVESS indeholder:
English: Each vial of 200 mg contains approximately 1.4 mmol (32 mg) sodium.
Danish: Et hætteglas med 200 mg indeholder ca. 1,4 mmol (32 mg) natrium.
English: Vernakalant has been administered to patients with an uncorrected QT less than 440 msec without an increased risk of torsade de pointes.
Danish: Andre sygdomme og tilstande, der ikke er undersøgt Vernakalant er blevet givet til patienter med ukorrigeret QT < 440 ms uden øget risiko for torsades de pointes.
English: • shortness of breath or a tightness in the chest
Danish: • stakåndethed eller strammen i brystet
English: Each ml of the diluted solution contains approximately 3.5 mg of sodium (sodium chloride 9 mg/ml (0.9 %) solution for injection), 0.64 mg sodium (5 % glucose solution for injection) or 3.2 mg sodium (Lactated Ringers solution for injection).
Danish: Hver ml fortyndet infusionsvæske indeholder ca. 3,5 mg natrium (natriumchlorid 9 mg/ml (0,9 %) infusionsvæske), 0,64 mg natrium (5 % glucose infusionsvæske, opløsning) eller 3,2 mg natrium (Ringer-lactat infusionsvæske, opløsning).
English: • Intravenous rhythm control AADs should not be used in the first 4 hours after BRINAVESS administration.
Danish: • Rytmekontrol med intravenøse antiarytmika må ikke anvendes i de første 4 timer efter administration af BRINAVESS.
English: Step 1: BRINAVESS vials should be visually inspected for particulate matter and discolouration before administration.
Danish: Trin 1: Kontroller hætteglassene med BRINAVESS visuelt for partikelindhold og misfarvning før indgivelse.
English: • The active substance is vernakalant hydrochloride.
Danish: • Aktivt stof: vernakalanthydrochlorid.
English: • Resumption or initiation of oral-maintenance antiarrhythmic therapy can be considered 2 hours after BRINAVESS administration.
Danish: • Genoptagelse eller initiering af oral vedligeholdelsesbehandling med antiarytmika kan overvejes 2 timer efter administration af BRINAVESS.
English: Educational material for healthcare professionals Summary of product characteristics, package leaflet and labelling
Danish: Produktresumé, indlægsseddel og etikettering
English: How to use BRINAVESS
Danish: Sådan skal De bruge BRINAVESS
English: Vernakalant was shown to provide relief of atrial fibrillation symptoms consistent with conversion to sinus rhythm.
Danish: Vernakalant afhjalp symptomerne fra atrieflimren i overensstemmelse med konvertering til sinusrytme.
English: Each vial of 500 mg contains approximately 3.5 mmol (80 mg) of sodium.
Danish: Et hætteglas med 500 mg indeholder ca. 3,5 mmol (80 mg) natrium.
English: • BRINAVESS should be used with caution in patients on oral AADs (class I and III), due to limited experience.
Danish: • BRINAVESS bør anvendes med forsigtighed hos patienter, der får orale antiarytmika (klasse I og III) grundet begrænset erfaring.
English: Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults
Danish: Hurtig konvertering af nyligt opstået atrieflimren til sinusrytme hos voksne.
English: These effects, seen within 24 hours of being given BRINAVESS, should pass quickly, however, if they do not you should consult your doctor.
Danish: Disse bivirkninger, som er set inden for 24 timer efter BRINAVESS er givet, bør forsvinde hurtigt.
English: Risk of atrial flutter may be increased in patients receiving class I AADs (see above).
Danish: Risikoen for atrieflagren kan være forøget hos patienter, der får klasse I antiarytmika (se ovenfor).
English: The patient should be further monitored for 2 hrs after the start of infusion and until clinical and ECG parameters have stabilised.
Danish: Patienten skal yderligere monitoreres i 2 timer efter infusionsstart og til de kliniske parametre og EKG er stabile.
English: In the performed clinical studies, the additive effect of the second dose, if any, cannot be independently established.
Danish: Den eventuelle additive effekt af en 2. dosis har ikke kunnet bedømmes selvstændigt i de udførte kliniske undersøgelser.
English: • urgency to have a bowel movement, diarrhoea
Danish: • akut afføringstrang, diarré
English: The safety of vernakalant has been evaluated in clinical studies involving 1,148 subjects (patients and healthy volunteers) who received treatment with it. Based on data from 1,018 patients in eight phase 2 and phase 3 trials, the most commonly reported adverse reactions (> 5 %) seen in the first 24 hours after receiving vernakalant were dysgeusia (taste disturbance) (17.9 %), sneezing (12.5 %), and paraesthesia (6.9 %).
Danish: Baseret på data fra 1.018 patienter i otte fase 2- og fase 3-undersøgelser var de mest almindeligt rapporterede bivirkninger (> 5 %) set inden for de første 24 timer, efter at vernakalanter givet: dysgeusi (smagsforstyrrelse) (17,9 %), nysen (12,5 %) og paræstesi (6,9 %).
English: Other medicines and BRINAVESS
Danish: Brug af anden medicin sammen med BRINAVESS
English: Has the patient received an intravenous rhythm control antiarrhythmic drug (class I and/or class III) within 4 hours of the time when BRINAVESS will be infused?
Danish: Har patienten fået intravenøse antiarytmika til rytmekontrol (klasse I og/eller III) inden for 4 timer før evt. administration af BRINAVESS?
English: Do not use BRINAVESS if you take certain other intravenous medicines (antiarrhythmics Class I and III) used to normalize an abnormal heart rhythm, 4 hours before BRINAVESS is to be used.
Danish: Brug ikke BRINAVESS, hvis De tager anden medicin i en blodåre (antiarytmika klasse I og III) til normalisering af unormal hjerterytme 4 timer før, BRINAVESS skal bruges.
English: Note: BRINAVESS concentrate for solution for infusion ranges from colourless to pale yellow.
Danish: Bemærk: BRINAVESS koncentrat til infusionsvæske, opløsning, kan variere fra farveløs til svagt gul.
English: This risk is higher in patients who use Class I antiarrhythmics (see section 4.8).
Danish: Denne risiko er større hos patienter, som får klasse I antiarytmika (se pkt.
English: - Alert HCP for use of antiarrhythmic drugs (AADs) prior to or after BRINAVESS.
Danish: - Læger og sundhedspersonale skal gøres opmærksom på anvendelse af antiarytmika før og efter BRINAVESS.
English: The patient is required to be monitored for signs and symptoms of a sudden decrease in blood pressure or heart rate for the duration of the infusion and for at least 15 minutes after the completion of the infusion.
Danish: Patienten skal monitoreres for tegn og symptomer på pludseligt fald i blodtryk eller hjertefrekvens under hele infusionen og i mindst 15 minutter efter afsluttet infusion.
English: Patients receiving vernakalant have a higher incidence of converting to atrial flutter within the first 2 hours post-dose.
Danish: Patienter, der fik vernakalant, havde en højere incidens af konvertering til atrieflagren inden for de første 2 timer efter dosering.
English: With a significantly higher conversion rate in patients treated with vernakalant, the incidence of bradycardia events was higher within the first 2 hours in vernakalant treated patients than in placebo-treated patients (1.6 % versus 0 %, respectively).
Danish: Med en signifikant højere konverteringshastighed hos patienter, der blev behandlet med vernakalant, var incidensen for bradykardi højere i de første 2 timer hos patienter, der var behandlet med vernakalant, end hos patienter, der havde fået placebo (henholdsvis 1,6 % og 0 %).