FrancophonIA/ELRC3.0 huggingface dataset:
English: Does the patient have hypersensitivity to the active substance or to any of the excipients?
Danish: Er patienten overfølsom over for det aktive stof eller over for et eller flere af hjælpestofferne?
English: The Marketing Authorisation Holder must agree about the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution.
Danish: Indehaveren af markedsføringstilladelsen skal før distribution blive enig med den relevante nationale myndighed om indhold og format af undervisningsmaterialet samt en kommunikationsplan.
English: Common: may affect up to 1 in 10 people
Danish: Almindelige: kan berøre op til 1 ud af 10 personer
English: The diluted sterile solution should be clear, colourless to pale yellow.
Danish: Den fortyndede sterile opløsning skal være klar, farveløs til svagt gul.
English: There is limited experience with vernakalant in patients with pacemakers.
Danish: Erfaring med vernakalant til patienter med pacemaker er begrænset.
English: For atrial fibrillation lasting longer than 48 hours, anticoagulation was required as per treatment guidelines.
Danish: Til atrieflimren med varighed over 48 timer var antikoagulering påkrævet i henhold til behandlingsvejledningerne.
English: The European Medicines Agency has waived the obligation to submit the results of studies with vernakalant in all subsets of the paediatric population in atrial fibrillation (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med vernakalant i alle undergrupper af den pædiatriske population ved atrieflimren (se pkt.
English: Direct-current cardioversion may be considered for patients who do not respond to therapy.
Danish: Defibrillering kan overvejes til patienter, som ikke responderer på behandling.
English: BRINAVESS is a concentrate for solution for infusion (sterile concentrate) which is clear and colourless to pale yellow.
Danish: BRINAVESS er et koncentrat til infusionsvæske, opløsning (sterilt koncentrat), som er klart og farveløst til svagt gul.
English: Dilute before use.
Danish: Fortyndes før anvendelse.
English: Treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm (47.0 % vernakalant, 14.0 % placebo; P value = 0.0001).
Danish: Behandling med vernakalant konverterede effektivt atrieflimren til sinusrytme (47,0 % vernakalant, 14,0 % placebo; P-værdi = 0,0001).
English: The vernakalant dose recommendation is a titrated therapy with 2 possible dose steps.
Danish: Dosisanbefaling for vernakalant er en titreret behandling med 2 mulige doseringstrin.
English: • if you have a very narrow heart valve, systolic blood pressure less than 100 mm Hg or advanced heart failure with symptoms at minimal exertion or at rest
Danish: • hvis De har en meget smal hjerteklap, systolisk blodtryk på under 100 mm Hg eller fremskreden hjertesvigt med symptomer ved minimal anstrengelse eller i hvile
English: This will be a slightly lower dose of 2 mg/kg, with a maximum calculated dose based upon 113 kg. Total doses of greater than 5 mg/kg should not be administered within 24 hours.
Danish: Dette vil være en lidt mindre dosis på 2 mg/kg med en maksimal dosis baseret på 113 kg. I alt bør De ikke få doser på mere end 5 mg/kg inden for 24 timer.
English: • The other ingredients are citric acid, sodium chloride, sodium hydroxide (E524) and water for injections.
Danish: • Øvrige indholdsstoffer: Citronsyre, natriumchlorid, natriumhydroxid (E524) og vand til injektionsvæsker.
English: Across the Phase 3 population, vernakalant treated patients had an increase in heart rate-corrected QT (using Fridericia's correction, QTcF) compared to placebo (22.1 msec and 18.8 msec placebo-subtracted peaks after first and second infusions, respectively).
Danish: På tværs af fase 3-populationen havde de patienter, der var behandlet med vernakalant, en stigning i hjertefrekvenskorrigeret QT (ved anvendelse af Fridericias korrektion, QTcF) sammenlignet med placebo (henholdsvis 22,1 ms og 18,8 ms placebo-subtraherede peaks efter 1. og 2. infusion).
English: BRINAVESS contains the active substance vernakalant hydrochloride.
Danish: BRINAVESS indeholder det aktive stof vernakalanthydrochlorid.
English: BRINAVESS vials are for single use only and must be diluted prior to administration.
Danish: Hætteglas med BRINAVESS er kun til engangsbrug og skal fortyndes før administration.
English: Patients > 100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.
Danish: Patienter > 100 kg: 30 ml BRINAVESS 20 mg/ml tilsættes til 120 ml infusionsvæske.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æskens og hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: It is preferable to avoid the use of BRINAVESS during pregnancy.
Danish: BRINAVESS bør undgås under graviditeten.
English: There is no information on the excretion of vernakalant/metabolites in animal milk.
Danish: Der er ingen oplysninger om udskillelse af vernakalant/metabolitter i mælk hos dyr.
English: Bradycardia was observed predominantly at the time of conversion to sinus rhythm.
Danish: Bradykardi sås overvejende på tidspunktet for konvertering til sinusrytme.
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.
Danish: • Patienter med svær aortastenose, patienter med systolisk blodtryk < 100 mm Hg og patienter med hjerteinsufficiens NYHA III og NYHA IV.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: kan berøre mere end 1 person ud af 10
English: Clinical Trial Design: The clinical effect of vernakalant in the treatment of patients with atrial fibrillation has been evaluated in three, randomised, double-blind, placebo-controlled studies, (ACT I, ACT II and ACT III) and in an active comparator trial versus intravenous amiodarone (AVRO).
Danish: Klinisk studiedesign: Den kliniske effekt af vernakalant i behandlingen af patienter med atrieflimren er blevet vurderet i tre randomiserede, dobbeltblindede, placekontrollerede undersøgelser (ACT I, ACT II og ACT III) og i et aktivt komparatorstudie versus intravenøs amiodaron (AVRO).
English: If conversion to sinus rhythm occurs during either the initial or second infusion, that infusion should be continued to completion.
Danish: Hvis konvertering til sinusrytme indtræder under 1. eller 2. infusion, bør denne infusion fortsætte til, den er afsluttet.
English: The higher cardioversion rate in SPECTRUM as compared to clinical phase 3 studies (70.2% vs 47% to 51%) is correlated with a shorter duration of the duration of the index atrial fibrillation period (median duration of 11.1 hours in SPECTRUM vs 17.7 to 28.2 hours in clinical studies).
Danish: Den højere konverteringshastighed i SPECTRUM sammenlignet med kliniske fase 3-studier (70,2% versus 47% til 51%) korrelerer med en kortere varighed af indeksperioden med atrieflimren (medianvarighed på 11,1 timer i SPECTRUM versus 17,7 til 28,2 timer i kliniske studier).
English: Prior to attempting pharmacological cardioversion, patients should be adequately hydrated and haemodynamically optimized and if necessary patients should be anticoagulated in accordance with treatment guidelines.
Danish: Før farmakologisk konvertering forsøges, skal patienterne være tilstrækkeligt hydreret og hæmodynamisk optimeret, og om nødvendigt bør patienterne antikoaguleres i henhold til behandlingsvejledningen.
English: Fertility Vernakalant was not shown to alter fertility in animal studies.
Danish: Fertilitet Det er ikke vist, at Vernakalant ændrer fertiliteten i dyreforsøg.
English: In embryo-foetal development studies with oral administration of vernakalant two times a day resulting in exposure levels (AUC) generally higher than those achieved in humans after a single intravenous dose of vernakalant malformations (misshapen/absent/fused skull bones including cleft palates, bent radius, bent/misshapen scapula, constricted trachea, absent thyroid, undescendent testes) occurred in rats and increased embryo-foetal lethality, increased number of foetuses with fused and/or additional sternebrae were seen in rabbits at the highest doses tested.
Danish: I undersøgelser vedrørende fosterudvikling med oral administration af vernakalant to gange dagligt ved eksponeringsniveauer (AUC), der generelt var højere end hos mennesker efter en enkelt intravenøs dosis vernakalant, opstod der misdannelser hos rotter (misdannede/manglende/sammenvoksede kranieknogler herunder ganespalte, bøjet spoleben, bøjet/misdannet skulderblad, forsnævret luftrør, manglende skjoldbruskkirtel, non-descensus testis) og øget fosterdødelighed, øget antal fostre med sammenvoksede og/eller ekstra brystben sås hos kaniner ved de højeste doser, som blev testet.
English: If any of the following signs or symptoms occurs, the administration of vernakalant should be discontinued and these patients should receive appropriate medical management:
Danish: Hvis et eller flere af følgende tegn eller symptomer opstår, skal administration af vernakalant afbrydes, og patienterne skal have hensigtsmæssig behandling:
English: • Observe the patient frequently and carefully for the entire duration of the infusion and for at least 15 minutes after completion of the infusion for: o Any signs or symptoms of a sudden decrease in blood pressure or heart rate, with or without symptomatic hypotension or bradycardia o Bradycardia o Hypotension o Unexpected ECG changes (see SmPC)
Danish: • Patienten skal observeres ofte og omhyggeligt under hele infusionen og i mindst 15 minutter efter afsluttet infusion for: o Tegn og symptomer på et pludseligt fald i blodtryk eller hjertefrekvens, med eller uden symptomatisk hypotension eller bradykardi o Bradykardi o Hypotension o Uventede EKG-forandringer (se SmPC)
English: During atrial fibrillation, the frequency- and voltage-dependent block of sodium channels further focuses the action of the medicine toward rapidly activating and partially depolarized atrial tissue rather than toward the normally polarized ventricle beating at lower heart rates.
Danish: Under atrieflimren fokuserer den frekvens- og spændingsafhængige blokering af natriumkanalerne yderligere virkningen af medicinen mod hurtigt aktiverende og delvist depolariseret atrievæv snarere end mod det normalt polariserede ventrikulære slag ved lavere hjertefrekvens.
English: • ECG changes (such as a clinically meaningful sinus pause, complete heart block, new bundle branch block, significant prolongation of the QRS or QT interval, changes consistent with ischaemia or infarction and ventricular arrhythmia)
Danish: • EKG-forandringer (så som klinisk betydningsfuld sinusarrest, komplet hjerteblok, nyt grenblok, signifikant forlængelse af QRS- eller QT-intervallet, forandringer i overensstemmelse med iskæmi eller infarkt og ventrikulær arytmi).
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis De ønsker yderligere oplysninger om BRINAVESS, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: In patients, average peak plasma concentrations of vernakalant were 3.9 μg/ml following a single 10-minute infusion of 3 mg/kg vernakalant hydrochloride, and 4.3 μg/ml following a second infusion of 2 mg/kg with a 15-minute interval between doses.
Danish: Hos patienterne var den gennemsnitlige peak-plasma koncentration 3,9 µg/ml efter en enkelt 10 minutters infusion på 3 mg/kg vernakalanthydrochlorid og 4,3 µg/ml efter 2. infusion på 2 mg/kg med 15 minutters interval mellem doserne.
English: • The patient should be adequately hydrated and haemodynamically optimised and adequately anticoagulated (if necessary) prior to administering BRINAVESS
Danish: • Patienten skal være tilstrækkeligt hydreret og hæmodynamisk optimeret, og om nødvendigt bør patienten antikoaguleres før administration af BRINAVESS.
English: • pain in your fingers and toes, a burning feelingcold sweats, hot flush
Danish: • smerter i fingre og tæer, brændende fornemmelse, koldsved; hedeture
English: Vernakalant is mainly eliminated by CYP2D6 mediated O-demethylation in CYP2D6 extensive metabolisers.
Danish: Vernakalant elimineres hovedsageligt via CYP2D6-medieret O-demetylering hos ekstensive CYP2D6-metabolizers.
English: Has the patient presented with an acute coronary syndrome (including myocardial infarction) in the last 30 days?
Danish: Har patienten haft et akut koronarsyndrom (herunder myokardieinfarkt) inden for de seneste 30 dage?
English: This is equivalent to 1.6 % of the recommended maximum daily dietary intake for an adult.
Danish: Dette svarer til 1,6 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: AVRO studied the effect of vernakalant versus intravenous amiodarone in patients with recent onset atrial fibrillation (3 hrs to 48 hrs).
Danish: AVRO undersøgte effekten af vernakalant versus intravenøs amiodaron hos patienter med nylig opstået atrieflimren (3-48 timer).
English: Conversion of atrial fibrillation to sinus rhythm occurred rapidly (median time to conversion 12 minutes from the start of infusion).
Danish: Konvertering af atrieflimren til sinusrytme indtrådte hurtigt (mediantid til konvertering var 12 minutter fra infusionsstart).
English: The mean elimination half-life of vernakalant in patients was approximately 3 hours in CYP2D6 extensive metabolisers and approximately 5.5 hours in poor metabolisers.
Danish: Vernakalants gennemsnitlige halveringstid hos patienter var ca. 3 timer hos ekstensive CYP2D6-metabolizers og ca. 5,5 timer hos patienter med dårlig metaboliseringsgrad.
English: If patients who received electrical cardioversion, intravenous antiarrhythmics or oral propafenone/flecainide within 90 minutes from the start of BRINAVESS infusion are regarded as treatment failures in addition to patients who did not convert for one minute within 90 minutes, the conversion rate among the 2,009 patients who received BRINAVESS was 67.3 % (1,352/2,009).
Danish: Hvis patienter, som fik elektrisk konvertering, intravenøse antiarytmika eller oral propafenon/flecainid inden for 90 minutter efter start på BRINAVESS-infusion, anses for at være ikke-responderende sammen med patienter, som ikke konverterede i ét minut inden for 90 minutter, var konverteringshastigheden blandt de 2.009 patienter, som fik BRINAVESS, 67,3 % (1.352/2.009).
English: The relative selectivity of vernakalant on atrial versus ventricular refractoriness is postulated to result from the block of currents regulated by ion channels that are expressed in the atria, but not in the ventricles, as well as the unique electrophysiologic condition of the fibrillating atria.
Danish: Vernakalants relative selektivitet med hensyn til atrial versus ventrikulær refraktærperiode hævdes at resultere fra blokering af strømme reguleret af ionkanaler, der udtrykkes i atrierne men ikke i ventriklerne, og de flimrende atriers unikke elektrofysiologiske tilstand.
English: For atrial fibrillation lasting less than 48 hours, immediate cardioversion was allowed.
Danish: Til atrieflimren med varighed under 48 timer var øjeblikkelig konvertering tilladt.
English: Its use in these patients is not recommended.
Danish: Vernakalant bør ikke anvendes til disse patienter.
English: BRINAVESS may not work in treating some other kinds of abnormal heart rhythms, however your doctor will be familiar with these.
Danish: Der kan være visse andre typer af unormal hjerterytme, som BRINAVESS ikke kan behandle, men lægen vil være bekendt med dette.
English: • pain or numbness at the infusion site, numbness, decreased skin sensation, or tingling feelings
Danish: • smerte eller følelsesløshed på infusionsstedet, følelsesløshed, nedsat følelse i huden eller prikkende fornemmelse
English: This is equivalent to 4 % of the recommended maximum daily dietary intake for an adult.
Danish: Dette svarer til 4 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: After dilution the concentration of the solution is 4 mg/ml vernakalant hydrochloride.
Danish: Efter fortynding er koncentrationen af opløsningen på 4 mg/ml vernakalanthydrochlorid.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: kan berøre op til 1 ud af 100 personer
English: No significant differences in safety or effectiveness were observed based on age, gender, use of rate control medications, use of antiarrhythmic medications, use of warfarin, history of ischaemic heart disease, renal impairment or expression of the cytochrome P450 2D6 enzyme.
Danish: Der var ingen signifikante forskelle i sikkerhed og effekt på basis af alder, køn, anvendelse af medicin til frekvenskontrol, anvendelse af antiarytmika, anvendelse af warfarin, iskæmisk hjertesygdom i anamnesen, nyreinsufficiens eller ekspression af cytokrom P450 2D6-enzymet.
English: Conversion of atrial fibrillation to sinus rhythm occurred rapidly (in responders the median time to conversion was 10 minutes from start of first infusion) and sinus rhythm was maintained through 24 hours (97 %).
Danish: Konvertering af atrieflimren til sinusrytme opstod hurtigt (hos respondenter var mediantiden til konvertering 10 minutter fra start af første infusion), og sinusrytmen blev opretholdt i 24 timer (97 %).
English: Read carefully the Summary of Product Characteristics and the Health Care Professional Information Card prior to the administration of BRINAVESS
Danish: Læs produktresuméet samt informationsmaterialet til sundhedspersonalet grundigt før administration af BRINAVESS
English: In preclinical studies, vernakalant blocks currents in all phases of the atrial action potential, including potassium currents that are expressed specifically in the atria (e.g., the ultra-rapid delayed rectifier and the acetylcholine dependent potassium currents).
Danish: I prækliniske undersøgelser blokerer vernakalant for strømme i alle faser af aktionspotentialet i atrierne inklusive kaliumkanaler, som udtrykkes specifikt i atrierne (fx den ultrahurtige forsinkede ensretter og de acetylcholinafhængige kaliumkanaler).
English: PARTICULARS TO APPEAR WITHIN THE OUTER PACKAGING (CARTON) PRE-INFUSION CHECK-LIST
Danish: MÆRKNING, DER SKAL ANFØRES INDE I DEN YDRE EMBALLAGE (KARTON) Tjekliste til anvendelse før infusion
English: • Acute coronary syndrome (including myocardial infarction) within the last 30 days.
Danish: • Akut koronarsyndrom (herunder myokardieinfarkt) inden for de seneste 30 dage.
English: Additionally, the ability of vernakalant to block the late component of the sodium current limits effects on ventricular repolarisation induced by blockade of potassium currents in the ventricle.
Danish: Desuden begrænser vernakalants evne til at blokere natriumstrømmens sene komponent effekten på den ventrikulære repolarisering, der er induceret ved blokering af kaliumkanaler i ventriklen.
English: The recommended initial infusion is 3 mg/kg to be infused over a 10-minute period with a maximum initial dose of 339 mg (84.7 ml of 4 mg/ml solution).
Danish: Den anbefalede initiale infusion er 3 mg/kg, som indgives over en periode på 10 minutter med en maksimal initial dosis på 339 mg (84,7 ml af 4 mg/ml opløsningen).
English: In clinical studies to date, patients who developed atrial flutter following treatment with vernakalant did not develop 1:1 atrioventricular conduction.
Danish: I kliniske undersøgelser til dato har ingen patienter, som fik atrieflagren efter behandling med vernakalant, udviklet 1:1 atrioventrikulær overledning.
English: Targeted effects on atrial tissue coupled with block of late sodium current suggests that vernakalant has a low proarrhythmic potential.
Danish: Den tilsigtede virkning på atrievævet koblet med blokering af den forsinkede natriumstrøm indikerer, at vernakalant har et lavt proarytmisk potentiale.
English: During this period, the patient should be carefully monitored for any signs or symptoms of a sudden decrease in blood pressure or heart rate.
Danish: I denne periode skal patienten monitoreres omhyggeligt for tegn og symptomer på pludseligt fald i blodtryk eller hjertefrekvens.
English: There is limited experience with the use of vernakalant in patients with previously documented LVEF ≤ 35 %.
Danish: Der er begrænset erfaring med anvendelse af vernakalant til patienter med tidligere dokumenteret venstre ventrikel ejektionsfraktion ≤ 35 %.
English: -For non-surgery patients: atrial fibrillation ≤ 7 days duration
Danish: Til ikke-opererede patienter: atrieflimren ≤ 7 dages varighed.
English: In patients with uncorrected hypokalaemia (serum potassium of less than 3.5 mmol/l), potassium levels should be corrected prior to use of vernakalant.
Danish: Hos patienter med ukorrigeret hypokalæmi (serumkalium < 3,5 mmol/l), bør kaliumkoncentrationen korrigeres før brug af vernakalant.
English: Create a solution with a concentration of 4 mg/ml following the dilution guidelines below: Patients ≤ 100 kg: 25 ml of BRINAVESS 20 mg/ml is added to 100 ml of diluent.
Danish: Tilbered en opløsning med en koncentration på 4 mg/ml i henhold til følgende fortyndingsvejledning: Patienter ≤ 100 kg: 25 ml BRINAVESS 20 mg/ml tilsættes til 100 ml infusionsvæske.
English: Acute vernakalant pharmacokinetics is not significantly influenced by gender, history of congestive heart failure, renal impairment, or concomitant administration of beta blockers and other medications, including warfarin, metoprolol, furosemide and digoxin.
Danish: Farmakokinetikken for akut vernakalant påvirkes ikke signifikant af køn, venstresidig hjerteinsuficiens i anamnesen, nyreinsufficiens eller samtidig administration af betablokkere og anden medicin herunder warfarin, metoprolol, furosemid og digoxin.
English: Single-use glass (Type 1) vials with a chlorobutyl rubber stopper and an aluminium overseal.
Danish: Engangshætteglas af glas (Type 1) med prop af chlorbutylgummi og aluminiumforsegling.
English: Do not re-start BRINAVESS.
Danish: Behandling med BRINAVESS må ikke sættes i gang igen.
English: Pack size of 1 vial includes either 10 ml or 25 ml of concentrate.
Danish: Pakning à 1 hætteglas med enten 10 ml eller 25 ml koncentrat.
English: Does the patient have severe bradycardia, sinus node dysfunction or second and third degree heart block, in the absence of a pacemaker?
Danish: Har patienten svær bradykardi, sinusknudedysfunktion eller 2. grads og 3. grads AV-blok uden pacemaker?
English: Clinically significant adverse reactions observed in clinical trials included hypotension and ventricular arrhythmia.
Danish: Klinisk signifikante bivirkninger, der er set i kliniske undersøgelser, inkluderede hypotension og ventrikulær arytmi (se pkt.
English: Vernakalant was not found to be effective in converting typical primary atrial flutter to sinus rhythm.
Danish: Vernakalant blev ikke fundet effektivt til konvertering af typisk primær atrieflagren til sinusrytme.
English: Hypotension can occur in a small number of patients (vernakalant 5.7 %, placebo 5.5 % in the first 2 hours post-dose).
Danish: Hypotension kan forekomme hos et lille antal patienter (vernakalant 5,7%, placebo 5,5 % inden for de første 2 timer efter dosis).
English: These anti-fibrillatory actions on refractoriness and conduction are thought to suppress re-entry, and are potentiated in the atria during atrial fibrillation.
Danish: Disse antiarytmiske virkninger på den refraktære periode og overledning menes at hæmme re-entry, og de potenseres i atrierne under atrieflimren.
English: Within the clinical development program, oral maintenance antiarrhythmic therapy was halted for a minimum of 2 hours after vernakalant administration.
Danish: I det kliniske udviklingsprogram blev den orale vedligeholdelsesbehandling med antiarytmika pauseret i mindst 2 timer efter administration af vernakalant.