FrancophonIA/ELRC3.0 huggingface dataset:
English: It prolongs Wenckebach cycle length and AH-, PQ-, QT- intervals; with no marked effect or weak increase on QTc-intervals, and with no change in HV- and QRS- intervals.
Danish: Det forlænger Wenckebach-cyklus, PQ- og QTintervallerne uden markant effekt eller mindre forøgelse af QTc-intervaller og uden ændring i QRS-bredden.
English: Dronedarone is a multichannel blocker inhibiting the potassium currents (including IK(Ach), IKur, IKr, IKs) and thus prolonging cardiac action potential and refractory periods (Class III).
Danish: Dronedaron er en multikanalblokker, der hæmmer kaliumstrømmen (inklusive IK (Ach), IKur, IKr, IKs) og dermed forlænger hjertets aktionspotentiale og refraktære perioder (klasse III).
English: • change in the results of blood tests used to check your liver function.
Danish: • ændring i resultaterne af blodprøver til kontrol af din leverfunktion.
English: • losing your sense of taste,
Danish: • tab af smagssans,
English: Take:
Danish: Tag:
English: Some adverse reactions were also identified during post-marketing surveillance.
Danish: Nogle bivirkninger blev også identifiseret ved bivirkningsovervågning efter markedsføring.
English: The safety and efficacy of MULTAQ in children aged below 18 years of age have not yet been established.
Danish: Pædiatrisk population MULTAQs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: MULTAQ does not usually affect your ability to drive or use machine.
Danish: MULTAQ påvirker normalt ikke evnen til at køre bil og bruge maskiner.
English: In ESC and ACC/AHA/HRS guidelines dronedarone has a class IA recommendation in patients with paroxysmal/persistent AF and coronary artery disease.
Danish: I ESC og ACC/AHA/HRS retningslinjer har dronedaron en klasse IA anbefaling hos patienter med paroksysmatisk/vedvarende AF og koronararteriesygdom.
English: This metabolite contributes to the pharmacological activity of dronedarone in humans.
Danish: Denne metabolit medvirker til den farmakologiske aktivitet af dronedaron hos mennesker.
English: Larger increases in creatinine after dronedarone initiation have been reported in the post-marketing setting.
Danish: Større kreatininstigninger efter initiering af dronedaron er blevet rapporteret efter markedsføring.
English: Careful monitoring during dronedarone administration is recommended by regular assessment of cardiac, hepatic and pulmonary function (see below).
Danish: Omhyggelig monitorering under dronedaron-behandling anbefales med jævnlig vurdering af hjerte-, leverog lungefunktion (se nedenfor).
English: In permanent AF, the AF has been present for a long time (at least during 6 months) and a decision has been made not to change back your heart rhythm to atrial normal rhythm with a treatment called cardioversion, - if you have instability (drops) in your blood pressure which can lead to inadequate arterial blood flow to your organs,
Danish: Ved permanent AF har AF været til stede længe (mindst 6 måneder), og der er truffet beslutning om ikke at ændre din hjerterytme tilbage til normal rytme med kardiovertering, - hvis du har ustabilitet (”fald”) i dit blodtryk som kan føre til utilstrækkelig arterielt blodcirklation i dine organer.
English: More gastrointestinal adverse events, mainly diarrhoea, were observed in the dronedarone group (12.9% versus 5.1%).
Danish: Flere gastrointestinale bivirkninger, primært diarré, blev observeret i dronedarongruppen (12,9% mod 5,1%).
English: Figure 1 - Relative risk (dronedarone 400 mg twice daily versus placebo) - first cardiovascular hospitalisation or death from any cause.
Danish: Figur 1 - Relative risiko-(dronedaron 400 mg to gange daglig versus placebo) - første hospitalsindlæggelse af kardiovaskulære årsager eller død af vilkårlig årsag.
English: Treatment should be initiated and monitored only under specialist supervision (see section 4.4).
Danish: Behandlingen bør kun initieres og monitoreres under supervision af en specialist (se pkt.
English: If alanine aminotransferase (ALT) levels are elevated ≥3 × upper limit of normal (ULN), ALT levels should be re-measured within 48 to 72 hours.
Danish: Hvis ALAT-niveauet stiger til ≥3 × den øvre grænse af referenceintervallet (ULN), skal ALAT-niveauet måles på ny inden for 48 til 72 timer.
English: • sirolimus, tacrolimus, everolimus and cyclosporine (used after a transplant),
Danish: • sirolimus, tacrolimus, everolimus og ciclosporin (anvendes efter organtransplantation),
English: • QTc Bazett interval ≥500 milliseconds
Danish: • QTc-interval (Bazett-korrigeret) ≥500 millisekunder
English: • some medicines for depression called tricyclic antidepressants,
Danish: • visse typer medicin mod depression, som kaldes tricykliske antidepressiva,
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og enhver efterfølgende opdatering offentliggjort på den europæiske webportal for lægemidler.
English: Effect of other medicinal products on dronedarone
Danish: Effekt af andre lægemidler på dronedaron
English: Concomitant intake of food increases dronedarone bioavailability by on average 2- to 4-fold.
Danish: Samtidigt fødeindtag øger biotilgængeligheden af dronedaron gennemsnitligt 2-4 gange.
English: If serum creatinine continues to rise then consideration should be given to further investigation and discontinuing treatment.
Danish: Hvis serumkreatinin fortsætter med at stige, bør det overvejes at undersøge dette nærmere og at seponere behandlingen.
English: This reduction was driven by the occurrence of significantly fewer thyroid and neurological events and a trend for less skin or ocular events, and fewer premature study drug discontinuations compared to the amiodarone group.
Danish: Denne reduktion blev drevet af forekomst af signifikant færre thyroide- og neurologiske hændelser, og en trend for færre hændelser i hud og øjne, samt færre tidlige seponeringer af studielægemiddel sammenlignet med amiodarongruppen.
English: The usual dose is one 400 mg tablet twice a day.
Danish: Den sædvanlige dosis er en tablet af 400 mg to gange daglig.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product.
Danish: Patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (total lactase deficiency) eller glucose/galactosemalabsorption, bør ikke anvende dette lægemiddel.
English: The major metabolic pathway includes N-debutylation to form the main circulating active metabolite followed by oxidation, oxidative deamination to form the inactive propanoic acid metabolite, followed by oxidation, and direct oxidation.
Danish: Den primære metaboliseringsvej inkluderer N-debutylering, der danner den primære, cirkulerende, aktive metabolit, efterfulgt af oxidering og oxidativ deaminering, der danner den inaktive propansyremetabolit, efterfulgt af oxidering og direkte oxidering.
English: Dronedarone and/or its metabolites also have been shown to inhibit transport proteins of the Organic Anion Transporter (OAT), Organic Anion Transporting Polypeptide (OATP) and Organic Cation Transporter (OCT) families in vitro.
Danish: Det er blevet vist, at dronedaron og/eller dets metabolitter også inhiberer følgende transportproteiner: organisk aniontransportere (OAT), organisk anion-transport-polypeptider (OATP) og organisk kation-transportere (OCT) in vitro.
English: Hypromellose (E464) Macrogol 6000
Danish: Tabletovertræk Hypromellose (E464) Macrogol 6000
English: The most common co-morbidities were hypertension (56.8%) and structural heart disease (41.5%) including coronary heart disease (21.8%).
Danish: De mest almindelige komorbiditeter var hypertension (56,8%) og strukturel hjertesygdom (41,5%) inklusive koronar hjertesygdom.
English: Since antiarrhythmic medicinal products may be ineffective or may be arrhythmogenic in patients with hypokalaemia, any potassium or magnesium deficiency should be corrected before initiation and during dronedarone therapy.
Danish: Da antiarytmiske lægemidler kan være ineffektive eller kan medføre arytmier hos patienter med hypokaliæmi, bør enhver kalium- eller magnesiummangel korrigeres inden påbegyndelse og under behandling med dronedaron.
English: Do not drink grapefruit juice while taking MULTAQ.
Danish: Du må ikke drikke grapefrugtjuice, når du er i behandling med MULTAQ.
English: • changes in your ECG (electrocardiogram) called QTc Bazett prolonged.
Danish: • ændringer i dit ekg (elektrokardiogram) kaldet langvarig QTc Bazett.
English: quinidine, disopyramide, dofetilide, sotalol, amiodarone,
Danish: propafenon, quinidin, disopyramid, dofetilid, sotalol, amiodaron,
English: Talk to your doctor or pharmacist before taking MULTAQ if
Danish: Kontakt lægen eller apotekspersonalet, før du tager MULTAQ, hvis
English: MULTAQ prevents repetition of your problem of irregular heart rhythm.
Danish: MULTAQ forebygger gentagelse af lidelsen med uregelmæssig hjerterytme.
English: • Liver problems including life threatening liver failure.
Danish: • leverproblemer inklusive livstruende leversvigt.
English: The mean exposure of the N-debutyl metabolite is decreased by 47% (see section 4.2).
Danish: Den gennemsnitlige eksponering af N-debutyl metabolit blev nedsat med 47 % (se pkt.
English: It is recommended to swallow the tablet whole with a drink of water during a meal.
Danish: Det anbefales, at synke tabletten hel med et glas vand i forbindelse med et måltid.
English: Antidepressants
Danish: Antidepressiva
English: Based on clinical experience, dronedarone has a low pro-arrhythmic effect and has shown a decrease in arrhythmic death in the ATHENA study (see section 5.1).
Danish: Baseret på klinisk erfaring, har dronedaron en lav proarytmisk effekt og har demonstreret en reduktion i arytmisk død i ATHENA-studiet (se pkt.
English: Medicinal products inducing torsades de pointes
Danish: Lægemidler der inducerer torsades de pointes
English: Dronedarone caused marked effects on embryo-foetal development at high doses in rats, such as increased post-implantation losses, reduced foetal and placental weights, and external, visceral and skeletal malformations.
Danish: Dronedaron medførte udprægede effekter på embryo-føtal udvikling ved høje doser i rotter, såsom øget afstødning af implantater, reduceret vægt af foster og placenta, samt eksterne viscerale og skeletale misdannelser.
English: - if you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure).
Danish: - hvis du har eller har haft en lidelse, hvor hjertet ikke kan pumpe blodet rundt i kroppen, så godt som det burde (en tilstand, der kaldes hjertesvigt).
English: • Stop taking your tablets and talk to your doctor straight away if you get pregnant while taking
Danish: • Du skal stoppe med at tage dine tabletter og straks tale med din læge, hvis du bliver gravid, mens du er i behandling med MULTAQ.
English: However, clinically significant INR elevations (≥5) usually within 1 week after starting dronedarone were reported in patients taking oral anticoagulants.
Danish: Klinisk signifikante INR-stigninger (≥5), som regel inden for 1 uge efter opstart af dronedaron, blev imidlertid rapporteret hos patienter, som tog orale antikoagulantia.
English: See leaflet for further information.
Danish: Læs indlægssedlen for at få mere information.
English: • Diarrhoea, vomiting when excessive as it can lead to kidney problems.
Danish: • diarré, udtalt opkastning, da det kan føre til nyreproblemer,
English: The most common reasons for discontinuation of therapy with dronedarone were gastrointestinal disorders (3.2% of patients versus 1.8% in the placebo group).
Danish: De hyppigste årsager til ophør af behandlingen med dronedaron var gastrointestinale forstyrrelser (3,2 % af patienter mod 1,8 % i placebogruppen).
English: If you have had a pacemaker fitted for this problem, you can use MULTAQ, - if you have a very slow heart beat (less than 50 beats a minute), - if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” (this interval is more than 500 milliseconds), - if you have a type of atrial fibrillation called permanent atrial fibrillation (AF).
Danish: Hvis du har fået indopereret en pacemaker for dette problem, kan du anvende MULTAQ, - hvis du har meget lav puls (under 50 slag pr. minut), - hvis dit ekg (elektrokardiogram) viser et hjerteproblem, der kaldes ”forlænget QT-korrigeret interval” (intervallet er længere end 500 millisekunder), - hvis du har en type atrieflimren, der kaldes permanent atrieflimren (AF).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dronedarone and its metabolites in milk.
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at dronedaron og dets metabolit udskilles i mælk.
English: The most frequent adverse reactions observed with dronedarone 400 mg twice daily in the 5 studies were diarrhoea (9%), nausea (5%) and vomiting (2%), fatigue and asthenia (7%).
Danish: Den hyppigst observerede bivirkning ved dronedaron 400 mg to gange daglig i de 5 studier var diarré (9%), kvalme (5%) og opkastning (2%), træthed og asteni (7%).
English: Patients ranged in age from 20 to 88 years, with the majority being Caucasian (97%), male (69%) patients.
Danish: Patienterne rangerede i alderen fra 20 til 88 år, heraf var størstedelen af kaukasisk afstamning (97%), mænd (69%).
English: The in vitro plasma protein binding of dronedarone and its N-debutyl metabolite is 99.7% and 98.5% respectively and is not saturable.
Danish: Dronedaron og dets N-debutylmetabolits in vitro-plasmaproteinbinding er henholdsvis 99,7 % og 98, 5 %, og er ikke mætbar.
English: • Do not take MULTAQ if you are a woman able to have children and you are not using a reliable contraceptive method.
Danish: • Du må ikke tage MULTAQ, hvis du er kvinde i den fødedygtige alder, og du ikke anvender pålidelig prævention.
English: • change in how things taste.
Danish: • ændringer i smagssansen.
English: Patients with symptoms of heart failure at rest or with minimal exertion within the previous month or who were hospitalised for heart failure during the previous month
Danish: Patienter med symptomer på hjerteinsufficiens under hvile eller under minimal fysisk anstrengelse inden for den foregående måned, eller patienter der har været indlagt for hjerteinsufficiens inden for den foregående måned.
English: It increases effective refractory periods (ERP) of the atrium, atrio-ventricular node, and ventricular ERP was slightly prolonged with a minimal degree of reverse frequency dependency.
Danish: Det øger effektive refraktære perioder (ERP) af atriet, atrioventrikulæreknude-ERP, og ventrikulær ERP med minimal grad af omvendt frekvensafhængighed.
English: Renal impairment is not expected to modify the pharmacokinetics of dronedarone because no unchanged compound was excreted in urine and only approximately 6% of the dose was excreted in urine as metabolites (see section 4.2).
Danish: Nedsat nyrefunktion forventes ikke at ændre dronedarons farmakokinetik, da intet uændret stof blev udskillet i urinen, og kun ca. 6 % af dosis blev udskillet i urinen som metabolitter (se pkt.
English: Some cases also reported increases in blood urea nitrogen possibly due to hypoperfusion secondary to developing CHF (pre-renal azotaemia).
Danish: I visse tilfælde rapporteredes også forhøjet blod urea nitrogen sandsynligvis pga. hypoperfusion sekundært til udvikling af hjerteinsufficiens (præ-renal azotæmi).
English: • dabigatran (a medicine for prevention of blood clot formation).
Danish: • dabigatran (medicin til forebyggelse af blodpropper).
English: The pharmacological action of dronedarone may induce a moderate QTc Bazett prolongation (about 10 msec), related to prolonged repolarisation.
Danish: Den farmakologiske effekt af dronedaron kan inducere en moderat forlængelse (ca. 10 millisekunder) af QTc Bazett interval, relateret til den forlængede repolarisering.
English: It is not known whether dronedarone and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).
Danish: Det er ukendt, hvorvidt dronedaron og/eller dets metabolitter kan fjernes ved dialyse (hæmodialyse, peritonealdialyse eller hæmofiltrering).
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis din læge har fortalt dig, at du ikke tåler visse sukkerarter, skal du tale med din læge, inden du tager dette lægemiddel.
English: Patients were to have at least one risk factor (including age, hypertension, diabetes, prior cerebrovascular accident, left atrium diameter ≥50 mm or LVEF <0.40) together with AF/AFL and sinus rhythm both documented within the last 6 months.
Danish: Patienter skulle have mindst én risikofaktor (inklusive alder, hypertension, diabetes, tidligere cerebrovaskulær hændelse, diameter af venstre forkammer ≥50 mm eller LVEF < 0,40), sammen med AF/AFL og sinusrytme, begge dokumenteret inden for de sidste 6 måneder.
English: • other medicines for high blood pressure, for chest pain caused by heart disease, or other heart problems, such as verapamil, diltiazem, nifedipine, metoprolol, propranolol or digoxin,
Danish: • anden medicin mod forhøjet blodtryk, mod brystsmerter pga. hjertesygdom eller andre hjerteproblemer, såsom verapamil, diltiazem, nifedipin, metoprolol, propranol eller digoxin,
English: The effect of renal impairment on dronedarone pharmacokinetics has not been evaluated in a specific study.
Danish: Effekten af nedsat nyrefunktion på dronedarons farmakokinetik er ikke blevet undersøgt i et specifikt studie.
English: You must tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Du skal fortælle det til lægen eller sige det på apoteket, hvis du tager noget af følgende medicin:
English: As compared to placebo, dronedarone lowered the risk of first AF/AFL recurrence during the 12-month study period by 25% (p = 0.00007).
Danish: Sammenlignet med placebo sænkede dronedaron risikoen for første tilbagevenden af AF/AFL i løbet af de 12 måneder studierne varede med 25% (p= 0,00007).
English: MULTAQ must not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.
Danish: MULTAQ må ikke gives til patienter med systolisk dysfunktion af venstre ventrikel eller til patienter med eksisterende eller tidligere episoder af hjerteinsufficiens.
English: a Determined from Cox regression model b P-value of interaction between baseline characteristics and treatment based on Cox regression model c Calcium antagonists with heart rate lowering effects restricted to diltiazem, verapamil and bepridil
Danish: a: Bestemt ud fra Cox regressionsmodel b: P-værdi af interaktion mellem baselinekarakteristika og behandling baseret på Cox regressionsmodel c: Calciumantagonister med nedsættende effekt på hjertefrekvensen begrænset til diltiazem, verapamil og bepridil
English: Patients with permanent atrial fibrillation
Danish: Patienter med permanent atrieflimren
English: Patients should be advised to consult a physician if they develop or experience signs or symptoms of heart failure, such as weight gain, dependent oedema, or increased dyspnoea.
Danish: Patienterne skal informeres om at kontakte en læge, hvis de udvikler eller oplever tegn eller symptomer på hjerteinsufficiens, såsom vægtøgning, behandlingsrelateret ødem eller forværret dyspnø.
English: No decreases in ethinylestradiol and levonorgestrel were observed in healthy subjects receiving dronedarone (800 mg twice daily) concomitantly with oral contraceptives.
Danish: Der blev ikke observeret fald i ethinylestradiol og levonorgestrel hos raske forsøgspersoner, der modtog dronedaron (800 mg to gange daglig) samtidigt med orale kontraceptiva.
English: A number of patients had been previously exposed to amiodarone (see section 4.4).
Danish: En antal patienter havde tidligere været eksponeret for amiodaron (se pkt.
English: The reduction in cardiovascular hospitalisation or death from any cause was consistent in all subgroups, irrespective of baseline characteristics or medicinal products (ACE inhibitors or AIIRAs; beta-blockers, digitalis, statins, calcium antagonists, diuretics) (see figure 1).
Danish: Reduktionen i kardiovaskulær indlæggelse eller død af vilkårlig årsag var konsistent i alle undergrupper, uanset baseline-karakteristika eller lægemidler (ACE-hæmmere eller AIIRA'er; beta-blokkere, digitalis, statiner, calciumantagonister, diuretika) (se figur 1).
English: There was a weak interaction between dronedarone and statins transported by OATP, such as rosuvastatin (which resulted in a mean 1.4-fold increase in rosuvastatin exposure).
Danish: Der var en svag interaktion mellem dronedaron og statiner transporteret af OATP, såsom rosuvastatin (hvilket resulterede i en 1,4-fold stigning i rosuvastatins plasmakoncentration).
English: An increase in creatininaemia should not necessarily lead to the discontinuation of treatment with ACE inhibitors or Angiotensin II Receptors Antagonists (AIIRAs).
Danish: Stigning i kreatinin bør ikke nødvendigvis føre til seponering af ACE-hæmmere eller angiotensin IIreceptorantagonister (AIIRAer).
English: Erythromycin, an oral macrolide, may induce torsades de pointes and, as such, is contraindicated (see section 4.3).
Danish: Erythromycin, et oralt makrolid, kan inducere torsades de pointes og er derfor kontraindiceret (se pkt.
English: Patients should be followed for the development of left ventricular systolic dysfunction during treatment.
Danish: Patienterne skal følges for udvikling af systolisk dysfunktion af venstre ventrikel under behandlingen.
English: In patients aged 65 years of age and over, dronedarone exposures are 23% higher in comparison with patients aged below 65 years of age.
Danish: Hos patienter i alderen 65 år eller over er plasmakoncentrationen af dronedaron 23 % højere sammenlignet med patienter under 65 år.
English: The terminal elimination half-life of dronedarone is around 25-30 hours and that of its N-debutyl metabolite around 20-25 hours.
Danish: Halveringstiden for den terminale elimination af dronedaron er ca. 25-30 timer og 20-25 timer for dets N-debutylmetabolit.
English: After intravenous administration the plasma clearance of dronedarone ranges from 130 to 150 L/h.
Danish: Efter intravenøs administration er plasmaclearance mellem 130 og 150 L/t.
English: In patients with coronary artery disease, clinical signs of heart failure and ECG should be regularly monitored to detect early signs of heart failure.
Danish: Hos patienter med koronararteriesygdom, skal kliniske tegn på hjerteinsufficiens og EKG overvåges regelmæssigt for at påvise tidlige tegn på hjerteinsufficiens.
English: EU/1/09/591/001 20 film-coated tablets EU/1/09/591/002 50 film-coated tablets EU/1/09/591/003 60 film-coated tablets EU/1/09/591/004 100x1 film-coated tablets
Danish: EU/1/09/591/001 20 filmovertrukne tabletter EU/1/09/591/002 50 filmovertrukne tabletter EU/1/09/591/003 60 filmovertrukne tabletter EU/1/09/591/004 100x1 filmovertrukne tabletter
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MULTAQ therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med MULTAQ skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: MULTAQ contains an active substance named dronedarone.
Danish: MULTAQ indeholder et aktivt stof, der hedder dronedaron.
English: Erythemas (including erythema and rash erythematous) Eczema
Danish: Erytem (inklusive erytema og erytematøst udslæt) Eksem
English: • other medicines used to control an irregular or fast heart beat such as flecainide, propafenone,
Danish: • anden medicin der bruges til at behandle uregelmæssige eller hurtige hjerteslag såsom flecainid,