FrancophonIA/ELRC3.0 huggingface dataset:
English: MULTAQ film-coated tablets are supplied in packs of 20, 50, 60 tablets in opaque PVC and aluminium blisters and 100x1 tablets in opaque PVC and aluminium perforated unit dose blisters.
Danish: MULTAQ filmovertrukne tabletter fås i pakninger af 20, 50, 60 tabletter i matte PVC- og aluminiumsblister, og 100x1 tabletter fås i matte, perforerede PVC- og aluminium-endosisblister.
English: Interstitial lung disease including pneumonitis and pulmonary fibrosis (see below)
Danish: Interstitiel lungesygdom, herunder pneumonitis og lungefibrose (se nedenfor)
English: No dose adjustment is required in patients with mild or moderate hepatic impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendigt hos patienter med mildt eller moderat nedsat leverfunktion (se pkt.
English: Medicinal products inducing torsades de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, certain oral macrolides (such as erythromycin), terfenadine and Class I and III antiarrhythmics are contraindicated because of the potential risk of proarrhythmia (see section 4.3).
Danish: Lægemidler, der inducerer torsades de pointes såsom phenothiaziner, cisaprid, bepridil, tricykliske antidepressiva, visse orale makrolider såsom erythromycin, terfenadin og antiarytmika klasse I og III, er kontraindicerede på grund af den potentielle risiko for proarytmi (se pkt.
English: • If you are taking some medicines against blood clot formation such as warfarin, your doctor will order a blood test called INR to check how well your medicine is working.
Danish: • Hvis du tager medicin mod dannelse af blodpropper såsom warfarin, vil din læge bestille en blodprøve,
English: In clinical studies, premature discontinuation due to adverse reactions occurred in 11.8% of the dronedarone-treated patients and in 7.7% in the placebo-treated group.
Danish: I kliniske studier blev behandlingen afbrudt før afslutning på grund af bivirkninger hos 11,8 % af de patienter der blev behandlet med dronedaron, og hos 7,7 % af patienterne i placebogruppen.
English: Consequently, INR should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per their label.
Danish: Derfor skal INR monitoreres tæt efter opstart af dronedaron hos patienter, som tager vitamin K-antagonister i henhold til ordination.
English: The other ingredients in the tablet coat are hypromellose (E464), macrogol 6000, titanium dioxide (E171), carnauba wax (E903).
Danish: - Øvrige indholdsstoffer i filmovertrækket: hypromellose (E464), macrogol 6000, titandioxid (E171), carnaubavoks (E903).
English: • you have swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase (which are signs and symptoms of heart failure),
Danish: • du får hævede fødder eller ben, vejrtrækningsproblemer, når du ligger ned eller under søvn, åndenød, når du går, eller du tager på i vægt (hvilket er tegn og symptomer på hjertesvigt),
English: Signs include swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase.
Danish: Symptomer inkluderer hævede fødder eller ben, vejrtrækningsproblemer når du ligger ned eller sover, åndenød når du bevæger dig, eller vægtøgning.
English: Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposure.
Danish: Gentagne doser på 200 mg ketoconazol daglig resulterede i en 17-dobbelt stigning i dronedaron plasmakoncentrationen.
English: If patients treated with dronedarone develop permanent AF, treatment with dronedarone should be discontinued.
Danish: Hvis patienter, der behandles med dronedaron, udvikler permanent AF, skal dronedaron seponeres.
English: The digoxin dose should be reduced by approximately 50%, serum levels of digoxin should be closely monitored and clinical and ECG monitoring is recommended.
Danish: Digoxindosis bør reduceres med ca. 50 %, og niveauet af digoxin i serum bør monitoreres nøje.
English: - if you are allergic to dronedarone or to any of the other ingredients of this medicine (listed in section 6), - if you have a problem with the nerves in your heart (heart block).
Danish: Tag ikke MULTAQ: - hvis du er allergisk over for dronedaron eller et af de øvrige indholdsstoffer i MULTAQ (angivet i punkt 6), - hvis du har problemer med nerveimpulser i hjertet (grenblok).
English: Patients ranged in age from 23 to 97 years and 42% were over 75 years old.
Danish: Patienterne rangerede aldersmæssigt fra 23 til 97 år, og 42 % var over 75 år.
English: You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when moving around, - if the percentage of blood leaving your heart each time it contracts is too low (condition called left ventricular dysfunction), - if you took amiodarone (another antiarrhythmic medicine) previously and experienced lung or liver problems, - if you take medicines for infection (including fungal infection or AIDS), allergies, heart beat problems, depression, after a transplant (see section below on “Other medicines and MULTAQ”.
Danish: Du kan have hævede fødder eller ben, vejrtrækningsproblemer, når du ligger ned eller sover, eller du får åndenød, når du bevæger dig, - hvis den mængde blod, der forlader dit hjerte hver gang, det trækker sig sammen, er for lille (en tilstand, der kaldes systolisk dysfunktion af venstre ventrikel), - hvis du for nylig har taget amiodaron (et andet antiarytmika) og fået problemer med lungerne eller leveren, - hvis du tager medicin mod infektioner (inklusive svampeinfektioner eller AIDS), allergi, problemer med pulsslagene, depression, efter organtransplantation (se afsnittet nedenfor: ”Brug af anden medicin sammen med MULTAQ”, som giver dig flere præcise detaljer om, hvilken medicin du ikke må tage sammen med MULTAQ), - hvis du har en alvorlig leversygdom, - hvis du har en alvorlig nyresygdom, - hvis du tager dabigatran (se afsnittet ”Brug af anden medicin sammen med MULTAQ” nedenfor).
English: However, ability to drive and use machines may be affected by adverse reactions such as fatigue.
Danish: Dog kan evnen til at føre motorkøretøj og betjene maskiner påvirkes ved bivirkninger såsom træthed.
English: The study was stopped prematurely due to an observed imbalance of deaths in the dronedarone group [n = 25 versus 12 (placebo), p = 0.027] (see sections 4.3 and 4.4).
Danish: Studiet blev afsluttet før planlagt på grund af en observeret ubalance i dødsfald i dronedarongruppen over for placebogruppen [n= 25 mod 12 (placebo), p = 0,027] (se pkt.
English: Beta-blockers and calcium antagonists
Danish: Beta-blokkere og calciumantagonister
English: You should stop taking MULTAQ,
Danish: Du skal ophøre med at tage MULTAQ,
English: Patients ranged in age from 28 to 90 years, 49% were more than 65 years old.
Danish: Patienterne var i alderen 28 til 90 år, 49% var ældre end 65 år.
English: Dronedarone can increase exposure of statins that are substrates of CYP 3A4 and/or P-gp substrates.
Danish: Dronedaron kan øge plasmakoncentrationen af statiner, der er substrater for CYP3A4 og/eller P-gp.
English: Statins
Danish: Statiner
English: No interaction was observed between dronedarone and losartan and an interaction between dronedarone and other AIIRAs is not expected.
Danish: Losartan og andre Angiotensin II-Receptor-Antagonister (AIIRAer) Der blev ikke observeret nogen interaktion mellem dronedaron og losartan, og der forventes ikke interaktion mellem dronedaron og andre AIIRAer.
English: If you forget to take MULTAQ
Danish: Hvis du har glemt at tage MULTAQ
English: It is predicted that dronedarone could also increase the exposure of lovastatin within the same range as simvastatin acid.
Danish: Det formodes, at dronedaron kan øge plasmakoncentrationen af lovastatin og atorvastatin i samme størrelsesorden som af simvastatinsyre.
English: Hemangiomas are not precancerous changes and do not transform into malignant hemangiosarcomas in either animals or man. None of these observations was considered relevant for humans.
Danish: Hæmangiomer er ikke præcancer-forandringer og transformeres ikke til maligne hæmangiosarkomer hverken hos dyr eller mennesker.
English: Taking this medicine
Danish: Hvordan du skal tage medicinen
English: • other skin problems such as redness of the skin or eczema (redness, itching, burning or blistering),
Danish: • andre hudproblemer såsom hudrødme eller eksem (rødme, kløe, brændende fornemmelse eller blisterdannelse),
English: However due to presystemic first pass metabolism, the absolute bioavailability of dronedarone (given with food) is 15%.
Danish: Den absolutte biotilgængelighed af dronedaron (indgivet med føde) er dog grundet præsystemisk first-pass metabolisme 15 %.
English: The interaction of dronedarone on calcium antagonists is described above (see section 4.4).
Danish: Calciumantagonister Interaktionen mellem dronedaron og calciumantagonister er beskrevet ovenfor (se pkt 4.4).
English: Therefore, concomitant use of ketoconazole as well as other potent CYP 3A4 inhibitors such as itraconazole, voriconazole, pozaconazole, ritonavir, telithromycin, clarithromycin or nefazodone is contraindicated (see section 4.3).
Danish: Derfor er samtidig behandling med ketoconazol såvel som andre potente CYP3A4inhibitorer såsom itraconazol, voriconazol, pozaconazol, ritonavir, telithromycin, clarithromycin eller nefazodon kontraindiceret (se pkt.
English: In EURIDIS and ADONIS, a total of 1,237 patients with a prior episode of AF or AFL were randomised in an outpatient setting and treated with either dronedarone 400 mg twice daily (n = 828) or placebo (n = 409) on top of conventional therapies (including oral anticoagulants, beta-blockers, ACE inhibitors or AIIRAs, chronic antiplatelet agents, diuretics, statins, digitalis, and calcium antagonists).
Danish: I EURIDIS og ADONIS blev sammenlagt 1237 patienter med tidligere AF eller AFL randomiseret ambulant og behandlet med enten dronedaron 400 mg to gange daglig (n= 828) eller placebo (n= 409) foruden konventionel behandling (inklusive orale antikoagulantia, betablokkere, ACE-hæmmere eller AIIRA'er, kronisk antitrombotika, diuretika, statiner, digitalis og calciumantagonister).
English: If AF reoccurs, discontinuation of dronedarone should be considered.
Danish: Dersom AF opstår igen, bør seponering af dronedaron overvejes.
English: A synergistic effect on heart rate and atrioventricular conduction is also possible.
Danish: En synergistisk indvirkning på hjertefrekvensen og den atrioventrikulære overledning er også mulig.
English: Patients should be warned to avoid grapefruit juice beverages while taking dronedarone.
Danish: Grapefrugtjuice Patienter bør frarådes at drikke grapefrugtjuice under behandlingen med dronedaron.
English: Therefore, patients should be warned to avoid grapefruit juice beverages while taking dronedarone (see section 4.4).
Danish: Derfor bør patienter rådes til at undgå at drikke grapefrugtjuice under behandling med dronedaron (se pkt.
English: In animal models, dronedarone reduces the heart rate.
Danish: Dronedaron reducerer hjertefrekvensen i dyremodeller.
English: Patients ranged in age from 27 to 96 years, 68% were more than 65 years old.
Danish: Patienterne var i alderen 27 til 96 år, 68% var ældre end 65 år.
English: • Slow heart beat.
Danish: • langsom puls.
English: A synergistic effect on heart rate and atrio-ventricular conduction is possible.
Danish: En synergistisk effekt på hjertefrekvens og atrioventrikulær overledning er mulig.
English: Immunosupressants
Danish: Immunsuppressiva
English: Following oral administration in fed condition, dronedarone is well absorbed (at least 70%).
Danish: Dronedaron bliver godt optaget (mindst 70 %) efter oral administration i ikke-fastende tilstand.
English: The co-administration of beta-blockers or calcium antagonists with depressant effect on sinus and atrio-ventricular node should be undertaken with caution.
Danish: Samtidig administration af beta-blokkere eller calciumantagonister med hæmmende effekt på sinusknuden og atrioventrikulærknuden bør ske med forsigtighed.
English: • changes in the results of one blood test: your blood creatinine level,
Danish: • ændringer i resultatet af en blodprøve, der viser, hvor meget kreatinin du har i blodet,
English: Dronedarone (400 mg twice daily) increased digoxin exposure by 2.5-fold by inhibiting P-gp transporter.
Danish: Dronedaron (400 mg to gange daglig) øgede digoxin-plasmakoncentrationen 2,5 gange ved hæmning af Pgp-transporteren.
English: • nefazodone (a medicine for depression),
Danish: • nefazodon (medicin mod depression)
English: • one tablet with the morning meal and
Danish: • en tablet i forbindelse med et morgenmåltid og
English: Women of child bearing potential and pregnancy
Danish: Kvinder i den fertile alder og graviditet
English: No interaction was observed between dronedarone and metformin, an OCT1 and OCT2 substrate.
Danish: Interaktion med metformin (OCT1- og OCT2-substrat) Der sås ingen interaktion mellem dronedaron og metformin (et OCT1- og OCT2-substrat).
English: Your doctor may recommend that you use a medicine against blood clot formation according to your condition.
Danish: Alt efter din tilstand kan din læge anbefale, at du tager blodfortyndende medicin (mod dannelse af blodpropper).
English: • Your doctor will order blood tests to check your liver function before you start taking
Danish: • Din læge vil tage blodprøver for at tjekke din leverfunktion, før du begynder at tage MULTAQ samt under behandlingen.
English: Calcium antagonists also have their exposure increased by dronedarone (400 mg twice daily) (verapamil by 1.4-fold, and nisoldipine by 1.5-fold).
Danish: Plasmakoncentrationen af calciumantagonister øges også af dronedaron (400 mg to gange daglig) (verapamil med 1,4 gange og nisoldipin 1,5 gange).
English: 5.2 Pharmacokinetic properties
Danish: 5.2 Farmakokinetiske egenskaber Absorption
English: Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience.
Danish: Tilfælde af institiel lungesygdom, herunder pneumonitis og lungefibrose, er rapporteret efter markedsføring.
English: Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience (frequency not known).
Danish: Der er rapporteret tilfælde af interstitiel lungesygdom, herunder pneumonitis og lungefibrose efter markedsføringen (ikke kendt frekvens).
English: Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
Danish: Hver filmovertrukken tablet indeholder 400 mg dronedaron (som hydrochlorid).
English: Hypromellose (E464) Maize starch
Danish: Hypromellose (E464) Majsstivelse
English: • Severe renal impairment (CrCl <30 ml/min)
Danish: • Alvorligt nedsat nyrefunktion (kreatininclearance <30 ml/min.)
English: Dronedarone (400 mg twice daily) increased simvastatin and simvastatin acid exposure by 4-fold and 2-fold respectively.
Danish: Dronedaron (400 mg to gange daglig) øgede plasmakoncentrationen af simvastatin og simvastatinsyre henholdsvis 4 og 2 gange.
English: The study was prematurely stopped after randomization of 3,149 patients (placebo = 1,577; dronedarone = 1,572) due to the significant increase in heart failure (placebo = 33; dronedarone = 80; HR = 2.49 (1.66-3.74)]; stroke [placebo = 8; dronedarone = 17; HR = 2.14 (0.92-4.96)] and cardiovascular death [placebo = 6; dronedarone = 15; HR = 2.53 (0.98-6.53)] (see sections 4.3 and 4.4).
Danish: Studiet blev stoppet før tid efter randomisering af 3.149 patienter (placebo = 1.577, dronedaron = 1.572) på grund af signifikant forøgelse af hjerteinsufficiens (placebo = 33, dronedaron = 80, HR = 2,49 (1,66-3,74), apopleksi [placebo = 8,
English: • Inflammation of the lungs (including scarring and thickening of the lungs).
Danish: • inflammation (betændelsesagtig tilstand) i lungerne (med dannelse af arvæv og fortykkelse af lungerne).
English: What you need to know before you take MULTAQ
Danish: Det skal du vide, før du begynder at tage MULTAQ
English: Other moderate inhibitors of CYP3A4 are also likely to increase dronedarone exposure.
Danish: Andre moderate hæmmere af CYP3A4 Andre moderate hæmmere af CYP3A4 kan sandsynligvis også øge dronedarons plasmakoncentration.
English: • one tablet during your evening meal.
Danish: • én tablet i forbindelse med dit aftensmåltid.
English: In clinical studies, increased levels of digitalis and/or gastrointestinal disorders indicating digitalis toxicity were observed when dronedarone was co-administered with digitalis.
Danish: I kliniske studier hvor dronedaron blev givet sammen med digitalis, blev der observeret et øget niveau af digitalis og/eller en stigning i gastrointestinale forstyrrelser, hvilket indikerer digitalistoksicitet.
English: Abdominal pain Dyspepsia
Danish: Abdominalsmerter Dyspepsi
English: Overall, due to the pharmacokinetic interaction and possible pharmacodynamic interaction, calcium antagonists with depressant effects on sinus and atrio-ventricular node such as verapamil and diltiazem should be used with caution when associated with dronedarone.
Danish: På grund af den farmakokinetiske interaktion og mulige farmakodynamiske interaktion, bør calciumantagonister med nedsættende effekt på sinus- og atrioventrikulærknude, såsom verapamil og diltiazem, samlet set anvendes med forsigtighed i forbindelse med dronedaron.
English: If you stop taking MULTAQ Do not stop taking this medicine without first talking to your doctor or pharmacist.
Danish: Du må ikke holde op med at tage medicinen uden først at tale med din læge eller spørge på apoteket.
English: Repeated doses of 300 ml of grapefruit juice three times daily resulted in a 3-fold increase in dronedarone exposure.
Danish: Gentagne doser grapefrugtjuice på 300 ml tre gange daglig resulterede i en 3-dobbelt stigning i dronedaronplasmakoncentrationen.
English: Clinical, ECG and biological monitoring is recommended, and digoxin dose should be halved (see section 4.4).
Danish: Klinisk set er EKG og biologisk overvågning anbefalet, og doseringen af digoxin bør halveres (se pkt.
English: Signs include stomach (abdominal) area pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other symptoms listed above), itching.
Danish: Symptomer inkluderer smerte eller ubehag i maveregion, manglende appetit, kvalme, opkastning, gulfarvning af hud eller det hvide af øjnene (gulsot), ualmindelig mørkfarvning af urin, træthed (særligt i forbindelse med symptomer anført ovenfor), kløe.
English: Potent CYP3A4 inducers such as rifampicin, phenobarbital, carbamazepine, phenytoin or St John's Wort are not recommended.
Danish: Potente CYP3A4-induktorer såsom rifampicin, phenobarbital, carbamazapin, phenytoin eller perikon bør ikke anvendes.
English: itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir (see section 4.5)
Danish: posaconazol, telithromycin, clarithromycin, nefazodon og ritonavir (se pkt.
English: Interaction with P-gp substrates Digoxin
Danish: Interaktion med P-gp substrat
English: These medicinal products should be initiated at low dose and up-titration should be done only after ECG assessment.
Danish: Disse lægemidler bør initieres ved lav dosis, og optitrering bør først ske efter ekg-evaluering.
English: Interaction with medicinal products metabolised by CYP 2D6 Beta-blockers
Danish: Interaktion med lægemidler der metaboliseres af CYP2D6
English: Take the next dose when you are normally due to take it.
Danish: Tag den næste dosis som planlagt.
English: The safety profile of dronedarone 400 mg twice daily in patients with atrial fibrillation (AF) or atrial flutter (AFL) is based on 5 placebo controlled studies, in which a total of 6,285 patients were randomised (3,282 patients received dronedarone 400 mg twice daily, and 2,875 received placebo).
Danish: Sikkerhedsprofilen af dronedaron 400 mg to gange daglig hos patienter med atrieflimren (AF) eller atrieflagren (AFL) er baseret på 5 placebokontrollerede studier, hvor 6285 patienter blev randomiseret (3282
English: Lower starting dose and maintenance doses of statins should be considered according to the statin label recommendations and patients monitored for clinical signs of muscular toxicity (see section 4.4).
Danish: Der bør overvejes lavere start- og vedligeholdelsesdoser af statiner i overensstemmelse med statinets produktinformation, og patienterne bør monitoreres for kliniske tegn på muskeltoksicitet (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 400 mg dronedarone (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 400 mg dronedaron (som hydrochlorid).
English: This rate should be considered in the context of the underlying elevated incidence of CHF in AF patients.
Danish: Denne hyppighed skal ses i sammenhæng med den underliggende øgede forekomst af kongestiv hjerteinsufficiens hos AFpatienter.
English: The other ingredients in the tablet core are hypromellose (E464), maize starch, crospovidone (E1202), poloxamer 407, lactose monohydrate (see section 2 under ‘MULTAQ contains lactose'), colloidal anhydrous silica, magnesium stearate (E572).
Danish: - Øvrige indholdsstoffer i tabletkernen: hypromellose (E464), majsstivelse, crospovidon (E1202), poloxamer 407, lactosemonohydrat (se pkt.
English: The PALLAS study was a randomised placebo-controlled study investigating the clinical benefit of dronedarone 400 mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors (patients with congestive heart failure ~ 69%, coronary heart disease ~ 41%, prior stroke or TIA ~ 27%; LVEF ≤40% ~ 20.7% and patients ≥75 years with hypertension and diabetes ~ 18%).
Danish: PALLAS-studiet var et randomiseret, placebokontrolleret studie, der undersøgte den kliniske fordel ved dronedaron 400 mg 2 gange daglig som supplement til standardbehandling hos patienter med permanent atrieflimren og yderligere risikofaktorer (patienter med kongestiv hjerteinsufficiens ~ 69%, hjertekarsygdom ~ 41%, tidligere apopleksi eller transitorisk cerebral iskæmi ~ 27%, venstre ventrikel ejektionsfraktion ≤40%
English: The incidence of the main safety endpoint defined as the occurrence of thyroid, hepatic, pulmonary, neurological, skin, eye or gastrointestinal specific events or premature study drug discontinuation following any adverse event was reduced by 20% in the dronedarone group compared to the amiodarone group (p = 0.129).
Danish: Forekomsten af hovedendepunktet med henblik på sikkerhed, defineret som forekomst af for tidlig seponering af studielægemiddel på grund af en vilkårlig bivirkning, eller forekomsten af bivirkninger i thyreoidea, lever, lunger, nervesystemet, hud, øjne eller i mavetarmkanalen, blev reduceret med 20% i dronedarongruppen sammenlignet med amiodarongruppen (p=0,129).
English: Crospovidone (E1202) Poloxamer 407
Danish: Crospovidon (E1202)
English: • one tablet during your morning meal and
Danish: • én tablet i forbindelse med dit morgenmåltid og
English: Dronedarone is extensively metabolised, mainly by CYP 3A4 (see section 4.5).
Danish: Dronedaron bliver metaboliseret i høj grad, primært af CYP3A4 (se pkt.
English: In the 5 placebo controlled studies, 0.6% of patients in the dronedarone group had pulmonary events versus 0.8% of patients receiving placebo.
Danish: Interstitiel lungesygdom inklusiv pneumoni og lungefibrose I de 5 placebokontrollerede studier fik 0,6 % af patienterne i dronedaron-gruppen lungeproblemer versus 0,8 % af de patienter, der fik placebo.
English: Hepatocellular liver injury, including life-threatening acute liver failure, has been reported in patients treated with dronedarone in the post-marketing setting.
Danish: Efter markedsføring er der indberettet hepatocellulære leverskader, herunder livstruende akut leverinsufficiens, hos patienter i behandling med dronedaron.
English: Interactions (see section 4.5)
Danish: Interaktioner (se pkt.
English: • one tablet with the evening meal.
Danish: • en tablet i forbindelse med et aftensmåltid.