FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of dronedarone and its N-debutyl metabolite both deviate moderately from dose proportionality: a 2-fold increase in dose results in an approximate 2.5- to 3.0-fold increase with respect to Cmax and AUC.
Danish: Farmakokinetikken for dronedaron og dets Ndebutylmetabolit afviger begge moderat fra dosisproportionalitet: En fordobling af dosis resulterer i en stigning på ca. 2,5-3 gange i Cmax og AUC.
English: In animals, dronedarone prevents atrial fibrillation or restores normal sinus rhythm depending on the model used.
Danish: Dronedaron forebygger atrieflimren eller genskaber normal sinusrytme i dyr, afhængigt af den anvendte model.
English: Dronedarone has no significant potential to inhibit CYP 1A2, CYP 2C9, CYP 2C19, CYP 2C8 and CYP 2B6.
Danish: Dronedaron besidder intet særligt potentiale til at inhibere CYP1A2, CYP2C9, CYP2C19, CYP2C8 eller CYP2B6.
English: In an in vitro study MAO contributed to the metabolism of the active metabolite of dronedarone.
Danish: I et in vitro-studie bidrog MAO til metabolismen af dronedarons aktive metabolit.
English: Cardiac disorders Congestive heart failure (see below)
Danish: Kongestiv hjerteinsufficiens (se nedenfor)
English: Observations were increased incidence of mammary gland tumors in female mice, histiocytic sarcomas in mice and hemangiomas at the mesenteric lymph node level in rats, all at the highest tested dose only (corresponding to an exposure of 5 to 10 times that of the human therapeutic dose).
Danish: Der observeredes øget forekomst af tumorer i mælkekirtler hos hunmus, histiocytiske sarkomer hos mus og hæmangiomer på mesenterial lymfeknudeniveau hos rotter, alle udelukkende ved højeste testede dosis (svarende til en plasmakoncentration på 5-10 gange terapeutisk dosis hos mennesker).
English: After repeated administration of 400 mg twice daily, steady state is reached within 4 to 8 days of treatment and the mean accumulation ratio for dronedarone ranges from 2.6 to 4.5.
Danish: Efter gentagen administration af 400 mg to gange daglig opnås steady-state inden for 4-8 dage, og den gennemsnitlige akkumulationsrate for dronedaron går fra 2,6 til 4,5.
English: Patients with coronary artery disease
Danish: Patienter med koronararteriesygdom
English: In clinical studies, 13% of patients received calcium antagonists concomitantly with dronedarone.
Danish: I kliniske studier fik 13 % af patienterne calciumantagonister samtidigt med dronedaron.
English: However, your ability to drive and use machines may be affected by side effects such as tiredness.
Danish: Dog kan din evne til at køre bil og bruge maskiner påvirkes af bivirkninger som træthed.
English: Since dronedarone is a weak inhibitor of CYP 2D6 in humans, it is predicted to have limited interaction on antidepressant medicinal products metabolised by CYP 2D6.
Danish: Da dronedaron er en svag inhibitor af CYP2D6 i mennesker, antages dronedaron i begrænset omfang at interagere med antidepressiva der metaboliseres af CYP2D6.
English: • some medicines against blood clot formation such as warfarin,
Danish: • visse typer medicin mod blodpropper såsom warfarin,
English: In chronic toxicity studies, slight and reversible phospholipidosis (accumulation of foamy macrophages) was observed in mesenteric lymph nodes mainly in the rat.
Danish: I studier om kronisk toksicitet, blev der observeret en mindre reversibel fosfolipidose (akkumulation af skumlignende makrofager) i mesenterale lymfeknuder, hovedsageligt i rotter.
English: If pulmonary toxicity is confirmed, treatment should be discontinued.
Danish: Dersom lungetoksicitet bekræftes, bør behandlingen seponeres.
English: Swallow the tablet whole with a drink of water during a meal.
Danish: Du skal synke tabletten hel med et glas vand i forbindelse med et måltid.
English: There have been spontaneously reported events of new or worsening heart failure during treatment with dronedarone.
Danish: Der er spontant indrapporteret tilfælde af nyopstået eller forværret hjerteinsufficiens under behandling med dronedaron.
English: • inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis).
Danish: • betændelse (inflammation) i blodkarrene (vasculitis inklusive leukocytoklastisk vasculitis).
English: Pantoprazole (40 mg once daily), a medicinal product which increases gastric pH without any effect on cytochrome P450, did not interact significantly on dronedarone pharmacokinetics.
Danish: Pantoprazol (40 mg én gang daglig), et lægemiddel der øger pH i mavesækken uden effekt på cytokrom P450, gav ingen signifikant ændring i dronedarons farmakokinetik.
English: Vasculitis, including leukocytoclastic vasculitis
Danish: Vasculitis, inklusive leukocytoklastisk vasculitis.
English: Assessment of intrinsic factors such as gender or age on the incidence of any treatment emergent adverse reactions showed an interaction for gender (female patients) for the incidence of any adverse reactions and for serious adverse reactions.
Danish: Vurdering af interne faktorer såsom køn eller alder på forekomsten af spontane bivirkninger viste en øget forekomst af en hvilken som helst bivirkning og af alvorlige bivirkninger forbundet med køn (kvindelige patienter).
English: When dabigatran etexilate 150 mg once daily was co-administered with dronedarone 400 mg twice daily, the dabigatran AUC0-24, and Cmax were increased by 100% and 70%, respectively.
Danish: Dabigatran Når dabigatranetexilat 150 mg en gang daglig blev co-administreret med dronedaron 400 mg to gange daglig, blev dabigatran AUC0-24 og Cmax øget med henholdsvis 100 % og 70 %.
English: • Second- or third- degree atrio-ventricular block, complete bundle branch block, distal block,
Danish: • 2. eller 3. grads atrioventrikulær blok, komplet grenblok, distalt blok, sinusknudedysfunktion,
English: Dronedarone is a moderate inhibitor of CYP 3A4, a mild inhibitor of CYP 2D6 and a potent inhibitor of P-glycoproteins (P-gp).
Danish: Dronedaron er en moderat inhibitor af CYP3A4 og en svag inhibitor af CYP2D6 og en potent inhibitor af P-glykoproteiner (P-gp).
English: You and your doctor should decide if you will take MULTAQ or breastfeed.
Danish: Du skal tale med din læge og beslutte om du vil tage MULTAQ eller amme.
English: • you have a condition when the vessel that supplies blood to heart muscle becomes hardened and narrowed (coronary artery disease).
Danish: • du har en lidelse, hvor de kar, der forsyner hjertet med blod, bliver hårde og forsnævrede (forkalkning af kranspulsårene).
English: • ritonavir (a medicine for AIDS infection),
Danish: • ritonavir (medicin mod aids),
English: Treatment with dronedarone can be initiated in an outpatient setting.
Danish: Behandling med dronedaron kan påbegyndes hos ambulante patienter.
English: sinus node dysfunction, atrial conduction defects, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
Danish: ledningsdefekt i atrier eller syg sinus-syndrom (gælder ikke ved brug i forbindelse med fungerende pacemaker)
English: Lower starting dose and maintenance doses of statins should be considered and patients monitored for clinical signs of muscular toxicity.
Danish: Lavere start- og vedligeholdelsesdoser af statiner bør overvejes, og patienter bør monitoreres for kliniske tegn på muskeltoksicitet.
English: Monoamine Oxidases contribute partially to the metabolism of the active metabolite of dronedarone (see section 4.5).
Danish: Monoaminoxidaser medvirker delvist til metaboliseringen af dronedarons aktive metabolit (se pkt 4.5).
English: EU/1/09/591/001 - cartons of 20 film-coated tablets EU/1/09/591/002 - cartons of 50 film-coated tablets EU/1/09/591/003 - cartons of 60 film-coated tablets EU/1/09/591/004 - cartons of 100 x 1 film-coated tablets
Danish: EU/1/09/591/001 - pakninger med 20 filmovertrukne tabletter EU/1/09/591/002 - pakninger med 50 filmovertrukne tabletter EU/1/09/591/003 - pakninger med 60 filmovertrukne tabletter EU/1/09/591/004 - pakninger med 100x1 filmovertrukne tabletter
English: However, proarrhythmic effects may occur in particular situations such as concomitant use with medicinal products favouring arrhythmia and/or electrolytic disorders (see sections 4.4 and 4.5).
Danish: Dog kan proarytmiske effekter forekomme i særlige tilfælde, såsom ved samtidig behandling med lægemidler der begunstiger arytmi og/eller elektrolytforstyrrelser (se pkt.
English: Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting dronedarone.
Danish: Antiarytmika af klasse I eller III (såsom flecainid, propafenon, quinidin, disopyramid, dofetilid, sotalol, amiodaron) skal seponeres, inden behandling med dronedaron påbegyndes.
English: You must not take any of the following with MULTAQ:
Danish: Du må ikke tage noget af følgende medicin sammen med MULTAQ:
English: A clinical study in patients with permanent AF (AF duration for at least 6 months) and cardiovascular risk factors was stopped early due to an excess of cardiovascular death, stroke and heart failure in patients receiving dronedarone (see section 5.1).
Danish: Et klinisk studie med patienter med permanent AF (AF-varighed mindst 6 måneder) og kardiovaskulære risikofaktorer blev stoppet før tid på grund af øget forekomst af kardiovaskulær død, apopleksi og hjerteinsufficiens hos de patienter, der fik dronedaron (se pkt.
English: If QTc Bazett interval is ≥500 milliseconds, dronedarone should be stopped (see section 4.3).
Danish: Hvis QTc Bazett intervallet er ≥ 500 msek., bør dronedaron seponeres (se pkt.
English: After oral administration in fed conditions, peak plasma concentrations of dronedarone and the main circulating active metabolite (N-debutyl metabolite) are reached within 3 to 6 hours.
Danish: Efter oral administration i ikke-fastende tilstand opnås peak plasmakoncentration af dronedaron og dets hovedmetabolit (N-debutylmetabolit) inden for 3-6 timer.
English: Respiratory, thoracic and mediastinal disorders
Danish: Respiratoriske, torakale og mediastinale sygdomme
English: What MULTAQ looks like and content of the pack MULTAQ is a white, oval, film-coated tablet (tablet) with a double wave marking on one side and “4142” on the other side.
Danish: MULTAQ er en hvid, oval, filmovertrukket tablet (tablet) med en dobbeltbølge på den ene side, og ”4142” på den anden side.
English: Dronedarone is contraindicated in patients with severe renal impairment (creatinine clearance (CrCl) <30 ml/min) (see section 4.3).
Danish: Dronedaron er kontraindiceret hos patienter med alvorlig nyreinsufficiens (kreatininclearance <30 ml/min) (se pkt.
English: In clinical studies, bradycardia was more frequently observed when dronedarone was given in combination with beta-blockers.
Danish: Der blev oftere observeret bradykardi i kliniske studier, når dronedaron blev givet i kombination med betablokkere.
English: MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF).
Danish: MULTAQ er indiceret til opretholdelse af sinusrytme hos voksne, klinisk stabile patienter med paroksystisk eller persisterende atrieflimren (AF) efter vellykket kardiovertering.
English: Rifampicin (600 mg once daily) decreased dronedarone exposure by 80% with no major change on its active metabolite exposure.
Danish: Rifampicin (600 mg en gang daglig) nedsatte plasmakoncentrationen af dronedaron med 80 % uden nogen særlig ændring i plasmakoncentrationen af den aktive metabolit.
English: In female patients, dronedarone exposures and its N-debutyl metabolite exposure are on average 1.3- to 1.9-fold higher as compared to male patients.
Danish: Plasmakoncentrationen af dronedaron og dets N-debutylmetabolit er gennemsnitligt 1,3 til 1,9 gange højere hos kvindelige patienter sammenlignet med mandlige patienter.
English: Patients should immediately report any symptoms of potential liver injury (such as sustained new-onset abdominal pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine or itching) to their physician.
Danish: Patienterne skal informeres om omgående at rapportere alle symptomer på potentielle leverskader (så som vedvarende, nyopståede abdominalsmerter, anoreksi, kvalme, opkastning, feber, utilpashed, træthed, gulsot, mørkfarvning af urin eller kløe) til deres læge.
English: Dronedarone does not affect the pharmacokinetics of clopidogrel and its active metabolite.
Danish: Interaktion med clopidogrel Dronedaron påvirker ikke farmakokinetikken af clopidogrel eller dets aktive metabolit.
English: A potential pharmacodynamic interaction can also be expected with beta-blockers, calcium antagonists and digitalis.
Danish: En potentiel farmakodynamisk interaktion kan også forventes med betablokkere, calciumantagonister og digitalis.
English: In clinical trials, there was no evidence of safety concerns when dronedarone was co-administered with statins metabolised by CYP 3A4.
Danish: I kliniske studier er der ikke fundet evidens for sikkerhedsproblemer ved samtidig administration af dronedaron og statiner, der metaboliseres af CYP3A4.
English: Heart, lung and blood tests
Danish: Undersøgelser af dit hjerte, lunger og blod
English: Dronedarone 800 mg daily increased metoprolol exposure by 1.6-fold and propranolol exposure by 1.3-fold (i.e. much below the 6-fold differences observed between poor and extensive CYP 2D6 metabolisers).
Danish: Dronedaron 800 mg daglig øgede metoprolol-plasmakoncentrationen 1,6 gange og propranolol-plasmakoncentrationen 1,3 gange (dvs. langt mindre end den 6-dobbelte forskel, der blev observeret mellem CYP2D6 extensive metabolisers og CYP2D6 poor metabolisers).
English: There was a weak interaction between dronedarone and atorvastatin (which resulted in a mean 1.7-fold increase in atorvastatin exposure).
Danish: Der var en svag interaktion mellem dronedaron og atorvastatin (hvilket gennemsnitligt resulterede i en 1,7-folds stigning i atorvastatinplasmakoncentrationen).
English: Rashes (including generalised, macular, maculo-papular) Pruritus
Danish: Udslæt (inklusive generaliseret, makuløst, makulopapuløst) Pruritus
English: • some medicines for epilepsy called phenobarbital, carbamazepine or phenytoin,
Danish: • visse typer medicin mod epilepsi, der kaldes phenobarbital, carbamazepin eller phenytoin,
English: If ALT levels are confirmed to be ≥3 × ULN, treatment with dronedarone should be withdrawn.
Danish: Hvis det bekræftes, at ALAT-niveauet er ≥3 × ULN, skal behandlingen med dronedaron seponeres.
English: Calcium antagonists, diltiazem and verapamil, are substrates and/or moderate inhibitors of CYP 3A4.
Danish: Calciumantagonisterne diltiazem og verapamil er substrater og/eller moderate inhibitorer af CYP3A4.
English: Heart Failure (including use in patients with unstable hemodynamic conditions with history of, or current heart failure or left ventricular systolic dysfunction, and pre-renal azotemia) Use in Permanent atrial fibrillation defined as an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician Pulmonary-interstitial lung disease (ILD)
Danish: Hjertesvigt (herunder patienter med ustabile hæmodynamiske forhold med nuværende eller historiske hjertesvigt eller venstre ventrikel systolisk dysfunktion, og pre-renal azotæmi) Anvendelse ved permanent atrieflimmer defineret som en AF varighed ≥ 6 måneder (eller varighed ukendt) og hvor forsøg på at genoprette sinusrytme ikke længere tages i betragtning af lægen Pulmonal interstitiel lungesygdom (ILD)
English: An increase in plasma creatinine (mean increase 10 μmol/L) has been observed with dronedarone 400 mg twice daily in healthy subjects and in patients.
Danish: En stigning i plasmakreatinin (gennemsnitlig stigning 10 μmol/L) er blevet observeret ved anvendelse af dronedaron 400 mg to gange daglig hos raske frivillige personer og hos patienter.
English: Repeated doses of diltiazem (240 mg twice daily), verapamil (240 mg once daily) and nifedipine (20 mg twice daily) resulted in an increase in dronedarone exposure of 1.7-, 1.4- and 1.2-fold, respectively.
Danish: Gentagne doser af diltiazem (240 mg to gange daglig), verapamil (240 mg én gang daglig) og nifedipin (20 mg to gange daglig) resulterede i en stigning i dronedaron-plasmakoncentrationen med henholdsvis 1,7-, 1,4og 1,2 gange.
English: The steady state mean dronedarone Cmax is 84-147 ng/ml and the exposure of the main N-debutyl metabolite is similar to that of the parent compound.
Danish: Gennemsnitlig steady-state Cmax af dronedaron er 84-147 ng/ml, og plasmakoncentrationen af den primære N-debutylmetabolit er i samme størrelsesorden.
English: • cisapride (a medicine for food and acid reflux from your stomach to your mouth),
Danish: • cisaprid (medicin mod opstød af mad og mavesyre op i munden),
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om MULTAQ findes på Det Europæiske Lægemiddelagenturs hjemmeside http:// www.ema.europa.eu.
English: The incidence of the primary efficacy endpoint defined as first recurrence of AF or premature study drug discontinuation for intolerance or lack of efficacy at 12 months was 75% in the dronedarone group and 59% in the amiodarone group (hazard ratio = 1.59, log-rank p-value <0.0001).
Danish: Forekomsten af det primære virkningsendepunkt, defineret som første tilbagevenden af AF eller for tidlig seponering af studielægemiddel på grund af intolerance eller mangel på effekt efter 12 måneder, var 75% i dronedarongruppen, og 59% i amiodarongruppen (hazard ratio
English: In the 5 placebo controlled studies, CHF occurred in the dronedarone group with rates comparable with placebo (very commonly, 11.2% versus 10.9%).
Danish: I de 5 placebokontrollerede studier opstod kongestiv hjerteinsufficiens i dronedaron-gruppen med en hyppighed, der var sammenlignelig med placebo (meget almindelig, 11,2 % mod 10,9%).
English: The clinical relevance of this observation is not known (see sections 4.4 and 5.2).
Danish: Den kliniske relevans af denne observation er ukendt (se pkt.
English: Of the total number of subjects in clinical studies of dronedarone, 73% were 65 years of age and over and 34% were 75 years of age and over.
Danish: I de kliniske studier med dronedaron var 73 % af forsøgspersonerne 65 år eller derover, og 34 % var 75 år eller derover.
English: Rare (1/10,000 to
Danish: Sjælden (≥ 1/10.000 to
English: MULTAQ is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: MULTAQ bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, der ikke anvender sikker kontraception.
English: Repeated doses of erythromycin (500 mg three times a day for 10 days) resulted in an increase in steady state dronedarone exposure of 3.8-fold.
Danish: Gentagne doser af erythromycin (500 mg tre gange daglig i ti dage) resulterede i 3,8-folds stigning i steady state-plasmakoncentrationen af dronedaron.
English: Moreover, digitalis has the potential to interact with dronedarone from a pharmacodynamic point of view.
Danish: Digitalis kan desuden potentielt interagere med dronedaron fra et farmakodynamisk synspunkt.
English: Photosensitivity reaction
Danish: Lysfølsomhedsreaktion er
English: Their co-administration is contraindicated (see section 4.3).
Danish: Samtidig administration er kontraindiceret (se pkt.
English: Grapefruit juice (CYP 3A4 inhibitor)
Danish: Grapefrugtjuice (CYP3A4-inhibitor)
English: Clinical, ECG and biological monitoring is recommended, and digoxin dose should be halved.
Danish: Klinisk og biologisk monitorering samt ekg-monitorering anbefales, og digoxindosis bør halveres.
English: • problems with your digestive system such as indigestion, diarrhoea, nausea, vomiting and stomach pain,
Danish: • problemer med dit fordøjelsessystem såsom fordøjelsesbesvær, diarré, kvalme, opkastning og mavesmerter.
English: • terfenadine (a medicine for allergies),
Danish: • terfenadin (medicin mod allergi)
English: During the course of the study, the number of deaths from any cause was comparable between the dronedarone (116/2,301) and placebo (139/2,327) groups.
Danish: Antallet af dødsfald af vilkårlig årsag var tilsvarende mellem dronedarongruppen (116/2301) og placebogruppen (139/2327).
English: • some medicines for fungal infections such as ketoconazole, voriconazole, itraconazole or posaconazole,
Danish: • visse typer medicin mod svampeinfektioner såsom ketoconazol, voriconazol, itraconazol eller posaconazol,
English: The pharmacokinetics of dronedarone in patients with AF is consistent with that in healthy subjects.
Danish: Farmakokinetikken for dronedaron hos patienter med AF er konsistent med den i raske frivillige.
English: International Normalised Ratio (INR) should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per their label.
Danish: International normaliseret ratio (INR) skal nøje monitoreres efter initiering af dronedaron hos patienter, der får K-vitamin antagonister.
English: Due to the pharmacokinetic interaction and possible pharmacodynamic interaction, beta-blockers should be used with caution concomitantly with dronedarone.
Danish: Grundet den farmakokinetiske interaktion, og en mulig farmakodynamisk interaktion, bør betablokkere anvendes med forsigtighed ved samtidig behandling med dronedaron.
English: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès et Lagrave F-33565 Carbon Blanc Cedex France
Danish: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès et Lagrave F-33565 Carbon Blanc Cedex Frankrig
English: Dronedarone has, therefore, the potential to interact on medicinal products substrates of P-glycoproteins, CYP 3A4 or CYP 2D6.
Danish: Derfor kan dronedaron potentielt interagere med lægemidler, der er substrater af P-glykoproteiner, CYP3A4 eller CYP2D6.
English: If a switch is envisaged, this should be done under the supervision of a specialist (see sections 4.3 and 5.1).
Danish: Hvis der planlægges et skift, skal det ske under supervision af en specialist (se pkt.
English: • some tranquilising medicines called phenothiazines,
Danish: • visse typer beroligende medicin, kaldet phenothiaziner,
English: Other medicines and MULTAQ
Danish: Brug af anden medicin sammen med MULTAQ
English: If you need to change from amiodarone (another medicine for irregular heart beat) to MULTAQ, your doctor can provide special recommendations, for example pausing amiodarone before switching.
Danish: Behandling med MULTAQ vil blive overvåget af en læge med erfaring i behandling af hjertesygdomme Hvis du skal skifte fra amiodaron (en anden medicin mod uregelmæssig hjerterytme) til MULTAQ, kan din læge give specielle anbefalinger f.eks. pause for amiodaron før der skiftes.
English: MULTAQ is used if you have a problem with your heart rhythm (your heart beats out of time - atrial fibrillation) and spontaneously, or through a treatment called cardioversion has changed your heartbeat back to normal rhythm.
Danish: MULTAQ anvendes, hvis du har problemer med dit hjerte, så hjertet slår ude af takt (atrieflimren), og spontant, eller under en behandling kaldet kardiovertering har ændret dit hjerteslag, så rytmen (pulsen) er normal.
English: Please tell any other person who checks your blood that you are taking MULTAQ.
Danish: Hvis der er andre personer, der undersøger dit blod, skal du sige til dem, at du er i behandling med MULTAQ.
English: Sanofi Winthrop Industrie 1 rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc Cedex - France
Danish: Sanofi Winthrop Industrie 1 rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc Cedex - Frankrig
English: Dronedarone reduced the incidence of cardiovascular hospitalisation or death from any cause by 24.2% when compared to placebo (p<0.0001).
Danish: Dronedaron reducerede forekomsten af hospitalsindlæggelse af kardiovaskulære årsager eller død af vilkårlig årsag med 24,2 % (relativ risikoreduktion) sammenlignet med placebo (p<0,0001).