natgillin/translations-raw huggingface dataset:
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). 
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).
Dersom AF opstår igen, bør seponering af dronedaron overvejes. 
If AF reoccurs, discontinuation of dronedarone should be considered.
En synergistisk indvirkning på hjertefrekvensen og den atrioventrikulære overledning er også mulig. 
A synergistic effect on heart rate and atrioventricular conduction is also possible.
Grapefrugtjuice Patienter bør frarådes at drikke grapefrugtjuice under behandlingen med dronedaron. 
Patients should be warned to avoid grapefruit juice beverages while taking dronedarone.
Derfor bør patienter rådes til at undgå at drikke grapefrugtjuice under behandling med dronedaron (se pkt. 
Therefore, patients should be warned to avoid grapefruit juice beverages while taking dronedarone (see section 4.4).
Dronedaron reducerer hjertefrekvensen i dyremodeller. 
In animal models, dronedarone reduces the heart rate.
Patienterne var i alderen 27 til 96 år, 68% var ældre end 65 år. 
Patients ranged in age from 27 to 96 years, 68% were more than 65 years old.
• langsom puls. 
• Slow heart beat.
En synergistisk effekt på hjertefrekvens og atrioventrikulær overledning er mulig. 
A synergistic effect on heart rate and atrio-ventricular conduction is possible.
Immunsuppressiva 
Immunosupressants
Dronedaron bliver godt optaget (mindst 70 %) efter oral administration i ikke-fastende tilstand. 
Following oral administration in fed condition, dronedarone is well absorbed (at least 70%).
Samtidig administration af beta-blokkere eller calciumantagonister med hæmmende effekt på sinusknuden og atrioventrikulærknuden bør ske med forsigtighed. 
The co-administration of beta-blockers or calcium antagonists with depressant effect on sinus and atrio-ventricular node should be undertaken with caution.
• ændringer i resultatet af en blodprøve, der viser, hvor meget kreatinin du har i blodet, 
• changes in the results of one blood test: your blood creatinine level,
Dronedaron (400 mg to gange daglig) øgede digoxin-plasmakoncentrationen 2,5 gange ved hæmning af Pgp-transporteren. 
Dronedarone (400 mg twice daily) increased digoxin exposure by 2.5-fold by inhibiting P-gp transporter.
• nefazodon (medicin mod depression) 
• nefazodone (a medicine for depression),
• en tablet i forbindelse med et morgenmåltid og 
• one tablet with the morning meal and
Kvinder i den fertile alder og graviditet 
Women of child bearing potential and pregnancy
Interaktion med metformin (OCT1- og OCT2-substrat) Der sås ingen interaktion mellem dronedaron og metformin (et OCT1- og OCT2-substrat). 
No interaction was observed between dronedarone and metformin, an OCT1 and OCT2 substrate.
Alt efter din tilstand kan din læge anbefale, at du tager blodfortyndende medicin (mod dannelse af blodpropper). 
Your doctor may recommend that you use a medicine against blood clot formation according to your condition.
• Din læge vil tage blodprøver for at tjekke din leverfunktion, før du begynder at tage MULTAQ samt under behandlingen. 
• Your doctor will order blood tests to check your liver function before you start taking
Plasmakoncentrationen af calciumantagonister øges også af dronedaron (400 mg to gange daglig) (verapamil med 1,4 gange og nisoldipin 1,5 gange). 
Calcium antagonists also have their exposure increased by dronedarone (400 mg twice daily) (verapamil by 1.4-fold, and nisoldipine by 1.5-fold).
5.2 Farmakokinetiske egenskaber Absorption 
5.2 Pharmacokinetic properties
Tilfælde af institiel lungesygdom, herunder pneumonitis og lungefibrose, er rapporteret efter markedsføring. 
Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience.
Der er rapporteret tilfælde af interstitiel lungesygdom, herunder pneumonitis og lungefibrose efter markedsføringen (ikke kendt frekvens). 
Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience (frequency not known).
Hver filmovertrukken tablet indeholder 400 mg dronedaron (som hydrochlorid). 
Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
Hypromellose (E464) Majsstivelse 
Hypromellose (E464) Maize starch
• Alvorligt nedsat nyrefunktion (kreatininclearance <30 ml/min.) 
• Severe renal impairment (CrCl <30 ml/min)
Dronedaron (400 mg to gange daglig) øgede plasmakoncentrationen af simvastatin og simvastatinsyre henholdsvis 4 og 2 gange. 
Dronedarone (400 mg twice daily) increased simvastatin and simvastatin acid exposure by 4-fold and 2-fold respectively.
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, 
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).
• inflammation (betændelsesagtig tilstand) i lungerne (med dannelse af arvæv og fortykkelse af lungerne). 
• Inflammation of the lungs (including scarring and thickening of the lungs).
Det skal du vide, før du begynder at tage MULTAQ 
What you need to know before you take MULTAQ
Andre moderate hæmmere af CYP3A4 Andre moderate hæmmere af CYP3A4 kan sandsynligvis også øge dronedarons plasmakoncentration. 
Other moderate inhibitors of CYP3A4 are also likely to increase dronedarone exposure.
• én tablet i forbindelse med dit aftensmåltid. 
• one tablet during your evening meal.
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. 
In clinical studies, increased levels of digitalis and/or gastrointestinal disorders indicating digitalis toxicity were observed when dronedarone was co-administered with digitalis.
Abdominalsmerter Dyspepsi 
Abdominal pain Dyspepsia
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. 
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.
Du må ikke holde op med at tage medicinen uden først at tale med din læge eller spørge på apoteket. 
If you stop taking MULTAQ Do not stop taking this medicine without first talking to your doctor or pharmacist.
Gentagne doser grapefrugtjuice på 300 ml tre gange daglig resulterede i en 3-dobbelt stigning i dronedaronplasmakoncentrationen. 
Repeated doses of 300 ml of grapefruit juice three times daily resulted in a 3-fold increase in dronedarone exposure.
Klinisk set er EKG og biologisk overvågning anbefalet, og doseringen af digoxin bør halveres (se pkt. 
Clinical, ECG and biological monitoring is recommended, and digoxin dose should be halved (see section 4.4).
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. 
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.
Potente CYP3A4-induktorer såsom rifampicin, phenobarbital, carbamazapin, phenytoin eller perikon bør ikke anvendes. 
Potent CYP3A4 inducers such as rifampicin, phenobarbital, carbamazepine, phenytoin or St John's Wort are not recommended.
posaconazol, telithromycin, clarithromycin, nefazodon og ritonavir (se pkt. 
itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir (see section 4.5)
Interaktion med P-gp substrat 
Interaction with P-gp substrates Digoxin
Disse lægemidler bør initieres ved lav dosis, og optitrering bør først ske efter ekg-evaluering. 
These medicinal products should be initiated at low dose and up-titration should be done only after ECG assessment.
Interaktion med lægemidler der metaboliseres af CYP2D6 
Interaction with medicinal products metabolised by CYP 2D6 Beta-blockers
Tag den næste dosis som planlagt. 
Take the next dose when you are normally due to take it.
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 
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).
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. 
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).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 400 mg dronedaron (som hydrochlorid). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 400 mg dronedarone (as hydrochloride).
Denne hyppighed skal ses i sammenhæng med den underliggende øgede forekomst af kongestiv hjerteinsufficiens hos AFpatienter. 
This rate should be considered in the context of the underlying elevated incidence of CHF in AF patients.
- Øvrige indholdsstoffer i tabletkernen: hypromellose (E464), majsstivelse, crospovidon (E1202), poloxamer 407, lactosemonohydrat (se pkt. 
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).
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% 
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%).
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). 
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).
Crospovidon (E1202) 
Crospovidone (E1202) Poloxamer 407
• én tablet i forbindelse med dit morgenmåltid og 
• one tablet during your morning meal and
Dronedaron bliver metaboliseret i høj grad, primært af CYP3A4 (se pkt. 
Dronedarone is extensively metabolised, mainly by CYP 3A4 (see section 4.5).
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. 
In the 5 placebo controlled studies, 0.6% of patients in the dronedarone group had pulmonary events versus 0.8% of patients receiving placebo.
Efter markedsføring er der indberettet hepatocellulære leverskader, herunder livstruende akut leverinsufficiens, hos patienter i behandling med dronedaron. 
Hepatocellular liver injury, including life-threatening acute liver failure, has been reported in patients treated with dronedarone in the post-marketing setting.
Interaktioner (se pkt. 
Interactions (see section 4.5)
• en tablet i forbindelse med et aftensmåltid. 
• one tablet with the evening meal.
indlagt med ny eller forværret hjerteinsufficiens og som havde haft mindst ét tilfælde af stakåndethed under minimal fysisk anstrengelse, eller under hvile (NYHA klasse III eller IV), eller som havde haft mindst et tilfælde af paroksystisk natlig dyspnø inden for en måned inden indlæggelsen. 
The ANDROMEDA study was conducted in 627 patients with left ventricular dysfunction, hospitalised with new or worsening heart failure and who had had at least one episode of shortness of breath on minimal exertion or at rest (NYHA class III or IV) or paroxysmal nocturnal dyspnoea within the month before admission.
Meget almindelig (forekommer hos flere end 1 patient ud af 10) 
Very common (may affect more than 1 in 10 people)
• Uigennemsigtige PVC/aluminium perforerede enhedsdosis-blister i pakninger af 100x1 filmovertrukne tabletter. 
• Opaque PVC/Aluminium blister in packs of 20, 50 and 60 film-coated tablets • Opaque PVC/Aluminium perforated unit dose blister in packs of 100x1 film-coated tablets.
Vedligeholdelse af sinusrytme 
Maintenance of sinus rhythm
Effekten af svært nedsat leverfunktion på dronedarons farmakokinetik er ikke fastlagt (se pkt. 
The effect of severe hepatic impairment on the pharmacokinetics of dronedarone was not assessed (see section 4.3).
Derfor frarådes samtidig administration af rifampicin og andre potente CYP3A4-induktorer såsom phenobarbital, carbamazepin, phenytoin eller perikon, da de vil nedsætte plasmakoncentrationen af dronedaron. 
Therefore, co-administration of rifampicin and other potent CYP 3A4 inducers such as phenobarbital, carbamazepine, phenytoin or St John's Wort is not recommended as they decrease dronedarone exposure.
Vitamin K antagonister Patienterne skal antikoagulansbehandles relevant i henhold til kliniske retningslinjer for AF. 
Patients should be appropriately anti-coagulated as per clinical AF guidelines.
Der er også indrapporteret tilfælde af kongestiv hjerteinsufficiens post-marketing (ikke kendt frekvens) (se pkt. 
Cases of CHF have also been reported in post-marketing experience (frequency not known) (see section 4.4).
Behandling med disse lægemidler bør påbegyndes ved lav dosis, og optitrering bør kun ske efter vurdering af ekg. 
These medicinal products should be initiated at low dose and up titration should be done only after ECG assessment.
Interaktion med warfarin og losartan (CYP2C9-substrater) 
Interaction with warfarin and losartan (CYP 2C9 substrates) Warfarin and other vitamin K antagonists
Dronedaron er kontraindiceret hos patienter i ustabil hæmodynamisk tilstand og med en anamnese med hjerteinsufficiens eller systolisk dysfunktion af venstre ventrikel (se pkt. 
Dronedarone is contraindicated in patients in unstable hemodynamic conditions, with history of, or current heart failure or left ventricular systolic dysfunction (see section 4.3).
LISTE OVER HJÆLPESTOFFER Indeholder også: Lactose. 
Also contains: lactose.
Almindelig (≥ 1/100 to < 1/10) 
Common (1/100 to
Potente CYP3A4-inhibitorer 
Potent CYP 3A4 inhibitors
Hvis hjerteinsufficiens udvikles, skal dronedaron seponeres. 
If heart failure develops, treatment with dronedarone should be discontinued.
• hudproblemer såsom udslæt eller kløe, 
• skin problems such as rash or itching,
Derfor kan CYP3A4-inhibitorer oginduktorer potentielt interagere med dronedaron. 
Therefore, inhibitors and inducers of CYP 3A4 have the potential to interact on dronedarone.
Interaktion med omeprazol (CYP2C19-substrat) Dronedaron påvirker ikke omeprazols farmakokinetik (et CYP2C19-substrat). 
Dronedarone does not affect the pharmacokinetics of omeprazole, a CYP 2C19 substrate.
Denne dosis bør tages som 
It should be taken as:
Hvis der udvikles systolisk dysfunktion af venstre ventrikel, skal dronedaron seponeres. 
If left ventricular systolic dysfunction develops, treatment with dronedarone should be discontinued.
4628 patienter blev randomiseret og behandlet i op til maksimalt 30 måneder (median opfølgning: 22 måneder) med enten dronedaron 400 mg to gange daglig (2301 patienter) eller placebo (2327 patienter), ud over konventionel behandling inklusive betablokkere (71 %), ACE-hæmmere eller AIIRA'er (69 %), 
Four thousand six hundred and twenty eight (4,628) patients were randomised and treated for up to 30 months maximum (median follow-up: 22 months) with either dronedarone 400 mg twice daily (2,301 patients) or placebo (2,327 patients), in addition to conventional therapy including beta-blockers (71%), ACE inhibitors or AIIRAs (69%) digitalis (14%), calcium antagonists (14%), statins (39%), oral anticoagulants (60%), chronic antiplatelet therapy (6%) and/or diuretics (54%).
• hvis du udvikler nedenstående tegn og symptomer på leverproblemer, skal du straks fortælle det til din læge: smerter i maveregionen eller ubehag, appetitløshed, kvalme, opkastning, gulfarvning af huden eller det hvide i øjnene (gulsot), usædvanlig mørkfarvning af urinen, træthed (særligt i forbindelse med andre symptomer anført ovenfor), kløe, 
• tell your doctor immediately if you develop any of these signs and symptoms of liver problems: 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,
Potent CYP3A4-induktorer 
Potent CYP3A4 inducers
Dronedaron er kontraindiceret hos patienter med alvorlig leverinsufficiens på grund af mangel på dokumentation (se pkt. 
Dronedarone is contraindicated in patients with severe hepatic impairment because of the absence of data (see sections 4.3 and 4.4).
Interaktion med lægemidler, der metaboliseres af CYP3A4 
Interaction with medicinal products metabolized by CYP 3A4 Dabigatran
MULTAQ påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
4.7 Effects on ability to drive and use machines MULTAQ has no or negligible influence on the ability to drive and use machines.
MULTAQ indeholder lactose 
MULTAQ contains lactose
MULTAQ 400 mg filmovertrukne tabletter dronedaron 
MULTAQ 400 mg film-coated tablets dronedarone
Interaktion med theofyllin (CYP1A2-substrat) Dronedaron 400 mg to gange daglig medførte ikke en stigning i steady-state theofyllinplasmakoncentrationen. 
Dronedarone 400 mg twice daily does not increase the steady state theophylline exposure.
Magnesiumstearat (E572) 
Lactose monohydrate Colloidal anhydrous silica Magnesium stearate (E572)
Sotalol skal seponeres før opstart af dronedaron (se pkt. 
Sotalol must be stopped before starting dronedarone (see sections 4.2 and 4.3).
Dronedaron bliver metaboliseret primært af CYP3A4 (se pkt. 
Dronedarone is primarily metabolised by CYP 3A4 (see section 5.2).
CYP3A4-induktorer 
CYP 3A4 inducers
70 mg/kg/dag i rotter, og 300 mg/kg/dag i mus. 
In 2-year oral carcinogenicity studies, the highest dronedarone dose administered for 24 months was 70 mg/kg/day in rats and 300 mg/kg/day in mice.
Dronedaron bør ikke tages sammen med grapefrugtjuice (se pkt. 
Grapefruit juice should not be taken together with to dronedarone (see section 4.5).
Carnaubavoks (E903) 
Titanium dioxide (E171) Carnauba wax (E903)
Nedsættelse af risiko for AF-relateret indlæggelse Effekten af dronedaron på reduktion af risiko for AF-relateret indlæggelse blev demonstreret hos patienter, 
Reduction of risk of AF-related hospitalisation
Symptomer inkluderer åndenød eller tør hoste. 
Signs include breathlessness or non-productive cough.
Sådan skal du tage MULTAQ 
How to take MULTAQ
47 % af patienterne var kvinder, 
Forty seven percent (47%) of patients were female and a majority was Caucasian (89%).
Dronedaron bør seponeres, hvis patienten udvikler nogle af de kontraindicerede tilstande (se pkt. 
Treatment with dronedarone should be stopped during the course of treatment, in case the patient develops any of the conditions which would lead to a contraindication as mentioned in section 4.3.
I sådanne tilfælde skal dronedaron seponeres (se pkt. 
In such cases dronedarone should be stopped (see sections 4.3 and 4.4).
Dyreforsøg har ikke påvist, at dronedaron påvirker fertiliteten. 
Dronedarone was not shown to alter fertility in animal studies.
Nedsat leverfunktion 
Liver function
• Co-administration med potente CYP3A4-inhibitorer såsom ketoconazol, itraconazol, voriconazol, 
• Co-administration with potent cytochrome P 450 (CYP) 3A4 inhibitors, such as ketoconazole,
Warfarin og andre vitamin K-antagonister Dronedaron (600 mg to gange daglig) forøgede niveauet af S-warfarin 1,2 gange uden ændring i R-warfarin, 
Dronedarone (600 mg twice daily) increased by 1.2-fold S-warfarin with no change in R-warfarin and only a 1.07 increase in International Normalised Ratio (INR).
• Anamnese med hjerteinsufficiens eller systolisk dysfunktion af venstre ventrikel 
• History of, or current heart failure or left ventricular systolic dysfunction
Hos patienter ≥75 år, skal kliniske tegn på hjertesinsufficiens og EKG overvåges regelmæssigt hvis der foreligger komorbiditeter (se pkt. 
In patients ≥75years old, clinical signs of heart failure and ECG should be monitored on a regular basis when co-morbidities are present (see sections 4.3, 4.4 and 5.1).
LÆGEMIDLETS NAVN MULTAQ 400 mg tabletter dronedaron 
NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg tablets dronedarone
Elektrolytforstyrrelser 
Electrolytes imbalance
Indehaver af markedsføringstilladelsen sanofi-aventis groupe 54, rue La Boétie 
Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France
LÆGEMIDLETS NAVN MULTAQ 400 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg film-coated tablets
Dosisjustering er ikke nødvendigt hos andre patienter med nedsat nyrefunktion (se pkt. 
No dose adjustment is required in other patients with renal impairment (see sections 4.4 and 5.2).
Patienter med en anamnese med hjerteinsufficiens eller systolisk dysfunktion af venstre ventrikel 
Patients with history of, or current heart failure or left ventricular systolic dysfunction
Leverskader 
Liver injury
Hos patienter som allerede er i behandling med beta-blokkere på det tidspunkt at dronedaronbehandlingen initieres, skal et EKG udføres og doseringen af beta-blokkere bør justeres hvis nødvendigt (se pkt. 
In patients already taking beta-blockers at time of dronedarone initiation, an ECG should be performed and the dose of beta-blocker should be adjusted if needed (see section 4.4).