FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who were taking amiodarone, an ECG was to be performed about 4 hours after the first administration to verify good tolerability.
Slovenian: Pri bolnikih, ki so jemali amiodaron, je bilo treba posneti EKG približno 4 ure po prvi uporabi za preverjenje dobrega prenašanja.
English: If you stop taking MULTAQ Do not stop taking this medicine without first talking to your doctor or pharmacist.
Slovenian: Če ste prenehali jemati zdravilo MULTAQ Ne nehajte jemati tega zdravila, ne da bi se posvetovali s svojim zdravnikom ali farmacevtom.
English: Cardiac clinical symptoms
Slovenian: Klinični srčni simptomi
English: Other antiarrhythmic medicinal products had to be withdrawn for at least 5 plasma half-lives prior to the first administration.
Slovenian: Druge antiaritmike je bilo treba opustiti vsaj 5 plazemskih razpolovnih časov pred prvo uporabo.
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).
Slovenian: - če imate ali ste imeli težavo, pri kateri srce ne more po telesu črpati krvi tako dobro, kot bi moralo (to stanje imenujemo srčno popuščanje).
English: Dronedarone displays indirect antiadrenergic effects and partial antagonism to adrenergic stimulation.
Slovenian: Dronedaron posredno deluje antiadrenergično in delno antagonizira adrenergično stimulacijo.
English: 4.7 Effects on ability to drive and use machines MULTAQ has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo MULTAQ nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: It belongs to a group of medicines called anti-arrhythmics that help regulate your heart beat.
Slovenian: Spada v skupino zdravil, ki jih imenujemo antiaritmiki in pomagajo uravnavati bitje srca.
English: Similar results were obtained on the incidence of cardiovascular hospitalisation with a risk reduction of 25.5% (p <0.0001).
Slovenian: Podobni so bili rezultati glede incidence kardiovaskularnih hospitalizacij z zmanjšanjem tveganja za 25,5 % (p = < 0,0001).
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.
Slovenian: Ocena vpliva intrinzičnih dejavnikov (npr. spola in starosti) na incidenco neželenih učinkov zaradi zdravljenja je pokazala interakcijo za spol (bolnice), kar zadeva incidenco vseh neželenih učinkov in resnih neželenih učinkov.
English: The Prescriber Guide should display information to help physician assess whether the patient is eligible for MULTAQ prescription and whether the patient remains within the prescribing information.
Slovenian: Vodnik za predpisovalca mora imeti navedene informacije, ki zdravniku pomagajo ugotoviti, ali je bolnik primeren za zdravljenje z zdravilom MULTAQ in ali ostaja v okviru informacij za predpisovanje.
English: An increase in creatininaemia should not necessarily lead to the discontinuation of treatment with ACE inhibitors or Angiotensin II Receptors Antagonists (AIIRAs).
Slovenian: Porast kreatininemije ni nujno razlog za prenehanje zdravljenja z zaviralci ACE ali antagonisti receptorjev angiotenzina II.
English: The pharmacological action of dronedarone may induce a moderate QTc Bazett prolongation (about 10 msec), related to prolonged repolarisation.
Slovenian: Farmakološko delovanje dronedarona lahko povzroči zmerno podaljšanje QTc po Bazettu (za približno 10 milisekund), kar je povezano s podaljšano repolarizacijo.
English: • telithromycin, erythromycin, or clarithromycin (antibiotics for infections),
Slovenian: • telitromicina, eritromicina ali klaritromicina (antibiotika za okužbe),
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.
Slovenian: Podaljša efektivne refraktarne periode (ERP) preddvorov, atrioventrikularnega vozla in rahlo podaljša ERP prekatov z minimalno stopnjo reverzne frekvenčne odvisnosti.
English: If a switch is envisaged, this should be done under the supervision of a specialist (see sections 4.3 and 5.1).
Slovenian: Če je predviden prehod, ga je treba opraviti pod nadzorom specialista (glejte poglavji 4.3 in 5.1).
English: There is limited information on the optimal timing to switch from amiodarone to dronedarone.
Slovenian: Informacij o najprimernejšem času za prehod z amiodarona na dronedaron je malo.
English: MULTAQ is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila MULTAQ ni priporočljivo uporabljati med nosečnostjo in pri tistih ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: After intravenous administration the plasma clearance of dronedarone ranges from 130 to 150 L/h.
Slovenian: Po intravenski uporabi je plazemski očistek dronedarona od 130 do 150 l/h.
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.
Slovenian: Pri bolnikih, starih 65 let in več, je bila izpostavljenost dronedaronu 23 % večja kot pri bolnikih, mlajših od 65 let.
English: In animal models, dronedarone reduces the heart rate.
Slovenian: V živalskih modelih dronedaron zmanjša srčno frekvenco.
English: A number of patients had been previously exposed to amiodarone (see section 4.4).
Slovenian: Številni bolniki so bili predhodno izpostavljeni amiodaronu (glejte poglavje 4.4).
English: If any of the above apply to you, do not take MULTAQ.
Slovenian: Če kaj od naštetega velja za vas, ne vzemite zdravila MULTAQ.
English: Management of plasma creatinine increase
Slovenian: Ravnanje v primeru zvišanega kreatinina v plazmi
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).
Slovenian: Študija je bila predčasno končana zaradi opaženega neravnovesja med smrtmi v skupini z dronedaronom [n = 25 v primerjavi z 12 (placebo), p = 0,027] (glejte poglavji 4.3 in 4.4).
English: Please tell any other person who checks your blood that you are taking MULTAQ.
Slovenian: Vsakomur, ki vam kontrolira kri, morate povedati, da jemljete zdravilo MULTAQ.
English: The DIONYSOS study compared the efficacy and safety of dronedarone (400 mg twice daily) versus amiodarone (600 mg daily for 28 days, then 200 mg daily thereafter) over 6 months.
Slovenian: Študija DIONYSOS je primerjala učinkovitost in varnost dronedarona (400 mg dvakrat na dan) z učinkovitostjo in varnostjo amiodarona (600 mg na dan 28 dni, potem po 200 mg na dan) v obdobju 6 mesecev.
English: The N-debutyl metabolite exhibits pharmacodynamic activity but is 3 to 10-times less potent than dronedarone.
Slovenian: N-debutilni presnovek je farmakodinamično aktiven, vendar od 3- do 10-krat manj močan kot dronedaron.
English: Encourage reporting to Pharmacovigilance
Slovenian: Spodbujanje farmakovigilančnega poročanja
English: • bepridil for chest pain caused by heart disease,
Slovenian: • bepridila za bolečine v prsih, ki jih povzroča koronarna bolezen,
English: The terminal elimination half-life of dronedarone is around 25-30 hours and that of its N-debutyl metabolite around 20-25 hours.
Slovenian: Terminalni eliminacijski razpolovni čas dronedarona je približno 25 do 30 ur, eliminacijski razpolovni čas N-debutilnega presnovka pa približno 20 do 25 ur.
English: The majority had hypertension (86%) and structural heart disease (60%) (including coronary artery disease: 30%; congestive heart failure (CHF): 30%; LVEF<45%: 12%).
Slovenian: Večina je imela hipertenzijo (86 %) in strukturno bolezen srca (60 %) (vključno s koronarno boleznijo [30 %], kongestivnim srčnim popuščanjem [30 %], LVEF < 45 % [12 %]).
English: The mean exposure of the N-debutyl metabolite is decreased by 47% (see section 4.2).
Slovenian: Povprečna izpostavljenost N-debutilnemu presnovku se poveča za 47 % (glejte poglavje 4.2).
English: 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.
Slovenian: Zdravljenje z dronedaronom je treba v teku zdravljenja ustaviti, če se bolniku pojavi kakšno stanje, ki bi povzročilo kontraindikacijo, kot je navedeno v poglavju 4.3.
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).
Slovenian: Ni pričakovati, da bi okvara ledvic spremenila farmakokinetiko dronedarona, ker se v urinu ni izločilo nič nespremenjene snovi, v obliki presnovkov pa se je v njem izločilo samo približno 6 % odmerka (glejte poglavje 4.2).
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.
Slovenian: Odmerek digoksina je treba zmanjšati za približno 50 %, natančno je treba kontrolirati koncentracijo digoksina v serumu in priporočljivo je klinično in elektrokardiografsko spremljanje.
English: Treatment should be initiated and monitored only under specialist supervision (see section 4.4).
Slovenian: Zdravljenje se sme uvesti in spremljati le pod nadzorom specialista (glejte poglavje 4.4).
English: Dronedarone has no significant potential to inhibit CYP 1A2, CYP 2C9, CYP 2C19, CYP 2C8 and CYP 2B6.
Slovenian: Dronedaron nima pomembnega potenciala za zaviranje CYP 1A2, CYP 2C9, CYP 2C19, CYP 2C8 in CYP 2B6.
English: Figure 1 - Relative risk (dronedarone 400 mg twice daily versus placebo) - first cardiovascular hospitalisation or death from any cause.
Slovenian: Slika 1 - Ocene relativnega tveganja (dronedaron 400 mg dvakrat na dan v primerjavi s placebom)prva kardiovaskularna hospitalizacija ali smrt zaradi kateregakoli vzroka.
English: • QTc Bazett interval ≥500 milliseconds
Slovenian: • Interval QTc po Bazettu ≥ 500 milisekund.
English: There have been spontaneously reported events of new or worsening heart failure during treatment with dronedarone.
Slovenian: Spontano so bili prijavljeni primeri novonastalega srčnega popuščanja ali poslabšanja srčnega popuščanja med zdravljenjem z dronedaronom.
English: 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.
Slovenian: V 2-letnih študijah kancerogenosti je bil največji odmerek dronedarona, uporabljan 24 mesecev, 70 mg/kg/dan pri podganah in 300 mg/kg/dan pri miših.
English: Patients developing permanent AF during treatment
Slovenian: Bolniki, ki se jim med zdravljenjem pojavi permanentna AF
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.
Slovenian: Dronedaron je v velikih odmerkih izrazito vplival na embrio-fetalni razvoj pri podganah in je povzročil npr. večje postimplantacijske izgube, zmanjšano maso plodov in placente ter zunanje, visceralne in skeletne malformacije.
English: If QTc Bazett interval is ≥500 milliseconds, dronedarone should be stopped (see section 4.3).
Slovenian: Če je interval QTc po Bazettu ≥ 500 milisekund, je treba prenehati uporabljati dronedaron (glejte poglavje 4.3).
English: Onset of dyspnoea or non-productive cough may be related to pulmonary toxicity and patients should be carefully evaluated clinically.
Slovenian: Pojav dispneje ali neproduktivnega kašlja je lahko povezan s toksičnimi učinki na pljuča, zato je treba bolnike natančno klinično oceniti.
English: In patients, dronedarone and its metabolite are completely eliminated from the plasma within 2 weeks after the end of a 400 mg twice daily-treatment.
Slovenian: Pri bolnikih se dronedaron in njegovi presnovki popolnoma odstranijo iz plazme v 2 tednih po koncu zdravljenja s 400 mg dvakrat na dan.
English: Other medicines and MULTAQ
Slovenian: Druga zdravila in zdravilo MULTAQ
English: • dabigatran (a medicine for prevention of blood clot formation).
Slovenian: • dabigatrana (zdravilo za preprečevanje nastanka krvnih strdkov).
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.
Slovenian: Če morate z amiodarona (to je drugo zdravilo za neredno bitje srca) preiti na zdravilo MULTAQ, vam bo zdravnik morda dal posebna navodila, na primer, da pred prehodom naredite premor z amiodaronom.
English: A potential pharmacodynamic interaction can also be expected with beta-blockers, calcium antagonists and digitalis.
Slovenian: Močno farmakodinamično medsebojno delovanje je mogoče pričakovati tudi z zaviralci beta, kalcijevimi antagonisti in digitalisom.
English: What you need to know before you take MULTAQ
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo MULTAQ
English: Effect of dronedarone on other medicinal products
Slovenian: Vpliv dronedarona na druga zdravila
English: After intravenous administration the volume of distribution at steady state (Vss) ranges from 1,200 to 1,400 L.
Slovenian: Po intravenski uporabi je porazdelitveni volumen v stanju dinamičnega ravnovesja (Vss) od 1200 do 1400 l.
English: • changes in the results of one blood test: your blood creatinine level,
Slovenian: • spremembe v izvidih ene preiskave krvi: koncentracije kreatinina v krvi,
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.
Slovenian: Farmakokinetika dronedarona in njegovega N-debutilnega presnovka se obe zmerno odmikata od sorazmernosti odmerku: 2-kratno povečanje odmerka povzroči približno 2,5- do 3,0-kratno povečanje Cmax in AUC.
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,
Slovenian: • druga zdravila proti visokemu krvnemu tlaku, bolečinam v prsih, ki so posledica koronarne bolezni, ali drugim težavam s srcem, npr. verapamil, diltiazem, nifedipin, metoprolol, propranolol, ali digoksin,
English: While you are taking MULTAQ, your doctor may perform tests to check your medical condition and how the medicine is working for you.
Slovenian: Med jemanjem zdravila MULTAQ vam bo zdravnik morda opravil preiskave, s katerimi bo preveril vaše zdravstveno stanje in kako vam zdravilo deluje.
English: • changes in your ECG (electrocardiogram) called QTc Bazett prolonged.
Slovenian: • spremembe v EKG (elektrokardiogramu), imenovane podaljšan interval „QTc po Bazettu“.
English: After oral administration, approximately 6% of the labelled dose is excreted in urine mainly as metabolites (no unchanged compound excreted in urine) and 84% are excreted in faeces mainly as metabolites.
Slovenian: Po peroralni uporabi se približno 6 % označenega odmerka izloči v urinu, predvsem v obliki presnovkov (nespremenjena spojina se v urinu ne izloči), 84 % pa se ga izloči v blatu, predvsem v obliki presnovkov.
English: Dronedarone could increase plasma concentrations of immunosupressants (tacrolimus, sirolimus, everolimus and cyclosporine).
Slovenian: Dronedaron lahko poveča koncentracijo imunosupresivov (takrolimusa, sirolimusa, everolimusa in ciklosporina) v plazmi.
English: It also prevents ventricular tachycardia and ventricular fibrillation in several animal models.
Slovenian: V več živalskih modelih prepreči tudi ventrikularno tahikardijo in ventrikularno fibrilacijo.
English: The recommended dose is 400 mg twice daily in adults.
Slovenian: Priporočeni odmerek za odrasle je 400 mg dvakrat na dan.
English: • sirolimus, tacrolimus, everolimus and cyclosporine (used after a transplant),
Slovenian: • sirolimus, takrolimus, everolimus in ciklosporin (uporabljajo se po presaditvah),
English: Signs include breathlessness or non-productive cough.
Slovenian: Med znaki so težko dihanje in neproduktiven kašelj.
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.
Slovenian: Pantoprazol (40 mg enkrat na dan), zdravilo, ki poveča želodčni pH brez vpliva na citokrom P450, ni bistveno vplival na farmakokinetiko dronedarona.
English: Bradycardia (see sections 4.3 and
Slovenian: Bradikardija (glejte poglavji 4.3 in 4.4)
English: The effect of renal impairment on dronedarone pharmacokinetics has not been evaluated in a specific study.
Slovenian: Vpliv okvare ledvic na farmakokinetiko dronedarona ni bil ocenjen v specifični študiji.
English: • one tablet during your morning meal and
Slovenian: • eno tableto med jutranjim obrokom in
English: If pulmonary toxicity is confirmed, treatment should be discontinued.
Slovenian: Če je pljučna toksičnost potrjena, je treba zdravljenje ukiniti.
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).
Slovenian: Dronedaron je blokator več kanalov in zavira tokove kalija (vključno z IK(Ach), IKur, IKr, IKs), s čimer podaljša srčni akcijski potencial in refraktarno periodo (III. skupina).
English: Interaction with clopidogrel
Slovenian: Medsebojno delovanje s klopidogrelom
English: It is predicted that dronedarone could also increase the exposure of lovastatin within the same range as simvastatin acid.
Slovenian: Predvidoma bi lahko dronedaron povečal izpostavljenost lovastatinu v enakem razponu kot izpostavljenost simvastatinski kislini.
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).
Slovenian: Zdravilo MULTAQ je indicirano za vzdrževanje sinusnega ritma po uspešni kardioverziji pri odraslih, klinično stabilnih bolnikih s paroksizmalno ali perzistentno atrijsko fibrilacijo (AF).
English: 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.
Slovenian: Študija ANDROMEDA je bila izvedena pri 627 bolnikih z disfunkcijo levega prekata, hospitaliziranih zaradi novonastalega srčnega popuščanja ali poslabšanja srčnega popuščanja, ki so imeli vsaj en pojav kratke sape med minimalno obremenitvijo ali v mirovanju (NYHA razred III ali IV) ali paroksizmalno nočno dispnejo v enem mesecu pred sprejemom.
English: Maintenance of sinus rhythm
Slovenian: Vzdrževanje sinusnega ritma
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).
Slovenian: Opažena je bila večja incidenca tumorjev mamarnih žlez pri mišjih samicah, histiocitnih sarkomov pri miših in hemangiomov na ravni mezenteričnih bezgavk pri podganah, vse samo pri največjem preizkušanem odmerku (ki ustreza od 5- do 10-krat tolikšni izpostavljenosti, kot je dosežena s terapevtskimi odmerki pri človeku).
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
Slovenian: a Določeno iz Coxovega regresijskega modela b Vrednost p za interakcijo med izhodiščnimi značilnostmi in zdravljenjem na podlagi Coxovega regresijskega modela c Kalcijevi antagonisti, ki znižujejo srčno frekvenco, omejeni na diltiazem, verapamil in bepridil
English: Administration of dronedarone to patients receiving digoxin will bring about an increase in the plasma digoxin concentration and thus precipitate symptoms and signs associated with digoxin toxicity.
Slovenian: Uporaba dronedarona pri bolnikih, ki dobivajo digoksin, povzroči povečanje koncentracije digoksina v plazmi in tako sproži simptome in znake toksičnosti digoksina.
English: Lactose monohydrate Colloidal anhydrous silica Magnesium stearate (E572)
Slovenian: laktoza monohidrat brezvodni koloidni silicijev dioksid magnezijev stearat (E572)
English: Heart, lung and blood tests
Slovenian: Preiskave srca, pljuč in krvi
English: Patients should be carefully evaluated for symptoms of Congestive Heart Failure.
Slovenian: Bolnike je treba natančno oceniti glede simptomov kongestivnega srčnega popuščanja.
English: Rifampicin (600 mg once daily) decreased dronedarone exposure by 80% with no major change on its active metabolite exposure.
Slovenian: Rifampicin (600 mg enkrat na dan) je zmanjšal izpostavljenost dronedaronu za 80 %, ni pa bistveno spremenil izpostavljenosti njegovemu aktivnemu presnovku.
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).
Slovenian: Najpogostejši razlog za prenehanje zdravljenja z dronedaronom so bile prebavne motnje (3,2 % bolnikov v primerjavi z 1,8 % v skupini s placebom).
English: In clinical studies, 13% of patients received calcium antagonists concomitantly with dronedarone.
Slovenian: V kliničnih študijah je 13 % bolnikov hkrati z dronedaronom dobivalo kalcijeve antagoniste.
English: Date of first authorisation: 26 November 2009 Date of latest renewal:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve pridobitve dovoljenja za promet: 26. november 2009
English: • Slow heart beat.
Slovenian: • Počasno bitje srca.
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).
Slovenian: Obstajalo je šibko medsebojno delovanje med dronedaronom in statini, ki jih transportira OATP, npr. rosuvastatinom (ki je povzročilo povprečno 1,4-kratno povečanje izpostavljenosti rosuvastatinu).
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.
Slovenian: Po ponavljajoči se uporabi 400 mg dvakrat na dan je stanje dinamičnega ravnovesja doseženo v 4 do 8 dneh zdravljenja; povprečno razmerje kopičenja je za dronedaron od 2,6 do 4,5.
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.
Slovenian: Hemangiomi niso predrakave spremembe in se ne pri živalih ne pri človeku ne spremenijo v maligne hemangiosarkome.
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.
Slovenian: Bolniki so morali imeti vsaj en dejavnik tveganja (vključno s starostjo, hipertenzijo, sladkorno boleznijo, predhodnim cerebrovaskularnim inzultom, premerom levega preddvora ≥ 50 mm ali LVEF < 0,40) ter AF/AU in sinusni ritem, oboje dokumentirano v zadnjih 6 mesecih.