natgillin/translations-raw huggingface dataset:
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. 
Bolniki morajo svojega zdravnika nemudoma obvestiti o vsakem možnem simptomu okvare jeter (npr. trajajočih novonastalih bolečinah v trebuhu, anoreksiji, navzei, bruhanju, zvišani telesni temperaturi, splošnem slabem počutju, zlatenici, temnem urinu ali srbenju).
• some medicines against blood clot formation such as warfarin, 
• nekatera zdravila za preprečevanje nastanka krvnih strdkov kot varfarin,
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. 
Dronedaron pri človeku šibko zavira CYP 2D6, zato ima predvidoma malo medsebojnih delovanj z antidepresivnimi zdravili, ki se presnovijo s CYP 2D6.
Patients should be followed for the development of left ventricular systolic dysfunction during treatment. 
Bolnike je treba kontrolirati glede nastanka sistolične disfunkcije levega prekata med zdravljenjem.
Therefore, inhibitors and inducers of CYP 3A4 have the potential to interact on dronedarone. 
Zaradi tega lahko zaviralci in induktorji CYP 3A4 medsebojno delujejo z dronedaronom.
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. 
Ponavljajoči se odmerki eritromicina (500 mg trikrat na dan 10 dni) so povzročili 3,8-kratno povečanje izpostavljenosti dronedaronu v stanju dinamičnega ravnovesja.
Blood creatinine increased* QTc Bazett prolonged # * ≥10% five days after treatment initiation (see section 4.4) # >450 msec in male >470 msec in female (see section 4.4) Description of selected adverse reactions 
* ≥ 10 % pet dni po začetku zdravljenja (glejte poglavje 4.4) # > 450 msec pri moških oz. > 470 msec pri ženskah (glejte poglavje 4.4)
• other skin problems such as redness of the skin or eczema (redness, itching, burning or blistering), 
• druge težave s kožo, npr. pordelost kože ali ekcem (rdečina, srbenje, pekoč občutek ali nastajanje mehurjev),
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%). 
Študija PALLAS je bila randomizirana, s placebom kontrolirana študija, ki je preučevala klinično korist dronedarona 400 mg dvakrat na dan poleg standardnega zdravljenja pri bolnikih s permanentno (kronično) atrijsko fibrilacijo in dodatnimi dejavniki tveganja (bolniki s kongestivnim srčnimi popuščanjem ~69 %, koronarno boleznijo srca ~41 %, predhodno možgansko kapjo ali TIA ~27 %, iztisni delež levega prekata [LVEF] ≤ 40 % ~20,7 % in bolnikih, starih 75 let ali več s hipertenzijo in sladkorno boleznijo ~18 %).
• some medicines for epilepsy called phenobarbital, carbamazepine or phenytoin, 
• nekatera zdravila za epilepsijo (fenobarbital, karbamazepin ali fenitoin),
Sanofi Winthrop Industrie 1 rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc Cedex - France 
Sanofi Winthrop Industrie 1 rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc Cedex - Francija
• ritonavir (a medicine for AIDS infection), 
• ritonavirja (zdravilo za aids),
Due to the pharmacokinetic interaction and possible pharmacodynamic interaction, beta-blockers should be used with caution concomitantly with dronedarone. 
Zaradi farmakokinetičnih in možnih farmakodinamičnih medsebojnih delovanj je treba zaviralce beta uporabljati previdno, kadar so uporabljeni istočasno z dronedaronom.
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). 
- Pomožne snovi v jedru tablete so hipromeloza (E464), koruzni škrob, krospovidon (E1202), poloksamer 407, laktoza monohidrat (glejte poglavje 2 razdelek »Zdravilo MULTAQ vsebuje laktozo«, brezvodni koloidni silicijev dioksid, magnezijev stearat (E572).
Patients ranged in age from 20 to 88 years, with the majority being Caucasian (97%), male (69%) patients. 
Bolniki so bili stari od 20 do 88 let; večina je bila belcev (97 %) in moških (69 %).
• some tranquilising medicines called phenothiazines, 
• nekaterih pomirjeval, imenovanih fenotiazini,
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. 
Število smrti zaradi kateregakoli vzroka je bilo med potekom študije v skupini z dronedaronom (116/2301) primerljivo tistemu v skupini s placebom (139/2327).
100x1 film-coated tablets 
100 x 1 filmsko obložena tableta
The active substance is dronedarone. 
- Zdravilna učinkovina je dronedaron.
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès et Lagrave F-33565 Carbon Blanc Cedex France 
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès et Lagrave F-33565 Carbon Blanc Cedex Francija
Repeated doses of 300 ml of grapefruit juice three times daily resulted in a 3-fold increase in dronedarone exposure. 
Ponavljajoči se odmerki 300 ml grenivkinega soka trikrat na dan so povzročili 3-kratno povečanje izpostavljenosti dronedaronu.
Therefore, patients should be warned to avoid grapefruit juice beverages while taking dronedarone (see section 4.4). 
Zato je treba bolnike opozoriti, naj med jemanjem dronedarona ne pijejo napitkov z grenivkinim sokom (glejte poglavje 4.4).
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. 
Filmsko obložene tablete MULTAQ so na voljo v pakiranjih po 20, 50 in 60 tablet v neprozornih pretisnih omotih iz PVC in aluminija ter kot 100 x 1 tableta v neprozornih perforiranih pretisnih omotih za enkratni odmerek.
Available pharmacodynamic/toxicological data in animals have shown excretion of dronedarone and its metabolites in milk. 
Farmakodinamski in toksikološki podatki, pridobljeni pri živalih, kažejo, da se dronedaron in njegovi presnovki izločajo v materinem mleku.
No dose adjustment is required in other patients with renal impairment (see sections 4.4 and 5.2). 
Drugim bolnikom z okvaro ledvic odmerka ni treba prilagoditi (glejte poglavji 4.4 in 5.2).
Larger increases in creatinine after dronedarone initiation have been reported in the post-marketing setting. 
Med obdobjem trženja so bili opisani večji porasti kreatinina po uvedbi dronedarona.
Cardiac disorders Congestive heart failure (see below) 
Zastojno srčno popuščanje (glejte spodaj)
• some medicines for reducing the cholesterol in your blood (such as simvastatin, lovastatin, 
• nekatera zdravila za znižanje holesterola v krvi (npr. simvastatin, lovastatin, atorvastatin ali rosuvastatin),
Monoamine Oxidases contribute partially to the metabolism of the active metabolite of dronedarone (see section 4.5). 
Monoaminooksidaze delno prispevajo k presnovi aktivnega presnovka dronedarona (glejte poglavje 4.5).
Dronedarone is extensively metabolised, mainly by CYP 3A4 (see section 4.5). 
Dronedaron se izdatno presnovi, predvsem s CYP 3A4 (glejte poglavje 4.5).
Swallow the tablet whole with a drink of water during a meal. 
Jemanje tega zdravila Tableto pogoltnite celo s kozarcem vode med jedjo.
quinidine, disopyramide, dofetilide, sotalol, amiodarone, 
kinidina, dizopiramida, dofetilida, sotalola ali amiodarona,
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%). 
Randomiziranih je bilo 4628 bolnikov, ki so bili zdravljeni do največ 30 mesecev (mediano spremljanje: 22 mesecev) bodisi z dronedaronom 400 mg dvakrat na dan (2301 bolnik) ali placebom (2327 bolnikov), in sicer poleg konvencionalnega zdravljenja, ki je vključevalo zaviralce beta (71 %), zaviralce ACE ali antagoniste receptorjev angiotenzina II (69 %), digitalis (14 %), kalcijeve antagoniste (14 %), statine (39 %), peroralne antikoagulanse (60 %), kronično antiagregacijsko zdravljenje (6 %) in/ali diuretike
Interaction with P-gp substrates Digoxin 
Medsebojno delovanje s substratom P-gp
Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting dronedarone. 
Pred začetkom zdravljenja z dronedaronom je treba prenehati uporabljati antiaritmike iz I. in III. skupine (npr. flekainid, propafenon, kinidin, dizopiramid, dofetilid, sotalol, amiodaron).
MULTAQ must not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure. 
Zdravila MULTAQ ne smejo dobiti bolniki s sistolično disfunkcijo levega prekata; prav tako ga ne smejo dobiti bolniki, ki imajo trenutno srčno popuščanje ali so ga imeli kdaj v preteklosti.
Do not use this medicine after the expiry date, which is stated on the blister and carton after “EXP.” The expiry date refers to the last day of that month. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli za oznako "EXP".
• other medicines used to control an irregular or fast heart beat such as flecainide, propafenone, 
• drugih zdravil, ki se uporabljajo za obvladovanje hitrega bitja srca, npr. flekainida, propafenona,
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. 
Ob sočasnem jemanju dabigatran eteksilata 150 mg enkrat dnevno in dronedarona 400 mg dvakrat dnevno se je AUC dabigatrana povečala za 100% in Cmax za 70%.
Treatment with dronedarone can be initiated in an outpatient setting. 
Zdravljenje z dronedaronom je mogoče uvesti ambulantno.
Sotalol must be stopped before starting dronedarone (see sections 4.2 and 4.3). 
Pred uvedbo dronedarona je treba končati zdravljenje s sotalolom (glejte poglavji 4.2 in 4.3).
Rare (1/10,000 to 
Redki ( 1/10.000 do
Dronedarone is primarily metabolised by CYP 3A4 (see section 5.2). 
Dronedaron se presnovi predvsem s CYP 3A4 (glejte poglavje 5.2).
Potent CYP3A4 inducers such as rifampicin, phenobarbital, carbamazepine, phenytoin or St John's Wort are not recommended. 
Močni induktorji CYP3A4, npr. rifampicin, fenobarbital, karbamazepin, fenitoin in šentjanževka, niso priporočljivi.
In clinical studies, increased levels of digitalis and/or gastrointestinal disorders indicating digitalis toxicity were observed when dronedarone was co-administered with digitalis. 
V kliničnih študijah so v primerih sočasne uporabe dronedarona in digitalisa opazili večjo koncentracijo digitalisa in/ali prebavne motnje, ki nakazujejo toksičnost digitalisa.
Patients ranged in age from 28 to 90 years, 49% were more than 65 years old. 
Bolniki so bili stari od 28 do 90 let; 49 % jih je bilo starih 65 let ali več.
The other ingredients in the tablet coat are hypromellose (E464), macrogol 6000, titanium dioxide (E171), carnauba wax (E903). 
- Pomožne snovi v oblogi tablete so hipromeloza (E464), makrogol 6000, titanov dioksid (E171), karnauba vosek (E903).
Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France 
Imetnik dovoljenja za promet sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - Francija
Moreover, digitalis has the potential to interact with dronedarone from a pharmacodynamic point of view. 
Poleg tega lahko digitalis z dronedaronom medsebojno deluje s farmakodinamičnega stališča.
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). 
V poštev pridejo manjši začetni odmerek in manjši vzdrževalni odmerki statinov v skladu z veljavnimi priporočili za posamezen statin, bolnike pa je treba kontrolirati glede kliničnih znakov toksičnih učinkov na mišice (glejte poglavje 4.4).
It is recommended to swallow the tablet whole with a drink of water during a meal. 
Tableto je priporočljivo zaužiti celo z nekaj vode in med jedjo.
Dronedarone is contraindicated in patients with severe hepatic impairment because of the absence of data (see sections 4.3 and 4.4). 
Dronedaron je zaradi pomanjkanja podatkov kontraindiciran pri bolnikih s hudo okvaro jeter (glejte poglavji 4.3 in 4.4).
If patients treated with dronedarone develop permanent AF, treatment with dronedarone should be discontinued. 
Če se bolnikom, ki prejemajo dronedaron, pojavi permanentna AF, je treba zdravljenje z dronedaronom ukiniti.
Some cases also reported increases in blood urea nitrogen possibly due to hypoperfusion secondary to developing CHF (pre-renal azotaemia). 
V nekaterih primerih je bila zabeležena tudi porast koncentracije sečnine v serumu, morda zaradi hipoperfuzije, ki je posledica pojava kongestivnega srčnega popuščanja (prerenalna azotemija).
Signs include swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase. 
Med znaki so oteklost stopal ali nog, težko dihanje leže ali med spanjem, kratka sapa med gibanjem ali povečanje telesne teže.
The pharmacokinetics of dronedarone in patients with AF is consistent with that in healthy subjects. 
Farmakokinetika dronedarona se pri bolnikih z AF sklada s tisto pri zdravih preiskovancih.
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. 
V kliničnih študijah je bilo med bolniki, zdravljenimi z dronedaronom 11,8 % predčasnih prekinitev zaradi neželenih učinkov in 7,7 % med tistimi, ki so dobivali placebo.
In elderly patients ≥75 years with multiple co-morbidities, clinical signs of heart failure and ECG should be monitored on a regular basis (see sections 4.2 and 5.1). 
Bolnike, stare 75 let ali več, ki imajo sočasno še druge bolezni je potrebno redno spremljati glede kliničnih znakov srčnega popuščanja in jim redno kontrolirati EKG (glejte poglavji 4.2 in 5.1).
A synergistic effect on heart rate and atrio-ventricular conduction is possible. 
Možen je sinergističen učinek na srčno frekvenco in atrioventrikularno prevajanje.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product. 
Zato ga ne smejo jemati bolniki z redkimi prirojenimi motnjami, kot so galaktozna intoleranca, oblika popolnoma zmanjšane aktivnosti laktaze ali malabsorbcija laktoze.
Patients ranged in age from 27 to 96 years, 68% were more than 65 years old. 
Bolniki so bili stari od 27 do 96 let; 68 % jih je bilo starih 65 let ali več.
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. 
Med znaki so bolečine ali nelagodje v trebuhu, izguba apetita, slabost v želodcu (siljenje na bruhanje), bruhanje, porumenelost kože in očesnih beločnic (zlatenica), nenavadno temen urin, utrujenost (zlasti skupaj z drugimi zgoraj naštetimi simptomi), srbenje.
A synergistic effect on heart rate and atrioventricular conduction is also possible. 
Možen je tudi sinergističen učinek na srčno frekvenco in atrioventrikularno prevajanje.
Crospovidone (E1202) Poloxamer 407 
Jedro tablete hipromeloza (E464) koruzni škrob krospovidon (E1202) poloksamer 407
More gastrointestinal adverse events, mainly diarrhoea, were observed in the dronedarone group (12.9% versus 5.1%). 
V skupini, ki je dobivala dronedaron, so opazili več neželenih učinkov na prebavilih, zlasti driske (12,9 % v primerjavi s 5,1 %).
In patients already on calcium antagonists or beta blockers at time of dronedarone initiation, an ECG should be performed and the dose should be adjusted if needed. 
Bolnikom, ki v času uvedbe dronedarona že dobivajo kalcijeve antagoniste ali zaviralce beta, je treba posneti EKG in jim odmerek prilagoditi, če je treba.
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). 
Dronedaron je kontraindiciran pri bolnikih v nestabilnem hemodinamskem stanju, s srčnim popuščanjem ali sistolično disfunkcijo levega prekata trenutno ali v anamnezi (glejte poglavje 4.3).
The results of one of the blood tests to check kidney function (blood creatinine levels) may be changed by MULTAQ. 
Zdravilo MULTAQ lahko spremeni izvide ene od preiskav krvi,s katero se preverja delovanje ledvic (koncentracija kreatinina v krvi).
Dronedarone (400 mg twice daily) increased digoxin exposure by 2.5-fold by inhibiting P-gp transporter. 
Dronedaron (400 mg dvakrat na dan) je z zavrtjem transporterja P-gp povečal izpostavljenost digoksinu za 2,5-krat.
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). 
Zato je sočasna uporaba ketokonazola in drugih močnih zaviralcev CYP 3A4, npr. itrakonazola, vorikonazola, pozakonazola, ritonavirja, telitromicina, klaritromicina in nefazodona, kontraindicirana (glejte poglavje 4.3).
Moreover, beta-blockers have the potential to interact with dronedarone from a pharmacodynamic point of view. 
Poleg tega lahko zaviralci beta z dronedaronom medsebojno delujejo s farmakodinamičnega stališča.
Adverse reactions are presented by system organ class. 
Neželeni učinki so razvrščeni po organskih sistemih.
MULTAQ 400 mg film-coated tablets dronedarone 
MULTAQ 400 mg filmsko obložene tablete dronedaron
• Your doctor will order blood tests to check your liver function before you start taking 
• Zdravnik bo naročil preiskave krvi za spremljanje delovanja jeter preden začnete prejemati zdravilo MULTAQ in med zdravljenjem.
• 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, 
- Zdravniku morate nemudoma povedati, če se vam pojavi kateri od naslednjih znakov in simptomov težav z jetri: bolečine ali nelagodje v trebuhu, izguba apetita, slabost v želodcu, slabost, bruhanje, porumenelost kože ali očesnih beločnic (zlatenica), nenavadno temen urin, utrujenost (zlasti v povezavi z drugimi zgoraj naštetimi simptomi), srbenje.
Grapefruit juice should not be taken together with to dronedarone (see section 4.5). 
Hkrati z dronedaronom se ne sme uživati grenivkinega soka (glejte poglavje 4.5).
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. 
Zato ni priporočljiva sočasna uporaba rifampicina in drugih močnih induktorjev CYP 3A4, kakršni so npr. fenobarbital, karbamazepin, fenitoin in šentjanževka, ker zmanjšajo izpostavljenost dronedaronu.
• problems with your digestive system such as indigestion, diarrhoea, nausea, vomiting and stomach pain, 
• težave s prebavnim sistemom, npr. prebavne motnje, driska, slabost v želodcu, bruhanje in bolečine v želodcu
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). 
V teh študijah je bilo randomiziranih skupaj 6285 bolnikov (3282 jih je dobivalo dronedaron 400 mg dvakrat na dan in 2875 placebo).
Calcium antagonists, diltiazem and verapamil, are substrates and/or moderate inhibitors of CYP 3A4. 
Kalcijeva antagonista diltiazem in verapamil sta substrata in/ali zmerna zaviralca CYP 3A4.
Dronedarone does not affect the pharmacokinetics of omeprazole, a CYP 2C19 substrate. 
Medsebojno delovanje z omeprazolom (substrat CYP 2C19) Dronedaron ne vpliva na farmakokinetiko omeprazola, substrata CYP 2C19.
You and your doctor should decide if you will take MULTAQ or breastfeed. 
ali boste jemali zdravilo MULTAQ ali boste dojili.
Grapefruit juice (CYP 3A4 inhibitor) 
Grenivkin sok (zaviralec CYP 3A4)
Dronedarone is a moderate inhibitor of CYP 3A4, a mild inhibitor of CYP 2D6 and a potent inhibitor of P-glycoproteins (P-gp). 
Dronedaron zmerno zavira CYP 3A4, blago zavira CYP 2D6 in močno zavira P-glikoproteine (P-gp).
In the 5 placebo controlled studies, 0.6% of patients in the dronedarone group had pulmonary events versus 0.8% of patients receiving placebo. 
Intersticijske bolezni pljuč, vključno s pnevmonitisom in pljučno fibrozo V 5 s placebom kontroliranih študijah so se pljučni dogodki pojavili pri 0,6 % bolnikov v skupini z dronedaronom in pri 0,8 % bolnikov, ki so prejemali placebo.
Uncommon (1/1,000 to 
Občasni ( 1/1.000 do
Interaction with medicinal products metabolised by CYP 2D6 Beta-blockers 
Medsebojna delovanja z zdravili, ki se presnovijo s CYP 2D6
Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience (frequency not known). 
Med obdobjem trženja so bili opisani primeri intersticijske bolezni pljuč, vključno s pnevmonitisom in pljučno fibrozo (pogostnost neznana).
• Liver problems including life threatening liver failure. 
• Težave z jetri, vključno s smrtno nevarno odpovedjo jeter.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of dronedarone (as hydrochloride). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 400 mg dronedarona (v obliki klorida).
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). 
Po 12 mesecih je bila incidenca te primarne končne točke v skupini z dronedaronom 75 % in v skupini z amiodaronom 59 % (razmerje ogroženosti = 1,59, vrednost p za log-rang < 0,0001).
Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride). 
Ena filmsko obložena tableta vsebuje 400 mg dronedarona (v obliki klorida).
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). 
Zaradi možnega tveganja proaritmičnih učinkov so kontraindicirana zdravila, ki inducirajo torsades de pointes, npr. fenotiazini, cisaprid, bepridil, triciklični antidepresivi, nekateri peroralni makrolidi (kot eritromicin), terfenadin in antiaritmiki iz I. in III. skupine (glejte poglavje 4.3).
What MULTAQ contains 
Kaj vsebuje zdravilo MULTAQ
• some medicines for fungal infections such as ketoconazole, voriconazole, itraconazole or posaconazole, 
• nekaterih zdravil za glivične okužbe, npr. ketokonazola, vorikonozola, itrakonazola ali pozakonazola,