natgillin/translations-raw huggingface dataset:
The study is a randomized, double-blind, placebo-controlled dose-finding study, in the indication of acquired protein C deficiency due to meningococcal sepsis (IMAG 112). 
Med druge izkušnje z uporabo zdravila CEPROTIN sodijo poročila o primerih in klinična študija pri skupaj 69 pediatričnih bolnikih s pridobljenim pomanjkanjem proteina C. Študija je randomizirana, dvojno slepa s placebom kontrolirana študija za ugotavljanje odmerka zdravila za indikacijo pridobljenega pomanjkanja proteina C zaradi meningokokne sepse (IMAG 112).
Concurrent anticoagulant medication (such as heparin) may have been responsible for these bleeding episodes. 
Za te krvavitve je bila lahko odgovorna sočasna antikoagulantna terapija (npr. s heparinom), vendar ni mogoče popolnoma izključiti možnosti, da je uporaba zdravila CEPROTIN dodatno prispevala k tem krvavitvam.
No formal clinical study in either paediatric or neonatal population with severe congenital protein C deficiency was ever conducted. 
Formalne klinične študije niso bile opravljene ne pri pediatričnih bolnikih ne pri novorojenčkih s hudim kongenitalnim pomanjkanjem proteina C, objavljenih pa je bilo več majhnih retrospektivnih in prospektivnih študij, v katerih so raziskovali druga področja klinične uporabe zdravila pri tej populaciji bolnikov.
System Organ Class Adverse Reaction 
Organski sistem Neželeni učinek Prednostni izraz
The expiry date refers to the last day of that month. 
Navodilo je bilo nazadnje revidirano dne .
It is given to you under close supervision of your doctor who is experienced in substitution therapy of coagulation factors/inhibitors and where monitoring of protein C activity is possible. 
Prejeli ga boste pod strogim nadzorom zdravnika z izkušnjami iz nadomestne terapije s faktorji ali zaviralci koagulacije, če bo mogoče spremljanje aktivnosti proteina C. Odmerjanje zdravila bo odvisno od vašega stanja in telesne mase.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV. 
Uvedeni ukrepi štejejo za učinkovite proti virusom z ovojnico, kakršni so HIV, HBV in HCV, ter proti virusu brez ovojnice HAV, lahko pa so omejene vrednosti proti virusom brez ovojnice, kakršen je parvovirus B19.
You may notice any of the following side effects after administration of CEPROTIN: 
Po prejemu zdravila CEPROTIN boste morda opazili katerega od naslednjih neželenih učinkov:
METHOD AND ROUTE(S) OF ADMINISTRATION 
POSTOPEK IN POT(I) UPORABE zdravila
CEPROTIN 1000 IU powder and solvent for solution for injection 
CEPROTIN 1000 i.e. prašek in vehikel za raztopino za injiciranje
Solvent Sterilised Water for Injections 
Vehikel sterilna voda za injekcije
Reconstitute lyophilised CEPROTIN powder for solution for injection, with the supplied solvent (Sterilised Water for Injections) using the sterile transfer needle. 
Liofilizirano zdravilo CEPROTIN prašek za raztopino za injiciranje rekonstituiramo s priloženim vehiklom (sterilna voda za injekcije) z uporabo sterilne pretočne igle.
Baxter AG Industriestrasse 67 A-1221 Vienna Austria 
BAXTER AG Industriestrasse 67 A-1221 Dunaj Avstrija
BAXTER AG Industriestrasse 67 A-1221 Vienna Austria 
Baxter AG Industriestrasse 67 A-1221 Dunaj Avstrija
Pruritus 
Serija
CEPROTIN is used in the treatment and prevention of thrombotic and haemorrhagic skin lesions (named purpura fulminans) in patients with severe congenital protein C deficiency. 
Zdravilo CEPROTIN se uporablja pri zdravljenju in preprečevanju trombotičnih in hemoragičnih kožnih lezij (imenovanih purpura fulminans) pri bolnikih s hudim prirojenim pomanjkanjem proteina C. Poleg tega lahko zdravilo CEPROTIN uporabljamo za zdravljenje redkega zapleta pri uporabi zdravila za redčenje krvi (antikoagulanta, imenovanega kumarin), ki lahko povzroči hudo poškodbo kože (nekrozo).
CEPROTIN 500 IU powder and solvent for solution for injection 
CEPROTIN 500 i.e. prašek in vehikel za raztopino za injiciranje
How to store CEPROTIN 
Shranjevanje zdravila CEPROTIN
The solution is drawn through the sterile filter needle into a sterile disposable syringe. 
Raztopino posesajte skozi sterilno filtrsko iglo v sterilno brizgo za enkratno uporabo.
CEPROTIN is administered by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections. 
Zdravilo CEPROTIN dajte bolniku z intravensko injekcijo po rekonstituciji praška za raztopino za injiciranje s sterilno vodo za injekcije.
The following ADRs have been reported in the post-marketing experience: 
V času trženja zdravila so bili sporočeni naslednji neželeni učinki:
Furthermore CEPROTIN is indicated for short-term prophylaxis in patients with severe congenital protein C deficiency if one or more of the following conditions are met: 
Zdravilo CEPROTIN je indicirano za uporabo pri purpuri fulminans in kumarinski kožni nekrozi pri bolnikih s hudim kongenitalnim pomanjkanjem proteina C. Zdravilo CEPROTIN je indicirano tudi za kratkotrajno profilakso pri bolnikih s hudim kongenitalnim pomanjkanjem proteina C, če je izpolnjen eden ali več od naslednjih pogojev:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular / repeated receipt of human plasma-derived Protein C products. 
Pri bolnikih, ki redno ali večkrat prejemajo pripravke s proteinom C, izdelane iz človeške plazme, po potrebi uvedite ustrezno cepljenje (proti hepatitisu A in B).
The reconstituted solution should be administered immediately by intravenous injection. 
Rekonstituirano raztopino dajte bolniku takoj, z intravensko injekcijo.
CEPROTIN 1000 IU powder and solvent for solution for injection Human Protein C 
CEPROTIN 1000 i.e. prašek in vehikel za raztopino za injiciranje humani protein C
CEPROTIN 1000 IU Powder for solution for injection Human Protein C IV 
CEPROTIN 1000 i.e. prašek za raztopino za injiciranje humani protein C i.v.
CEPROTIN 500 IU Powder for solution for injection Human Protein C IV 
CEPROTIN 500 i.e. prašek za raztopino za injiciranje humani protein C i.v.
Human albumin, sodium chloride and sodium citrate.2H2O 
Humani albumin, natrijev klorid in natrijev citrat .
CEPROTIN 500 IU powder and solvent for solution for injection Human Protein C 
CEPROTIN 500 i.e. prašek in vehikel za raztopino za injiciranje humani protein C
You should not do both. 
Enega in drugega ne smete početi hkrati.
Statins should be used with caution. 
Statine je treba uporabljati previdno.
Both compounds bind mainly to albumin. 
Obe spojini se vežeta predvsem na albumin.
A risk to the newborns/infants cannot be excluded. 
Tveganja za novorojence/dojenčke ni mogoče izključiti.
The following risks: 
Naslednja tveganja:
• feeling tired, 
• utrujenost,
• your skin being more sensitive to the sun, 
• večja občutljivost kože za sonce,
There is no specific antidote available. 
Specifičnega antidota ni.
This effect is considered specific to this species and not relevant to humans. 
Ta učinek velja za specifičnega za to živalsko vrsto in ni pomemben za človeka.
Efficacy and safety were comparable in elderly patients who did not suffer from other cardiovascular diseases and younger patients. 
Učinkovitost in varnost sta bili primerljivi pri starejših bolnikih brez drugih kardiovaskularnih bolezni in pri mlajših bolnikih.
Lactose is a type of sugar. 
Laktoza je vrsta sladkorja.
Each of these factors has a limited influence on dronedarone. 
Vsak od teh dejavnikov ima omejen vpliv na dronedaron.
It is recommended to monitor renal function periodically and to consider further investigations as needed. 
Priporočljivo je redno spremljati delovanje ledvic in razmisliti o dodatnih preiskavah, kot so potrebne.
The mean exposure across studies was 13 months. 
Povprečna izpostavljenost v študijah je bila 13 mesecev.
The tablet cannot be divided into equal doses. 
Tablete ni mogoče razdeliti na enake odmerke.
These effects most likely result from its electrophysiological properties belonging to all four Vaughan-Williams classes. 
Ti učinki so najverjetneje posledica njegovih elektrofizioloških lastnosti, ki pripadajo vsem štirim skupinam po Vaughan-Williamsu.
In ATHENA study, the maximum follow-up was 30 months. 
V študiji ATHENA je bilo najdaljše obdobje spremljanja 30 mesecev.
Appropriate investigation and close observation of patients should continue until normalisation of ALT. 
Ustrezne preiskave in natančno opazovanje bolnikov je treba nadaljevati, dokler se ALT ne normalizira.
The educational material is a Prescriber Guide to: 
Izobraževalno gradivo je predpisovalčev vodnik za:
In most patients this increase occurs early after treatment initiation and reaches a plateau after 7 days. 
Pri večini bolnikov se ta porast pojavi zgodaj po začetku zdravljenja in doseže plato po 7 dneh.
AF recurrence was 63.5% versus 42%, respectively. 
Ponovitev AF je bilo 63,5 % v primerjavi z 42 %.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Your doctor will take this into account when checking your blood levels and will use another reference of the “normal” value of blood creatinine. 
Zdravnik bo pri kontroli krvi to upošteval in bo uporabil drugo referenčno "normalno" vrednost za kreatinin v krvi.
• change in how things taste. 
• spremembe v okusu stvari,
MULTAQ and some other medicines can affect each other and cause serious side effects. 
Zdravilo MULTAQ in nekatera druga zdravila lahko medsebojno vplivajo in povzročijo resne neželene učinke.
Due to its safety profile (see sections 4.3 and 4.4), MULTAQ should only be prescribed after alternative treatment options have been considered. 
Zaradi njegovega profila varnosti (glejte poglavji 4.3 in 4.4), se lahko zdravilo MULTAQ predpiše šele potem, ko so bile pretehtane vse druge možnosti zdravljenja.
The primary endpoint of the study was the time to first hospitalisation for cardiovascular reasons or death from any cause. 
Primarna končna točka študije je bil čas do prve hospitalizacije zaradi kardiovaskularnih vzrokov ali do smrti zaradi kateregakoli vzroka.
• Your doctor may also do other blood tests. 
• Zdravnik bo morda naročil tudi druge preiskave krvi.
• rifampicin - for tuberculosis. 
• rifampicin - za tuberkulozo.
MULTAQ is used only in adults. 
Zdravilo MULTAQ se uporablja le pri odraslih.
Patients who received amiodarone within 4 weeks prior to randomisation were not included. 
Bolniki, ki so v 4 tednih pred randomizacijo dobili amiodaron, niso bili vključeni.
Reduction of risk of AF-related hospitalisation 
Zmanjšanje tveganja za hospitalizacijo zaradi AF
Anaphylactic reactions including angioedema 
Anafilaktične reakcije, vključno z angioedemom
Your heart might beat very slowly or you may feel dizzy. 
V tem primeru vam lahko srce bije zelo počasi ali ste omotični.
In some cases, MULTAQ treatment may need to be stopped. 
V nekaterih primerih je lahko potrebno prenehanje zdravljenja z zdravilom MULTAQ.
Electrolytes imbalance 
Neravnovesje elektrolitov
Your doctor may change the dose of any other medicines you are taking. 
Zdravnik vam lahko spremeni odmerek kateregakoli drugega zdravila, ki ga jemljete.
If a dose is missed, patients should take the next dose at the regular scheduled time and should not double the dose. 
Če bolnik izpusti odmerek, mora vzeti naslednji odmerek ob redno predvidenem času in odmerka ne sme podvojiti.
These changes are linked to the therapeutic effect of dronedarone and do not reflect toxicity. 
Te spremembe so povezane s terapevtskim učinkom dronedarona in niso izraz toksičnosti.
Liver function tests should be performed prior to initiation of treatment with dronedarone, after one week and after one month following initiation of treatment and then repeated monthly for six months, at months 9 and 12, and periodically thereafter. 
Teste jetrne funkcije je treba opraviti pred začetkom zdravljenja z dronedaronom, en teden in en mesec po začetku zdravljenja, in jih šest mesecev ponavljati vsak mesec, nato 9. in 12. mesec in periodično v nadaljevanju.
• Your doctor may check your lungs. 
• Zdravnik vam bo morda pregledal pljuča.
MULTAQ with food and drink 
Zdravilo MULTAQ skupaj s hrano in pijačo
You must tell your doctor or pharmacist if you are taking any of the following medicines: 
Zdravniku ali farmacevtu morate povedati, če jemljete katero od naslednjih zdravil:
• Allergic reactions, including swelling of the face, lips, mouth, tongue or throat. 
• Alergijske reakcije, vključno z otekanjem obraza, ustnic, ust, jezika ali žrela.
If an increase in creatininaemia is observed, serum creatinine should be re-measured after a further 7 days. 
Če kreatininemija poraste, je treba kreatinin v serumu ponovno izmeriti po nadaljnjih 7 dneh.
In the event of overdose, treatment should be supportive and directed toward alleviating symptoms. 
V primeru prevelikega odmerjanja mora biti zdravljenje podporno in usmerjeno v olajšanje simptomov.
Twenty five percent (25%) had AF at baseline. 
Petindvajset odstotkov (25 %) jih je izhodiščno imelo AF.
Interactions (see section 4.5) 
Medsebojna delovanja (glejte poglavje 4.5)
Hepatotoxicity are concerned by the additional minimization measures. 
Hepatotoksičnost so predmet dodatnih ukrepov za zmanjšanje tveganj.
• It is not known if MULTAQ passes into your breast milk. 
• Ni znano, ali zdravilo MULTAQ prehaja v materino mleko.
The content and format of the MULTAQ Prescriber guide, together with the communication and distribution plan should be agreed with the National Competent Authority in each Member State prior to distribution. 
O vsebini in obliki MULTAQ vodnika za predpisovalca ter o načrtu komunikacije in distribucije le-teh, se je potrebno predhodno uskladiti s pristojnimi nacionalnimi organi v vsaki državi članici.
Treatment with MULTAQ will be overseen by a doctor who is experienced in the treatment of heart disease. 
Zdravljenje z zdravilom MULTAQ bo nadzoroval zdravnik, ki ima izkušnje z zdravljenjem srčnih bolezni.
• Periodic safety update reports (PSURs) 
Redno posodobljena poročila o varnosti zdravila (PSUR)
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MULTAQ therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z zdravilom MULTAQ, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
• some medicines for depression called tricyclic antidepressants, 
• nekaterih zdravil za depresijo, imenovanih triciklični antidepresivi,
In the event of overdose, monitor the patient's cardiac rhythm and blood pressure. 
V primeru prevelikega odmerjanja bolniku kontrolirajte srčni ritem in krvni tlak.
If no further increase in creatininaemia is observed, this value should be used as the new reference baseline taking into account that this may be expected with dronedarone. 
Če ni nadaljnjega porasta kreatininemije, je treba to ugotovljeno vrednost uporabiti kot novo referenčno izhodišče in upoštevati, da je to med uporabo dronedarona pričakovano.
Gender, age and weight are factors that influence the pharmacokinetics of dronedarone. 
Spol, starost in telesna masa so dejavniki, ki vplivajo na farmakokinetiko dronedarona.
It should be considered that amiodarone may have a long duration of action after discontinuation due to its long half-life. 
Upoštevati je treba, da lahko amiodaron zaradi svojega dolgega razpolovnega časa deluje še zelo dolgo po prenehanju uporabe.
Do not use this medicine if you notice any visible sign of deterioration (see section 6). 
Tega zdravila ne smete uporabiti, če opazite kakšne vidne znake kvarjenja (glejte poglavje 6).
It reduces alpha-adrenergic blood pressure response to epinephrine and beta1 and beta2 responses to isoproterenol. 
Zmanjša alfa-adrenergični odziv krvnega tlaka na adrenalin in odziv beta1 in beta2 na izoproterenol.
Children and adolescents MULTAQ is not recommended in children and adolescents below 18 years of age. 
Otroci in mladostniki Zdravilo MULTAQ ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
Patients with coronary artery disease 
Bolniki z boleznijo koronarnih arterij
Tell your doctor about all the medicines you take. 
Zdravniku morate povedati za vsa zdravila, ki jih jemljete.
• MULTAQ is not recommended if you are pregnant or you think you may be pregnant. 
• Uporaba zdravila MULTAQ ni priporočljiva, če ste noseči ali domnevate, da ste noseči.
QT prolongation 
Podaljšanje QT
If this applies to you (or you are not sure), please talk to your doctor or pharmacist before taking MULTAQ. 
Če to velja za vas (ali če niste prepričani), se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo MULTAQ.
In animals, dronedarone prevents atrial fibrillation or restores normal sinus rhythm depending on the model used. 
Pri živalih dronedaron prepreči atrijsko fibrilacijo ali obnovi normalen sinusni ritem, odvisno od uporabljenega modela.
In the pooled data from EURIDIS and ADONIS as well as in the individual trials, dronedarone consistently delayed the time to first recurrence of AF/AFL (primary endpoint). 
Tako po kumulativnih podatkih preskušanj EURIDIS in ADONIS kot v obeh posameznih preskušanjih je dronedaron dosledno podaljšal čas do prve ponovitve AF/AU (primarna končna točka).
• losing your sense of taste, 
• izguba okusa,
If alanine aminotransferase (ALT) levels are elevated ≥3 × upper limit of normal (ULN), ALT levels should be re-measured within 48 to 72 hours. 
Če je ALT (alanin-aminotransferaza) zvišana na ≥ 3-kratno zgornjo normalno mejo (ZNM), je treba meritev ALT ponoviti v 48 do 72 urah.
It non-competitively antagonises adrenergic activities (Class II). 
Nekompetitivno antagonizira adrenergične učinke (III. skupina).
There was no increased risk of hypotension, bradycardia and heart failure. 
Tveganje hipotenzije, bradikardije in srčnega popuščanja se ni povečalo.
Following oral administration in fed condition, dronedarone is well absorbed (at least 70%). 
Po peroralni uporabi na poln želodec se dronedaron dobro absorbira (vsaj 70 %).
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Some adverse reactions were also identified during post-marketing surveillance. 
Nekaj neželenih učinkov so opazili tudi med nadzorom v obdobju trženja zdravila.
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Treatment should be supportive and based on symptoms. 
Zdravljenje mora biti podporno in simptomatsko.
Forty seven percent (47%) of patients were female and a majority was Caucasian (89%). 
Sedeminštirideset odstotkov (47 %) je bilo žensk in večina je bilo belk (89 %).
Patients had at least one ECG-documented AF/AFL episode during the last 3 months and were in sinus rhythm for at least one hour and were followed for 12 months. 
Bolniki so imeli v zadnjih 3 mesecih vsaj eno z EKG dokumentirano epizodo AF/AU, so bili v sinusnem ritmu vsaj eno uro ter so jih spremljali 12 mesecev.
Patients could be in AF/AFL or in sinus rhythm after spontaneous conversion or following any procedures. 
Bolniki so lahko imeli AF/AU ali sinusni ritem po spontani konverziji ali po kakršnemkoli ukrepu.
• Bradycardia <50 beats per minute (bpm) 
• Bradikardija < 50 utripov na minuto.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• If you are taking some medicines against blood clot formation such as warfarin, your doctor will order a blood test called INR to check how well your medicine is working. 
• Če jemljete kakšna zdravila proti nastajanju krvnih strdkov, na primer varfarin, vam bo zdravnik naročil preiskavo krvi, imenovano INR, da bo preveril, kako dobro deluje zdravilo.
It is recommended to perform ECGs serially, at least every 6 months. 
Priporočljive so redne kontrole EKG vsaj enkrat na 6 mesecev.
The safety and efficacy of MULTAQ in children aged below 18 years of age have not yet been established. 
Varnost in učinkovitost zdravila MULTAQ nista ugotovljeni pri otrocih, mlajših od 18 let.
The clinical relevance of this observation is not known (see sections 4.4 and 5.2). 
Klinični pomen tega opažanja ni znan (glejte poglavji 4.4 in 5.2).
• Patients in unstable hemodynamic conditions 
• Bolniki z nestabilnimi hemodinamskimi stanji.
What MULTAQ is and what it is used for 
Kaj je zdravilo MULTAQ in za kaj ga uporabljamo
• Your doctor may look at your heart's electrical activity using an ECG (electrocardiogram) 
• Zdravnik vam lahko kontrolira električno delovanje srca z napravo za EKG (elektrokardiografijo).
Your doctor will consider all available treatment options before prescribing MULTAQ to you. 
Zdravnik bo razmislil o vseh možnostih zdravljenja, preden vam bo predpisal zdravilo MULTAQ.
However due to presystemic first pass metabolism, the absolute bioavailability of dronedarone (given with food) is 15%. 
Toda zaradi predsistemske presnove prvega prehoda je absolutna biološka uporabnost dronedarona (danega s hrano) 15 %.
• Patients with liver and lung toxicity related to the previous use of amiodarone 
• Bolniki s toksičnimi učinki na jetra ali pljuča, povezanimi s predhodno uporabo amiodarona.
Patients with symptoms of heart failure at rest or with minimal exertion within the previous month or who were hospitalised for heart failure during the previous month 
Bolniki s simptomi srčnega popuščanja v mirovanju ali med minimalnim naporom v preteklem mesecu, ali ki so bili hospitalizirani zaradi srčnega popuščanja v preteklem mesecu
Pharmacotherapeutic group: cardiac therapy, antiarrhythmics class III, ATC code: C01BD07 
Farmakoterapevtska skupina: zdravila za bolezni srca, antiaritmik skupine III. Oznaka ATC: C01BD07
If you forget to take MULTAQ 
Če ste pozabili vzeti zdravilo MULTAQ
Monitoring of co-administered medicinal products like digoxin and anti-coagulants is necessary. 
Potrebne so kontrole sočasno uporabljanih zdravil, npr. digoksina in antikoagulansov.
If serum creatinine continues to rise then consideration should be given to further investigation and discontinuing treatment. 
Če kreatinin v serumu še naprej narašča, pridejo v poštev dodatne preiskave in prenehanje zdravljenja.
The most common co-morbidities were hypertension (56.8%) and structural heart disease (41.5%) including coronary heart disease (21.8%). 
Najpogostejša komorbidna stanja so bila hipertenzija (56,8 %) in strukturne bolezni srca (41,5 %), vključno s koronarno boleznijo (21,8 %).
A total of 504 patients with documented AF were randomised, 249 received dronedarone and 255 received amiodarone. 
Skupaj so bili randomizirani 504 bolniki z dokumentirano AF: 249 jih je dobilo dronedaron in 255 amiodaron.
• Do not take MULTAQ if you are a woman able to have children and you are not using a reliable contraceptive method. 
• Ne jemljite zdravila MULTAQ, če ste ženska, ki bi lahko zanosila, in ne uporabljate zanesljive kontracepcije.