FrancophonIA/ELRC3.0 huggingface dataset:
English: Dronedarone has, therefore, the potential to interact on medicinal products substrates of P-glycoproteins, CYP 3A4 or CYP 2D6.
Croatian: Stoga, dronedaron može ući u interakciju s lijekovima koji su supstrati P-glikoproteina, CYP3A4 ili CYP2D6.
English: Medicinal products inducing torsades de pointes
Croatian: Lijekovi koji induciraju torsades de pointes
English: In such cases dronedarone should be stopped (see sections 4.3 and 4.4).
Croatian: U takvim slučajevima liječenje dronedaronom treba prekinuti (vidjeti dijelove 4.3. i 4.4).
English: • you have a condition when the vessel that supplies blood to heart muscle becomes hardened and narrowed (coronary artery disease).
Croatian: • ako imate bolest kod koje dolazi do otvrdnuća i sužavanja krvnih žila koje opskrbljuju srčani mišić krvlju (bolest koronarnih arterija).
English: 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).
Croatian: Primjena dronedarona (600 mg dvaput na dan) povećala je koncentraciju S-varfarina 1,2 puta, nije utjecala na koncentraciju R-varfain, a međunarodni normalizirani omjer (INR) povećala je samo za 1,07.
English: This reduction was driven by the occurrence of significantly fewer thyroid and neurological events and a trend for less skin or ocular events, and fewer premature study drug discontinuations compared to the amiodarone group.
Croatian: Na to je smanjenje najviše utjecao značajno manji broj događaja povezanih sa štitnjačom i neuroloških nuspojava te tendencija manjeg broja kožnih i očnih nuspojava kao i manje prijevremenih prekida primjene lijeka u usporedbi sa skupinom koja je primala amiodaron.
English: Patients should be followed for the development of left ventricular systolic dysfunction during treatment.
Croatian: U bolesnika treba pratiti eventualni razvoj sistoličke disfunkcije lijeve klijetke tijekom liječenja.
English: The effect of renal impairment on dronedarone pharmacokinetics has not been evaluated in a specific study.
Croatian: Učinak oštećenja bubrežne funkcije na farmakokinetiku dronedarona nije ispitan u posebnom ispitivanju.
English: The effect of severe hepatic impairment on the pharmacokinetics of dronedarone was not assessed (see section 4.3).
Croatian: Nije ispitan učinak teškog oštećenja jetrene funkcije na farmakokinetiku dronedarona (vidjeti dio 4.3).
English: A synergistic effect on heart rate and atrioventricular conduction is also possible.
Croatian: Također je moguć sinergistički učinak na srčani ritam i atrioventikularnu provodljivost.
English: Repeated doses of erythromycin (500 mg three times a day for 10 days) resulted in an increase in steady state dronedarone exposure of 3.8-fold.
Croatian: Ponovljene doze eritromicina (500 mg triput na dan tijekom 10 dana) dovele su do 3,8 puta veće izloženosti dronedaronu u stanju dinamičke ravnoteže.
English: Therefore, patients should be warned to avoid grapefruit juice beverages while taking dronedarone (see section 4.4).
Croatian: Bolesnike stoga treba upozoriti da tijekom liječenja dronedaronom izbjegavaju napitke koji sadrže sok od grejpa (vidjeti dio 4.4).
English: • Slow heart beat.
Croatian: • Spori otkucaji srca.
English: Patients should immediately report any symptoms of potential liver injury (such as sustained new-onset abdominal pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine or itching) to their physician.
Croatian: Bolesnici svome liječniku odmah moraju prijaviti svaki simptom mogućeg oštećenja jetre (poput novonastalih upornih bolova u abdomenu, anoreksije, mučnine, povraćanja, vrućice, malaksalosti, umora, žutice, tamne mokraće ili svrbeža).
English: Interstitial lung disease including pneumonitis and pulmonary fibrosis
Croatian: Intersticijske bolesti pluća uključujući pneumonitis i plućnu fibrozu
English: Follow up, including ECG (electrocardiogram), is recommended during treatment.
Croatian: Tijekom liječenja se preporučuju kontrolni pregledi, uključujući EKG (elektrokardiogram).
English: 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.
Croatian: MULTAQ filmom obložene tablete dolaze u pakiranjima od 20, 50, 60 tableta u neprozirnim PVC/ aluminij blisterima te u pakiranju sa 100x1 tabletom u neprozirnim PVC/aluminij perforiranim blisterima s jediničnim dozama.
English: In the 5 placebo controlled studies, 0.6% of patients in the dronedarone group had pulmonary events versus 0.8% of patients receiving placebo.
Croatian: U 5 placebom kontroliranih ispitivanja plućni su događaji nastupili u 0,6% bolesnika koji su primali dronedaron i u 0,8% bolesnika koji su primali placebo.
English: • some medicines for fungal infections such as ketoconazole, voriconazole, itraconazole or posaconazole,
Croatian: • neke lijekove za liječenje gljivičnih infekcija, kao što su ketokonazol, vorikonazol, itrakonazol ili posakonazol,
English: Careful monitoring during dronedarone administration is recommended by regular assessment of cardiac, hepatic and pulmonary function (see below).
Croatian: Tijekom primjene dronedarona preporučuje se pažljivo praćenje bolesnika u obliku redovitih kontrola srčane, jetrene i plućne funkcije (vidjeti u nastavku).
English: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET sanofi-aventis groupe
English: More gastrointestinal adverse events, mainly diarrhoea, were observed in the dronedarone group (12.9% versus 5.1%).
Croatian: U skupini koja je primala dronedaron primijećen je veći broj gastrointestinalnih nuspojava, uglavnom proljeva (12,9% naspram 5,1%).
English: Patients should be warned to avoid grapefruit juice beverages while taking dronedarone.
Croatian: Bolesnike treba upozoriti da tijekom liječenja dronedaronom izbjegavaju napitke koji sadrže sok od grejpa.
English: Monitor patients during treatment and discontinue dronedarone when required ECG
Croatian: • nadzor bolesnika tijekom liječenja i prekid liječenja dronedaronom kad je to potrebno - EKG
English: Patients ranged in age from 28 to 90 years, 49% were more than 65 years old.
Croatian: Dob bolesnika se kretala u rasponu od 28 do 90 godina, 49% ih je bilo starije od 65 godina.
English: Dronedarone (400 mg twice daily) increased digoxin exposure by 2.5-fold by inhibiting P-gp transporter.
Croatian: Primjena dronedarona (400 mg dvaput na dan) povećala je izloženost digoksinu 2,5 puta uslijed inhibicije transportera P-gp-a.
English: Interaction with omeprazole (CYP 2C19 substrate)
Croatian: Interakcija s omeprazolom (supstratom CYP2C19)
English: Liver injury
Croatian: Oštećenje jetre
English: Patients ranged in age from 23 to 97 years and 42% were over 75 years old.
Croatian: Dob bolesnika kretala se u rasponu od 23 do 97 godina, a njih 42% bilo je starije od 75 godina.
English: The results of one of the blood tests to check kidney function (blood creatinine levels) may be changed by MULTAQ.
Croatian: MULTAQ može utjecati na nalaze jedne od krvnih pretraga za provjeru funkcije bubrega (razina kreatinina u krvi).
English: Erythromycin, an oral macrolide, may induce torsades de pointes and, as such, is contraindicated (see section 4.3).
Croatian: Eritromicin Eritromicin, peroralni makrolid, može inducirati torsades de pointes pa je stoga kontraindiciran (vidjeti dio 4.3).
English: Due to the pharmacokinetic interaction and possible pharmacodynamic interaction, beta-blockers should be used with caution concomitantly with dronedarone.
Croatian: Zbog farmakokinetičke interakcije i moguće farmakodinamičke interakcije potreban je oprez kod istodobne primjene beta-blokatora i dronedarona.
English: Calcium antagonists, diltiazem and verapamil, are substrates and/or moderate inhibitors of CYP 3A4.
Croatian: Antagonisti kalcija diltiazem i verapamil su supstrati i/ili umjereni inhibitori CYP3A4.
English: 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).
Croatian: U ispitivanjima EURIDIS i ADONIS u ambulantnim je uvjetima ukupno 1237 bolesnika s prethodnom epizodom fibrilacije ili undulacije atrija bilo randomizirano u skupinu koja je primala dronedaron u dozi od 400 mg dvaput na dan (n = 828) ili placebo ( n= 409) kao dodatak standardnoj terapiji (uključujući oralne antikoagulanse, beta-blokatore, ACE inhibitore ili antagoniste receptora angiotenzina II, kroničnu terapiju antitromboticima, diuretike, statine, digitalis i antagoniste kalcija).
English: However, clinically significant INR elevations (≥5) usually within 1 week after starting dronedarone were reported in patients taking oral anticoagulants.
Croatian: Međutim, u bolesnika koji su uzimali oralne antikoagulanse prijavljeno je klinički značajno povećanje INR-a (≥ 5), obično u roku od tjedan dana nakon početka liječanja dronedaronom.
English: Dronedarone is primarily metabolised by CYP 3A4 (see section 5.2).
Croatian: Dronedaron se prvenstveno metabolizira pomoću CYP3A4 (vidjeti dio 5.2).
English: Antidepressants
Croatian: Antidepresivi
English: In animals, dronedarone prevents atrial fibrillation or restores normal sinus rhythm depending on the model used.
Croatian: U životinja, ovisno o upotrijebljenom modelu, dronedaron sprječava fibrilaciju atrija ili ponovno uspostavlja normalan sinusni ritam.
English: Repeated doses of 300 ml of grapefruit juice three times daily resulted in a 3-fold increase in dronedarone exposure.
Croatian: Ponovljene doze od 300 ml soka od grejpa triput na dan dovele su do trostrukog povećanja izloženosti dronedaronu.
English: A synergistic effect on heart rate and atrio-ventricular conduction is possible.
Croatian: Moguć je sinergistički učinak na srčani ritam i atrioventikularnu provodljivost.
English: In the 5 placebo controlled studies, CHF occurred in the dronedarone group with rates comparable with placebo (very commonly, 11.2% versus 10.9%).
Croatian: U 5 placebom kontroliranih ispitivanja stopa pojave kongestivnog zatajenja srca bila je slična u skupini koja je primala dronedaron i onoj koja je primala placebo (vrlo često, 11,2% naspram 10,9%).
English: 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).
Croatian: Stoga je kontraindicirana istodobna primjena ketokonazola kao i drugih snažnih inhibitora CYP3A4 poput itrakonazola, vorikonazola, posakonazola, ritonavira, telitromicina, klaritromicina ili nefazodona (vidjeti dio 4.3).
English: • 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,
Croatian: • odmah obavijestite liječnika ako primijetite neki od sljedećih znakova i simptoma problema s jetrom: bol ili nelagodu u području trbuha (abdomena), gubitak teka, mučninu, povraćanje, žutu boju kože ili bjeloočnica (žuticu), neobično tamnu boju mokraće, umor (posebno u kombinaciji s drugim prethodno navedenim simptomima), svrbež,
English: Your doctor will take this into account when checking your blood levels and will use another reference of the “normal” value of blood creatinine.
Croatian: Liječnik će o tome voditi računa kad bude analizirao nalaze krvnih pretraga pa će kao referentnu uzeti neku drugu "normalnu"
English: Grapefruit juice should not be taken together with to dronedarone (see section 4.5).
Croatian: Dronedaron se ne smije uzimati zajedno sa sokom od grejpa (vidjeti dio 4.5).
English: Rare (1/10,000 to
Croatian: Rijetko (≥1/10 000 i <1/1000)
English: These medicinal products should be initiated at low dose and up-titration should be done only after ECG assessment.
Croatian: Liječenje navedenim lijekovima treba započeti niskim dozama koje se smiju postupno povećavati tek nakon EKG procjene.
English: Vasculitis, including leukocytoclastic vasculitis
Croatian: uključujući leukocitoklastični vaskulitis
English: • problems with your digestive system such as indigestion, diarrhoea, nausea, vomiting and stomach pain,
Croatian: • problemi s probavnim sustavom, kao što su probavne smetnje, proljev, mučnina, povraćanje i bolovi u želucu,
English: Patients ranged in age from 27 to 96 years, 68% were more than 65 years old.
Croatian: Dob bolesnika se kretala u rasponu od 27 do 96 godina, 68% ih je bilo starije od 65 godina.
English: In subjects with moderate hepatic impairment, dronedarone unbound exposure is increased by 2-fold.
Croatian: U bolesnika s umjerenim oštećenjem jetrene funkcije izloženost nevezanom dronedaronu je dvostruko viša.
English: 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.
Croatian: U kliničkim je ispitivanjima do prijevremenog prekida liječenja zbog nuspojava došlo u 11,8% bolesnika liječenih dronedaronom te u 7,7% bolesnika koji su primali placebo.
English: In clinical studies, increased levels of digitalis and/or gastrointestinal disorders indicating digitalis toxicity were observed when dronedarone was co-administered with digitalis.
Croatian: U kliničkim su ispitivanjima kod istodobne primjene dronedarona i digitalisa primijećene povišene koncentracije digitalisa i/ili gastrointestinalni poremećaji koji upućuju na toksičnost digitalisa.
English: 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).
Croatian: Treba razmotriti nižu početnu dozu i niže doze održavanja statina u skladu s preporukama za doziranje pojedinog statina, a bolesnike treba nadzirati kako bi se uočili mogući klinički znakovi mišićne toksičnosti (vidjeti dio 4.4).
English: Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposure.
Croatian: Ponovljene doze ketokonazola od 200 mg na dan dovele su do 17 puta veće izloženosti dronedaronu.
English: If you stop taking MULTAQ Do not stop taking this medicine without first talking to your doctor or pharmacist.
Croatian: Nemojte prestati uzimati ovaj lijek bez prethodnog savjetovanja s liječnikom ili ljekarnikom.
English: In an in vitro study MAO contributed to the metabolism of the active metabolite of dronedarone.
Croatian: U jednom in vitro ispitivanju monoaminooksidaza je pridonijela metabolizmu aktivnog metabolita dronedarona.
English: The other ingredients in the tablet coat are hypromellose (E464), macrogol 6000, titanium dioxide (E171), carnauba wax (E903).
Croatian: Pomoćne tvari u ovojnici tablete su: hipromeloza (E464), makrogol 6000, titanijev dioksid (E171), karnauba vosak (E903).
English: 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).
Croatian: Pomoćne tvari u jezgri tablete su: hipromeloza (E464), kukuruzni škrob, krospovidon (E1202), poloksamer 407, laktoza hidrat (vidjeti dio 2 'MULTAQ sadrži laktozu'), bezvodni koloidni silicijev dioksid, magnezijev stearat (E572).
English: Some adverse reactions were also identified during post-marketing surveillance.
Croatian: Neke nuspojave bile su identificirane tijekom praćenja nakon stavljanja lijeka u promet.
English: In patients with coronary artery disease, clinical signs of heart failure and ECG should be regularly monitored to detect early signs of heart failure.
Croatian: Potrebno je redovito pratiti kliničke znakove zatajenja srca i EKG u bolesnika s bolešću koronarnih arterija, kako bi se otkrili rani znakovi zatajenja srca.
English: Patients should be appropriately anti-coagulated as per clinical AF guidelines.
Croatian: Bolesnici moraju primati odgovarajuću antikoagulantnu terapiju u skladu s kliničkim smjernicama za liječenje fibrilacije atrija.
English: Tell your doctor, he/she will check your lung.
Croatian: Obavijestite svog liječnika, koji će Vam pregledati pluća.
English: Rifampicin (600 mg once daily) decreased dronedarone exposure by 80% with no major change on its active metabolite exposure.
Croatian: Induktori CYP3A4 Primjena rifampicina (u dozi od 600 mg jedanput dnevno) dovela je do smanjenja izloženosti dronedaronu za 80%, ali nije značajno utjecala na izloženost aktivnom metabolitu.
English: The efficacy of dronedarone in the reduction of risk of AF-related hospitalisation was demonstrated in patients with AF or a history of AF and additional risk factors in the ATHENA multicenter, multinational, double blind, and randomised placebo-controlled study.
Croatian: Smanjenje rizika hospitalizacije povezane s fibrilacijom atrija Djelotvornost dronedarona u smanjivanju rizika hospitalizacije povezane s fibrilacijom atrija dokazana je u bolesnika s trenutnom ili u anamnezi prisutnom FA te dodatnim faktorima rizika u sklopu multicentričnog, međunarodnog, dvostruko slijepog i randomiziranog, placebom kontroliranog ispitivanja
English: The interaction of dronedarone on calcium antagonists is described above (see section 4.4).
Croatian: Antagonisti kalcija Interakcija dronedarona i antagonista kalcija opisana je prethodno (vidjeti dio 4.4).
English: 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.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i na kutiji iza oznake "EXP".
English: However, ability to drive and use machines may be affected by adverse reactions such as fatigue.
Croatian: Međutim, na sposobnost upravljanja vozilima i rada sa strojevima mogu utjecati nuspojave poput umora.
English: Cases of CHF have also been reported in post-marketing experience (frequency not known) (see section 4.4).
Croatian: Slučajevi kongestivnog zatajenja srca prijavljeni su i nakon stavljanja lijeka u promet (učestalost nepoznata) (vidjeti dio 4.4).
English: Grapefruit juice (CYP 3A4 inhibitor)
Croatian: Sok od grejpa (inhibitor CYP3A4)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of dronedarone (as hydrochloride).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 400 mg dronedarona (u obliku dronedaronklorida).
English: Your doctor may recommend that you use a medicine against blood clot formation according to your condition.
Croatian: Ovisno o Vašem zdravstvenom stanju, liječnik Vam može preporučiti uzimanje lijekova protiv zgrušavanja krvi.
English: 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%).
Croatian: primali dronedaron u dozi od 400 mg dvaput na dan (2301 bolesnik) ili placebo (2327 bolesnika) kao dodatak standardnoj terapiji koja je uključivala beta-blokatore (71%), ACE inhibitore ili antagoniste receptora angiotenzina II (69%), digitalis (14%), antagoniste kalcija (14%), statine (39%), oralne antikoagulanse (60%), kroničnu terapiju antitromboticima (6%) i/ili diuretike (54%).
English: 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).
Croatian: Nakon što je randomizirano 3149 bolesnika (placebo=1577; dronedaron=1572), ispitivanje je prijevremeno prekinuto zbog značajnog povećanja broja slučajeva zatajenja srca (placebo=33; dronedaron=80; HR=2,49 (1,66-3,74)], moždanog udara [placebo=8;
English: What MULTAQ looks like and content of the pack MULTAQ is a white, oval, film-coated tablet (tablet) with a double wave marking on one side and “4142” on the other side.
Croatian: MULTAQ tableta je bijela, ovalna, filmom obložena tableta (tableta) s dvostrukom valovitom oznakom na jednoj i oznakom “4142” na drugoj strani.
English: • sirolimus, tacrolimus, everolimus and cyclosporine (used after a transplant),
Croatian: • sirolimus i takrolimus, everolimus i ciklosporin (primjenjuju se nakon presađivanja organa), • Gospinu travu - biljni lijek za depresiju,
English: The majority had hypertension (86%) and structural heart disease (60%) (including coronary artery disease: 30%; congestive heart failure (CHF): 30%; LVEF<45%: 12%).
Croatian: Većina je imala hipertenziju (86%) i strukturnu bolest srca (60%) (uključujući bolest koronarnih arterija:
English: MULTAQ contains lactose
Croatian: MULTAQ sadrži laktozu
English: If heart failure develops, treatment with dronedarone should be discontinued.
Croatian: Razvije li se zatajenje srca, liječenje dronedaronom mora se prekinuti.
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.
Croatian: Bolesnici su morali imati barem jedan faktor rizika (uključujući dob, hipertenziju, dijabetes, pretrpljen cerebrovaskularni incident, promjer lijevog atrija ≥ 50 mm ili ejekcijsku frakciju lijeve klijetke (LVEF)
English: If QTc Bazett interval is ≥500 milliseconds, dronedarone should be stopped (see section 4.3).
Croatian: ≥ 500 milisekundi, mora se prekinuti primjena dronedarona (vidjeti dio 4.3).
English: Interaction with medicinal products metabolised by CYP 2D6 Beta-blockers
Croatian: Interakcija s lijekovima koji se metaboliziraju pomoću CYP2D6
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).
Croatian: • Tegoba kod koje srce ne može pumpati krv tijelom onako kako bi trebalo (kongestivno zatajenje srca).
English: The pharmacokinetics of dronedarone in patients with AF is consistent with that in healthy subjects.
Croatian: Farmakokinetika dronedarona u bolesnika s fibrilacijom atrija dosljedna je onoj u zdravih ispitanika.
English: 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.
Croatian: Stoga se ne preporučuje istodobna primjena rifampicina i drugih potentnih induktora CYP3A4, poput fenobarbitala, karbamazepina, fenitoina ili Gospine trave, jer ti lijekovi smanjuju izloženost dronedaronu.
English: If alanine aminotransferase (ALT) levels are elevated ≥3 × upper limit of normal (ULN), ALT levels should be re-measured within 48 to 72 hours.
Croatian: Ako su razine alanin aminotransferaze (ALT) povišene ≥ 3 puta iznad gornje granice normale (GGN),
English: The steady state mean dronedarone Cmax is 84-147 ng/ml and the exposure of the main N-debutyl metabolite is similar to that of the parent compound.
Croatian: Srednji Cmax dronedarona u stanju dinamičke ravnoteže iznosi 84-147 ng/ml, a izloženost glavnom