FrancophonIA/ELRC3.0 huggingface dataset:
English: *The adverse reactions included in the table occurred within 24 hours of administration of vernakalant (see sections 4.2 and 5.2) with an incidence > 0.1 % of vernakalant patients and higher than placebo **see section below
Croatian: * Nuspojave navedene u tablici nastupile su unutar 24 sata od primjene vernakalanta (vidjeti dijelove 4.2 i 5.2) s incidencijom > 0,1 % u bolesnika na vernakalantu i više nego na placebu
English: • a change in your sense of smell
Croatian: • promjene osjeta mirisa
English: In these studies treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm as compared with placebo (see Table 2).
Croatian: U tim je ispitivanjima primjenom vernakalanta učinkovito postignuta konverzija fibrilacije atrija u sinusni ritam, u usporedbi s placebom (vidjeti Tablicu 2).
English: Efficacy was studied in a total of 390 haemodynamically stable adult patients with short duration atrial fibrillation including patients with hypertension (40.5 %), ischaemic heart disease (12.8 %), valvular heart disease (9.2 %) and CHF (10.8 %).
Croatian: Djelotvornost se ispitivala u ukupno 390 hemodinamski stabilnih odraslih bolesnika s kratkotrajnom fibrilacijom atrija, uključujući bolesnike s hipertenzijom (40,5 %), ishemijskom bolešću srca (12,8 %), bolešću srčanih zalistaka (9,2 %) i kongestivnim zatajenjem srca (10,8 %).
English: After dilution the concentration of the solution is 4 mg/ml vernakalant hydrochloride.
Croatian: Nakon razrjeđivanja, koncentracija otopine je 4 mg/ml vernakalantklorida.
English: The relative selectivity of vernakalant on atrial versus ventricular refractoriness is postulated to result from the block of currents regulated by ion channels that are expressed in the atria, but not in the ventricles, as well as the unique electrophysiologic condition of the fibrillating atria.
Croatian: Pretpostavlja se da je relativna selektivnost vernakalanta na refrakternost atrija, naspram djelovanja na refrakternost ventrikula, posljedica blokade protoka iona reguliranog ionskim kanalima koji su izraženi u atrijima, ali ne i u ventrikulima, kao i jedinstvenog elektrofiziološkog stanja atrija tijekom fibrilacije.
English: • The active substance is vernakalant hydrochloride.
Croatian: • Djelatna tvar je vernakalantklorid.
English: To ensure proper administration, a sufficient amount of BRINAVESS 20 mg/ml should be prepared at the outset of therapy to deliver the initial and second infusion should it be warranted.
Croatian: Za ispravnu primjenu lijeka potrebno je već na početku terapije pripremiti dovoljnu količinu lijeka BRINAVESS 20 mg/ml da se nakon početne infuzije po potrebi može primijeniti i druga.
English: Has the patient presented with an acute coronary syndrome (including myocardial infarction) in the last 30 days?
Croatian: Je li bolesnik imao akutni koronarni sindrom (uključujući infarkt miokarda) u posljednjih 30 dana?
English: If conversion to sinus rhythm has not occurred, the patient's vital signs and cardiac rhythm should be observed for an additional 15 minutes.
Croatian: Ako ne nastupi konverzija u sinusni ritam, pratite vitalne znakove i srčani ritam bolesnika dodatnih
English: • eye irritation, watery eyes or changes in your vision
Croatian: • nadraženost oka, suzenje očiju ili promjene vida
English: In AVRO, the amiodarone infusion was given over 2 hours (i.e., 1 hour loading dose of 5 mg/kg, followed by 1 hour maintenance infusion of 50 mg).
Croatian: U ispitivanju AVRO davala se infuzija amiodarona tijekom 2 sata (tj. 1 sat infuzija udarne doze od 5 mg/kg, a zatim 1 sat infuzija doze održavanja od 50 mg).
English: Furthermore, it has not been evaluated in patients with clinically meaningful valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis and its use cannot be recommended in such cases.
Croatian: Nadalje, vernakalant nije ispitivan u bolesnika s klinički značajnom stenozom srčanog zaliska, hipertrofičnom opstruktivnom kardiomiopatijom, restriktivnom kardiomiopatijom ili konstriktivnim perikarditisom pa se ne može preporučiti njegova primjena u takvim slučajevima.
English: Across the Phase 3 population, vernakalant treated patients had an increase in heart rate-corrected QT (using Fridericia's correction, QTcF) compared to placebo (22.1 msec and 18.8 msec placebo-subtracted peaks after first and second infusions, respectively).
Croatian: U ispitivanjima faze III, bolesnici liječeni vernakalantom imali su produljen QT-interval nakon korekcije srčane frekvencije (korekcija prema Fridericiji, QTcF) u odnosu na placebo (vršna vrijednost od 22,1 ms nakon prve odnosno 18,8 ms nakon druge infuzije kad se oduzme placebo).
English: These arrhythmias typically presented as asymptomatic, monomorphic, non-sustained (average 3-4 beats) ventricular tachycardias.
Croatian: Te su aritmije u pravilu bile asimptomatske, monomorfne, kratkotrajne (u prosjeku 3-4 otkucaja) ventrikularne tahikardije.
English: Targeted effects on atrial tissue coupled with block of late sodium current suggests that vernakalant has a low proarrhythmic potential.
Croatian: Ciljani učinci na tkivo atrija u kombinaciji s blokadom kasnog protoka natrijevih iona pokazuju da vernakalant ima slab proaritmijski potencijal.
English: • Patients with severe aortic stenosis, patients with systolic blood pressure < 100 mm Hg, and patients with heart failure class NYHA III and NYHA IV.
Croatian: • Bolesnici s teškom stenozom aorte, bolesnici čiji je sistolički krvni tlak < 100 mm Hg i bolesnici sa zatajenjem srca stupnja III i IV prema NYHA klasifikaciji.
English: It should be taken into account that some people may get dizzy after receiving BRINAVESS, usually within the first 2 hours (see section “Possible side effects”).
Croatian: obično u prva 2 sata nakon primjene (vidjeti dio "Moguće nuspojave".)
English: Pack size of 1 vial includes either 10 ml or 25 ml of concentrate.
Croatian: Pakiranje od 1 bočice sadrži koncentrat od 10 ml ili 25 ml.
English: Acute vernakalant pharmacokinetics is not significantly influenced by gender, history of congestive heart failure, renal impairment, or concomitant administration of beta blockers and other medications, including warfarin, metoprolol, furosemide and digoxin.
Croatian: Na akutnu farmakokinetiku vernakalanta nisu značajno utjecali spol, anamneza kongestivnog zatajenja srca, oštećenje funkcije bubrega ni istodobna primjena beta blokatora i drugih lijekova, uključujući varfarin, metoprolol, furosemid i digoksin.
English: The recommended initial infusion is 3 mg/kg to be infused over a 10-minute period with a maximum initial dose of 339 mg (84.7 ml of 4 mg/ml solution).
Croatian: Preporučena doza za početnu infuziju je 3 mg/kg, a treba je primijeniti tijekom 10 minuta, dok maksimalna doza za početnu infuziju iznosi 339 mg (84,7 ml otopine koncentracije 4 mg/ml).
English: Patients > 100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.
Croatian: Bolesnici > 100 kg: 30 ml lijeka BRINAVESS 20 mg/ml dodaje se u 120 ml otopine za razrjeđivanje.
English: BRINAVESS should not be administered as an intravenous push or bolus.
Croatian: BRINAVESS se ne smije primijeniti brzom intravenskom injekcijom ili u bolusu.
English: What you need to know before you use BRINAVESS Do not use BRINAVESS
Croatian: Što morate znati prije nego počnete primati BRINAVESS
English: Tell your doctor if you have a pacemaker.
Croatian: Obavijestite liječnika ako imate ugrađen elektrostimulator srca.
English: BRINAVESS will be given to you by a health care professional.
Croatian: BRINAVESS će Vam dati zdravstveni radnik.
English: If haemodynamically stable atrial flutter is observed after the initial infusion, the second infusion may be administered as patients may convert to sinus rhythm (see sections 4.4 and 4.8).
Croatian: Ako se nakon početne infuzije pojavi hemodinamski stabilna undulacija atrija, može se primijeniti druga infuzija jer može doći do konverzije u sinusni ritam (vidjeti dijelove 4.4 i
English: 15 rue du Bicentenaire 92800 Puteaux France
Croatian: 15 rue du Bicentenaire
English: A pre-infusion checklist is provided with the medicinal product.
Croatian: Uz lijek je priložen predinfuzijski kontrolni upitnik.
English: Single-use glass (Type 1) vials with a chlorobutyl rubber stopper and an aluminium overseal.
Croatian: Staklene bočice (staklo tipa 1) za jednokratnu uporabu s čepom od klorobutilne gume i aluminijskim zaštitnim zatvaračem.
English: As the clinical trial experience in patients with advanced hepatic impairment is limited, vernakalant is not recommended in these patients.
Croatian: Budući da su iskustva iz kliničkih ispitivanja u bolesnika s uznapredovalim oštećenjem funkcije jetre ograničena, ne preporučuje se primjena vernakalanta u tih bolesnika.
English: The initial infusion is administered as a 3 mg/kg dose over 10 minutes.
Croatian: Početna infuzija se primjenjuje u dozi od 3 mg/kg tijekom 10 minuta.
English: Prior to attempting pharmacological cardioversion, patients should be adequately hydrated and haemodynamically optimized and if necessary patients should be anticoagulated in accordance with treatment guidelines.
Croatian: Prije nego se pokuša farmakološka kardioverzija, bolesnici moraju biti primjereno hidrirani i hemodinamski u optimalnom stanju, a po potrebi im treba dati antikoagulanse, sukladno terapijskim smjernicama.
English: No significant differences in safety or effectiveness were observed based on age, gender, use of rate control medications, use of antiarrhythmic medications, use of warfarin, history of ischaemic heart disease, renal impairment or expression of the cytochrome P450 2D6 enzyme.
Croatian: Nisu opažene značajne razlike u sigurnosti primjene i učinkovitosti s obzirom na dob, spol, uzimanje lijekova za kontrolu frekvencije srca, antiaritmika, varfarina, anamnezu ishemijske bolesti srca, oštećenje funkcije bubrega ili ekspresiju enzima citokroma P450 2D6.
English: Glucuronidation and renal excretion are the main mechanisms of elimination in CYP2D6 poor metabolisers.
Croatian: Glukuronidacija i izlučivanje putem bubrega glavni su mehanizmi eliminacije u slabih metabolizatora CYP2D6.
English: Dizziness has been reported within the first 2 hours after receiving it (see section 4.8).
Croatian: U prva 2 sata nakon primanja lijeka prijavljena je omaglica (vidjeti dio 4.8).
English: Vernakalant was not found to be effective in converting typical primary atrial flutter to sinus rhythm.
Croatian: Pokazalo se da vernakalant nije učinkovit u konverziji tipične primarne undulacije atrija u sinusni ritam.
English: Patients should be carefully observed for the entire duration of the infusion and for at least 15 minutes after completion of the infusion with assessment of vital signs and continuous cardiac rhythm monitoring.
Croatian: Bolesnike se mora pažljivo promatrati cijelo vrijeme trajanja infuzije i još najmanje 15 minuta nakon završetka infuzije, uz procjenu vitalnih znakova i kontinuirano praćenje srčanog ritma.
English: Additionally, the ability of vernakalant to block the late component of the sodium current limits effects on ventricular repolarisation induced by blockade of potassium currents in the ventricle.
Croatian: Osim toga, sposobnost vernakalanta da blokira kasnu komponentu protoka natrijevih iona ograničava učinak na repolarizaciju ventrikula izazvanu blokadom protoka kalijevih iona u ventrikulu.
English: The checklist should be placed on the infusion container to be read by the healthcare professional who will administer BRINAVESS.
Croatian: Kontrolni upitnik se mora staviti na infuzijski spremnik kako bi ga pročitao zdravstveni radnik koji će primijeniti BRINAVESS.
English: Vernakalant given by infusion is not expected to perpetrate meaningful drug interactions due to the rapid distribution and transient exposure, low protein binding, lack of inhibition of other CYP P450 enzymes tested (CYP3A4, 1A2, 2C9, 2C19 or 2E1) and lack of P-glycoprotein inhibition in a digoxin transport assay.
Croatian: Ne očekuje se da će vernakalant primijenjen infuzijom ostvariti značajne interakcije s drugim lijekovima zbog brze raspodjele i prolazne izloženosti, slabog vezanja za proteine, izostanka inhibicije drugih ispitanih enzima CYP P450 (CYP3A4, 1A2, 2C9, 2C19 ili 2E1) kao i izostanka inhibicije P-glikoproteina u testu transporta digoksina.
English: The primary endpoint was the proportion of patients that achieved sinus rhythm (SR) at 90 minutes after initiating therapy, limiting the conclusions to the effects seen in this time window.
Croatian: Primarna mjera ishoda ispitivanja bio je udio bolesnika koji su postigli sinusni ritam do 90. minute nakon početka terapije, zbog čega su zaključci ograničeni na učinke zabilježene u tom vremenskom okviru.
English: • Continue to monitor the patient for 2 hrs after the start of infusion and until clinical and ECG parameters have stabilised.
Croatian: • Nastavite nadzirati bolesnika tijekom 2 sata od početka infuzije sve dok se ne stabiliziraju klinički i elektrokardiografski parametri.
English: If your heart beat has not returned to normal 15 minutes after the end of your first dose, you may be given a second dose.
Croatian: Ako se 15 minuta nakon primjene prve doze rad srca ne normalizira, možda ćete primiti i drugu dozu.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake "Rok valjanosti" ili "EXP".
English: • certain heart diseases involving the heart muscle, lining that surrounds the heart and a severe narrowing of the heart valves
Croatian: • neke srčane bolesti koje zahvaćaju srčani mišić ili srčanu ovojnicu te jako suženje srčanih zalistaka
English: Conversion of atrial fibrillation to sinus rhythm occurred rapidly (in responders the median time to conversion was 10 minutes from start of first infusion) and sinus rhythm was maintained through 24 hours (97 %).
Croatian: Konverzija fibrilacije atrija u sinusni ritam nastupila je vrlo brzo (u bolesnika koji su odgovorili na liječenje medijan vremena do konverzije iznosio je 10 minuta od početka prve infuzije), a sinusni se ritam održao tijekom 24 sata (97 %).
English: Does the patient have severe bradycardia, sinus node dysfunction or second and third degree heart block, in the absence of a pacemaker?
Croatian: Ima li bolesnik tešku bradikardiju, poremećaj funkcije sinusnog čvora ili srčani blok drugog ili trećeg stupnja bez ugrađenog elektrostimulatora srca?
English: • Acute coronary syndrome (including myocardial infarction) within the last 30 days.
Croatian: • Akutni koronarni sindrom (uključujući infarkt miokarda) u prethodnih 30 dana.
English: ACT II examined the effect of vernakalant on patients who developed atrial fibrillation of < 3 days duration after recently undergoing coronary artery bypass graft, (CABG) and/or valvular surgery (atrial fibrillation occurred more than 1 day but less than 7 days after surgery).
Croatian: U ispitivanju ACT II ispitivan je učinak vernakalanta u bolesnika s fibrilacijom atrija u trajanju < 3 dana koja se pojavila nedugo nakon ugradnje premosnice koronarnih arterija (CABG) i/ili kirurškog zahvata na zaliscima (fibrilacija atrija nastala više od jednog, ali manje od sedam dana nakon kirurškog zahvata).
English: • Observe the patient frequently and carefully for the entire duration of the infusion and for at least 15 minutes after completion of the infusion for: o Any signs or symptoms of a sudden decrease in blood pressure or heart rate, with or without symptomatic hypotension or bradycardia o Bradycardia o Hypotension o Unexpected ECG changes (see SmPC)
Croatian: • Često i pažljivo motrite bolesnika tijekom čitavog trajanja infuzije te još najmanje 15 minuta po njezinu završetku kako biste uočili eventualnu pojavu: o bilo kakvih znakova ili simptoma iznenadnog pada krvnog tlaka ili srčane frekvencije, sa ili bez simptomatske hipotenzije ili bradikardije o bradikardije o hipotenzije o neočekivanih promjena na EKG-u (vidjeti Sažetak opisa svojstava lijeka) Ako se pojave takvi znakovi, odmah prekinite primjenu lijeka BRINAVESS i uvedite odgovarajuće medicinske mjere.
English: The higher cardioversion rate in SPECTRUM as compared to clinical phase 3 studies (70.2% vs 47% to 51%) is correlated with a shorter duration of the duration of the index atrial fibrillation period (median duration of 11.1 hours in SPECTRUM vs 17.7 to 28.2 hours in clinical studies).
Croatian: (70,2% u odnosu na 47% do 51%) u korelaciji je s kraćim trajanjem razdoblja indeksne fibrilacije atrija (medijan trajanja 11,1 sati u SPECTRUM-u naspram 17,7 do 28,2 sati u kliničkim ispitivanjima).
English: Each vial of 500 mg contains approximately 3.5 mmol (80 mg) of sodium.
Croatian: Jedna bočica od 500 mg sadrži približno 3,5 mmol (80 mg) natrija.
English: BRINAVESS is available in pack of 1 vial containing 200 mg or 500 mg of vernakalant hydrochloride.
Croatian: BRINAVESS je dostupan u veličini pakiranja koje sadrži 1 bočicu s 200 mg ili 500 mg vernakalantklorida.
English: Each vial of 200 mg contains approximately 1.4 mmol (32 mg) sodium.
Croatian: Jedna bočica od 200 mg sadrži približno 1,4 mmol (32 mg) natrija.
English: Step 3: Inspection of the solution
Croatian: 3.korak: Provjera otopine
English: Does the patient have heart failure class NYHA III or NYHA IV?
Croatian: Ima li bolesnik zatajenje srca stupnja III i IV prema NYHA klasifikaciji?
English: The mean elimination half-life of vernakalant in patients was approximately 3 hours in CYP2D6 extensive metabolisers and approximately 5.5 hours in poor metabolisers.
Croatian: Prosječno poluvrijeme eliminacije vernakalanta iznosilo je približno 3 sata u jakih metabolizatora te približno 5,5 sati u slabih metabolizatora CYP2D6.
English: Hypotension can occur in a small number of patients (vernakalant 5.7 %, placebo 5.5 % in the first 2 hours post-dose).
Croatian: U malog broja bolesnika može se javiti hipotenzija (vernakalant 5,7 %, placebo 5,5 % u prva 2 sata nakon primjene doze).
English: If conversion to sinus rhythm occurs during either the initial or second infusion, that infusion should be continued to completion.
Croatian: Ako tijekom početne ili druge infuzije nastupi konverzija u sinusni ritam, ta se infuzija mora primijeniti do kraja.
English: Treatment with vernakalant, converted 51.7 % of patients to SR at 90 minutes versus 5.2 % with amiodarone resulting in a significantly faster conversion rate from AF to SR within the first 90 minutes compared to amiodarone (log-rank P-value < 0.0001).
Croatian: Konverzija u sinusni ritam u roku od 90 minuta postignuta je u 51,7 % bolesnika liječenih vernakalantom naspram 5,2 % bolesnika koji su primili amiodaron; to ukazuje da se vernakalantom postiže značajno brža konverzija fibrilacije atrija u sinusni ritam u prvih 90 minuta u odnosu na amiodaronom (log-rank P-vrijednost < 0,0001).
English: Uncommon: Lacrimation increased; eye irritation; visual impairment
Croatian: Manje često: pojačano suzenje; iritacija oka; smetnje vida
English: • irritation, itching at the infusion site
Croatian: • nadraženost, svrbež na mjestu infuzije
English: In clinical studies to date, patients who developed atrial flutter following treatment with vernakalant did not develop 1:1 atrioventricular conduction.
Croatian: U dosadašnjim kliničkim ispitivanjima u bolesnika u kojih se nakon primjene vernakalanta razvila undulacija atrija nije došlo do atrioventrikularnog provođenja 1:1.
English: AVRO studied the effect of vernakalant versus intravenous amiodarone in patients with recent onset atrial fibrillation (3 hrs to 48 hrs).
Croatian: U ispitivanju AVRO određivao se učinak vernakalanta naspram intravenski primijenjenog amiodarona u bolesnika u kojih je nedavno nastupila fibrilacija atrija (3 do 48 sati ranije).
English: Preparation of BRINAVESS for infusion
Croatian: Priprema lijeka BRINAVESS za infuziju
English: -For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration
Croatian: - u bolesnika nakon kirurškog zahvata na srcu: fibrilacija atrija koja traje ≤ 3 dana.
English: • if you have had new or worsening chest pain (angina) diagnosed by your doctor as an acute coronary syndrome in the last 30 days or you have had a heart attack in the last 30 days
Croatian: • ako ste alergični na vernakalantklorid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) • ako se u prethodnih 30 dana kod Vas pojavila ili pogoršala bol u prsištu (angina) koju su liječnici dijagnosticirali kao akutni koronarni sindrom, ili ako ste u prethodnih 30 dana imali srčani udar
English: Correvio Tel: + 34 93 179 05 36
Croatian: Tel: +34 93 179 05 36
English: Before giving you this medicine, your doctor will decide whether to test your blood to see how well it clots and also to see your potassium level.
Croatian: Krvne pretrage Prije nego što Vam primijeni ovaj lijek, liječnik će odlučiti je li potrebno napraviti krvne pretrage kojima bi se provjerilo zgrušavanje krvi i odredila razina kalija u krvi.
English: The initial dose is 339 mg (84.7 ml of 4 mg/ml solution).
Croatian: 339 mg (84,7 ml otopine koncentracije 4 mg/ml).
English: • pain or numbness at the infusion site, numbness, decreased skin sensation, or tingling feelings
Croatian: • bol ili utrnulost na mjestu primjene infuzije, utrnulost, smanjena osjetljivost kože ili trnci
English: EXP Diluted solution: use within 12 hours and store at or below 25 °C.
Croatian: Razrijeđena otopina: primijeniti u roku od 12 sati i čuvati na temperaturi od 25°C ili nižoj.
English: Although vernakalant is a substrate of CYP2D6, population pharmacokinetic (PK) analyses demonstrated that no substantial differences in the acute exposure of vernakalant (Cmax and AUC0-90min) were observed when weak or potent CYP2D6 inhibitors were administered within 1 day prior to vernakalant infusion compared to patients that were not on concomitant therapy with CYP2D6 inhibitors.
Croatian: Iako je vernakalant supstrat enzima CYP2D6, analize populacijske farmakokinetike pokazale su da nema bitnih razlika u akutnoj izloženosti vernakalantu (Cmax i AUC0-90 min) u bolesnika koji su primili slabe ili jake inhibitore CYP2D6 unutar 1 dana prije primjene infuzije vernakalanta, u odnosu na bolesnike koji istodobno nisu primili inhibitore CYP2D6.
English: • feeling light-headed or fainting, generally feeling unwell, feeling drowsy or sleepy
Croatian: • osjećaj ošamućenosti ili nesvjestica, opće loše osjećanje, omamljenost ili pospanost
English: The safety of vernakalant has been evaluated in clinical studies involving 1,148 subjects (patients and healthy volunteers) who received treatment with it. Based on data from 1,018 patients in eight phase 2 and phase 3 trials, the most commonly reported adverse reactions (> 5 %) seen in the first 24 hours after receiving vernakalant were dysgeusia (taste disturbance) (17.9 %), sneezing (12.5 %), and paraesthesia (6.9 %).
Croatian: Na temelju podataka prikupljenih u 1018 bolesnika u osam kliničkih ispitivanja faze II i faze III, najčešće prijavljene nuspojave povezane s primjenom lijeka (> 5 %) opažene u prva 24 sata nakon primjene vernakalanta bile su disgeuzija (poremećaj osjeta okusa) (17,9 %), kihanje (12,5 %) i parestezija (6,9 %).
English: Clinical Trial Design: The clinical effect of vernakalant in the treatment of patients with atrial fibrillation has been evaluated in three, randomised, double-blind, placebo-controlled studies, (ACT I, ACT II and ACT III) and in an active comparator trial versus intravenous amiodarone (AVRO).
Croatian: Plan kliničkih ispitivanja: Klinički učinak vernakalanta u liječenju bolesnika s fibrilacijom atrija ispitivan je u tri randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja (ACT I, ACT II i ACT III) te u jednom kliničkom ispitivanju s aktivnim usporednim lijekom naspram intravenski primijenjenim amiodaronom (AVRO).
English: This medicine contains 80 mg of sodium (main component of cooking/table salt) in each vial of 500 mg.
Croatian: Ovaj lijek sadrži 80 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici od 500 mg.