FrancophonIA/ELRC3.0 huggingface dataset:
English: Do NOT give other IV antiarrhythmic medicines (class I and/or class III) for at least 4 hours after infusion of BRINAVESS.
Croatian: NE SMIJETE primijeniti druge intravenske antiaritmike (skupine I i/ili III) najmanje 4 sata nakon infuzije lijeka BRINAVESS.
English: There is limited experience with the use of intravenous rhythm control antiarrhythmics (class I and class III) in the first 4 hours after vernakalant administration, therefore these agents must not be used within this period (see section 4.3).
Croatian: Iskustvo s primjenom intravenskih antiaritmika za kontrolu srčanog ritma (skupine I i III) u prva 4 sata nakon primjene vernakalanta je ograničeno; stoga se unutar ovog razdoblja ti lijekovi ne smiju primjenjivati (vidjeti dio 4.3).
English: In preclinical studies, vernakalant blocks currents in all phases of the atrial action potential, including potassium currents that are expressed specifically in the atria (e.g., the ultra-rapid delayed rectifier and the acetylcholine dependent potassium currents).
Croatian: U pretkliničkim ispitivanjima vernakalant je blokirao protok iona u svim fazama akcijskog potencijala u atriju, uključujući i protok kalijevih iona specifičnih za atrije (npr. ultra brzi kanali s odgođenim ispravljačima i kalijevi kanali ovisni o acetilkolinu).
English: If you get dizzy, you should avoid driving or operating machinery after receiving BRINAVESS.
Croatian: Ako osjetite omaglicu nakon što primite BRINAVESS, trebate izbjegavati upravljanje vozilima i rukovanje strojevima.
English: Some patients with typical atrial flutter were included in ACT II and ACT III and vernakalant was not found to be effective in converting atrial flutter.
Croatian: U ispitivanja ACT II i ACT III bili su uključeni i neki bolesnici s tipičnom undulacijom atrija te nije utvrđena djelotvornost vernakalanta u konverziji undulacije atrija.
English: How to store BRINAVESS Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije
English: • low blood pressure, slow heart beat, feeling dizzy
Croatian: • nizak krvni tlak, usporen rad srca, omaglica • kašalj, bolnost nosa
English: Vernakalant was studied in 116 pts with atrial fibrillation (3 hrs to 48 hrs) including patients with hypertension (74.1 %), IHD (19 %), valvular heart disease (3.4 %) and CHF (17.2 %).
Croatian: Djelotvornost u usporedbi s amiodaronom (AVRO) Vernakalant se ispitivao u 116 bolesnika s fibrilacijom atrija (3 do 48 sati), uključujući bolesnike s hipertenzijom (74,1 %), ishemijskom bolešću srca (19 %), bolešću srčanih zalistaka (3,4 %) i kongestivnim zatajenjem srca (17,2 %).
English: No dose adjustment is required for these conditions, nor on the basis of age, serum creatinine or CYP2D6 metaboliser status.
Croatian: Nije potrebno prilagođavati dozu lijeka zbog navedenih stanja kao ni temeljem dobi, vrijednosti kreatinina u serumu ili statusa metabolizacije putem CYP2D6.
English: Vernakalant is an antiarrhythmic medicine that acts preferentially in the atria to prolong atrial refractoriness and to rate-dependently slow impulse conduction.
Croatian: Vernakalant je antiaritmik koji pretežno djeluje u atrijima, gdje produljuje refrakternost i usporava provodljivost impulsa ovisno o frekvenciji.
English: Hypotension reported as a serious adverse experience or leading to medicinal product discontinuation occurred in CHF patients following exposure to vernakalant in 1.8 % of these patients compared to 0.3 % in placebo.
Croatian: Hipotenzija koja je prijavljena kao ozbiljna nuspojava ili je zahtijevala prekid primjene lijeka nastupila je nakon izloženosti vernakalantu u 1,8 % bolesnika s kongestivnim zatajenjem srca, u odnosu na 0,3 % takvih bolesnika koji su primili placebo.
English: The patient should be further monitored for 2 hrs after the start of infusion and until clinical and ECG parameters have stabilised.
Croatian: Bolesnike se i dalje mora nadzirati tijekom 2 sata od početka infuzije sve dok se klinički i elektrokardiografski parametri ne stabiliziraju.
English: During this period, the patient should be carefully monitored for any signs or symptoms of a sudden decrease in blood pressure or heart rate.
Croatian: U tom je razdoblju potrebno pozorno nadzirati bolesnika kako bi se uočili eventualni znakovi ili simptomi iznenadnog pada krvnog tlaka ili srčane frekvencije.
English: If patients who received electrical cardioversion, intravenous antiarrhythmics or oral propafenone/flecainide within 90 minutes from the start of BRINAVESS infusion are regarded as treatment failures in addition to patients who did not convert for one minute within 90 minutes, the conversion rate among the 2,009 patients who received BRINAVESS was 67.3 % (1,352/2,009).
Croatian: Ako se bolesnici koji su primili električnu kardioverziju, intravenski antiaritmik ili peroralni propafenon/flekainid unutar 90 minuta od početka infuzije BRINAVESS smatraju neuspjehom liječenja, uz bolesnike koji unutar 90 minuta nisu postigli konverziju u sinusni ritam u trajanju od najmanje jedne minute, stopa konverzije u 2009 bolesnika koji su primili BRINAVESS bila je 67,3 % (1352/2009).
English: • Patients with prolonged QT at baseline (uncorrected > 440 msec), or severe bradycardia, sinus node dysfunction or second degree and third degree heart block in the absence of a pacemaker.
Croatian: • Bolesnici s produljenim QT-intervalom na početku liječenja (nekorigirani > 440 ms) ili teškom bradikardijom, poremećajem funkcije sinusnog čvora ili srčanim blokom drugog ili trećeg stupnja bez ugrađenog elektrostimulatora srca.
English: Common: Paraesthesia; dizziness
Croatian: Često: parestezija; omaglica
English: This medicine contains 32 mg sodium (main component of cooking/table salt) in each 200 mg vial.
Croatian: Ovaj lijek sadrži 32 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici od 200 mg.
English: Of the patients who did not convert to sinus rhythm, the incidence of bradycardia events in the first 2 hours post-dose was similar in placebo and vernakalant treated groups (4.0% and 3.8%, respectively).
Croatian: Među bolesnicima u kojih nije nastupila konverzija u sinusni ritam, incidencija bradikardije u prva 2 sata nakon primjene doze bila je slična u skupini koja je primala placebo (4,0 %) i onoj koja je primala vernakalant (3,8 %).
English: There is limited experience with the use of vernakalant in patients with previously documented LVEF ≤ 35 %, its use in these patients is not recommended.
Croatian: Iskustvo s primjenom vernakalanta u bolesnika s prethodno dokumentiranom ejekcijskom frakcijom lijevog ventrikula (LVEF) ≤ 35 % je ograničeno pa se njegova primjena u tih bolesnika ne preporučuje.
English: In patients, average peak plasma concentrations of vernakalant were 3.9 μg/ml following a single 10-minute infusion of 3 mg/kg vernakalant hydrochloride, and 4.3 μg/ml following a second infusion of 2 mg/kg with a 15-minute interval between doses.
Croatian: Nakon jedne 10-minutne infuzije vernakalantklorida u dozi od 3 mg/kg prosječna vršna koncentracija vernakalanta u plazmi bolesnika bila je 3,9 μg/ml, a nakon druge infuzije u dozi od 2 mg/kg, uz razmak od 15 minuta između doza, iznosila je 4,3 μg/ml.
English: Each ml of the diluted solution contains approximately 3.5 mg of sodium (sodium chloride 9 mg/ml (0.9 %) solution for injection), 0.64 mg sodium (5 % glucose solution for injection) or 3.2 mg sodium (Lactated Ringers solution for injection).
Croatian: Jedan ml razrijeđene otopine sadrži približno 3,5 mg natrija (otopina natrijevog klorida za injekciju od 9 mg/ml (0,9 %)), 0,64 mg natrija (5 %-tna otopina glukoze za injekciju) ili 3,2 mg natrija (Ringerova otopina s laktatom za injekciju).
English: By 24 hours there appears to be insignificant levels of vernakalant.
Croatian: Izgleda da je 24 sata nakon primjene koncentracija vernakalanta zanemariva.
English: Efficacy from Post-Marketing Observational Study In the post-approval safety study SPECTRUM that included 1,778 patients with 2,009 BRINAVESS treatment episodes, effectiveness was assessed as the proportion of patients who converted to sinus rhythm for at least one (1) minute within 90 minutes from the start of BRINAVESS infusion, excluding patients who received electrical cardioversion or intravenous Class I/III antiarrhythmics for cardioversion within the 90-minute window.
Croatian: U ispitivanju sigurnosti primjene lijeka nakon stavljanja u promet SPECTRUM, u koje je bilo uključeno 1778 bolesnika s 2009 epizoda liječenja lijekom BRINAVESS, djelotvornost je procijenjena kao udio bolesnika koji su unutar 90 minuta od početka BRINAVESS infuzije postigli konverziju u sinusni ritam u trajanju od najmanje jedne minute, isključujući bolesnike koji su tijekom 90-minutnog razdoblja primili električnu kardioverziju ili intravenske antiaritmike skupine I/III za kardioverziju.
English: - Alert HCP about the need of precautions when using BRINAVESS in haemodynamically stable patients with congestive heart failure NYHA I and NYHA II and the need to monitor patients with valvular heart disease closely.
Croatian: - Upozorenje zdravstvenim radnicima da je potreban oprez kada se BRINAVESS primjenjuje u hemodinamski stabilnih bolesnika s kongestivnim zatajenjem srca NYHA stupnja I i II te da bolesnike s bolešću srčanih zalistaka treba pozorno nadzirati.
English: Vernakalant was shown to provide relief of atrial fibrillation symptoms consistent with conversion to sinus rhythm.
Croatian: Utvrđeno je da vernakalant olakšava simptome fibrilacije atrija sukladno konverziji u sinusni ritam.
English: Uncommon: Hypoaesthesia; burning sensation; parosmia; syncope; somnolence
Croatian: Manje često: hipoestezija; osjećaj žarenja; parosmija; sinkopa;
English: Posology BRINAVESS is dosed by patient body weight, with a maximum calculated dose based upon 113 kg.
Croatian: Doza lijeka BRINAVESS određuje se prema tjelesnoj težini bolesnika, a najviša je doza izračunata na temelju težine od 113 kg.
English: • The patient should be adequately hydrated and haemodynamically optimised and adequately anticoagulated (if necessary) prior to administering BRINAVESS
Croatian: • Prije primjene lijeka BRINAVESS bolesnik mora biti primjereno hidriran i u optimalnom hemodinamskom stanju te mu treba (po potrebi) dati odgovarajuće antikoagulanse
English: This is equivalent to 4 % of the recommended maximum daily dietary intake for an adult.
Croatian: 4% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: The use in CHF patients corresponding to NYHA III or NYHA IV is contraindicated (see section 4.3).
Croatian: Primjena u bolesnika s kongestivnim zatajenjem srca koje odgovara NYHA stupnju III ili IV je kontraindicirana (vidjeti dio 4.3).
English: Treatment success (responder) was defined as conversion of atrial fibrillation to sinus rhythm within 90 minutes.
Croatian: definiran je kao konverzija fibrilacije atrija u sinusni ritam unutar 90 minuta.
English: Efficacy in patients who developed atrial fibrillation post cardiac surgery (ACT II) Efficacy was studied in patients with atrial fibrillation after cardiac surgery in ACT II, a phase 3, double-blind, placebo-controlled, parallel group study (ACT II) in 150 patients with sustained atrial fibrillation (3 hours to 72 hours duration) that occurred between 24 hours and 7 days post coronary artery bypass graft and/or valvular surgery.
Croatian: Djelotvornost u bolesnika u kojih se fibrilacija atrija razvila nakon operacije srca (ACT II) Ispitivala se djelotvornost u bolesnika s fibrilacijom atrija nakon operacije srca u dvostruko slijepom, placebom kontroliranom ispitivanju faze III u usporednim skupinama (ACT II), u kojemu je sudjelovalo 150 bolesnika s produljenom fibrilacijom atrija (u trajanju od 3 do 72 sata) koja se razvila
English: BRINAVESS should be administered by intravenous infusion in a monitored clinical setting appropriate for cardioversion.
Croatian: BRINAVESS se mora primijeniti intravenskom infuzijom u kontroliranim kliničkim uvjetima u kojima se može provesti kardioverzija.
English: Cumulative doses of greater than 5 mg/kg should not be administered within 24 hours.
Croatian: Tijekom 24 sata ne smije se primijeniti kumulativna doza viša od 5 mg/kg.
English: It is unknown whether vernakalant/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se vernakalant/metaboliti u majčino mlijeko.
English: However, in post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Croatian: Međutim, nakon stavljanja lijeka u promet uočeni su rijetki slučajevi undulacije atrija s atrioventrikularnim provođenjem 1:1.
English: Caution should be exercised when used in breast-feeding women.
Croatian: Potreban je oprez kada se primjenjuje kod dojilja.
English: • pain in your fingers and toes, a burning feelingcold sweats, hot flush
Croatian: • bol u prstima ruku i nogu, osjećaj žarenja, hladan znoj, navale vrućine • hitan poriv na stolicu, proljev
English: This medicinal product contains 32 mg sodium per 200 mg vial, equivalent to 1.6 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 32 mg natrija po jednoj bočici od 200 mg, što odgovara 1,6 % maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Pripremljeni lijek ne bi se smio čuvati dulje od 24 sata na temperaturi od 2° C do 8 °C, osim ako razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: • Intravenous rhythm control AADs should not be used in the first 4 hours after BRINAVESS administration.
Croatian: • Intravenski antiaritmici za kontrolu srčanog ritma ne smiju se primjenjivati u prva 4 sata nakon primjene lijeka BRINAVESS.
English: It is preferable to avoid the use of BRINAVESS during pregnancy.
Croatian: Preporučuje se izbjegavati primjenu lijeka BRINAVESS u trudnoći.
English: BRINAVESS 20 mg/ml sterile concentrate vernakalant hydrochloride IV
Croatian: BRINAVESS 20 mg/ml sterilni koncentrat vernakalantklorid i.v.
English: For patients above 113 kg, vernakalant has a fixed dose.
Croatian: Bolesnici tjelesne težine > 113 kg Za bolesnike tjelesne težine iznad 113 kg, vernakalant se primjenjuje u fiksnoj dozi.
English: Note: BRINAVESS concentrate for solution for infusion ranges from colourless to pale yellow.
Croatian: Napomena: BRINAVESS koncentrat za otopinu za infuziju je bezbojan do blijedožut.
English: If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 2 mg/kg may be administered (maximum second infusion of 226 mg (56.5 ml of 4 mg/ml solution)).
Croatian: Ako unutar 15 minuta od završetka početne infuzije ne nastupi konverzija u sinusni ritam, može se primijeniti druga infuzija u dozi od 2 mg/kg tijekom 10 minuta (maksimalna doza za drugu infuziju iznosi 226 mg (56,5 ml otopine koncentracije 4 mg/ml)).
English: With a significantly higher conversion rate in patients treated with vernakalant, the incidence of bradycardia events was higher within the first 2 hours in vernakalant treated patients than in placebo-treated patients (1.6 % versus 0 %, respectively).
Croatian: Uz značajno veću stopu konverzije u bolesnika koji su primali vernakalant, incidencija bradikardije u prva 2 sata bila je veća u bolesnika liječenih vernakalantom nego u onih koji su primali placebo (1,6 % naspram 0 %).
English: Patients receiving vernakalant have a higher incidence of converting to atrial flutter within the first 2 hours post-dose.
Croatian: Bolesnici koji primaju vernakalant imaju veću incidenciju konverzije u undulaciju atrija unutar prva 2 sata nakon davanja doze.
English: BRINAVESS is a concentrate for solution for infusion (sterile concentrate) which is clear and colourless to pale yellow.
Croatian: BRINAVESS je koncentrat za otopinu za infuziju (sterilni koncentrat) koji je bezbojan do blijedožut.
English: Atrial Flutter
Croatian: Undulacija atrija
English: The recommended initial dose is 3 mg/kg, with a maximum calculated dose based upon 113 kg.
Croatian: Preporučena početna doza je 3 mg/kg, a najviša dopuštena doza izračunata je na temelju bolesnika tjelesne težine 113 kg.
English: • Resumption or initiation of oral-maintenance antiarrhythmic therapy can be considered 2 hours after BRINAVESS administration.
Croatian: • Nastavak ili uvođenje peroralne terapije održavanja antiaritmicima može se razmotriti nakon što su prošla 2 sata od primjene lijeka BRINAVESS.
English: 10 mL: EU/1/10/645/001
Croatian: EU/1/10/645/001
English: No dose adjustment of vernakalant is required on the basis of CYP2D6 metaboliser status, or when vernakalant is administered concurrently with 2D6 inhibitors.
Croatian: Nije potrebno prilagođavati dozu vernakalanta na temelju statusa metabolizacije putem CYP2D6 ili kod istodobne primjene vernakalanta i inhibitora 2D6.
English: Do not use this medicine if you notice particulate matter or discolouration.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da sadrži vidljive čestice ili je sadržaj promijenio boju.
English: Do not re-start BRINAVESS.
Croatian: BRINAVESS se ne smije ponovno uvoditi.
English: BRINAVESS vials are for single use only and must be diluted prior to administration.
Croatian: Bočice lijeka BRINAVESS namijenjene su isključivo za jednokratnu primjenu i prije primjene se moraju razrijediti.
English: In patients with valvular heart disease, there was a higher incidence of ventricular arrhythmia events in vernakalant patients until 24 hours after dosing.
Croatian: Bolest srčanih zalistaka Bolesnici s bolešću srčanih zalistaka koji su primali vernakalant imali su veću incidenciju događaja ventrikularne aritmije unutar 24 sata nakon doziranja.
English: - Alert HCP for use of antiarrhythmic drugs (AADs) prior to or after BRINAVESS.
Croatian: - Upozorenje zdravstvenim radnicima o primjeni antiaritmijskih lijekova prije ili nakon lijeka
English: Resumption or initiation of oral maintenance antiarrhythmic therapy can be considered starting 2 hours after vernakalant administration.
Croatian: Nastavak ili uvođenje peroralne terapije održavanja antiaritmicima može se razmotriti nakon što su prošla 2 sata od primjene vernakalanta.
English: The osmolality of the medicinal product is controlled between the following range: 270-320 mOsmol/kg
Croatian: 270-320 mOsmol/kg.
English: Due to the higher incidence of the adverse reactions of hypotension and ventricular arrhythmia in patients with CHF, vernakalant should be used cautiously in haemodynamically stable patients with CHF functional classes NYHA I to II.
Croatian: Zbog veće incidencije nuspojava hipotenzije i ventrikularne aritmije u bolesnika s kongestivnim zatajenjem srca, vernakalant se mora primjenjivati uz oprez u hemodinamski stabilnih bolesnika s kongestivnim zatajenjem srca funkcionalnog stupnja I do II prema NYHA klasifikaciji.
English: BRINAVESS should be administered in a monitored clinical setting appropriate for cardioversion by a well-qualified healthcare professional.
Croatian: BRINAVESS mora primijeniti dobro osposobljen zdravstveni radnik u kontroliranim kliničkim uvjetima u kojima se može provesti kardioverzija.
English: The Marketing Authorisation Holder shall provide a check list in each pack, the text of which is included in Annex IIIA.
Croatian: • Dodatne mjere minimizacije rizika Nositelj odobrenja će u svakom pakiranju priložiti kontrolni upitnik, čiji se sadržaj navodi u Dodatku
English: Package leaflet: Information for the user BRINAVESS 20 mg/ml concentrate for solution for infusion vernakalant hydrochloride
Croatian: Uputa o lijeku: Informacije za korisnika BRINAVESS 20 mg/ml koncentrat za otopinu za infuziju vernakalantklorid
English: - Alert HCP for adverse reactions, which may occur after BRINAVESS administration, including hypotension, bradycardia, atrial flutter, or ventricular arrhythmia.
Croatian: BRINAVESS, uključujući hipotenziju, bradikardiju, undulaciju atrija i ventrikularnu aritmiju.
English: Atrial fibrillation patients receiving vernakalant have a higher incidence of converting to atrial flutter within the first 2 hours post-dose (1.2 % versus 0 % in placebo).
Croatian: Bolesnici s fibrilacijom atrija koji primaju vernakalant imaju veću incidenciju konverzije u undulaciju atrija u prva 2 sata nakon primjene doze (1,2 % naspram 0 % kod placeba).
English: If conversion to sinus rhythm did not occur with the initial infusion or within the 15 minute observation period, administer a 2 mg/kg second infusion over 10 minutes.
Croatian: Ako konverzija u sinusni ritam ne nastupi tijekom početne infuzije ili tijekom 15-minutnog razdoblja promatranja, primijenite drugu infuziju u dozi od 2 mg/kg tijekom 10 minuta.
English: It is not known whether BRINAVESS passes into the breast milk.
Croatian: Nije poznato izlučuje li se BRINAVESS u majčino mlijeko.
English: In post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Croatian: Nakon stavljanja lijeka u promet uočeni su rijetki slučajevi undulacije atrija s atrioventrikularnim provođenjem 1:1.
English: • ECG changes (such as a clinically meaningful sinus pause, complete heart block, new bundle branch block, significant prolongation of the QRS or QT interval, changes consistent with ischaemia or infarction and ventricular arrhythmia)
Croatian: novonastali blok grane, značajno produljenje QRS-kompleksa ili QT-intervala, promjene koje odgovaraju ishemiji ili infarktu i ventrikularna aritmija)
English: This leaflet was last revised in Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u (mjesec GGGG)
English: Vernakalant must not be administered in patients who received intravenous AADs (class I and III) within 4 hours prior to vernakalant (see section 4.3).
Croatian: Vernakalant se ne smije primijeniti u bolesnika koji su intravenski primili antiaritmike (skupine I i III) unutar 4 sata prije primjene vernakalanta (vidjeti dio 4.3).
English: This medicinal product contains 80 mg sodium per 500 mg vial, equivalent to 4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 80 mg natrija po jednoj bočici od 500 mg, što odgovara 4 % maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: Recommended diluents are sodium chloride 9 mg/ml (0.9 %) solution for injection, Lactated Ringers solution for injection, or 5 % glucose for solution for injection.
Croatian: Preporučene otopine za razrjeđivanje su otopina natrijevog klorida za injekciju od 9 mg/ml (0,9 %), Ringerova otopina s laktatom za injekciju ili 5 %-tna otopina glukoze za injekciju.
English: It must not be administered in patients who received intravenous AADs (class I and III) within 4 hours prior to vernakalant (see section 4.3).
Croatian: Ne smije se primijeniti u bolesnika koji su intravenski primili antiaritmike (skupine I i III) unutar 4 sata prije primjene vernakalanta (vidjeti dio 4.3).
English: • decreased feeling or sensitivity of the mouth
Croatian: • umor • smanjen osjet ili osjetljivost u ustima
English: Within the first 2 hours, ventricular arrhythmia occurred in 6.4 % of patients treated with vernakalant versus none after placebo.
Croatian: Unutar prva 2 sata, ventrikularna aritmija se javila u 6,4 % bolesnika koji su primili vernakalant u odnosu na niti jednog bolesnika u placebo skupini.
English: Vernakalant is mainly eliminated by CYP2D6 mediated O-demethylation in CYP2D6 extensive metabolisers.
Croatian: Eliminacija Vernakalant se u jakih metabolizatora CYP2D6 uglavnom eliminira O-demetilacijom posredovanom
English: 25 mL: 500 mg/25 mL
Croatian: 500 mg/25 ml