FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder shall ensure that all healthcare professionals (HCP) involved in the administration of BRINAVESS are provided with a healthcare professional information pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da vsi zdravstveni delavci, vključeni pri uporabi zdravila BRINAVESS, dobijo paket z informacijami za zdravstveno osebje, ki vsebuje naslednje:
English: Does the patient have prolonged QT interval at baseline (uncorrected > 440 msec)?
Slovenian: Ali ima bolnik izhodiščno podaljšanje QT intervala (nekorigirani > 440 ms)?
English: Pack size of 1 vial includes either 10 ml or 25 ml of concentrate.
Slovenian: Velikost pakiranja z 1 vialo obsega ali 10 ml ali 25 ml koncentrata.
English: In all studies, patients received a 10minute infusion of 3.0 mg/kg BRINAVESS (or matching placebo) followed by a 15-minute observation period.
Slovenian: V vseh študijah so bolniki dobili 10-minutno infuzijo 3,0 mg/kg zdravila BRINAVESS (ali ujemajoč se placebo), temu pa je sledilo 15-minutno obdobje opazovanja.
English: For patients above 113 kg, vernakalant has a fixed dose.
Slovenian: Za bolnike s telesno maso nad 113 kg ima vernakalant določen odmerek.
English: BRINAVESS may not work in treating some other kinds of abnormal heart rhythms, however your doctor will be familiar with these.
Slovenian: Zdravilo BRINAVESS lahko ne deluje na določene vrste motenj srčnega ritma, s katerimi pa je vaš zdravnik seznanjen.
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).
Slovenian: Če se po začetni infuziji pojavi hemodinamsko stabilna atrijska undulacija, je mogoče uporabiti drugo infuzijo, kajti bolnik lahko preide v sinusni ritem (glejte poglavji 4.4 in 4.8).
English: Median time to conversion to SR as reported among all patients who, as per the investigator judgement, converted to SR was 12 minutes and in most of the treatment episodes (60.4%) only one infusion was administered.
Slovenian: Mediani čas do pretvorbe v sinusni ritem 12 minut je bil naveden med vsemi bolniki, ki so po presoji preiskovalca prešli na sinusni ritem, v večini primerov zdravljenja (60,4%) pa je bila uporabljena le ena infuzija.
English: Hypotension can occur in a small number of patients (vernakalant 5.7 %, placebo 5.5 % in the first 2 hours post-dose).
Slovenian: Pri maloštevilnih bolnikih se lahko pojavi hipotenzija (vernakalant 5,7 %, placebo 5,5 % v prvih dveh urah po odmerku).
English: BRINAVESS must NOT be given to any patients with a “YES” response below:
Slovenian: Zdravila BRINAVESS NE smete dati nobenemu bolniku, pri katerem je vsaj en odgovor na spodnja vprašanja pritrdilen:
English: Conversion of atrial fibrillation to sinus rhythm occurred rapidly (median time to conversion 12 minutes from the start of infusion).
Slovenian: Prehod iz atrijske fibrilacije v sinusni ritem se je pojavil hitro (mediani čas do prehoda 12 minut od začetka infuzije).
English: Contents of the pack and other information What BRINAVESS contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo BRINAVESS
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.
Slovenian: • Bolniki s hudo aortno stenozo, bolniki s sistoličnim krvnim tlakom < 100 mm Hg in bolniki s srčnim popuščanjem v razredu NYHA III ali NYHA IV.
English: There was no meaningful difference when stratifying the analysis by therapeutic indication (i.e. non-surgery and post-cardiac surgery patients).
Slovenian: Pri stratifikaciji analize po terapevtski indikaciji (tj. pri bolnikih brez kirurškega posega in po srčnem kirurškem posegu) ni bilo pomembne razlike.
English: In patients, the typical total body clearance of vernakalant was estimated to be 0.41 l/hr/kg.
Slovenian: Pri bolnikih je ocenjeni značilni celotni telesni očistek vernakalanta 0,41 l/h/kg.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodilo v zvezi z redčenjem zdravila pred dajanjem glejte poglavje 6.6.
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).
Slovenian: Predklinične študije so pokazale, da vernakalant blokira tokove v vseh fazah preddvornega akcijskega potenciala, vključno s kalijevimi tokovi, ki so specifično izraženi v preddvorih (tj. ultrahitri odloženi izravnalni in od acetilholina odvisni kalijevi tokovi).
English: BRINAVESS may be available in different vial sizes (available vial sizes to be inserted locally).
Slovenian: Zdravilo BRINAVESS je lahko na voljo v vialah različnih velikosti (velikosti vial, ki so na voljo, vstavi država članica).
English: • Hypotension
Slovenian: • hipotenzija
English: In an electrophysiological study in patients, vernakalant significantly prolonged atrial effective refractory period in a dose-dependent manner, which was not associated with a significant increase in ventricular effective refractory period.
Slovenian: V elektrofiziološki študiji pri bolnikih je vernakalant bistveno in od odmerka odvisno podaljšal efektivno refraktarno obdobje preddvorov, to pa ni bilo povezano z bistvenim podaljšanjem efektivnega refraktarnega obdobja prekatov.
English: The use in CHF patients corresponding to NYHA III or NYHA IV is contraindicated (see section 4.3).
Slovenian: Uporaba pri bolnikih s kongestivnim srčnim popuščanjem v razredu NYHA III ali NYHA IV je kontraindicirana (glejte poglavje 4.3).
English: No formal interaction studies have been undertaken with vernakalant injection.
Slovenian: Formalne študije medsebojnega delovanja z injekcijami vernakalanta niso bile izvedene.
English: - Alert HCP for use of antiarrhythmic drugs (AADs) prior to or after BRINAVESS.
Slovenian: - Opozorilo za zdravstveno osebje glede uporabe antiaritmikov (AAD- antiarrhythmic drugs) pred uporabo zdravila BRINAVESS in po njej.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo BRINAVESS Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Table 2: Conversion of Atrial Fibrillation to Sinus Rhythm in ACT I and ACT III Duration of
Slovenian: Preglednica 2: Prehod iz atrijske fibrilacije v sinusni ritem v študijah ACT I in ACT III
English: Single-use glass (Type 1) vials with a chlorobutyl rubber stopper and an aluminium overseal.
Slovenian: Viale iz stekla (tipa 1) za enkratno uporabo s klorobutilnim gumijastim zamaškom in aluminijsko prekrivno zaporko.
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
Slovenian: * V preglednico vključeni neželeni učinki so se pojavili v 24 urah po uporabi vernakalanta (glejte poglavji 4.2 in 5.2) s pojavnostjo pri > 0,1 % bolnikov z vernakalantom in višje od placeba.
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.
Slovenian: Opazili niso nobenih pomembnih razlik v varnosti in učinkovitosti glede na starost, spol, uporabo zdravil za uravnavanje frekvence, uporabo antiaritmičnih zdravil, uporabo varfarina, anamnezo ishemične bolezni srca, okvaro ledvic ali ekspresijo encima 2D6 citokroma P450.
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).
Slovenian: V študiji AVRO so infuzijo amiodarona dali v 2 urah (tj. 1-urni polnilni odmerek 5 mg/kg, nato 1-urna vzdrževalna infuzija 50 mg).
English: What BRINAVESS is and what it is used for What you need to know before you use BRINAVESS How to use BRINAVESS
Slovenian: Kaj je zdravilo BRINAVESS in za kaj ga uporabljamo Kaj morate vedeti, preden začnete uporabljati zdravilo BRINAVESS Kako se uporablja zdravilo BRINAVESS
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)
Slovenian: • spremembe EKG (npr. klinično pomembna sinusna pavza, kompletni srčni blok, nov kračni blok, pomembna razširitev kompleksa QRS ali podaljšanje intervala QT, spremembe, ki ustrezajo ishemiji ali infarktu, ali prekatne motnje srčnega ritma)
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).
Slovenian: Načrt kliničnih preskušanj: Klinični učinek vernakalanta pri bolnikih z atrijsko fibrilacijo so ocenili v treh randomiziranih, dvojno slepih, s placebom kontroliranih študijah (ACT I, ACT II in ACT III) ter v preskušanju AVRO z aktivnim primerjalnim zdravilom (intravenski amiodaron).
English: These arrhythmias typically presented as asymptomatic, monomorphic, non-sustained (average 3-4 beats) ventricular tachycardias.
Slovenian: Te motnje srčnega ritma so se praviloma pojavljale kot asimptomatske, monomorfne, neobstojne (povprečno 3-4 utripi) prekatne tahikardije.
English: There is no experience on the use of BRINAVESS in children and adolescents less than 18 years of age; therefore its use is not recommended.
Slovenian: Z uporabo zdravila BRINAVESS pri otrocih in mladostnikih, mlajših od 18 let, ni izkušenj, zato uporabe pri njih ne priporočamo.
English: Overall, the combination of effects of vernakalant on cardiac potassium and sodium currents results in substantial antiarrhythmic effects that are mainly concentrated in the atria.
Slovenian: Skupaj tako kombinirani učinki vernakalanta na kalijeve in natrijeve tokove v srcu povzročijo izrazite antiaritmične učinke, ki so v glavnem osredotočeni na preddvore.
English: • decreased feeling or sensitivity of the mouth
Slovenian: • zmanjšan občutek ali občutljivost v ustih
English: There is no clinical experience with direct-current cardioversion under 2 hours post-dose.
Slovenian: Kliničnih izkušenj s kardioverzijo z enosmernim tokom manj kot dve uri po odmerku ni.
English: Read all steps before administration.
Slovenian: Pred dajanjem zdravila preberite vse korake.
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.
Slovenian: Primarni opazovani dogodek je bil delež bolnikov, ki so dosegli sinusni ritem v 90 minutah po uvedbi zdravljenja, pri čemer so zaključki omejeni na učinke, ki so bili vidni v tem časovnem okvirju.
English: In embryo-foetal development studies with oral administration of vernakalant two times a day resulting in exposure levels (AUC) generally higher than those achieved in humans after a single intravenous dose of vernakalant malformations (misshapen/absent/fused skull bones including cleft palates, bent radius, bent/misshapen scapula, constricted trachea, absent thyroid, undescendent testes) occurred in rats and increased embryo-foetal lethality, increased number of foetuses with fused and/or additional sternebrae were seen in rabbits at the highest doses tested.
Slovenian: V študijah embriofetalnega razvoja so s peroralno uporabo vernakalanta dvakrat na dan dosegli izpostavljenost (AUC), ki je bila na splošno večja kot je dosežena pri človeku po enem intravenskem odmerku vernakalanta; pri največjih testiranih odmerkih so ugotovili malformacije (napačno oblikovane/odsotne/združene lobanjske kosti, vključno s palatoshizo, upognjeno koželjnico, upognjeno/napačno oblikovano lopatico, zožen sapnik, odsotnost ščitnice, nespuščena moda) pri podganah ter večjo embriofetalno umrljivost in večje število plodov z združenimi in/ali dodatnimi segmenti prsnice (sternebrae) pri kuncih.
English: BRINAVESS, your breathing, heart beat, blood pressure and the electrical activity of your heart will be checked.
Slovenian: Medtem ko boste dobivali zdravilo BRINAVESS, vam bodo nadzirali dihanje, srčni utrip, krvni tlak in električno delovanje srca.
English: The vernakalant dose recommendation is a titrated therapy with 2 possible dose steps.
Slovenian: Za odmerjanje vernakalanta je priporočljivo titrirano zdravljenje z dvema možnima korakoma odmerjanja.
English: However, blockade of cationic currents, including hERG channels and cardiac voltage-dependent sodium channels, which are present in the ventricles has been documented.
Slovenian: Dokumentirana pa je bila blokada kationskih tokov, vključno s kanali hERG in napetostno odvisnimi srčnimi natrijevimi kanali, ki so prisotni v prekatih.
English: This is equivalent to 4 % of the recommended maximum daily dietary intake for an adult.
Slovenian: To je enako 4 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: The initial dose is 339 mg (84.7 ml of 4 mg/ml solution).
Slovenian: Začetni odmerek je 339 mg (84,7 ml 4 mg/ml raztopine).
English: Talk to your doctor before using BRINAVESS if you have any of the following problems:
Slovenian: Pred začetkom uporabe zdravila BRINAVESS se posvetujte z zdravnikom, če imate katero od naslednjih težav:
English: This is equivalent to 1.6 % of the recommended maximum daily dietary intake for an adult.
Slovenian: To je enako 1,6 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle.
English: In these studies treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm as compared with placebo (see Table 2).
Slovenian: V teh študijah je vernakalant učinkovito dosegel prehod iz atrijske fibrilacije v sinusni ritem v primerjavi s placebom (glejte preglednico 2).
English: The free fraction of vernakalant in human serum is 53-63 % at concentration range of 1-5 μg/ml.
Slovenian: V območju koncentracij od 1 do 5 µg/ml je delež prostega vernakalanta v serumu pri človeku od 53 do 63 %.
English: Correvio Тел.
Slovenian: Тел.
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.
Slovenian: Sorazmerna selektivnost vernakalanta za refraktarnost preddvorov v primerjavi s prekati naj bi bila posledica blokade tokov reguliranih z ionskimi kanali, ki so izraženi v preddvorih, ne pa v prekatih, pa tudi edinstvenega elektrofiziološkega stanja v preddvorih med fibrilacijo.
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 %).
Slovenian: Učinkovitost so raziskali pri skupaj 390 hemodinamsko stabilnih odraslih bolnikih s kratkotrajno atrijsko fibrilacijo; med njimi so bili bolniki s hipertenzijo (40,5 %), ishemično boleznijo srca (12,8 %), boleznijo srčnih zaklopk (9,2 %) in kongestivnim srčnim popuščanjem (10,8 %).
English: No dose adjustment is required for these conditions, nor on the basis of age, serum creatinine or CYP2D6 metaboliser status.
Slovenian: Prav tako odmerka ni treba prilagoditi glede na starost, serumski kreatinin ali metabolno stanje s CYP2D6.
English: • if you have a very narrow heart valve, systolic blood pressure less than 100 mm Hg or advanced heart failure with symptoms at minimal exertion or at rest
Slovenian: • če imate zelo zoženo katero od srčnih zaklopk, sistolični krvni tlak manj kot 100 mm Hg ali napredovalo srčno popuščanje s simptomi že ob minimalnem naporu ali v mirovanju.
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 %).
Slovenian: Prehod iz atrijske fibrilacije v sinusni ritem se je pojavil hitro (pri odzivnih bolnikih je bil mediani čas do prehoda 10 minut od začetka prve infuzije) in sinusni ritem se je ohranil v obdobju 24 ur (97 %).
English: • certain kinds of heart beat problems, (such as an awareness of your heart beating (palpitations)
Slovenian: • določene vrste težav s srčnim utripom (npr. izpuščeni utripi, zavedanje bitja srca (palpitacije) ali dodaten srčni utrip)
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. - Alert HCP about BRINAVESS special warnings and precautions in patients with, clinically meaningful valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis, previously documented LVEF ≤ 35 %, advanced hepatic impairment.
Slovenian: • Bolniki s hudo aortno stenozo, bolniki s sistoličnim krvnim tlakom < 100 mm Hg in bolniki s srčnim popuščanjem v razredu NYHA III ali NYHA IV. - Opozorilo za zdravstveno osebje glede posebnih opozoril in previdnostnih ukrepov za zdravilo BRINAVESS pri bolnikih s klinično pomembno stenozo zaklopk, hipertrofično obstruktivno kardiomiopatijo, restriktivno kardiomiopatijo ali konstriktivnim perikarditisom, predhodno dokumentiranim iztisnim deležem levega prekata (LVEF) ≤ 35 %, z napredovalo okvaro jeter.
English: Post-cardiac surgery patients: No dose adjustment necessary.
Slovenian: Bolniki po kardiokirurški operaciji: Prilagoditev odmerka ni potrebna.
English: Vernakalant was not found to be effective in converting typical primary atrial flutter to sinus rhythm.
Slovenian: Za vernakalant ni ugotovljeno, da bi učinkovito doseglo prehod tipične primarne atrijske undulacije v sinusni ritem.
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.
Slovenian: Izkušenj z uporabo vernakalanta pri bolnikih s predhodno dokumentiranim iztisnim deležem levega prekata (LVEF) ≤ 35 % je malo, zato njegove uporabe pri takšnih bolnikih ne priporočamo.
English: BRINAVESS contains sodium
Slovenian: Zdravilo BRINAVESS vsebuje natrij
English: • decreased feeling or sensitivity
Slovenian: • zmanjšan občutek za občutljivost
English: Correvio Tel: +49 69 33 29 62 76
Slovenian: Tel: +49 69 33 29 62 76
English: The patient should be further monitored for 2 hrs after the start of infusion and until clinical and ECG parameters have stabilised.
Slovenian: Bolnike je treba še naprej nadzorovati 2 uri po začetku infundiranja ter dokler se klinični in elektrokardiografski parametri ne stabilizirajo.
English: - Keep this leaflet.
Slovenian: **Glejte spodaj.
English: This risk is higher in patients who use Class I antiarrhythmics (see section 4.8).
Slovenian: Tveganje je večje pri bolnikih, ki prejemajo antiaritmike iz I. skupine (glejte poglavje 4.8).
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).
Slovenian: Študija ACT II je preučevala učinek vernakalanta pri bolnikih, ki se jim je pojavila < 3 dni trajajoča atrijska fibrilacija po nedavni obvodni koronarni operaciji (CABG) in/ali operaciji zaklopk (atrijska fibrilacija se je pojavila več kot 1 dan, a manj kot 7 dni po operaciji).
English: Patients with hepatic impairment: No dose adjustment necessary (see sections 4.4 and 5.2).
Slovenian: Bolniki z okvaro jeter: Prilagoditev odmerka ni potrebna (glejte poglavji 4.4 in 5.2).
English: AVRO studied the effect of vernakalant versus intravenous amiodarone in patients with recent onset atrial fibrillation (3 hrs to 48 hrs).
Slovenian: Študija AVRO je primerjala učinek vernakalanta in intravenskega amiodarona pri bolnikih s pred kratkim nastalo atrijsko fibrilacijo (od 3 ure do 48 ur).
English: Patients with renal impairment: No dose adjustment necessary (see section 5.2).
Slovenian: Bolniki z okvaro ledvic: Prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Has the patient presented with an acute coronary syndrome (including myocardial infarction) in the last 30 days?
Slovenian: Ali je bolnik imel akutni koronarni sindrom (vključno z miokardnim infarktom) v zadnjih 30 dneh?
English: • The other ingredients are citric acid, sodium chloride, sodium hydroxide (E524) and water for injections.
Slovenian: • Pomožne snovi so citronska kislina, natrijev klorid, natrijev hidroksid (E524) in voda za injekcije.
English: It is not known whether BRINAVESS passes into the breast milk.
Slovenian: Ni znano, ali zdravilo BRINAVESS prehaja v materino mleko.
English: • your blood pressure (such as a very low blood pressure causing a serious heart condition)
Slovenian: • krvnega tlaka (kot zelo nizek krvni tlak, ki povzroči nevarno stanje srca) (občasni) • električnega delovanja srca (občasni)
English: Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults
Slovenian: Hitra konverzija nedavno nastale atrijske fibrilacije v sinusni ritem pri odraslih
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”).
Slovenian: običajno se pojavi v prvih 2 urah (glejte poglavje "Možni neželeni učinki ").
English: The recommended initial dose is 3 mg/kg, with a maximum calculated dose based upon 113 kg.
Slovenian: Priporočeni začetni odmerek je 3 mg/kg, z največjim izračunanim odmerkom za 113 kg.
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).
Slovenian: Če štejemo za neuspeh zdravljenja bolnike, ki so prejeli električno kardioverzijo, intravenske antiaritmike ali peroralni propafenon/flekainid v 90 minutah od začetka infuzije zdravila BRINAVESS, poleg bolnikov, ki v 90 minutah niso pretvorili niti ene minute, je bila stopnja konverzije 67,3% (1.352/2.009) med 2.009 bolniki, ki so prejeli zdravilo BRINAVESS.
English: Targeted effects on atrial tissue coupled with block of late sodium current suggests that vernakalant has a low proarrhythmic potential.
Slovenian: Usmerjeni učinki na tkivo preddvorov v povezavi z blokado poznega toka natrija kažejo, da je proaritmični potencial vernakalanta majhen.
English: Treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm (47.0 % vernakalant, 14.0 % placebo; P value = 0.0001).
Slovenian: Vernakalant je učinkovito dosegel prehod iz atrijske fibrilacije v sinusni ritem (vernakalant 47,0 %, placebo 14,0 %, vrednost p =
English: Dizziness has been reported within the first 2 hours after receiving it (see section 4.8).
Slovenian: V prvih dveh urah po uporabi vernakalanta so poročali o omotici (glejte poglavje 4.8).
English: Step 3: Inspection of the solution
Slovenian: 3. korak: Raztopino preglejte