FrancophonIA/ELRC3.0 huggingface dataset:
English: However, acute intravenous administration of vernakalant is not expected to markedly impact the PK of chronically administered 2D6 substrates, as a consequence of vernakalant's short half-life and the ensuing transient nature of 2D6 inhibition.
Slovenian: Vendar ni pričakovati, da bi akutno intravensko dajanje vernakalanta izrazito vplivalo na farmakokinetiko kronično uporabljanih substratov 2D6, ker je razpolovni čas vernakalanta kratek in zato inhibicija 2D6 prehodna.
English: EXP Diluted solution: use within 12 hours and store at or below 25 °C.
Slovenian: Razredčena raztopina: uporabite v 12 urah in shranjujte pri temperaturi do vključno 25 °C.
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.
Slovenian: ACT III je bilo vključenih nekaj bolnikov z značilno atrijsko undulacijo in za vernakalanta ni bilo ugotovljeno, da bi učinkovito konvertiralo atrijsko undulacijo.
English: Correvio Tel: +39 02 600 63037
Slovenian: Tel: +39 02 600 63037
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.
Slovenian: Poleg tega zdravilo ni bilo ovrednoteno pri bolnikih s klinično pomembno stenozo zaklopk, hipertrofično obstruktivno kardiomiopatijo, restriktivno kardiomiopatijo ali konstriktivnim perikarditisom.
English: • low blood pressure, slow heart beat, feeling dizzy
Slovenian: • nizek krvni tlak, počasen srčni utrip, omotica
English: Each vial of 200 mg contains approximately 1.4 mmol (32 mg) sodium.
Slovenian: Ena viala z 200 mg vsebuje približno 1,4 mmol (32 mg) natrija.
English: • Acute coronary syndrome (including myocardial infarction) within the last 30 days.
Slovenian: • Akutni koronarni sindrom (vključno z miokardnim infarktom) v zadnjih 30 dneh.
English: Contains citric acid, sodium chloride, water for injections, sodium hydroxide (E524).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje citronsko kislino, natrijev klorid, vodo za injekcije, natrijev hidroksid (E524).
English: Does the patient have severe bradycardia, sinus node dysfunction or second and third degree heart block, in the absence of a pacemaker?
Slovenian: Ali ima bolnik hudo bradikardijo, disfunkcijo sinusnega vozla ali srčni blok 2. ali 3. stopnje brez srčnega spodbujevalnika?
English: • eye irritation, watery eyes or changes in your vision
Slovenian: • draženje očesa, solzenje ali spremembe vida
English: BRINAVESS should be administered by intravenous infusion in a monitored clinical setting appropriate for cardioversion.
Slovenian: Zdravilo BRINAVESS je treba dati v intravenski infuziji v nadzorovanem okolju, primernem za kardioverzijo.
English: Correvio Tel: + 34 93 179 05 36
Slovenian: Tel: +34 93 179 05 36
English: Hypotension typically occurs early, either during the infusion or early after the end of the infusion, and can usually be corrected by standard supportive measures.
Slovenian: Hipotenzija se praviloma pojavi zgodaj, bodisi med infundiranjem bodisi kmalu po koncu infundiranja.
English: Patients > 100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.
Slovenian: Bolniki s telesno maso > 100 kg: 30 ml zdravila BRINAVESS 20 mg/ml dodajte 120 ml vehikla.
English: Within the clinical development program, oral maintenance antiarrhythmic therapy was halted for a minimum of 2 hours after vernakalant administration.
Slovenian: V programu kliničnega razvoja so peroralno vzdrževalno zdravljenje z antiaritmiki prekinili za vsaj 2 uri po dajanju vernakalant.
English: • shortness of breath or a tightness in the chest
Slovenian: • kratka sapa ali tiščanje v prsih
English: If conversion to sinus rhythm occurs during either the initial or second infusion, that infusion should be continued to completion.
Slovenian: Če bolnik med začetno ali med drugo infuzijo preide v sinusni ritem, je treba infuzijo dokončati.
English: Vernakalant is an antiarrhythmic medicine that acts preferentially in the atria to prolong atrial refractoriness and to rate-dependently slow impulse conduction.
Slovenian: Vernakalant je antiaritmično zdravilo, ki prednostno deluje v preddvorih, tako da podaljša njihovo refraktarnost in od frekvence odvisno upočasni prevajanje impulzov.
English: The amount of BRINAVESS you may be given will depend on your weight.
Slovenian: Količina zdravila BRINAVESS, ki jo boste dobili, je odvisna od vaše telesne mase.
English: Each vial of 500 mg contains approximately 3.5 mmol (80 mg) of sodium.
Slovenian: Ena viala s 500 mg vsebuje približno 3,5 mmol (80 mg) natrija.
English: What you need to know before you use BRINAVESS Do not use BRINAVESS
Slovenian: Kaj morate vedeti, preden začnete uporabljati zdravilo BRINAVESS Ne uporabljajte zdravila BRINAVESS:
English: The checklist should be placed on the infusion container to be read by the healthcare professional who will administer BRINAVESS.
Slovenian: Kontrolni seznam je treba namestiti na vsebnik infuzije z namenom, da ga prebere zdravstveni delavec, ki bo dal zdravilo BRINAVESS.
English: • numbness or tingling that occurs in the mucosa or tissues of the oral cavity
Slovenian: • otrplost ali mravljinčenje, ki se pojavita v ustni sluznici ali ustnem tkivu
English: This medicine contains 80 mg of sodium (main component of cooking/table salt) in each vial of 500 mg.
Slovenian: To zdravilo vsebuje 80 mg natrija (glavna sestavina kuhinjske/namizne soli) v eni viali s 500 mg.
English: Bradycardia was observed predominantly at the time of conversion to sinus rhythm.
Slovenian: Bradikardijo so opažali predvsem v času prehoda v sinusni ritem.
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.
Slovenian: Zmožnost vernakalanta za blokado pozne komponente natrijevega toka poleg tega omeji učinek na repolarizacijo prekatov, ki jo izzove blokada kalijevih tokov v prekatu.
English: If the patient was in atrial fibrillation or atrial flutter at the end of the 15-minute observation period, a second 10-minute infusion of 2.0 mg/kg BRINAVESS (or matching placebo) was administered.
Slovenian: Če je imel bolnik na koncu 15-minutnega obdobja opazovanja atrijsko fibrilacijo ali atrijsko undulacijo, je bila uporabljena druga 10-minutna infuzija 2,0 mg/kg zdravila BRINAVESS (ali ujemajočega se placeba).
English: Posology BRINAVESS is dosed by patient body weight, with a maximum calculated dose based upon 113 kg.
Slovenian: Zdravilo BRINAVESS se odmerja glede na bolnikovo telesno maso z največjim izračunanim odmerkom na podlagi mase 113 kg.
English: Preparation of BRINAVESS for infusion
Slovenian: Priprava zdravila BRINAVESS za infundiranje
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.
Slovenian: Vernakalant je substrat za CYP2D6, toda populacijske farmakokinetične analize niso pokazale bistvene razlike v akutni izpostavljenosti vernakalantu (Cmax in AUC0-90min), če so bili v 1 dnevu pred infuzijo vernakalanta uporabljeni šibki ali močni zaviralci CYP2D6, kot če je bil vernakalant uporabljen pri bolnikih, ki sočasno niso prejemali zaviralcev CYP2D6.
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).
Slovenian: Z uporabo intravenskih antiaritmikov za kontrolo srčnega ritma (skupini I in III) v prvih 4 urah po uporabi vernakalanta je malo izkušenj, zato se jih med tem obdobjem ne sme uporabljati (glejte poglavje 4.3).
English: BRINAVESS should not be administered as an intravenous push or bolus.
Slovenian: Zdravila BRINAVESS se ne sme injicirati z intravenskim vbrizganjem oz. kot bolus.
English: Vernakalant has a minor to moderate influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Vernakalant ima blag do zmeren vpliv na sposobnost vožnje in upravljanje strojev.
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 %).
Slovenian: Vernakalant so raziskali pri 116 bolnikih z atrijsko fibrilacijo (trajanje od 3 ure do 48 ur), med njimi so bili bolniki s hipertenzijo (74,1 %), ishemično boleznijo srca (19 %), boleznijo srčnih zaklopk (3,4 %) in kongestivnim srčnim popuščanjem (17,2 %).
English: Read carefully the Summary of Product Characteristics and the Health Care Professional Information Card prior to the administration of BRINAVESS
Slovenian: Pred uporabo zdravila pozorno preberite Povzetek glavnih značilnosti zdravila in kartico z informacijami za zdravstvene delavce.
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.
Slovenian: - Opozorilo za zdravstveno osebje, da je pri uporabi zdravila BRINAVESS pri hemodinamsko stabilnih bolnikih s kongestivnim srčnim popuščanjem v razredih NYHA I in II potrebna previdnost ter da je treba bolnike z boleznijo srčnih zaklopk skrbno nadzorovati.
English: - Alert HCP on BRINAVESS contraindications:
Slovenian: Opozorilo za zdravstveno osebje glede kontraindikacij za zdravilo BRINAVESS:
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.
Slovenian: Če bolnik ne preide v sinusni ritem, morate še 15 minut spremljati njegove vitalne znake in srčni ritem.
English: As a precautionary measure, it is preferable to avoid the use of BRINAVESS during pregnancy.
Slovenian: Iz previdnosti se je uporabi zdravila BRINAVESS med nosečnostjo bolje izogniti.
English: In patients with valvular heart disease, there was a higher incidence of ventricular arrhythmia events in vernakalant patients until 24 hours after dosing.
Slovenian: Pri bolnikih z boleznijo srčnih zaklopk je bila pojavnost prekatnih motenj srčnega ritma večja pri tistih, ki so dobivali vernakalant do 24 ur po odmerjanju.
English: If atrial flutter is observed as secondary to treatment, continuation of infusion should be considered (see section 4.2).
Slovenian: Če se sekundarno po uporabi zdravila pojavi atrijska undulacija, pride v poštev nadaljevanje infuzije (glejte poglavje 4.2).
English: • taste disturbances
Slovenian: • motnje okušanja
English: BRINAVESS will be given to you by a health care professional.
Slovenian: Zdravilo BRINAVESS vam bo dal zdravstveni delavec.
English: Within the first 2 hours, ventricular arrhythmia occurred in 6.4% of patients treated with vernakalant versus none after placebo.
Slovenian: V prvih dveh urah se je pojavila ventrikularna aritmija pri 6,4% bolnikov, zdravljenih z vernakalantom, v primerjavi z nobenim po placebu.
English: Risk of atrial flutter may be increased in patients receiving class I AADs (see above).
Slovenian: Tveganje za atrijsko undulacijo je lahko pri bolnikih, ki prejemajo antiaritmike skupine I, povečano (glejte zgoraj).
English: Uncommon: Pain in extremity
Slovenian: Občasni: bolečina v okončini
English: There is no information on the excretion of vernakalant/metabolites in animal milk.
Slovenian: Informacij o izločanju vernakalanta oz. njegovih presnovkov v mleko pri živalih ni.
English: This medicine contains 32 mg sodium (main component of cooking/table salt) in each 200 mg vial.
Slovenian: To zdravilo vsebuje 32 mg natrija (glavna sestavina kuhinjske/namizne soli) v eni viali z 200 mg.
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).
Slovenian: Pri zdravljenju z vernakalantom je prehod v sinusni ritem v obdobju do 90 minut doseglo 51,7 % bolnikov, z amiodaronom pa 5,2 %, pri čemer je pri zdravljenju z vernakalantom značilno hitreje prišlo do prehoda iz atrijske fibrilacije v sinusni ritem v prvih 90 minutah kot pri zdravljenju z amiodaronom (vrednost p z log-rang testom < 0,0001).
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).
Slovenian: Med bolniki, ki niso prešli v sinusni ritem, je bila pojavnost dogodkov bradikardije v prvih 2 urah po odmerku v skupini s placebom podobna (4,0 %) kot v skupini z vernakalantom (3,8 %).
English: Efficacy in patients with sustained atrial fibrillation, (ACT I and ACT III) Primary efficacy endpoint was the proportion of subjects with short duration atrial fibrillation (3 hours to 7 days) who had a treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of one minute within 90 minutes of first exposure to study drug.
Slovenian: Učinkovitost pri bolnikih z obstojno atrijsko fibrilacijo (ACT I in ACT III) Primarni opazovani dogodek učinkovitosti je bil delež preiskovancev s kratkotrajno atrijsko fibrilacijo (od 3 ure do 7 dni), pri katerih je bil z zdravilom dosežen prehod iz atrijske fibrilacije v sinusni ritem za vsaj eno minuto in v 90 minutah od prve izpostavljenosti raziskovanemu zdravilu.
English: Your doctor will consider if you need additional rhythm control medicine 4 hours after using BRINAVESS.
Slovenian: Zdravnik bo presodil, če 4 ure po uporabi zdravila BRINAVESS potrebujete dodatno zdravilo za urejanje srčnega ritma.
English: In clinical studies to date, patients who developed atrial flutter following treatment with vernakalant did not develop 1:1 atrioventricular conduction.
Slovenian: V kliničnih študijah do danes se po zdravljenju z vernakalantom nobenemu bolniku, pri katerem se je pojavila atrijska undulacija, ni pojavilo atrioventrikularno prevajanje 1:1.
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.
Slovenian: V tem obdobju je treba pri bolnikih skrbno spremljati ali se pojavijo kakršni koli znaki ali simptomi nenadnega znižanja krvnega tlaka ali srčnega utripa.
English: • The patient should be adequately hydrated and haemodynamically optimised and adequately anticoagulated (if necessary) prior to administering BRINAVESS
Slovenian: • Pred dajanjem zdravila BRINAVESS morajo biti bolniki ustrezno hidrirani in hemodinamsko optimizirani ter (po potrebi) na ustreznem antikoagulantnem zdravljenju.
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).
Slovenian: Priporočena začetna infuzija je 3 mg/kg in jo je treba dati v teku 10 minut z največjim začetnim odmerekom 339 mg (84,7 ml raztopine s koncentracijo 4 mg/ml).
English: Has the patient received an intravenous rhythm control antiarrhythmic drug (class I and/or class III) within 4 hours of the time when BRINAVESS will be infused?
Slovenian: Ali je bolnik prejel intravenski antiaritmik za kontrolo srčnega ritma (skupine I in/ali III) v 4 urah pred načrtovano infuzijo zdravila BRINAVESS?
English: The initial infusion is administered as a 3 mg/kg dose over 10 minutes.
Slovenian: Začetna infuzija je 3 mg/kg in jo je treba dati v teku 10 minut.
English: These anti-fibrillatory actions on refractoriness and conduction are thought to suppress re-entry, and are potentiated in the atria during atrial fibrillation.
Slovenian: Domnevno ta antifibrilacijska učinka na refraktarnost in prevajanje zavreta kroženje in sta v preddvorih med atrijsko fibrilacijo izrazitejša.
English: In addition, acute exposure of vernakalant in poor metabolisers of CYP2D6 is only minimally different when compared to that of extensive metabolisers.
Slovenian: Poleg tega je akutna izpostavljenost vernakalantu pri osebah s slabo funkcijo CYP2D6 le minimalno drugačna kot pri osebah z dobro funkcijo CYP2D6.
English: After dilution the concentration of the solution is 4 mg/ml vernakalant hydrochloride.
Slovenian: Po redčenju je koncentracija raztopine 4 mg/ml vernakalantijevega klorida.
English: Correvio Tél: +33 1 77 68 89 17
Slovenian: Tél: +33 1 77 68 89 17
English: • The active substance is vernakalant hydrochloride.
Slovenian: • Učinkovina je vernakalantijev klorid.
English: Vernakalant is a moderate, competitive inhibitor of CYP2D6.
Slovenian: Vernakalant zmerno, kompetitivno zavira CYP2D6.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single- and repeated-dose toxicity, and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti enega in ponavljajočih se odmerkov in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Do not re-start BRINAVESS.
Slovenian: Zdravila ne smete dati ponovno.
English: Any vials exhibiting particulate matter or discolouration should not be used.
Slovenian: Vial, ki vsebujejo delce ali imajo spremenjeno barvo vsebine, ne smete uporabiti.
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.
Slovenian: • Bolniki z izhodiščnim podaljšanjem QT (nekorigirani QT > 440 ms) ali s hudo bradikardijo, disfunkcijo sinusnega vozla ali srčnim blokom 2. ali 3. stopnje brez srčnega spodbujevalnika.
English: As the clinical trial experience in patients with advanced hepatic impairment is limited, vernakalant is not recommended in these patients.
Slovenian: Izkušenj pri bolnikih z napredovalo okvaro jeter iz kliničnih preskušanj je malo, zato vernakalanta pri takšnih bolnikih ne priporočamo.
English: Create a solution with a concentration of 4 mg/ml following the dilution guidelines below: Patients ≤ 100 kg: 25 ml of BRINAVESS 20 mg/ml is added to 100 ml of diluent.
Slovenian: Pripravite raztopino s koncentracijo 4 mg/ml z upoštevanjem naslednjih navodil za razredčenje: Bolniki s telesno maso ≤ 100 kg: 25 ml zdravila BRINAVESS 20 mg/ml dodajte 100 ml vehikla.
English: -For non-surgery patients: atrial fibrillation ≤ 7 days duration
Slovenian: - za nekirurške bolnike: atrijska fibrilacija, ki traja ≤ 7 dni.
English: What BRINAVESS looks like and contents of the pack
Slovenian: Izgled zdravila BRINAVESS in vsebina pakiranja
English: The diluted sterile solution should be clear, colourless to pale yellow.
Slovenian: Razredčena sterilna raztopina mora biti bistra in brezbarvna do bledorumena.
English: Common: Hypotension Uncommon: Flushing; hot flush; pallor
Slovenian: Pogosti: hipotenzija Občasni: zardevanje, vročinski oblivi, bledica
English: Patients receiving vernakalant have a higher incidence of converting to atrial flutter within the first 2 hours post-dose.
Slovenian: Med bolniki, ki prejmejo vernakalant, je večja pojavnost prehoda v atrijsko undulacijo v prvih 2 urah po odmerku.
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.
Slovenian: Hipotenzija, ki so jo opisali kot resen neželen učinek ali je povzročila prenehanje uporabe zdravila, se je pojavila pri 1,8 % bolnikih s kongestivnim srčnim popuščanjem, ki so prejemali vernakalant, in pri 0,3 % tistih, ki so prejemali placebo.
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.
Slovenian: To zdravilo vsebuje 32 mg natrija v eni viali z 200 mg, kar je enako 1,6 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča WHO in znaša 2 g.
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.
Slovenian: Zaradi večje pojavnosti teh neželenih učinkov (hipotenzije in prekatnih motenj srčnega ritma) pri bolnikih s kongestivnim srčnim popuščanjem je potrebna previdnost pri uporabi vernakalanta pri hemodinamsko stabilnih bolnikih s kongestivnim srčnim popuščanjem v funkcijskih razredih NYHA I in II.
English: Uncommon: Hypoaesthesia; burning sensation; parosmia; syncope; somnolence
Slovenian: Občasni: hipestezije, pekoč občutek, parozmija, sinkopa, zaspanost
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).
Slovenian: En ml razredčene raztopine vsebuje približno 3,5 mg natrija (9 mg/ml (0,9 %) raztopina natrijevega klorida za injiciranje), 0,64 mg natrija (5 % raztopina glukoze za injiciranje) ali 3,2 mg natrija (raztopina Ringerjevega laktata za injiciranje).
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).
Slovenian: Bolniki z atrijsko fibrilacijo, ki prejemajo vernakalant, imajo v prvih 2 urah po odmerku večjo pojavnost prehoda v atrijsko undulacijo (1,2 % v primerjavi z 0 % pri placebu).
English: Vernakalant is mainly eliminated by CYP2D6 mediated O-demethylation in CYP2D6 extensive metabolisers.
Slovenian: Vernakalant se pri dobrih metabolizatorjih s CYP2D6 v glavnem odstrani z O-demetilacijo, ki poteka s CYP2D6.
English: - Alert HCP for adverse reactions, which may occur after BRINAVESS administration, including hypotension, bradycardia, atrial flutter, or ventricular arrhythmia.
Slovenian: - Opozorilo za zdravstveno osebje glede neželenih učinkov, ki se lahko pojavijo po uporabi zdravila BRINAVESS, vključno s hipotenzijo, bradikardijo, atrijsko undulacijo ali prekatno motnjo srčnega ritma.
English: Note: BRINAVESS concentrate for solution for infusion ranges from colourless to pale yellow.
Slovenian: Opomba: Zdravilo BRINAVESS koncentrat za raztopino za infundiranje je brezbarvno do bledorumeno.
English: Very common: may affect more than 1 in 10 people
Slovenian: Drugi neželeni učinki Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
English: In the performed clinical studies, the additive effect of the second dose, if any, cannot be independently established.
Slovenian: Na podlagi opravljenih kliničnih študij ni mogoče neodvisno ugotoviti,
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).
Slovenian: Fridericieve korekcije, QTcF) v primerjavi s placebom (22,1 ms oz. 18,8 ms za vrhova z odštetim placebom po prvi oz. drugi infuziji).
English: -For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration
Slovenian: - za bolnike po kardiokirurškem posegu: atrijska fibrilacija, ki traja ≤ 3 dni.
English: If you get dizzy, you should avoid driving or operating machinery after receiving BRINAVESS.
Slovenian: Če se pri vas pojavi omotica, po prejetju zdravila BRINAVESS ne upravljajte vozil ali strojev.