FrancophonIA/ELRC3.0 huggingface dataset:
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 226 mg (56.5 ml of 4 mg/ml solution) may be administered.
Slovenian: Če v 15 minutah po koncu začetne infuzije ne pride do konverzije v sinusni ritem, je mogoče uporabiti drugo 10-minutno infuzijo 226 mg (56,5 ml 4 mg/ml raztopine).
English: BRINAVESS must be diluted before it is used.
Slovenian: Zdravilo BRINAVESS je treba pred uporabo razredčiti.
English: BRINAVESS is available in pack of 1 vial containing 200 mg or 500 mg of vernakalant hydrochloride.
Slovenian: Zdravilo BRINAVESS je na voljo v velikosti pakiranja: 1 viala z 200 mg ali 500 mg vernakalantijevega klorida.
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)
Slovenian: • Pri bolniku je treba med infundiranjem in še vsaj 15 minut po zaključku infundiranja pogosto in skrbno preveriti, če ima: o znake ali simptome nenadnega znižanja krvnega tlaka ali srčne frekvence z ali brez simptomatske hipotenzije ali bradikardije o bradikardijo o hipotenzijo o nepredvidene spremembe na EKG (glejte SmPC) Če se ti znaki pojavijo, takoj prenehajte z dajanjem zdravila BRINAVESS, bolniki pa morajo biti deležni ustrezne terapevtske obravnave.
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.
Slovenian: Pred poskusom farmakološke kardioverzije morajo biti bolniki ustrezno hidrirani in hemodinamsko optimizirani.
English: However, in post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Slovenian: Vendar pa so v obdobju po začetku trženja zdravila v redkih primerih opazili atrijsko undulacijo z atrioventrikularnim prevajanjem 1:1.
English: Educational material for healthcare professionals Summary of product characteristics, package leaflet and labelling
Slovenian: Povzetek glavnih značilnosti zdravila, navodilo za uporabo, ovojnina
English: With respect to reproduction no effects on pregnancy, embryo-foetal development, parturition or postnatal development were observed after intravenous administration of vernakalant at exposure levels (AUC) similar or below the human exposure levels (AUC) achieved after a single intravenous dose of vernakalant.
Slovenian: Kar zadeva sposobnost razmnoževanja, ni bilo ugotovljenih učinkov na nosečnost, embriofetalni razvoj, porod ali postnatalni razvoj po intravenski uporabi vernakalanta ob izpostavljenosti (AUC),
English: BRINAVESS should be administered in a monitored clinical setting appropriate for cardioversion by a well-qualified healthcare professional.
Slovenian: Zdravilo mora dati dobro usposobljen zdravstveni delavec v nadzorovanem okolju, primernem za kardioverzijo.
English: Cumulative doses of greater than 5 mg/kg should not be administered within 24 hours.
Slovenian: 24 urah se ne sme aplicirati kumulativnega odmerka, večjega od 5 mg/kg.
English: • pain or numbness at the infusion site, numbness, decreased skin sensation, or tingling feelings
Slovenian: • bolečina na mestu infundiranja, otrplost, zmanjšana občutljivost kože alimravljinčenje
English: BRINAVESS 20 mg/ml sterile concentrate vernakalant hydrochloride IV
Slovenian: BRINAVESS 20 mg/ml sterilen koncentrat vernakalantijev klorid i.v.
English: Fertility Vernakalant was not shown to alter fertility in animal studies.
Slovenian: V študijah na živalih vernakalant ni spremenil plodnosti.
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.
Slovenian: Priporočena sredstva za redčenje so 9 mg/ml (0,9 %) raztopina natrijevega klorida za injiciranje, raztopina Ringerjevega laktata za injiciranje in 5 % raztopina glukoza za injiciranje.
English: Common: Bradycardia**; atrial flutter** Uncommon: Sinus arrest; ventricular tachycardia; palpitations; bundle branch block left; ventricular extrasystoles; AV block first degree; AV block complete; bundle branch block right; sinus bradycardia; ECG QRS complex prolonged; cardiogenic shock
Slovenian: Občasni: sinusni zastoj, prekatna tahikardija, palpitacije, levokračni blok, prekatne ekstrasistole, AV blok prve stopnje, popolni AV blok, desnokračni blok, sinusna bradikardija, razširitev kompleksa QRS na EKG, kardiogeni šok
English: Table 1: Adverse reactions with BRINAVESS *
Slovenian: Preglednica 1: Neželeni učinki z zdravilom BRINAVESS* Bolezni živčevja
English: How to use BRINAVESS
Slovenian: Kako se uporablja zdravilo BRINAVESS
English: It is preferable to avoid the use of BRINAVESS during pregnancy.
Slovenian: Uporabi zdravila BRINAVESS se je namreč med nosečnostjo bolje izogniti.
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.
Slovenian: V študiji varnosti SPECTRUM po odobritvi zdravila, ki je vključevala 1.778 bolnikov z 2.009 epizodami zdravljenja z zdravilom BRINAVESS, je bila učinkovitost ocenjena kot delež bolnikov, ki so v 90 minutah od začetka infuzije zdravila BRINAVESS prešli v sinusni ritem vsaj eno (1) minuto,
English: Uncommon: Lacrimation increased; eye irritation; visual impairment
Slovenian: Občasni: močnejše solzenje, draženje oči, okvara vida
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.
Slovenian: Ves čas infundiranja ter še vsaj 15 minut po zaključku infundiranja je treba pri bolnikih skrbno spremljati vitalne znake in ves čas nadzorovati srčni ritem.
English: Caution should be exercised when used in breast-feeding women.
Slovenian: Uporaba pri doječih ženskah zahteva previdnost.
English: • pain in your fingers and toes, a burning feelingcold sweats, hot flush
Slovenian: • bolečine v prstih rok in nog, pekoč občutek
English: Valvular heart disease
Slovenian: Bolezen srčnih zaklopk
English: It is unknown whether vernakalant/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se vernakalant oz. njegovi presnovki izločajo v materino mleko.
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)).
Slovenian: Če bolnik v 15 minutah po koncu začetne infuzije ne preide v sinusni ritem, je mogoče uporabiti drugo 10-minutno infuzijo 2 mg/kg z največjim odmerekom za drugo infuzijo 226 mg (56,5 ml raztopine s koncentracijo 4 mg/ml).
English: In post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Slovenian: V obdobju po začetku trženja zdravila so v redkih primerih opazili atrijsko undulacijo z atrioventrikularnim prevajanjem 1:1.
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.
Slovenian: 10-minutni infuziji 3 mg/kg vernakalantijevega klorida ter 4,3 µg/ml po drugi infuziji 2 mg/kg s 15-minutnim presledkom med odmerkoma.
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).
Slovenian: Ne sme se aplicirati bolnikom, ki so v 4 urah pred vernakalantom prejeli intravenske antiaritmike (skupine I in III) (glejte poglavje 4.3).
English: Patients with CHF showed a higher overall incidence of hypotensive events, during the first 2 hours after dose in patients treated with vernakalant compared to patients receiving placebo (13.4 % versus 4.7 %, respectively).
Slovenian: Pri bolnikih s kongestivnim srčnim popuščanjem je bila celotna pojavnost hipotenzivnih dogodkov v prvih 2 urah po odmerku zdravila večja med bolniki, ki so prejeli vernakalant (13,4 %), kot med bolniki, ki so prejeli placebo (4,7 %).
English: • urgency to have a bowel movement, diarrhoea
Slovenian: • nujno siljenje na blato, driska
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).
Slovenian: Vernakalant se ne sme aplicirati bolnikom, ki so v 4 urah pred vernakalantom prejeli intravenske antiaritmike (skupine I in III) (glejte poglavje 4.3).
English: BRINAVESS 20 mg/ml concentrate for solution for infusion
Slovenian: BRINAVESS 20 mg/ml koncentrat za raztopino za infundiranje
English: BRINAVESS works by changing your irregular or fast heart beat to a normal heart beat.
Slovenian: Zdravilo BRINAVESS deluje tako, da spremeni nereden ali hiter srčni utrip v normalnega.
English: Dilute before use.
Slovenian: POSTOPEK UPORABE Pred uporabo razredčite.
English: • your heart beat (such as a very fast (uncommon) or very slow heart beat (common), a missed beat (uncommon), or a short pause in the normal activity of your heart (uncommon))
Slovenian: • srčnega utripa (zelo hiter utrip (občasni) ali zelo počasen utrip (pogosti), preskok srčnega utripa
English: Atrial Flutter
Slovenian: Atrijska undulacija
English: • feeling light-headed or fainting, generally feeling unwell, feeling drowsy or sleepy
Slovenian: • občutek vrtoglavosti ali omedlevica, splošno slabo počutje, občutek dremavosti ali zaspanosti • izcedek iz nosu, vnetje žrela
English: Use of AADs (antiarrhythmic drugs) prior to or after vernakalant Vernakalant cannot be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant, due to lack of data.
Slovenian: Uporaba antiaritmikov pred vernakalantom ali po njem Zaradi pomanjkanja podatkov vernakalant ne moremo priporočiti bolnikom, ki so 4-24 ur pred vernakalantom prejeli intravenske antiaritmike (skupine I in III).
English: • Continue to monitor the patient 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
English: Cases of serious hypotension have been reported during and immediately following vernakalant infusion.
Slovenian: Med infundiranjem in takoj po infundiranju vernakalanta so poročali o primerih resne hipotenzije.
English: Patients should be frequently monitored for the duration of the infusion and for at least 15 minutes after the completion of the infusion for signs and symptoms of a sudden decrease in blood pressure or heart rate.
Slovenian: Pri bolniku je treba med infundiranjem in še vsaj 15 minut po zaključku infundiranja pogosto preveriti, če ima znake in simptome nenadnega znižanja krvnega tlaka ali srčne frekvence.
English: • certain heart diseases involving the heart muscle, lining that surrounds the heart and a severe narrowing of the heart valves
Slovenian: srčno popuščanje določene bolezni srca, ki prizadenejo srčno mišico, srčno ovojnico in hudo zoženje srčnih zaklopk bolezen srčnih zaklopk težave z jetri če jemljete druga zdravila za urejanje srčnega ritma
English: There is limited experience with vernakalant in patients with pacemakers.
Slovenian: Izkušenj z vernakalantom pri bolnikih s srčnim spodbujevalnikom je malo.
English: Vernakalant was shown to provide relief of atrial fibrillation symptoms consistent with conversion to sinus rhythm.
Slovenian: †Cochran-Mantel-Haenszlov test Ugotovljeno je bilo, da vernakalant olajša simptome atrijske fibrilacije, skladno s prehodom v sinusni ritem.
English: • pale skin
Slovenian: • suha usta • bleda koža
English: Prior to administration the prescriber is asked to determine eligibility of the patient through use of the supplied checklist.
Slovenian: zdravilu je priložen kontrolni seznam, s katerim mora predpisovalec pred uporabo zdravila preveriti, če je bolnik primeren za zdravljenje s tem zdravilom.
English: Uncommon: Dyspnoea; throat irritation; oropharyngeal pain; nasal congestion; suffocation feeling; choking sensation; rhinorrhoea Gastrointestinal disorders Common: Nausea; paraesthesia oral; vomiting Uncommon: Dry mouth; diarrhoea; hypoaesthesia oral; defecation urgency
Slovenian: Pogosti: navzea, parestezija v ustih, bruhanje Občasni: suha usta, driska, hipestezija v ustih, nuja po defekaciji Bolezni kože in podkožja Pogosti: srbenje, hiperhidroza Občasni: generalizirano srbenje, hladen znoj
English: One patient who received 3 mg/kg of vernakalant over 5 minutes (instead of the recommended 10 minutes) developed haemodynamically stable wide complex tachycardia which resolved without sequelae.
Slovenian: Enemu bolniku, ki je prejel 3 mg/kg vernakalanta v 5 minutah (namesto v priporočenih 10 minutah),
English: If you think that you may have been given too much BRINAVESS, tell your doctor straight away.
Slovenian: Če ste dobili večji odmerek zdravila BRINAVESS, kot bi smeli Če menite, da ste dobili preveč zdravila BRINAVESS, to nemudoma povejte zdravniku.
English: How to store BRINAVESS Contents of the pack and other information
Slovenian: Vsebina pakiranja in dodatne informacije
English: Glucuronidation and renal excretion are the main mechanisms of elimination in CYP2D6 poor metabolisers.
Slovenian: Pri slabih metabolizatorjih s CYP2D6 sta glavna mehanizma odstranjevanja glukuronidacija in izločanje skozi ledvice.
English: In adults it is used if you have a fast, irregular heart beat called atrial fibrillation which has started recently, less than or equivalent to 7 days, for non-surgery patients and less than or equivalent to 3 days for post-cardiac surgery patients.
Slovenian: ki se vam je pojavil pred kratkim, pred 7 dnevi ali manj, za nekirurške bolnike in 3 dnevi ali manj za bolnike po kardiokirurškem posegu.
English: • if you take certain other intravenous medicines (antiarrhythmics Class I and III) used to normalize an abnormal heart rhythm, 4 hours before BRINAVESS is to be used
Slovenian: • če ste v 4 urah pred tem, ko naj bi vzeli zdravilo BRINAVESS, vzeli določena druga intravenska zdravila (antiaritmike skupine I in III), ki se uporabljajo za ureditev nepravilnega srčnega ritma.
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.
Slovenian: Spol, anamneza kongestivnega srčnega popuščanja, okvara ledvic ali sočasno prejemanje blokatorjev beta in drugih zdravil (vključno z varfarinom, metoprololom, furosemidom in digoksinom) ne vpliva pomembno na akutno farmakokinetiko vernakalanta.
English: • Use of intravenous rhythm control antiarrhythmics (class I and class III) within 4 hours prior to, as well as in the first 4 hours after, BRINAVESS administration.
Slovenian: • Uporaba intravenskih antiaritmikov za kontrolo srčnega ritma (skupine I in III) v 4 urah pred uporabo in prve 4 ure po uporabi vernakalanta.
English: Vernakalant should be used with caution in patients on oral AADs (class I and III), due to limited experience.
Slovenian: Vernakalant je treba pri bolnikih, ki prejemajo peroralne antiaritmike (skupine I in III), zaradi pomanjkanja izkušenj uporabljati previdno.
English: Common: Paraesthesia; dizziness
Slovenian: Zelo pogosti: disgevzija Pogosti: parestezije, omotica
English: -For non-surgery patients: atrial fibrillation ≤ 7 days duration -For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration
Slovenian: Hitra konverzija nedavno nastale atrijske fibrilacije v sinusni ritem pri odraslih - za nekirurške bolnike: atrijska fibrilacija, ki traja ≤ 7 dni - za bolnike po kardiokirurškem posegu: atrijska fibrilacija, ki traja ≤ 3 dni
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.
Slovenian: To zdravilo vsebuje 80 mg natrija v eni viali s 500 mg, kar je enako 4 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča WHO in znaša 2 g. 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Do not use BRINAVESS if you take certain other intravenous medicines (antiarrhythmics Class I and III) used to normalize an abnormal heart rhythm, 4 hours before BRINAVESS is to be used.
Slovenian: Zdravila BRINAVESS ne jemljite, če ste 4 ure pred uporabo zdravila BRINAVESS uporabili nekatera druga zdravila za urejanje nenormalnega srčnega ritma (intravenske antiaritmike skupine I in III).
English: Patients with a history of CHF showed a higher incidence of ventricular arrhythmia in the first two hours post dose (6.4% for vernakalant compared to 1.6% in placebo).
Slovenian: Pri bolnikih z anamnezo kongestivnega srčnega popuščanja je bila v prvih dveh urah po odmerku pojavnost prekatnih motenj srčnega ritma večja (6,4 % z vernakalantom in 1,6 % s placebom).
English: Each 25 ml vial contains 500 mg of vernakalant hydrochloride equivalent to 452.5 mg of vernakalant.
Slovenian: Ena 25 ml viala vsebuje 500 mg vernakalantijevega klorida, kar ustreza 452,5 mg vernakalanta.
English: Name and address of the manufacturer responsible for batch release
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Geodis Logistics Netherlands B.V.
English: PARTICULARS TO APPEAR WITHIN THE OUTER PACKAGING (CARTON) PRE-INFUSION CHECK-LIST
Slovenian: PODATKI NA ZUNANJI OVOJNINI (ŠKATLA) KONTROLNI SEZNAM PRED INFUNDIRANJEM ZDRAVILA
English: Elderly (≥ 65 years): No dose adjustment necessary.
Slovenian: Starejši (≥ 65 let):
English: ACT I and ACT III studied the effect of vernakalant in the treatment of patients with sustained atrial fibrillation > 3 hours but not more than 45 days in duration.
Slovenian: Študiji ACT I in ACT III sta preučevali učinek vernakalanta pri bolnikih z obstojno atrijsko fibrilacijo,
English: • choking sensation
Slovenian: • občutek dušenja
English: If you get any side effects, talk to your doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: BRINAVESS 20 mg/ml concentrate for solution for infusion vernakalant hydrochloride
Slovenian: BRINAVESS 20 mg/ml koncentrat za raztopino za infundiranje vernakalantijev klorid
English: Correvio Puh/Tel: +41 848 00 79 70
Slovenian: Puh/Tel: +41 848 00 79 70
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.
Slovenian: P450 (CYP3A4, 1A2, 2C9, 2C19 ali 2E1) in v preizkusu transporta digoksina ne zavre Pglikoproteina.
English: Each vial contains 500 mg vernakalant hydrochloride equivalent to 452.5 mg vernakalant.
Slovenian: Ena viala vsebuje 500 mg vernakalantijevega klorida, kar ustreza 452,5 mg vernakalanta.
English: Step 1: BRINAVESS vials should be visually inspected for particulate matter and discolouration before administration.
Slovenian: 1. korak: Pred uporabo morate viale zdravila BRINAVESS pregledati in se prepričati, da ne vsebujejo delcev in da vsebina ni spremenila barve.
English: The osmolality of the medicinal product is controlled between the following range: 270-320 mOsmol/kg
Slovenian: bistra in brezbarvna do bledorumena raztopina s pH približno 5,5 Osmolalnost zdravila je kontrolirana v območju 270-320 mOsmol/kg.
English: This will be a slightly lower dose of 2 mg/kg, with a maximum calculated dose based upon 113 kg. Total doses of greater than 5 mg/kg should not be administered within 24 hours.
Slovenian: Ta odmerek bo nekoliko manjši, 2 mg/kg, z največjim izračunanim odmerkom za 113 kg.
English: BRINAVESS contains the active substance vernakalant hydrochloride.
Slovenian: Kaj je zdravilo BRINAVESS in za kaj ga uporabljamo Zdravilo BRINAVESS vsebuje učinkovino vernakalantijev klorid.
English: Correvio Tél/Tel: +41 848 00 79 70
Slovenian: Tél/Tel: +41 848 00 79 70
English: • BRINAVESS cannot be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant, due to lack of data.
Slovenian: • Zdravila BRINAVESS zaradi pomanjkanja podatkov ne moremo priporočiti bolnikom, ki so 4-24 ur pred vernakalantom prejeli intravenski antiaritmik (skupine I in III).
English: Each ml of concentrate contains 20 mg vernakalant hydrochloride equivalent to 18.1 mg vernakalant.
Slovenian: En ml koncentrata vsebuje 20 mg vernakalantijevega klorida, kar ustreza 18,1 mg vernakalanta.
English: Correvio Tlf: +41 848 00 79 70
Slovenian: Tlf: +41 848 00 79 70
English: Direct-current cardioversion may be considered for patients who do not respond to therapy.
Slovenian: Za bolnike, ki se na zdravljenje ne odzovejo, pride v poštev kardioverzija z enosmernim tokom.
English: Sodium hydroxide (E524) (for pH-adjustment)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi citronska kislina (E330) natrijev klorid voda za injekcije natrijev hidroksid (E524) (za uravnavanje pH)
English: In patients with uncorrected hypokalaemia (serum potassium of less than 3.5 mmol/l), potassium levels should be corrected prior to use of vernakalant.
Slovenian: Bolnikom z nekorigirano hipokaliemijo (koncentracija kalija v serumu manj kot
English: Common: Infusion site pain; feeling hot; infusion site paraesthesia Uncommon: Fatigue; infusion site irritation; infusion site hypersensitivity; infusion site pruritus; malaise
Slovenian: Občasni: utrujenost, draženje na mestu infundiranja, preobčutljivost na mestu infundiranja, srbenje na mestu infundiranja, splošno slabo počutje
English: There are no clinical data on repeat doses after the initial and second infusions.
Slovenian: Kliničnih podatkov o ponovni uporabi po začetni in drugi infuziji ni. Kot kaže, je koncentracija vernakalanta po 24 urah zanemarljiva.
English: Each vial contains 200 mg vernakalant hydrochloride equivalent to 181 mg vernakalant.
Slovenian: Ena viala vsebuje 200 mg vernakalantijevega klorida, kar ustreza 181 mg vernakalanta.
English: Each 10 ml vial contains 200 mg of vernakalant hydrochloride equivalent to 181 mg of vernakalant.
Slovenian: Ena 10 ml viala vsebuje 200 mg vernakalantijevega klorida, kar ustreza 181 mg vernakalanta.
English: Clinically significant adverse reactions observed in clinical trials included hypotension and ventricular arrhythmia.
Slovenian: Med klinično pomembnimi neželenimi učinki v kliničnih preskušanjih so bile hipotenzija in prekatne motnje srčnega ritma (glejte poglavji 4.4 Hipotenzija, Kongestivno srčno popuščanje).
English: Correvio Sími: +41 848 00 79 70
Slovenian: Sími: +41 848 00 79 70
English: The patient is required to be monitored for signs and symptoms of a sudden decrease in blood pressure or heart rate for the duration of the infusion and for at least 15 minutes after the completion of the infusion.
Slovenian: Bolnika je treba med infundiranjem ter še vsaj 15 minut po zaključku infundiranja nadzorovati glede znakov in simptomov nenadnega znižanja krvnega tlaka ali srčne frekvence.
English: Correvio Τηλ: +41 848 00 79 70
Slovenian: Τηλ: +41 848 00 79 70
English: These effects, seen within 24 hours of being given BRINAVESS, should pass quickly, however, if they do not you should consult your doctor.
Slovenian: • kihanje Ta neželena učinka, ki se opazita v 24 urah po dajanju zdravila BRINAVESS, naj bi minila hitro.