natgillin/translations-raw huggingface dataset:
BRINAVESS should not be administered as an intravenous push or bolus.
Zdravila BRINAVESS se ne sme injicirati z intravenskim vbrizganjem oz. kot bolus.
Vernakalant has a minor to moderate influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Vernakalant ima blag do zmeren vpliv na sposobnost vožnje in upravljanje strojev.
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 %).
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 %).
Read carefully the Summary of Product Characteristics and the Health Care Professional Information Card prior to the administration of BRINAVESS
Pred uporabo zdravila pozorno preberite Povzetek glavnih značilnosti zdravila in kartico z informacijami za zdravstvene delavce.
- 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.
- 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.
- Alert HCP on BRINAVESS contraindications:
Opozorilo za zdravstveno osebje glede kontraindikacij za zdravilo BRINAVESS:
If conversion to sinus rhythm has not occurred, the patient's vital signs and cardiac rhythm should be observed for an additional 15 minutes.
Če bolnik ne preide v sinusni ritem, morate še 15 minut spremljati njegove vitalne znake in srčni ritem.
As a precautionary measure, it is preferable to avoid the use of BRINAVESS during pregnancy.
Iz previdnosti se je uporabi zdravila BRINAVESS med nosečnostjo bolje izogniti.
In patients with valvular heart disease, there was a higher incidence of ventricular arrhythmia events in vernakalant patients until 24 hours after dosing.
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.
If atrial flutter is observed as secondary to treatment, continuation of infusion should be considered (see section 4.2).
Če se sekundarno po uporabi zdravila pojavi atrijska undulacija, pride v poštev nadaljevanje infuzije (glejte poglavje 4.2).
• taste disturbances
• motnje okušanja
BRINAVESS will be given to you by a health care professional.
Zdravilo BRINAVESS vam bo dal zdravstveni delavec.
Within the first 2 hours, ventricular arrhythmia occurred in 6.4% of patients treated with vernakalant versus none after placebo.
V prvih dveh urah se je pojavila ventrikularna aritmija pri 6,4% bolnikov, zdravljenih z vernakalantom, v primerjavi z nobenim po placebu.
Risk of atrial flutter may be increased in patients receiving class I AADs (see above).
Tveganje za atrijsko undulacijo je lahko pri bolnikih, ki prejemajo antiaritmike skupine I, povečano (glejte zgoraj).
Uncommon: Pain in extremity
Občasni: bolečina v okončini
There is no information on the excretion of vernakalant/metabolites in animal milk.
Informacij o izločanju vernakalanta oz. njegovih presnovkov v mleko pri živalih ni.
This medicine contains 32 mg sodium (main component of cooking/table salt) in each 200 mg vial.
To zdravilo vsebuje 32 mg natrija (glavna sestavina kuhinjske/namizne soli) v eni viali z 200 mg.
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).
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).
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).
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 %).
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.
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.
Your doctor will consider if you need additional rhythm control medicine 4 hours after using BRINAVESS.
Zdravnik bo presodil, če 4 ure po uporabi zdravila BRINAVESS potrebujete dodatno zdravilo za urejanje srčnega ritma.
In clinical studies to date, patients who developed atrial flutter following treatment with vernakalant did not develop 1:1 atrioventricular conduction.
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.
During this period, the patient should be carefully monitored for any signs or symptoms of a sudden decrease in blood pressure or heart rate.
V tem obdobju je treba pri bolnikih skrbno spremljati ali se pojavijo kakršni koli znaki ali simptomi nenadnega znižanja krvnega tlaka ali srčnega utripa.
• The patient should be adequately hydrated and haemodynamically optimised and adequately anticoagulated (if necessary) prior to administering BRINAVESS
• Pred dajanjem zdravila BRINAVESS morajo biti bolniki ustrezno hidrirani in hemodinamsko optimizirani ter (po potrebi) na ustreznem antikoagulantnem zdravljenju.
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).
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).
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?
Ali je bolnik prejel intravenski antiaritmik za kontrolo srčnega ritma (skupine I in/ali III) v 4 urah pred načrtovano infuzijo zdravila BRINAVESS?
The initial infusion is administered as a 3 mg/kg dose over 10 minutes.
Začetna infuzija je 3 mg/kg in jo je treba dati v teku 10 minut.
These anti-fibrillatory actions on refractoriness and conduction are thought to suppress re-entry, and are potentiated in the atria during atrial fibrillation.
Domnevno ta antifibrilacijska učinka na refraktarnost in prevajanje zavreta kroženje in sta v preddvorih med atrijsko fibrilacijo izrazitejša.
In addition, acute exposure of vernakalant in poor metabolisers of CYP2D6 is only minimally different when compared to that of extensive metabolisers.
Poleg tega je akutna izpostavljenost vernakalantu pri osebah s slabo funkcijo CYP2D6 le minimalno drugačna kot pri osebah z dobro funkcijo CYP2D6.
After dilution the concentration of the solution is 4 mg/ml vernakalant hydrochloride.
Po redčenju je koncentracija raztopine 4 mg/ml vernakalantijevega klorida.
• The active substance is vernakalant hydrochloride.
• Učinkovina je vernakalantijev klorid.
Vernakalant is a moderate, competitive inhibitor of CYP2D6.
Vernakalant zmerno, kompetitivno zavira CYP2D6.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single- and repeated-dose toxicity, and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti enega in ponavljajočih se odmerkov in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Do not re-start BRINAVESS.
Zdravila ne smete dati ponovno.
Any vials exhibiting particulate matter or discolouration should not be used.
Vial, ki vsebujejo delce ali imajo spremenjeno barvo vsebine, ne smete uporabiti.
• 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.
• 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.
As the clinical trial experience in patients with advanced hepatic impairment is limited, vernakalant is not recommended in these patients.
Izkušenj pri bolnikih z napredovalo okvaro jeter iz kliničnih preskušanj je malo, zato vernakalanta pri takšnih bolnikih ne priporočamo.
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.
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.
-For non-surgery patients: atrial fibrillation ≤ 7 days duration
- za nekirurške bolnike: atrijska fibrilacija, ki traja ≤ 7 dni.
What BRINAVESS looks like and contents of the pack
Izgled zdravila BRINAVESS in vsebina pakiranja
The diluted sterile solution should be clear, colourless to pale yellow.
Razredčena sterilna raztopina mora biti bistra in brezbarvna do bledorumena.
Common: Hypotension Uncommon: Flushing; hot flush; pallor
Pogosti: hipotenzija Občasni: zardevanje, vročinski oblivi, bledica
Patients receiving vernakalant have a higher incidence of converting to atrial flutter within the first 2 hours post-dose.
Med bolniki, ki prejmejo vernakalant, je večja pojavnost prehoda v atrijsko undulacijo v prvih 2 urah po odmerku.
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.
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.
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.
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.
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.
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.
Uncommon: Hypoaesthesia; burning sensation; parosmia; syncope; somnolence
Občasni: hipestezije, pekoč občutek, parozmija, sinkopa, zaspanost
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).
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).
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).
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).
Vernakalant is mainly eliminated by CYP2D6 mediated O-demethylation in CYP2D6 extensive metabolisers.
Vernakalant se pri dobrih metabolizatorjih s CYP2D6 v glavnem odstrani z O-demetilacijo, ki poteka s CYP2D6.
- Alert HCP for adverse reactions, which may occur after BRINAVESS administration, including hypotension, bradycardia, atrial flutter, or ventricular arrhythmia.
- 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.
Note: BRINAVESS concentrate for solution for infusion ranges from colourless to pale yellow.
Opomba: Zdravilo BRINAVESS koncentrat za raztopino za infundiranje je brezbarvno do bledorumeno.
Very common: may affect more than 1 in 10 people
Drugi neželeni učinki Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
In the performed clinical studies, the additive effect of the second dose, if any, cannot be independently established.
Na podlagi opravljenih kliničnih študij ni mogoče neodvisno ugotoviti,
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).
Fridericieve korekcije, QTcF) v primerjavi s placebom (22,1 ms oz. 18,8 ms za vrhova z odštetim placebom po prvi oz. drugi infuziji).
-For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration
- za bolnike po kardiokirurškem posegu: atrijska fibrilacija, ki traja ≤ 3 dni.
If you get dizzy, you should avoid driving or operating machinery after receiving BRINAVESS.
Če se pri vas pojavi omotica, po prejetju zdravila BRINAVESS ne upravljajte vozil ali strojev.
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.
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).
BRINAVESS must be diluted before it is used.
Zdravilo BRINAVESS je treba pred uporabo razredčiti.
BRINAVESS is available in pack of 1 vial containing 200 mg or 500 mg of vernakalant hydrochloride.
Zdravilo BRINAVESS je na voljo v velikosti pakiranja: 1 viala z 200 mg ali 500 mg vernakalantijevega klorida.
• 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)
• 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.
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.
Pred poskusom farmakološke kardioverzije morajo biti bolniki ustrezno hidrirani in hemodinamsko optimizirani.
However, in post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Vendar pa so v obdobju po začetku trženja zdravila v redkih primerih opazili atrijsko undulacijo z atrioventrikularnim prevajanjem 1:1.
Educational material for healthcare professionals Summary of product characteristics, package leaflet and labelling
Povzetek glavnih značilnosti zdravila, navodilo za uporabo, ovojnina
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.
Kar zadeva sposobnost razmnoževanja, ni bilo ugotovljenih učinkov na nosečnost, embriofetalni razvoj, porod ali postnatalni razvoj po intravenski uporabi vernakalanta ob izpostavljenosti (AUC),
BRINAVESS should be administered in a monitored clinical setting appropriate for cardioversion by a well-qualified healthcare professional.
Zdravilo mora dati dobro usposobljen zdravstveni delavec v nadzorovanem okolju, primernem za kardioverzijo.
Cumulative doses of greater than 5 mg/kg should not be administered within 24 hours.
24 urah se ne sme aplicirati kumulativnega odmerka, večjega od 5 mg/kg.
• pain or numbness at the infusion site, numbness, decreased skin sensation, or tingling feelings
• bolečina na mestu infundiranja, otrplost, zmanjšana občutljivost kože alimravljinčenje
BRINAVESS 20 mg/ml sterile concentrate vernakalant hydrochloride IV
BRINAVESS 20 mg/ml sterilen koncentrat vernakalantijev klorid i.v.
Fertility Vernakalant was not shown to alter fertility in animal studies.
V študijah na živalih vernakalant ni spremenil plodnosti.
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.
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.
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
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
Table 1: Adverse reactions with BRINAVESS *
Preglednica 1: Neželeni učinki z zdravilom BRINAVESS* Bolezni živčevja
How to use BRINAVESS
Kako se uporablja zdravilo BRINAVESS
It is preferable to avoid the use of BRINAVESS during pregnancy.
Uporabi zdravila BRINAVESS se je namreč med nosečnostjo bolje izogniti.
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.
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,
Uncommon: Lacrimation increased; eye irritation; visual impairment
Občasni: močnejše solzenje, draženje oči, okvara vida
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.
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.
Caution should be exercised when used in breast-feeding women.
Uporaba pri doječih ženskah zahteva previdnost.
• pain in your fingers and toes, a burning feelingcold sweats, hot flush
• bolečine v prstih rok in nog, pekoč občutek
Valvular heart disease
Bolezen srčnih zaklopk
It is unknown whether vernakalant/metabolites are excreted in human milk.
Ni znano, ali se vernakalant oz. njegovi presnovki izločajo v materino mleko.
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)).
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).
In post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
V obdobju po začetku trženja zdravila so v redkih primerih opazili atrijsko undulacijo z atrioventrikularnim prevajanjem 1:1.
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.
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.
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).
Ne sme se aplicirati bolnikom, ki so v 4 urah pred vernakalantom prejeli intravenske antiaritmike (skupine I in III) (glejte poglavje 4.3).
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).
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 %).
• urgency to have a bowel movement, diarrhoea
• nujno siljenje na blato, driska
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).
Vernakalant se ne sme aplicirati bolnikom, ki so v 4 urah pred vernakalantom prejeli intravenske antiaritmike (skupine I in III) (glejte poglavje 4.3).
BRINAVESS 20 mg/ml concentrate for solution for infusion
BRINAVESS 20 mg/ml koncentrat za raztopino za infundiranje
BRINAVESS works by changing your irregular or fast heart beat to a normal heart beat.
Zdravilo BRINAVESS deluje tako, da spremeni nereden ali hiter srčni utrip v normalnega.
Dilute before use.
POSTOPEK UPORABE Pred uporabo razredčite.
• 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))
• srčnega utripa (zelo hiter utrip (občasni) ali zelo počasen utrip (pogosti), preskok srčnega utripa
Atrial Flutter
Atrijska undulacija
• feeling light-headed or fainting, generally feeling unwell, feeling drowsy or sleepy
• občutek vrtoglavosti ali omedlevica, splošno slabo počutje, občutek dremavosti ali zaspanosti • izcedek iz nosu, vnetje žrela