natgillin/translations-raw huggingface dataset:
- Alert HCP for use of antiarrhythmic drugs (AADs) prior to or after BRINAVESS.
- Opozorilo za zdravstveno osebje glede uporabe antiaritmikov (AAD- antiarrhythmic drugs) pred uporabo zdravila BRINAVESS in po njej.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo BRINAVESS Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Table 2: Conversion of Atrial Fibrillation to Sinus Rhythm in ACT I and ACT III Duration of
Preglednica 2: Prehod iz atrijske fibrilacije v sinusni ritem v študijah ACT I in ACT III
Single-use glass (Type 1) vials with a chlorobutyl rubber stopper and an aluminium overseal.
Viale iz stekla (tipa 1) za enkratno uporabo s klorobutilnim gumijastim zamaškom in aluminijsko prekrivno zaporko.
*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
* 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.
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.
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.
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).
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).
What BRINAVESS is and what it is used for What you need to know before you use BRINAVESS How to use BRINAVESS
Kaj je zdravilo BRINAVESS in za kaj ga uporabljamo Kaj morate vedeti, preden začnete uporabljati zdravilo BRINAVESS Kako se uporablja zdravilo BRINAVESS
• 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)
• 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)
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).
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).
These arrhythmias typically presented as asymptomatic, monomorphic, non-sustained (average 3-4 beats) ventricular tachycardias.
Te motnje srčnega ritma so se praviloma pojavljale kot asimptomatske, monomorfne, neobstojne (povprečno 3-4 utripi) prekatne tahikardije.
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.
Z uporabo zdravila BRINAVESS pri otrocih in mladostnikih, mlajših od 18 let, ni izkušenj, zato uporabe pri njih ne priporočamo.
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.
Skupaj tako kombinirani učinki vernakalanta na kalijeve in natrijeve tokove v srcu povzročijo izrazite antiaritmične učinke, ki so v glavnem osredotočeni na preddvore.
• decreased feeling or sensitivity of the mouth
• zmanjšan občutek ali občutljivost v ustih
There is no clinical experience with direct-current cardioversion under 2 hours post-dose.
Kliničnih izkušenj s kardioverzijo z enosmernim tokom manj kot dve uri po odmerku ni.
Read all steps before administration.
Pred dajanjem zdravila preberite vse korake.
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.
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.
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.
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.
BRINAVESS, your breathing, heart beat, blood pressure and the electrical activity of your heart will be checked.
Medtem ko boste dobivali zdravilo BRINAVESS, vam bodo nadzirali dihanje, srčni utrip, krvni tlak in električno delovanje srca.
The vernakalant dose recommendation is a titrated therapy with 2 possible dose steps.
Za odmerjanje vernakalanta je priporočljivo titrirano zdravljenje z dvema možnima korakoma odmerjanja.
However, blockade of cationic currents, including hERG channels and cardiac voltage-dependent sodium channels, which are present in the ventricles has been documented.
Dokumentirana pa je bila blokada kationskih tokov, vključno s kanali hERG in napetostno odvisnimi srčnimi natrijevimi kanali, ki so prisotni v prekatih.
This is equivalent to 4 % of the recommended maximum daily dietary intake for an adult.
To je enako 4 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
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.
The initial dose is 339 mg (84.7 ml of 4 mg/ml solution).
Začetni odmerek je 339 mg (84,7 ml 4 mg/ml raztopine).
Talk to your doctor before using BRINAVESS if you have any of the following problems:
Pred začetkom uporabe zdravila BRINAVESS se posvetujte z zdravnikom, če imate katero od naslednjih težav:
This is equivalent to 1.6 % of the recommended maximum daily dietary intake for an adult.
To je enako 1,6 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle.
In these studies treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm as compared with placebo (see Table 2).
V teh študijah je vernakalant učinkovito dosegel prehod iz atrijske fibrilacije v sinusni ritem v primerjavi s placebom (glejte preglednico 2).
The free fraction of vernakalant in human serum is 53-63 % at concentration range of 1-5 μg/ml.
V območju koncentracij od 1 do 5 µg/ml je delež prostega vernakalanta v serumu pri človeku od 53 do 63 %.
Correvio Тел.
Тел.
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.
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.
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 %).
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 %).
No dose adjustment is required for these conditions, nor on the basis of age, serum creatinine or CYP2D6 metaboliser status.
Prav tako odmerka ni treba prilagoditi glede na starost, serumski kreatinin ali metabolno stanje s CYP2D6.
• 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
• 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.
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 %).
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 %).
• certain kinds of heart beat problems, (such as an awareness of your heart beating (palpitations)
• določene vrste težav s srčnim utripom (npr. izpuščeni utripi, zavedanje bitja srca (palpitacije) ali dodaten srčni utrip)
• 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.
• 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.
Post-cardiac surgery patients: No dose adjustment necessary.
Bolniki po kardiokirurški operaciji: Prilagoditev odmerka ni potrebna.
Vernakalant was not found to be effective in converting typical primary atrial flutter to sinus rhythm.
Za vernakalant ni ugotovljeno, da bi učinkovito doseglo prehod tipične primarne atrijske undulacije v sinusni ritem.
There is limited experience with the use of vernakalant in patients with previously documented LVEF ≤ 35 %, its use in these patients is not recommended.
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.
BRINAVESS contains sodium
Zdravilo BRINAVESS vsebuje natrij
• decreased feeling or sensitivity
• zmanjšan občutek za občutljivost
The patient should be further monitored for 2 hrs after the start of infusion and until clinical and ECG parameters have stabilised.
Bolnike je treba še naprej nadzorovati 2 uri po začetku infundiranja ter dokler se klinični in elektrokardiografski parametri ne stabilizirajo.
- Keep this leaflet.
**Glejte spodaj.
This risk is higher in patients who use Class I antiarrhythmics (see section 4.8).
Tveganje je večje pri bolnikih, ki prejemajo antiaritmike iz I. skupine (glejte poglavje 4.8).
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).
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).
Patients with hepatic impairment: No dose adjustment necessary (see sections 4.4 and 5.2).
Bolniki z okvaro jeter: Prilagoditev odmerka ni potrebna (glejte poglavji 4.4 in 5.2).
AVRO studied the effect of vernakalant versus intravenous amiodarone in patients with recent onset atrial fibrillation (3 hrs to 48 hrs).
Študija AVRO je primerjala učinek vernakalanta in intravenskega amiodarona pri bolnikih s pred kratkim nastalo atrijsko fibrilacijo (od 3 ure do 48 ur).
Patients with renal impairment: No dose adjustment necessary (see section 5.2).
Bolniki z okvaro ledvic: Prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
Has the patient presented with an acute coronary syndrome (including myocardial infarction) in the last 30 days?
Ali je bolnik imel akutni koronarni sindrom (vključno z miokardnim infarktom) v zadnjih 30 dneh?
• The other ingredients are citric acid, sodium chloride, sodium hydroxide (E524) and water for injections.
• Pomožne snovi so citronska kislina, natrijev klorid, natrijev hidroksid (E524) in voda za injekcije.
It is not known whether BRINAVESS passes into the breast milk.
Ni znano, ali zdravilo BRINAVESS prehaja v materino mleko.
• your blood pressure (such as a very low blood pressure causing a serious heart condition)
• krvnega tlaka (kot zelo nizek krvni tlak, ki povzroči nevarno stanje srca) (občasni) • električnega delovanja srca (občasni)
Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults
Hitra konverzija nedavno nastale atrijske fibrilacije v sinusni ritem pri odraslih
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”).
običajno se pojavi v prvih 2 urah (glejte poglavje "Možni neželeni učinki ").
The recommended initial dose is 3 mg/kg, with a maximum calculated dose based upon 113 kg.
Priporočeni začetni odmerek je 3 mg/kg, z največjim izračunanim odmerkom za 113 kg.
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).
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.
Targeted effects on atrial tissue coupled with block of late sodium current suggests that vernakalant has a low proarrhythmic potential.
Usmerjeni učinki na tkivo preddvorov v povezavi z blokado poznega toka natrija kažejo, da je proaritmični potencial vernakalanta majhen.
Treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm (47.0 % vernakalant, 14.0 % placebo; P value = 0.0001).
Vernakalant je učinkovito dosegel prehod iz atrijske fibrilacije v sinusni ritem (vernakalant 47,0 %, placebo 14,0 %, vrednost p =
Dizziness has been reported within the first 2 hours after receiving it (see section 4.8).
V prvih dveh urah po uporabi vernakalanta so poročali o omotici (glejte poglavje 4.8).
Step 3: Inspection of the solution
3. korak: Raztopino preglejte
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.
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.
EXP Diluted solution: use within 12 hours and store at or below 25 °C.
Razredčena raztopina: uporabite v 12 urah in shranjujte pri temperaturi do vključno 25 °C.
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.
ACT III je bilo vključenih nekaj bolnikov z značilno atrijsko undulacijo in za vernakalanta ni bilo ugotovljeno, da bi učinkovito konvertiralo atrijsko undulacijo.
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.
Poleg tega zdravilo ni bilo ovrednoteno pri bolnikih s klinično pomembno stenozo zaklopk, hipertrofično obstruktivno kardiomiopatijo, restriktivno kardiomiopatijo ali konstriktivnim perikarditisom.
• low blood pressure, slow heart beat, feeling dizzy
• nizek krvni tlak, počasen srčni utrip, omotica
Each vial of 200 mg contains approximately 1.4 mmol (32 mg) sodium.
Ena viala z 200 mg vsebuje približno 1,4 mmol (32 mg) natrija.
• Acute coronary syndrome (including myocardial infarction) within the last 30 days.
• Akutni koronarni sindrom (vključno z miokardnim infarktom) v zadnjih 30 dneh.
Contains citric acid, sodium chloride, water for injections, sodium hydroxide (E524).
SEZNAM POMOŽNIH SNOVI Vsebuje citronsko kislino, natrijev klorid, vodo za injekcije, natrijev hidroksid (E524).
Does the patient have severe bradycardia, sinus node dysfunction or second and third degree heart block, in the absence of a pacemaker?
Ali ima bolnik hudo bradikardijo, disfunkcijo sinusnega vozla ali srčni blok 2. ali 3. stopnje brez srčnega spodbujevalnika?
• eye irritation, watery eyes or changes in your vision
• draženje očesa, solzenje ali spremembe vida
BRINAVESS should be administered by intravenous infusion in a monitored clinical setting appropriate for cardioversion.
Zdravilo BRINAVESS je treba dati v intravenski infuziji v nadzorovanem okolju, primernem za kardioverzijo.
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.
Hipotenzija se praviloma pojavi zgodaj, bodisi med infundiranjem bodisi kmalu po koncu infundiranja.
Patients > 100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.
Bolniki s telesno maso > 100 kg: 30 ml zdravila BRINAVESS 20 mg/ml dodajte 120 ml vehikla.
Within the clinical development program, oral maintenance antiarrhythmic therapy was halted for a minimum of 2 hours after vernakalant administration.
V programu kliničnega razvoja so peroralno vzdrževalno zdravljenje z antiaritmiki prekinili za vsaj 2 uri po dajanju vernakalant.
• shortness of breath or a tightness in the chest
• kratka sapa ali tiščanje v prsih
If conversion to sinus rhythm occurs during either the initial or second infusion, that infusion should be continued to completion.
Če bolnik med začetno ali med drugo infuzijo preide v sinusni ritem, je treba infuzijo dokončati.
Vernakalant is an antiarrhythmic medicine that acts preferentially in the atria to prolong atrial refractoriness and to rate-dependently slow impulse conduction.
Vernakalant je antiaritmično zdravilo, ki prednostno deluje v preddvorih, tako da podaljša njihovo refraktarnost in od frekvence odvisno upočasni prevajanje impulzov.
The amount of BRINAVESS you may be given will depend on your weight.
Količina zdravila BRINAVESS, ki jo boste dobili, je odvisna od vaše telesne mase.
Each vial of 500 mg contains approximately 3.5 mmol (80 mg) of sodium.
Ena viala s 500 mg vsebuje približno 3,5 mmol (80 mg) natrija.
What you need to know before you use BRINAVESS Do not use BRINAVESS
Kaj morate vedeti, preden začnete uporabljati zdravilo BRINAVESS Ne uporabljajte zdravila BRINAVESS:
The checklist should be placed on the infusion container to be read by the healthcare professional who will administer BRINAVESS.
Kontrolni seznam je treba namestiti na vsebnik infuzije z namenom, da ga prebere zdravstveni delavec, ki bo dal zdravilo BRINAVESS.
• numbness or tingling that occurs in the mucosa or tissues of the oral cavity
• otrplost ali mravljinčenje, ki se pojavita v ustni sluznici ali ustnem tkivu
This medicine contains 80 mg of sodium (main component of cooking/table salt) in each vial of 500 mg.
To zdravilo vsebuje 80 mg natrija (glavna sestavina kuhinjske/namizne soli) v eni viali s 500 mg.
Bradycardia was observed predominantly at the time of conversion to sinus rhythm.
Bradikardijo so opažali predvsem v času prehoda v sinusni ritem.
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.
Zmožnost vernakalanta za blokado pozne komponente natrijevega toka poleg tega omeji učinek na repolarizacijo prekatov, ki jo izzove blokada kalijevih tokov v prekatu.
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.
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).
Posology BRINAVESS is dosed by patient body weight, with a maximum calculated dose based upon 113 kg.
Zdravilo BRINAVESS se odmerja glede na bolnikovo telesno maso z največjim izračunanim odmerkom na podlagi mase 113 kg.
Preparation of BRINAVESS for infusion
Priprava zdravila BRINAVESS za infundiranje
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.
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.
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).
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).