FrancophonIA/ELRC3.0 huggingface dataset:
English: If any of the above apply to you (or you are not sure), talk to your doctor.
Croatian: Ako se nešto od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku.
English: Contents of the pack and other information What BRINAVESS contains
Croatian: Sadržaj pakiranja i druge informacije Što BRINAVESS sadrži
English: If these events occur during the first infusion of vernakalant, patients should not receive the second dose.
Croatian: Ako navedeni događaji nastupe tijekom prve infuzije vernakalanta, bolesnici ne smiju primiti drugu dozu.
English: What BRINAVESS is and what it is used for What you need to know before you use BRINAVESS How to use BRINAVESS
Croatian: Što je BRINAVESS i za što se koristi Što morate znati prije nego počnete primati BRINAVESS
English: Patients who did not respond to treatment were managed by the physician using standard care.
Croatian: U bolesnika koji nisu odgovorili na liječenje liječnici su primjenjivali standardne postupke.
English: The number of vials of BRINAVESS concentrate required to prepare the appropriate quantity of solution for the treatment of an individual patient will depend on the patient's weight, and the vial size.
Croatian: Broj bočica koncentrata lijeka BRINAVESS potreban za pripremu odgovarajuće količine otopine za liječenje pojedinog bolesnika ovisit će o tjelesnoj težini bolesnika i veličini bočice.
English: However, a syringe pump is acceptable provided that the calculated volume can be accurately given within the specified infusion time.
Croatian: Prihvatljiva je i injekcijska pumpa pod uvjetom da se izračunati volumen može precizno dozirati u zadanom vremenu trajanja infuzije.
English: In patients with hepatic impairment, exposures were elevated by 9 to 25 %.
Croatian: U bolesnika s oštećenjem funkcije jetre izloženost je bila veća za 9 do 25 %.
English: The European Medicines Agency has waived the obligation to submit the results of studies with vernakalant in all subsets of the paediatric population in atrial fibrillation (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja vernakalanta u svim podskupinama pedijatrijske populacije u fibrilaciji atrija (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Very common: Sneezing
Croatian: Vrlo često: kihanje
English: It will be given to you into your vein over 10 minutes.
Croatian: Lijek ćete primati u venu tijekom 10 minuta.
English: What BRINAVESS looks like and contents of the pack
Croatian: Kako BRINAVESS izgleda i sadržaj pakiranja
English: The amount of BRINAVESS you may be given will depend on your weight.
Croatian: Količina lijeka BRINAVESS koju ćete primiti ovisi o Vašoj tjelesnoj težini.
English: • you are taking other rhythm control medicines
Croatian: • ako uzimate druge lijekove za kontrolu srčanog ritma
English: If any of the following signs or symptoms occurs, the administration of vernakalant should be discontinued and these patients should receive appropriate medical management:
Croatian: Ako se pojavi neki od sljedećih znakova ili simptoma, mora se prekinuti primjena vernakalanta, a bolesnici moraju biti odgovarajuće medicinski zbrinuti:
English: Clear and colourless to pale yellow solution with a pH of approximately 5.5.
Croatian: Bistra i bezbojna do blijedožuta otopina čiji je pH približno 5,5.
English: BRINAVESS may be available in different vial sizes (available vial sizes to be inserted locally).
Croatian: 5. BRINAVESS može biti dostupan u bočicama različite veličine (dostupne veličine bočica unijeti lokalno).
English: There is no relevant use of vernakalant in children and adolescents < 18 years of age in the current indication and therefore it should not be used in this population.
Croatian: Nema relevantne primjene vernakalanta u djece i adolescenata mlađih od 18 godina u trenutačnoj indikaciji te se stoga ne smije primjenjivati u ovoj populaciji.
English: Important Instructions when using BRINAVESS
Croatian: Važne upute pri uporabi lijeka BRINAVESS
English: Overall, BRINAVESS was effective in 70.2% (1,359/1,936) of these patients.
Croatian: Sveukupno, BRINAVESS je bio učinkovit u 70,2% (1359/1936) bolesnika.
English: • decreased feeling or sensitivity
Croatian: • smanjeni osjet ili osjetljivost
English: • pale skin
Croatian: • blijeda koža
English: In the performed clinical studies, the additive effect of the second dose, if any, cannot be independently established.
Croatian: U provedenim se kliničkim ispitivanjima nije mogao neovisno utvrditi aditivan učinak druge doze, ako je i postojao.
English: Instructions on dose calculation, preparation of the solution for infusion, and method of administration.
Croatian: Upute za izračunavanje doze, pripremu otopine za infuziju i način primjene.
English: Vernakalant has been administered to patients with an uncorrected QT less than 440 msec without an increased risk of torsade de pointes.
Croatian: Vernakalant se primjenjivao u bolesnika s nekorigiranim QT-intervalom kraćim od 440 ms bez povećanja rizika za pojavu torsade de pointes.
English: BRINAVESS contains sodium
Croatian: BRINAVESS sadrži natrij
English: If atrial flutter is observed as secondary to treatment, continuation of infusion should be considered (see section 4.2).
Croatian: Ako se opazi undulacija atrija kao sekundarni rezultat liječenja, treba razmotriti nastavak infuzije (vidjeti dio 4.2).
English: For atrial fibrillation lasting less than 48 hours, immediate cardioversion was allowed.
Croatian: Kod fibrilacije atrija koja je trajala manje od 48 sati bilo je dozvoljeno odmah pokušati kardioverziju.
English: The diluted sterile concentrate is chemically and physically stable for 12 hours at or below 25 °C.
Croatian: Razrijeđen sterilni koncentrat kemijski je i fizikalno stabilan tijekom 12 sati na temperaturi od 25 °C ili nižoj.
English: Treatment with vernakalant did not affect the response rate to electrical cardioversion (including the median number of shocks or joules required for successful cardioversion) in cases when attempted within 2 to 24 hours of study medicine administration.
Croatian: Liječenje vernakalantom nije utjecalo na stopu odgovora na električnu kardioverziju (uključujući medijan broja defibrilacija ili džula potrebnih za uspješnu kardioverziju) u slučajevima kada je ona pokušana 2 do 24 sata nakon primjene ispitivanog lijeka.
English: • excessive sweating, itching
Croatian: • prekomjerno znojenje, svrbež
English: Pharmacotherapeutic group: Cardiac therapy, other antiarrhythmics class I and III; ATC code: C01BG11.
Croatian: Farmakoterapijska skupina: Lijekovi koji djeluju na srce, ostali antiaritmici skupine I i III, ATK oznaka: C01BG11.
English: The vernakalant dose recommendation is a titrated therapy with 2 possible dose steps.
Croatian: Preporuka za doziranje vernakalanta je titrirati dozu uz 2 moguća koraka u doziranju.
English: Your doctor will consider if you need additional rhythm control medicine 4 hours after using BRINAVESS.
Croatian: Liječnik će razmotriti treba li Vam dati dodatni lijek za kontrolu srčanog ritma 4 sata nakon što primite BRINAVESS.
English: • A sudden drop in blood pressure or heart rate, with or without symptomatic hypotension or bradycardia
Croatian: • iznenadan pad krvnog tlaka ili srčane frekvencije, sa ili bez simptomatske hipotenzije ili bradikardije
English: Vernakalant is a moderate, competitive inhibitor of CYP2D6.
Croatian: Vernakalant je umjereni kompetitivni inhibitor CYP2D6.
English: BRINAVESS, your breathing, heart beat, blood pressure and the electrical activity of your heart will be checked.
Croatian: Dok primate BRINAVESS, kontrolirat će Vam se disanje, brzina otkucaja srca, krvni tlak i električna aktivnost srca.
English: Conversion of atrial fibrillation in patients with longer-duration atrial fibrillation (> 7 days and ≤ 45 days) assessed as a secondary efficacy endpoint in a total of 185 patients did not show statistically significant differences between vernakalant and placebo.
Croatian: U konverziji fibrilacije atrija u bolesnika s dugotrajnijom fibrilacijom atrija (> 7 dana i ≤ 45 dana), što je postavljeno kao sekundarna mjera ishoda za djelotvornost, u ukupno 185 bolesnika nisu utvrđene statistički značajne razlike između vernakalanta i placeba.
English: This risk is higher in patients who use Class I antiarrhythmics (see section 4.8).
Croatian: Taj je rizik veći u bolesnika koji uzimaju antiaritmike skupine I (vidjeti dio 4.8).
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))
Croatian: • otkucajima srca (kao što su veoma brzi (manje često) ili veoma spori otkucaji srca (često), izostanak jednog otkucaja (manje često) ili kratka stanka u normalnoj aktivnosti srca (manje često))
English: Does the patient have hypersensitivity to the active substance or to any of the excipients?
Croatian: Je li bolesnik preosjetljiv na djelatnu tvar ili neku od pomoćnih tvari?
English: During atrial fibrillation, the frequency- and voltage-dependent block of sodium channels further focuses the action of the medicine toward rapidly activating and partially depolarized atrial tissue rather than toward the normally polarized ventricle beating at lower heart rates.
Croatian: Tijekom fibrilacije atrija o frekvenciji i naponu ovisna blokada natrijevih kanala dodatno usmjerava djelovanje ovog lijeka na brzo aktivirajuće i djelomično depolarizirano tkivo atrija, umjesto na normalno polarizirano tkivo ventrikula s nižom frekvencijom otkucaja srca.
English: Information on how to prepare the solution is available at the end of this leaflet.
Croatian: Informacije o pripremi otopine nalaze se na kraju ove upute o lijeku.
English: There is no information on the excretion of vernakalant/metabolites in animal milk.
Croatian: Nema podataka o izlučivanju vernakalanta/metabolita u mlijeko životinja.
English: The Marketing Authorisation Holder shall ensure that all healthcare professionals (HCP) involved in the administration of BRINAVESS are provided with a healthcare professional information pack containing the following:
Croatian: Nositelj odobrenja će osigurati da svi zdravstveni radnici uključeni u primjenu lijeka BRINAVESS dobiju paket s informacijama za zdravstvene radnike, koji uključuje sljedeće:
English: Treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm (47.0 % vernakalant, 14.0 % placebo; P value = 0.0001).
Croatian: Liječenje vernakalantom učinkovito je konvertiralo fibrilaciju atrija u sinusni ritam (47,0 % vernakalant, 14,0 % placebo; P-vrijednost = 0,0001).
English: Contains citric acid, sodium chloride, water for injections, sodium hydroxide (E524).
Croatian: Sadrži citratnu kiselinu, natrijev klorid, vodu za injekcije, natrijev hidroksid (E524).
English: Uncommon: Blood pressure diastolic increased
Croatian: Manje često: povišen dijastolički krvni tlak
English: In patients, the typical total body clearance of vernakalant was estimated to be 0.41 l/hr/kg.
Croatian: Procjenjuje se da tipičan ukupni klirens vernakalanta iz tijela bolesnika iznosi 0,41 l/hr/kg.
English: BRINAVESS may not work in treating some other kinds of abnormal heart rhythms, however your doctor will be familiar with these.
Croatian: BRINAVESS možda neće imati učinka na neke druge poremećaje srčanog ritma, no liječnik zna koji su to poremećaji.
English: This is equivalent to 1.6 % of the recommended maximum daily dietary intake for an adult.
Croatian: To odgovara 1,6 % preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: In general, bradycardia responded well to discontinuation of treatment and/or administration of atropine.
Croatian: Općenito, bolesnici u kojih se javila bradikardija u pravilu su dobro odgovorili na prekid liječenja i/ili na primjenu atropina.
English: Vernakalant has a minor to moderate influence on the ability to drive and use machines.
Croatian: Vernakalant malo do umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In clinical studies, the need for anticoagulation prior to administration of vernakalant was assessed as per clinical practice of the treating physician.
Croatian: U kliničkim se ispitivanjima potreba za primjenom antikoagulansa prije primjene vernakalanta procjenjivala sukladno kliničkoj praksi nadležnog liječnika.
English: Bradycardia was observed predominantly at the time of conversion to sinus rhythm.
Croatian: Bradikardija je zapažena uglavnom u vrijeme konverzije u sinusni ritam.
English: • The other ingredients are citric acid, sodium chloride, sodium hydroxide (E524) and water for injections.
Croatian: • Drugi sastojci su citratna kiselina, natrijev klorid, natrijev hidroksid (E524) i voda za injekcije.
English: • Hypotension
Croatian: • hipotenzija
English: There is no experience on the use of BRINAVESS in children and adolescents less than 18 years of age; therefore its use is not recommended.
Croatian: Nema iskustva s primjenom lijeka BRINAVESS u djece i adolescenata mlađih od 18 godina; stoga se primjena u ovih bolesnika ne preporučuje.
English: PARTICULARS TO APPEAR WITHIN THE OUTER PACKAGING (CARTON) PRE-INFUSION CHECK-LIST
Croatian: PODACI KOJI SE MORAJU NALAZITI UNUTAR VANJSKOG PAKIRANJA (KUTIJE) PREDINFUZIJSKI
English: In addition, acute exposure of vernakalant in poor metabolisers of CYP2D6 is only minimally different when compared to that of extensive metabolisers.
Croatian: Osim toga, akutna izloženost vernakalantu u slabih metabolizatora CYP2D6 samo se minimalno razlikuje od akutne izloženosti u jakih metabolizatora.
English: Other medicines and BRINAVESS
Croatian: Drugi lijekovi i BRINAVESS
English: The diluted sterile solution should be clear, colourless to pale yellow.
Croatian: Razrijeđena sterilna otopina mora biti bistra, bezbojna do blijedožuta.
English: Clinically significant adverse reactions observed in clinical trials included hypotension and ventricular arrhythmia.
Croatian: Klinički značajne nuspojave opažene u kliničkim ispitivanjima bile su hipotenzija i ventrikularna aritmija.
English: The Marketing Authorisation Holder must agree about the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution.
Croatian: Sažetak opisa svojstva lijeka, Uputu o lijeku i Označavanje lijeka Nositelj odobrenja mora prije distribucije s nadležnim nacionalnim tijelom dogovoriti sadržaj i format edukacijskog materijala te komunikacijski plan.
English: Conversion of atrial fibrillation to sinus rhythm occurred rapidly (median time to conversion 12 minutes from the start of infusion).
Croatian: Konverzija fibrilacije atrija u sinusni ritam nastupila je vrlo brzo (medijan vremena do konverzije bio je 12 minuta od početka infuzije).
English: • if you have an abnormally slow heart rate or skipped heart beats and do not have a pacemaker, or you have conduction disturbance called QT prolongation - which can be seen on an ECG by your doctor
Croatian: • ako imate neprirodno usporen rad srca ili Vam otkucaji srca preskaču, a nemate ugrađen elektrostimulator srca (engl. pacemaker), ili imate poremećaj provodljivosti koji se zove produljeni QT-interval, koji Vaš liječnik može očitati na EKG-u
English: As a precautionary measure, it is preferable to avoid the use of BRINAVESS during pregnancy.
Croatian: Kao mjeru opreza poželjno je izbjegavati primjenu lijeka BRINAVESS u trudnoći.
English: BRINAVESS works by changing your irregular or fast heart beat to a normal heart beat.
Croatian: BRINAVESS djeluje tako da mijenja nepravilan ili ubrzan rad srca u normalan rad srca.
English: Within the clinical development program, oral maintenance antiarrhythmic therapy was halted for a minimum of 2 hours after vernakalant administration.
Croatian: U okviru programa kliničkog razvoja, terapija održavanja oralnim antiaritmicima bila je obustavljena na najmanje 2 sata nakon primjene vernakalanta.
English: Overall, the combination of effects of vernakalant on cardiac potassium and sodium currents results in substantial antiarrhythmic effects that are mainly concentrated in the atria.
Croatian: U cjelini, kombinacija učinaka vernakalanta na protok kalijevih i natrijevih iona u srcu rezultira znatnim antiaritmijskim djelovanjem koje je uglavnom usredotočeno na atrije.
English: Median time to conversion to SR as reported among all patients who, as per the investigator judgement, converted to SR was 12 minutes and in most of the treatment episodes (60.4%) only one infusion was administered.
Croatian: Medijan prijavljenog vremena do konverzije u sinusni ritam u svih bolesnika koji su prema ocjeni ispitivača postigli konverziju bio je 12 minuta, a u većini epizoda liječenja (60,4%) primijenjena je samo jedna infuzija.
English: • if you have a very narrow heart valve, systolic blood pressure less than 100 mm Hg or advanced heart failure with symptoms at minimal exertion or at rest
Croatian: • ako imate vrlo sužen srčani zalistak, sistolički krvni tlak manji od 100 mm Hg ili uznapredovalo zatajenje srca sa simptomima koji se javljaju pri minimalnom naporu ili u mirovanju
English: The check list will be provided with an adhesive in order to be placed on the infusion container.
Croatian: Kontrolni upitnik će se isporučivati sa samoljepljivom vrpcom kako bi ga se moglo staviti na infuzijski spremnik.
English: In an electrophysiological study in patients, vernakalant significantly prolonged atrial effective refractory period in a dose-dependent manner, which was not associated with a significant increase in ventricular effective refractory period.
Croatian: U elektrofiziološkom ispitivanju u bolesnika vernakalant je značajno i ovisno o dozi produljio efektivno refrakterno razdoblje atrija, što nije bilo povezano sa značajnim povećanjem efektivnog refrakternog razdoblja ventrikula.
English: There is no clinical experience with direct-current cardioversion under 2 hours post-dose.
Croatian: Nema kliničkog iskustva s kardioverzijom istosmjernom strujom manje od 2 sata nakon primjene doze.
English: Talk to your doctor before using BRINAVESS if you have any of the following problems:
Croatian: Obratite se svom liječniku prije nego primite BRINAVESS ako imate neku od sljedećih tegoba: • zatajenje srca
English: Patients with hepatic impairment: No dose adjustment necessary (see sections 4.4 and 5.2).
Croatian: Bolesnici s oštećenjem funkcije jetre: Nije potrebno prilagođavati dozu (vidjeti dijelove 4.4 i 5.2).
English: No formal interaction studies have been undertaken with vernakalant injection.
Croatian: Nisu provedena formalna ispitivanja interakcija vernakalanta primijenjenog putem injekcije.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja:
English: These anti-fibrillatory actions on refractoriness and conduction are thought to suppress re-entry, and are potentiated in the atria during atrial fibrillation.
Croatian: Smatra se da ti antifibrilacijski učinci na refrakternost i provodljivost potiskuju kruženje (engl. re-entry) impulsa, a potencirani su u atrijima tijekom fibrilacije atrija.
English: For atrial fibrillation lasting longer than 48 hours, anticoagulation was required as per treatment guidelines.
Croatian: Kod fibrilacije atrija koja je trajala dulje od 48 sati morala se primijeniti antikoagulacijska terapija sukladno terapijskim smjernicama.
English: Does the patient have prolonged QT interval at baseline (uncorrected > 440 msec)?
Croatian: Ima li bolesnik produljen QT-interval na početku liječenja (nekorigirani > 440 ms)?
English: In all studies, patients received a 10minute infusion of 3.0 mg/kg BRINAVESS (or matching placebo) followed by a 15-minute observation period.
Croatian: U svim su ispitivanjima bolesnici primili 10-minutnu infuziju lijeka BRINAVESS u dozi od 3,0 mg/kg (ili odgovarajući placebo), a zatim bi uslijedilo 15-minutno razdoblje promatranja.
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.
Croatian: Što se tiče reprodukcije, nisu opaženi učinci na skotnost, embriofetalni razvoj, okot ili postnatalni razvoj nakon intravenske primjene vernakalanta pri razinama izloženosti (AUC) sličnima ili nižima od razina izloženosti (AUC) koje se u ljudi postižu nakon jednokratne intravenske doze vernakalanta.
English: There are no data from the use of vernakalant hydrochloride in pregnant women.
Croatian: Nema podataka o primjeni vernakalantklorida u trudnica.
English: Patients with congestive heart failure (CHF) have been identified as a population at higher risk for hypotension.
Croatian: Utvrđeno je da su bolesnici s kongestivnim zatajenjem srca populacija s povećanim rizikom za razvoj hipotenzije.
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.
Croatian: U ispitivanjima ACT I i ACT III ispitivan je učinak vernakalanta u liječenju bolesnika s produljenom fibrilacijom atrija koja je trajala > 3 sata, ali ne dulje od 45 dana.
English: • certain kinds of heart beat problems, (such as an awareness of your heart beating (palpitations)
Croatian: • neke vrste poremećaja rada srca (npr. svjesnost o kucanju srca (palpitacije) ili dodatni otkucaj srca)
English: Resumption or initiation of oral maintenance antiarrhythmic therapy after this time period can be considered (see sections 4.3 and 4.4).
Croatian: Nakon tog razdoblja može se razmotriti nastavak ili uvođenje peroralne terapije održavanja antiaritmicima (vidjeti dijelove 4.3 i 4.4).
English: EU/1/10/645/001 EU/1/10/645/002
Croatian: EU/1/10/645/002
English: In embryo-foetal development studies with oral administration of vernakalant two times a day resulting in exposure levels (AUC) generally higher than those achieved in humans after a single intravenous dose of vernakalant malformations (misshapen/absent/fused skull bones including cleft palates, bent radius, bent/misshapen scapula, constricted trachea, absent thyroid, undescendent testes) occurred in rats and increased embryo-foetal lethality, increased number of foetuses with fused and/or additional sternebrae were seen in rabbits at the highest doses tested.
Croatian: U istraživanjima učinaka na embriofetalni razvoj nakon peroralne primjene vernakalanta dvaput na dan, pri čemu je postignuta razina izloženosti (AUC) u pravilu bila veća od one koja se postiže u ljudi nakon jednokratne intravenske doze vernakalanta, kod primjene najviših ispitivanih doza u štakora zabilježene su malformacije (deformacija/odsutnost/spajanje kostiju lubanje uključujući rascjep nepca, savijena palčana kost, savijena/deformirana lopatična kost, suženje dušnika, odsutnost štitne žlijezde, nespušteni testisi), a u kunića povećana embriofetalna smrtnost i veći broj fetusa sa spojenim i/ili dodatnim segmentima prsne kosti.
English: With continuation of the medicine infusion as recommended above, the majority of these patients continue to convert to sinus rhythm.
Croatian: S nastavkom infuzije lijeka, kako je prethodno preporučeno, u većine je bolesnika nastupila konverzija u sinusni ritam.
English: Table 2: Conversion of Atrial Fibrillation to Sinus Rhythm in ACT I and ACT III Duration of
Croatian: Tablica 2: Konverzija fibrilacije atrija u sinusni ritam u ispitivanjima ACT I i ACT III Trajanje fibrilacije atrija
English: Common: Pruritus; hyperhidrosis Uncommon: Pruritus generalised; cold sweat
Croatian: Često: pruritus; hiperhidroza Manje često: pruritus generalizirani; hladan znoj
English: • shortness of breath or a tightness in the chest
Croatian: • nedostatak zraka ili stezanje u prsima
English: - Alert HCP on BRINAVESS contraindications:
Croatian: - Upozorenje zdravstvenim radnicima o kontraindikacijama lijeka BRINAVESS: