FrancophonIA/ELRC3.0 huggingface dataset:
English: The long-term effects of ivabradine on growth, puberty and general development as well as the longterm efficacy of therapy with ivabradine in childhood to reduce cardiovascular morbidity and mortality have not been studied.
Slovenian: Dolgoročni učinki ivabradina na rast, puberteto in splošen razvoj, kakor tudi dolgoročna učinkovitost terapije z ivabradinom za zmanjševanje srčno-žilne obolevanosti in umrljivosti v otroški dobi niso bili preučevani.
English: If there is no improvement in symptoms of angina within 3 months after start of treatment, treatment of ivabradine should be discontinued.
Slovenian: Če se simptomi angine pektoris ne izboljšajo po 3 mesecih od uvedbe zdravljenja, se mora zdravljenje z ivabradinom prekiniti.
English: Also contains lactose.
Slovenian: Zdravilo vsebuje tudi laktozo.
English: Severe bradycardia should be treated symptomatically in a specialised environment.
Slovenian: Bolnike s hudo bradikardijo je treba zdraviti simptomatsko v specializiranem okolju.
English: There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine.
Slovenian: Ni dokazov o tveganju za (preveliko) bradikardijo ob vrnitvi na sinusni ritem pri sprožanju farmakološke kardioverzije pri bolnikih, ki se zdravijo z ivabradinom.
English: In this subgroup of patients, the safety profile of ivabradine is in line with the one of the overall population.
Slovenian: Pri tej podskupini bolnikov je bil varnostni profil ivabradina v skladu s tistim pri celotni populaciji bolnikov.
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine Accord.
Slovenian: Koledar, ki je natisnjen na pretisnem omotu s tabletami, vam pomaga, da si zapomnite, kdaj ste nazadnje vzeli tableto zdravila Ivabradine Accord.
English: The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night.
Slovenian: Možen nastanek tovrstnih pojavov svetlikanja je treba upoštevati pri vožnji ali upravljanju strojev v pogojih, kjer se lahko nenadno spreminja jakost svetlobe, zlasti med vožnjo ponoči.
English: The intake of the tablet during meals is recommended in order to decrease intra-individual variability in exposure (see section 4.2).
Slovenian: Priporočljivo je jemanje tablet v času obrokov za zmanjšanje intraindividualne spremenljivosti v izpostavljenosti (glejte poglavje 4.2).
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB17.
Slovenian: Farmakoterapevtska skupina: zdravila za bolezni srca, druga zdravila za bolezni srca, oznaka ATC: C01EB17.
English: If atrial fibrillation develops during treatment, the balance of benefits and risks of continued ivabradine treatment should be carefully reconsidered.
Slovenian: Če se atrijska fibrilacija razvije med zdravljenjem, je treba pazljivo pretehtati ravnovesje med koristmi in tveganji nadaljnjega zdravljenja z ivabradinom.
English: If you are pregnant and have taken Ivabradine Accord, talk to your doctor.
Slovenian: Če ste noseči in ste jemali zdravilo Ivabradine Accord, se posvetujte z zdravnikom.
English: The safety and efficacy of ivabradine in the treatment of chronic heart failure in children aged below 18 years have not yet been established.
Slovenian: Varnost in učinkovitost ivabradina pri zdravljenju kroničnega srčnega popuščanja pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: Since tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Ker tablete vsebujejo laktozo, bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze ali galaktoze ne smejo jemati tega zdravila.
English: Hazard ratio [95% CI]
Slovenian: Razmerje tveganja [95 % interval p-vrednost
English: The use of ivabradine is not recommended immediately after a stroke since no data is available in these situations.
Slovenian: Jemanje ivabradina takoj po možganski kapi ni priporočljivo, ker ni podatkov za uporabo pri tovrstnih stanjih.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ivabradine film-coated tablets in all subsets of the paediatric population in the treatment of angina pectoris.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Ivabradine filmsko obložene tablete za vse podskupine pediatrične populacije za zdravljenje angine pektoris.
English: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom
Slovenian: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Združeno kraljestvo
English: The most common adverse reactions with ivabradine, luminous phenomena (phosphenes) and bradycardia, are dose dependent and related to the pharmacological effect of the medicinal product.
Slovenian: Najpogostnejši neželeni učinki pri uporabi ivabradina, pojavi svetlikanja (fosfeni) in bradikardija, so odvisni od odmerka in povezani s farmakološkim delovanjem zdravila.
English: If any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine Accord.
Slovenian: Če karkoli od naštetega velja za vas, se takoj pogovorite z zdravnikom pred jemanjem zdravila Ivabradine Accord ali med njim.
English: Verapamil, diltiazem or strong CYP 3A4 inhibitors were received by 7.1% of patients during the study.
Slovenian: Verapamil, diltiazem ali močne zaviralce CYP3A4 je med spremljanjem prejemalo 7,1 % bolnikov.
English: The major active metabolite is the N-desmethylated derivative (S 18982) with an exposure about 40% of that of the parent compound.
Slovenian: Glavni aktivni presnovek je N-demetilirani derivat (S 18982) z izpostavljenostjo, ki znaša približno 40 % tiste pri matični učinkovini.
English: Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when a tachyarrhythmia occurs (e.g. ventricular or supraventricular tachycardia).
Slovenian: Ivabradin ni učinkovit pri zdravljenju ali preprečevanju srčnih aritmij in verjetno izgubi učinkovitost ob pojavu tahiartimije (na primer ventrikularne ali supraventrikularne tahikardije).
English: WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary
Slovenian: WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Madžarska
English: The concomitant use of CYP3A4 inducing medicinal products may require an adjustment of the dose of ivabradine.
Slovenian: Sočasna uporaba zdravil, ki spodbujajo CYP3A4, lahko zahteva prilagajanje odmerka ivabradina.
English: Drug-drug interaction studies have established that CYP3A4 inhibitors increase ivabradine plasma concentrations, while inducers decrease them.
Slovenian: Študije o medsebojnih delovanjih z zdravili so pokazale, da zaviralci CYP3A4 povečujejo koncentracijo ivabradina v plazmi, medtem ko jo spodbujevalci zmanjšujejo.
English: The Ndesmethylated derivative of ivabradine has been identified as the main active metabolite in humans.
Slovenian: N-demetilirani derivat ivabradina so določili kot glavni aktivni presnovek pri ljudeh.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ivabradine film-coated tabletsin children aged 0 to less than 6 months in the treatment of chronic heart failure.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Ivabradine filmsko obložene tablete za otroke od 0 do manj kot 6 mesecev starosti za zdravljenje kroničnega srčnega popuščanja.
English: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom or
Slovenian: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Združeno kraljestvo ali
English: * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Slovenian: *Pogostnost neželenih učinkov iz spontanega poročanja je izračunana na podlagi podatkov iz kliničnih študij
English: In dogs given ivabradine (doses of 2, 7 or 24 mg/kg/day) for one year, reversible changes in retinal function were observed but were not associated with any damage to ocular structures.
Slovenian: Pri psih, ki so jim dajali ivabradin (v odmerkih 2 mg/kg/dan, 7 mg/kg/dan ali 24 mg/kg/dan) eno leto, so opazili reverzibilne spremembe delovanja mrežnice, ki pa niso bile povezane z nobenimi poškodbami očesnih struktur.
English: Lack of benefit on clinical outcomes in patients with symptomatic chronic stable angina pectoris
Slovenian: Pomanjkanje pozitivnih učinkov na klinične izide pri bolnikih s simptomatsko kronično stabilno angino pektoris
English: However, in the absence of extensive data, non urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.
Slovenian: Toda ker ni obsežnejših podatkov, je treba razmisliti o neurgentni kardioverziji z enosmernim tokom v 24 urah po zadnjem odmerku ivabradina.
English: Limited data are available in patients with mild to moderate hypotension, and ivabradine should therefore be used with caution in these patients.
Slovenian: Podatki pri bolnikih z blago do zmerno hipotenzijo so omejeni, zato se mora pri teh bolnikih ivabradin uporabljati previdno.
English: Additional efficacy of ivabradine in combination with dihydropyridine calcium channel blockers has not been established (see section 5.1).
Slovenian: Dodatne učinkovitosti ivabradina v kombinaciji z dihidropiridinskimi zaviralci kalcijevih kanalčkov niso zasledili (glejte poglavje 5.1).
English: If you forget to take a dose of Ivabradine Accord, take the next dose at the usual time.
Slovenian: Če ste pozabili vzeti zdravilo Ivabradine Accord Če ste pozabili vzeti odmerek zdravila Ivabradine Accord, vzemite naslednji odmerek ob običajnem času.
English: Excretion of metabolites occurs to a similar extent via faeces and urine.
Slovenian: Izločanje presnovkov poteka v podobnem obsegu z blatom in urinom.
English: The treatment has to be initiated only in patient with stable heart failure.
Slovenian: Zdravljenje se lahko uvede le pri bolnikih s stabilnim srčnim popuščanjem.
English: The potent CYP3A4 inhibitors ketoconazole (200 mg once daily) and josamycin (1 g twice daily) increased ivabradine mean plasma exposure by 7 to 8 fold.
Slovenian: Močna zaviralca CYP3A4 ketokonazol (200 mg enkrat na dan) in josamicin (1 g dvakrat na dan) sta povečala srednjo izpostavljenost ivabradinu v plazmi za 7- do 8-krat.
English: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: V kliničnih študijah so poročali o naslednjih neželenih učinkih, ki so razvrščeni po naslednji pogostnosti: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Ivabradine Accord may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Slovenian: Zdravilo Ivabradine Accord lahko povzroča začasne vidne pojave svetlikanja (prehodno povečanje svetlosti v vidnem polju, glejte “Možni neželeni učinki”).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate določenih vrst sladkorja, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: If the combination appears necessary, close cardiac monitoring is needed (see section 4.4).
Slovenian: Če se kombinacija zdi potrebna, je treba pozorno spremljati delovanje srca (glejte poglavje 4.4).
English: WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary or
Slovenian: WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Madžarska ali
English: Ivabradine is not recommended in patients with AV-block of 2nd degree.
Slovenian: Ivabradin ni priporočljiv pri bolnikih z atrioventrikularnim blokom 2. stopnje.
English: Other secondary endpoints: - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Slovenian: Drugi sekundarni končni izidi: - smrt zaradi različnih vzrokov - smrt zaradi odpovedi srca - hospitalizacija zaradi kateregakoli vzroka - hospitalizacija zaradi srčno-žilnega vzroka
English: Combination with calcium channel blockers
Slovenian: Sočasna uporaba z zaviralci kalcijevih kanalčkov
English: Heart rate reduction, as caused by ivabradine, may exacerbate QT prolongation, which may give rise to severe arrhythmias, in particular Torsade de pointes.
Slovenian: Zniževanje srčne frekvence, ki ga povzroči ivabradin, lahko poslabša podaljšanje intervala QT, kar lahko povzroči hude aritmije, še posebej Torsade de pointes.
English: Ivabradine Accord should be taken during meals.
Slovenian: Zdravilo Ivabradine Accord morate jemati med obrokom.
English: Given that the heart rate may fluctuate considerably over time, serial heart rate measurements, ECG or ambulatory 24-hour monitoring should be considered when determining resting heart rate before initiation of ivabradine treatment and in patients on treatment with ivabradine when titration is considered.
Slovenian: Glede na to, da lahko srčna frekvenca precej niha, je treba razmisliti o zaporednem merjenju srčne frekvence, EKG-ju in 24-urnem ambulantnem spremljanju, ko se določa srčna frekvenca v mirovanju pred uvedbo zdravljenja z ivabradinom ter pri bolnikih, ki jemljejo ivabradin in pri katerih je potrebno razmisliti o titriranju odmerka.
English: Ivabradine Accord with food and drink Avoid grapefruit juice during treatment with Ivabradine Accord.
Slovenian: Zdravilo Ivabradine Accord skupaj s hrano in pijačo Med zdravljenjem z zdravilom Ivabradine Accord se izogibajte uživanju grenivkinega soka.
English: - Renal impairment: the impact of renal impairment (creatinine clearance from 15 to 60 ml/min) on ivabradine pharmacokinetic is minimal, in relation with the low contribution of renal clearance (about 20 %) to total elimination for both ivabradine and its main metabolite S 18982 (see section
Slovenian: - Ledvična okvara: vpliv ledvične okvare (očistek kreatinina od 15 ml/min do 60 ml/min) na farmakokinetiko ivabradina je minimalen, kar je povezano z majhnim prispevkom ledvičnega očistka (približno 20 %) k skupnemu izločanju tako ivabradina kot njegovega glavnega presnovka S 18982 (glejte poglavje 4.2).
English: When treatment modifications are made in chronic heart failure patients treated with ivabradine blood pressure should be monitored at an appropriate interval (see section 4.8).
Slovenian: Kadar se pri bolnikih s kroničnim srčnim popuščanjem, zdravljenih z ivabradinom, zdravljenje spremeni, je potrebno v primernem intervalu spremljati krvni tlak (glejte poglavje 4.8).
English: Under triggering circumstances (e.g. rapid changes in luminosity), partial inhibition of Ih by ivabradine underlies the luminous phenomena that may be occasionally experienced by patients.
Slovenian: V sprožilnih okoliščinah (na primer ob hitrih spremembah svetlosti) je delno zaviranje Ih zaradi ivabradina osnova za pojave svetlikanja, ki jih lahko občasno opažajo bolniki.
English: These data are consistent with the pharmacological effect of ivabradine related to its interaction with hyperpolarisation-activated Ih currents in the retina, which share extensive homology with the cardiac pacemaker If current.
Slovenian: Ti podatki so skladni s farmakološkim učinkom ivabradina, povezanim z njegovim medsebojnim delovanjem z mrežničnimi hiperpolarizacijsko sproženimi tokovi Ih, ki si delijo obsežno homologijo s srčnim frekvenčno urejevalnim tokom If.
English: 14x1 film-coated tablets 28x1 film-coated tablets 56x1 film-coated tablets 84x1 film-coated tablets 98x1 film-coated tablets 100x1 film-coated tablets 112x1 film-coated tablets
Slovenian: 14 x 1 filmsko obložena tableta 28 x 1 filmsko obložena tableta 56 x 1 filmsko obložena tableta 84 x 1 filmsko obložena tableta 98 x 1 filmsko obložena tableta 100 x 1 filmsko obložena tableta 112 x 1 filmsko obložena tableta
English: High exposures to ivabradine that may occur when ivabradine is given in combination with strong CYP3A4 inhibitors may result in an excessive decrease in heart rate although this risk is reduced with moderate CYP3A4 inhibitors (see sections 4.3, 4.4 and 4.5).
Slovenian: Velika izpostavljenost ivabradinu, ki se lahko pojavi ob jemanju ivabradina v kombinaciji z močnimi zaviralci CYP3A4, lahko povzroči preveliko znižanje srčne frekvence, medtem ko je ob zmernih zaviralcih CYP3A4 tovrstno tveganje zmanjšano (glejte poglavja 4.3, 4.4 in 4.5).
English: Ivabradine Accord mainly works by reducing the heart rate by a few beats per minute.
Slovenian: Zdravilo Ivabradine Accord deluje predvsem tako, da znižuje srčno frekvenco za nekaj utripov na minuto.
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation: - in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals; - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
Slovenian: Ivabradin ne vpliva na znotrajsrčno prevajanje, kontraktilnost (ni negativnega inotropnega učinka) ali repolarizacijo prekatov: - v kliničnih elektrofizioloških študijah ivabradin ni vplival na čase atrioventrikularnega ali intraventrikularnega prevajanja ali na interval QT s popravkom; - pri bolnikih z disfunkcijo levega prekata (iztisnim deležem levega prekata med 30 in 45 %)
English: In particular, the additional benefit over 5 mg twice daily was established in a reference-controlled study versus atenolol: total exercise duration at trough was increased by about 1 minute after one month of treatment with 5 mg twice daily and further improved by almost 25 seconds after an additional 3-month period with forced titration to 7.5 mg twice daily.
Slovenian: Dodatni koristni učinek od odmerka 5 mg dvakrat na dan so zlasti dokazali v referenčni kontrolirani študiji v primerjavi z atenololom: skupno trajanje vadbe v času najnižje koncentracije se je povečalo za približno 1 minuto po enem mesecu zdravljenja z odmerkom 5 mg dvakrat na dan in še nadalje izboljšalo za skoraj 25 sekund po dodatnem 3-mesečnem obdobju z obveznim titriranjem na 7,5 mg dvakrat na dan.
English: What Ivabradine Accord is and what it is used for
Slovenian: Kaj je zdravilo Ivabradine Accord in za kaj ga uporabljamo
English: Heart failure must be stable before considering ivabradine treatment.
Slovenian: Srčno popuščanje mora biti stabilno, pred odločitvijo za zdravljenje z ivabradinom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Ivabradine Accord Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The main pharmacodynamic property of ivabradine in humans is a specific dose dependent reduction in heart rate.
Slovenian: Poglavitna farmakološka lastnost ivabradina pri ljudeh je specifično, od odmerka odvisno zniževanje srčne frekvence.
English: Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris because ivabradine has no benefits on cardiovascular outcomes (e.g. myocardial infarction or cardiovascular death ) (see section 5.1).
Slovenian: Ivabradin je indiciran samo za simptomatsko zdravljenje kronične stabilne angine pektoris, ker nima pozitivnih učinkov na srčno-žilne izide (npr. miokardni infarkt ali srčno-žilno smrt) (glejte poglavje 5.1).
English: In patients aged 75 years or more, a lower starting dose should be considered (2.5 mg twice daily i.e. one half 5 mg tablet twice daily) before up-titration if necessary.
Slovenian: Pri bolnikih, starih 75 ali več let, se mora razmisliti o manjšem začetnem odmerku (2,5 mg dvakrat na dan, to je eno polovico 5-mg tablete dvakrat na dan), ki se lahko nato poveča, če je potrebno.
English: PK/PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15-20 mg twice daily.
Slovenian: Analiza razmerja med farmakokinetiko in farmakodinamiko je pokazala, da se srčna frekvenca znižuje skoraj linearno s povečevanjem koncentracije ivabradina in S 18982 v plazmi ob odmerkih do 15 mg do 20 mg dvakrat na dan.
English: Linearity/non linearity The kinetics of ivabradine is linear over an oral dose range of 0.5 - 24 mg.
Slovenian: Linearnost/nelinearnost Kinetika ivabradina je linearna v razponu peroralnih odmerkov od 0,5 mg do 24 mg.
English: Special populations - Elderly: no pharmacokinetic differences (AUC and Cmax) have been observed between elderly (≥ 65 years) or very elderly patients (≥ 75 years) and the overall population (see section 4.2).
Slovenian: Posebne skupine bolnikov - Starejši bolniki: med starejšimi (≥ 65 let) ali najstarejšimi (≥ 75 let) bolniki in celotno populacijo niso opazili razlik v farmakokinetiki (površini pod krivuljo (AUC) ter največji koncentraciji v plazmi) (glejte poglavje 4.2).
English: - Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4 inhibitors (e.g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate.
Slovenian: - Zmerni zaviralci CYP3A4: o sočasni uporabi ivabradina z drugimi zmernimi zaviralci CYP3A4 (na primer flukonazolom) se lahko odloča ob začetnem odmerku 2,5 mg dvakrat na dan in če je srčna frekvenca med mirovanjem nad 70 utripov na minuto, ob spremljanju srčne frekvence.
English: What you need to know before you take Ivabradine Accord
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ivabradine Accord
English: When pregnant animals were treated during organogenesis at exposures close to therapeutic doses, there was a higher incidence of foetuses with cardiac defects in the rat and a small number of foetuses with ectrodactylia in the rabbit.
Slovenian: Ko so breje živali prejemale ivabradin med organogenezo pri izpostavljenostih, ki so bile blizu terapevtskim odmerkom, so opazili večjo pojavnost fetusov s srčnimi napakami pri podganah in majhno število fetusov z ektrodaktilijo pri kuncih.
English: The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5).
Slovenian: Uporabi ivabradina se je treba izogibati pri bolnikih, ki imajo prirojeni sindrom podaljšanega intervala QT ali se zdravijo z zdravili, ki ga podaljšujejo (glejte poglavje 4.5).
English: A randomised, double blind, placebo controlled study was performed in 116 paediatric patients (17 aged [6-12]months, 36 aged [1-3] years and 63 aged [3-18] years) with CHF and dilated cardiomyopathy (DCM) on top of optimal background treatment.
Slovenian: Randomizirana, dvojno slepa, s placebom nadzorovana študija je vključevala 116 pediatričnih bolnikov (17 bolnikov, starih [6-12] mesecev, 36 bolnikov, starih [1-3] leta in 63 bolnikov, starih [3-18] let) s kroničnim srčnim popuščanjem in dilatirano kardiomiopatijo (DKM), ki so prejemali ivabradin poleg optimalnega osnovnega zdravljenja.