FrancophonIA/ELRC3.0 huggingface dataset:
English: The maximum plasma concentration following chronic administration at the recommended dose of 5 mg twice daily is 22 ng/ml (CV=29%).
Croatian: Maksimalna koncentracija u plazmi nakon kronične primjene uz preporučenu dozu od 5 mg dva puta na dan je 22 ng/ml (CV=29%).
English: Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy - France
Croatian: Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy - Francuska
English: There was no evidence of pharmacological tolerance (loss of efficacy) developing during treatment nor of rebound phenomena after abrupt treatment discontinuation.
Croatian: Nije dokazano da tijekom liječenja nastaje farmakološka tolerancija (gubitak djelotvornosti), niti povratni fenomeni nakon naglog prekida liječenja.
English: Bradycardia was reported by 17.9 % of patients in the ivabradine group (2.1% in the placebo group).
Croatian: Bradikardija je zabilježena u 17,9% bolesnika koji su uzimali ivabradin (2,1% u placebo skupini).
English: The results on the primary endpoint are mainly driven by the heart failure endpoints, hospitalisation for worsening heart failure (absolute risk reduced by 4.7 %) and deaths from heart failure (absolute risk reduced by 1.1 %).
Croatian: Rezultati vezani za primarni ishod većim dijelom su posljedica ishoda zatajenja srca, ishoda hospitalizacija zbog pogoršanja zatajenja srca (smanjenje apsolutnog rizika za 4,7%) i smrti zbog zatajenja srca (smanjenje apsolutnog rizika za 1,1%).
English: However, in post-marketing experience, cases of impaired driving ability due to visual symptoms have been reported.
Croatian: Međutim, u posmarketinškom periodu zabilježeni su slučajevi smanjene sposobnosti upravljanja vozilom zbog vidnih poremećaja.
English: No data are available in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Croatian: O bolesnicima s teškim oštećenjem jetre nema podataka (vidjeti dijelove 4.2 i 4.3).
English: The antianginal and anti-ischaemic efficacy of ivabradine was preserved in diabetic patients (n = 457) with a similar safety profile as compared to the overall population.
Croatian: Antianginalna i antiishemijska djelotvornost ivabradina potvrđena je u dijabetičara (n=457) sa sličnim sigurnosnim profilom kao u ukupne populacije.
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB17.
Croatian: Farmakoterapijska skupina: Lijekovi koji djeluju na srce, ostali srčani pripravci, ATK oznaka: C01EB17.
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.
Croatian: U poticajnim okolnostima (npr. brze svjetlosne promjene), djelomična inhibicija Ih struje ivabradinom podliježe svjetlosnim fenomenima koje bolesnici mogu povremeno doživjeti.
English: If any of the above applies to you, talk straight away to your doctor before or while taking Corlentor.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas, razgovarajte o tome s liječnikom prije nego što počnete uzimati Corlentor, ili kada ga već uzimate.
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.
Croatian: Najčešće nuspojave ivabradina, svjetlosni fenomeni (fosfeni) i bradikardija, ovise o dozi i povezane su s farmakološkim učinkom lijeka.
English: No data are available in patients with creatinine clearance below 15 ml/min.
Croatian: Nema podataka o primjeni u bolesnika s klirensom kreatinina ispod 15 ml/min.
English: Ivabradine is contra-indicated in patients with severe hypotension (blood pressure < 90/50 mmHg) (see section 4.3).
Croatian: Ivabradin je kontraindiciran u bolesnika s teškim oblikom hipotenzije (krvni tlak < 90/50 mmHg) (vidjeti dio 4.3).
English: Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur.
Croatian: Bolesnike treba upozoriti na znakove i simptome fibrilacije atrija te savjetovati da se jave svom liječniku ukoliko se oni pojave.
English: Ivabradine is therefore not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.
Croatian: Zbog toga se ivabradin ne preporučuje u bolesnika s fibrilacijom atrija ili drugim srčanim aritmijama koje interferiraju s funkcijom sinusnog čvora.
English: In the ivabradine group, 67% of patients were treated with 7.5 mg twice a day.
Croatian: U skupini bolesnika liječenih ivabradinom, 67% bolesnika liječeno je s dozom 7,5 mg dva puta na dan.
English: Corlentor mainly works by reducing the heart rate by a few beats per minute.
Croatian: Corlentor poglavito djeluje smanjivanjem srčane frekvencije za nekoliko otkucaja u minuti.
English: Do not take Corlentor if you are pregnant or are planning to have a baby (see “Do not take Corlentor”).
Croatian: Ne uzimajte Corlentor ako ste trudni ili planirate imati dijete (vidjeti “Nemojte uzimati Corlentor”).
English: There are no or limited amount of data from the use of ivabradine in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni ivabradina u trudnica ograničeni.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana..
English: The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years.
Croatian: Početna doza ivabradina ne smije prelaziti 5 mg dva puta na dan u bolesnika mlađih od 75 godina.
English: Luminous phenomena (phosphenes) were reported by 14.5% of patients, described as a transient enhanced brightness in a limited area of the visual field.
Croatian: Svjetlosni fenomeni (fosfeni): zabilježeni u 14,5% bolesnika, opisani kao prolazna povećana svjetlost u ograničenom dijelu vidnoga polja.
English: What Corlentor contains - The active substance is ivabradine (as hydrochloride).
Croatian: Što Corlentor sadrži - Djelatna tvar je ivabradin (u obliku ivabradinklorida).
English: Ivabradine should be used with caution in heart failure patients with NYHA functional classification IV due to limited amount of data in this population.
Croatian: Ivabradin se mora primjenivati s oprezom u bolesnika s zatajenjem srca stupnja IV prema NYHA funkcijskoj klasifikaciji zbog ograničene količine podataka u ovoj skupini bolesnika.
English: In this subgroup of patients, the safety profile of ivabradine is in line with the one of the overall population.
Croatian: U ovoj podskupini bolesnika sigurnosni profil ivabradina jednak je profilu cjelokupne populacije.
English: Excretion of metabolites occurs to a similar extent via faeces and urine.
Croatian: Izlučivanje metabolita odvija se u sličnoj mjeri putem stolice i mokraće.
English: - Chronic heart failure in adult patients whose heart rate is over or equal to 75 beats per minute.
Croatian: - Kronično zatajenje srca kod odraslih bolesnika koji imaju puls veći ili jednak 75 otkucaja u minuti.
English: Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes.
Croatian: Manje od 1% bolesnika mijenjalo je zbog poremećaja vida svoj dnevni ritam i prekinulo liječenje.
English: Przedsiebiorstwo Farmaceutyczne ANPHARM S.A. ul.
Croatian: Wicklow, Irska Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
English: The twice-daily dosing regimen of ivabradine gave uniform efficacy over 24 hours.
Croatian: Režim doziranja ivabradina od dva puta na dan rezultirao je ujednačenom učinkovitošću tijekom 24 sata.
English: Animal studies indicate that ivabradine is excreted in milk.
Croatian: Ispitivanja na životinjama ukazuju da se ivabradin izlučuje u majčino mlijeko.
English: This also applies to patients with a low heart rate, in particular when heart rate decreases below 50 bpm, or after dose reduction (see section 4.2).
Croatian: Ovo se također odnosi i na bolesnike s niskom srčanom frekvencijom, osobito kada se srčana frekvencija smanji na ispod 50 otkucaja u minuti, ili nakon smanjenja doze (vidjeti dio 4.2).
English: The usual recommended starting dose of ivabradine is 5 mg twice daily.
Croatian: Uobičajena preporučena početna doza ivabradina jest 5 mg dva puta na dan.
English: No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers such as amlodipine.
Croatian: Nema sigurnosnih pitanja vezano za primjenu ivabradina s nitratima i dihidropiridinskim blokatorima kalcijevih kanala kao što je amlodipin.
English: Atrial fibrillation - Cardiac arrhythmias
Croatian: Fibrilacija atrija - srčane aritmije
English: Additional efficacy of ivabradine in combination with dihydropyridine calcium channel blockers has not been established (see section 5.1).
Croatian: Nije utvrđena dodatna djelotvornost ivabradina u kombinaciji s dihidropiridinskim blokatorima kalcijevih kanala (vidjeti dio 5.1).
English: Outcomes of these evaluations support the lack of environmental risk of ivabradine and ivabradine does not pose a threat to the environment.
Croatian: Ishodi ovih procjena podupiru nepostojanje rizika ivabradina za okoliš pa shodno tome ivabradin ne predstavlja opasnost za okolinu.
English: In the SIGNIFY study atrial fibrillation was observed in 5.3% of patients taking ivabradine compared to 3.8% in the placebo group.
Croatian: U kliničkom ispitivanju SIGNIFY, fibrilacija atrija zabilježena je u 5,3% bolesnika koji su uzimali ivabradin u usporedbi s 3,8% u placebo skupini.
English: The use of ivabradine is not recommended immediately after a stroke since no data is available in these situations.
Croatian: Primjena ivabradina ne preporučuje se neposredno nakon moždanog udara jer nema kliničkih podataka u ovim stanjima.
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.
Croatian: Jaki su CYP3A4 inhibitori ketokonazol (200 mg jedanput na dan) i jozamicin (1 g dva puta na dan) povećavali srednju izloženost ivabradina u plazmi za 7 do 8 puta.
English: If you forget to take Corlentor
Croatian: Ako ste zaboravili uzeti Corlentor:
English: The antianginal and anti-ischaemic efficacy of ivabradine was studied in five double-blind randomised trials (three versus placebo, and one each versus atenolol and amlodipine).
Croatian: Antianginalna i antiishemijska djelotvornost ivabradina ispitana je u pet dvostruko slijepih, randomiziranih studija (tri u odnosu na placebo, a po jedna u odnosu na atenolol i amlodipin).
English: Chronic heart failure is a heart disease which happens when your heart cannot pump enough blood to the rest of your body.
Croatian: Kronično zatajenje srca je bolest srca koja nastaje kada Vaše srce svojim radom ne može opskrbiti Vaše tijelo dostatnom količinom krvi.
English: Ivabradine is approximately 70% plasma protein bound and the volume of distribution at steady-state is close to 100 l in patients.
Croatian: Oko 70% ivabradina veže se na proteine plazme, a volumen distribucije u stanju dinamičke ravnoteže je blizu 100 l u bolesnika.
English: Ivabradine is indicated : - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Croatian: Ivabradin je indiciran: - u odraslih bolesnika koji ne podnose beta-blokatore ili je njihova primjena kontraindicirana - ili u kombinaciji s beta blokatorima u bolesnika koji nisu adekvatno kontrolirani s optimalnom dozom beta blokatora.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Corlentor in one or more subsets of the paediatric population in the treatment of chronic heart failure (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Corlentor u jednoj ili više podskupina pedijatrijske populacije u liječenju kroničnog zatajenja srca (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza "Rok valjanosti".
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.
Croatian: Kada su skotne životinje tretirane tijekom organogeneze koncentracijama koje su bile približne terapijskim dozama, u štakora je zabilježena veća incidencija fetusa sa srčanim greškama, a u kunića mali broj fetusa sa ektrodaktilijom.
English: The onset of phosphenes is generally within the first two months of treatment after which they may occur repeatedly.
Croatian: Fosfeni nastaju općenito unutar prva dva mjeseca liječenja, nakon čega se mogu opetovano javljati.
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Corlentor.
Croatian: Obavijestite svog liječnika ukoliko dojite ili planirate dojiti budući da se dojenje treba obustaviti ukoliko uzimate Corlentor.
English: Grapefruit juice: ivabradine exposure was increased by 2-fold following the co-administration with grapefruit juice.
Croatian: Sok od grejpa: izloženost ivabradinu dvostruko se povećala nakon istodobne primjene soka od grejpa.
English: It is used in combination with standard therapy, including beta-blocker therapy or when betablockers are contraindicated or not tolerated.
Croatian: Lijek se koristi u kombinaciji sa standardnom terapijom, uključujući beta-blokatore ili kada su beta blokatori kontraindicirani ili se ne podnose.
English: Efficacy was confirmed with 7.5 mg twice daily.
Croatian: Djelotvornost je potvrđena s dozom od 7,5 mg dva puta na dan.
English: Heart rate reduction, as caused by ivabradine, may exacerbate QT prolongation, which may give rise to severe arrhythmias, in particular Torsade de pointes.
Croatian: Smanjenje srčane frekvencije, kao što to uzrokuje ivabradin, može pogoršati QT prolongaciju, što može uzrokovati teške aritmije, osobito Torsade de pointes
English: The main efficacy criterion was the composite of cardiovascular death, hospitalization for acute MI or hospitalization for new onset or worsening heart failure.
Croatian: Glavni kriterij djelotvornosti je bio kardiovaskularni mortalitet, hospitalizacija zbog akutnog infarkta miokarda ili hospitalizacija zbog novonastalog ili pogoršanje postojećeg srčanog zatajenja.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE
English: AV 2nd degree block, AV 3rd degree block Sick sinus syndrome
Croatian: AV blok 2. stupnja, AV blok 3. stupnja
English: Irregular rapid contraction of the heart, abnormal perception of heartbeat, uncontrolled blood pressure, headache, dizziness and blurred vision (cloudy vision).
Croatian: Nepravilan, brzi rad srca, abnormalna percepcija rada srca, nekontrolirani krvni tlak, glavobolja, omaglica i zamućen vid (zamagljen vid).
English: Drug-drug interaction studies have established that CYP3A4 inhibitors increase ivabradine plasma concentrations, while inducers decrease them.
Croatian: Ispitivanjima interakcije između dva lijeka utvrđeno je da CYP3A4 inhibitori povećavaju koncentraciju ivabradina u plazmi, dok ih induktori smanjuju.
English: To date, there is no evidence of a toxic effect of ivabradine on the retina, but the effects of long-term ivabradine treatment beyond one year on retinal function are currently not known.
Croatian: Do danas nije dokazano toksično djelovanje ivabradina na mrežnicu, ali ne postoje podaci o učincima ivabradina na funkciju mrežnice tijekom liječenja dužeg od jedne godine.
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.
Croatian: U bolesnika u dobi od 75 godina ili starijih, mora se razmotriti mogućnost davanja niže početne doze (2,5 mg dva puta na dan, tj. jednu polovicu tablete od 5 mg dva puta na dan) prije povišenja doze, ukoliko je to potrebno.
English: Do not take Corlentor if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Corlentor”).
Croatian: Nemojte uzimati Corlentor ako možete zatrudnijeti osim ako koristite pouzdanu kontracepciju (vidjeti „Nemojte uzimati Corlentor”).
English: Contra-indication of concomitant use
Croatian: Kontraindikacije za istodobnu primjenu
English: CYP3A4 inhibitors and inducers are liable to interact with ivabradine and influence its metabolism and pharmacokinetics to a clinically significant extent.
Croatian: CYP3A4 inhibitori i induktori mogu stupiti u interakciju s ivabradinom i u klinički značajno mjeri utjecati na njegov metabolizam i farmakokinetiku.
English: Inversely, potent inhibitors and inducers may substantially affect ivabradine plasma concentrations (see section 4.5).
Croatian: Obrnuto, jaki inhibitori i induktori mogu u velikoj mjeri negativno utjecati na koncentracije ivabradina u plazmi (vidjeti dio 4.5).
English: The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation.
Croatian: Učinci na srce odnose se specifično na sinusni čvor, bez učinka na intraatrijska, atrioventrikulska ili intraventrikulska vremena provođenja, niti na kontraktilnost miokarda ili ventrikulsku repolarizaciju.
English: Special populations - Older people: 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
Croatian: Posebne populacije - Starije osobe: između starijih osoba (≥ 65 godina), ili vrlo starih bolesnika (≥ 75 godina) te ukupne populacije nisu zapažene farmakokinetičke razlike (AUC i Cmax) (vidjeti dio 4.2).
English: Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
Croatian: Bolesnici koji boluju od kroničnog zatajenja srca s intraventrikularnim provodnim defektom (blok lijeve grane, blok desne grane) i s ventrikularnom disinkronijom trebaju biti pažljivo praćeni.
English: Fertility Studies in rats have shown no effect on fertility in males and females (see section 5.3).
Croatian: Ispitivanja su pokazala da nema učinka na plodnost u mužjaka i ženki štakora. (vidjeti dio 5.3).
English: Symptoms Overdose may lead to severe and prolonged bradycardia (see section 4.8).
Croatian: Simptomi Predoziranje može dovesti do teške i produljene bradikardije (vidjeti dio 4.8).
English: The concomitant use of CYP3A4 inducing medicinal products may require an adjustment of the dose of ivabradine.
Croatian: Pri istovremenoj uporabi lijekova koji induciraju CYP3A4 potrebno je podešavanje doze ivabradina.
English: Luminous phenomena (phosphenes) are described as a transient enhanced brightness in a limited area of the visual field (see section 4.8).
Croatian: Svjetlosni fenomeni (fosfeni) opisuju se kao prolazno pojačana svjetlost u ograničenom dijelu vidnoga polja (vidjeti dio 4.8).
English: After dose reduction, heart rate should be monitored (see section 4.4).
Croatian: Nakon smanjenja doze, mora se pratiti srčana frekvencija (vidjeti dio 4.4).
English: How to store Corlentor
Croatian: Kako čuvati Corlentor
English: Preferred Term
Croatian: Preporučeni naziv
English: Temporary cardiac electrical pacing may be instituted if required.
Croatian: Ukoliko je potrebno, može se primjeniti privremeni elektrostimulator srca.
English: Heart failure must be stable before considering ivabradine treatment.
Croatian: Zatajenje srca mora biti uspješno kontrolirano prije razmatranja terapije s ivabradinom.
English: Potassium-depleting diuretics (thiazide diuretics and loop diuretics): hypokalemia can increase the risk of arrhythmia.
Croatian: Diuretici koji troše kalij (tiazidni diuretici i diuretici Henleove petlje): hipokalijemija može povećati rizik nastanka aritmija.
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).
Croatian: Ukoliko se mijenja liječenje krvnog tlaka u bolesnika s kroničnim zatajenjem srca liječenih ivabradinom potrebno je pratiti vrijednosti krvnog tlaka u odgovarajućim intervalima (vidjeti dio 4.8).
English: The starting dose should not exceed one tablet of Corlentor 5 mg twice daily.
Croatian: Početna doza ne smije prelaziti jednu tabletu Corlentor 5 mg dva puta na dan.
English: de los Madroños, 33 28043 Madrid Spain
Croatian: Laboratorios Servier, S.L. Avda. de los Madroños, 33 28043 Madrid Španjolska
English: There was a significant improvement in NYHA class at last recorded value, 887 (28%) of patients on ivabradine improved versus 776 (24%) of patients on placebo (p=0.001).
Croatian: Zabilježeno je značajno poboljšanje NYHA stupnja kod posljednje zabilježene vrijednosti, 887 (28%) bolesnika liječenih ivabradinom postiglo je poboljšanje za razliku od 776 (24%) bolesnika u placebo skupini (p=0,001).
English: - Hepatic impairment: in patients with mild hepatic impairment (Child Pugh score up to 7) unbound AUC of ivabradine and the main active metabolite were about 20% higher than in subjects with normal hepatic function.
Croatian: - Oštećenje jetre: u bolesnika s blagim oštećenjem jetre (Child Pugh bod do 7) vrijednosti nevezanog AUC ivabradina i glavnog aktivnog metabolita bile su 20% više nego u ispitanika s normalnom funkcijom jetre.
English: The usual recommended starting dose is one tablet of Corlentor 5 mg twice daily increasing if necessary to one tablet of Corlentor 7.5 mg twice daily.
Croatian: Uobičajena doza je jedna tableta Corlentora od 5 mg dva puta na dan, koja se, ako je potrebno, povećava na jednu tabletu Corlentora od 7,5 mg dva puta na dan.
English: In a pooled analysis of all the Phase II/III double blind controlled clinical trials with a duration of at least 3 months including more than 40,000 patients, the incidence of atrial fibrillation was 4.86% in ivabradine treated patients compared to 4.08% in controls, corresponding to a hazard ratio of 1.26, 95% CI [1.15-1.39].
Croatian: Objedinjena analiza svih dvostruko slijepih kliničkih ispitivanja Faze II/III koja su trajala najmanje tri mjeseca i uključivala više od 40 000 bolesnika pokazala je da je incidencija fibrilacije atrija bila 4,86% u bolesnika liječenih ivabradinom u usporedbi s 4,08% u kontrolnim skupinama, što odgovara omjeru hazarda 1,26%, 95% CI [1,15-1,39].
English: Ivabradine should therefore be used with precaution in this population.
Croatian: Ivabradin se u tih bolesnika treba upotrebljavati uz mjere opreza.
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).
Croatian: Velike koncentracije ivabradina, do kojih može doći kada se ivabradin primjenjuje u kombinaciji s jakim CYP3A4 inhibitorima, mogu rezultirati prekomjernim usporenjem srčane frekvencije, iako je rizik smanjen kod umjerenih CYP3A4 inhibitora (vidjeti dijelove 4.3, 4.4 i 4.5).
English: Severe bradycardia should be treated symptomatically in a specialised environment.
Croatian: Tešku bradikardiju valja liječiti simptomatski u zdravstvenim ustanovama.