FrancophonIA/ELRC3.0 huggingface dataset:
English: These episodes occurred most frequently shortly after blood pressure treatment was modified, were transient, and did not affect the treatment effect of ivabradine.
Croatian: Te su se epizode najčešće javile ubrzo nakon prilagodbe terapije za krvni tlak, bile su prolazne prirode i nisu utjecale na terapijski učinak ivabradina.
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).
Croatian: Tijekom kliničkih ispitivanja zabilježene su sljedeće nuspojave, koje su razvrstane prema sljedećim kategorijama učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: - If you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
Croatian: − ako već uzimate lijekove za liječenje gljivičnih infekcija (kao što su ketokonazol, itrakonazol),
English: About 4% of an oral dose is excreted unchanged in urine.
Croatian: Približno 4% peroralno primijenjene doze izlučuje se u nepromijenjenom obliku kroz mokraću.
English: These trials included a total of 4,111 patients with chronic stable angina pectoris, of whom 2,617 received ivabradine.
Croatian: U tim je ispitivanjima sudjelovalo ukupno 4111 bolesnika s kroničnom stabilnom anginom pektoris, od kojih je njih 2617 primalo ivabradin.
English: No influence on glucose or lipid metabolism was observed.
Croatian: Nije opažen utjecaj na metabolizam glukoze ni lipida.
English: Very rare (may affect up to 1 in 10,000 people) - Irregular heartbeats.
Croatian: Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba) − nepravilni otkucaji srca
English: However, in postmarketing experience, cases of impaired driving ability due to visual symptoms have been reported.
Croatian: Međutim, nakon stavljanja lijeka u promet prijavljeni su slučajevi smanjene sposobnosti upravljanja vozilima zbog vidnih simptoma.
English: The treatment has to be initiated only in patient with stable heart failure.
Croatian: Liječenje treba započeti samo u bolesnika sa stabilnim zatajivanjem srca.
English: The absence of pharmacokinetic difference between the 2 formulations was shown in an open-label randomised two-period cross-over study in 24 adult healthy volunteers.
Croatian: Nepostojanje razlike u farmakokinetici tih dviju formulacija dokazano je u otvorenom, randomiziranom, ukriženom ispitivanju provedenom s 24 zdrava dobrovoljca.
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 obrate svom liječniku ako se oni pojave.
English: Treatment effect on the primary composite endpoint, its components and secondary endpoints
Croatian: Učinak liječenja na primarnu kompozitnu mjeru ishoda, njezine pojedinačne sastavnice i sekundarne mjere ishoda
English: If you are being treated for stable angina pectoris
Croatian: Ako se liječite zbog stabilne angine pektoris
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.
Croatian: U pasa koji su primali ivabradin (doze od 2, 7 ili 24 mg/kg/dan) tijekom godine dana primijećene su reverzibilne promjene funkcije mrežnice, ali one nisu bile povezane s oštećenjem očnih struktura.
English: - Unstable or acute heart failure.
Croatian: Nestabilno ili akutno zatajenje srca
English: OPA/Alu/PVC-Alu blisters, paper carton.
Croatian: OPA/Al/PVC-Al blisteri, kartonska kutija
English: - If you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much).
Croatian: − ako imate simptome kao što su umor, omaglica ili nedostatka zraka (to bi moglo značiti da Vam srce radi presporo)
English: The safety and efficacy of ivabradine for the treatment of chronic heart failure in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost ivabradina u liječenju kroničnog zatajivanja srca u djece mlađe od 18 godina nisu ustanovljene.
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 zatajivanje srca je srčana bolest koja nastaje kada srce svojim radom ne može opskrbiti ostatak tijela dostatnom količinom krvi.
English: Ivabradine is eliminated with a main half-life of 2 hours (70 - 75% of the AUC) in plasma and an effective half-life of 11 hours.
Croatian: Ivabradin se eliminira uz glavni poluvijek od 2 sata (70 - 75% AUC-a) u plazmi i efektivni poluvijek od 11 sati.
English: Ivabradine is the S-enantiomer with no bioconversion demonstrated in vivo.
Croatian: Ivabradin je S-enantiomer koji ne pokazuje biokonverziju in vivo.
English: - If you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment.
Croatian: − ako Vam je krvni tlak nekontroliran, osobito nakon promjene terapije za snižavanje tlaka
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Croatian: meflokin, halofantrin, pentamidin, cisaprid, intravenski eritromicin).
English: A specific study to assess the possible influence of ivabradine on driving performance has been performed in healthy volunteers where no alteration of the driving performance was evidenced.
Croatian: Provedeno je specifično ispitivanje kako bi se ocijenio mogući utjecaj ivabradina na sposobnost upravljanja vozilima u zdravih dobrovoljaca, a u kojem nije primijećen nikakav učinak na tu sposobnost.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
English: If the combination appears necessary, close cardiac monitoring is needed.
Croatian: Ako se ta kombinacija pokaže neophodnom, potrebno je pažljivo pratiti srčanu funkciju.
English: If you still have angina symptoms and if you have tolerated the 5 mg twice daily dose well, the dose may be increased.
Croatian: Ako i dalje imate simptome angine i dobro podnosite dozu od 5 mg dvaput na dan, ona se može povećati.
English: • Anti-malarial medicines (such as mefloquine or halofantrine).
Croatian: • lijekove za malariju (kao što su meflokin ili halofantrin)
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 primarnu mjeru ishoda uglavnom su posljedica ishoda zatajivanja srca, hospitalizacije zbog pogoršanja zatajivanja srca (smanjenje apsolutnog rizika za 4,7%) i smrti zbog zatajivanja srca (smanjenje apsolutnog rizika za 1,1%).
English: It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers.
Croatian: Lijek se koristi u odraslih bolesnika koji ne podnose ili ne smiju uzimati lijekove za srce koji se zovu beta-blokatori.
English: Women of child-bearing potential should use appropriate contraceptive measures during treatment (see section 4.3).
Croatian: Žene reproduktivne dobi moraju koristiti odgovarajuće kontracepcijske mjere tijekom liječenja (vidjeti dio 4.3).
English: The safety profile, over one year, was similar to the one described in adult CHF patients.
Croatian: Sigurnosni profil tijekom jedne godine bio je sličan onom opisanom u odraslih bolesnika s kroničnim zatajivanjem srca.
English: Heart failure must be stable before considering ivabradine treatment.
Croatian: Zatajivanje srca mora biti stabilno prije nego što se počne razmatrati liječenje ivabradinom.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili na neku od pomoćnih tvari navedenih u dijelu 6.1
English: Patients received standard care including beta-blockers (89%), ACE inhibitors and/or angiotensin II antagonists (91%), diuretics (83%), and anti-aldosterone agents (60%).
Croatian: Bolesnici su primali standardno liječenje, uključujući beta-blokatore (89%), ACE inhibitore i/ili antagoniste angiotenzina II (91%), diuretike (83%) i antagoniste aldosterona (60%).
English: - Rifampicin (an antibiotic).
Croatian: − rifampicin (antibiotik)
English: However, in the absence of extensive data, non-urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.
Croatian: Međutim, s obzirom da nema mnogo podataka, provođenje elektrokardioverzije koja nije hitna može se razmotriti 24 sata nakon posljednje doze ivabradina.
English: They can also be described as a halo, coloured flashes, image decomposition or multiple images.
Croatian: Mogu se opisati i kao aureola, raznobojni bljeskovi, rastavljanje slike ili višestruke slike.
English: - Unstable angina.
Croatian: Nestabilna angina
English: As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Croatian: Budući da je liječenje angine ili kroničnog zatajivanja srca obično doživotno, nemojte prestati uzimati lijek ako prethodno o tome niste razgovarali sa svojim liječnikom.
English: At higher doses, the decrease in heart rate is no longer proportional to ivabradine plasma concentrations and tends to reach a plateau.
Croatian: Kod viših doza, usporenje srčane frekvencije više nije proporcionalno plazmatskim koncentracijama ivabradina i obično doseže plato.
English: If any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine Zentiva.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas, odmah se obratite svom liječniku prije nego što počnete uzimati Ivabradine Zentiva ili tijekom liječenja.
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) prijavljeni su u 14,5% bolesnika, a opisani su kao prolazna pojačana svjetlost u ograničenom dijelu vidnog polja.
English: Temporary cardiac electrical pacing may be instituted if required.
Croatian: Ako je potrebno, može se uvesti privremena elektrostimulacija srca.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ivabradine in all subsets of the paediatric population for the treatment of angina pectoris.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja ivabradina u svim podskupinama pedijatrijske populacije u liječenju angine pektoris.
English: It is recommended that the treating physician should be experienced in the management of chronic heart failure.
Croatian: Preporučuje se da liječnik koji provodi liječenje ima iskustva s liječenjem kroničnog zatajivanja srca.
English: - If you are suffering from cardiogenic shock (a heart condition treated in hospital).
Croatian: − ako bolujete od kardiogenog šoka (stanja koje se liječi u bolnici)
English: In this study, the antianginal and anti-ischaemic benefits of ivabradine were confirmed in patients aged 65 years or more.
Croatian: U tom su ispitivanju potvrđeni antianginozni i antiishemijski korisni učinci ivabradina u bolesnika u dobi od 65 ili više godina.
English: This increase in heart rate can cause the chest pain in people who suffer from angina.
Croatian: To ubrzanje pulsa može uzrokovati bol u prsnom košu u osoba koje boluju od angine.
English: In the ivabradine group, 67% of patients were treated with 7.5 mg twice a day.
Croatian: U skupini liječenoj ivabradinom, 67% bolesnika bilo je liječeno dozom od 7,5 mg dvaput na dan.
English: The twice-daily dosing regimen of ivabradine gave uniform efficacy over 24 hours.
Croatian: Režim primjene ivabradina dvaput na dan doveo je do ujednačene djelotvornosti tijekom 24 sata.
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: Antianginozna i antiishemijska djelotvornost ivabradina očuvana je u bolesnika sa šećernom bolešću (n=457) uz sličan sigurnosni profil kao i u cjelokupnoj populaciji.
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 preporučene doze od 5 mg dvaput na dan iznosi 22 ng/ml (CV = 29%).
English: - Phenytoin (for epilepsy).
Croatian: − fenitoin (za epilepsiju)
English: - If you are having a heart attack.
Croatian: − ako imate srčani udar
English: • Certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole).
Croatian: • određene vrste lijekova za liječenje anksioznosti, shizofrenije ili drugih psihoza (kao što su pimozid, ziprasidon, sertindol)
English: - If you suffer from a heart rhythm disorder.
Croatian: − ako bolujete od poremećaja srčanog ritma
English: Efficacy was confirmed with 7.5 mg twice daily.
Croatian: Djelotvornost je potvrđena s dozom od 7,5 mg dvaput na dan.
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: The European Medicines Agency has waived the obligation to submit the results of studies with ivabradine in children aged 0 to less than 6 months for the treatment of chronic heart failure.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja ivabradina u djece u dobi od 0 do manje od 6 mjeseci u liječenju kroničnog zatajivanja srca.
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.
Croatian: Nema dokaza o riziku od (prekomjerne) bradikardije pri povratku u sinusni ritam kod farmakološke kardioverzije u bolesnika koji se liječe ivabradinom.
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 primjenjivati uz oprez u bolesnika s zatajivanjem srca stupnja IV prema NYHA funkcijskoj klasifikaciji zbog ograničene količine podataka u toj populaciji.
English: Ivabradine efficacy was fully maintained throughout the 3- or 4-month treatment periods in the efficacy trials.
Croatian: Djelotvornost ivabradina bila je potpuno održana tijekom razdoblja liječenja od 3 do 4 mjeseca u ispitivanjima djelotvornosti.
English: Bradycardia was reported by 17.9 % of patients in the ivabradine group (2.1% in the placebo group).
Croatian: Bradikardija je prijavljena u 17,9% bolesnika koji su uzimali ivabradin (2,1% u skupini koja je primala placebo).
English: - QT prolonging medicines to treat either heart rhythm disorders or other conditions:
Croatian: − lijekove koji produljuju QT-interval, a primjenjuju se za liječenje poremećaja srčanog ritma ili drugih bolesti:
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: Antianginozna i antiishemijska djelotvornost ivabradina ispitana je u pet dvostruko slijepih, randomiziranih ispitivanja (tri u odnosu na placebo, a po jedno u odnosu na atenolol i amlodipin).
English: Ivabradine Zentiva mainly works by reducing the heart rate by a few beats per minute.
Croatian: Ivabradine Zentiva prvenstveno djeluje tako da usporava puls za nekoliko otkucaja u minuti.
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Ivabradine Zentiva 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Croatian: U nekim slučajevima (npr. ako ste starija osoba) postoji mogućnost da Vam liječnik propiše pola doze, tj. jednu polovicu tablete lijeka Ivabradine Zentiva od 5 mg (što odgovara količini od 2,5 mg ivabradina) ujutro i jednu polovicu tablete od 5 mg navečer.
English: - In patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30 and 45%), ivabradine did not have any deleterious influence on LVEF.
Croatian: − u bolesnika s disfunkcijom lijeve klijetke (ejekcijska frakcija lijeve klijetke [engl. left ventricular ejection fraction, LVEF] između 30 i 45%), ivabradin nije imao nikakav štetan učinak na LVEF.
English: If atrial fibrillation develops during treatment, the balance of benefits and risks of continued ivabradine treatment should be carefully reconsidered.
Croatian: Ako se tijekom liječenja razvije fibrilacija atrija, potrebno je pažljivo ponovno razmotriti omjer koristi i rizika daljnjeg liječenja ivabradinom.
English: Phosphenes may also be described as a halo, image decomposition (stroboscopic or kaleidoscopic effects), coloured bright lights, or multiple image (retinal persistency).
Croatian: Fosfeni se također mogu opisati kao aureola, rastavljanje slike (stroboskopski ili kaleidoskopski učinak), jarka obojena svjetlost ili višestruke slike (mrežnična perzistencija).
English: No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 mL/min (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s insuficijencijom bubrega i klirensom kreatinina iznad 15 ml/min (vidjeti dio 5.2).
English: The major active metabolite is the N-desmethylated derivative (S 18982) with an exposure about 40% of that of the parent compound.
Croatian: Glavni aktivni metabolit je N-desmetilirani derivat (S 18982), a izloženost ovom derivatu iznosi približno 40% izloženosti ishodišnom spoju.
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 o primjeni u tim situacijama.
English: Other medicines and Ivabradine Zentiva
Croatian: Drugi lijekovi i Ivabradine Zentiva
English: Verapamil, diltiazem or strong CYP 3A4 inhibitors were received by 7.1% of patients during the study.
Croatian: Verapamil, diltiazem ili snažne inhibitore CYP3A4 je tijekom ispitivanja primalo 7,1% bolesnika.
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 ili više godina treba razmotriti nižu početnu dozu (2,5 mg dvaput na dan, tj. polovicu tablete od 5 mg dvaput na dan) prije povišenja doze, ako je to potrebno.
English: The concomitant use of CYP3A4 inducing medicinal products may require an adjustment of the dose of ivabradine.
Croatian: Istodobna primjena lijekova koji induciraju CYP3A4 može zahtijevati prilagodbu doze ivabradina.
English: Animal studies indicate that ivabradine is excreted in milk.
Croatian: Ispitivanja na životinjama pokazuju da se ivabradin izlučuje u majčino mlijeko.
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).
Croatian: Ivabradin nije djelotvoran u liječenju ili prevenciji srčanih aritmija i vjerojatno gubi djelotvornost kada nastupi tahiaritmija (npr. ventrikulska ili supraventrikulska tahikardija).
English: • Cisapride (against the gastro-oesophageal reflux).
Croatian: • cisaprid (lijek za gastroezofagealni refluks)
English: Excretion of metabolites occurs to a similar extent via faeces and urine.
Croatian: Metaboliti se u sličnoj mjeri izlučuju i putem fecesa i putem mokraće.
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: Crospovidone Magnesium stearate
Croatian: Jezgra: manitol krospovidon magnezijev stearat
English: The total clearance is about 400 mL/min and the renal clearance is about 70 mL/min.
Croatian: Ukupni klirens iznosi oko 400 ml/min, a bubrežni klirens oko 70 ml/min.
English: - If you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure).
Croatian: − ako imate simptome fibrilacije atrija (neuobičajeno visok puls u mirovanju [iznad 110 otkucaja u minuti] ili nepravilan puls bez vidljivog uzroka, što otežava njegovo mjerenje)
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 okolnostima s prisutnim okidačima (npr. brze svjetlosne promjene), djelomična inhibicija Ih struje ivabradinom u pozadini je svjetlosnih fenomena koje bolesnici mogu povremeno doživjeti.
English: Outcomes of these evaluations support the lack of environmental risk of ivabradine and ivabradine does not pose a threat to the environment.
Croatian: Rezultati tih procjena govore u prilog nepostojanju rizika za okoliš kod ivabradina te stoga ivabradin ne predstavlja opasnost za okoliš.
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: To se odnosi i na bolesnike s niskom srčanom frekvencijom, osobito kada ona padne ispod 50 otkucaja u minuti ili nakon smanjenja doze (vidjeti dio 4.2).
English: Primary composite endpoint Components of the composite: - CV death - Hospitalisation for worsening HF Other secondary endpoints - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Croatian: Primarna kompozitna mjera ishoda Sastavnice kompozitne mjere ishoda: - smrt zbog kardiovaskularnih uzroka - hospitalizacija zbog pogoršanja zatajivanja srca Ostale sekundarne mjere ishoda - smrt zbog bilo kojeg uzroka - smrt zbog zatajivanja srca - hospitalizacija zbog bilo kojeg uzroka - hospitalizacija zbog kardiovaskularnih uzroka
English: The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
Croatian: Najčešći simptomi zatajivanja srca su nedostatak zraka, iscrpljenost, umor i oticanje gležnjeva.
English: No data are available in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Croatian: Nema dostupnih podataka o primjeni u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 4.3).
English: Ivabradine Zentiva may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Croatian: Ivabradine Zentiva može uzrokovati privremene svjetlosne vidne fenomene (privremeno pojačanu svjetlost u vidnom polju (pogledajte dio 4. „Moguće nuspojave“).
English: Grapefruit juice: ivabradine exposure was increased by 2-fold following the co-administration with grapefruit juice.
Croatian: Sok od grejpa: izloženost ivabradinu povećala se za dva puta nakon njegove primjene istodobno sa sokom od grejpa.
English: • Pentamidine (an antiparasitic medicine).
Croatian: • pentamidin (lijek za parazitske infekcije)