FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal renal function is 5 mg twice daily.
Croatian: Dozu treba sniziti na 5 mg jednom dnevno kada indicirana doza u slučaju normalne funkcije bubrega iznosi 5 mg dva puta dnevno.
English: Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal renal function is 10 mg twice daily.
Croatian: Dozu treba sniziti na 5 mg dva puta dnevno kada indicirana doza u slučaju normalne funkcije bubrega iznosi 10 mg dva puta dnevno.
English: Control
Croatian: Pretrage
English: XELJANZ 5 mg film-coated tablets tofacitinib
Croatian: XELJANZ 5 mg filmom obložene tablete tofacitinib
English: Vaccine studies
Croatian: Ispitivanja s cjepivima
English: Dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal hepatic function is 5 mg twice daily.
Croatian: Dozu treba sniziti na 5 mg jednom dnevno kada indicirana doza u slučaju normalne funkcije jetre iznosi 5 mg dva puta dnevno.
English: In the clinical studies in UC, changes in liver enzyme tests observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Croatian: U kliničkim ispitivanjima ulceroznog kolitisa promjene u pretragama jetrenih enzima opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
English: XELJANZ 10 mg film-coated tablets tofacitinib
Croatian: XELJANZ 10 mg filmom obložene tablete tofacitinib
English: Remissiona With prior TNF inhibitor failure
Croatian: Prethodno neuspješno liječenje inhibitorom TNF-a
English: Each film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Croatian: Jedna filmom obložena tableta sadrži 5 mg tofacitiniba u obliku tofacitinibcitrata.
English: Tofacitinib 10 mg twice daily monotherapy N=394
Croatian: Tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno N=394
English: Tofacitinib 10 mg twice daily monotherapy N=243
Croatian: Tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno N=243
English: You can start the Xeljanz 11 mg prolonged-release tablets once daily the day following the last dose of XELJANZ 5 mg film-coated tablets.
Croatian: Dan nakon što ste uzeli zadnju dozu XELJANZ 5 mg filmom obloženih tableta možete započeti s uzimanjem XELJANZ 11 mg tableta s produljenim oslobađanjem, koje trebate uzimati jednom dnevno.
English: Each film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Croatian: Jedna filmom obložena tableta sadrži 10 mg tofacitiniba u obliku tofacitinibcitrata.
English: Switching between tofacitinib 11 mg prolonged-release tablets and tofacitinib 5mg film-coated tablets
Croatian: Prelazak s tofacitinib tableta s produljenim oslobađanjem od 11 mg na tofacitinib filmom obložene tablete od 5 mg, i obratno
English: Tofacitinib 10 mg twice daily + MTX Mean difference from placebob
Croatian: Tofacitinib 10 mg dva puta dnevno + MTX Srednja vrijednost razlike od placeba (CI)
English: In the clinical studies in UC, changes in lipids observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Croatian: U kliničkim ispitivanjima ulceroznog kolitisa promjene u lipidima opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
English: • skin blisters
Croatian: • mjehure na koži
English: Each prolonged-release tablet contains tofacitinib citrate, equivalent to 11 mg tofacitinib.
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 11 mg tofacitiniba u obliku tofacitinibcitrata.
English: - if you have had diverticulitis (a type of inflammation of the large intestine) or ulcers in stomach or intestines (see section 4) - if you have kidney problems - if you are planning to get vaccinated, tell your doctor.
Croatian: - ako imate problema s bubrezima - ako se planirate cijepiti, obavijestite svog liječnika.
English: Examination of age, sex, race, baseline disease activity and PsA subtype did not identify differences in response to tofacitinib.
Croatian: Ispitivanja dobi, spola, rase, početne aktivnosti bolesti i podtipa
English: Included TNF Inhibitor naïve patients.
Croatian: Uključuje bolesnike koji nisu prethodno primali inhibitor TNF-a.
English: In the clinical studies in UC, changes in ALC observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Croatian: U kliničkim ispitivanjima ulceroznog kolitisa promjene u ALC-u opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
English: • stomach ache
Croatian: Steatoza jetre
English: Table 3: Low haemoglobin value Low haemoglobin value (Section 4.4)
Croatian: Niska razina hemoglobina (vidjeti dio 4.4)
English: Creatinine clearance
Croatian: Prijavljivanje nuspojava
English: In the clinical studies in UC, changes in ANC observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Croatian: U kliničkim ispitivanjima ulceroznog kolitisa promjene u ABN-u opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
English: CARTON FOR 11 MG BLISTER PACK
Croatian: KUTIJA ZA BLISTER PAKIRANJA S TABLETAMA OD 11 MG
English: Certain types of vaccines should not be given when taking XELJANZ.
Croatian: Bolesnik koji uzima XELJANZ ne smije biti cijepljen određenim cjepivima.
English: Without prior TNF inhibitor failureb
Croatian: Bez prethodno neuspješnog liječenja inhibitorom TNF-a b
English: Date of first authorisation: 22nd May 2017
Croatian: Datum prvog odobrenja: 22. svibnja 2017
English: Available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2 međutim nije moguće dati preporuku o doziranju.
English: Severe hypotension (< 90/50 mmHg)
Croatian: Teška hipotenzija (< 90/50 mmHg)
English: In this way Ivabradine Accord helps to control and reduce the number of angina attacks.
Croatian: Na taj način, Ivabradin Accord pomaže u kontroliranju i smanjenju broja napadaja angine.
English: If you forget to take a dose of Ivabradine Accord, take the next dose at the usual time.
Croatian: Ako zaboravite uzeti jednu dozu Ivabradin Accorda, uzmite sljedeću dozu u uobičajeno vrijeme.
English: and 45%), ivabradine did not have any deleterious influence on LVEF.
Croatian: 45%), ivabradin nije imao nikakav poguban utjecaj na LVEF.
English: If you think that the effect of Ivabradine Accord is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako mislite da je učinak Ivabradin Accorda prejak ili preslab, razgovarajte s liječnikom ili ljekarnikom.
English: ibutilide, amiodarone).
Croatian: sotalol, ibutilid, amiodaron).
English: Children Ivabradine Accord is not intended for use in children and adolescents younger than 18 years.
Croatian: Djeca Ivabradin Accord nije namijenjen djeci ni adolescentima mlađima od 18 godina.
English: Ivabradine Accord should be taken during meals.
Croatian: Ivabradin Accord treba uzimati tijekom obroka.
English: ECG prolonged QT interval
Croatian: Prolongiran QT interval u EKG-u
English: If you are pregnant and have taken Ivabradine Accord, talk to your doctor.
Croatian: Ako ste trudni, a uzeli ste Ivabradin Accord, obratite se liječniku.
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine Accord.
Croatian: Kalendar otisnut na blister pakiranju koje sadržava tablete, trebao bi Vam pomoći da zapamtite kada ste zadnji put uzeli tabletu Ivabradin Accorda.
English: Spain or
Croatian: Španjolska ili
English: Ivabradine is not recommended in patients with AV-block of 2nd degree.
Croatian: Ivabradin se ne preporučuje u bolesnika sa AV-blokom 2. stupnja.
English: 4.5 Interaction with other medicinal products and other forms of interaction Pharmacodynamic interactions
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Unstable or acute heart failure
Croatian: Nestabilno ili akutno zatajenje srca
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.
Croatian: Sigurnost i djelotvornost ivabradina u liječenju kroničnog zatajenja srca u djece u dobi do 18 godina još nisu ustanovljene.
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 oznake „Rok valjanosti“ i „EXP“.
English: AV-block of 3rd degree
Croatian: AV-blok 3. stupnja
English: If you take more Ivabradine Accord than you should:
Croatian: Ako uzmete više Ivabradin Accorda nego što ste trebali:
English: What Ivabradine Accord is and what it is used for
Croatian: Što je Ivabradin Accord i za što se koristi
English: Ivabradine Accord contains lactose
Croatian: Ivabradin Accord sadrži laktozu
English: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom or
Croatian: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Ujedinjeno Kraljevstvo ili
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).
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: Other medicines and Ivabradine Accord
Croatian: Drugi lijekovi i Ivabradin Accord
English: Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products
Croatian: Primjena u bolesnika s kongenitalnim QT-sindromom ili liječenih s lijekovima koji produljuju QTinterval
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 slijedeće nuspojave, a prema učestalosti razvrstane su na sljedeći način: 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 any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine Accord.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas, razgovarajte o tome s liječnikom prije nego što počnete uzimati Ivabradin Accord, ili kada ga već uzimate.
English: What you need to know before you take Ivabradine Accord
Croatian: Što morate znati prije nego počnete uzimati Ivabradin Accord
English: Sino-atrial block
Croatian: Sinusatrijski blok
English: The starting dose was 0.02 mg/kg bid in age-subset [6-12]months, 0.05 mg/kg bid in [1-3] years and [3-18] years <40 kg, and 2.5 mg bid in [3-18] years and ≥ 40 kg.
Croatian: Početna doza bila je 0,02 mg/kg/dan dva puta na dan u starosnoj podskupini [6-12] mjeseci, 0,05 mg/kg/dan dva puta na dan u starosnim podskupinama [1-3] godine i [3-18] godine s <40 kg te 2,5 mg/kg/dan dva puta na dan u starosnoj podskupini [3-18] godina s ≥ 40 kg.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Resting heart rate below 70 beats per minute prior to treatment Cardiogenic shock
Croatian: Preosjetljivost na djelatnu tvar ili na neku od pomoćnih tvari navedenih u dijelu 6.1 Srčana frekvencija u mirovanju prije liječenja sporija od 70 otkucaja u minuti Kardiogeni šok
English: Bradycardia AV 1st degree block (ECG prolonged PQ
Croatian: AV blok prvog stupnja (produžen PQ interval u EKG-u)
English: Ivabradine Accord 7.5 mg
Croatian: Ivabradin Accord 7,5 mg
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
Croatian: Ivabradin ne utječe na intrakardijalno provođenje, kontraktilnost (nema negativnog inotropnog učinka) ili na ventrikulsku repolarizaciju: - u kliničkim ispitivanjima elektrofiziologije, ivabradin nije imao učinka na atrioventrikulska ili na intraventrikulska vremena provođenja ili korigirane QT-intervale; - u bolesnika s disfunkcijom lijeve klijetke (istisna frakcija lijeve klijetke (LVEF) između 30 i
English: Use in patients with AV-block of 2
Croatian: Primjena u bolesnika sa AV-blokom 2. stupnja
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
Croatian: 14x1 filmom obložena tableta 28x1 filmom obložena tableta 56x1 filmom obložena tableta 84x1 filmom obložena tableta 98x1 filmom obložena tableta 100x1 filmom obložena tableta 112x1 filmom obložena tableta
English: What Ivabradine Accord contains - The active substance is ivabradine (as hydrochloride).
Croatian: Što Ivabradin Accord sadrži - Djelatna tvar je ivabradin (u obliku ivabradinklorida).
English: It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers.
Croatian: Lijek se koristi kod odraslih bolesnika koji ne podnose ili ne smiju uzimati lijekove za srce koji se zovu betablokatori.
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).
Croatian: Ivabradin je indiciran samo za simptomatsko liječenje kronične stabilne angine pektoris jer nema koristi kod kardiovaskularnih ishoda (npr. infarkt miokarda ili kardiovaskularna smrtnost) (vidjeti dio 5.1).
English: Ivabradine Accord with food and drink Avoid grapefruit juice during treatment with Ivabradine Accord.
Croatian: Ivabradin Accord s hranom i pićem Tijekom liječenja s Ivabradin Accordom izbjegavajte konzumiranje soka od grejpa.
English: Ivabradine Accord mainly works by reducing the heart rate by a few beats per minute.
Croatian: Ivabradin Accord poglavito djeluje smanjivanjem srčane frekvencije za nekoliko otkucaja u minuti.
English: Lack of benefit on clinical outcomes in patients with symptomatic chronic stable angina pectoris
Croatian: Nedostatak koristi kod kliničkih ishoda u bolesnika sa simptomima kronične stabilne angine pektoris
English: In a 97-patient randomised placebo-controlled study, the data collected during specific ophthalmologic investigations, aiming at documenting the function of the cone and rod systems and the ascending visual pathway (i.e. electroretinogram, static and kinetic visual fields, colour vision, visual acuity), in patients treated with ivabradine for chronic stable angina pectoris over 3 years, did not show any retinal toxicity.
Croatian: U randomiziranom, placebom kontroliranom ispitivanju na 97 bolesnika, podaci prikupljeni tijekom specifičnih oftalmoloških pretraga, s ciljem utvrđivanja funkcije sustava ćunjića i štapića te ascendentnog vidnog puta (npr. elektroretinogram, statička i kinetička perimetrija, opažanje boja, oštrina vida), nisu ukazali na toksično djelovanje ivabradina na mrežnicu kod bolesnika sa kroničnom stabilnom anginom pektoris liječenih tijekom 3 godine.
English: Talk to your doctor if you are breast-feeding or intending to breastfeed as breastfeeding should be discontinued if you take Ivabradine Accord.
Croatian: Obavijestite svog liječnika ukoliko dojite ili planirate dojiti budući da se dojenje treba obustaviti ukoliko uzimate Ivabradin Accord.
English: Use in patients with a low heart rate
Croatian: Primjena u bolesnika s niskom srčanom frekvencijom
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.
Croatian: Randomizirano, dvostruko slijepo, placebo kontrolirano ispitivanje provedeno je na 116 pedijatrijskih bolesnika (17 bolesnika starosti [6-12] mjeseci, 36 bolesnika starosti [1-3] godine i 63 bolesnika starosti [3-18] godina) s kroničnim zatajenjem srca i dilatativnom kardiomiopatijom (DKM) koji su primali uobičajenu terapiju.
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.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja ivabradin filmom obloženih tableta u svim podskupinama pedijatrijske populacije u liječenju angine pektoris i koronarne arterijske bolesti.
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.
Croatian: Nisu istraženi dugotrajni učici ivabradina na rast, pubertet i opći razvoj kao ni dugotrajna učinkovitost liječenja ivabradinom u djetinjstvu na smanjenje kardiovaskularnog pobola ni smrtnosti.
English: Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle spasms, changes in laboratory parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.
Croatian: Osjećaj lupanja srca i neuobičajeni otkucaji srca, osjećaj slabosti (mučnina), zatvor, proljev, bol u trbuhu, osjećaj vrtnje (vrtoglavica), poteškoće u disanju (dispneja), Spazmi mišića i promjene u laboratorijskim pretragama: visoka razina mokraćne kiseline u krvi, prekomjeran broj eozinofila (vrsta bijelih krvnih stanica) i povišena razina kreatinina u krvi (nastaje zbog raspada mišića), kožni osip, angioedem (kao npr. oticanje lica, jezika ili grla, poteškoće u disanju ili gutanju), niski krvni tlak, gubitak svijesti, osjećaj umora, osjećaj slabosti, abnormalni nalaz EKG-a, dvoslike, oštećen vid.
English: Ivabradine Accord may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Croatian: Ivabradin Accord može uzrokovati privremene vidne poremećaje (prolazna povećana svjetlost u ograničenom dijelu vidnoga polja), (vidjeti dio 4 “Moguće nuspojave”).
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.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja ivabradin filmom obloženih tableta u djece starosti do 6 mjeseci u liječenju kroničnog zatajenja srca.
English: Ivabradine Accord is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Croatian: Ivabradin Accord je lijek za srce koji se primjenjuje u liječenju: - Simptomatske stabilne angine pektoris (koja je karakterizirana pojavom bolova u prsnom košu) u odraslih bolesnika koji imaju puls jednak ili veći od 70 otkucaja u minuti.
English: Severe hepatic insufficiency
Croatian: Teška insuficijencija jetre
English: If you stop taking Ivabradine Accord:
Croatian: Ako prestanete uzimati Ivabradin Accord:
English: The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial conducted in 6505 adult patients with stable chronic CHF (for  4 weeks), NYHA class II to IV, with a reduced left ventricular ejection fraction (LVEF  35%) and a resting heart rate  70 bpm.
Croatian: Ispitivanje SHIFT, veliko multicentrično, međunarodno, randomizirano, dvostruko slijepo, placebo kontrolirano ispitivanje ishoda, provedeno je na 6505 odraslih bolesnika sa stabilnim kroničnim zatajenjem srca (s trajanjem  4 tjedana), NYHA stupanj II-IV, sa smanjenom ejekcijskom frakcijom lijeve klijetke (LVEF  35%) i srčanom frekvencijom u mirovanju  70/min.
English: INFORMATION IN BRAILLE Ivabradine Accord 5 mg
Croatian: PODACI NA BRAILLEOVOM PISMU Ivabradin Accord 5 mg
English: A large dose of Ivabradine Accord could make you feel breathless or tired because your heart slows down too much.
Croatian: Velika doza Ivabradin Accorda mogla bi djelovati tako da osjećate umor ili nedostatak zraka jer je došlo do usporenja rada srca.
English: Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes.
Croatian: 1% bolesnika mijenjalo je zbog poremećaja vida svoj dnevni ritam i prekinulo liječenje.
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).
Croatian: Treba izbjegavati primjenu ivabradina u bolesnika s QT-sindromom ili onih koji se liječe s pripravcima koji produljuju QT-interval (vidjeti dio 4.5).
English: Urticaria, itching, skin reddening, feeling unwell.
Croatian: Urtikarija (koprivnjača), svrbež, crvenilo kože, opće loše osjećanje.
English: Do not take Ivabradine Accord if you are pregnant or are planning to have a baby (see “Do not take Ivabradine Accord”).
Croatian: Ne uzimajte Ivabradin Accord ako ste trudni ili planirate imati dijete (vidjeti “Nemojte uzimati Ivabradin Accord”).
English: A large outcome study, BEAUTIFUL, was performed in 10917 patients with coronary artery disease and left ventricular dysfunction (LVEF<40%) on top of optimal background therapy with 86.9% of patients receiving beta-blockers.
Croatian: Veliko ispitivanje BEAUTIFUL, provedeno je na 10 917 bolesnika s koronarnom arterijskom bolešću i disfunkcijom lijeve klijetke (LVEF < 40%) koji su primali uobičajenu terapiju, i od kojih je 86,9% bolesnika primalo beta blokatore.
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
English: Ivabradine must not be initiated in patients with a pre-treatment resting heart rate below 70 beats per minute (see section 4.3).
Croatian: Ivabradin se ne smije primjenjivati u bolesnika u kojih je prije liječenja srčana frekvencija u mirovanju sporija od 70 otkucaja u minuti (vidjeti dio 4.3).
English: If you forget to take Ivabradine Accord:
Croatian: Ako ste zaboravili uzeti Ivabradin Accord:
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.
Croatian: - Umjereni CYP3A4 inhibitori: istovremena primjena ivabradina s drugim umjerenim CYP3A4 inhibitorima (npr. flukonazol) je moguća uz početnu dozu od 2,5 mg dva puta na dan, te ako je srčana frekvencija u mirovanju veća od 70/min te uz praćenje frekvencije srca.
English: Do not take Ivabradine Accord if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Ivabradine Accord”).
Croatian: Nemojte uzimati Ivabradin Accord ako možete zatrudnijeti osim ako koristite pouzdanu kontracepciju (vidjeti „Nemojte uzimati Ivabradin Accord”).