FrancophonIA/ELRC3.0 huggingface dataset:
English: These studies have shown embryotoxic and teratogenic effects (see section 5.3).
Danish: Forsøgene viste embryotoksiske og teratogene virkninger (se pkt.
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.
Danish: Hos hund førte ivabradindoser på 2, 7 eller 24 mg/kg/dag i et år til observation af reversible forandringer i retinafunktionen, men var ikke forbundet med skader i okulære strukturer.
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB17.
Danish: Farmakoterapeutisk klassifikation: Hjerteterapi, andre hjertemidler, ATC-kode: C01EB17.
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.
Danish: Ivabradin udskilles med en hovedhalveringstid på 2 timer (70-75 % af AUC) i plasma og en effektiv eliminationshalveringstid på 11 timer.
English: If this happens to you, be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.
Danish: Hvis De får det, skal De udvise forsigtighed, når De kører bil eller betjener maskiner, specielt på tidspunkter, hvor der kan forekomme pludselige ændringer i lysintensiteten, især ved nattekørsel.
English: Luminous visual phenomena (brief moments of increased brightness, most often caused by sudden changes in light intensity).
Danish: Lysfænomener (kortvarige lysglimt, der ofte skyldes pludselige forandringer i lysets intensitet).
English: If the combination appears necessary, close cardiac monitoring is needed.
Danish: Hvis kombinationen er nødvendig, skal hjertefunktionen monitoreres omhyggeligt.
English: Concomitant use with precaution
Danish: Samtidig anvendelse med forsigtighed
English: Ivabradine is approximately 70% plasma protein bound and the volume of distribution at steady-state is close to 100 l in patients.
Danish: Ivabradin er ca. 70 % bundet til plasmaproteiner, og fordelingsvolumenet i steady-state er næsten 100 l hos patienter.
English: Ivabradine is the S-enantiomer with no bioconversion demonstrated in vivo.
Danish: Ivabradin er S-enantiomeren, og der er ikke påvist bioomdannelse in vivo.
English: They can also be described as a halo, coloured flashes, image decomposition or multiple images.
Danish: De kan også beskrives som en ring, farvede lysglimt, billedopløsning eller mangfoldige billeder.
English: The maximum plasma concentration following chronic administration at the recommended dose of 5 mg twice daily is 22 ng/ml (CV=29%).
Danish: Den maksimale plasmakoncentration efter kronisk administration i den anbefalede dosis på 5 mg to gange daglig er ca. 22 ng/ml (CV = 29%).
English: Modification in the heart functioning (the symptoms are a slowing down of the heart rate).
Danish: Forandringer i hjertets funktion (viser sig ved, at pulsen bliver langsommere).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Les Laboratoires Servier
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Les Laboratoires Servier
English: At usual recommended doses, heart rate reduction is approximately 10 bpm at rest and during exercise.
Danish: I de normalt anbefalede doser er reduktionen af hjertefrekvensen ca. 10 slag/min i hvile og under arbejde.
English: It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker.
Danish: Det anvendes også i kombination med betablokkere til voksne patienter, hvis sygdom ikke er fuldstændigt kontrolleret med en betablokker.
English: Phosphenes may also be described as a halo, image decomposition (stroboscopic or kaleidoscopic effects), coloured bright lights, or multiple image (retinal persistency).
Danish: Fosfener kan også beskrives som en ring, billeddekomposition (stroboskopiske eller kaleidoskopiske effekter), farvet, stærkt lys eller multipel billeddannelse (retinal persistens).
English: Date of latest renewal: 25/10/2010
Danish: Dato for første markedsføringstilladelse: 25. oktober 2005 Dato for seneste fornyelse: 25 oktober 2010
English: Ivabradine is contra-indicated in patients with severe hypotension (blood pressure < 90/50 mmHg) (see section 4.3).
Danish: Ivabradin er kontraindiceret til patienter med svær hypotension (blodtryk < 90/50 mmHg) (se pkt.
English: No influence on glucose or lipid metabolism was observed.
Danish: = Der blev ikke set påvirkning af glukose- eller lipidmetabolismen.
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.
Danish: Lysfænomener (fosfener) rapporteredes af 14,5 % af patienterne, som beskrev dem som et forbigående lysglimt i en begrænset del af synsfeltet.
English: If you are being treated for chronic heart failure
Danish: Hvis De bliver behandlet for kronisk hjertesvigt
English: It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers.
Danish: Det anvendes til voksne patienter, som ikke kan tåle eller ikke kan anvende hjertemedicin af typen betablokkere.
English: Ivabradine is rapidly and almost completely absorbed after oral administration with a peak plasma level reached in about 1 hour under fasting condition.
Danish: Ivabradin absorberes hurtigt og næsten fuldstændigt efter oral administration, og peakplasmakoncentrationen nås inden for ca. 1 time under fastende betingelser.
English: Grapefruit juice: ivabradine exposure was increased by 2-fold following the co-administration with grapefruit juice.
Danish: Grapefrugtjuice: Eksponeringen for ivabradin blev øget med en faktor 2 ved samtidig indtagelse af grapefrugtjuice.
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).
Danish: I de kliniske studier er der rapporteret om følgende bivirkninger, som er opstillet efter hyppighed i henhold til denne konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In the SIGNIFY study atrial fibrillation was observed in 5.3% of patients taking ivabradine compared to 3.8% in the placebo group.
Danish: I SIGNIFY-studiet blev der observeret atrieflimren hos 5,3% af de patienter, der tog ivabradin sammenlignet med 3,8% i placebogruppen.
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.
Danish: Analyse af PK/PD-forholdet har vist, at hjertefrekvensen falder næsten lineært med stigende plasmakoncentrationer af ivabradin og S 18982 i doser op til 15-20 mg to gange daglig.
English: Stable angina is a heart disease which happens when the heart does not receive enough oxygen.
Danish: Stabil hjertekrampe er en hjertesygdom, som opstår, når hjertet ikke får tilstrækkeligt med ilt.
English: D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
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.
Danish: Ivabradin bør anvendes med forsigtighed hos patienter med hjerteinsufficiens af NYHA-klasse IV, da der kun foreligger begrænsede data for denne population.
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.
Danish: Eftersom hjertefrekvensen kan variere betydeligt over tid, bør seriemålinger af hjertefrekvensen, ekg eller ambulant 24-timers monitorering overvejes ved bestemmelse af hjertefrekvensen i hvile før initiering af ivabradinbehandlingen samt hos patienter i ivabradinbehandling, når titrering overvejes.
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).
Danish: Dette gælder også for patienter med lav hjertefrekvens, især hvis hjertefrekvensen falder til under 50 slag/min, eller efter dosisreduktion (se pkt.
English: Data are insufficient to draw conclusions in patients with moderate hepatic impairment.
Danish: Der er ikke tilstrækkelige data til at trække konklusioner hos patienter med moderat leverinsufficiens.
English: Contra-indication of concomitant use
Danish: Kontraindikationer for samtidig anvendelse
English: The main pharmacodynamic property of ivabradine in humans is a specific dose dependent reduction in heart rate.
Danish: Den vigtigste farmakodynamiske egenskab af ivabradin hos mennesker er en specifik dosisafhængig reduktion af hjertefrekvensen.
English: The major active metabolite is the N-desmethylated derivative (S 18982) with an exposure about 40% of that of the parent compound.
Danish: Den aktive hovedmetabolit er N-demethylderivatet (S 18982) med en eksponering på ca. 40 % af moderstoffets eksponering.
English: As ivabradine may cause bradycardia, the resulting combination of hypokalemia and bradycardia is a predisposing factor to the onset of severe arrhythmias, especially in patients with long QT syndrome, whether congenital or substance-induced.
Danish: Da ivabradin kan medføre bradykardi, er den resulterende kombination af hypokaliæmi og bradykardi en prædisponerende faktor til svære arytmier, især hos patienter med langt QT-syndrom, hvad enten det er kongenitalt eller lægemiddel-induceret.
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.
Danish: De almindeligste bivirkninger ved ivabradin - lysfænomener (fosfener, fotopsier) og bradykardi - er dosisafhængige og relateret til lægemidlets farmakologiske effekt.
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 %).
Danish: Hvad angår det primære endepunkt, skyldes resultatet især komponenterne hjerteinsufficiens i form af indlæggelse på grund af tiltagende hjerteinsufficiens (absolut risikoreduktion 4,7 %) og død på grund af hjerteinsufficiens (absolut risikoreduktion 1,1 %).
English: If atrial fibrillation develops during treatment, the balance of benefits and risks of continued ivabradine treatment should be carefully reconsidered.
Danish: Hvis der under behandlingen opstår atrieflimren, skal balancen mellem fordele og ulemper ved fortsat ivabradinbehandlingen overvejes nøje.
English: Irregular rapid contraction of the heart, abnormal perception of heartbeat, uncontrolled blood pressure, headache, dizziness and blurred vision (cloudy vision).
Danish: Uregelmæssig hurtig sammentrækning af hjertet, unormal fornemmelse af hjerteslag, ukontrolleret blodtryk, hovedpine, svimmelhed og uskarpt syn (uklart syn).
English: Patients received standard care including beta-blockers (89 %), ACE inhibitors and/or angiotensin II antagonists (91 %), diuretics (83 %), and anti-aldosterone agents (60 %).
Danish: Patienterne fik standardbehandling, der omfattede betablokkere (89 %), ACE-hæmmere og/eller angiotensin II-antagonister (91 %), diuretika (83 %) og aldosteronantagonister (60 %).
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
Danish: - Nedsat nyrefunktion: Påvirkningen af nedsat nyrefunktion (kreatininclearance fra 15 til 60 ml/min) på ivabradins farmakokinetik er minimal, sammenholdt med det lille bidrag af renal clearance (ca. 20 %) til den samlede elimination af både ivabradin og dets hovedmetabolit S 18982 (se pkt.
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.
Danish: Disse data er konsistente med den farmakologiske effekt af ivabradin, relateret til dets interaktion med hyperpolarisations-aktiverede Ih jonkanalstrømme i retina, som har omfattende fælles homologi med den kardiale pacemaker If jonkanalstrøm.
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.
Danish: Det er ikke dokumenteret, at der foreligger en risiko for (voldsom) bradykardi ved genoprettelse af sinusrytme efter indledning af farmakologisk kardiovertering hos patienter, der får ivabradin.
English: Phosphenes were generally reported to be of mild to moderate intensity.
Danish: Fosfener rapporteredes normalt som lette eller moderate i intensitet.
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.
Danish: Specielt blev den yderligere nytte i forhold til 5 mg to gange daglig dokumenteret i et reference-kontrolleret studie versus atenolol: den samlede arbejdsvarighed ved trough-koncentrationer var øget med ca. 1 minut efter en måneds behandling med 5 mg to gange daglig og yderligere forbedret med næsten 25 sek. efter yderligere 3 måneder med tvungen stigning til 7,5 mg to gange daglig.
English: About stable angina pectoris (usually referred to as “angina”):
Danish: Stabil angina pectoris (også kaldet ”hjertekrampe”):
English: Potassium-depleting diuretics (thiazide diuretics and loop diuretics): hypokalemia can increase the risk of arrhythmia.
Danish: Ikke-kaliumbesparende diuretika (thiazid-diuretika og loop-diuretika): Hypokaliæmi kan øge risikoen for arytmi.
English: The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years.
Danish: Startdosis af ivabradin bør ikke overskride 5 mg to gange dagligt hos patienter under 75 år.
English: The twice-daily dosing regimen of ivabradine gave uniform efficacy over 24 hours.
Danish: Et doseringsregime med to daglige doser ivabradin gav ensartede resultater i 24 timer.
English: The efficacy of 5 and 7.5 mg twice daily was consistent across studies on exercise test parameters (total exercise duration, time to limiting angina, time to angina onset and time to 1 mm ST segment depression) and was associated with a decrease of about 70% in the rate of angina attacks.
Danish: Effekten af 5 og 7,5 mg to gange daglig var konsistent i alle studier på arbejdstestparametre (samlet arbejdsvarighed, tid indtil limiterende angina, tid indtil start af angina og tid indtil 1 mm ST-segmentdepression) og var ledsaget af et fald på ca. 70 % i antallet af anginaanfald.
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Corlentor.
Danish: Tal med lægen, hvis De ammer eller ønsker at amme, da amning skal ophøre, hvis De tager Corlentor.
English: The difference in heart rate between ivabradine and placebo arms was 10.8 bpm at 28 days, 9.1 bpm at 12 months and 8.3 bpm at 24 months.
Danish: Forskellen i hjertefrekvens mellem ivabradin- og placeboarmen var 10,8 slag i minuttet efter 28 dage, 9,1 slag i minuttet efter 12 måneder og 8,3 slag i minuttet efter 24 måneder.
English: Atrial fibrillation has been more common in patients using concomitantly amiodarone or potent class I anti-arrhythmics.
Danish: Atrieflimren har været hyppigere hos patienter, der samtidigt tager amiodaron eller potente klasse I-antiarytmika.
English: 0.5% of patients experienced a severe bradycardia below or equal to 40 bpm.
Danish: 0,5 % af patienterne fik svær bradykardi under eller svarende til 40 slag/minut.
English: Analysis of heart rate reduction with doses up to 20 mg twice daily indicates a trend towards a plateau effect which is consistent with a reduced risk of severe bradycardia below 40 bpm (see section 4.8).
Danish: Analyser af hjertefrekvensreduktionen efter doser op til 20 mg to gange daglig tyder på en tendens til en plateaueffekt, som er konsistent med en nedsat risiko for svær bradykardi under 40 slag/min (se pkt.
English: and 45%), ivabradine did not have any deleterious influence on LVEF.
Danish: mellem 30 og 45 %) havde ivabradin ingen negativ indflydelse på LVEF.
English: The average plasma concentration is 10 ng/ml (CV=38%) at steady-state.
Danish: Den gennemsnitlige plasmakoncentration i steady-state er 10 ng/ml (CV = 38%).
English: Cytochrome P450 3A4 (CYP3A4)
Danish: CYP3A4 (Cytokrom P450 3A4)
English: This increase in heart rate can cause the chest pain in people who suffer from angina.
Danish: Denne øgning af hjertefrekvensen kan forårsage smerter i brystet hos personer, som lider af hjertekrampe.
English: What you need to know before you take Corlentor
Danish: Det skal De vide, før De begynder at tage Corlentor
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: De kan finde yderligere oplysninger om Corlentor på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Palpitations, supraventricular extrasystoles
Danish: Ikke almindelig Palpitationer, supraventrikulære ekstrasystoler
English: Ivabradine is contra-indicated for use in patients with severe hepatic insufficiency, since it has not been studied in this population and a large increase in systemic exposure is anticipated (see sections 4.3 and 5.2).
Danish: Ivabradin er kontraindiceret til patienter med svær leverinsufficiens, da det ikke er undersøgt hos denne population, og der forudses en stor stigning i systemisk eksponering (se pkt.
English: Do not take Corlentor if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Corlentor”).
Danish: Tag ikke Corlentor, hvis De kan blive gravid, medmindre De anvender sikker prævention (se ”Tag ikke Corlentor”).
English: Ivabradine is therefore not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.
Danish: Ivabradin kan derfor ikke anbefales til patienter med atrieflimren eller andre hjertearytmier, der påvirker sinusknudens funktion.
English: Silica, colloidal anhydrous (E 551)
Danish: Silica, kolloid vandfri (E551)
English: The reduction in the primary endpoint was observed consistently irrespective of gender, NYHA class, ischaemic or non-ischaemic heart failure aetiology and of background history of diabetes or hypertension.
Danish: Risikoreduktionen for det primære endepunkt forekom konsekvent uanset køn, NYHA-klasse, hjerteinsufficiens med/uden iskæmisk ætiologi og anamnese med diabetes eller hypertension.
English: If you stop taking Corlentor
Danish: Hvis De holder op med at tage Corlentor
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).
Danish: Der sås en signifikant forbedring i NYHA-klasse ved den sidst registrerede bestemmelse, hvor 887 patienter (28 %), der fik ivabradin, opnåede bedring versus 776 patienter (24 %), der fik placebo (p=0,001).
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).
Danish: Virkningen af ivabradin på angina pectoris og iskæmi blev undersøgt i fem dobbeltblinde randomiserede studier (tre versus placebo og et versus hhv. atenolol og amlodipin).
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.
Danish: Effekten af ivabradin på angina pectoris og iskæmi var bevaret hos diabetespatienter (n = 457) med samme sikkerhedsprofil som for hele populationen.
English: Symptoms Overdose may lead to severe and prolonged bradycardia (see section 4.8).
Danish: Symptomer Overdosering kan medføre svær og forlænget bradykardi (se pkt.
English: Ivabradine is metabolised by CYP3A4 only and it is a very weak inhibitor of this cytochrome.
Danish: Ivabradin metaboliseres kun af CYP3A4 og er en meget svag hæmmer af dette cytokrom.
English: A small statistically significant increase in the PCE was observed in a pre-specified subgroup of patients with angina patients in CCS class II or higher at baseline (n=12049) (annual rates 3.4% versus 2.9%, relative risk ivabradine/placebo 1.18, p=0.018), but not in the subgroup of the overall angina population in CCS class ≥ I (n=14286) (relative risk ivabradine/placebo 1.11, p=0.110).
Danish: En lille statistisk signifikant stigning i PCE blev observeret i en præ-specificeret subgruppe af patienter med angina pectoris i CCS-klasse II eller højere ved baseline (n=12.049) (årsrate 3,4% versus 2,9%, relativ risiko ivabradin/placebo 1,18, p=0,018), men ikke i subgruppen af den totale anginapopulation i CCS-klasse ≥ I (n=14.286) (relativ risiko ivabradin/placebo 1,11, p=0,110).
English: Other medicines and Corlentor
Danish: Brug af anden medicin sammen med Corlentor
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.
Danish: De stærkeCYP3A4-hæmmere ketoconazol (200 mg en gang daglig) og josamycin (1 g to gange daglig) øgede den gennemsnitlige plasmaeksponering for ivabradin 7-8 gange.
English: If you forget to take Corlentor
Danish: Hvis De har glemt at tage Corlentor
English: The effects on blood pressure and peripheral vascular resistance were minor and not clinically significant.
Danish: Der var kun mindre virkninger på blodtryk og perifer karmodstand uden klinisk signifikans.
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).
Danish: Når der foretages ændringer i behandlingen hos patienter med kronisk hjerteinsufficiens, der er i behandling med ivabradin, skal blodtrykket kontrolleres med passende intervaller (se pkt.
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect up to 1 in 10 people uncommon: may affect up to 1 in 100 people rare: may affect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Danish: Ikke almindelig: kan påvirke op til 1 ud af 100 mennesker Sjælden: kan påvirke op til 1 ud af 1.000 mennesker Meget sjælden: kan påvirke op til 1 ud af 10.000 mennesker Ikke kendt: kan ikke bedømmes ud fra forhåndenværende data
English: The concomitant use of CYP3A4 inducing medicinal products may require an adjustment of the dose of ivabradine.
Danish: Samtidig anvendelse af CYP3A4-induktorer kan nødvendiggøre dosisjustering af ivabradin.