FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of bradycardia with poor haemodynamic tolerance, symptomatic treatment including intravenous betastimulating medicinal products such as isoprenaline may be considered.
Danish: Hvis der optræder bradykardi med dårlig hæmodynamisk tolerans, kan symptomatisk behandling, inklusive intravenøs behandling med β-stimulerende lægemidler som fx isoprenalin, overvejes.
English: Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy - France
Danish: Fremstilleren Les Laboratoires Servier 905 route de Saran F-45520 Gidy Frankrig
English: No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/min (see section 5.2).
Danish: Dosisjustering er ikke nødvendig til patienter med nyreinsufficiens og kreatininclearance over 15 ml/min (se pkt.
English: - Chronic heart failure in adult patients whose heart rate is over or equal to 75 beats per minute.
Danish: - Kronisk hjertesvigt hos voksne patienter med en puls på mindst 75 slag i minuttet.
English: - The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, colloidal anhydrous silica (E 551), and in the tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172).
Danish: Øvrige indholdsstoffer: lactosemonohydrat, magnesiumstearat (E 470 B), majsstivelse, maltodextrin, kolloid vandfri silica (E 551) og i tabletovertrækket: hypromellose (E 464), titandioxid (E 171), macrogol 6000, glycerol (E 422), magnesiumstearat (E 470 B), gul jernoxid (E 172) og rød jernoxid (E 172).
English: The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
Danish: De almindeligste symptomer på hjertesvigt er åndenød, træthed, udmattelse og hævede ankler.
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.
Danish: De kardiale virkninger er specifikke for sinusknuden og uden effekt på hverken de intra-atriale, atrioventrikulære eller intraventrikulære overledningstider eller på den myokardiale kontraktilitet eller den ventrikulære repolarisering.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: INFORMATION IN BRAILLE CORLENTOR 5 mg
Danish: INFORMATION I BRAILLESKRIFT CORLENTOR 5 mg
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.
Danish: - Nedsat leverfunktion: Hos patienter med let leverinsufficiens (Child-Pugh Score op til 7) var AUC for ubundet ivabradin og dets aktive hovedmetabolit ca. 20 % større end hos patienter med normal leverfunktion.
English: Precautions for use
Danish: Forsigtighedsregler ved anvendelsen
English: Ivabradine has low affinity for CYP3A4, shows no clinically relevant CYP3A4 induction or inhibition and is therefore unlikely to modify CYP3A4 substrate metabolism or plasma concentrations.
Danish: Ivabradin har lav affinitet til CYP3A4, viser ingen klinisk relevant induktion eller hæmning af CYP3A4- og vil derfor sandsynligvis ikke modificere metabolismen af CYP3A4substrater eller deres plasmakoncentrationer.
English: Women of child-bearing potential should use appropriate contraceptive measures during treatment (see section 4.3).
Danish: Kvinder i den fertile alder Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen (se pkt.
English: Treatment of chronic heart failure
Danish: Behandling af kronisk hjerteinsufficiens
English: Corlentor may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Danish: Corlentor kan forårsage forbigående lysfænomener (forbigående lysglimt i synsfeltet, se under ”Bivirkninger”).
English: Efficacy was confirmed with 7.5 mg twice daily.
Danish: Effekten blev bekræftet med 7,5 mg to gange daglig.
English: Ivabradine is extensively metabolised by the liver and the gut by oxidation through cytochrome P450 3A4 (CYP3A4) only.
Danish: Ivabradin undergår en omfattende metabolisering i leveren og tarmen ved oxidation, udelukkende ved hjælp af cytokrom P450 3A4 (CYP3A4).
English: Moderate CYP3A4 inhibitors: specific interaction studies in healthy volunteers and patients have shown that the combination of ivabradine with the heart rate reducing agents diltiazem or verapamil resulted in an increase in ivabradine exposure (2 to 3 fold increase in AUC) and an additional heart rate reduction of 5 bpm.
Danish: Moderate CYP3A4-hæmmere: specifikke interaktionsstudier hos raske frivillige og patienter har vist, at kombinationen af ivabradin med de hjertefrekvenssænkende stoffer diltiazem eller verapamil medførte en øgning af eksponeringen overfor ivabradin (to til tre gange øgning af AUC) samt en yderligere reduktion af hjertefrekvensen på 5 slag/min.
English: Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate.
Danish: Ivabradin er et rent hjertefrekvenssænkende stof, som virker ved selektiv og specifik hæmning af den kardiale pacemaker If jonkanalstrøm, som kontrollerer den spontane, diastoliske depolarisering i sinusknuden og regulerer hjertefrekvensen.
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.
Danish: SHIFT-studiet var et stort multicenter, internationalt, randomiseret dobbeltblindt placebokontrolleret resultatstudie, der omfattede 6.505 voksne patienter med stabil kronisk hjerteinsufficiens (i ≥ 4 uger), NYHA-klasse II-IV, med nedsat venstre ventrikels uddrivningsfraktion (LVEF ≤ 35 %) og hvilepuls ≥ 70 slag i minuttet.
English: Inversely, potent inhibitors and inducers may substantially affect ivabradine plasma concentrations (see section 4.5).
Danish: Omvendt kan stærke hæmmere og induktorer påvirke plasmakoncentrationerne af ivabradin i betydeligt omfang (se pkt.
English: It is recommended to regularly clinically monitor ivabradine treated patients for the occurrence of atrial fibrillation (sustained or paroxysmal), which should also include ECG monitoring if clinically indicated (e.g. in case of exacerbated angina, palpitations, irregular pulse).
Danish: Det anbefales, at patienter, som behandles med ivabradin, kontrolleres regelmæssigt for atrieflimren (kronisk eller paroksystisk), inklusive ekg-registrering, hvis klinisk nødvendigt (fx i tilfælde af accelereret angina, palpitationer eller uregelmæssig puls).
English: Angina is more likely to happen when the heart beats faster in situations such as exercise, emotion, exposure to the cold or after eating.
Danish: Hjertekrampe optræder hyppigere i situationer, hvor hjertet slår hurtigere fx under arbejde, ved sindsbevægelser, udsættelse for kulde eller efter spisning.
English: Increased plasma concentrations of ivabradine may be associated with the risk of excessive bradycardia (see section 4.4).
Danish: Øget plasmakoncentration af ivabradin kan ledsages af risiko for kraftig bradykardi (se pkt.
English: - CYP3A4 inducers: CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, Hypericum perforatum [St John's Wort]) may decrease ivabradine exposure and activity.
Danish: - CYP3A4-induktorer: CYP3A4-induktorer (fx rifampicin, barbiturater, phenytoin, Hypericum perforatum [perikon]) kan nedsætte eksponeringen over for ivabradin og aktiviteten af ivabradin.
English: A MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co. Wicklow, Ireland Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Danish: Les Laboratoires Servier Industrie, 905, route de Saran - F-45520 Gidy, Frankrig Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co. Wicklow, Irland Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
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.
Danish: I et større studie, BEAUTIFUL, der omfattede 10.917 patienter med koronararteriesygdom og dysfunktion af venstre ventrikel (LVEF <40 %), blev ivabradin givet sammen med optimal igangværende behandling, hvor 86,9 % af patienterne fik β-blokkere.
English: INFORMATION IN BRAILLE CORLENTOR 7.5 mg
Danish: INFORMATION I BRAILLESKRIFT CORLENTOR 7,5 mg
English: In this study, the antianginal and anti-ischaemic benefits of ivabradine were confirmed in patients aged 65 years or more.
Danish: I dette studie blev ivabradins positive effekt på angina pectoris og iskæmi bekræftet hos patienter på 65 år og derover.
English: Do not take Corlentor if you are pregnant or are planning to have a baby (see “Do not take Corlentor”).
Danish: De må ikke tage Corlentor, hvis De er gravid eller planlægger at blive gravid (se under ”Tag ikke Corlentor”).
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.
Danish: Den sædvanlige startdosis er en Corlentortablet på 5 mg to gange daglig, og den kan om nødvendigt øges til en Corlentortablet på 7,5 mg to gange daglig.
English: Glycerol (E 422) Magnesium stearate (E 470 B) Yellow iron oxide (E172) Red iron oxide (E172)
Danish: Glycerol (E422) Magnesiumstearat (E470 B) Gul jernoxid (E172) Rød jernoxid (E172)
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 Corlentor 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Danish: I nogle tilfælde (fx hvis De er ældre) kan Deres læge halvere dosis, dvs. en halv Corlentor-tablet på 5 mg (svarende til 2,5 mg ivabradin) om morgenen og en halv tablet på 5 mg om aftenen.
English: The study showed no difference in the rate of the primary composite endpoint (PCE) in the ivabradine group by comparison to the placebo group (relative risk ivabradine/placebo 1.08, p=0.197).
Danish: Studiet viste ingen forskel for det primære sammensatte effektmål (PCE) i ivabradingruppen sammenlignet med placebogruppen (relativ risiko ivabradin/placebo 1,08, p=0,197).
English: The study showed no difference in the rate of the primary composite outcome in the ivabradine group by comparison to the placebo group (relative risk ivabradine:placebo 1.00, p=0.945).
Danish: Studiet viste ingen forskel i det primære sammensatte effektmål ved sammenligning af ivabradingruppen og placebogruppen (relativ risiko for ivabradin:placebo 1,00; p=0,945).
English: Reproductive toxicity studies showed no effect of ivabradine on fertility in male and female rats.
Danish: Reproduktionstoksikologiske studier viste ingen effekt af ivabradin på fertiliteten hos han- og hunrotter.
English: Ivabradine efficacy was fully maintained throughout the 3- or 4-month treatment periods in the efficacy trials.
Danish: I effektstudierne opretholdtes den fulde effekt af ivabradin under hele behandlingsforløbet på 3-4 måneder.
English: The usual recommended starting dose of ivabradine is 5 mg twice daily.
Danish: Den normalt anbefalede initialdosis er 5 mg ivabradin to gange dagligt.
English: Caution should be exercised when using ivabradine in patients with moderate hepatic impairment.
Danish: Der bør udvises forsigtighed ved anvendelse af ivabradin til patienter med moderat leverinsufficiens.
English: Combination with calcium channel blockers
Danish: Kombination med calciumantagonister
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).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Corlentor i en eller flere undergrupper af den pædiatriske population med kronisk hjerteinsufficiens (se pkt.
English: Ventricular extrasystoles Atrial fibrillation
Danish: Ventrikulære ekstrasystoler Atrieflimren
English: Österreich Servier Austria GmbH Tel: +43 (1) 524 39 99
Danish: Servier Austria GmbH Tel: +43 (1) 524 39 99
English: Lactose monohydrate Magnesium stearate (E 470 B) Maize starch
Danish: Lactosemonohydrat Magnesiumstearat (E470 B) Majsstivelse
English: Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5).
Danish: Anvendelse af ivabradin hos patienter med kongenit QT-syndrom eller hos patienter, som behandles med QT-forlængende lægemidler, skal undgås (se pkt.
English: Rare: Urticaria, itching, skin reddening, feeling unwell.
Danish: Sjælden: Nældefeber, kløe, rødme af huden, utilpashed.
English: Heart rate reduction, as caused by ivabradine, may exacerbate QT prolongation, which may give rise to severe arrhythmias, in particular Torsade de pointes.
Danish: Nedsat hjertefrekvens, forårsaget af ivabradin, kan forværre QT-forlængelse, hvilket kan give anledning til svære arytmier, især torsades de pointes.
English: No dose adjustment is required in patients with mild hepatic impairment.
Danish: Dosisjustering er ikke nødvendig til patienter med mild leverinsufficiens.
English: Ivabradine may cause transient luminous phenomena consisting mainly of phosphenes (see section 4.8).
Danish: Ivabradin kan forårsage forbigående lysfænomener, hovedsageligt omfattende fosfener (se pkt.
English: The intake of St John's Wort should be restricted during the treatment with ivabradine.
Danish: Indtagelse af perikon skal begrænses under behandling med ivabradin.
English: Use in patients with a low heart rate
Danish: Anvendelse til patienter med lav hjertefrekvens
English: Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction.
Danish: Behandlingen skal stoppes, hvis hjertefrekvensen forbliver under 50 slag/min, eller symptomer på bradykardi persisterer på trods af dosisreduktion.
English: Do not throw away any medicine via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Therefore, ivabradine is contra-indicated during pregnancy (see section 4.3).
Danish: Ivabradin er derfor kontraindiceret under graviditet (se pkt.
English: Ivabradine can interact also with the retinal current Ih which closely resembles cardiac If.
Danish: Ivabradin kan interagere med den retinale jonkanalstrøm Ih, som ligner den kardiale If meget.
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.
Danish: Hos patienter på 75 år og derover, bør det overvejes at starte med en lavere dosis hos disse patienter (2,5 mg to gange daglig, dvs. en halv 5 mg tablet to gange daglig), før dosis om nødvendigt øges.
English: Measurement of heart rate
Danish: Måling af hjertefrekvens
English: Corlentor (ivabradine) 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.
Danish: Corlentor (ivabradin) er hjertemedicin, som anvendes til behandling af: - Symptomerne ved stabil angina pectoris (en lidelse, som forårsager smerter i brystet) hos voksne patienter med en puls på mindst 70 slag i minuttet.
English: The combination of ivabradine 10 mg twice daily with St John's Wort was shown to reduce ivabradine AUC by half.
Danish: Det er vist, at kombinationen af 10 mg ivabradin to gange daglig med perikon nedsætter ivabradin-AUC til det halve.
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].
Danish: I en puljet analyse af alle fase II/III-dobbeltblindede kontrollerede kliniske studier med en varighed på mindst 3 måneder, der inkluderede flere end 40.000 patienter, var incidensen af atrieflimren 4,86% hos ivabradinbehandlede patienter sammenlignet med 4,08% i kontrolgruppen, svarende til en hazard ratio på 1,26, 95% KI [1,15-1,39].
English: No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers such as amlodipine.
Danish: Der er ikke sat spørgsmålstegn ved sikkerheden af ivabradin i kombination med nitratpræparater og dihydropyridin-calciumantagonister som fx amlodipin.
English: A significant effect was observed on the primary composite endpoint in the overall group of patients receiving beta blocker therapy (hazard ratio: 0.85, 95%CI [0.76;0.94]).
Danish: Der sås en signifikant virkning på det primære sammensatte endepunkt i den totale gruppe af patienter, der fik betablokkerbehandling (hazard ratio: 0,85; 95 % KI [0,76;0,94]).
English: (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os,
Danish: itraconazol), makrolidantibiotika (clarithromycin, erythromycin per os, josamycin, telithromycin),
English: ECG prolonged QT interval * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Danish: Ikke almindelig Forhøjet kreatinin i blodet Forlænget QT-interval i ekg * Hyppighed for spontant indberettede bivirkninger beregnet på grundlag af kliniske forsøg
English: The concomitant use of potent CYP3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contra-indicated (see section 4.3).
Danish: Samtidig anvendelse af stærke CYP3A4-hæmmere som fx azol-antimykotika (ketoconazol, itraconazol), makrolidantibiotika (clarithromycin, erythromycin per os, josamycin, telithromycin), hiv proteasehæmmere (nelfinavir, ritonavir) og nefazodon er kontraindiceret (se pkt.
English: Luminous phenomena (phosphenes)
Danish: Meget almindelig Lysfænomen (fosfener, fotopsier) Almindelig
English: Luminous phenomena (phosphenes) are described as a transient enhanced brightness in a limited area of the visual field (see section 4.8).
Danish: Lysfænomenerne (fosfener) beskrives som et forbigående lysglimt i en begrænset del af synsfeltet (se pkt.
English: The concomitant use of ivabradine with these medicinal products is contraindicated (see section 4.3).
Danish: Samtidig anvendelse af ivabradin og disse lægemidler er kontraindiceret (se pkt.
English: Ivabradine was shown not to influence the metabolism and plasma concentrations of other CYP3A4 substrates (mild, moderate and strong inhibitors).
Danish: Det er påvist, at ivabradin ikke påvirker metabolismen og plasmakoncentrationerne af andre CYP3A4substrater (svage, moderate og stærke hæmmere).
English: Furthermore as elevated heart rate adversely affects the heart functioning and vital prognosis in patients with chronic heart failure, the specific heart rate lowering action of ivabradine helps to improve the heart functioning and vital prognosis in these patients.
Danish: Eftersom hurtig puls påvirker hjertefunktion og forventet levetid negativt hos patienter med kronisk hjertesvigt, er ivabradins evne til at nedsætte pulsen med til at forbedre hjertefunktionen og levetiden hos disse patienter.
English: The starting dose should not exceed one tablet of Corlentor 5 mg twice daily.
Danish: Startdosis bør ikke være mere end en Corlentor-tablet på 5 mg to gange dagligt.
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.
Danish: Ved trigning (fx hurtig ændring i lysstyrken), skyldes de lysfænomener, som lejlighedsvis opleves af patienterne, ivabradins partielle hæmning af Ih .
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).
Danish: Høj eksponering over for ivabradin, som kan indtræffe, hvis ivabradin gives i kombination med kraftige CYP3A4-hæmmere, kan medføre et meget stort fald i hjertefrekvensen, selvom denne risiko er nedsat med moderate CYP3A4-hæmmere (se pkt.
English: If you are pregnant and have taken Corlentor, talk to your doctor.
Danish: Tal med Deres læge, hvis De er gravid og har taget Corlentor.
English: Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.
Danish: Symptomatisk behandling af kronisk stabil angina pectoris Ivabradin er indiceret til symptomatisk behandling af kronisk stabil angina pectoris hos voksne med koronararteriesygdom og normal sinusrytme og hjertefrekvens ≥ 70 slag i minuttet.
English: A large outcome study, SIGNIFY, was performed in 19102 patients with coronary artery disease and without clinical heart failure (LVEF > 40%), on top of optimal background therapy.
Danish: Der blev udført et stort outcome-studie, SIGNIFY, der omfattede 19.102 patienter med koronararteriesygdom og uden klinisk hjerteinsufficiens (LVEF > 40 %) i optimal igangværende behandling.
English: In a 889-patients randomised placebo-controlled study, ivabradine given on top of atenolol 50 mg o.d. showed additional efficacy on all ETT parameters at the trough of drug activity (12 hours after oral intake).
Danish: I et randomiseret, placebokontrolleret studie, som omfattede 889 patienter, blev ivabradin givet sammen med atenolol 50 mg en gang dagligt, og der sås øget effekt på alle parametre i en arbejdstolerancetest ved trough-niveauet for lægemidlets virkning (12 timer efter oral indgift).
English: Treatment with ivabradine was associated with an average reduction in heart rate of 15 bpm from a baseline value of 80 bpm.
Danish: Ivabradinbehandling medførte en gennemsnitlig reduktion i hjertefrekvensen på 15 slag i minuttet fra en baselineværdi på 80 slag i minuttet.
English: After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension.
Danish: Efter to ugers behandling kan dosis øges til 7,5 mg to gange dagligt, hvis hjertets hvilefrekvens er over 60 slag i minuttet, eller reduceres til 2,5 mg to gange dagligt (½ tablet a 5 mg to gange dagligt), hvis hvilefrekvensen vedvarende er under 50 slag i minuttet eller ved symptomer som svimmelhed, træthed eller hypotension på grund af bradykardi.