FrancophonIA/ELRC3.0 huggingface dataset:
English: However, there is no available data regarding the efficacy of nicorandil repeated oral administration in patients with cardiac failure NYHA III-IV classes.
Danish: Der foreligger imidlertid ingen data om virkningen af gentagen oral administration af nicorandil til patienter med hjertesvigt af NYHA klasse III-IV.
English: Nicorandil may induce hyperkalaemia.
Danish: Nicorandil kan medføre hyperkaliæmi.
English: In addition one of the following was also in force: left ventricular hypertrophy on the ECG, left ventricular ejection fraction ≤45%, or an end diastolic dimension of >55mm, age ≥65, diabetes, hypertension, peripheral vascular disease, or cerebrovascular disease.
Danish: Desuden var der tale om følgende: EKG viste hypertrofi af venstre ventrikel, venstre ventrikel havde en uddrivningsfraktion ≤45 % eller et slutdiastolisk mål >55 mm, alder ≥65 år, diabetes, hypertension, perifer karsygdom eller cerebrovaskulær sygdom.
English: In summary the IONA study was a randomised, double blind, placebo controlled study carried out in 5126 patients more than 45 years old with chronic stable angina, treated with standard anti-anginal therapies and at high risk of cardiovascular events defined by either previous myocardial infarction, or coronary artery bypass grafting, or coronary artery disease confirmed by angiography, or a positive exercise test in the previous two years.
Danish: Sammenfattende var IONA-undersøgelsen en randomiseret, dobbeltblindet, placebokontrolleret undersøgelse hos 5 126 patienter på over 45 år med kronisk stabil angina, der blev behandlet med sædvanlige antianginøse midler og havde høj risiko for kardiovaskulære hændelser defineret som enten tidligere myokardieinfarkt, koronararterie-bypassoperation, angiografisk dokumenteret koronararteriesygdom, eller positiv motionstest inden for de foregående to år.
English: Available data on cardiovascular prevention may suggest a favourable effect of nicorandil in reducing cardiovascular risk, mainly by a reduction of hospitalisation.
Danish: De foreliggende data om kardiovaskulær forebyggelse kan tyde på en gunstig virkning af nicorandil til reduktion af kardiovaskulær risiko, navnlig i form af reduktion i antallet af indlæggelser.
English: Due to the divergent national decisions taken by Member States (MS) concerning the authorisation of Ikorel and its associated names and Dancor and its associated names, these products were included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, requested by the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh).
Danish: På grund af divergerende nationale afgørelser blandt medlemsstaterne om godkendelsen af Ikorel og relaterede navne samt Dancor og relaterede navne blev disse lægemidler optaget på listen over lægemidler til harmonisering af produktresuméet efter anmodning fra koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)).
English: Therefore a statement regarding the interaction with NSAIDs was recommended by the CHMP for this section of the SmPC, making also a cross reference to section 4.4.
Danish: CHMP anbefalede derfor en erklæring om interaktion med NSAID i dette punkt af produktresuméet, således at der også indsættes en krydshenvisning til punkt 4.4.
English: The objectives are to quantify the rates of ulceration in patients treated with nicorandil (including but not restricted to gastrointestinal, skin, ocular, mucosal, anal sites; alone or in multiple locations), as well as subsequent erosion, perforation, haemorrhage, abscess formation, fistulae and delayed wound healing in a real world setting; together with identification of high risk subgroups, other risk factors, and a dose and time effect assessment.
Danish: Målet er at kvantificere forekomsten af ulcerationer hos patienter, der behandles med nicorandil (herunder bl.a. gastrointestinale, dermale, okulære, mukosale og anale ulcerationer, enten isolerede eller med flere lokalisationer), samt efterfølgende erosion, perforation, blødning, abscesdannelse, fistler og forsinket sårheling under virkelige omstændigheder; hertil kommer udpegelse af højrisikoundergrupper og andre risikofaktorer og vurdering af doseringens og tidens indvirkning.
English: The overall action improves blood flow to post-stenotic regions and the oxygen balance in the myocardium.
Danish: Den samlede virkning forbedrer blodtilførslen til de poststenotiske områder og iltbalancen i myokardiet.
English: Efficacy in the clinical programme was based on the measurement of anginal attack rates on exercise tests.
Danish: I det kliniske program blev virkningen fastlagt ved det antal anginatilfælde, der blev udløst ved motionstest.
English: The Current Guidelines from the European Society of Cardiology (ESC) for the management of stable angina pectoris5 dated on 2013 provide the following recommendations for the use of nicorandil in pharmacological therapy to improve symptoms and/or reduce ischaemia in patients with stable angina:
Danish: De gældende retningslinjer fra European Society of Cardiology (ESC) for behandling af stabil angina pectoris5 fra 2013 indeholder følgende anbefalinger for brug af nicorandil til medikamentel symptomlindring og/eller mindskelse af iskæmi hos patienter med stabil angina:
English: In addition, beside a possible difference in response between Caucasian and Japanese (as regards to weight), most of the studies in view of which the 5 mg b.i.d.
Danish: Ud over en mulig forskel i respons mellem kaukasiske og japanske patienter (hvad angår vægt) er doseringen 5 mg to gange dagligt fastlagt på grundlag af undersøgelser, der hovedsagelig er åbne og ukontrollerede.
English: Furthermore, nicorandil has demonstrated a spasmolytic activity in both in vitro and in vivo studies and reverses coronary spasm induced by methacholine or noradrenalin.
Danish: Derudover har nicorandil vist spasmolytisk aktivitet både ved in vitro- og in vivo-undersøgelser og standser koronarspasme induceret af metakolin og noradrenalin.
English: However, the primary endpoint is weak as it includes the criterion “reduction of hospitalisation” which is subjective criteria for cardiovascular prevention in patient with coronary heart disease (CHD) patients with angina.
Danish: Det primære endepunkt er imidlertid svagt, da det indbefatter »reduktion i antallet af indlæggelser« som er et subjektivt kriterium for kardiovaskulær forebyggelse hos patienter med koronar hjertesygdom og angina.
English: Section 4.2 - Posology and Method of Administration
Danish: Punkt 4.2 - Dosering og administration
English: Overall, nicorandil shows moderate efficacy to improve exercise capacity versus placebo and seems to be comparable to other anti-anginal therapies.
Danish: Sammenlignet med placebo medfører nicorandil overordnet en moderat forbedring af den fysiske kapacitet og synes at være sammenligneligt med andre antianginøse midler.
English: Several clinical studies1,2,3,4 in patients with angina pectoris have shown that treatment with nicorandil 10 and 20 mg twice daily prolongs the time to onset of ischemia during exercise and the total exercise duration.
Danish: Flere kliniske undersøgelser1,2,3,4 hos patienter med angina pectoris har vist, at nicorandil 10 og 20 mg to gange dagligt forlænger tiden før indsættelsen af iskæmi udløst af fysisk aktivitet og den samlede fysiske aktivitetsvarighed.
English: However, the CHMP is of the view that the level of the oxidation process may not be clinically relevant as only a single case of methemoglobinemia
Danish: Det er dog CHMP's opfattelse, at oxidationsprocessen ikke nødvendigvis har et klinisk relevant omfang, da der kun er indberettet et enkelt tilfælde af methæmoglobinæmi ved anvendelse af nicorandil.
English: In addition to its anti-anginal properties, nicorandil is thought to have cardio protective properties.
Danish: Foruden antianginøse virkninger menes nicorandil at have hjertebeskyttende egenskaber.
English: Nicorandil has been shown to exert a direct effect on the coronary arteries, both on normal and stenotic segments, without leading to a steal phenomenon.
Danish: Nicorandil er påvist at have direkte virkning på koronararterierne, både normale og stenotiske afsnit, uden at medføre steal-fænomen.
English: This is in contrast to the dosing schedule in Japan where 5 mg b.i.d.
Danish: Dette står i modsætning til doseringsplanen i Japan, hvor 5 mg to gange dagligt er den anbefalede startdosis.
English: The IONA study was conducted at a time when the standard of care of managing patient with CHD was different from that of present times in terms of revascularisation, antianginal strategies etc., and does not allow a conclusion regarding the prevention of cardiovascular events for CHD patients with angina.
Danish: IONA-undersøgelsen blev udført på et tidspunkt, hvor standardbehandlingen af patienter med koronar hjertesygdom adskilte sig fra den nuværende, hvad angår revaskularisering, antianginøse strategier mv., og giver ikke mulighed for at drage en konklusion om forebyggelse af kardiovaskulære hændelser hos patienter med koronar hjertesygdom og angina.
English: In addition, two hemodynamic studies (SG 002 and EMD 034) studied hemodynamic effects of single oral doses of nicorandil (40 mg, 60 mg, 80 mg) in a total of 21 pharmacodynamically evaluable patients with severe heart failure (N.Y.H.A.
Danish: Der er desuden udført to undersøgelser (SG 002 og EMD 034) af de hæmodynamiske virkninger af en oral enkeltdosis af nicorandil (40 mg, 60 mg og 80 mg) hos i alt 21 farmakodynamisk
English: the CHMP was of the opinion that the benefit/risk ratio of Ikorel and associated names and Dancor and associated names is considered to be favourable.
Danish: anså CHMP benefit/risk-forholdet for at være positivt for Ikorel og relaterede navne samt Dancor og relaterede navne.
English: The CHMP adopted a positive opinion recommending the variation to the terms of the marketing authorisations for which the summary of products characteristics, labelling and package leaflet as set out in Annex III of the CHMP opinion for Ikorel and associated names and Dancor and associated names (see Annex I).
Danish: CHMP vedtog en positiv udtalelse, der anbefaler ændring af betingelserne for markedsføringstilladelsen for Ikorel og relaterede navne samt Dancor og relaterede navne, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III til CHMP's udtalelse (se bilag I).
English: Taking the above into account the CHMP was of the view that for the treatment of symptomatic stable angina, nicorandil should be considered in second line.
Danish: På denne baggrund var CHMP af den opfattelse, at nicorandil bør betragtes som andetvalgsbehandling til symptomatisk stabil angina.
English: NSAIDs can cause clinically important damage of the gastrointestinal tract, increasing the incidence of bleeding in the upper gastrointestinal tract and of perforation, although serious complications and death are relatively infrequent.
Danish: NSAID kan medføre klinisk betydningsfuld beskadigelse af mave-tarm-kanalen med øget tendens til blødning i den øvre del af mave-tarm-kanalen og perforation, skønt alvorlige komplikationer og dødsfald er forholdsvis sjældne.
English: The CHMP addressed a list of questions to the MAHs, pointing out the sections of the products SmPC where divergences existed.
Danish: CHMP stillede en række spørgsmål til indehaveren af markedsføringstilladelsen og udpegede de punkter i produktresuméet, hvor der var afvigelser.
English: Nicorandil was synthesised and developed by Chugai Pharmaceutical Co., Ltd in 1975 as a product producing coronary vasodilatation.
Danish: Nicorandil blev i 1975 syntetiseret og udviklet som en koronar vasodilator af Chugai Pharmaceutical Co., Ltd.
English: Nicorandil may also induce gastrointestinal ulceration, perforation and haemorrhage; therefore, the simultaneous administration of nicorandil with NSAIDs can increase the risk of gastrointestinal ulceration, perforation and haemorrhage due to a synergistic effect.
Danish: Nicorandil kan desuden bevirke gastrointestinal ulceration, perforation og blødning; samtidig administration af nicorandil og NSAID kan derfor øge risikoen for gastrointestinal ulceration, perforation og blødning som følge af synergistisk virkning.
English: In addition, the adverse events observed in post market experience outweigh the marginal benefit in prevention of cardiovascular events in patients with stable angina.
Danish: De bivirkninger, der er iagttaget efter markedsføring, opvejer desuden den marginale fordel ved forebyggelse af kardiovaskulære hændelser hos patienter med stabil angina.
English: The hemodynamic results led to the conclusion that nicorandil produced a beneficial effect in congestive heart failure (CHF) evaluated patients, by exerting an unloading effect and improving cardiac pump function.
Danish: De hæmodynamiske resultater ledte til den konklusion, at nicorandil frembragte en gavnlig virkning hos patienter, der var vurderet til at have kongestiv hjerteinsufficiens, fordi det havde aflastende virkning og forbedrede hjertets pumpefunktion.
English: In patients concomitantly receiving NSAIDs including acetylsalicylic acid for both cardiovascular prevention and anti-inflammatory dosages, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage (see section
Danish: Hos patienter i samtidig behandling med NSAID, herunder acetylsalicylsyre i kardiovaskulært forebyggende eller antiinflammatoriske doser, er der øget risiko for svære komplikationer, såsom gastrointestinal ulceration, perforation og blødning (se punkt 4.4).
English: Nicorandil is a vasodilator agent with a dual mechanism of action, which leads to relaxation of smooth tonic vascular muscles in both venous and arterial part of vessels.
Danish: Nicorandil er en vasodilator med dobbelt virkningsmekanisme, som bevirker afslappelse af karrenes toniske glatmuskulatur i såvel den venøse som den arterielle del af karsystemet.
English: Nicorandil has a direct effect on coronary arteries without leading to a steal phenomenon.
Danish: Nicorandil virker direkte på koronararterierne uden at medføre steal-fænomen.
English: Due to its nitrate moiety, nicorandil relaxes also vascular smooth muscle, particularly in the venous system via an increase in intracellular cyclic guanosine monophosphate (GMP).
Danish: Som følge af nitratdelen virker nicorandil afslappende på karrenes glatmuskulatur, navnlig den venøse, ved at øge den intracellulære koncentration af cyklisk guanosinmonofosfat (GMP).
English: Efficacy of nicorandil on cardiovascular risk in patients with stable angina mainly lays on the pivotal study IONA6 and the supportive study by Nishimura7 (2009) which enrolled a too small number of patients to assess efficacy on morbi-mortality endpoints appropriately.
Danish: Forebyggelse af kardiovaskulære hændelser hos patienter med stabil koronar hjertesygdom Virkningen af nicorandil på den kardiovaskulære risiko hos patienter med stabil angina pectoris bygger især på hovedundersøgelsen IONA6 og den støttende undersøgelse Nishimura7 (2009), der indrullerede for få patienter til vurdering af virkningen på endepunkterne morbiditet/mortalitet.
English: This activation of potassium channels induces vascular cell membrane hyperpolarisation with an arterial muscle relaxant effect, thereby leading to arterial dilatation and afterload reduction.
Danish: Ved aktiveringen af kaliumkanalerne bliver den vaskulære cellemembran hyperpolariseret, hvorved arteriernes muskulatur afslappes med deraf følgende arteriel dilatation og reduktion af afterload.
English: In addition a PASS, retrospective study based on a patient cohort, is already planned by the MAHs.
Danish: Foruden en sikkerhedsundersøgelse efter markedsføring (PASS) har indehaverne af markedsføringstilladelse allerede planlagt en retrospektiv undersøgelse baseret på en kohorte af patienter.
English: Nicorandil may act partly through the nitrate moiety, which seems to be the trigger of methemoglobinemia through an oxidation process.
Danish: Effekten af nicorandil kan delvis skyldes nitratdelen, der synes at udløse methæmoglobinæmi ved en oxidationsproces.
English: This section of the SmPC has been harmonised to include the relevant available information.
Danish: Dette punkt i produktresuméet er blevet harmoniseret, så det indeholder de relevante foreliggende oplysninger.
English: In addition, the activation of the potassium channel leads to cardioprotective effects mimicking ischemic pre-conditioning.
Danish: Aktiveringen af kaliumkanalerne har desuden kardioprotektive virkninger svarende til iskæmisk prækonditionering.
English: With the current knowledge, the early diagnosis and the identification of nicorandil treatment as a possible cause to the emergence of ulceration are the best way to prevent more severe ulceration and to ensure recovery.
Danish: Tidlig diagnose og udpegelse af behandlingen med nicorandil som mulig årsag til ulceration er ud fra den nuværende viden det bedste tiltag til at forebygge sværere ulceration og sikre restitution.
English: A potassium channel opening action provides arterial vasodilation, thus reducing afterload, while the nitrate component promotes venous relaxation and a reduction in preload.
Danish: Det bevirker arteriel vasodilatation ved at åbne calciumkanalerne og reducerer derved afterload, mens nitratkomponenten medfører venøs karafslappelse og reduktion af preload.
English: It is more likely to occur in patients with specific risk factors such as those receiving potassium supplements or potassium-sparing diuretics.
Danish: Hyperkaliæmi forekommer oftest i forbindelse med specifikke risikofaktorer, såsom brug af kaliumtilskud eller kaliumbesparende diuretika.
English: increases the risk of ulceration, and does not guarantee a safe use for a symptomatic treatment.
Danish: Det konkluderes, at en dosis på 20 mg to gange dagligt synes at øge risikoen for ulceration og ikke garanterer sikker anvendelse til symptomatisk behandling.
English: IONA is the only study showing a beneficial effect of nicorandil associated with standard antianginal therapy on the prevention of cardiovascular events in patients with stable angina.
Danish: IONA er den eneste undersøgelse, hvor nicorandil i forbindelse med sædvanlige antianginøse midler er påvist at have forebyggende virkning på kardiovaskulære hændelser hos patienter med stabil angina.
English: • In case of beta-blocker intolerance or poor efﬁcacy attempt monotherapy with a calcium channel blocker (CCB): use long-acting nitrate, or nicorandil (Class I, level of evidence C).
Danish: • Ved intolerans over for eller manglende virkning af betablokkere forsøges monoterapi med en calciumkanalblokker: der anvendes et langtidsvirkende nitrat, eller nicorandil (klasse I,
English: Thus, the endpoints were analysed for the 20 mg b.i.d.
Danish: Endepunkterne blev derfor analyseret med hensyn til doseringen 20 mg to gange dagligt.
English: doses seemed to give the best compromise between efficacy and clinical acceptability.
Danish: Doseringerne 10 og 20 mg to gange dagligt synes således at være det bedste kompromis mellem virkning og klinisk acceptabilitet.
English: In the context of ulceration, early diagnosis of ulcerations and nicorandil withdrawal appear to be the most adequate measure leading to healing and prompt recovering.
Danish: Hvad angår ulceration synes tidlig diagnose af ulceration og seponering af nicorandil at være den mest velegnede foranstaltning til heling og hurtig restitution.
English: They have also been associated with damage to the distal small intestine and colon.
Danish: NSAID er desuden blevet sat i forbindelse med beskadigelse af den distale tyndtarm og tyktarmen.
English: Nicorandil 20 mg was more effective in reducing resting systolic blood pressure (SBP) and increasing total exercise work load (55% vs 94%).
Danish: Nicorandil, 10 mg to gange dagligt, var her lige så effektivt som 20 mg to gange dagligt til at øge tiden til indsætten af angina og nedsætte tiden til en ST-segmentsænkning på 1 mm. Nicorandil 20 mg var mere effektivt til at nedsætte det systoliske hvileblodtryk og øge den totale fysiske arbejdsbelastning (55 % mod 94 %).
English: Following all the changes in the SmPC there were amendments made to the package leaflet (PL).
Danish: I henhold til alle ændringerne i produktresuméet blev indlægssedlen ændret tilsvarende.
English: It possesses a potassium-channel opening effect.
Danish: Det åbner kaliumkanalerne.
English: Section 4.4 - Special warnings and precautions for use Initially lack of glucose-6-phosphate-dehydrogenase was added as contraindication.
Danish: Oprindelig var glucose-6-phosphat-dehydrogenasemangel anført som kontraindikation.
English: One study performed by Meany and colleagues8 (1989) on 46 patients, compared nicorandil 10 mg b.i.d.
Danish: I en undersøgelse, der blev udført af Meany et al. 8 (1989) hos 46 patienter, blev nicorandil, 10 mg to gange dagligt og 20 mg to gange dagligt, sammenlignet med placebo.
English: Furthermore, the secondary endpoint, the composite of cardiovascular death and MI, does not reach statistical significance and thus confirms the weakness and irrelevancy of the primary endpoint.
Danish: Det sekundære endepunkt, der er sammensat af kardiovaskulær dødelighed og myokardieinfarkt, når desuden ikke statistisk signifikans.
English: The daily dose in Asiatic patients cannot be extrapolated to the European patients; this is acknowledged by the CHMP.
Danish: CHMP hæftede sig ved, at den daglige dosis hos asiatiske patienter ikke kan ekstrapoleres til europæiske patienter.
English: Be careful to avoid nitrate tolerance (Class IIb, level of evidence C).
Danish: (klasse IIb, evidensniveau C).
English: Oral nicorandil to reduce cardiac death after coronary revascularization in hemodialysis patients: a randomized trial.
Danish: 7 Nishimura M, Tokoro T, Nishida M, et al. Oral nicorandil to reduce cardiac death after coronary revascularization in hemodialysis patients: a randomized trial.
English: Coronary heart disease (CHD) patients
Danish: Patienter med koronar hjertesygdom
English: In the meantime, it is acknowledged by the CHMP that in the context of ulceration, early diagnosis of ulcerations and nicorandil withdrawal appear to be the most adequate measure leading to healing and prompt recovering.
Danish: I mellemtiden anser CHMP tidlig diagnose af ulcerationer og seponering af nicorandil for at være den mest hensigtsmæssige foranstaltning til heling og hurtig restitution efter ulceration.
English: There is a strong increase in adverse events such as GI ulceration, skin ulceration, GI haemorrhage occurring at 40 mg per day.
Danish: Ved 40 mg dagligt er der en kraftig stigning i bivirkninger såsom gastrointestinal ulceration, hudulceration og gastrointestinal blødning.
English: The dose recommendation for the prevention of CHD events in patients with stable angina pectoris has been deleted from the SmPC.
Danish: I produktresuméet slettes dosisanbefalingen for forebyggelse af hændelser vedrørende koronar hjertesygdom hos patienter med stabil angina pectoris.
English: The proposed indication should be revised as follows: <Invented name> is indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line anti-anginal therapies (such as beta-blockers and/or calcium antagonists).
Danish: der ikke er tilfredsstillende kontrolleret, eller når førstevalgsbehandlingerne af angina (såsom betablokkere og/eller calciumantagonister) er kontraindicerede eller ikke tolereres.
English: Furthermore, the composite of the 3 heterogeneous criteria of this primary endpoint, cardiovascular death, myocardial infarction (MI) and hospitalisation, is mainly
Danish: Det primære endepunkt er desuden sammensat af de tre heterogene kriterier kardiovaskulær dødelighed, myokardieinfarkt og indlæggelser og drives hovedsagelig af reduktionen i indlæggelser med grænsesignifikans (p=0,014).
English: 1 Hughes LO, Rose EL, Lahiri A, et al.
Danish: Hughes LO, Rose EL, Lahiri A, et al. Comparison of nicorandil and atenolol in stable angina pectoris.