FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Odbor CHMP je ob upoštevanju navedenega zgoraj menil, da je treba pri zdravljenju simptomatske stabilne angine pektoris v drugem redu zdravljenja razmisliti o uporabi nikorandila.
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.
Slovenian: Vendar je primarni opazovani dogodek slab, saj vključuje merilo „zmanjšanje hospitalizacij“, kar je subjektivno merilo za oceno preprečevanja srčno-žilnih dogodkov pri bolnikih, ki imajo koronarno bolezen srca (KBS) z angino pektoris.
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.
Slovenian: je odbor CHMP menil, da se razmerje med koristmi in tveganji zdravila Okorel in povezanih imen ter zdravila Dancor in povezanih imen šteje za ugodno.
English: The half-life of 6 to 8 hours permits twice daily dosage, and total-daily dosages between 10 and 40 mg have been effective in patients with chronic stable angina.
Slovenian: Razpolovna doba 6 do 8 ur omogoča odmerjanje dvakrat na dan, pri čemer so pri bolnikih s kronično stabilno angino pektoris učinkoviti skupni dnevni odmerki od 10 do 40 mg.
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.
Slovenian: Študija IONA je bila izvedena v času, ko je bila standardna oskrba pri zdravljenju bolnikov s KBS z vidika revaskularizacije, antianginioznih strategij itd. drugačna od današnje, zato ne omogoča zaključka glede preprečevanja srčno-žilnih dogodkov pri bolnikih, ki imajo KBS z angino pektoris.
English: The CHMP also recommended the information on the absence of pharmacodynamic interaction between nicorandil and acenocoumarol to be reflected in the SmPC with a cross reference to section 4.4 in order to refer the physician to the risk of ulcerations and associated bleeding.
Slovenian: Odbor CHMP je priporočil tudi, da se v povzetek glavnih značilnosti zdravila vključijo informacije o odsotnosti farmakodinamičnih interakcij med nikorandilom in acenokumarolom s sklicem na poglavje 4.4, da se zdravnike opozori na tveganje za razjede in posledične krvavitve.
English: In conclusion, based on the assessment of the MAHs' proposals and responses and following the discussions of the Committee, the CHMP adopted harmonised sets of product information documents of Ikorel and associate names and Dancor and associated names.
Slovenian: V zaključku je odbor CHMP na podlagi ocene predlogov in odgovorov imetnikov dovoljenja za promet z zdravilom ter razprave v odboru potrdil usklajene sklope dokumentov z informacijami o zdravilu za zdravilo Ikorel in povezana imena ter zdravilo Dancor in povezana imena.
English: The CHMP therefore requested the MAHs to include a statement mentioning that nicorandil should be used with caution in such a population.
Slovenian: Odbor CHMP je zato zahteval, da imetniki dovoljenja za promet z zdravilom vključijo navedbo, da je treba nikorandil pri tej populaciji uporabljati previdno.
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).
Slovenian: Sprejel je pozitivno mnenje, v katerem je priporočil spremembo pogojev dovoljenj za promet z zdravili, za katera so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo opredeljeni v Prilogi III k mnenju odbora CHMP o zdravilu Ikorel in povezanih imenih ter zdravilu Dancor in povezanih imenih (glejte Prilogo I).
English: Coronary heart disease (CHD) patients
Slovenian: Bolniki s koronarno boleznijo srca (KBS)
English: Overall, nicorandil shows moderate efficacy to improve exercise capacity versus placebo and seems to be comparable to other anti-anginal therapies.
Slovenian: Na splošno se je nikorandil izkazal za zmerno učinkovitega pri izboljšanju telesne zmogljivosti v primerjavi s placebom in je primerljiv z drugimi zdravili proti angini pektoris.
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.
Slovenian: Dokazano je tudi, da ima nikorandil neposreden učinek na koronarne arterije, tako na normalne kot stenozne predele, ne da bi pri tem povzročil kradežni pojav.
English: However, the important identified risk of ulceration (gastrointestinal (GI), skin, mucosal, genital and ocular) and perforations, fistula and abscesses has been recognized and monitored since 1997.
Slovenian: Po drugi strani pa od leta 1997 opažajo in spremljajo pomembno ugotovljeno tveganje za razjede (v prebavilih, na koži, sluznici, spolovilih in očeh) in perforacijo, fistulo ter absces.
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).
Slovenian: Zdravilo <izmišljeno ime> je indicirano pri odraslih za simptomatsko zdravljenje bolnikov s stabilno angino pektoris, pri katerih ta ni zadovoljivo nadzorovana ali pri katerih so kontraindicirana zdravila proti angini pektoris prve izbire (na primer antagonisti adrenergičnih receptorjev beta in/ali zaviralci kalcijevih kanalčkov) ali pa jih ne prenašajo.
English: doses seemed to give the best compromise between efficacy and clinical acceptability.
Slovenian: Posledično se je zdelo, da odmerka 10 in 20 mg dvakrat na dan omogočata najboljši kompromis med učinkovitostjo in klinično sprejemljivostjo.
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.
Slovenian: Študija IONA je bila randomizirana dvojno slepa s placebom kontrolirana študija, v kateri je sodelovalo 5126 bolnikov, starejših od 45 let, s kronično stabilno angino pektoris, ki so prejemali standardna zdravila proti angini pektoris in pri katerih je obstajalo veliko tveganje za srčno-žilne dogodke zaradi srčnega infarkta v preteklosti, premostitvene operacije koronarnih arterij, bolezni koronarnih arterij, potrjene z angiografijo, ali pozitivnega obremenitvenega testa v preteklih dveh letih.
English: For consistency the MAHs should provide a common DHPC, if required by the national authority.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo zaradi doslednosti zagotoviti skupno neposredno obvestilo, če to zahteva nacionalni organ.
English: The overall action improves blood flow to post-stenotic regions and the oxygen balance in the myocardium.
Slovenian: Na splošno s svojim delovanjem izboljša dotok krvi v poststenotične predele in ravnovesje kisika v miokardiju.
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).
Slovenian: S pomočjo nitratne skupine nikorandil sprošča tudi gladke mišice krvnih žil, zlasti v venskem sistemu, tako da zviša ravni cikličnega gvanozinmonofosfata v celicah.
English: There is a lack of clinical data concerning the safety of the use of nicorandil in cardiac failure NYHA III-IV.
Slovenian: Prav tako manjkajo klinični podatki o varnosti uporabe nikorandila pri srčnem popuščanju razreda III-IV po NYHA.
English: Nicorandil was synthesised and developed by Chugai Pharmaceutical Co., Ltd in 1975 as a product producing coronary vasodilatation.
Slovenian: Nikorandil je leta 1975 sintetizirala in razvila družba Chugai Pharmaceutical Co., Ltd kot zdravilo, ki povzroča vazodilatacijo koronarnih arterij.
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.
Slovenian: IONA je edina študija, ki je pokazala ugoden učinek nikorandila, povezan s standardnim zdravljenjem angine pektoris, na preprečevanje srčno-žilnih dogodkov pri bolnikih s stabilno angino pektoris.
English: The MAHs should evaluate the impact of this DHPC after it is sent out.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo ovrednotiti vpliv tega obvestila, potem ko bo razposlano.
English: It possesses a potassium-channel opening effect.
Slovenian: Učinkuje tako, da odpira kalijeve kanalčke.
English: This section of the SmPC has been harmonised to include the relevant available information.
Slovenian: To poglavje povzetka glavnih značilnosti zdravila je bilo usklajeno, tako da so bile vključene ustrezne razpoložljive informacije.
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.
Slovenian: Nikorandil je vazodilatator z dvojnim mehanizmom delovanja, ki povzroči relaksacijo gladkih toničnih mišic krvnih žil, tako v venskem kot v arterijskem delu krvnih žil.
English: The dose recommendation for the prevention of CHD events in patients with stable angina pectoris has been deleted from the SmPC.
Slovenian: Priporočila za odmerjanje pri preprečevanju dogodkov KBS pri bolnikih s stabilno angino pektoris so bila izbrisana iz povzetka glavnih značilnosti zdravila.
English: The net effect is to reduce ventricular preload and afterload.
Slovenian: Neto učinek je zmanjšanje prekatne predobremenitve in sistoličnega bremena.
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
Slovenian: Pri bolnikih, ki sočasno prejemajo nesteroidna protivnetna zdravila, vključno z acetilsalicilno kislino, za preprečevanje srčno-žilnih dogodkov ali protivnetno zdravljenje, obstaja povečano tveganje za resne zaplete, kot so razjede v prebavilih, perforacija in krvavitev (glejte poglavje 4.4).
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.
Slovenian: Aktivacija kalijevih kanalčkov povzroči hiperpolarizacijo žilne celične membrane, ki ima relaksacijski učinek na mišice arterij, posledici pa sta dilatacija arterij in zmanjšanje sistoličnega bremena.
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.
Slovenian: Poleg tega neželeni dogodki, ki so jih opažali v obdobju trženja, odtehtajo zanemarljivo korist pri preprečevanju srčno-žilnih dogodkov pri bolnikih s stabilno angino pektoris.
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.
Slovenian: Na podlagi hemodinamskih rezultatov so zaključili, da je imel nikorandil ugoden učinek pri ovrednotenih bolnikih s kongestivnim srčnim popuščanjem (KSP), saj je zmanjšal obremenjenost in izboljšal delovanje srčne črpalke.
English: Section 4.2 - Posology and Method of Administration
Slovenian: Poglavje 4.2 - Odmerjanje in način uporabe
English: However, there is no available data regarding the efficacy of nicorandil repeated oral administration in patients with cardiac failure NYHA III-IV classes.
Slovenian: Vendar pa ni na voljo nobenih podatkov o učinkovitosti večkratnih peroralnih odmerkov nikorandila pri bolnikih s srčnim popuščanjem razreda III-IV po NYHA.
English: Nicorandil may act partly through the nitrate moiety, which seems to be the trigger of methemoglobinemia through an oxidation process.
Slovenian: Nikorandil lahko deloma deluje preko nitratne skupine, ki verjetno lahko z oksidacijo sproži methemoglobinemijo.
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.
Slovenian: Poleg tega, da so možne razlike v odzivu med belci in Japonci (na podlagi telesne mase), je imela večina študij, na podlagi katerih je bil določen odmerek 5 mg dvakrat na dan, odprte nekontrolirane protokole.
English: The CHMP addressed a list of questions to the MAHs, pointing out the sections of the products SmPC where divergences existed.
Slovenian: Odbor CHMP je imetniku dovoljenja za promet z zdravilom predložil seznam vprašanj, v katerem je izpostavil poglavja povzetka glavnih značilnosti zdravila, v katerih prihaja do razhajanj.
English: Hyperkalaemia occurs infrequently with NSAIDs.
Slovenian: Hiperkaliemija se redko pojavi pri uporabi nesteroidnih protivnetnih zdravil.
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.
Slovenian: Poleg tega so študije in vitro ter in vivo pokazale, da ima nikorandil spazmolitično delovanje in preprečuje nadaljnje koronarne spazme, povzročene z metaholinom ali noradrenalinom.
English: • If CCB monotherapy or combination therapy (CCB with beta-blocker) is unsuccessful, substitute the CCB with a long-acting nitrate or nicorandil.
Slovenian: • če monoterapija z zaviralcem kalcijevih kanalčkov ali kombinirana terapija (zaviralec kalcijevih kanalčkov in antagonist adrenergičnih receptorjev beta) ni uspešna, zamenjajte zaviralec kalcijevih kanalčkov z dolgodelujočim nitratom ali nikorandilom.
English: Therefore, the simultaneous administration of nicorandil with NSAIDs can increase the risk of hyperkalaemia due to a synergistic effect.
Slovenian: Sočasna uporaba nikorandila z nesteroidnimi protivnetnimi zdravili lahko tako zaradi sinergističnega učinka poveča tveganje za hiperkaliemijo.
English: Several sections of the summary of product characteristics were assessed and re worded.
Slovenian: Ocenili in spremenili so več poglavij povzetka glavnih značilnosti zdravila.
English: A potassium channel opening action provides arterial vasodilation, thus reducing afterload, while the nitrate component promotes venous relaxation and a reduction in preload.
Slovenian: Z odpiranjem kalijevih kanalčkov povzroči vazodilatacijo arterij in s tem zmanjša sistolično breme, nitratni del pa spodbuja relaksacijo ven in s tem zmanjša predobremenitev.
English: In addition, the activation of the potassium channel leads to cardioprotective effects mimicking ischemic pre-conditioning.
Slovenian: Poleg tega ima aktivacija kalijevih kanalčkov tudi zaščitne učinke na srce, ki posnemajo ishemično prekondicioniranje.
English: Oral nicorandil to reduce cardiac death after coronary revascularization in hemodialysis patients: a randomized trial.
Slovenian: Nishimura M, Tokoro T, Nishida M, et al. Oral nicorandil to reduce cardiac death after coronary revascularization in hemodialysis patients: a randomized trial.
English: One study performed by Meany and colleagues8 (1989) on 46 patients, compared nicorandil 10 mg b.i.d.
Slovenian: V eni študiji, ki so jo izvedli Meany in sodelavci8 (1989) in v kateri je sodelovalo 46 bolnikov, so nikorandil v odmerku 10 mg dvakrat na dan in 20 mg dvakrat na dan primerjali s placebom.
English: • the summary of products characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee;
Slovenian: • odbor je na podlagi predložene dokumentacije in znanstvene razprave v odboru ocenil povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom,
English: increases the risk of ulceration, and does not guarantee a safe use for a symptomatic treatment.
Slovenian: Zdi se torej, da odmerek 20 mg dvakrat na dan poveča tveganje za razjede in ne zagotavlja varne uporabe za simptomatsko zdravljenje.
English: In addition a PASS, retrospective study based on a patient cohort, is already planned by the MAHs.
Slovenian: Poleg tega imetniki dovoljenja za promet z zdravilom že načrtujejo študijo o varnosti zdravila v obdobju trženja (PASS), retrospektivno študijo, ki bo temeljila na kohorti bolnikov.
English: Hereafter it is summarised the main points discussed for the harmonisation of the different sections of the SmPC.
Slovenian: Glavne točke razprave o usklajevanju različnih poglavij povzetka glavnih značilnosti zdravila so povzete v nadaljevanju.
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).
Slovenian: • če bolniki ne prenašajo antagonistov adrenergičnih receptorjev beta ali če poskus monoterapije z zaviralcem kalcijevih kanalčkov ni bil dovolj učinkovit: uporabite dolgodelujoči nitrat ali nikorandil (razred I, raven dokazov C);
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.
Slovenian: Odbor CHMP je zato priporočil, da se v to poglavje povzetka glavnih značilnosti zdravila vključi navedba o medsebojnem delovanju z nesteroidnimi protivnetnimi zdravili in pri tem doda sklic na poglavje 4.4.
English: Nicorandil is a vasodilator agent used to treat angina.
Slovenian: Nikorandil je vazodilatator, ki se uporablja za zdravljenje angine pektoris.
English: Nicorandil 20 mg was more effective in reducing resting systolic blood pressure (SBP) and increasing total exercise work load (55% vs 94%).
Slovenian: V tej študiji je bil nikorandil v odmerku 10 mg dvakrat na dan prav tako učinkovit kot v odmerku 20 mg dvakrat na dan pri podaljšanju časa do pojava angine pektoris in skrajšanju časa do 1-mm znižanja spojnice ST. Nikorandil v odmerku 20 mg je bil učinkovitejši pri znižanju sistoličnega krvnega tlaka (SKT) med mirovanjem in povečanju skupne obremenitve med vadbo (55 % v primerjavi s 94 %).
English: Considering the low number of patients enrolled in this study, no conclusion regarding the efficacy of 10 mg b.i.d.
Slovenian: Zaradi majhnega števila bolnikov, ki so sodelovali v tej študiji, pa zaključka glede učinkovitosti odmerka 10 mg dvakrat na dan v primerjavi z 20 mg dvakrat na dan ni bilo mogoče podati.
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.
Slovenian: Nikorandil lahko povzroči tudi razjede v prebavilih, perforacijo in krvavitev, zato lahko sočasna uporaba nikorandila in nesteroidnih protivnetnih zdravil zaradi sinergističnega učinka poveča tveganje za razjede v prebavilih, perforacijo in krvavitev.
English: This results in an increased pooling in capacitance vessels with a decrease in preload.
Slovenian: To povzroči povečano zbiranje krvi v kapacitivnih žilah, s čimer se zmanjša predobremenitev.
English: Postural hypotension was observed, although only after the first administration, whether it was 40 or 60 mg.
Slovenian: Pri odmerkih 40 in 60 mg so opazili posturalno hipotenzijo, ki se je sicer pojavila samo po prvem odmerjanju.
English: Pre-referral meetings between the EMA and marketing authorisation holders (MAHs) were held.
Slovenian: Evropska agencija za zdravila in imetniki dovoljenja za promet z zdravilom so se sestali na prednapotitvenih sejah.
English: Nicorandil provides a dual mode of action leading to relaxation of vascular smooth muscle.
Slovenian: Zanj je značilno dvojno delovanje, s katerim povzroči relaksacijo gladkih mišic krvnih žil.
English: There is a strong increase in adverse events such as GI ulceration, skin ulceration, GI haemorrhage occurring at 40 mg per day.
Slovenian: Pri uporabi odmerka 40 mg na dan se število neželenih dogodkov, kot so razjede v prebavilih, razjede na koži in krvavitev v prebavilih, močno poveča.
English: 6 The IONA Study group: Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in angina (IONA) randomized trial.
Slovenian: 5 ESC guidelines on the management of stable coronary artery disease European Heart Journal (2013) 34, 2949-3003 6 The IONA Study group: Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in angina (IONA) randomized trial.
English: 1 Hughes LO, Rose EL, Lahiri A, et al.
Slovenian: Hughes LO, Rose EL, Lahiri A, et al. Comparison of nicorandil and atenolol in stable angina pectoris.
English: Furthermore, the composite of the 3 heterogeneous criteria of this primary endpoint, cardiovascular death, myocardial infarction (MI) and hospitalisation, is mainly
Slovenian: Poleg tega je na rezultate za opazovani dogodek, sestavljen iz treh heterogenih meril, ki so bila srčno-žilna smrt, srčni infarkt in hospitalizacija, v največji meri vplivalo zmanjšanje hospitalizacij z zanemarljivo statistično značilnostjo (p = 0,014).
English: This is in contrast to the dosing schedule in Japan where 5 mg b.i.d.
Slovenian: Razpored odmerjanja na Japonskem, kjer je 5 mg dvakrat na dan priporočeni začetni odmerek, je v nasprotju s to ugotovitvijo.
English: In addition to its anti-anginal properties, nicorandil is thought to have cardio protective properties.
Slovenian: Poleg tega, da je nikorandil učinkovit proti angini, naj bi imel tudi zaščitne učinke na srce.
English: Exercise capacity after single and twice-daily doses of nicorandil in chronic stable angina pectoris.
Slovenian: Meany TB, Richardson P, Camm AJ, et al. Exercise capacity after single and twice-daily doses of nicorandil in chronic stable angina pectoris.
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.
Slovenian: Kar zadeva razjede, se zdi, da je najprimernejši ukrep za zagotovitev celjenja in hitrega okrevanja zgodnja diagnoza in prekinitev zdravljenja z nikorandilom.
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.
Slovenian: Sekundarni opazovani dogodek, ki sta ga sestavljala srčno-žilna smrt in srčni infarkt, pa ni dosegel statistične
English: failed to show any objective improvement in exercise performance as compared to placebo.
Slovenian: Odmerek pet (5) mg nikorandila dvakrat na dan ni povzročil nobenega objektivnega izboljšanja telesne zmogljivosti v primerjavi s placebom.
English: Following all the changes in the SmPC there were amendments made to the package leaflet (PL).
Slovenian: Po spremembi povzetka glavnih značilnosti zdravila je bilo ustrezno spremenjeno tudi navodilo za uporabo.
English: This compares with around five to seven days when no stimulating factor is used.
Slovenian: To je primerljivo s približno pet do sedmimi dnevi, ko ni uporabljen noben spodbujajoči faktor.