FrancophonIA/ELRC3.0 huggingface dataset:
English: This should reflect that nicorandil should be used with caution in patients with glucose-6-phosphate-dehydrogenase deficiency as this may lead to methemoglobinemia based on the theoretical mechanism of triggering this process by metabolism of organic nitrates resulting in the formation of nitrites.
Croatian: Ona treba upozoriti na to da se nikorandil treba koristiti oprezno u bolesnika s deficijencijom glukoze-6-fosfatadehidrogenaze budući da to može dovesti do metemoglobinemije na temelju teoretskog mehanizma aktiviranja ovog procesa metabolizmom organskih nitrata što rezultira formiranjem nitrita.
English: Overall, nicorandil shows moderate efficacy to improve exercise capacity versus placebo and seems to be comparable to other anti-anginal therapies.
Croatian: Načelno, nikorandil je pokazao umjerenu djelotvornost za poboljšanje kapaciteta u odnosu na placebo te se čini da je usporediv s drugim antianginalnim terapijama.
English: The dose recommendation for the prevention of CHD events in patients with stable angina pectoris has been deleted from the SmPC.
Croatian: Preporučena doza za prevenciju CHD događaja u bolesnika sa stabilnom anginom pektoris izbrisana je iz SmPC-a.
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.
Croatian: Ispitivanje IONA provedeno je u trenutku kada je standard skrbi i liječenja bolesnika s CHD-om bio drugačiji od današnjeg u smislu revaskularizacije, antianginalnih strategija itd. te ne dopušta donošenje zaključka u vezi s prevencijom kardiovaskularnih događaja za bolesnike s CHD-om s anginom.
English: Section 5.3 - Precllinical safety data
Croatian: Odjeljak 5.3. - Pretklinički podaci o sigurnosti
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.
Croatian: CHMP je također preporučio da se u SmPC uvrste informacije o izostanku farmakodinamičke interakcije između nikorandila i acenokumarola s unakrsnom referencom na odjeljak 4.4. kako bi se liječnika upozorilo na rizik od ulceracija i s njima povezanog krvarenja.
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.
Croatian: Zaključno, ispitivanje IONA bilo je randomizirano, dvostruko slijepo, placebo kontrolirano ispitivanje provedeno na 5 126 bolesnika starijih od 45 godina s kroničnom stabilnom anginom, liječenih standardnim antianginalnim terapijama i izloženih visokom riziku od kardiovaskularnih događaja koji su definirani povećanjem ranije miokardijalne infrakcije ili ugradnjom premosnice koronarne arterije ili bolešću koronarne arterije koja je potvrđena angiografom ili pozitivnim testom vježbanja u prethodne dvije godine.
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.
Croatian: NSAID-ovi mogu uzrokovati klinički značajno oštećenje grastrointestinalnog trakta, čime se povećava incidencija krvarenja u gornjem gastrointestinalnom traktu i perforacija iako su ozbiljne komplikacije i smrt relativno rijetki.
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.
Croatian: Nekoliko kliničkih ispitivanja 1,2,3,4 u bolesnika s anginom pektoris pokazalo je da terapija nikorandilom od 10 i 20 mg dva puta na dan može odgoditi vrijeme nastupanja ishemije tijekom vježbanja i ukupno trajanje vježbanja.
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).
Croatian: Uslijed različitih nacionalnih odluka donesenih u državama članicama vezanih uz odobrenje lijeka Ikorel i njegovih povezanih naziva, te lijeka Dancor i njegovih povezanih naziva, ti su lijekovi uvršteni na popis lijekova za usklađivanje sažetka opisa svojstava lijeka (SmPC) koje je zatražila Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh).
English: They have also been associated with damage to the distal small intestine and colon.
Croatian: Također su povezani s oštećenjem distalnog tankog crijeva i debelog crijeva.
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:
Croatian: Aktualne smjernice Europskog društva za kardiologiju (ESC) za kontrolu stabilne angine pektoris5 izdane 2013. navode sljedeće preporuke za primjenu nikorandila u farmakološkoj terapiji kako bi se poboljšali simptomi i/ili smanjila ishemija u bolesnika sa stabilnom anginom:
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
Croatian: No, CHMP smatra da koncentracija postupka oksidacije ne može biti klinički relevantna budući da je prijavljen samo jedan slučaj metemoglobinemije pri primjeni nikorandila.
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.
Croatian: Ciljevi su kvantifikacija stopa ulceracije u bolesnika liječenih nikorandilom (uključujući, između ostaloga, gastrointestinalne, kožne, okularne, mukozalne, analne lokacije; samostalne ili na više lokacija), kao i posljedičnu eroziju, perforaciju, krvarenje, formiranje apcesa, fistule i odgođeno zacjeljivanje rana u stvarnom okruženju; zajedno s identifikacijom podgrupa visokog rizika, drugih faktora, te ocjene djelovanja doze i vremena.
English: Coronary heart disease (CHD) patients
Croatian: Bolesnici s koronarnom bolesti srca (CHD)
English: Available data on cardiovascular prevention may suggest a favourable effect of nicorandil in reducing cardiovascular risk, mainly by a reduction of hospitalisation.
Croatian: Dostupni podaci o kardiovaskularnoj prevenciji mogu ukazivati na povoljno djelovanje nikorandila u smanjivanju kardiovaskularnog rizika, uglavnom snižavajući broj hospitalizacija.
English: Grounds for the variation to the terms of the marketing authorisations
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje u promet
English: Considering the low number of patients enrolled in this study, no conclusion regarding the efficacy of 10 mg b.i.d.
Croatian: S obzirom na mali broj bolesnika upisanih u ovo ispitivanje, nije bilo moguće donijeti zaključak u vezi s djelotvornosti 10 mg b.i.d. u odnosu na 20 mg b.i.d.
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.
Croatian: Stoga je CHMP preporučio izjavu o interakciji s NSAID-ovima u ovom odjeljku SmPC-a, s unaksrsnom referencom na odjeljak 4.4.
English: The MAHs should evaluate the impact of this DHPC after it is sent out.
Croatian: Nositelji odobrenja trebaju ocijeniti učinak DHPC-a nakon slanja.
English: Ultimately, this results in an improved oxygen balance in the myocardium and improved blood flow in the post-stenotic areas of the myocardium.
Croatian: Naposljetku, to rezultira poboljšanjem ravnoteže kisika u miokardu te poboljšanjem protoka krvi u post-stenoznim područjima miokarda.
English: This is in contrast to the dosing schedule in Japan where 5 mg b.i.d.
Croatian: To je u suprotnosti s rasporedom doziranja u Japanu gdje se doza od 5 mg b.i.d. preporuča kao početna doza.
English: According to the Guideline on SmPC (dated September 2009), available information on pediatric patients should be summarised using some standard statements in section 4.2.
Croatian: U skladu sa smjernicom o SmPC-u (izdanom u rujnu 2009.), dostupne informacije o pedijatrijskim bolesnicima trebaju se sažeti uz primjenu određenih standardnih izjava u odjeljku 4.2. Vezano uz pedijatrijsku populaciju preporuča se sljedeća formulacija:
English: The overall action improves blood flow to post-stenotic regions and the oxygen balance in the myocardium.
Croatian: Cjelokupno djelovanje poboljšava protok krvi do post-stenoznih područja i ravnotežu kisika u miokardu.
English: Nicorandil has dual pharmacological effects; activation of ATP-sensitive inward-rectifier potassium channels and (similar to nitroglycerin) increased production of nitric oxide.
Croatian: Nikorandil ima dualno farmakološko djelovanje; aktiviranje ulaznih ispravljačkih kanala natrija osjetljivih na ATP i (slično nitroglicerinu) povećana proizvodnja dušikovog monoksida.
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.
Croatian: Zaključno, na temelju ocjene prijedloga nositelja odobrenja i odgovora te nakon rasprava Odbora, CHMP je usvojio usklađenu skupinu dokumenata koji sadrže informacija o lijeku za Ikorel i povezane nazive te Dankor i povezane nazive.
English: However, two contraindications related to the risk of acute pulmonary oedema and hypovolemia were added in this section.
Croatian: No, u ovom su odjeljku dodane dvije kontraindikacije povezane s rizikom akutnog pulmonarnog edema i hipovolemije.
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).
Croatian: <Zaštićeno ime> indiciran je u odraslih osoba za simptomatičnu terapiju bolesnika sa stabilnom anginom pektoris koja se neprimjereno kontrolira ili imaju kontraindikaciju ili ne podnose antianginalne terapije prve linije (poput beta-blokatora i/ili antagonista kalcija).
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.
Croatian: Uz postojeća saznanja, rana dijagnoza i identifikacija terapije nikorandila kao mogućeg uzroka pojave ulceracije najbolji su način da se spriječi ozbiljnija ulceracija i da se osigura oporavak.
English: Nicorandil has no direct effect on myocardial contractility.
Croatian: Nikorandil nema izravan učinak na mikoradijalnu kontraktivnost.
English: This section of the SmPC has been harmonised to clarify and harmonise the relevant available information.
Croatian: Ovaj odjeljak SmPC-a usklađen je te su u njemu pojašnjene i usklađene relevantne dostupne informacije.
English: Section 5.2 - Pharmacokinetic properties
Croatian: Odjeljak 5.2. - Farmakokinetička svojstva
English: There is a strong increase in adverse events such as GI ulceration, skin ulceration, GI haemorrhage occurring at 40 mg per day.
Croatian: Prisutno je značajno povećanje nuspojava poput gastrointestinalne ulceracije, ulceracije kože, gastrointestinalnog krvarenja koje nastupa pri dozi od 40 mg na dan.
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.
Croatian: Hemodinamski rezultati doveli su do zaključka da je nikorandil proizveo korisno djelovanje u ocijenjenih bolesnika s kongestivnim zatajenjem srca (CHF) tako što je potaknuo učinak rasterećivanja i poboljšao funkciju srčane pumpe.
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).
Croatian: CHMP je donio pozitivno mišljenje u kojem preporučuje izmjenu uvjeta odobrenja za stavljanje lijekova u promet za koje su sažetak opisa svojstava lijekova, označavanje i uputa o lijeku navedeni u Prilogu III. mišljenja CHMP-a za Ikorel i povezane nazive te Dankor i povezane nazive (vidi Prilog I.).
English: The CHMP addressed a list of questions to the MAHs, pointing out the sections of the products SmPC where divergences existed.
Croatian: CHMP je nositeljima odobrenja dostavio popis pitanja, ističući odjeljke SPC-a za lijekove u kojima su prisutne razlike.
English: Nicorandil may act partly through the nitrate moiety, which seems to be the trigger of methemoglobinemia through an oxidation process.
Croatian: Nikorandil može djelomično djelovati kroz nitratni dio, za koji se čini da je aktivator metemoglobinemije kroz postupak oksidacije.
English: It possesses a potassium-channel opening effect.
Croatian: Ima učinak otvaranja kanala natrija.
English: The daily dose in Asiatic patients cannot be extrapolated to the European patients; this is acknowledged by the CHMP.
Croatian: Dnevna doza u azijskih bolesnika ne može se ekstrapolirati na europske bolesnike.
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).
Croatian: • U slučaju nepodnošenja beta-blokatora ili slabe djelotvornosti pokušane monoterapije blokatorima kanala kalcija (CCB-a): primjena dugodjelujućeg nitrata ili nikorandila (klasa I., razina dokaza C).
English: 1989;63(21):66J-70J.
Croatian: Am J Cardiol. 1989;63(21):66J-70J.
English: The mechanism of action of nicorandil as a nicotinamide ester was clarified and the wording harmonised.
Croatian: Pojašnjen je mehanizam djelovanja nikorandila kao nikotinamid estera, a tekst je usklađen.
English: The impairment of fertility and the embryotoxicity and peri- and post-natal toxicity were clarified.
Croatian: Pojašnjeno je štetno djelovanje na plodnost i embriotoksičnost te perinatalna i postnatalna toksičnost.
English: Nicorandil has a direct effect on coronary arteries without leading to a steal phenomenon.
Croatian: Nikorandil ima izravno djelovanje na koronarne arterije bez uzrokovanja fenomena krađe.
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.
Croatian: Nadalje, nuspojave uočene nakon izdavanja odobrenja za stavljanje lijeka u promet nadmašuju marginalnu korist u prevenciji kardiovaskularnih događaja u bolesnika sa stabilnom anginom.
English: In addition, the activation of the potassium channel leads to cardioprotective effects mimicking ischemic pre-conditioning.
Croatian: Nadalje, aktiviranje kanala natrija rezultira kardio-zaštitnim učincima koji oponašaju ishemijsko prethodno stanje.
English: Therefore, the simultaneous administration of nicorandil with NSAIDs can increase the risk of hyperkalaemia due to a synergistic effect.
Croatian: Stoga, istovremena primjena nikorandila s NSAID-ovima može povećati rizik od hiperkalemije uslijed sinergijskog djelovanja.
English: There is a lack of clinical data concerning the safety of the use of nicorandil in cardiac failure NYHA III-IV.
Croatian: Nedostaju klinički podaci o sigurnosti primjene nikorandila u slučaju srčanog zatajenja NYHA III-IV.
English: Section 4.2 - Posology and Method of Administration
Croatian: Odjeljak 4.2 - Doziranje i način primjene
English: doses seemed to give the best compromise between efficacy and clinical acceptability.
Croatian: Posljedičnom, čini se da doze od 10 i 20 mg b.i.d. predstavljaju najbolji kompromis između djelotvornosti i kliničke prihvatljivosti.
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.
Croatian: Uz to, nikorandil je pokazao spazmolitičko djelovanje kako u ispitivanjima in vitro tako i u ispitivanjima in vivo i otklanja koronarni spazam induciran metakolinom ili noradrenalinom.
English: Several sections of the summary of product characteristics were assessed and re worded.
Croatian: Ocijenjeno je i preformulirano nekoliko dijelova sažetka opisa svojstava lijeka.
English: The net effect is to reduce ventricular preload and afterload.
Croatian: Neto djelovanje je smanjenje vetrikularnog prethodnog i naknadnog opterećenja.
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.
Croatian: Djelovanje nikorandila na kardiovaskularni rizik u bolesnika sa stabilnom anginom uglavnom se oslanja na pivotalno ispitivanje IONA6 i podržavajuće ispitivanje Nishimura7 (2009.) tijekom kojeg je upisan premalen broj bolesnika za primjerenu ocjenu djelotvornosti na završne točke morbi-mortaliteta.
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.
Croatian: To aktiviranje kanala natrija inducira hiperpolarizaciju membrane vaskularnih stanica s opuštajućim učinkom na arterijske mišiće, stoga rezultira arterijskom dilatacijom i smanjenjem naknadnog opterećenja.
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
Croatian: U bolesnika koji istovremeno primaju NSAID-ove, uključujući acetilsalicilnu kiselinu za kardiovaskularnu prevenciju i antiupalna doziranja, prisutan je povećan rizik od komplikacija, poput gastrointestinalne ulceracije, perforacije i krvarenja (vidjeti odjeljak 4.4.).
English: Following all the changes in the SmPC there were amendments made to the package leaflet (PL).
Croatian: Nakon svih izmjena u SmPC-u izvršene su izmjene upute o lijeku.
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.
Croatian: Nadalje, uz moguće razlike u odgovoru između bijelaca i Japanaca (s obzirom na tjelesnu masu), najčešća ispitivanja u pogledu kojih je doza od 5 mg b.i.d. utvrđena, bila su otvoreni nekontrolirani protokoli.
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.
Croatian: IONA je jedino ispitivanje koje je pokazalo korisno djelovanje nikorandila povezano sa standardnom antianginalnom terapijom u prevenciji kardiovaskularnih događaja u bolesnika sa stabilnom anginom.
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.
Croatian: Utvrđeno je da nikorandil ima izravni učinak na koronarne arterije, kako na normalne tako i na stenozne segmente, bez uzrokovanja fenomena krađe.
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.
Croatian: Nikorandil može također inducirati gastrointestinalnu ulceraciju, perforaciju i krvarenje; stoga istovremena primjena nikorandila s NSAID-ovima može povećati rizik od gastrointestinalne ulceracije, perforacije i krvarenja uslijed sinergijskog djelovanja.
English: Nicorandil was synthesised and developed by Chugai Pharmaceutical Co., Ltd in 1975 as a product producing coronary vasodilatation.
Croatian: Tvrtka Chugai Pharmaceutical Co., Ltd sintetizirala je i razvila lijek Nikorandil 1975. kao lijek koji proizvodi koronarnu dilataciju.
English: In addition to its anti-anginal properties, nicorandil is thought to have cardio protective properties.
Croatian: Nadalje, uz svoja antianginalna svojstva, smatra se da nikorandil ima i zaštitno djelovanje na srce.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet;
Croatian: • je predmet upućivanja bilo usklađivanje sažetka opisa svojstava lijeka, označivanja i upute o lijeku;
English: Furthermore, the composite of the 3 heterogeneous criteria of this primary endpoint, cardiovascular death, myocardial infarction (MI) and hospitalisation, is mainly
Croatian: Nadalje, kombinacija triju heterogenih kriterija ove primarne završne točke, kardiovaskularna smrt, infarkt miokarda (IM) i hospitalizacija, uglavnom je potaknuta smanjenjem hospitalizacije s marginalnim značajem (p=0,014).
English: However, there is no available data regarding the efficacy of nicorandil repeated oral administration in patients with cardiac failure NYHA III-IV classes.
Croatian: No, nema dostupnih podataka u vezi s djelotvornošću ponovljene oralne primjene nikorandila u bolesnika sa srčanim zatajenjem NYHA III-IV kategorija.
English: Section 5.1 - Pharmacodynamic properties
Croatian: Odjeljak 5.1. - Farmakodinamička svojstva
English: Nicorandil provides a dual mode of action leading to relaxation of vascular smooth muscle.
Croatian: Nikorandil osigurava dvostruki način djelovanja za opuštanje vaskularnog glatkog mišića.
English: The European Commission notified the European Medicines Agency/ Committee for Medicinal Products for Human Use (EMA/CHMP) secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product information (PI) for the above-mentioned products and thus to harmonise them across the EU.
Croatian: Direktive 2001/83/EZ kako bi se uklonile razlike između nacionalno odobrenih informacija o lijeku (PI) za prethodno navedene lijekove i uskladila ih diljem EU-a.
English: In addition a PASS, retrospective study based on a patient cohort, is already planned by the MAHs.
Croatian: Nadalje, nositelji odobrenja već planiraju PASS, retrospektivno ispitivanje temeljeno na kohorti bolesnika.
English: A potassium channel opening action provides arterial vasodilation, thus reducing afterload, while the nitrate component promotes venous relaxation and a reduction in preload.
Croatian: Otvaranje kanala natrija osigurava arterijsku vazodilataciju, te time smanjuje prekomjerno punjenje, dok komponenta nitrata potiče opuštanje vena i smanjenje preopterećenja.