FrancophonIA/ELRC3.0 huggingface dataset:
English: • Dapoxetine, a medicine used to treat premature ejaculation.
Danish: • Dapoxetin, medicin til behandling af for tidlig sædafgang.
English: If you forget to take <Invented name>
Danish: Hvis du har glemt at tage Angicor
English: If advanced, ulcers may develop into perforation, fistula, or abscess formation.
Danish: Fremskredne ulcerationer kan udvikle sig til perforation, fistler eller abscesdannelse.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier har ikke vist direkte eller indirekte skadelige virkninger for så vidt angår reproduktionstoksicitet (se pkt.
English: Nicorandil pharmacokinetics are linear from 5 mg to 40 mg.
Danish: Nicorandils farmakokinetik er lineær ved doser fra 5 mg til 40 mg.
English: Your doctor may progressively increase the dose to reduce the frequency of headaches.
Danish: Din læge vil muligvis øge din dosis gradvist for at nedsætte risikoen for hovedpine.
English: Fertility There are insufficient data on fertility to estimate the risk for humans (see section 5.3).
Danish: Der foreligger ikke tilstrækkelige data vedrørende fertilitet til at kunne vurdere risikoen hos mennesker (se pkt.
English: On the blister, it is clearly indicated which tablet is the drying agent.
Danish: På blisterkortet er det vist tydeligt, hvilken tablet der er tørremidlet.
English: • If you have low blood potassium level and your doctor has prescribed potassium supplements,
Danish: • Hvis du har et lavt indhold af kalium i blodet, og din læge har udskrevet kaliumtilskud til dig,
English: (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Danish: (≥1/10.000, <1/1,000), Meget sjælden (<1/10.000), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • If your eyes become red, itchy or swollen.
Danish: • Hvis dine øjne bliver røde, begynder at klø eller hæve.
English: After 4-5 mg intravenous dosing (5 min infusion), the total body clearance was approximately 40-55 L/hour.
Danish: Efter 4-5 mg administreret intravenøst (5 min. infusion) var total-clearance ca. 40-55 l/t.
English: Radioactivity passed through the placenta in pregnant rats after administration of radioactively marked nicorandil.
Danish: Radioaktivitet passerede placentaen hos drægtige rotter efter administration af radioaktivt mærket nicorandil.
English: <Invented name> with alcohol
Danish: Brug af Angicor sammen med alkohol
English: Nicorandil may lower your blood pressure.
Danish: Nicorandil kan sænke dit blodtryk.
English: A lower starting dose of 5 mg twice daily may be used in patients particularly prone to headache.
Danish: En lavere startdosis på 5 mg to gange dagligt kan anvendes hos patienter, der har særlig tendens til hovedpine.
English: Patients were excluded from the study if they were receiving a sulphonylurea as it was felt these patients may not benefit; (sulphonylurea agents have the potential to close potassium channels and may thus antagonise some of the effects of nicorandil).
Danish: Patienter blev ekskluderet fra studiet, hvis de fik et sulfonylurinstof, da man mente, at disse patienter ikke ville have gavn af behandlingen (sulfonylurinstof kan lukke kaliumkanaler og kan derved modvirke nogle af nicorandils virkninger).
English: The only possible treatment is to stop nicorandil.
Danish: Den eneste behandlingsmulighed er at stoppe med at tage nicorandil.
English: Nicorandil is only slightly bound to human plasma proteins (bound fraction estimated at about 25%).
Danish: Nicorandil bindes kun i begrænset omfang til humane plasmaproteiner (den bundne fraktion er estimeret til ca. 25 %).
English: - In case you are particularly prone to headache, a lower dose of 5 mg twice daily might be prescribed by your doctor, for the first few days (2 to 7 days).
Danish: - Hvis du har særlig tendens til at få hovedpine, kan lægen udskrive en lavere dosis på 5 mg to gange dagligt til de første par dage (2 til 7 dage).
English: There is no significant hepatic first pass effect.
Danish: Der er ingen signifikant first-pass effekt i leveren.
English: Nicorandil has no direct effect on myocardial contractility.
Danish: Nicorandil har ingen direkte effekt på den myokardielle kontraktilitet.
English: You should avoid taking this medicine while you are pregnant.
Danish: Du må ikke tage denne medicin, mens du er gravid.
English: Besides the nicorandil tablets, each blister contains active substance-free silica gel tablets as desiccant in a separate blister segment which is marked accordingly.
Danish: Ud over nicorandil-tabletter indeholder hvert blisterkort en silicagel-tablet uden aktivt stof som tørrekapsel i et separat blister-segment, som er etiketteret tilsvarende.
English: Therapeutic doses of nicorandil may lower the blood pressure.
Danish: Terapeutiske doser af nicorandil kan sænke blodtrykket.
English: Animal studies have shown that nicorandil is excreted in small amounts into the breast milk.
Danish: Dyrestudier har vist, at nicorandil udskilles i små mængder i mælk.
English: The tablet of 10 mg can be divided into equal doses.
Danish: 10 mg tabletten kan deles i to lige store doser.
English: • Yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine - This may be signs of liver problems.
Danish: • Gulfarvning af huden og øjnene, lys afføring, mørkfarvet urin - Dette kan være tegn på leverproblemer
English: They are refractory to treatment and most only respond to withdrawal of nicorandil treatment.
Danish: De er modstandsdygtige over for behandling, og de fleste responderer kun på seponering af nicorandil.
English: Dapoxetine should be prescribed with caution in patients taking nicorandil due to possible reduced orthostatic tolerance.
Danish: Dapoxetin skal ordineres med forsigtighed til patienter, der tager nicorandil, på grund af mulig nedsat ortostatisk tolerance.
English: Nicorandil does not affect the pharmacodynamics of acenocoumarol.
Danish: Nicorandil påvirker ikke acenocoumarols farmakodynamik.
English: <Invented name> is used to prevent or attenuate painful, straining symptoms (angina pectoris) of your heart disease.
Danish: Angicor anvendes til at forebygge eller lindre de smertefulde, udmattende symptomer (angina pectoris) på din hjertesygdom.
English: • Feeling of weakness.
Danish: • Svaghedsfølelse.
English: Nicorandil is mainly eliminated in urine as metabolites since parent product is less than 1%, of the administered dose in human urines (0-48 hours).
Danish: Nicorandil udskilles hovedsageligt i urinen som metabolitter, da det uomdannede lægemiddel udgør mindre end 1 % af den administerede dosis i human urin (0-48 timer).
English: Furthermore, the reduction of end-diastolic pressure and wall tension decreases the extravascular component of vascular resistance.
Danish: Desuden bevirker reduktionen i slutdiastolisk tryk og Vægspændning, at den ekstravaskulære del af den vaskulære modstand mindskes.
English: <Invented name> contains a medicine called nicorandil.
Danish: Angicor indeholder et lægemiddel, der hedder nicorandil.
English: If you drink alcohol while you are treated with <Invented name>, your blood pressure may be decreased even further.
Danish: Hvis du drikker alkohol, mens du tager Angicor, kan dit blodtryk blive sænket yderligere.
English: Indeed, as with other vasodilators, blood pressure-lowering effects as well as dizziness and feeling weakness induced by nicorandil can reduce the ability to drive or to use machines.
Danish: Som ved behandling med andre vasodilatorer kan såvel den blodtrykssænkende effekt som svimmelhed og svaghedsfølelse, forårsaget af nicorandil, nedsætte evnen til at føre motorkøretøj og betjene maskiner.
English: You should not breast-fed while you are taking this medicine.
Danish: Du må ikke amme, mens du tager denne medicin.
English: Uncommon (may affect up to 1 in 100 people) • Decrease in blood pressure.
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) • Nedsat blodtryk.
English: Following exposure to nicorandil at doses that were maternally toxic, embryotoxicity was observed in the rat and rabbit.
Danish: Efter eksponering for nicorandil ved maternelle toksiske doser blev der observeret embryotoksicitet hos rotter og kaniner.
English: • If you have glucose 6 Phosphate Deshydrogenase deficiency.
Danish: • Hvis du har glucose-6-fosfatdehydrogenase-mangel.
English: The frequencies of adverse reactions reported with nicorandil are summarised in the following table by system organ class (in MedDRA) and by frequency.
Danish: Hyppigheden af bivirkninger rapporteret med nicorandil er opstillet i nedenstående tabel efter systemorganklasse (i henhold til MedDRA) og hyppighed.
English: • Medicines for inflammation (corticosteroids, non-inflammatory steroidal drugs such as ibuprofen).
Danish: • Medicin mod betændelsestilstande (kortikosterodier, non-steroide antiinflammatoriske lægemidler såsom ibuprofen).
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 vist at udøve en direkte effekt på koronarterierne, både på normale og stenotiske Segmenter, uden at medføre ”steal phenomenon”.
English: No clinically relevant modifications of the nicorandil pharmacokinetic profile is evidenced in population at risk such as elderly people, liver disease patients and chronic renal failure patients.
Danish: Der er ikke vist klinisk relevante ændringer af nicorandils farmakokinetiske profil i risikopopulationer som f.eks. ældre patienter, patienter med leversygdom og patienter med kronisk nyresvigt.
English: Patients with diverticular disease may be at particular risk of fistula formation or bowel perforation during nicorandil treatment.
Danish: Patienter med divertikelsygdom kan have større risiko for fisteldannelse eller tarmperforering under nicorandilbehandling.
English: This is because <Invented name> may affect the way some other medicines work.
Danish: Dette skyldes, at Angicor kan påvirke virkningen af nogle typer medicin.
English: Stop taking straight away nicorandil and talk to your doctor if you experience any of the following:
Danish: Du skal straks holde op med at tage nicorandil og tale med lægen, hvis du får en eller flere af følgende bivirkninger:
English: Histopathological changes of the testes (diminished spermatogenic cells) were determined in repeat dose toxicity studies.
Danish: Histopatologiske testikelændringer (nedsat antal spermceller) blev konstateret i toksicitetsstudier med gentagne doser.
English: The recommended dose is: - The usual starting dose is 10 mg twice daily.
Danish: Den anbefalede dosis er: - Den sædvanlige startdosis er 10 mg to gange dagligt.
English: N-(2-hydroxyethyl)-nicotinamide is the most abundant metabolite (about 8.9% of the administered dose within 48 hours) followed by nicotinuric acid, (5.7%), nicotinamide (1.34%), N-methyl-nicotinamide (0.61%) and nicotinic acid (0.40%).
Danish: N-(2-hydroxyethyl)-nicotinamid er den mest fremtrædende metabolit (ca.8,9 % af den administrerede dosis inden for 48 timer), efterfulgt af nicotinurinsyre (5,7 %), nicotinamid (1,34 %), N-methyl-nicotinamid (0,61 %) og nicotinsyre (0,40 %).
English: For the tablet of 20 mg, the score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Danish: Delekærven på 20 mg tabletten er kun beregnet til, at du kan dele tabletten, hvis du har svært ved at sluge den hel.
English: • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
Danish: • Hævelse af ansigt, læber, mund, tunge, svælg eller hals, som kan give synkebesvær eller vejrtrækningsbesvær
English: If not successful, increase in circulating plasma volume by substitution of fluid is recommended.
Danish: Hvis dette ikke hjælper, anbefales det at øge det cirkulerende plasmavolumen ved væskesubstitution.
English: Patients with liver and/or renal impairment There are no special dosage requirements for patients with liver and/or renal impairment.
Danish: Patienter med nedsat lever- og/eller nyrefunktion Der er ingen særlige dosisanbefalinger for patienter med nedsat lever- og/eller nyrefunktion.
English: The composite primary endpoint (coronary heart disease (CHD) death, non-fatal myocardial infarction, or unplanned hospital admission for cardiac chest pain), occurred in 337 patients (13.1%) of patients treated with nicorandil 20 mg twice daily compared with 389 patients (15.5%) of patients receiving placebo (hazard ratio 0.83; 95% confidence interval (CI) 0.72 to 0.97; p=0.014).
Danish: Det primære sammensatte endepunkt (død af koronar hjertesygdom (CHD), ikke-dødeligt myokardieinfarkt eller ikke-planlagt hospitalsindlæggelse pga. kardielle brystsmerter) forekom hos 337 (13,1 %) af de patienter, der fik nicorandil 20 mg to gange dagligt, sammenlignet med 389 (15,5 %) af de patienter, der fik placebo (hazard ratio 0,83; 95 % konfidensinterval (CI) 0,72 til 0,97; p=0,014).
English: • Medicine for impotence such as sildenafil, tadalafil or vardenafil.
Danish: • Medicin mod impotens som f.eks. sildenafil, tadalafil eller vardenafil.
English: • Hypovolaemia
Danish: • Hypovolæmi
English: • Very fast, uneven or forceful heart-beat (palpitations)
Danish: • Meget hurtige, uregelmæssige eller kraftige hjerteslag (hjertebanken)
English: In plasma unchanged nicorandil accounted for 45.5% of the radioactive AUC and the alcohol metabolite, N-(2-hydroxyethyl)-nicotinamide for 40.5%.
Danish: I plasma var uomdannet nicorandil ansvarlig for 45,5 % af det radioaktive AUC, og alkoholmetabolitten, N-(2-hydroxyethyl)-nicotinamid, var ansvarlig for 40,5 %.
English: - Gastrointestinal ulcerations Nicorandil induced ulceration may occur at different locations in the same patient.
Danish: Nicorandil-induceret ulceration kan forekomme forskellige steder hos samme patient.
English: In addition, the following adverse reactions have been reported with different frequencies in the IONA (Impact of Nicorandil in Angina) study, where nicorandil has been used on top of standard therapy in patients with stable angina and at high risk of cardiovascular events (see section 5.1).
Danish: Derudover er følgende bivirkninger blevet rapporteret med forskellig hyppighed i IONA- (Impact of Nicorandil in Angina) studiet, hvor nicorandil blev anvendt som supplement til standardbehandling hos patienter med stabil angina og med høj risiko for kardiovaskulære hændelser (se pkt.
English: If you do accidentally take any of these drying agent tablets, they should not harm you but you should straight away talk to your doctor.
Danish: Hvis du ved et uheld kommer til at sluge tørremidlet, vil det sandsynligvis ikke skade dig, men du bør alligevel kontakte din læge straks.
English: Due to lack of data, caution is advised to use nicorandil in patients with heart failure class NHYA III or IV.
Danish: På grund af manglende data skal der udvises forsigtighed ved brug af nicorandil til patienter med NYHA-klasse III eller IV hjertesvigt.
English: Based on available information, the time between starting nicorandil use and the onset of ulceration ranges from shortly after initiating nicorandil treatment to several years after starting nicorandil.
Danish: Baseret på tilgængelige oplysninger kan tiden fra behandlingsstart med nicorandil til udvikling af ulceration variere fra kort tid efter til adskillige år efter initiering af nicorandil.
English: Healthcare professionals should be aware of the importance of a timely diagnosis of nicorandil-induced ulcerations and of a rapid withdrawal of nicorandil treatment in case of occurrence of such ulcerations.
Danish: Læger og sundhedspersonale skal være opmærksomme på vigtigheden af tidlig diagnosticering af nicorandilinducerede ulcerationer og af hurtig seponering af nicorandil i tilfælde af sådanne ulcerationer.
English: • Patients with shock (including cardiogenic shock), severe hypotension, or left ventricular dysfunction with low filling pressure or cardiac decompensation
Danish: • Patienter med shock (herunder kardiogent shock), svær hypotension, venstre ventrikel dysfunktion med lavt fyldningstryk eller kardiel dekompensation
English: • if you have a low blood volume.
Danish: • hvis du har lavt blodvolumen.
English: The metabolism of nicorandil is not significantly affected by cimetidine (a CYP inhibitor), or rifampicin (a CYP3A4 inducer).
Danish: Nicorandils metabolisme påvirkes ikke i signifikant grad af cimetidin (en CYP-hæmmer) eller rifampicin (en CYP3A4-induktor).
English: 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 antianginal therapies and at high risk of cardiovascular events defined by either: 1) previous myocardial infarction, or 2) coronary artery bypass grafting , or 3) coronary artery disease confirmed by angiography, or a positive exercise test in the previous two years, together with one of the following: left ventricular hypertrophy on the ECG, left ventricular ejection fraction ≤45%, or an end diastolic dimension of >55 mm, age
Danish: IONA-studiet var et randomiseret, dobbeltblindet, placebokontrolleret studie med 5.126 patienter over 45 år med kronisk stabil angina, som fik standardbehandling mod angina pectoris, og som havde en høj risiko for kardiovaskulære hændelser, enten defineret ved: 1) tidligere myokardieinfarkt eller 2) koronar bypass-operation eller 3) koronararterie-sygdom bekræftet ved angiografi, eller ved en positiv motionstest inden for de foregående to år sammen med ét af følgende: venstre ventrikelhypertrofi på ekg, venstre ventrikeluddrivningsfraktion ≤45 % eller slutdiastolisk dimension på >55 mm, alder ≥65, diabetes, hypertension, perifer vaskulær sygdom eller cerebrovaskulær sygdom.
English: Severe hyperkalaemia has been very rarely reported with nicorandil.
Danish: Alvorlig hyperkaliæmi er blevet rapporteret meget sjældent med nicorandil.
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: Nicorandil har derudover vist spasmolytisk aktivitet i både in vitro og in vivo studier og ophæver koronarspasme forårsaget af methacholin eller noradrenalin.
English: The metabolism of organic nitrates can result in the formation of nitrites which may trigger methemoglobinemia in patients with glucose-6-phosphate dehydrogenase deficiency.
Danish: Metaboliseringen af organiske nitrater kan resultere i dannelse af nitritter, som kan udløse methæmoglobinæmi hos patienter med glucose-6-phosphat-dehydrogenasemangel.
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: Denne aktivering af kaliumkanaler inducerer vaskulær hyperpolarisering af cellemembranen med arteriel muskelafslappende effekt, hvilket medfører arteriel vasodilation og reduktion af afterload.
English: The usual therapeutic range is 10 to 20 mg twice daily.
Danish: Det sædvanlige terapeutiske område er 10 mg til 20 mg to gange dagligt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for 10 mg and 20 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON til 10 mg og 20 mg
English: • Aspirin (acetylsalicylic acid).
Danish: • Acetylsalicylsyre.
English: Gastrointestinal ulcerations
Danish: Gastrointestinale ulcerationer
English: Nicorandil is principally metabolised in the liver by denitration in a series of compounds without cardiovascular activity.
Danish: Nicorandil metaboliseres hovedsagligt i leveren ved denitrifikation til en række stoffer uden kardiovaskulær aktivitet.
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 (cGMP).
Danish: På grund af dets nitratdel har nicorandil også en afslappende virkning på den vaskulære glatte muskulatur, især i venesystemet, via en stigning i intracellulært cyklisk guanosinmonophosphat (cGMP).
English: • Eye injuries
Danish: • Øjenskader
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg nicorandil.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg nicorandil.
English: It works by increasing the blood flow through the blood vessels of the heart.
Danish: Det virker ved at øge blodgennemstrømningen i hjertets blodkar.
English: Fertility studies showed no effects on mating ability in either male or female rats, but decreases in the number of live fetuses and implantation sites were noted at high doses.
Danish: Fertilitetsstudier viste ingen påvirkning af parringsevnen hos hverken han- eller hunrotter, men et nedsat antal levende fostre og implantationssteder blev observeret ved høje doser.
English: • if you have a build-up of fluid in the lungs (pulmonary oedema).
Danish: • hvis du har væske i lungerne (lungeødem).
English: • High potassium levels in the blood (hyperkalaemia)
Danish: • Højt indhold af kalium i blodet (hyperkalæmi)
English: At steady state, the accumulation ratio (based on AUC) is around 2 for 20 mg bid tablet and 1.7 for 10 mg bid tablet.
Danish: Ved steady state er akkumulationsratio (baseret på AUC) omkring 2 for 20 mg to gange dagligt og 1,7 for 10 mg to gange dagligt.
English: Therefore caution is advised when concomitant use of acetylsalicylic acid or NSAIDs and nicorandil is considered (see section 4.5).
Danish: Der rådes derfor til forsigtighed, hvis samtidig behandling med acetylsalicylsyre eller NSAID og nicorandil overvejes (se pkt.
English: Progressive dose titration may reduce the frequency of these headaches (see section 4.2).
Danish: Gradvis dosistitrering kan reducere hyppigheden af hovedpine (se pkt.
English: QUALITATIVE AND QUANTITAVE COMPOSITION [To be completed nationally]
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING [Udfyldes nationalt]
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkel frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Nicorandil acts in parts through its organic nitrate moiety.
Danish: Nicorandil virker til dels via dets organiske nitratdel.
English: Ulcerations
Danish: Ulcerationer
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrations stedet
English: Do not take aspirin or any medicines for inflammation (corticosteroids).
Danish: Du må ikke tage acetylsalicylsyre eller medicin mod betændelsestilstande (kortikosteroider).
English: Detailed information on this medicine is available on the website of {MS/Agency}
Danish: Andre informationskilder Du kan finde yderligere oplysninger om dette lægemiddel på {medlemsland/myndighed}hjemmeside
English: Do not take this medicine and talk to your doctor if you are taking the following:
Danish: Tag ikke Angicor og tal med lægen, hvis du tager:
English: Decrease of blood-pressure
Danish: Blodtryksfald
English: It is not known whether nicorandil is excreted in human milk, therefore <Invented name> is not recommended during breastfeeding.
Danish: Det er ukendt, hvorvidt nicorandil udskilles i human mælk; derfor frarådes brug af Angicor under amning.
English: If nicorandil is used concomitantly with antihypertensive agents or other medicinal products with blood pressure lowering effect (e.g. vasodilators, tricyclic antidepressants, alcohol), the blood pressure lowering effect may be increased.
Danish: Hvis nicorandil anvendes samtidigt med antihypertensiva eller andre lægemidler med blodtrykssænkende effekt (f.eks. vasodilatorer, tricykliske antidepressiva, alkohol) kan den blodtrykssænkende effekt blive forstærket.
English: PHARMACEUTICAL FORM AND CONTENTS Tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Tabletter