FrancophonIA/ELRC3.0 huggingface dataset:
English: The term urinary incontinence is used to describe the condition of involuntary leakage of urine.
Danish: Termen urininkontinens anvendes til at beskrive en tilstand med ufrivillig urinlækage.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Incurin excede the risks for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches, and recommended that Incurin be given a marketing authorisation.
Danish: Udvalget for Veterinærmedicinske Lægemidler (CVMP) konkluderede, at fordelene ved Incurin opvejer risiciene ved behandling af hormonafhængig urininkontinens som følge af sphincter mekanisme inkompetence hos ovariehysterektomerede tæver, og anbefalede udstedelse af markedsføringstilladelse for Incurin.
English: Estriol contained in Incurin is a short-acting natural oestrogen which binds to the oestrogen receptor.
Danish: Den estriol, der er indeholdt i Incurin, er et kortvirkende naturligt østrogen, som binder sig til østrogenreceptoren.
English: What is the risk associated with Incurin?
Danish: Hvilken risiko er der forbundet med Incurin?
English: Why has Incurin been approved?
Danish: Hvorfor blev Incurin godkendt?
English: Scientific findings strongly suggest a relationship between the incidence of urinary incontinence and oestrogen depletion.
Danish: De videnskabelige resultater indicerer kraftigt, at der er en forbindelse mellem forekomsten af urininkontinens og østrogenreduktion.
English: Incurin is not to be used in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches.
Danish: Incurin må ikke anvendes til intakte tæver, da effekten kun er blevet fastslået hos ovariehysterektomerede tæver.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Incurin to Intervet International B.V. on 24 March 2000 and renewed in it 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Incurin til Intervet International B.V.
English: Incurin is used for the treatment of hormone-dependent urinary incontinence resulting from sphincter mechanism incompetence (SMI) in ovariohysterectomised bitches (i.e. in dogs having had the ovaries and uterus removed surgically).
Danish: Incurin anvendes til behandling af hormonafhængig urininkontinens som følge af sphincter mekanisme inkompetence (SMI) hos ovariehysterektomerede tæver (dvs. hos hunde, som kirurgisk har fået fjernet æggestokkene og livmoderen).
English: It is known to occur in bitches, with the incidence being highest after ovariectomy.
Danish: Det er almindelig kendt, at den forekommer hos tæver, med største hyppighed efter ovariektomi.
English: The results show that Incurin is efficient and safe to use against urinary incontinence due to SMI in ovariohysterectomised dogs.
Danish: Resultaterne viser, at Incurin er effektivt og sikkert til anvendelse mod urininkontinens som følge af SMI hos ovariehysterektomerede hunde.
English: What is Incurin?
Danish: Hvad er Incurin?
English: What is Incurin used for?
Danish: Hvad anvendes Incurin til?
English: How has Incurin been studied?
Danish: Hvordan blev Incurin undersøgt?
English: What benefit has Incurin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Incurin?
English: How does Incurin work?
Danish: Hvordan virker Incurin?
English: For advise on dosing please see the Package Leaflet.
Danish: Vejledning i dosering fremgår af indlægssedlen.
English: No changes were introduced.
Danish: Der blev ikke foretaget nogen ændringer.
English: class III and IV).
Danish: klasse III og IV).
English: The results of this PASS are awaited in Q1 2015.
Danish: Resultaterne af denne PASS forventes at foreligge i Q1 2015.
English: In general, it can be stated, that the treatment should be conducted with the lowest effective dose.
Danish: Generelt kan det fastslås, at behandlingen bør ske med den laveste effektive dosis.
English: The European and Asian development plans have been conducted independently in the two different populations.
Danish: Den europæiske og den asiatiske udviklingsplan er tilrettelagt uafhængigt af hinanden hos to forskellige populationer.
English: Labelling The labelling was reviewed during this procedure.
Danish: Etiketteringen blev gennemgået ved denne procedure.
English: The following phrase was recommended regarding the paediatric populations:
Danish: Følgende sætning blev anbefalet for pædiatriske populationer:
English: These doses were therefore used in all the major controlled trials.
Danish: Disse doser blev derfor anvendt i alle de kontrollerede hovedundersøgelser.
English: Ikorel and Dancor medicinal products are registered and marketed in the following EU Members States: Austria, Denmark, France, Ireland, the Netherlands, Portugal and United Kingdom.
Danish: Lægemidlerne Ikorel og Dancor er registreret og markedsføres i følgende EU-medlemsstater: Østrig, Danmark, Frankrig, Irland, Nederlandene, Portugal og Det Forenede Kongerige.
English: The results of the IONA study were summarised following the same wording for both groups of products.
Danish: Resultaterne af IONA-undersøgelsen blev sammenfattet med samme ordlyd for begge grupper af lægemidler.
English: However this was based on limited evidence via literature10 (Ekanayaka, 2014).
Danish: Dette byggede dog på begrænset evidens fra litteraturen10 (Ekanayaka, 2014).
English: The CHMP considers that the DHPC should also inform about the main modifications of the product information following the outcome of this harmonisation procedure; this should be decided at national level by each competent authority, if deemed necessary.
Danish: CHMP finder, at denne DHPC også bør oplyse om de vigtigste ændringer af produktinformationen som resultat af denne harmoniseringsprocedure; dette bør besluttes på nationalt plan af de enkelte kompetente myndigheder, hvis de finder det nødvendigt.
English: While the IONA study does not provide adequate support for a prevention indication, the totality of the data, including IONA, provide good support for the new symptomatic indication proposed above.
Danish: Mens IONA-undersøgelsen ikke giver tilstrækkelig støtte for indikationen forebyggelse, udgør de samlede data, herunder IONA, et godt grundlag for den nye symptomatiske indikation, der foreslås ovenfor.
English: Postural hypotension was observed, although only after the first administration, whether it was 40 or 60 mg.
Danish: Der iagttoges ortostatisk hypotension, dog kun efter den første administration, uanset om der var tale om 40 eller 60 mg.
English: However, strong uncertainties regarding this preventive effect do not allow any recommendation and cannot support such an indication.
Danish: Som følge af den store usikkerhed om denne forebyggende virkning kan der imidlertid ikke fremsættes en anbefaling, og der er ikke grundlag for en sådan indikation.
English: They are also available in the EU under other trade names: Adancor, Angicor and Nicorandil Zentiva.
Danish: De fås desuden i EU under andre handelsnavne: Adancor, Angicor og Nicorandil Zentiva.
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.
Danish: Europa-Kommissionen underrettede sekretariatet for Det Europæiske Lægemiddelagentur/Udvalget for Humanmedicinske Lægemidler (EMA/CHMP) om en officiel indbringelse i medfør af artikel 30 i direktiv 2001/83/EF med henblik på at ophæve divergenserne mellem de nationalt godkendte produktoplysninger for ovennævnte lægemidler og derved harmonisere dem i EU.
English: In addition, this study is limited by the enrolled population with low revascularisation.
Danish: Derudover begrænses undersøgelsen af den indrullerede population med lav revaskularisering.
English: The effect on venous capacitance was less than with nitrates.
Danish: Virkningen på den venøse kapacitans var mindre end virkningen af nitrater.
English: Section 4.1 - Therapeutic indications i. Angina pectoris
Danish: Punkt 4.1 - Terapeutiske indikationer i. Angina pectoris
English: The reduction in preload was proportionally more important than that of the afterload.
Danish: Reduktionen i preload var forholdsvis større end i afterload.
English: <Invented name> is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
Danish: <særnavn> frarådes anvendt hos pædiatriske patienter, da sikkerheden og virkningen ikke er klarlagt hos denne patientgruppe.
English: The CHMP noted that the daily dose in Asiatic patients is below the one defined in European patients.
Danish: CHMP bemærkede, at den daglige dosis hos asiatiske patienter er lavere end den, der er fastlagt for europæiske patienter.
English: There were no major discrepancies between the existing wordings in the different SmPCs.
Danish: Der var ingen større afvigelser mellem den eksisterende ordlyd af de forskellige produktresuméer.
English: The impairment of fertility and the embryotoxicity and peri- and post-natal toxicity were clarified.
Danish: Fertilitetsnedsættelse, embryotoksicitet og peri- og postnatal toksicitet blev tydeliggjort.
English: This risk of ulcerations was mainly established based on safety reports received in association with the marketed product.
Danish: Denne risiko for ulcerationer blev hovedsagelig fastlagt på grundlag af sikkerhedsindberetninger for det markedsførte lægemiddel.
English: Event counts were presented by the different daily doses in the previous Periodic Safety Update Report for nicorandil (reporting period 01-March-2010 to 28- February
Danish: Antallet af hændelser ved de forskellige dagsdoser er angivet i den foregående periodiske sikkerhedsopdateringsrapport for nicorandil (indberetningsperiode 1. marts 2010 - 28. februar 2013).
English: The information/education to gain a knowledge that allows this diagnosis is the best risk minimisation measure identified so far.
Danish: Oplysning/oplæring i den nødvendige viden til at stille denne diagnose er den hidtil bedste påviste risikominimeringsforanstaltning.
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;
Danish: • det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaverne af markedsføringstilladelse, er vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelser i udvalget,
English: Therefore, a contra-indication is not considered justified, however a warning statement is requested by the CHMP.
Danish: En kontraindikation synes derfor ikke berettiget, men CHMP anmodede om, at der blev indsat en advarsel.
English: The net effect is to reduce ventricular preload and afterload.
Danish: Nettovirkningen er mindsket ventrikulær preload og afterload.
English: Caution is advised when nicorandil is used in combination with other medical products that may increase potassium levels (see sections 4.4 and 4.8).
Danish: Forsigtighed anbefales, når nicorandil anvendes i kombination med andre lægemidler, der kan øge kaliumkoncentrationen (se punkt 4.4 og 4.8).
English: Overall summary of the scientific evaluation of Ikorel and associated names, and Dancor and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Ikorel og relaterede navne samt Dancor og relaterede navne (se bilag I)
English: This results in an increased pooling in capacitance vessels with a decrease in preload.
Danish: Dette resulterer i øget ophobning i kapacitanskarrene med mindskelse af preload.
English: This section was clarified by indicating that the tablets should not be removed from the blister strip until intake (with cross references to the sections 4.4 and 6.4) as they are affected by humidity and mentioning of the absence of effect with food intake.
Danish: Dette punkt blev præciseret dels med angivelse af, at tabletten ikke bør fjernes fra blisterkortet, før den indtages (med krydshenvisninger til punkt 4.4 og 6.4), da den er følsom for fugt, dels med nævnelse af manglende virkning ved fødeindtagelse.
English: Therefore, the CHMP is of opinion that this indication is not supported due to lack of appropriate data.
Danish: CHMP anser derfor ikke denne indikation for at være underbygget, da der savnes fyldestgørende data.
English: Several sections of the summary of product characteristics were assessed and re worded.
Danish: Flere punkter i produktresumeet blev gennemgået og omformuleret.
English: Others studies did not enrol patients with stable angina and thus are not relevant to evaluate its efficacy for the treatment of angina.
Danish: Andre undersøgelser indrullerede ikke patienter med stabil angina og er derfor ikke relevante for vurderingen af virkningen til behandling af angina.
English: The mechanism of action of nicorandil as a nicotinamide ester was clarified and the wording harmonised.
Danish: Nicorandils virkningsmekanisme som en nicotinamidester blev præciseret, og ordlyden harmoniseret.
English: Pre-referral meetings between the EMA and marketing authorisation holders (MAHs) were held.
Danish: Inden indbringelsen blev der afholdt forberedende møder mellem EMA og indehaverne af markedsføringstilladelse.
English: Consequently, as none of the performed studies show efficacy at doses lower than 20 mg b.i.d., and as the toxicity is dose dependant and appears at 20 mg b.i.d., the indication should be restricted to second line treatment as recommended in section 4.1 for safety reasons.
Danish: Da ingen af de udførte undersøgelser viser virkning af doser under 20 mg to gange dagligt, og da toksiciteten er dosisafhængig og viser sig ved 20 mg to gange dagligt, bør indikationen af sikkerhedsgrunde begrænses til andetvalgsbehandling som anbefalet i punkt 4.1.
English: However, two contraindications related to the risk of acute pulmonary oedema and hypovolemia were added in this section.
Danish: Der blev dog tilføjet to kontraindikationer vedrørende akut lungeødem og hypovolæmi under dette punkt.
English: According to the risk management plan assessed separately in a worksharing procedure9, a DHPC emphasising the risk of ulceration is already planned to be disseminated in all member states.
Danish: I henhold til den risikostyringsplan, der er vurderet særskilt i en arbejdsdelingsprocedure9, planlægges en direkte henvendelse til sundhedspersoner (DHPC) i alle medlemsstater; risikoen for ulceration vil her blive fremhævet.
English: The statistically significant superiority of a single 5 mg dose over placebo was not considered as relevant evidence for efficacy after repeated dosing, as it was an acute administration only, and this was not the objective of the study.
Danish: Den statistisk signifikante overlegenhed af en enkeltdosis på 5 mg i forhold til placebo blev ikke fundet at være relevant evidens for virkningen efter gentagen dosering, da der kun var tale om akut administration, som ikke var undersøgelsens formål.
English: Therefore the 20 mg daily dose could not be generalised.
Danish: En dagsdosis på 20 mg kan derfor ikke generaliseres.
English: The SG 002 study was an open label non-controlled study and EMD 034 study was a double-blind randomized cross over study.
Danish: Undersøgelse SG 002 var en åben, ukontrolleret undersøgelse, og EMD 034 var en dobbeltblindet, randomiseret overkrydsningsundersøgelse.
English: Furthermore Japanese studies with double blind randomised controlled design have used higher single doses, i.e., 10 or 30 mg nicorandil.
Danish: dobbeltblindet, randomiseret, kontrolleret design er der desuden anvendt højere enkeltdoser, dvs. 10 eller 30 mg nicorandil.
English: The anti-ischemic activity of nicorandil seems to be comparable to that of diltiazem, nifedipine, nitrates and propranolol.
Danish: Den antiiskæmiske virkning af nicorandil synes at være sammenlignelig med virkningen af diltiazem, nifedipin, nitrater og propranolol.
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.
Danish: Halveringstiden på 6-8 timer gør det muligt at dosere to gange dagligt, og en samlet dagsdosis på mellem 10 og 40 mg har været effektiv hos patienter med kronisk stabil angina.
English: For consistency the MAHs should provide a common DHPC, if required by the national authority.
Danish: Af hensyn til ensartetheden bør indehaveren af markedsføringstilladelse forelægge en fælles DHPC, hvis en sådan kræves af den nationale myndighed.
English: Nicorandil has no direct effect on myocardial contractility.
Danish: Nicorandil har ingen direkte virkning på myokardiets kontraktilitet.
English: The number of patients treated by nicorandil per dosage is unavailable; it is thus unknown whether a dose reduction would allow a reduction in ulceration without lack of efficacy.
Danish: Det er ikke oplyst, hvor mange patienter, der blev behandlet med hver dosis af nicorandil; det vides derfor ikke, om dosisreduktion ville have kunnet medført mindre ulceration uden at mindske virkningen.
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.
Danish: Ifølge retningslinjerne for produktresuméer (dateret september 2009) bør punkt 4.2 indeholde en sammenfatning af de foreliggende oplysninger om pædiatriske patienter med brug af visse standarderklæringer.
English: The MAHs should evaluate the impact of this DHPC after it is sent out.
Danish: Indehaverne af markedsføringstilladelserne bør vurdere virkningen af denne DHPC, når den er udsendt.
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.
Danish: Den påviste vigtige risiko for ulceration (gastrointestinal, dermal, mukosal, genital og okulær) og perforationer, fistler og abscesser har været kendt og overvåget siden 1997.
English: Hyperkalaemia occurs infrequently with NSAIDs.
Danish: Hyperkaliæmi optræder ikke ofte i forbindelse med NSAID.
English: However, the 5 mg dose although active in Japanese patients has shown to induce modest haemodynamic changes.
Danish: 5 mg dosen har virkning hos japanske patienter, men udløser imidlertid kun beskedne hæmodynamiske ændringer.
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.
Danish: Det bør heraf fremgå, at nicorandil bør anvendes med forsigtighed hos patienter med glukose-6-fosfat dehydrogenasemangel, da dette kan medføre methæmoglobinæmi ud fra den teoretiske mekanisme for denne proces, der tilskrives metabolisering af organiske nitrater med påfølgende nitritdannelse.
English: Hereafter it is summarised the main points discussed for the harmonisation of the different sections of the SmPC.
Danish: Det følgende er en sammenfatning af hovedpunkterne i drøftelserne af harmoniseringen af de forskellige punkter i produktresuméet.
English: Nicorandil has dual pharmacological effects; activation of ATP-sensitive inward-rectifier potassium channels and (similar to nitroglycerin) increased production of nitric oxide.
Danish: Nicorandil har dobbelt farmakologisk virkning, nemlig aktivering af ATP-følsomme inward-rectifier kaliumkanaler og (ligesom nitroglycerin) øget produktion af kvælstofoxid.
English: Ultimately, this results in an improved oxygen balance in the myocardium and improved blood flow in the post-stenotic areas of the myocardium.
Danish: Dette resulterer i sidste instans i forbedret iltbalance i myokardiet og bedre blodgennemstrømning i de poststenotiske områder af myokardiet.
English: Furthermore, the reduction of enddiastolic pressure and wall tension decreases the extravascular component of vascular resistance.
Danish: Gennem lavere slutdiastolisk tryk og vægspænding mindskes desuden den ekstravaskulære komponent af den vaskulære modstand.
English: The CHMP was therefore of the view that the indication of cardiovascular prevention was not further supported.
Danish: CHMP anså således ikke indikationen kardiovaskulær forebyggelse for at være underbygget yderligere.
English: Therefore, the simultaneous administration of nicorandil with NSAIDs can increase the risk of hyperkalaemia due to a synergistic effect.
Danish: Samtidig administration af nicorandil og NSAID kan derfor øge risikoen for hyperkaliæmi på grund af synergistisk virkning.
English: No dose recommendation is proposed for prevention of CHD events and the product information was adapted accordingly.
Danish: Der foreslås ingen dosisanbefaling til forebyggelse af hændelser vedrørende koronar hjertesygdom, og produktinformationen blev ændret tilsvarende.
English: This section of the SmPC has been harmonised to clarify and harmonise the relevant available information.
Danish: Dette punkt i produktresuméet er blevet harmoniseret, så det præciserer og harmoniserer de relevante foreliggende oplysninger.
English: As specified in the current ICH guidance on ”Ethnic factors in the acceptability of foreign clinical data” dated 1998 evaluation of the pharmacokinetics and pharmacodynamics and their comparability in the three major racial groups most relevant to the ICH regions (Asian, Black, Caucasian) is critical to the registration of medicines in the ICH regions.
Danish: Som angivet i den gældende ICH-vejledning om etniske faktorer i acceptabiliteten af fremmede kliniske data (»Ethnic factors in the acceptability of foreign clinical data«) fra 1998 er det afgørende, der ved registrering af lægemidler i ICH-regionerne foretages en vurdering af farmakokinetik og farmakodynamik og sammenligneligheden heraf hos de tre hovedracegrupper med størst relevans for ICH-regionerne (asiatisk, sort, kaukasisk).
English: The step of a retrospective assessment as part of the pharmacovigilance plan is a pre-requisite for a thorough understanding of the factors leading to the development of ulcerations.
Danish: Retrospektiv vurdering bør indgå i planen for lægemiddelovervågning og er en forudsætning for tilstrækkelig indsigt i de faktorer, der fører til ulceration.
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.
Danish: CHMP anbefalede desuden, at fraværet af farmakodynamisk interaktion mellem nicorandil og acenocoumarol fremgår af produktresuméet med en krydshenvisning til punkt 4.4 for at gøre lægen opmærksom på risikoen for ulceration og den dermed forbundne blødning.
English: Nicorandil is a vasodilator agent used to treat angina.
Danish: Nicorandil er en vasodilator, der anvendes til behandling af angina.
English: Section 5.3 - Precllinical safety data
Danish: Punkt 5.3 - Prækliniske sikkerhedsdata
English: The main objective criterion of efficacy was exercise capacity reported in terms of time to onset of angina, total exercise duration and time to 1 mm ST segment depression.
Danish: Hovedkriteriet for virkning var den fysiske kapacitet, der blev angivet som den tid, der gik før indsættelsen af angina, den totale fysiske aktivitetsvarighed og tiden før 1 mm STsegmentsænkning.
English: It appears that most cases, beside GI ulcerations, were reported at a higher dose than 20 mg/day.
Danish: Størstedelen af tilfældene (bortset fra gastrointestinale ulcerationer) synes at være blevet indberettet ved højere doser end 20 mg dagligt.