FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of the HOPE and PEACE trials seem to support the beneficial effect of perindopril observed in the EUROPA study for patients with medium to high risk of cardiac events.
Danish: Resultaterne af HOPE- og PEACE-undersøgelserne synes at underbygge den gavnlige virkning af perindopril, der er iagttaget i EUROPA-undersøgelsen for patienter med middelhøj til høj risiko for kardiale hændelser.
English: The subsequent dosage of <COVERSYL and associated names> should be adjusted according to blood pressure response.
Danish: Efterfølgende dosering af <COVERSYL og øvrige navne> skal justeres efter blodtryksreaktion.
English: reduced total peripheral vascular resistance,
Danish: reduceret samlet perifer karmodstand,
English: Dosage adjustment in renal insufficiency is desirable depending on the degree of impairment (creatinine clearance).
Danish: Dosisjustering ved nyreinsufficiens er ønskelig, afhængigt af graden af insufficiens (kreatininclearance).
English: Pacemaker therapy is indicated for therapy-resistant bradycardia.
Danish: Pacemaker-behandling er indiceret ved behandlingsresistent bradycardia.
English: NAME OF THE MEDICINAL PRODUCT <COVERSYL and associated names (see Annex I)>, <strength>, tablets <[See Annex I - to be completed nationally]>
Danish: LÆGEMIDLETS NAVN <COVERSYL og øvrige navne (se bilag I)>, <styrke>, tabletter <[Se bilag I - Udfyldes nationalt]>
English: During the randomised period of the EUROPA study, only serious adverse events were collected.
Danish: I den randomiserede periode af EUROPA-undersøgelsen er kun oplysninger om alvorlige bivirkninger blevet indsamlet.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Perindoprilat is eliminated in the urine and the half-life of the unbound fraction is approximately 3 to 5 hours.
Danish: Perindoprilat elimineres i urinen, og halveringstiden for den ubundne fraktion er ca. 3 til 5 timer.
English: It improves large artery elasticity and decreases the media: lumen ratio of small arteries.
Danish: Det forbedrer de store arteriers elasticitet og reducerer de små arteriers media:lumen relation.
English: Coversyl and associated names contain perindopril, a well-known, potent angiotensin converting enzyme inhibitor (ACE-I), marketed in France as Coversyl 2 and 4 mg since 1988, the entire European Union, and world-wide in more than 10 countries including USA and Japan.
Danish: Coversyl og tilknyttede navne indeholder perindopril, en velkendt hæmmer af Angiotensin Converting Enzyme (ACE-hæmmer), der markedsføres i hele EU, bl.a. siden 1988 i Frankrig under navnet Coversyl 2 og 4 mg, foruden i flere end 10 andre lande verden over, herunder USA og Japan.
English: In addition to active perindoprilat, perindopril yields five metabolites, all inactive.
Danish: Ud over det aktive perindoprilat, danner perindopril fem metabolitter, der alle er inaktive.
English: Reproduction toxicology studies (rats, mice, rabbits and monkeys) showed no sign of embryotoxicity or teratogenicity.
Danish: Reproduktionstoksicitetsstudier (rotter, mus, kaniner og aber) viste ingen tegn på embryotoksicitet eller teratogenicitet.
English: Hypertension: Treatment of hypertension
Danish: Hypertension Behandling af hypertension
English: Consistency for secondary variables was also observed and even a significant effect was shown on the occurrence of heart failure in the overall population.
Danish: Der iagttoges desuden konsistens for sekundære variabler, og der påvistes tilmed betydelig effekt på forekomsten af hjerteinsufficiens i den samlede population.
English: Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.
Danish: Vitale tegn, serumelektrolytter og kreatininkoncentrationer skal overvåges vedvarende.
English: In those instances where swelling was confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms.
Danish: I de tilfælde, hvor hævelserne var begrænset til ansigt og læber, er symptomerne generelt svundet uden behandling, selvom antihistaminer har haft gavnlig effekt på symptomerne.
English: In these patients, treatment should be started under close medical supervision with low doses and careful dose titration.
Danish: Hos disse patienter skal behandlingen indledes under tæt lægeligt opsyn med lave doser og omhyggelig dosistitrering.
English: Routine monitoring of potassium and creatinine are part of normal medical practice for these patients (see 4.8 “Undesirable effects”).
Danish: Rutinemæssig kontrol af kalium og kreatinin indgår i den normale medicinske praksis for disse patienter (se 4.8 ”Bivirkninger”).
English: Perindopril reduces left ventricular hypertrophy.
Danish: Perindopril reducerer hypertrofi af venstre ventrikel.
English: If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Danish: Hypotension, som opstår på grund af denne mekanisme, kan korrigeres ved volumenekspansion.
English: Perindopril acts through its active metabolite, perindoprilat.
Danish: Perindopril virker gennem sin aktive metabolit, perindoprilat.
English: Controlled studies with ACE inhibitors have not been done in humans, but in a limited number of cases with first trimester exposure there do not appear to have been any malformations consistent with human foetotoxicity as described below.
Danish: Kontrollerede studier med ACE-hæmmere er ikke gennemført på mennesker, men i et begrænset antal tilfælde af brug i første trimester synes der ikke at have været nogen misdannelser, der kan forenes med human fosterforgiftning som beskrevet nedenfor.
English: In these patients consideration should be given to using a different type of dialysis membrane or different class of antihypertensive agent.
Danish: Hos disse patienter bør det overvejes, om man skal bruge en anden type dialysemembran eller en anden klasse af antihypertensive midler.
English: The dose may be increased to 8 mg once daily after one month of treatment.
Danish: Dosis kan øges til 8 mg én gang dagligt efter en måneds behandling.
English: As a consequence, peripheral blood flow increases, with no effect on heart rate.
Danish: Som følge af dette øges den perifere blodgennemstrømning, uden at hjertefrekvensen påvirkes.
English: Nevertheless the Applicant has tried to address the results of two studies (PEACE and HOPE) where patients with stable CAD and normal fraction ejection were included.
Danish: Ansøgeren har alligevel forsøgt at behandle resultaterne af to undersøgelser (PEACE og HOPE), hvori der indgik patienter med stabil karonararteriesygdom og normal uddrivningsfraktion.
English: Table 1: dosage adjustment in renal impairment creatinine clearance (ml/min)
Danish: Tabel 1: dosisjustering ved nedsat nyrefunktion kreatininclearance (ml/min.)
English: It is possible that this mechanism contributes to the blood pressure-lowering action of ACE inhibitors and is partially responsible for certain of their side effects (e.g. cough).
Danish: Det er muligt, at denne mekanisme medvirker til ACE-hæmmernes blodtrykssænkende virkning og er delvist ansvarlig for nogle af deres bivirkninger (fx hoste).
English: The following undesirable effects have been observed during treatment with perindopril and ranked under the following frequency:
Danish: Følgende bivirkninger er observeret under behandling med perindopril og er inddelt efter hyppighed, som følger:
English: The Company has provided data showing that this population is not so heterogeneous but quite similar to the whole population included in EUROPE study, at least in terms of revascularisation techniques and concomitant treatments.
Danish: Firmaet har fremlagt oplysninger, der viser, at denne patientgruppe ikke er så uensartet, men i vidt omfang svarer til hele populationen i EUROPA-undersøgelsen, i hvert fald hvad angår revaskulariseringsteknik og ledsagende behandling.
English: A starting dose of 2 mg is recommended in such patients and the initiation of treatment should take place under medical supervision.
Danish: Til disse patienter anbefales en startdosis på 2 mg, og behandlingen bør indledes under lægeligt opsyn.
English: No mutagenicity has been observed in in vitro or in vivo studies.
Danish: Der er ikke observeret nogen mutagenicitet i in vitro- eller in vivo- studier.
English: This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment.
Danish: Sandsynligheden for forekomst af dette fænomen var tilsyneladende størst i de første ugers kombinationsbehandling og hos patienter med nedsat nyrefunktion.
English: In the chronic oral toxicity studies (rats and monkeys), the target organ is the kidney, with reversible damage.
Danish: I de kroniske orale toksicitetsstudier (rotter og aber) er målorganet nyren med reversibel skade.
English: Perindopril reduces peripheral vascular resistance, leading to blood pressure reduction.
Danish: Perindopril reducerer den perifere karmodstand, hvilket medfører en reduktion af blodtrykket.
English: (See 4.5 Interaction with other medicinal products and other forms of interaction, Antidiabetics.)
Danish: (Se 4.5 Interaktion med andre lægemidler og andre former for interaktion, Antidiabetika.)
English: • Second and third trimesters of pregnancy (see 4.6 “Pregnancy and lactation”).
Danish: • Graviditet i andet og tredje trimester (se 4.6 ”Graviditet og amning”).
English: Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, emergency therapy should be administered promptly.
Danish: Hvis tunge, glottis eller larynx er involveret, er der risiko for obstruktion af luftvejene, og nødbehandling skal gives omgående.
English: Since ACE inactivates bradykinin, inhibition of ACE also results in an increased activity of circulating and local kallikreinkinin systems (and thus also activation of the prostaglandin system).
Danish: Eftersom ACE inaktiverer bradykinin, resulterer hæmning af ACE også i en forhøjet aktivitet af cirkulerende og lokale kallikrein-kinin-systemer (og dermed også aktivering af prostaglandinsystemet).
English: Therefore the combination of perindopril with the above-mentioned drugs is not recommended (see section 4.4).
Danish: Derfor anbefales samtidig brug af perindopril og de ovennævnte lægemidler ikke (se afsnit 4.4).
English: Anaphylactic reactions during desensitisation:
Danish: Anafylaktiske reaktioner under desensibilisering
English: In the Final Assessment report (dated on 14.02.2005), the indication proposed by the RMS was restricted to “Reduction of risk of recurrent MI in patients with a history of MI” considering that the risk reduction was only demonstrated on the “non fatal MI” component of the primary endpoint and that the effect of perindopril was only clearly established in patients with previous MI.
Danish: I den endelige vurderingsrapport (dateret den 14.2.2005) blev den af referencemedlemsstaten foreslåede indikation begrænset til "Reduktion af risiko for recidiv af MI hos patienter med tidligere MI" i betragtning af, at risikoreduktion kun var påvist for komponenten "ikke dødelig MI" i det primære endepunkt, og at virkningen af perindopril kun var klart godtgjort hos patienter med tidligere MI.
English: The patient should be under close medical supervision until complete and sustained resolution of symptoms has occurred.
Danish: Patienten skal være under omhyggelig observation, indtil symptomerne er svundet fuldstændigt og permanent.
English: Perindopril kinetics are modified in patients with cirrhosis : hepatic clearance of the parent molecule is reduced by half.
Danish: Perindoprils kinetik er modificeret hos patienter med cirrhosis: leverclearance for grundmolekylet halveres.
English: If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline.
Danish: Hvis der opstår hypotension, bør patienten placeres liggende og, om nødvendigt, gives intravenøs infusion af saltvand.
English: ClCR ≥ 60
Danish: ClKR ≥ 60
English: In comparative studies, the first administration of 2 mg of <COVERSYL and associated names> to patients with mild to moderate heart failure was not associated with any significant reduction of blood pressure as compared to placebo.
Danish: I komparative studier er den første dosis af 2 mg <COVERSYL og øvrige navne> hos patienter med mild til moderat hjerteinsufficiens ikke sat i forbindelse med nogen væsentlig nedsættelse af blodtrykket sammenlignet med placebo.
English: The plasma half-life of perindopril is equal to 1 hour.
Danish: Plasmahalveringstiden for perindopril er lig med 1 time.
English: Similar considerations apply to patients with ischaemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
Danish: Lignende overvejelser gør sig gældende for patienter med iskæmisk hjertesygdom eller cerebrovaskulær sygdom, hvor et for stort fald i blodtrykket kan resultere i myokardieinfarkt eller cerebrovaskulære tilfælde.
English: It is recommended that <COVERSYL and associated names>, generally associated with a nonpotassium-sparing diuretic and/or digoxin and/or a beta blocker, be introduced under close medical supervision with a recommended starting dose of 2 mg taken in the morning.
Danish: Det anbefales, at behandlingen med <COVERSYL og øvrige navne>, der normalt sker i forbindelse med et ikke kaliumbesparende diuretikum og/eller digoxin og/eller en betablokker, indledes under tæt lægeligt opsyn med en anbefalet startdosis på 2 mg, der tages om morgenen.
English: If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.
Danish: Hvis samtidig brug er indiceret på grund af påvist hypokaliæmi, skal lægemidlerne anvendes med forsigtighed og hyppig kontrol af serumkalium.
English: The combination of lithium and perindopril is generally not recommended (see 4.5 Interaction with other medicinal products and other forms of interaction).
Danish: Samtidig brug af litium og perindopril anbefales generelt ikke (se 4.5 Interaktion med andre lægemidler og andre former for interaktion).
English: Perindopril is currently indicated for the treatment of hypertension and symptomatic heart failure”.
Danish: Perindopril er på nuværende tidspunkt indiceret til behandling af hypertension og symptomatisk hjerteinsufficiens.
English: As ingestion of food decreases conversion to perindoprilat, hence bioavailability, <COVERSYL and associated names> should be administered orally in a single daily dose in the morning before a meal.
Danish: Eftersom indtagelse af føde nedsætter omdannelsen af perindoprilat og dermed biotilgængeligheden, skal <COVERSYL og øvrige navne> indgives oralt i en enkelt daglig dosis om morgenen før et måltid.
English: Concomitant use of these agents may increase the hypotensive effects of perindopril.
Danish: Samtidig brug af disse lægemidler kan forøge den hypotensive effekt af perindopril.
English: In diabetic patients treated with oral antidiabetic agents or insulin, glycaemic control should be closely monitored during the first month of treatment with an ACE inhibitor.
Danish: Hos diabetespatienter, der behandles med orale antidiabetika eller insulin, skal den glykæmiske kontrol overvåges nøje under den første måneds behandling med en ACE-hæmmer.
English: Acute renal failure, usually reversible, has been reported in this situation.
Danish: I denne situation er der rapporteret om akut nyresvigt, som regel reversibelt.
English: There is no experience regarding the administration of < COVERSYL and associated names> in patients with a recent kidney transplantation.
Danish: Der er ingen erfaringer med hensyn til behandling med <COVERSYL og øvrige navne> hos patienter, som for nylig har fået foretaget nyretransplantation.
English: Reproductive system and breast disorders: Uncommon: impotence
Danish: Reproduktionssystem- og brystforstyrrelser: Ualmindelige: impotens
English: The possibility of hypotensive effects can be reduced by discontinuation of the diuretic, by increasing volume or salt intake prior to initiating therapy with low and progressive doses of perindopril.
Danish: Muligheden for hypotensive virkninger kan reduceres ved at seponere den diuretiske behandling og dermed øge volumen- eller saltindtaget før initiering af behandlingen med lave og gradvist større doser af perindopril.
English: 2.- The second issue addresses the question whether the beneficial effect may extend beyond a mere reduction of MI to a reduction of cardiac events.
Danish: 2.- Det andet punkt vedrører, hvorvidt den gavnlige virkning ud over den blotte reduktion i myokardieinfarkt kan tænkes at strække sig til en reduktion af kardiale hændelser.
English: The higher percentage of patients who had at least 70% narrowing of one or more major arteries (82.4% vs. 60.5%) would reflect serious coronary lesions in the group of patients with a history of revascularisation and with no history of MI.
Danish: Den højere procentdel af patienter med en forsnævring på mindst 70 % af en eller flere større arterier (82,4 % mod 60,5 %) måtte forventes at afspejle svære koronarforandringer hos gruppen af patienter med tidligere revaskularisering og uden tidligere MI.
English: Evaluation of Clinical Efficacy
Danish: Vurdering af klinisk virkning
English: Concomitant use with nitroglycerin and other nitrates, or other vasodilators, may further reduce blood pressure.
Danish: Samtidig brug af nitroglycerin og andre nitrater eller andre karudvidende midler kan reducere blodtrykket yderligere
English: Dosage in patients with renal impairment should be based on creatinine clearance as outlined in table 1 below:
Danish: Dosis hos patienter med nedsat nyrefunktion skal baseres på kreatininclearance, som vist i nedenstående tabel 1:
English: 2 mg on the day of dialysis * Dialysis clearance of perindoprilat is 70 ml/min.
Danish: 2 mg på dialysedagen * Dialyseclearance for perindoprilat er 70 ml/min.
English: ACE inhibitors may cause a fall in blood pressure.
Danish: ACE-hæmmere kan forårsage fald i blodtrykket.
English: Ear and labyrinth disorders: Common: tinnitus
Danish: Øre- og labyrintforstyrrelser: Almindelige: tinnitus
English: Dialysis clearance of perindoprilat is equal to 70 ml/min.
Danish: Dialyseclearance for perindoprilat er lig med 70 ml/min.
English: As further consistency is shown for the secondary variables, it is reasonable to extend the indication from “reduction of MI” to “reduction of cardiac events”, a term that includes patients with a history of MI and/or a history of revascularisation.
Danish: Da der er vist yderligere konsistens for de sekundære variabler, er det rimeligt at udvide indikationen fra "reduktion af MI" til "reduktion af kardiale hændelser", et begreb, der indbefatter patienter med tidligere MI og/eller tidligere revaskularisering.
English: Since treatment with diuretics may be a contributory factor to the above, they should be discontinued and renal function should be monitored during the first weeks of <COVERSYL and associated names> therapy.
Danish: Eftersom behandling med diuretika kan være en medvirkende faktor ved ovennævnte, skal en sådan behandling seponeres, og nyrefunktionen skal overvåges under de første ugers behandling med <COVERSYL og øvrige navne>.
English: • The following description of the observed side-effects has been added in Section 4.8: Clinical trials:
Danish: • Følgende beskrivelse af de iagttagne bivirkninger er tilføjet i afsnit 4.8:
English: 4 mg per day
Danish: 4 mg pr. dag
English: Difficulties in making comparisons among the different trials are recognised as they include a different population and use different endpoints.
Danish: Det er almindelig anerkendt, at det er vanskeligt at sammenligne på tværs af forskellige kliniske undersøgelser, da de omfatter forskellige patientgrupper og har forskelligt endepunkt.
English: If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered.
Danish: Behandling med angiotensin II-infusion og/eller intravenøse katekolaminer kan, hvis dette er tilgængeligt, også overvejes.
English: An adjunctive therapy with a thiazide diuretic produces an additive-type of synergy.
Danish: Supplerende behandling med et thiazid-diuretikum giver en synergisk additiv virkning.
English: Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death.
Danish: I sjældne tilfælde er ACE-hæmmere blevet sat i forbindelse med et syndrom, der starter med cholestatisk ikterus og progredierer til fulminant levernekrose og (undertiden) død.
English: Consistency was noted between the various components of the primary endpoint although significance was only reached for prevention of MI. A significant effect was noted on the occurrence of heart failure.
Danish: Det bemærkedes, at der var konsistens mellem de forskellige komponenter i det primære endepunkt, selv om der kun var signifikans for beskyttelse mod MI. Der bemærkedes en signifikant virkning på forekomsten af hjerteinsufficiens.
English: The EUROPA study was a multicentre, international, randomised, double-blind, placebocontrolled clinical trial lasting 4 years.
Danish: EUROPA-forsøget var et internationalt, randomiseret, dobbeltblindt, placebokontrolleret klinisk multicenterforsøg af 4 års varighed.
English: 2 mg every other day
Danish: 2 mg hver anden dag
English: For patients on haemodialysis, the dose should be taken after dialysis.
Danish: Hos patienter i hæmodialyse skal dosis tages efter dialysen.
English: In perindopril-treated patients, hypotension was observed in 6 patients, angioedema in 3 patients and sudden cardiac arrest in 1 patient.
Danish: Hos de perindopril-behandlede patienter iagttoges hypotension hos 6 patienter, angioødem hos 3 patienter og pludseligt hjertestop hos 1 patient.
English: Inhibition of ACE results in a reduction of angiotensin II in the plasma, which leads to increased plasma renin activity (by inhibition of the negative feedback of renin release) and reduced secretion of aldosterone.
Danish: Hæmning af ACE resulterer i en reduktion af angiotensin II i plasmaet, som bevirker en øget plasmareninaktivitet (ved hæmning af den negative feedback fra reninfrigørelse) og reduceret sekretion af aldosteron.
English: Use of perindopril with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see section 4.4).
Danish: Samtidig brug af perindopril og litium anbefales ikke, men hvis dette er nødvendigt, skal serumlitiumkoncentrationerne overvåges nøje (se afsnit 4.4).
English: Patients with stable coronary artery disease:
Danish: Patienter med stabil koronararteriesygdom:
English: In the same patients, these reactions have been avoided when the ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.
Danish: Hos de samme patienter er disse reaktioner undgået, når ACE-hæmmerbehandlingen blev pauseret, men vendte tilbage efter utilsigtede belastninger.
English: Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function.
Danish: Perindopril skal anvendes med ekstrem forsigtighed hos patienter med kollagene karsygdomme, immunsuppressiv behandling, behandling med allopurinol eller procainamid eller en kombination af disse komplicerende faktorer, især hvis der er kendt tidligere nedsat nyrefunktion.