FrancophonIA/ELRC3.0 huggingface dataset:
English: The indication under review is based on the results of the EUROPA study, a trial designed to evaluate the ability of Perindopril to reduce the risk of the combined endpoint of cardiovascular death, non-fatal acute MI and cardiac arrest with successful resuscitation in patients with stable coronary heart disease, without evidence of heart failure.
Danish: Den omhandlede indikation bygger på resultaterne af EUROPA-undersøgelsen, hvis formål var at vurdere Perindoprils evne til at mindske risikoen for det kombinerede endepunkt, der bestod af kardiovaskulære dødsfald, ikke-dødeligt akut MI og hjertestop med vellykket genoplivning, hos patienter med stabil koronar hjertesygdom uden tegn på hjerteinsufficiens.
English: (See 4.4 Special warnings and special precautions for use, Haemodialysis Patients.)
Danish: (Se 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen, Hæmodialysepatienter.)
English: 2 mg per day
Danish: 2 mg pr. dag
English: Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE).
Danish: Perindopril er en hæmmer af det enzym, der omdanner angiotensin I til angiotensin II (Angiotensin Converting Enzyme, ACE).
English: In some patients with congestive heart failure who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with < COVERSYL and associated names>.
Danish: Hos nogle patienter med kongestiv hjerteinsufficiens, hvis blodtryk er normalt eller lavt, kan der forekomme yderligere nedsættelse af det systemiske blodtryk ved behandling med <COVERSYL og øvrige navne>.
English: The combination of an ACE inhibitor and a thiazide also decreases the risk of hypokalaemia induced by the diuretic treatment.
Danish: Kombinationen af en ACE-hæmmer og et thiazid mindsker også risikoen for hypokaliæmi som følge af den diuretiske behandling.
English: Twelve thousand two hundred and eighteen (12218) patients aged over 18 were randomised to perindopril 8 mg (n=6110) or placebo (n=6108).
Danish: Tolvtusindtohundredeogatten (12218) patienter over 18 år blev randomiseret til 8 mg perindopril (n=6110) eller placebo (n=6108).
English: • Hypersensitivity to perindopril, to any of the excipients or to any other ACE inhibitor;
Danish: • Overfølsomhed over for perindopril, et eller flere af hjælpestofferne eller enhver anden ACE
English: Marketing Authorisation Holder
Danish: Indehaver af markedføringstilladelse
English: Pregnancy and lactation: (See section 4.3 “Contraindications” and section 4.6 “Pregnancy and lactation”).
Danish: Graviditet og amning (Se afsnit 4.3 ”Kontraindikationer” og afsnit 4.6 ”Graviditet og amning”).
English: Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose.
Danish: Patienter med et stærk aktiveret renin-angiotensin-aldosteronsystem (især renovaskulær hypertension, salt- og/eller volumendepletering, cardial dekompensation eller alvorligt forhøjet blodtryk) kan opleve et for stort fald i blodtrykket efter den indledende dosis.
English: At its meeting of 25-28 July 2005, the CHMP considered the data on efficacy presented by the MAHs and concluded that it had been shown that Coversyl and associated names was effective in the reduction of risk of cardiac events in patients with stable coronary artery disease with a history of myocardial infarction and/or revascularisation.
Danish: På sit møde den 25.-28. juli 2005 behandlede CHMP de af indehaverne af markedsføringstilladelsen fremlagte oplysninger, og konkluderede, at det var godtgjort, at Coversyl og tilknyttede navne var effektivt til reduktion af risiko for kardiale hændelser hos patienter med stabil koronararteriesygdom og tidligere myokardieinfarkt og/eller revaskularisering.
English: Blood and the lymphatic system disorders:
Danish: Forstyrrelser i blod- og lymfekarsystemet:
English: Elimination of perindoprilat is decreased in the elderly, and also in patients with heart or renal failure.
Danish: Eliminering af perindoprilat er nedsat hos ældre patienter samt hos patienter med hjerte- eller nyreinsufficiens.
English: The converting enzyme, or kinase, is an exopeptidase that allows conversion of angiotensin I into the vasoconstrictor angiotensin II as well as causing the degradation of the vasodilator bradykinin into an inactive heptapeptide.
Danish: Det konverterende enzym, eller kinase, er en exopeptidase, der tillader omdannelse af angiotensin I til det karsammentrækkende angiotensin II samt forårsager nedbrydning af det karudvidende bradykinin til et inaktivt heptapeptid.
English: As with other ACE inhibitors, perindopril may be less effective in lowering blood pressure in black people than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.
Danish: Som det er tilfældet med andre ACE-hæmmere, kan perindopril være mindre effektiv til sænkning af blodtrykket hos patienter af negroid afstamning end patienter af anden afstamning, muligvis på grund af en højere prævalens af tilstande med lavt renin hos hypertensive patienter af negroid afstaming.
English: Psychiatric disorders: Uncommon: mood or sleep disturbances
Danish: Psykiatriske forstyrrelser: Ualmindelige: humørsvingninger eller søvnforstyrrelser
English: • The posology in Section 4.2 has been updated as follows:
Danish: • Doseringsanvisningen i afsnit 4.2 er ajourført således:
English: However, angiotensin converting enzyme inhibitors, as a class, have been shown to induce adverse effects on late foetal development, resulting in foetal death and congenital effects in rodents and rabbits: renal lesions and an increase in peri- and postnatal mortality have been observed.
Danish: Dog er ACE-hæmmere som klasse påvist at have negative virkninger på den sene fosterudviklng, der resulterer i fosterdød og medfødte defekter hos gnavere og kaniner: Der er observeret nyrelæsioner og en øget peri- og postnatal mortalitet.
English: Hypertension: < COVERSYL and associated names> may be used in monotherapy or in combination with other classes of antihypertensive therapy.
Danish: Hypertension <COVERSYL og øvrige navne> kan bruges som monoterapi eller i kombination med andre former for behandling mod hypertension
English: Clinical trials:
Danish: Kliniske forsøg:
English: Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicines (insulins, oral hypoglycaemic agents) may cause an increased blood-glucose lowering effect with risk of hypoglycaemia.
Danish: Epidemiologske studier antyder, at samtidig brug af ACE-hæmmere og antidiabetiske lægemidler (insulin, orale hypoglykæmiske midler) kan forårsage en øget blodsukkersænkende effekt med risiko for hypoglykæmi.
English: Few patients experienced serious adverse events: 16 (0.3%) of the 6122 perindopril patients and 12 (0.2%) of the 6107 placebo patients.
Danish: Alvorlige bivirkninger optrådte hos få patienter: 16 (0,3 %) af de 6 122 perindopril-patienter og 12 (0,2 %) af de 6 107 placebo-patienter.
English: The Applicant was also requested to justify the indication based on the results of relevant published literature on other ACE-Is in terms of patients to be included and goals of therapy.
Danish: Ansøgeren blev desuden anmodet om at begrunde indikationen ud fra resultater fra relevant litteratur vedrørende andre ACE-hæmmere, dels hvad angår de patienter, der skal indgå, dels behandlingens formål.
English: This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment.
Danish: Sandsynligheden for dette er størst hos de patienter , der har mere alvorlige grader af hjerteinsufficiens, som afspejlet i brugen af høje doser loop-diuretika, hyponatriæmi eller nedsat nyrefunktion.
English: Heart failure: Treatment of symptomatic heart failure
Danish: Hjerteinsufficiens Behandling af symptomatisk hjerteinsufficiens
English: In cases of renal impairment (creatinine clearance < 60 ml/min) the initial perindopril dosage should be adjusted according to the patient's creatinine clearance (see 4.2 “Posology and method of administration”) and then as a function of the patient's response to treatment.
Danish: I tilfælde af nedsat nyrefunktion (kreatininclearance < 60 ml/min) skal startdosis af perindopril justeres efter patientens kreatininclearance (se 4.2 ”Dosering og indgivelsesmåde”) og derpå efter patientens respons på behandlingen.
English: The treatment with perindopril 8 mg once daily resulted in a significant absolute reduction in the primary endpoint of 1.9% (relative risk reduction of 20%, 95%CI [9.4; 28.6] - p<0.001).
Danish: Behandlingen med perindopril 8 mg en gang daglig resulterede i en signifikant absolut reduktion i det primære endepunkt på 1,9% (relativ risikoreduktion på 20% (95% CI [9,4; 28,6] - p<0,001).
English: A beneficial effect of perindopril was observed for all individual subcomponents of the primary combined endpoint, although only the risk reduction in “non-fatal MI” reached statistical significance.
Danish: Der sås en gavnlig virkning af perindopril for hver enkelt delkomponent i det primære kombinerede endepunkt, dog var risikoreduktionen kun signifikant for "ikke-dødelig MI."
English: This wording was based on a significant relative risk reduction (RRR) of 20% (95% CI [9.4; 28.6] p=0.0003) in the primary combined endpoint of cardiovascular mortality, non-fatal myocardial infarction (MI) or cardiac arrest with successful resuscitation observed in the EUROPA study.
Danish: Denne ordlyd byggede på den signifikante relative risikoreduktion (RRR) på 20 % (95 % SI [9,4; 28,6] p=0,0003) som i EUROPA-undersøgelsen blev iagttaget for det primære kombinerede endepunkt kardiovaskulær dødelighed, ikke-dødeligt myokardieinfarkt (MI) og hjertestop med vellykket genoplivning.
English: If concomitant use of the abovementioned agents is deemed appropriate, regular monitoring of serum potassium is recommended.
Danish: Hvis det anses for passende at anvende samtidig behandling med ovennævnte midler, anbefales regelmæssig kontrol af serumkalium.
English: • The MAH has implemented the text proposed by the CHMP in the SPC:
Danish: • Indehaveren af markedsføringstilladelsen har i produktresuméet anvendt den af CHMP foreslåede tekst:
English: Very rare: hepatitis either cytolytic or cholestatic (see section 4.4 Special warnings and special precautions for use)
Danish: Meget sjældne: hepatitis, enten cytolytisk eller cholestatisk (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen)
English: If an episode of unstable angina pectoris (major or not) occurs during the first month of perindopril treatment, a careful appraisal of the benefit/risk should be performed before treatment continuation.
Danish: Hvis der indtræffer en (større eller mindre) episode med ustabil angina pectoris i løbet af den første måneds behandling med perindopril, skal fordele og risici afvejes nøje, før behandlingen fortsættes.
English: Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and enhance the already increased risk of lithium toxicity with ACE inhibitors.
Danish: Samtidig brug af thiazid-diuretika kan forhøje risikoen for litiumforgiftning og øge den allerede eksisterende risiko for litiumforgiftning ved ACE-hæmmere.
English: • no untoward safety findings related to the extension of the indication have been identified.
Danish: • Der har ikke været ugunstige fund af sikkerhedsmæssig art i forbindelse med indikationsudvidelsen
English: In patients with symptomatic heart failure, hypotension following the initiation of therapy with ACE inhibitors may lead to some further impairment in renal function.
Danish: Hos patienter med symptomatisk hjerteinsufficiens, kan hypotension efter initiering af behandlingen med ACE-hæmmere medføre yderligere nedsættelse af nyrefunktionen.
English: Heart failure: <COVERSYL and associated names> reduces cardiac work by a decrease in pre-load and after-load.
Danish: Hjerteinsufficiens <COVERSYL og øvrige navne> reducerer hjertearbejdet gennem reduceret for- og efterbelastning.
English: Rarely, acute renal failure may occur, especially in patients with compromised renal function such as those who are elderly or dehydrated.
Danish: I sjældne tilfælde kan der forekomme akut nyresvigt, især hos patienter med nedsat nyrefunktion, som fx ældre eller dehydrerede patienter.
English: Eye disorders: Common: vision disturbance
Danish: Øjenforstyrrelser: Almindelige: synsforstyrrelser
English: ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Danish: ACE-hæmmerinduceret hoste skal overvejes som en del af den differentiale diagnose ved hoste.
English: Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
Danish: Symptomer i forbindelse med overdosering af ACE-hæmmere kan omfatte hypotension, kredsløbsshock, elektrolytforstyrrelser, nyresvigt, hyperventilation, tachycardia, palpitationer, bradycardia, svimmelhed, angst og hoste.
English: Angioedema associated with laryngeal oedema may be fatal.
Danish: Angioødem kan sammen med ødem af larynx være fatalt.
English: The dose should be individualised according to the patient profile (see 4.4 “Special warnings and special precautions for use”) and blood pressure response.
Danish: Dosis skal fastlægges efter individuel vurdering af patientprofilen (se 4.4 ”Særlige advarsler og forsigtighedsregler vedrørende brugen”) og patientens blodtryksreaktion.
English: 15 < ClCR < 30
Danish: 15 < ClKR < 30
English: If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with < COVERSYL and associated names> (see section 4.4 “Special warnings and special precautions for use”).
Danish: Hvis det er muligt, bør den diuretiske behandling seponeres 2 til 3 dage, før behandlingen med <COVERSYL og øvrige navne> indledes (se afsnit 4.4 ”Særlige advarsler og forsigtighedsregler vedrørende brugen”).
English: If hypotension becomes symptomatic, a reduction of dose or discontinuation of < COVERSYL and associated names> may be necessary.
Danish: Hvis hypotensionen bliver symptomatisk, kan det være nødvendigt at reducere dosis eller seponere behandlingen med <COVERSYL og øvrige navne>.
English: If renovascular hypertension is also present there is an increased risk of severe hypotension and renal insufficiency.
Danish: Hvis patienten også har renovaskulær hypertension, er der en forhøjet risiko for alvorlig hypotension og nyreinsufficiens.
English: Patients at high risk of symptomatic hypotension e.g. patients with salt depletion with or without hyponatraemia, patients with hypovolaemia or patients who have been receiving vigorous diuretic therapy should have these conditions corrected, if possible, prior to therapy with <COVERSYL and associated names>.
Danish: Patienter med høj risiko for symptomatisk hypotension, fx patienter, der er saltdepleterede med eller uden hyponatriæmi, patienter med hypovolæmi eller patienter, der har modtaget kraftig diuretikabehandling, skal så vidt muligt have disse tilstande korrigeret før behandling med <COVERSYL og øvrige navne>.
English: Common: hypotension and effects related to hypotension Very rare: arrhythmia, angina pectoris, myocardial infarction and stroke, possibly secondary to excessive hypotension in high-risk patients (see 4.4 Special warnings and special precautions for use).
Danish: Almindelige: hypotension og virkninger relateret til hypotension Meget sjældne: rytmeforstyrrelser, angina pectoris, myokardieinfarkt og slagtilfælde, muligvis sekundært til udtalt hypotension hos højrisikopatienter (se 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: The trial population had evidence of coronary artery disease with no evidence of clinical signs of heart failure.
Danish: Den population, som undersøgelsens omfattede, viste tegn på koronararteriesygdom uden kliniske tegn på hjerteinsufficiens.
English: 30 < ClCR < 60
Danish: 30 < ClKR < 60
English: Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including perindopril.
Danish: Der er observeret forhøjet serumkalium hos nogle patienter, der er blevet behandlet med ACEhæmmere, inklusive perindopril.
English: Diabetic patients:
Danish: Diabetespatienter
English: Dosage reduction and/or discontinuation of the diuretic and/or <COVERSYL and associated names> may be required.
Danish: Dosisreduktion og/eller seponering af den diuretiske behandling og/eller COVERSYL kan være påkrævet.
English: However, the quantity of perindoprilat formed is not reduced and therefore no dosage adjustment is required (see also sections 4.2 “Posology and method of administration” and 4.4 “Special warnings and special precautions for use”).
Danish: Dog reduceres mængden af dannet perindoprilat ikke, og derfor er dosisjustering ikke påkrævet (se også afsnit 4.2 ”Dosering og indgivelsesmåde” og 4.4 “Særlige advarsler og forsigtighedsregler vedrørende brugen”).
English: Blood pressure, renal function and serum potassium should be monitored closely, both before and during treatment with <COVERSYL and associated names> (see section 4.4 “Special warnings and special precautions for use”).
Danish: Blodtryk, nyrefunktion og serumkalium skal nøje overvåges, både før og under behandling med <COVERSYL og øvrige navne> (se afsnit 4.4 ”Særlige advarsler og forsigtighedsregler vedrørende brugen”).
English: The main efficacy criterion was the composite of cardiovascular mortality, non fatal myocardial infarction and/or cardiac arrest with successful resuscitation.
Danish: Hovedkriteriet for virkning var sammensat af kardiovaskulær dødelighed, ikke dødeligt myokardieinfarkt og/eller hjertestop med vellykket genoplivning.
English: Therefore the use of <COVERSYL and associated names> is not recommended in women who are breast-feeding.
Danish: Derfor frarådes brugen af <COVERSYL og øvrige navne> til kvinder, der ammer.
English: Increases in blood urea and plasma creatinine, hyperkalaemia reversible on discontinuation may occur, especially in the presence of renal insufficiency, severe heart failure and renovascular hypertension.
Danish: Der kan forekomme forhøjede mængder urinstoffer i blodet, stigning i plasmakreatinin og hyperkaliæmi, især i tilfælde af nyreinsufficiens, alvorlig hjerteinsufficiens og renovaskulær hypertension.
English: In patients with a congenital deficiency of G-6PDH, very rare cases of haemolytic anaemia have been reported (see section 4.4 Special warnings and special precautions for use).
Danish: Hos patienter med en medfødt mangel på G-6PDH er der i meget sjældne tilfælde rapporteret hæmolytisk anæmi (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: In patients at increased risk of symptomatic hypotension, initiation of therapy and dose adjustment should be closely monitored (see 4.2 “Posology and method of administration” and 4.8 “Undesirable effects”).
Danish: Hos patienter med forhøjet risiko for symptomatisk hypotension, skal initiering af behandlingen og dosisjustering overvåges nøje (se 4.2 ”Dosering og indgivelsesmåde” og 4.8 ”Bivirkninger”).
English: The Applicant should focus in particular on the patients with a history of revascularisation but without history of MI, as this population is heterogeneous in terms of severity of lesions, revascularisation technique and concomitant treatments.
Danish: Navnlig bør ansøgeren fokusere på patienter med tidligere revaskularisering, men uden tidligere MI, da denne population er uensartet hvad angår forandringernes sværhed og den anvendte revaskulariseringsteknik og ledsagende behandling.
English: MARKETING AUTHORISATION HOLDER <[See Annex I- to be completed nationally]>
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN <[Se bilag I - Udfyldes nationalt]>
English: These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
Danish: Disse reaktioner blev undgået ved at pausere ACE-hæmmerbehandlingen før hver afærese.
English: Overall, 90% of the patients had a previous myocardial infarction and/or a previous coronary revascularisation.
Danish: Tilsammen havde 90 % af patienterne tidligere haft myokardieinfarkt og/eller tidligere koronar revaskularisering.
English: Background information on the type II variation through the MRP
Danish: Baggrundsoplysninger om type II-ændringen via den gensidige anerkendelsesprocedure
English: Patients on diuretics, and especially those who are volume and/or salt depleted, may experience excessive reduction in blood pressure after initiation of therapy with an ACE inhibitor.
Danish: Patienter i diuretisk behandling, og især volumen- og/eller saltdepleterede patienter, kan opleve et for stort fald i blodtrykket efter initiering af behandling med en ACE-hæmmer.
English: At the end of the MRP procedure there was a discrepancy between CMS regarding the wording of the indication that adequately reflects the EUROPA data.
Danish: Ved afslutningen af den gensidige anerkendelsesprocedure havde de berørte medlemsstater anvendt forskellig ordlyd af den indikation, der skulle afspejle oplysningerne fra EUROPA-undersøgelsen.
English: This may include the administration of adrenaline and/or the maintenance of a patent airway.
Danish: Denne kan inkludere indgift af adrenalin og/eller forholdsregler med henblik på at sikre patienten tilstrækkelig lufttilførsel.
English: In the light of the above the CHMP concludes that the proposed indication for Coversyl “Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation” is adequately supported by the information provided.
Danish: På baggrund af ovenstående konkluderer CHMP, at den ansøgte indikation for Coversyl "Stabil koronararteriesygdom: Reduktion af risiko for kardiale hændelser hos patienter med tidligere myokardieinfarkt og/eller revaskularisering" er tilstrækkeligt underbygget af de forelagte oplysninger.
English: <COVERSYL and associated names> 2 mg: 2 mg perindopril tert-butylamine salt, equivalent to 1.669 mg perindopril
Danish: <COVERSYL og øvrige navne> 2 mg: 2 mg perindopril tertiært butylaminsalt svarende til 1,669 mg perindopril
English: • It is proposed to add the following indication in section 4.1: “Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.”
Danish: • foreslås det at tilføje følgende indikation i afsnit 4.1: "Stabil koronararteriesygdom: Reduktion af risiko for kardiale hændelser hos patienter med tidligere myokardieinfarkt og/eller revaskularisering."
English: Nervous system disorders:
Danish: Forstyrrelser i nervesystemet:
English: Anaphylactoid reactions have been reported in patients dialysed with high flux membranes, and treated concomitantly with an ACE inhibitor.
Danish: Der er rapporteret anafylaktiske reaktioner hos patienter dialyseret med high-flux membraner i samtidig behandling med en ACE-hæmmer.
English: Uncommon: renal insufficiency Very rare: acute renal failure
Danish: Ualmindelige: nyreinsufficiens Meget sjældne: akut nyresvigt
English: Sympathomimetics: Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Danish: Sympathomimetiske midler Sympathomimetiske midler kan reducere den antihypertensive effekt af ACE-hæmmere.