FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients and is more likely to occur in patients who have been volumedepleted e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting, or who have severe renin-dependent hypertension (see sections 4.5 “Interaction with other medicaments and other forms of interaction” and 4.8 “Undesirable effects”).
Danish: Symptomatisk hypotension ses sjældent hos patienter med ukompliceret hypertension og opstår mere sandsynligt hos patienter, der er volumendepleterede, fx som følge af diuretisk behandling, saltrestriktioner i kosten, dialyse, diarré eller opkastninger, eller patienter med alvorlig reninafhængig hypertension (se afsnit 4.5 ”Interaktion med andre lægemidler og og andre former for interaktion” og 4.8 ”Bivirkninger”).
English: <COVERSYL and associated names> 4 mg: 4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg perindopril
Danish: <COVERSYL og øvrige navne)> 4 mg: 4 mg perindopril tertiært butylaminsalt svarende til 3,338 mg perindopril
English: In severe heart failure and in other patients considered to be at high risk (patients with impaired renal function and a tendency to have electrolyte disturbances, patients receiving simultaneous treatment with diuretics and/or treatment with vasodilating agents), treatment should be initiated under careful supervision (see 4.4 “Special warnings and special precautions for use”).
Danish: Hos patienter med svær hjerteinsufficiens og andre patienter i en højrisikogruppe (patienter med nedsat nyrefunktion og tendens til elektrolytforstyrrelser, patienter i samtidig behandling med diuretika og/eller behandling med karudvidende midler), skal behandlingen indledes under nøje overvågning (se 4.4 ”Særlige advarsler og forsigtighedsregler vedrørende brugen”).
English: This is especially likely in patients with renal insufficiency.
Danish: Sandsynligheden for dette er især stor hos patienter med nyreinsufficiens.
English: Uncommon: angioedema of face, extremities, lips, mucous membranes, tongue, glottis and/or larynx, urticaria (see 4.4 Special warnings and special precautions for use).
Danish: Ualmindelige: angioødem i ansigt, ekstremiteter, læber, slimhinder, tunge, glottis og/eller larynx, urticaria (se 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: 2 mg perindopril tert-butylamine salt, equivalent to 1.669 mg perindopril <[To be completed nationally]>
Danish: 2 mg perindopril tertiært butylaminsalt svarende til 1,669 mg perindopril <[Udfyldes nationalt]>
English: In hypertensive patients in whom the diuretic cannot be discontinued, therapy with < COVERSYL and associated names> should be initiated with a 2 mg dose.
Danish: Hos hypertensive patienter, hvor den diuretiske behandling ikke kan seponeres, bør behandlingen med <COVERSYL og øvrige navne> indledes med en dosis på 2 mg. Nyrefunktion og serumkalium skal overvåges.
English: Respiratory, thoracic and mediastinal disorders: Common: cough, dyspnoea Uncommon: bronchospasm Very rare: eosinophilic pneumonia, rhinitis
Danish: Respiratoriske, torakale og mediastinale forstyrrelser: Almindelige: hoste, dyspnø Ualmindelige: bronkospasme Meget sjældne: eosinofil pneumoni, næsekatar
English: Potassium sparing diuretics (e.g. spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Danish: Kaliumbesparende diuretika (fx spironolacton, triamteren eller amilorid), kaliumtilskud eller kaliumholdige salterstatninger kan bevirke væsentlige forhøjelser i serumkalium.
English: Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when <COVERSYL and associated names> has been given concomitantly with a diuretic.
Danish: Nogle hypertensive patienter uden kendte tidligere nyrekarsygdomme har udviklet øgede mængder urinstof i blodet og forhøjet serumkreatinin, sædvanligvis i mild og forbigående grad, særligt når COVERSYL er givet samtidig med et diuretikum.
English: 4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg perindopril <[To be completed nationally]>
Danish: 4 mg perindopril tertiært butylaminsalt svarende til 3,338 mg perindopril <[Udfyldes nationalt]>
English: Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and/or larynx has been reported rarely in patients treated with ACE inhibitors, including <COVERSYL and associated names> (see 4.8 Undesirable effects).
Danish: Angioødem i ansigt, ekstremiteter, læber, slimhinder, tunge, glottis og/eller larynx er i sjældne tilfælde rapporteret hos patienter i behandling med ACE-hæmmere, inklusive <COVERSYL og øvrige navne> (se 4.8 Bivirkninger).
English: In patients with a history of myocardial infarction and/or revascularisation, an absolute reduction of 2.2% corresponding to a RRR of 22.4% (95%CI [12.0; 31.6] - p<0.001) in the primary endpoint was observed by comparison to placebo.
Danish: Hos patienter med tidligere myokardieinfarkt og/eller revaskularisering, observeredes en absolut reduktion på 2,2% svarende til en RRRpå 22,4% (95% CI [12,0; 31,6] - p <0,001) i det primære endepunkt sammenlignet med placebo.
English: Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see 4.3 Contraindications).
Danish: Patienter med angioødem i anamnesen, uden relation til ACE-hæmmerbehandling, kan have forhøjet risiko for angioødem ved ACE-hæmmerbehandling (Se 4.3 Kontraindikationer).
English: Skin and subcutaneous tissue disorders:
Danish: Hud- og subkutane vævsforstyrrelser:
English: decreased left and right ventricular filling pressures,
Danish: nedsat fyldningstryk i venstre og højre ventrikel,
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Danish: Reversible forhøjelser i koncentrationer af serumlitium og forgiftning er rapporteret ved samtidig brug af litium og ACE-hæmmere.
English: Decreases in haemoglobin and haematocrit, thrombocytopenia, leucopenia/neutropenia, and cases of agranulocytosis or pancytopenia, have been reported very rarely.
Danish: I meget sjældne tilfælde er der rapporteret reduktioner af hæmoglobin- og hæmatokritvolumen, trombocytopeni, leukopeni/neutropeni og tilfælde af agranulocytose eller pancytopeni.
English: Hypersensitivity/Angioedema:
Danish: Overfølsomhed/Angioødem
English: Concomitant use of certain anaesthetic medicinal products, tricyclic antidepressants and antipsychotics with ACE inhibitors may result in further reduction of blood pressure (see section 4.4).
Danish: Tricykliske antidepressive midler/antipsykotiske midler/narkotiske midler Samtidig brug af visse narkotiske lægemidler, tricykliske antidepressive midler og antipsykotiske midler og ACE-hæmmere kan resultere i yderligere reduktion af blodtrykket (se afsnit 4.4).
English: Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up (see 4.8 Undesirable effects).
Danish: Patienter, der modtager ACE-hæmmerbehandling, og som udvikler ikterus eller markante forhøjelser af leverenzymer, skal seponere ACE-hæmmerbehandlingen og modtage passende medicinsk opfølgning (4.8 Bivirkninger).
English: More patients withdrew for cough, hypotension or other intolerance on perindopril than on placebo, 6.0% (n=366) versus 2.1% (n=129) respectively.
Danish: hoste, hypotension eller anden intolerance, var større i perindopril-gruppen end i placebo-gruppen, nemlig 6,0 % (n=366) mod 2,1 % (n=129).
English: • History of angioedema associated with previous ACE inhibitor therapy;
Danish: • Angioødem i anamnesen i forbindelse med tidligere behandling med en ACE-hæmmer;
English: Common: headache, dizziness, vertigo, paresthaesia Very rare: confusion
Danish: Almindelige: hovedpine, svimmelhed, vertigo, paræstesier Meget sjældne: konfusion
English: Symptomatic heart failure:
Danish: Symptomatisk hjerteinsufficiens
English: Potassium sparing diuretics, potassium supplements or potassium-containing salt substitutes: The combination of perindopril and potassium sparing diuretics, potassium supplements or potassiumcontaining salt substitutes is generally not recommended (see 4.5 Interaction with other medicinal products and other forms of interaction).
Danish: Kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige salterstatninger Samtidig brug af perindopril og kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige salterstatninger anbefales generelt ikke (se 4.5 Interaktion med andre lægemidler og andre former for interaktion).
English: In some patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, who have been treated with ACE inhibitors, increases in blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been seen.
Danish: Hos nogle patienter med bilateral nyrearteriestenose eller stenose af arterien til en solitær nyre er der set øgning i mængden af urinstof i blodet og forhøjelse af serumkreatinin ved behandling med ACEhæmmere.
English: Patients at risk for the development of hyperkalaemia include those with renal insufficiency, uncontrolled diabetes mellitus, or those using concomitant potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin).
Danish: Patienter, som har risiko for at udvikle hyperkaliæmi, omfatter patienter med nyreinsufficiens, ukontrolleret diabetes mellitus eller patienter i samtidig behandling med kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige salterstatninger eller patienter, der tager anden medicin i forbindelse med forhøjet serumkalium (fx heparin).
English: As with other ACE inhibitors, < COVERSYL and associated names> should be given with caution to patients with mitral valve stenosis and obstruction in the outflow of the left ventricle such as aortic stenosis or hypertrophic cardiomyopathy.
Danish: Aorta- og mitralklapstenose/hypertrofisk kardiomyopati Som ved alle andre ACE-hæmmere bør <COVERSYL og øvrige navne> gives med forsigtighed til patienter med mitralklapstenose og obstrueret outflow fra venstre ventrikel, som fx aortastenose eller hypertrofisk kardiomypati.
English: Musculoskeletal, connective tissue and bone disorders: Common: muscle cramps
Danish: Muskelskeletale, bindevævs- og knogleforstyrrelser: Almindelige: muskelkramper
English: Neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors.
Danish: Der er rapporteret neutropeni/agranulocytose, trombocytopeni og anæmi hos patienter i ACEhæmmerbehandling.
English: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.
Danish: Reduktion af risikoen for hjertetilfælde hos patienter med myokardieinfarkt og/eller revaskularisering i anamnesen.
English: Elderly patients should receive 2 mg once daily for one week, then 4 mg once daily the next week, before increasing the dose up to 8 mg once daily depending on renal function (see Table 1 “Dosage adjustment in renal impairment”).
Danish: Ældre patienter skal have 2 mg en gang daglig i en uge og derefter 4 mg en gang daglig i den næste uge, før dosis øges til maksimalt 8 mg en gang daglig afhængigt af nyrefunktionen (se tabel 1 ”Dosisjustering ved nedsat nyrefunktion”).
English: Patients receiving ACE inhibitors during desensitisation treatment (e.g. hymenoptera venom) have experienced anaphylactoid reactions.
Danish: Patienter i ACE-hæmmerbehandling og samtidig desensibiliseringsbehandling (fx hymenoptera venom) har oplevet anafylaktiske reaktioner.
English: Perindopril may be used concomitantly with acetylsalicylic acid (when used as a thrombolytic), thrombolytics, beta-blockers and/or nitrates.
Danish: Acetylsalicylsyre, trombolytter, betablokkere, nitrater Perindopril kan anvendes samtidigt med acetylsalicylsyre (når denne bruges som en trombolyt), trombolytter, betablokkere og/eller nitrater.
English: Perindopril is active in all grades of hypertension : mild, moderate, severe ; a reduction in systolic and diastolic blood pressures in both supine and standing positions is observed.
Danish: Perindopril er aktivt ved alle grader af hypertension: mild, moderat og alvorlig.
English: Most of the patients received the study medication on top of conventional therapy including platelet inhibitors, lipid lowering agents and beta-blockers.
Danish: De fleste af patienterne modtog undersøgelsens medicinering sideløbende med konventionel terapi bestående i trombocytfunktionshæmmende midler, lipidsænkende midler og betablokkere.
English: In elderly patients treatment should be initiated at a dose of 2 mg which may be progressively increased to 4 mg after one month then to 8 mg if necessary depending on renal function (see table below).
Danish: Ved ældre patienter skal behandlingen indledes med en dosis på 2 mg, som gradvist kan øges til 4 mg efter én måned og derpå til 8 mg, hvis det er nødvendigt, alt afhængigt af nyrefunktionen (se nedenstående tabel).
English: Rarely, patients receiving ACE inhibitors during low-density lipoprotein (LDL) apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions.
Danish: Anafylaktiske reaktioner under low density lipoprotein(LDL)-afærese I sjældne tilfælde har patienter i ACE-hæmmerbehandling under low density lipoptrotein (LDL)afærese med dextransulfat oplevet livstruende anafylaktiske reaktioner.
English: Cough has been reported with the use of ACE inhibitors.
Danish: Der er rapporteret hoste ved brug af ACE-hæmmere.
English: Prolonged ACE inhibitor exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Danish: Længerevarig brug af ACE-hæmmere under andet og tredje trimester medfører kendt human fosterforgiftning (nedsat nyrefunktion, oligohydramnion, forsinket forbening af kraniet) og neonatal forgiftning (nyresvigt, hypotension, hyperkaliæmi) (se 5.3 ”Prækliniske sikkerhedsdata”).
English: Neutropenia/Agranulocytosis/Thrombocytopenia/Anaemia:
Danish: Neutropeni/agranulocytose/trombocytopeni/anæmi
English: • Section 5.1 has been updated to include the results of the EUROPA trial as follows: Patients with stable coronary artery disease:
Danish: • Afsnit 5.1 er blevet ajourført, så resultaterne af EUROPA-undersøgelsen indgår på følgende måde:
English: Stable coronary artery disease:
Danish: Stabil koronararteriesygdom:
English: 1.- The Applicant should justify the proposed indication based on the results of the EUROPA trial and relevant published literature on other ACE-Is in terms of patients to be included and goals of therapy.
Danish: 1.- Ud fra resultaterne af EUROPA-undersøgelsen og relevante publicerede artikler om andre ACEhæmmere bør ansøgeren begrunde den foreslåede indikation med hensyn til, hvilke patienter der skal indgå, og behandlingens formål.
English: The CHMP has recommended the granting of the variation of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III for Coversyl and related names (see Annex I).
Danish: CHMP har anbefalet at godkende ændringen af markedsføringstilladelserne (se bilag I).
English: “Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation”.
Danish: "Stabil koronararteriesygdom: Reduktion af risiko for kardiale hændelser hos patienter med tidligere myokardieinfarkt og/eller revaskularisering."
English: Additionally, NSAIDs and ACE inhibitors exert an additive effect on the increase in serum potassium and may result in a deterioration of renal function.
Danish: Nonsteroide antiinflammatoriske lægemidler og ACE-hæmmere kan desuden medvirke til yderligere at forøge serumkalium, hvilket kan resultere i yderligere nedsættelse af nyrefunktionen.
English: No dosage adjustment is necessary in patients with hepatic impairment (see sections 4.4 “Special warnings and special precautions for use” and 5.2 “Pharmacokinetic properties”)
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat leverfunktion (se afsnit 4.4 “Særlige advarsler og forsigtighedsregler vedrørende brugen” og 5.2 ”Farmakokinetiske egenskaber”).
English: Common: nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhoea, constipation Uncommon: dry mouth
Danish: Almindelige: kvalme, opkastninger, mavesmerter, dysgeusi, dyspepsi, diarré, forstoppelse Ualmindelige: tør mund
English: Lithium:
Danish: Litium
English: In man, perindopril has been confirmed to demonstrate vasodilatory properties.
Danish: Det er blevet bekræftet, at perindopril udviser karudvidende egenskaber hos mennesker.
English: In patients with symptomatic heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed.
Danish: Der er observeret symptomatisk hypotension hos patienter med symptomatisk hjerteinsufficiens med eller uden hermed forbundet nyreinsufficiens.
English: ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
Danish: ACE-hæmmere giver højere incidens af angioødem hos patienter af negroid afstamning end patienter af anden afstamning.
English: Non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin ≥ 3 g/day:
Danish: Nonsteroide antiinflammatoriske lægemidler (NSAID) inklusive aspirin ≥ 3 g/dag Indgift af nonsteroide antiinflammatoriske lægemidler kan reducere ACE-hæmmeres antihypertensive effekt.
English: Elevation of liver enzymes and serum bilirubin have been reported rarely.
Danish: I sjældne tilfælde er der rapporteret forhøjelse af leverenzymer og serumbilirubin.
English: Gastro-intestinal disorders:
Danish: Gastrointestinale forstyrrelser:
English: Cardio-vascular disorders:
Danish: Kardiovaskulære forstyrrelser:
English: COVERSYL should be introduced at a dose of 4 mg once daily for two weeks, then increased to 8 mg once daily, depending on renal function and provided that the 4 mg dose is well tolerated.
Danish: Behandling med COVERSYL bør indledes med en dosering på 4 mg én gang dagligt i to uger, der efterfølgende øges til 8 mg én gang dagligt, afhængigt af patientens nyrefunktion og forudsat at doseringen 4 mg tolereres godt.
English: Antihypertensive agents and vasodilators:
Danish: Antihypertensive midler og karudvidende midler
English: Hyperkalaemia:
Danish: Hyperkaliæmi
English: Dosage adjustment in renal impairment:
Danish: Dosisjustering ved nedsat nyrefunktion
English: Antidiabetic agents:
Danish: Antidiabetika
English: Stable coronary artery disease: <COVERSYL and associated names> should be introduced at a dose of 4 mg once daily for two weeks, then increased to 8 mg once daily, depending on renal function and provided that the 4 mg dose is well tolerated.
Danish: Behandling med <COVERSYL and associated names> skal indledes med en dosis på 4 mg en gang daglig i to uger, hvorefter dosis øges til 8 mg en gang daglig afhængigt af nyrefunktionen og forudsat, at en dosis på 4 mg er veltolereret.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients <[To be completed nationally]> 6.2 Incompatibilities <[To be completed nationally]>
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer <[Udfyldes nationalt]>
English: Common: asthenia Uncommon: sweating
Danish: Generelle forstyrrelser: Almindelige: asteni Ualmindelige: sveden
English: A non-statistically significant favourable trend was observed in the other two components.
Danish: For de andre to komponenter sås en ikke-signifikant gunstig tendens.
English: Although serum potassium usually remains within normal limits, hyperkalaemia may occur in some patients treated with perindopril.
Danish: Kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige salterstatninger Selvom serumkalium sædvanligvis forbliver i normalområdet, kan der forekomme hyperkaliæmi hos nogle patienter, der behandles med perindopril.
English: Perindopril may be removed from the general circulation by haemodialysis.
Danish: Perindopril kan fjernes fra det systemiske kredsløb ved hæmodialyse.
English: The recommended treatment of overdosage is intravenous infusion of normal saline solution.
Danish: Den anbefalede behandling af overdosering er intravenøs infusion af saltvandsopløsning Hvis der opstår hypotension, skal patienten anbringes i shockstilling.
English: Although a statistically significant benefit was not shown for two of the three components of the composite endpoint due to the smaller number of occurrences, a positive tendency in favour of perindopril was observed.
Danish: Ansøgeren blev desuden anmodet om at begrunde Perindoprils gavnlige virkning ud over den blotte reduktion af MI. Der blev ikke påvist statistisk signifikant gavnlig virkning for to af de tre komponenter i det sammensatte endepunkt på grund af det mindre antal forekomster, dog var der en positiv tendens i perindoprils favør.
English: (See 5.3 “Preclinical safety data”) Should exposure to perindopril have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Såfremt der er sket brug af perindopril fra andet trimester af graviditeten, anbefales ultralydskontrol af nyrefunktionen og kraniet.
English: Kidney transplantation:
Danish: Nyretransplantation
English: 6.4 Special precautions for storage <[To be completed nationally]> 6.6 Nature and contents of container <[To be completed nationally]> 6.6 Instructions for use and handling < and disposal> <[To be completed nationally]>
Danish: 6.6 Eventuelle instruktioner vedrørende anvendelse og håndtering <[Udfyldes nationalt]>
English: Diuretics:
Danish: Diuretika
English: In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, <COVERSYL and associated names> may block angiotensin II formation secondary to compensatory renin release.
Danish: Kirurgi/anæstesi <COVERSYL og øvrige navne> kan blokere angiotensin II-dannelsen sekundært til kompenserende reninafgivelse hos patienter, som får foretaget større operationer eller under anæstesi med midler, som giver hypotension.
English: Discontinuation of treatment does not lead to a rebound effect.
Danish: Seponering af behandlingen medfører ikke hurtig blodtryksstigning.
English: This is more likely to occur in patients with pre-existing renal impairment.
Danish: Sandsynligheden for dette er større hos patienter, som på forhånd havde nedsat nyrefunktion.
English: Symptomatic hypotension may occur following initiation of therapy with < COVERSYL and associated names>; this is more likely in patients who are being treated concurrently with diuretics.
Danish: Symptomatisk hypotension kan forekomme efter indledning af behandlingen med <COVERSYL og øvrige navne>.
English: As it was expected that the subgroup of patients with a history of revascularisation but with no history of MI was heterogeneous in terms of severity of lesions, revascularisation technique and concomitant treatments, the Applicant was asked to address this issue in order to justify the inclusion of this specific group of patients in the proposed indication.
Danish: Patientundergruppen med tidligere revaskularisering, men uden tidligere MI, forventedes at være uensartet med hensyn til forandringernes sværhed, den anvendte revaskulariseringsteknik og den ledsagende behandling.
English: This dose may be increased by increments of 2 mg at intervals of no less than 2 weeks to 4 mg once daily if tolerated.
Danish: Dosis kan øges med 2 mg i intervaller på mindst 2 uger til 4 mg én gang dagligt, hvis patienten kan tåle det. Justering af dosis skal baseres på den enkelte patients kliniske reaktion.