FrancophonIA/ELRC3.0 huggingface dataset:
English: At the time of the study, beta-blockade alone, or in combination with diuretics had shown to reduce rates of many CV events by 15-45%.
Danish: På tidspunktet for undersøgelsen havde betablokade alene eller i kombination med diuretika vist sig at reducere forekomsten af mange kardiovaskulære hændelser med 15-45 %.
English: Dosage in special patient groups
Danish: Dosering til særlige patientgrupper
English: If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.
Danish: Hvis Deres nyrefunktion er nedsat, kan samtidig brug af disse typer medicin føre til forværring af nyrefunktionen.
English: The most likely symptoms, depending on the extent of overdose, are hypotension, tachycardia, possibly bradycardia.
Danish: De mest sandsynlige symptomer, som afhænger af omfanget af overdosering, er hypotension, takykardi og muligvis bradykardi.
English: Minimal conversion of losartan to its active metabolite was seen in about one percent of individuals studied.
Danish: Der sås minimal omdannelse af losartan til dets aktive metabolit hos ca. 1% af de undersøgte individer.
English: When losartan is administered orally, about 4% of the dose is excreted unchanged in the urine, and about 6% of the dose is excreted in the urine as active metabolite.
Danish: Når losartan administreres peroralt, udskilles ca. 4% af dosis uændret i urinen, og ca. 6% af dosis udskilles via urinen som aktiv metabolit.
English: Both losartan and its active metabolite are ≥99% bound to plasma proteins, primarily albumin.
Danish: Både losartan og dets aktive metabolit bindes ≥99% til plasmaproteiner, primært albumin.
English: Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system.
Danish: Patienter med primær hyperaldosteronisme vil generelt ikke respondere på antihypertensiva, der virker ved hæmning af renin-angiotensinsystemet.
English: WEEK 2 (Day 8-14)
Danish: UGE 2 (dag 8-14)
English: LIFE-Study
Danish: LIFE-undersøgelsen
English: Co-administration of lithium and losartan should be undertaken with caution.
Danish: Samtidig administration af lithium og losartan bør foretages med forsigtighed.
English: • if you have problems with your heart valves or heart muscle,
Danish: • hvis De har problemer med hjerteklapperne eller hjertemusklen,
English: Based on the data submitted during the Article 30 Referral procedure and the outcome of the EU worksharing project assessment of these paediatric data, the CHMP considered that the conclusions of the European Paediatric Worksharing Project on losartan needed to be incorporated into sections 4.2, 4.4, 4.8, 5.1 and 5.2 of Summary of Product Characteristics and the relevant sections of the Package Leaflet.
Danish: På baggrund af de data, der blev indsendt under artikel 30-indbringelsesproceduren, og resultatet af EU-arbejdsgruppens vurdering af disse pædiatriske data var CHMP af den opfattelse, at det europæiske pædiatriske arbejdsprojekt vedrørende losartan skulle inkorporeres i afsnit 4.2, 4.4, 4.8, 5.1 og 5.2 i produktresuméet og de relevante afsnit af indlægssedlen.
English: About 14% of an intravenously- or orally-administered dose of losartan is converted to its active metabolite.
Danish: Ca. 14% af en intravenøs eller peroralt administreret dosis af losartan omdannes til dets aktive metabolit.
English: The following side effects have been reported with Cozaar:
Danish: Følgende bivirkninger er set for Cozaar:
English: These results were confirmed during period II of the study where patients were randomized to continue losartan or placebo, after three weeks of treatment.
Danish: Disse resultater blev bekræftet under periode II i undersøgelsen, hvor patienter blev randomiseret til at fortsætte med losartan eller placebo efter tre ugers behandling.
English: In vitro and in vivo losartan and its pharmacologically active carboxylic acid metabolite E-3174 block all physiologically relevant actions of angiotensin II, regardless of the source or route of its synthesis.
Danish: In vitro og in vivo blokerer losartan og dets farmakologisk aktive carboxylsyremetabolit E-3174 alle fysiologisk relevante virkninger af angiotensin-II, uafhængig af kilde eller syntesevej.
English: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144 Rome
Danish: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144 Rome, Italien
English: WEEK 1 (day 1-7)
Danish: UGE 1 (dag 1-7)
English: Treatment of intoxication
Danish: Behandling af forgiftning
English: If goal blood pressure (< 140/90 mmHg) was not reached, hydrochlorothiazide (12.5 mg) was added first and, if needed, the dose of Losartan or atenolol was then increased to 100 mg once daily.
Danish: Hvis det forud fastsatte blodtryk (<140/90 mmHg) ikke blev nået, tilføjedes først hydrochlorthiazid (12,5 mg) og hvis nødvendigt blev dosis af losartan eller atenolol øget til 100 mg én gang dagligt.
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, INDGIVELSESVEJE, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: As observed for angiotensin converting enzyme inhibitors, losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Danish: Som det blev bemærket i forbindelse med angiotensinkonverterende enzymhæmmere er losartan og de andre angiotensinantagonister tilsyneladende mindre effektive til sænkning af blodtrykket hos negroide personer i forhold til ikke-negroide, muligvis på grund af større prævalens af lav-renin tilstande i den negroide hypertensive population.
English: Cozaar may be taken with or without food.
Danish: De kan tage Cozaar med eller uden mad.
English: It is not known whether losartan is excreted in human milk.
Danish: Det vides ikke, om losartan udskilles i modermælken hos mennesker.
English: The pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups.
Danish: Metabolittens farmakokinetiske parametre adskilte sig i højere grad mellem aldersgrupperne.
English: Read all of this leaflet carefully before taking this medicine.
Danish: Læs denne indlægssseddel grundigt, inden De begynder at tage medicinen.
English: Cozaar 12.5 mg, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
Danish: Cozaar 12.5 mg, 25 mg, 50 mg og 100 mg indeholder kalium i følgende mængder: Henholdsvis 1,06 mg (0,027 mEq), 2,12 mg (0,054 mEq), 4,24 mg (0,108 mEq) og 8,48 mg (0,216 mEq).
English: • elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
Danish: • Forhøjet ALAT (alaninaminotransferase i blodet), som sædvanligvis forsvinder, når behandlingen stoppes.
English: A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
Danish: En alvorlig allergisk reaktion (udslæt, kløe, hævelse af ansigt, læber, mund eller svælg, som gør det svært at synke eller trække vejret).
English: There was also a significant risk reduction for doubling of the serum creatinine and for end-stage renal failure in the patient group treated with losartan.
Danish: Der var desuden en signifikant risikoreduktion, hvad angår fordoblingen af serumkreatinin og terminalt nyresvigt, i den patientgruppe, der blev behandlet med losartan.
English: Patients with High Blood Pressure
Danish: Patienter med forhøjet blodtryk
English: The rates of cardiovascular death and myocardial infarction were not significantly different between the treatment groups.
Danish: Hyppigheden af kardiovaskulær død og myokardieinfarkt var ikke signifikant forskellig behandlingsgrupperne imellem.
English: Symptoms of intoxication
Danish: Symptomer på forgiftning
English: - Renal protection in patients with Type-2 diabetes and proteinuria The CHMP considered the benefit/risk ratio of this indication is positive.
Danish: - Nyrebeskyttelse hos patienter med type 2-diabetes og proteinuri CHMP var af den opfattelse, at benefit/risk-forholdet for denne indikation er positivt.
English: • if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently,
Danish: • hvis De har forsnævring eller blokering af de blodkar, der fører til nyrerne, eller hvis De for nylig har fået nyretransplantation,
English: Angiotensin II, a potent vasoconstrictor, is the primary active hormone of the renin/angiotensin system and an important determinant of the pathophysiology of hypertension.
Danish: Angiotensin-II, der er en potent vasokonstriktor, er det primære aktive hormon i renin-angiotensinsystemet og en betydningsfuld determinant for hypertensions patofysiologi.
English: Measurements of blood pressure 24 hours post-dose relative to 5 - 6 hours post-dose demonstrated blood pressure reduction over 24 hours; the natural diurnal rhythm was retained.
Danish: Blodtryksmåling 24 timer efter dosering i forhold til 5-6 timer efter dosering viste reduktion af blodtrykket i løbet af 24 timer; den naturlige døgnrytme blev bibeholdt.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt Dem, at der er visse sukkerarter, De ikke kan tåle, skal De kontakte Deres læge, før De tager denne medicin.
English: Losartan tablets should be swallowed with a glass of water.
Danish: Losartantabletter bør sluges med et glas vand.
English: • if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 ‘Possible side effects'),
Danish: • hvis De tidligere har haft angioødem (hævelse af ansigt, læber, svælg og/eller tunge) (se også afsnit 4 "Bivirkninger"),
English: Angiooedema.
Danish: Angioødem.
English: As a consequence the observed 25% risk reduction with losartan versus atenolol brings the protective effect of losartan on stroke in the same range as for other antihypertensives.
Danish: Som en følge heraf bringer den iagttagede risikoreduktion på 25 % med losartan versus atenolol den beskyttende virkning af losartan på slagtilfælde på niveau med andre antihypertensiva.
English: However, losartan is excreted in the milk of lactating rats.
Danish: Dog udskilles losartan i mælken hos diende rotter.
English: Special caution is necessary when you are treated with a ß-blocker concomitantly,
Danish: Det er nødvendigt at være særlig forsigtig, hvis De samtidig er i behandling med en beta-blokker,
English: Via G. Fabbroni 6, 00191 Rome, Italy
Danish: Via G. Fabbroni 6, 00191 Rome, Italien
English: • very rapid and irregular heartbeat (artrial fibrillation) brain attack (stroke),
Danish: • Meget hurtige og uregelmæssige hjerteslag (atrieflimren), slagtilfælde (hjernen)
English: Losartan is predominantly metabolised by cytochrome P450 (CYP) 2C9 to the active carboxy-acid metabolite.
Danish: Losartan metaboliseres hovedsageligt via cytokrom P450 (CYP) 2C9 til den aktive carboxylsyremetabolit.
English: Hyperkalaemia (serum potassium >5.5 mmol/l) occurred in 1.5% of patients in hypertension clinical trials.
Danish: (serumkalium >5,5 mmol/l) forekom hos 1,5% af patienterne i hypertensionsundersøgelserne.
English: • too less sugar in the blood (hypoglycaemia),
Danish: • For lidt sukker i blodet (hypoglykæmi)
English: The lowest doses studied, 2.5 mg and 5 mg, corresponding to an average daily dose of 0.07 mg/ kg, did not appear to offer consistent antihypertensive efficacy.
Danish: De laveste doser, der blev undersøgt, 2,5 mg og 5 mg, som svarer til en gennemsnitlig daglig dosis på 0,07 mg/kg, syntes ikke at give en konsistent antihypertensiv virkning.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: Therefore, the proposed indication was considered approvable after a majority vote by the CHMP plenum and is supported with the following wording: “reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy, documented by ECG”.
Danish: Den foreslåede indikation blev derfor godkendt efter en flertalsafstemning på CHMP's plenarmøde og understøttes af følgende ordlyd: “risikoreduktion af slagtilfælde hos hypertensive patienter med ventresidig ventrikelhypertrofi dokumenteret ved EKG”.
English: The observation of the ELITE I Study, that, compared with captopril, Losartan reduced the mortality risk, was not confirmed in the subsequent ELITE II Study, which is described in the following.
Danish: Observationen i ELITE I-undersøgelsen, at losartan reducerede risikoen for dødsfald sammenlignet med captopril, blev ikke bekræftet i den efterfølgende ELITE II-undersøgelse, som beskrives nedenfor.
English: Blood pressure reduction at the end of the dosing interval was 70 - 80 % of the effect seen 5-6 hours postdose.
Danish: Reduktion af blodtrykket i slutningen af dosisintervallet var 70-80% af effekten set 5-6 timer efter dosering.
English: During the referral procedure, the MAH proposed amending the indication to substitute “cardiovascular morbidity and mortality” with “stroke”.
Danish: Under indbringelsesproceduren foreslog indehaveren af markedsføringstilladelsen at ændre indikationen, således at “kardiovaskulær morbiditet og mortalitet” blev erstattet med “slagtilfælde”.
English: • if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain),
Danish: • hvis De har sygdom i hjertets kranspulsårer (forårsaget af nedsat blodgennemstrømning i hjertets blodkar), eller De har sygdom i hjernens blodkar (forårsaget af nedsat blodcirkulation i hjernen),
English: When angiotensin II antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Danish: Når angiotensin II-antagonister administreres samtidigt med NSAID (dvs. selektive COX-2 hæmmere, acetylsalicylsyre i antiinflammatoriske doser og non-selektive NSAID) kan afsvækning af den antihypertensive virkning forekomme.
English: A low dose of hydrochlorothiazide should be added and/ or the dose of Cozaar should be increased to 100 mg once daily based on blood pressure response.
Danish: En lav dosis hydrochlorthiazid bør tilføjes og/eller dosis af Cozaar bør øges til 100 mg én gang dagligt på basis af blodtryksrespons.
English: Losartan may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes, hypertension and microalbuminuria (>30 mg/24 hours) or proteinuria (>900 mg/24 hours).
Danish: Losartan kan desuden udsætte progressionen af diabetisk nefropati og er desuden indiceret til at hæmme progressionen af nyresygdom hos patienter med type 2-diabetes, hypertension og mikroalbuminuri (> 30 mg/24 timer) eller proteinuri (> 900 mg/24 timer).
English: Cozaar (losartan) was included in the list of products for Product Information harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of the Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised SPCs and therefore to harmonise these divergent SPCs across the European Union.
Danish: Listen er udarbejdet af CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentrale godkendelsesprocedurer (human)) i overensstemmelse med artikel 30, stk. 2, i direktiv 2001/83/EF med henblik på at udrede afvigelser mellem de nationalt godkendte produktresuméer og herved harmonisere disse divergerende produktresuméer i hele Den Europæiske Union.
English: Despite these increases, antihypertensive activity and suppression of plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade.
Danish: Selv med disse stigninger bibeholdes den antihypertensive aktivitet og suppressionen af plasmaaldosteronkoncentrationen, hvilket tyder på angiotensin-II-receptorblokering.
English: The Losartan Intervention For Endpoint Reduction in Hypertension [LIFE] study was a randomised, triple-blind, active-controlled study in 9193 hypertensive patients aged 55 to 80 years with ECGdocumented left-ventricular hypertrophy.
Danish: LIFE (The Losartan Intervention For Endpoint Reduction In Hypertension) var en randomiseret, trippelblindet, aktiv kontrolleret undersøgelse foretaget hos 9193 hypertensive patienter i alderen 55 til 80 år med EKG-diagnosticeret hypertrofi af venstre ventrikel.
English: The primary endpoint of the study was a composite endpoint of doubling of the serum creatinine endstage renal failure (need for dialysis or transplantation) or death.
Danish: Undersøgelsens primære effektmål var det kombinerede effektmål med fordobling af serumkreatinin, endstage nyresvigt (behov for dialyse eller transplantation) eller død.
English: After a majority voting at the CHMP plenum, the CHMP recommended that the following wording be proposed to reflect the data from the ELITE I and II studies, within a second-line indication: “Treatment of chronic heart failure (in patients aged 60 or over), when treatment with ACE inhibitors is not considered suitable due to incompatibility or contraindications.
Danish: Efter en flertalsafstemning på CHMP's plenarmøde anbefalede CHMP at foreslå følgende ordlyd med henblik på at sikre overensstemmelse med dataene fra ELITE I og II-undersøgelserne i forbindelse med en andetvalgsindikation: “Behandling af kronisk hjerteinsufficiens (hos patienter i alderen 60 år og derover), når behandling med ACE-hæmmere ikke anses for at være egnet på grund af inkompatibilitet eller kontraindikationer.
English: The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment.
Danish: Den største blodtrykssænkende virkning bør være nået 3-6 uger efter start af behandling.
English: Renal transplantation There is no experience in patients with recent kidney transplantation.
Danish: Nyretransplantation Der er ingen erfaring med patienter, der for nylig er blevet nyretransplanteret.
English: In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta-blocker .
Danish: I behandlingen af nedsat hjertefunktion er Cozaar normalt kombineret med et diuretikum (medicin som øger mængden af vand, der passerer ud gennem nyrerne) og/eller digitalis (medicin som er med til at gøre hjertet stærkere og mere effektivt) og/eller beta-blokkere.
English: However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people.
Danish: Som det dog er tilfældet med megen anden medicin til behandling af forhøjet blodtryk, kan Cozaar medføre svimmelhed eller døsighed hos nogle mennesker.
English: Investigators were instructed to titrate the study medication to 100 mg daily as appropriate; 72 % of patients were taking the 100 mg daily dose for the majority of the time.
Danish: Investigatorerne blev instrueret i at titrere forsøgsmedicinen til 100 mg én gang dagligt, hvis dette var relevant; 72% af patienterne fik 100 mg dagligt det meste af tiden.
English: Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment.
Danish: Baseret på farmakokinetiske data, som viser signifikant forhøjede plasmakoncentrationer af losartan hos cirrhotiske patienter, bør det overvejes at anvende en lavere dosis til patienter med nedsat leverfunktion i anamnesen.
English: Therefore the results observed with losartan in comparison with atenolol in the LIFE study with regard to cardiovascular morbidity/mortality do not apply for black patients with hypertension and left ventricular hypertrophy.
Danish: Derfor var de resultater, der sås for losartan sammenlignet med atenolol i LIFEundersøgelsen med hensyn til kardiovaskulær morbiditet/mortalitet, ikke gældende for negroide patienter med hypertension og hypertrofi af venstre ventrikel.
English: For the following individual and combined components of the primary endpoint, the results showed a significant risk reduction in the group treated with Losartan: 25.3 % risk reduction for doubling of the serum creatinine (p = 0.006); 28.6 % risk reduction for end-stage renal failure (p = 0.002); 19.9 % risk reduction for end-stage renal failure or death (p = 0.009); 21.0 % risk reduction for doubling of serum creatinine or end-stage renal failure (p = 0.01).
Danish: For følgende individuelle og kombinerede komponenter af de primære effektmål viste resultaterne ligeledes signifikant risikoreduktion i gruppen, der blev behandlet med losartan: 25,3% risikoreduktion i fordobling af serumkreatinin (p=0,006); 28,6% risikoreduktion i kronisk nyresvigt (p=0,002); 19,9% risikoreduktion i kronisk nyresvigt eller død (p=0,009); 21,0% risikoreduktion i fordobling af serumkreatinin eller kronisk nyresvigt (p=0,01).
English: Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000 Ljubljana
Danish: Slovenien Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000 Ljubljana, Slovenien
English: • changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure,
Danish: • Forandringer i nyrefunktionen (kan forsvinde ved stop af behandling), herunder nyresvigt
English: Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites.
Danish: Efter peroral administration absorberes losartan godt og undergår first-pass metabolisme, hvorved der dannes en aktiv carboxylsyremetabolit og andre inaktive metabolitter.
English: Germany MSD Chibropharm GmbH Postfach 1202 D-85530 Haar
Danish: MSD Chibropharm GmbH Postfach 1202 D-85530 Haar, Tyskland
English: The reason for this broader indication is that the LIFE study was not a placebo-controlled study, studying the effect on stroke only compared to placebo, but an actively controlled study, comparing a losartan based with an atenolol based antihypertensive treatment using a primary composite endpoint of CV death, stroke and MI.
Danish: Begrundelsen for denne bredere indikation er, at LIFE-undersøgelsen ikke var en placebokontrolleret undersøgelse til vurdering af virkningen på slagtilfælde alene sammenlignet med placebo, men derimod en aktivt kontrolleret undersøgelse, hvori en losartan-baseret antihypertensiv behandling blev sammenlignet med en atenolol-baseret antihypertensiv behandling under anvendelse af det sammensatte primære slutmål kardiovaskulær død, slagtilfælde og myokardieinfarkt.
English: During administration of Losartan, removal of the angiotensin II negative feedback on renin secretion leads to increased plasma renin activity (PRA).
Danish: Under administration af losartan leder fjernelse af angiotensin-II's negative feed-back på reninsekretionen til øget plasmareninaktivitet (PRA).
English: Cozaar This leaflet was last approved in
Danish: Cozaar Denne indlægsseddel blev senest godkendt