FrancophonIA/ELRC3.0 huggingface dataset:
English: Other antihypertensives, with the exception of ACE-inhibitors, angiotensin II antagonists or beta-blockers were added if necessary to reach the goal blood pressure.
Danish: Andre antihypertensiva, undtagen ACE-hæmmere, angiotensin II-antagonister eller beta-blokkere, blev tilføjet hvis dette var nødvendigt for at opnå det ønskede blodtryk.
English: In patients with heart failure, with or without renal impairment, there is - as with other drugs acting on the renin-angiotensin system - a risk of severe arterial hypotension, and (often acute) renal impairment.
Danish: Hos patienter med hjerteinsufficiens, med eller uden nyreinsufficiens, er der, som med andre lægemidler der påvirker renin-angiotensinsystemet, risiko for svær arteriel hypotension og (ofte akut) nyreinsufficiens.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Danish: Der er rapporteret om reversible forhøjelser i serum lithiumkoncentrationerne samt toksicitet ved samtidig administration af lithium og ACE-hæmmere.
English: if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body (see section 3 ‘Dosage in special patient groups'),
Danish: • hvis De får diuretika (vanddrivende medicin som øger mængden af vand, der passerer ud gennem nyrerne), eller hvis De er på saltbegrænset diæt, som medfører stort tab af væske og salt fra kroppen (se afsnit 3 "Dosering til særlige patientgrupper"),
English: Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy.
Danish: Forhøjet ALAT forekom sjældent og forsvandt sædvanligvis efter seponering af behandlingen.
English: Angiotensin II also stimulates smooth muscle cell proliferation.
Danish: Angiotensin-II stimulerer også formeringen af celler i den glatte muskulatur.
English: Since then the beneficial effect of atenolol regarding CV morbidity and mortality has been questioned.
Danish: Siden er der sat spørgsmålstegn ved den gavnlige virkning af atenolol med hensyn til kardiovaskulær morbiditet og mortalitet.
English: The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years.
Danish: Lægen kan tilråde en lavere dosis, især for visse patienter i starten af behandlingen, f.eks. patienter som får vanddrivende medicin i høje doser, patienter med nedsat leverfunktion eller patienter over 75
English: 1 tablet = 12,5 mg daily Use this card first
Danish: 1 tablet = 12,5 mg dagligt Anvend dette blisterkort først
English: Plasma concentrations of Losartan are not altered in patients with a creatinine clearance above 10 ml/minute.
Danish: Losartans plasmakoncentration er uændret hos patienter med kreatinin-clearance >10 ml/minut.
English: Always take Cozaar exactly as your doctor has instructed you.
Danish: Tag altid Cozaar nøjagtigt efter lægens anvisning.
English: Should exposure to losartan have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis eksponering for losartan har fundet sted fra 2. trimester af graviditeten, anbefales ultralydskontrol af nyrefunktionen og kraniet.
English: if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland).
Danish: • hvis de har primær hyperaldosteronisme (et syndrom der er forbundet med øget udskillelse af hormonet aldosteron fra binyrerne, som skyldes en abnormitet i kirtlen).
English: In the LIFE-Study black patients treated with Losartan had a higher risk of suffering the primary combined endpoint, i.e. a cardiovascular event (e.g. cardiac infarction, cardiovascular death) and especially stroke, than the black patients treated with atenolol.
Danish: I LIFE-undersøgelsen havde de negroide patienter, der havde fået behandling med losartan, større risiko for at blive ramt af det primære sammensatte effektmål, dvs. en kardiovaskulær hændelse (f.eks. hjerteinfarkt, kardiovaskulær død) og især stroke, end de negroide patienter, som blev behandlet med atenolol.
English: In the ELITE Study carried out over 48 weeks in 722 patients with heart failure (NYHA Class II-IV), no difference was observed between the patients treated with Losartan and those treated with captopril was observed with regard to the primary endpoint of a long-term change in renal function.
Danish: I ELITE-undersøgelsen, som var af 48 ugers varighed, sås hos patienter (n=722) med hjerteinsufficiens (NYHA klasse II-IV) ingen forskel mellem de patienter, der blev behandlet med losartan og de patienter, der fik captopril med hensyn til det primære effektmål for en langtidsændring i nyrefunktionen.
English: Limited pharmacokinetic data are available in hypertensive children above one month of age (see 5.2 : Pharmacokinetic properties).
Danish: Der foreligger begrænsede farmakokinetiske data for hypertensive børn, der er over én måned gamle (se afsnit 5.2: Farmakokinetiske egenskaber).
English: Ear and labyrinth disorders: common: vertigo
Danish: Øre og labyrint Almindelig: Vertigo.
English: The main areas of disharmony of the existing Summary of Product Characteristics were section 4.1 Therapeutic Indications, section 4.3 Contraindications, and section 4.4 Special Warnings and Precautions for Use.
Danish: De vigtigste afvigelser i de eksisterende produktresuméer fandtes i afsnit 4.1 Terapeutiske indikationer, afsnit 4.3 Kontraindikationer og afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen.
English: Both biliary and urinary excretion contribute to the elimination of losartan and its metabolites.
Danish: Udskillelse både i galde og urin bidrager til elimination af losartan og dets metabolitter.
English: Like other substances that directly affect the renin-angiotensin system, losartan has been shown to induce adverse effects on the late foetal development, resulting in foetal death and malformations.
Danish: Som andre lægemidler, der direkte påvirker renin-angiotensinsystemet, inducerer losartan bivirkninger i det sene stadie af fosterudviklingen, som medfører fosterdød og misdannelser.
English: happening in 1 in 100 to 1 in 10 patients uncommon happening in 1 in 1,000 to 1 in 100 patients rare:
Danish: Forekommer hos 1 ud af 100 til 1 ud af 10 patienter Ikke almindelig: Forekommer hos 1 ud af 1.000 til 1 ud af 100 patienter Sjælden:
English: Increase in the PRA leads to an increase in angiotensin II in plasma.
Danish: Øget PRA fører til øget koncentration af angiotensin-II i plasma.
English: A recent review in the BMJ shows that specifically the preventive effect on stroke of atenolol is lower than for other antihypertensives; RR of 1.26 (95%CI: 1.15 to 1.38).
Danish: En nylig redegørelse i BMJ (British Medical Journal) viser, at især den forebyggende virkning af atenolol på slagtilfælde er mindre end virkningen af andre antihypertensiva; RR på 1,26 (95 %-konfidensinterval: 1,15-1,38).
English: There are limited data on the efficacy and safety of losartan in children and adolescents aged 6-16 years old for the treatment of hypertension (see 5.1: Pharmacodynamic properties).
Danish: Der er begrænsede data om virkningen af og sikkerheden ved losartan hos børn og unge i alderen 6-16 år i forbindelse med behandling af hypertension (se afsnit 5.1: Farmakodynamiske egenskaber).
English: Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning).
Danish: Nogle patienter kan få yderligere virkning ved øgning af dosis til 100 mg én gang dagligt (om morgenen).
English: When pregnancy is diagnosed, treatment with losartan should be stopped immediately and, if appropriate, alternative therapy should be started.
Danish: Når graviditet diagnosticeres, bør behandling med losartan seponeres omgående, og hvis det er hensigtsmæssigt, bør alternativ behandling påbegyndes.
English: In female hypertensive patients the plasma levels of losartan were up to twice as high as in male hypertensive patients, while the plasma levels of the active metabolite did not differ between men and women.
Danish: Hos hypertensive kvinder var losartans plasmakoncentration op til to gange højere end hos hypertensive mænd, mens den aktive metabolits plasmakoncentration ikke var forskellig mellem mænd og kvinder.
English: Treatment with losartan, as compared with placebo, resulted in a 16.1% risk reduction in the number of patients reaching the primary composite endpoint.
Danish: Behandling med losartan sammenlignet med placebo medførte en risikoreduktion på 16,1 % i antallet af patienter, der nåede det sammensatte primære slutmål.
English: Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorbtion Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Galactoseintolerance, Lapp-lactasemangel, glucose/galactosemalabsorption Patienter med sjælden arvelig galactoseintolerance, Lapp-lactasemangel eller glucose/galactosemalabsorption bør ikke tage denne medicin.
English: Concomitant use of angiotensin II antagonists or diuretics and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Danish: Samtidig anvendelse af angiotensin II-antagonister eller diuretika og NSAID kan medføre øget risiko for forværring af nyrefunktionen, herunder mulig akut nyresvigt og stigning i serumkalium, især hos patienter med eksisterende dårlig nyrefunktion.
English: • severe chest pain (angina pectoris),
Danish: • Stærke smerter i brystet (angina pectoris)
English: • diarrhoea,
Danish: • Diarré
English: • numbness or tingling sensation (paraesthesia),
Danish: • Følelsesløshed eller snurrende fornemmelse (paræstesi)
English: [To be implemented nationally]
Danish: [Udfyldes nationalt]
English: Compared to patients with normal renal function, the AUC for Losartan is about 2-times higher in haemodialysis dialysis patients.
Danish: Sammenlignet med patienter med normal nyrefunktion er losartans AUC ca. 2 gange højere hos patienter i hæmodialyse.
English: The rise in trough diastolic blood pressure was the same in patients receiving placebo and in those continuing losartan at the lowest dose in each group, again suggesting that the lowest dose in each group did not have significant antihypertensive effect.
Danish: Stigningen i det laveste diastoliske blodtryk var dog den samme hos de patienter, der fik placebo, og hos dem, der fortsatte på losartan på den laveste dosis i hver gruppe, hvilket igen antyder, at den laveste dosis i hver gruppe ikke havde en signifikant antihypertensiv virkning.
English: It was found that concomitant treatment of losartan with rifampicine (inducer of matabolism enzymes) gave a 40% reduction in plasma concentration of the active metabolite.
Danish: Samtidig behandling med losartan og rifampicin (inducer af metabolismeenzymer) gav en reduktion på 40% i plasmakoncentrationen af den aktive metabolit.
English: If you become pregnant while on losartan, tell your doctor immediately.
Danish: Hvis De bliver gravid, mens De tager Cozaar, skal De omgående kontakte lægen.
English: The results showed roughly similar pharmacokinetic parameters of losartan following oral administration in infants and toddlers, preschool children, school age children and adolescents.
Danish: Resultaterne viste groft set lignende farmakokinetiske parametre for losartan efter peroral administration hos spædbørn og små børn, børn i førskolealderen, børn i skolealderen samt unge.
English: Angiotensin II binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and elicits several important biological actions, including vasoconstriction and the release of aldosterone.
Danish: Angiotensin-II bindes til den AT1-receptor, som findes i mange væv (f.eks. vaskulær glat muskulatur, binyrerne, nyrerne og hjertet), og frembringer mange betydningsfulde biologiske reaktioner, herunder vasokonstriktion og frigørelse af aldosteron.
English: Following oral administration, plasma concentrations of losartan and its active metabolite decline polyexponentially with a terminal half-life of about 2 hours and 6-9 hours, respectively.
Danish: Efter peroral administration falder losartans og dets aktive metabolits plasmakoncentration polyeksponentielt med en terminal halveringstid på henholdsvis ca. 2 timer og 6-9 timer.
English: The proposed indication is based on the results from the RENAAL study, where the effect of losartan was investigated on a composite primary endpoint of renal endpoints and mortality in patients with Type II diabetes mellitus with proteinuria.
Danish: Den foreslåede indikation er baseret på resultaterne af RENAAL-undersøgelsen, hvori losartans virkning blev undersøgt med et primært slutmål, der var sammensat af nyrerelaterede slutmål og mortalitet hos patienter med type II-diabetes mellitus med proteinuri.
English: Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Danish: Losartan bør anvendes med forsigtighed til patienter med bilateral nyrearteriestenose eller stenose af en arterie, der fører til en solitær nyre.
English: Cozaar may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide).
Danish: Cozaar kan administreres sammen med andre antihypertensiva, især sammen med diuretika (f.eks. hydrochlorthiazid).
English: - The use of losartan in paediatric patients should be included in sections 4.2, 4.4, 4.8, 5.1 and 5.2 of the SPC, and the relevant sections of the Package Leaflet.
Danish: - Anvendelse af losartan til pædiatriske patienter bør inkluderes i afsnit 4.2, 4.4, 4.8, 5.1 og 5.2 i produktresuméet samt i de relevante afsnit i indlægssedlen.
English: Therefore, the CHMP considered that this is an acceptable indication.
Danish: CHMP var derfor af den opfattelse, at denne indikation kan accepteres.
English: if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,
Danish: • hvis De kaster voldsomt op eller har kraftig diarré, som fører til stort tab af væske og/eller salt fra kroppen,
English: During oncedaily dosing with 100 mg, neither losartan nor its active metabolite accumulates significantly in plasma.
Danish: Ved dosering én gang dagligt med 100 mg akkumuleres hverken losartan eller dets aktive metabolit i plasma signifikant.
English: The Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan RENAAL study was a controlled clinical study conducted worldwide in 1513 Type 2 diabetic patients with proteinuria, with or without hypertension.
Danish: RENAAL-undersøgelsen (The Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan) var en kontrolleret, klinisk verdensomspændende undersøgelse med 1513 type 2-diabetikere med proteinuri, med eller uden hypertension.
English: The primary endpoint was the composite of cardiovascular morbidity and mortality as measured by a reduction in the combined incidence of cardiovascular death, stroke and myocardial infarction.
Danish: Det primære effektmål var sammensætningen af kardiovaskulær morbiditet og mortalitet målt ved en reduktion i den kombinerede incidens af kardiovaskulær død, stroke og myokardieinfarkt.
English: If you forget to take Cozaar
Danish: Hvis De har glemt at tage Cozaar
English: Other substances inducing hypotension like tricyclic antidepressants, antipsychotics, baclofene, amifostine: Concomitant use with these drugs that lower blood pressure, as main or side-effect, may increase the risk of hypotension.
Danish: Andre lægemidler, som inducerer hypotension, f.eks. tricykliske antidepressiva, antipsykotika, baclofen, amifostin: Samtidig anvendelse af disse lægemidler, der som hoved- eller sideeffekt sænker blodtrykket, kan øge risikoen for hypotension.
English: Cozaar is used
Danish: Cozaar anvendes til
English: Importantly, an ongoing study (HEAAL) comparing 50mg with 150mg losartan in patients with heart failure, may give relevant information on the dosing issue and address other open issues such as the negative results observed in patients on beta-blockers and losartan.
Danish: Det blev især bemærket, at en løbende undersøgelse (HEAAL), hvori forskerne sammenligner 50 mg losartan med 150 mg losartan hos patienter med hjerteinsufficiens, kan give relevante oplysninger om dosering og behandle problemstillinger såsom de negative resultater, der blev observeret hos patienter, som fik betablokkere og losartan.
English: The long-term efficacy of antihypertensive therapy with losartan in childhood to reduce cardiovascular morbidity and mortality has also not been established.
Danish: Den langsigtede virkning af antihypertensiv behandling med losartan i barndommen, hvad angår reduktion af den kardiovaskulære morbiditet og mortalitet, blev heller ikke fastlagt.
English: In a clinical study conducted in type 2 diabetic patients with nephropathy, 9.9% of patients treated with Losartan tablets developed hyperkalaemia >5.5 mEq/l and 3.4% of patients treated with placebo (see section 4.4, ‘Electrolyte imbalances').
Danish: I en klinisk undersøgelse med type 2-diabetikere med nefropati, udviklede 9,9% af de patienter, der blev behandlet med losartantabletter, og 3,4% af de patienter, der fik placebo, hyperkaliæmi >5,5 mEq/l (se pkt.
English: Hypotension and Electrolyte/Fluid Imbalance
Danish: Hypotension og elektrolyt-/væskeforstyrrelser
English: The dose-response relationship became very obvious in the low dose group compared to the middle dose group (period I: -6.2 mmHg vs. -11.65 mmHg), but was attenuated when comparing the middle dose group with the high dose group (period I: -11.65 mmHg vs. -12.21 mmHg).
Danish: Dosis-respons-forholdet blev meget tydeligt i lavdosisgruppen sammenlignet med mellemdosisgruppen (periode I: -6,2 mmHg kontra -11,65 mmHg), men blev svækket, når mellemdosisgruppen blev sammenlignet med højdosisgruppen (periode I: -11,65 mmHg kontra -12,21 mmHg).
English: In controlled clinical trials for essential hypertension, hypertensive patients with left ventricular hypertrophy, chronic heart failure as well as for hypertension and type 2 diabetes mellitus with renal disease, the most common adverse event was dizziness.
Danish: I kontrollerede kliniske undersøgelser af essentiel hypertension, hypertensive patienter med hypertrofi af venstre ventrikel, kronisk hjerteinsufficiens samt hypertension og type 2-diabetes mellitus med nyresygdom, var den mest almindelige bivirkning svimmelhed.
English: A package containing 35 tablets (21 pcs of 12.5 mg tablet and 14 pcs of the 50 mg tablet) or 28 tablets (21 pcs of 12.5 mg tablet and 7 pcs of the 50 mg tablet) is available in a PVC/PE/PVDC titration blister package.
Danish: En pakning med 35 tabletter (21 stk. à 12,5 mg og 14 stk. à 50 mg) eller 28 tabletter (21 stk. à 12,5 mg og 7 stk. à 50 mg) kan fås i en PVC/PE/PVDC titreringspakning.
English: The combination of losartan with a beta-blocker should be used with caution”.
Danish: Kombinationen af losartan og en betablokker bør anvendes med forsigtighed”.
English: Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure.
Danish: Cozaar forhindrer, at angiotensin II binder sig til disse receptorer, hvilket får blodkarrene til at slappe af og dermed sænker blodtrykket.
English: These conditions should be corrected prior to administration of Cozaar, or a lower starting dose should be used (see section 4.2).
Danish: Disse tilstande bør korrigeres før administration af Cozaar, eller der bør anvendes lavere startdosis (se pkt.
English: 2 tablets = 25 mg once daily
Danish: 2 tabletter = 25 mg dagligt
English: In repeated dose toxicity studies, the administration of losartan induced a decrease in the red blood cell parameters (erythrocytes, haemoglobin, haematocrit), a rise in urea-N in the serum and occasional rises in serum creatinine, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages).
Danish: I gentagne dosistoksicitetsundersøgelser inducerede administration af losartan et fald i de røde blodcelleparametre (erytrocytter, hæmoglobin, hæmatokrit), en stigning i urinstof-N i serum og lejlighedsvise stigninger i serumkreatinin, fald i hjertevægt (uden histologisk korrelat) og gastrointestinale forandringer (læsion af slimhindemembranen, mavesår, erosioner, blødninger).
English: In a clinical trial it was found that fluconazole (inhibitor of CYP2C9) decreases the exposure to the active metabolite by approximately 50%.
Danish: I en klinisk undersøgelse reducerede fluconazol (CYP2C9-hæmmer) eksponeringen over for den aktive metabolit med ca. 50%.
English: Pharmacokinetics in paediatric patients
Danish: Farmakokinetikken hos pædiatriske patienter
English: Patients with a history of angiooedema (swelling of the face, lips, throat, and/ or tongue) should be closely monitored (See section 4.8).
Danish: Patienter med angioødem i anamnesen (hævelse af ansigt, læber, svælg og/eller tunge) bør monitoreres nøje (se pkt.
English: Following oral and intravenous administration of 14C-labeled losartan potassium, circulating plasma radioactivity primarily is attributed to losartan and its active metabolite.
Danish: Efter peroral og intravenøs administration af 14C-mærket losartankalium, er cirkulerende plasmaradioaktivitet primært knyttet til losartan og dets aktive metabolit.
English: Hypertensive type II diabetic patients with proteinuria ≥ 0.5 g/day The usual starting dose is 50 mg once daily.
Danish: Hypertensive type 2-diabetikere med proteinuri ≥0,5 g/dag Normal startdosis er 50 mg én gang dagligt.
English: The adverse experience profile for paediatric patients appears to be similar to that seen in adult patients.
Danish: Bivirkningsprofilen for pædiatriske patienter ser ud til at være den samme som for voksne patienter.
English: In controlled clinical studies, once-daily administration of Losartan to patients with mild to moderate essential hypertension produced statistically significant reductions in systolic and diastolic blood pressure.
Danish: I kontrollerede kliniske undersøgelser, hvor losartan blev administreret én gang dagligt til patienter med mild til moderat essentiel hypertension, opnåedes statistisk signifikant reduktion af systolisk og diastolisk blodtryk.
English: Contra-indications (SPC section 4.3)
Danish: Kontraindikationer (produktresumé, afsnit 4.3)
English: The combination of losartan with a beta-blocker should be used with caution (see section 5.1).
Danish: Kombinationen af losartan og en beta-blokker bør anvendes med forsigtighed (se pkt.
English: Patients who weighted >20kg to < 50 kg received either 2.5, 25 or 50 mg of losartan daily and patients who weighted > 50 kg received either 5, 50 or 100 mg of losartan daily.
Danish: Patienter, som vejede > 20 kg til < 50 kg fik enten 2,5, 25 eller 50 mg losartan dagligt, og patienter, som vejede > 50 kg, fik enten 5, 50 eller 100 mg losartan dagligt.
English: Therefore, concomitant use is not recommended.
Danish: Derfor frarådes samtidig anvendelse.
English: In patients with mild to moderate alcohol-induced hepatic cirrhosis, the plasma levels of losartan and its active metabolite after oral administration were respectively 5 and 1.7 times higher than in young male volunteers (see section 4.2 and 4.4).
Danish: Hos patienter med mild til moderat alkoholinduceret levercirrose var losartans og dets aktive metabolits plasmakoncentration efter peroral administration henholdsvis 5 og 1,7 gange højere end hos unge frivillige mænd (se pkt.
English: EXPO 2000, east wing, sections B1 & B2, 1st fl.
Danish: 55 Nikola Vaptzarov blvd. EXPO 2000, east wing, sections B1 & B2, 1st fl.