FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no sufficient therapeutic experience with losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA class IV) as well as in patients with heart failure and symptomatic life threatening cardiac arrhythmias.
Danish: Der er begrænset terapeutisk erfaring med losartan til patienter med hjerteinsufficiens og samtidig svær nyreinsufficiens, til patienter med svær hjerteinsufficiens (NYHA klasse IV) samt til patienter med hjerteinsufficiens og symptomatisk livstruende hjertearytmi.
English: Whilst the ELITE I indicated an reduction in risk of mortality due to heart failure in patients taking losartan, as compared to captopril, the ELITE II study was not powered to establish equal efficacy between losartan and captopril.
Danish: ELITE I påviste en reduceret risiko for mortalitet som følge af hjerteinsufficiens hos patienter, der tager losartan, sammenlignet med patienter, der tager captopril, hvorimod ELITE II-undersøgelsen ikke havde styrke til at fastslå, om virkningen af losartan og captopril er ligeværdig.
English: This applies particularly when losartan is given in the presence of other conditions (fever, dehydratation) likely to impair renal function.
Danish: Dette gælder især, når losartan gives, hvor andre tilstande er til stede (feber, dehydrering), der kan nedsætte nyrefunktionen.
English: Doses above 1.4 mg/ kg (or in excess of 100 mg) daily have not been studied in pediatric patients.
Danish: Doser over 1,4 mg/kg (eller mere end 100 mg) dagligt er ikke blevet undersøgt hos pædiatriske patienter.
English: The plasma concentrations of the active metabolite are not altered in patients with renal impairment or in heamodialysis patients.
Danish: Den aktive metabolits plasmakoncentrationer er uændret hos patienter med nyreinsufficiens eller hos patienter i hæmodialyse.
English: Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively.
Danish: Losartans og dets aktive metabolits gennemsnitlige maksimalkoncentration nås i løbet af henholdsvis 1 time og 3-4 timer.
English: In this study losartan was generally well tolerated, as shown by a therapy discontinuation rate on account of adverse events that was comparable to the placebo group.
Danish: Losartan var i denne undersøgelse generelt veltålt, dokumenteret ved en seponeringsincidens på grund af bivirkninger svarende til placebos.
English: Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Danish: Cozaar tilhører en medicingruppe, der er kendt som angiotensin II-receptorantagonister.
English: The difference in blood pressure increase as compared to placebo was largest in the middle dose group (6.70 mm Hg middle dose vs. 5.38 mmHg high dose).
Danish: Forskellene i blodtryksstigningen sammenlignet med placebo var størst i middeldosisgruppen (6,70 mmHg for middeldosis kontra 5,38 mmHg for højdosis).
English: WHAT Cozaar IS AND WHAT IT IS USED FOR
Danish: COZAARS VIRKNING OG HVAD DE SKAL BRUGE DET TIL
English: Neopharmed SpA Via G. Fabbroni 6, 00191 Rome, Italy
Danish: Neopharmed SpA Via G. Fabbroni 6, 00191 Rome, Italien
English: Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten.
Danish: Angiotensin II er et stof, der dannes i kroppen, og som binder sig til receptorer i blodkarrene og får dem til at trække sig sammen.
English: The usual starting and maintenance dose is 50 mg once daily for most patients.
Danish: Normal start- og vedligeholdelsesdosis er 50 mg én gang dagligt til de fleste patienter.
English: - Heart Failure (as second line, when ACE inhibitors are unsuitable).
Danish: - Hjerteinsufficiens (som andetvalgspræparat, når ACE-hæmmere ikke er egnede).
English: • low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics),
Danish: • Lavt blodtryk (især efter stort tab af vand fra blodkarrene i kroppen, f.eks. hos patienter med alvorligt nedsat hjertefunktion eller ved behandling med store doser vanddrivende medicin)
English: The LIFE study has been assessed in the past and this has led to the registration of the more extensive indication, i.e. the reduction of the cardiovascular morbidity and mortality (as measured by the combined incidence of CV death, stroke and MI) instead of stroke only.
Danish: LIFE-undersøgelsen er tidligere blevet evalueret, hvilket førte til registrering af den mere omfattende indikation, dvs. reduceret kardiovaskulær morbiditet og mortalitet (som målt ved den kombinerede forekomst af kardiovaskulær død, slagtilfælde og myokardieinfarkt) i stedet for slagtilfælde alene.
English: Pregnancy and Lactation
Danish: Graviditet og amning
English: Tatoiou Street, Nea Erythraia 14671 Greece
Danish: Grækenland VIANEX A.E. Tatoiou Street, Nea Erythraia 14671, Grækenland
English: • shortness of breath (dyspnoea),
Danish: • Åndenød (dyspnø)
English: The usual initial dose of Cozaar in patients with heart failure is 12.5 mg once daily.
Danish: Den normale startdosis for Cozaar til patienter med hjerteinsufficiens er 12,5 mg én gang dagligt.
English: In a controlled clinical trial on patients with cardiac insufficiency, increase in blood urea, serum creatinine and serum potassium has been reported.
Danish: I en kontrolleret, klinisk undersøgelse med patienter med hjerteinsufficiens er der blevet rapporteret om øget carbamid og serumkreatinin samt serumkalium.
English: • too much potassium in the blood (hyperkalaemia).
Danish: • For meget kalium i blodet (hyperkaliæmi).
English: SPECIAL STORAGE CONDITIONS Store in the original bottle.
Danish: UDLØBSDATO Udløbsdato SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale flaske.
English: In the LIFE study an additional benefit was noted with regards to stroke for the losartan based strategy, and effects were similar with regard to MI and CV mortality, indicating that the demonstrated beneficial effect of beta-blockade on CV morbidity and mortality in general was also present for losartan.
Danish: I LIFE-undersøgelsen blev der registreret en yderligere fordel med hensyn til slagtilfælde under anvendelse af den losartanbaserede strategi, og virkningerne var tilsvarende, hvad angår myokardieinfarkt og kardiovaskulær mortalitet, hvilket peger på, at den påviste gavnlige virkning af betablokade på kardiovaskulær morbiditet og mortalitet generelt set også gjaldt for losartan.
English: For patients with intravascular volume-depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section 4.4).
Danish: Til patienter med intravaskulær væskemangel (f.eks. i forbindelse med højdosis diuretikabehandling) bør en startdosis på 25 mg én gang dagligt overvejes (se pkt.
English: • itching (pruritus),
Danish: • Kløe (pruritus)
English: The dose may be increased to 100 mg once daily based on blood pressure response from one month after initiation of therapy onwards.
Danish: Dosis kan øges til 100 mg én gang dagligt afhængigt af blodtryksrespons efter én måneds behandling.
English: -Reduction in risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy” (“LIFE indication”)”
Danish: -Risikoreduktion af kardiovaskulær morbiditet og mortalitet hos hypertensive patienter med “venstresidig ventrikelhypertrofi (“LIFE-indikationen”)”.
English: • back pain and urinary track infection.
Danish: • Rygsmerter og urinvejsinfektion.
English: Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
Danish: Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
English: Therapeutic Indications (SPC section 4.1)
Danish: Terapeutiske indikationer (produktresumé, afsnit 4.1)
English: Unless continued ARB therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Med mindre fortsat ARB-behandling anses for at være essentiel, bør patienter, der planlægger graviditet, skiftes til alternative anithypertensive behandlinger, som har en etableret sikkerhedsprofil for anvendelse under graviditet.
English: What Cozaar contains
Danish: Cozaar indeholder
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som det er tilfældet med andre vasodilatorer er særlig forsigtighed indiceret hos patienter, der har aorta- eller mitralstenose eller obstruktiv hypertrofisk kardiomyopati.
English: Investigations: common: hypoglycaemia, hyperkalaemia
Danish: Undersøgelser Almindelig: Hypoglykæmi, hyperkaliæmi.
English: Treatment with losartan resulted in a 13.0% risk reduction (p=0.021, 95 % confidence interval 0.77-0.98) compared with atenolol for patients reaching the primary composite endpoint.
Danish: Behandlingen med losartan resulterede i en risikoreduktion på 13% (p=0,021, 95% konfidensinterval 0,77-0,98) sammenlignet med atenolol for patienter, der nåede det primære sammensatte effektmål.
English: Chronic heart failure
Danish: Kronisk hjerteinsufficiens
English: In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily.
Danish: I særlige tilfælde kan dosis justeres til maksimalt 100 mg én gang dagligt.
English: Treatment with losartan reduced the risk of stroke by 25% relative to atenolol (p=0.001 95% confidence interval 0.63-0.89).
Danish: Behandling med losartan reducerede risikoen for stroke med 25% i forhold til atenolol (p=0,001, 95% konfidensinterval 0,63-0,89).
English: In both comparator-controlled (not placebo-controlled) clinical studies on patients with heart failure the tolerability of Losartan was superior to that of captopril, measured on the basis of a significantly lower rate of discontinuations of therapy on account of adverse events and a significantly lower frequency of cough.
Danish: I begge disse sammenlignende kontrollerede (ikke placebokontrollerede) kliniske undersøgelser af hjerteinsufficienspatienter tåltes losartan generelt bedre end captopril målt ved en signifikant lavere incidens af seponering på grund af bivirkninger og en signifikant lavere incidens af hoste.
English: • inflammation of the liver (hepatitis),
Danish: • Leverbetændelse (hepatitis)
English: Other antihypertensive agents (diuretics, calcium antagonists, alpha- and beta-receptor blockers and also centrally acting antihypertensives) were permitted as supplementary treatment depending on the requirement in both groups.
Danish: Andre antihypertensive lægemidler (diuretika, calciumantagonister, alfa- og betablokkere samt centralt virkende antihypertensiva) var tilladt som tillægsbehandling efter behov i begge grupper.
English: The pharmacokinetics of losartan and its active metabolite are linear with oral losartan potassium doses up to 200 mg.
Danish: Losartans og dets aktive metabolits farmakokinetik er lineær med perorale doser af losartankalium på op til 200 mg.
English: Nervous system disorders: not known: migraine
Danish: Nervesystemet Ikke kendt: Migræne.
English: Coronary heart disease and cerebrovascular disease As with any antihypertensive agents, excessive blood pressure decrease in patients with ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke.
Danish: Koronar hjertesygdom og cerebrovaskulær sygdom Som det er tilfældet med andre antihypertensiva kan et kraftigt fald i blodtrykket hos patienter med iskæmisk kardiovaskulær og cerebrovaskulær sygdom medføre myokardieinfarkt eller stroke.
English: Bulgaria Merck Sharp & Dohme Bulgaria EOOD
Danish: Merck Sharp & Dohme Bulgaria EOOD
English: In controlled clinical trials for essential hypertension with losartan the following adverse events were reported
Danish: I kontrollerede kliniske undersøgelser af essentiel hypertension med losartan blev følgende bivirkninger rapporteret:
English: Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofene, amifostine,
Danish: Blodtrykkes kan også sænkes med en af følgende typer/slags medicin: Tricyklisk antidepressiv medicin,
English: • Treatment of essential hypertension.
Danish: • Behandling af essentiel hypertension.
English: Cardiac disorder: Uncommon: palpitations, angina pectoris
Danish: Hjerte Ikke almindelig: Palpitationer, angina pectoris.
English: Hypertensive patients with left ventricular hypertrophy In a controlled clinical trial in hypertensive patients with left ventricular hypertrophy the following adverse events were reported:
Danish: Hypertensive patienter med hypertrofi af venstre ventrikel I en kontrolleret undersøgelse med hypertensive patienter med hypertrofi af venstre ventrikel blev følgende bivirkninger rapporteret:
English: Electrolyte imbalances
Danish: Elektrolytforstyrrelser
English: Data in the paediatric population are limited.
Danish: Der foreligger begrænsede data for den pædiatriske population.
English: The use of losartan is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and
Danish: Anvendelse af losartan er kontraindiceret i 2. og 3. trimester af graviditeten (se pkt.
English: The following wording has been added to SPC Section 4.4 Special warnings and precautions for use:
Danish: Følgende ordlyd er tilføjet produktresuméets afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen:
English: Cozaar 25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7 or 28 tablets.
Danish: Cozaar 25 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 7 eller 28 tabletter.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Cozaar and associated names (see Annex I).
Danish: anbefaler CHMP ændring af markedsføringstilladelserne for Cozaar og tilknyttede navne (se bilag I).
English: The results showed that the treatment with Losartan (327 events) as compared with placebo (359 events) resulted in a 16.1 % risk reduction (p = 0.022) in the number of patients reaching the primary composite endpoint.
Danish: Resultaterne viste, at behandling med losartan (327 hændelser) sammenlignet med placebo (359 hændelser) gav 16,1% risikoreduktion (p=0,022) for, at patienter nåede det primære, samlede effektmål.
English: Neither Losartan nor the active metabolite can be removed by haemodialysis.
Danish: Hverken losartan eller den aktive metabolit kan fjernes ved hæmodialyse.
English: Hypertension Studies
Danish: Hypertensionsundersøgelser
English: - Treatment of essential hypertension
Danish: - Behandling af essentiel hypertension
English: Do not take Cozaar
Danish: Tag ikke Cozaar hvis
English: The following wording has been added to SPC Section 5.1.Pharmacodynamic Properties:
Danish: Følgende ordlyd er tilføjet produktresuméet, afsnit 5.1 Farmakodynamiske egenskaber:
English: Concomitant use of losartan and ACE-inhibitors has shown to impair renal function.
Danish: Samtidig brug af losartan og ACE-hæmmere har vist sig at svække nyrefunktionen.
English: Uncommon: symptomatic hypotension (especially in patients with intravascular volume depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics), dose-related orthostatic effects, rash.
Danish: Ikke almindelig: Symptomatisk hypotension (især hos patienter med intravaskulær væskemangel, f.eks. patienter med svær hjerteinsufficiens eller i behandling med højdosis diuretika), dosisrelateret orthostatiske effekter, udslæt.
English: Losartan is a synthetic oral angiotensin-II receptor (type AT1) antagonist.
Danish: Losartan er en syntetisk, peroral angiotensin-II-receptorantagonist (type AT1).
English: Therefore, the CHMP proposed that the indication should be re-worded to “Treatment of renal disease in patients with hypertension and Type II diabetes mellitus with proteinuria > 0.5g/day as part of an antihypertensive treatment” to reflect the inclusion criteria of the RENAAL study.
Danish: CHMP foreslog derfor, at indikationen skulle ændres til “Behandling af nyresygdom hos patienter med hypertension og type IIdiabetes mellitus med proteinuri > 0,5 g/dag som led i en antihypertensiv behandling”, således at den ville stemme overens med inklusionskriterierne i RENAAL-undersøgelsen.
English: The active substance is losartan potassium.
Danish: Det aktive indholdsstof er losartankalium.
English: Unless continued losartan therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Med mindre losartanbehandling anses for essentiel, bør patienter, der planlægger graviditet, skiftes til alternativ antihypertensiv behandling, som har en etableret sikkerhedsprofil for anvendelse under graviditet.
English: HDPE bottles of 100 tablets.
Danish: HDPE-flasker à 100 tabletter.
English: Vascular disorders: not known: orthostatic hypotension
Danish: Vaskulære sygdomme Ikke kendt: Orthostatisk hypotension.
English: - Treatment of essential hypertension.
Danish: - Behandling af essentiel hypertension.
English: In a controlled clinical trial in patients with cardiac insufficiency the following adverse events were reported:
Danish: I en kontrolleret undersøgelse med patienter med hjerteinsufficiens blev følgende bivirkninger rapporteret:
English: Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes
Danish: Cozaar forsinker nedgang i nyrefunktionen hos patienter med forhøjet blodtryk og type II-diabetes.
English: • to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor.
Danish: • at behandle patienter med kronisk nedsat hjertefunktion, når lægen finder behandling med særlige lægemidler, der kaldes angiotensinkonverterende enzymhæmmere uegnet (ACEhæmmere, medicin til at sænke blodtrykket).
English: Patients with proteinuria and a serum creatinine of 1.3 - 3.0 mg/dl were randomised to receive Losartan 50 mg once a day, titrated if necessary, to achieve blood pressure response, or to placebo, on a background of conventional antihypertensive therapy excluding ACE-inhibitors and angiotension II antagonists.
Danish: Patienter med proteinuri og serumkreatinin på 1,3-3,0 mg/dl blev, i tillæg til konventionel antihypertensiv behandling med undtagelse af ACE-hæmmere og angiotensin II-antagonister, randomiseret til losartan 50 mg én gang dagligt, og blev titreret til, hvis nødvendigt, til blodtryksrespons, eller placebo.
English: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem The Netherlands
Danish: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, Holland
English: The dose may later be increased to 100 mg losartan (two tablets Cozaar 50 mg) once daily depending on your blood pressure response.
Danish: Dosis kan senere øges til 100 mg losartan (to tabletter Cozaar 50 mg) én gang dagligt, afhængigt af hvordan Deres blodtryk reagerer på behandlingen.
English: HDPE bottles of 100 or 300 tablets.
Danish: HDPE-flasker à 100 tabletter eller 300 tabletter.
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Danish: - Indbringelsen skulle afdække harmoniseringen af produktresuméer, etikettering og indlægsseddel.
English: In the ELITE II Study Losartan 50 mg once daily (starting dose 12.5 mg, increased to 25 mg, then 50 mg once daily) was compared with captopril 50 mg three times daily (starting dose 12.5 m, increased to 25 mg and then to 50 mg three times daily).
Danish: I ELITE II-undersøgelsen blev losartan 50 mg én gang dagligt (startdosis 12,5 mg titreret til 25 mg og derefter 50 mg én gang dagligt) sammenlignet med captopril 50 mg tre gange dagligt (startdosis 12,5 mg titreret til 25 mg og derefter 50 mg tre gange dagligt).
English: The CHMP considered that the following contra-indications needed to be included in the SPC for Cozaar in all MSs: Pregnancy and lactation; Severely reduced liver function; Angina pectoris; Myocardial infraction; Cerebrovascular disease; Renal artery stenosis; Kidney transplant patients.
Danish: CHMP var af den opfattelse, at følgende kontraindikationer skulle inkluderes i produktresuméet for Cozaar i alle medlemsstater: graviditet og amning, svært reduceret leverfunktion, angina pectoris, myokardieinfarkt, cerebrovaskulær sygdom, nyrearteriestenose, nyretransplanterede patienter.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD/MM/YYYY}> <{DD month YYYY}>
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Store Cozaar in the original package.
Danish: Opbevar Cozaar i den originale yderpakning.
English: The following wording has been added to SPC Section 5.2 Pharmacokinetic properties:
Danish: Følgende ordlyd er tilføjet produktresuméet, afsnit 5.2 Farmakokinetiske egenskaber:
English: The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan is not recommended (see section 4.5).
Danish: Brug af kaliumbesparende diuretika, kaliumtilskud og kaiumholdige salterstatninger sammen med losartan anbefales ikke (se pkt.
English: non-steroidal anti-inflammatory drugs such as indomethacin, including cox-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood lowering effect of losartan.
Danish: • NSAID som f.eks. indomethacin, herunder COX-2-hæmmere (medicin som hjælper på betændelsestilstande, og som også kan bruges til smertelindring), da disse kan nedsætte losartans blodtrykssænkende virkning.
English: At the end of three weeks, losartan administration once daily lowered trough blood pressure in a dose-dependent manner.
Danish: Efter tre uger medførte administrationen af losartan én gang dagligt en sænkning af det laveste blodtryk på en dosisafhængig måde.
English: Patients were randomised to once daily Losartan 50 mg or once daily atenolol 50 mg.
Danish: Patienterne blev randomiseret til losartan 50 mg én gang dagligt eller atenolol 50 mg én gang dagligt.
English: Because of the potential for adverse effects on the nursing infant, losartan is contraindicated during breast-feeding (see section 4.3).
Danish: På grund af de potentielle bivirkninger hos det ammede barn, er losartan kontraindiceret under amning (se pkt.
English: As with other drugs that block angiotensin II or its effects, concomitant use of other drugs which retain potassium (e.g. potassium-sparing diuretics: amiloride, triamterene, spironolactone) or may increase potassium levels (e.g. heparin), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium.
Danish: Som ved andre stoffer, der blokerer angiotensin-II eller dets virkning, kan samtidig brug af andre lægemidler, som tilbageholder kalium (f.eks. kaliumbesparende diuretika: Amilorid, triamteren, spironolacton), eller som kan forhøje kaliumkoncentrationerne (f.eks. heparin), kaliumtilskud eller kaliumholdige salterstatninger, medføre stigninger i serumkalium.
English: Romania Merck Sharp & Dohme Romania S.R.L.
Danish: Rumænien Merck Sharp & Dohme Romania S.R.L.