FrancophonIA/ELRC3.0 huggingface dataset:
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: • inflammation of blood vessels (vasculitis including Henoch-Schönlein purpura),
Danish: • Betændelse i blodkarrene (vasculitis, herunder Schönlein Henochs purpura)
English: No difference in exposure was found with concomitant treatment with fluvastatin (weak inhibitor of CYP2C9).
Danish: Der blev ikke fundet forskel i eksponeringen ved samtidig behandling med fluvastatin (svag hæmmer af CYP2C9).
English: Both Losartan and its principal active metabolite have a far greater affinity for the AT1-receptor than for the AT2-receptor.
Danish: Losartan og dets aktive metabolit har begge en meget større affinitet for AT1-receptoren end for AT2receptoren.
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 lavest undersøgte doser, 2,5 mg og 5 mg, svarende til en gennemsnitlig daglig dosis på 0,07 mg/kg, gav ingen konsistent antihypertensiv effekt.
English: Read all of this leaflet carefully before you start taking this medicine
Danish: Læs denne indlægssseddel grundigt, inden De begynder at tage medicinen.
English: Following an oral dose/intravenous administration of 14C-labeled losartan in man, about 35 % / 43 % of radioactivity is recovered in the urine and 58 %/ 50 % in the faeces.
Danish: Efter en peroral dosis/intravenøs administration af 14C-mærket losartan til mennesker, blev ca. 35 %/43 % af radioaktiviteten genfundet i urin og 58 %/50 % i fæces.
English: Hyperkalaemia (serum potassium >5.5 mmol/l) occurred in 1.5 % of patients in hypertension clinical trials.
Danish: Hyperkaliæmi (serumkalium >5,5 mmol/l) forekom hos 1,5 % af patienterne i hypertensionsundersøgelserne.
English: This applies particularly when losartan is given in the presence of other conditions (fever, dehydration) 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: Angioedema.
Danish: Angioødem.
English: The adverse experience profile for pediatric 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: (It is also better to avoid COZAAR in early pregnancy
Danish: (Det er også bedst at undgå Cozaar tidligt i graviditeten - se "Graviditet og amning"),
English: In these clinical trials, the most common adverse event was dizziness.
Danish: I disse kliniske undersøgelser var den mest almindelige bivirkning svimmelhed.
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: Administration of the oral suspension
Danish: Administration af den orale opløsning
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: The following side effects have been reported with COZAAR:
Danish: Følgende bivirkninger er set for Cozaar:
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: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products 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: Special caution is necessary when you are treated with a ßblocker concomitantly,
Danish: Det er nødvendigt at være særlig forsigtig, hvis De samtidig er i behandling med en beta-blokker,
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: • if your liver function is severely impaired,
Danish: • hvis Deres leverfunktion er alvorligt nedsat,
English: • 2nd and 3rd trimester of pregnancy (see section 4.6).
Danish: • 2. og 3 trimester af graviditeten (se pkt.
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 år.
English: ANNEX II SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG II PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: The long-term efficacy of antihypertensive therapy with losartan in childhood to reduce cardiovascular morbidity and mortality has also not been established.
Danish: Langtidsvirkningen af antihypertensiv behandling med losartan i barndommen til reduktion af kardiovaskulær morbiditet og mortalitet er heller ikke undersøgt.
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 er tilfældet med megen anden medicin til behandling af forhøjet blodtryk, kan losartan medføre svimmelhed eller døsighed hos nogle mennesker.
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 section 5.1).
Danish: Der er begrænset dokumentation for losartans sikkerhed og virkning hos børn og unge i alderen 6-16 år mht. behandling for hypertension (se pkt.
English: Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored especially patients with heart failure and a creatinine clearance between 30-50 ml/min should be closely monitored.
Danish: Derfor bør kaliums plasmakoncentration såvel som kreatinin-clearance monitoreres tæt, især patienter med hjertesvigt og kreatinin-clearance på 30-50 ml/min bør monitoreres tæt.
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: • 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: • Treatment of essential hypertension in adults and in children and adolescents 6 - 16 years of age.
Danish: • Behandling af essentiel hypertension hos voksne og hos børn og unge i alderen 6-16 år.
English: • In a controlled clinical trial in 177 hypertensive pediatric patients 6 to 16 years of age
Danish: • I en kontrolleret klinisk undersøgelse hos 177 hypertensive pædiatriske patienter i alderen 6-16 år
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: Dosisresponsforholdet var meget tydeligt i den gruppe, der fik lav dosis sammenlignet med den gruppe, der fik middeldosis (periode I: -6,2 mmHg versus -11,65 mmHg), men det var mindre tydeligt, når man sammenlignede gruppen, der fik middeldosis med gruppen, der fik høj dosis (periode I: -11,65 mmHg versus -12,21 mmHg).
English: A low dose of hydrochlorothiazide should be added and/ or the dose of losartan should be increased to 100 mg once daily based on blood pressure response.
Danish: En lav dosis hydrochlorthiazid bør tilføjes og/eller dosis af losartan bør øges til 100 mg én gang dagligt på basis af blodtryksrespons.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with <Cozaar and associated names - See Annex I - To be completed nationally> in one or more subsets of the paediatric population in Hypertension, Proteinuria.
Danish: Det europæiske Lægemiddelagentur har udsat forpligtigelsen til at indsende resultaterne fra studierne af Cozaar og tilhørende navne (Se bilag I) i en eller flere af undergrupperne af de pædiatriske patienter med hypertension, proteinuri.
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: In patients with heart failure, with or without renal impairment, there is - as with other medicinal products 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: PHARMACEUTICAL FORM AND CONTENTS 200 ml oral suspension
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 200 ml oral suspension
English: Always take COZAAR exactly as your doctor has instructed you.
Danish: Tag altid Cozaar nøjagtigt efter lægens anvisning.
English: Do not take a double dose to make up for a forgottendose.
Danish: De må ikke tage dobbeltdosis som erstatning for den glemte dosis.
English: Kit: Do not store above 25°C.
Danish: Pakning: Må ikke opbevares ved temperaturer over 25 °C.
English: See package leaflet for instructions on how to prepare COZAAR 2.5 mg/ml oral suspension.
Danish: Se indlægssedlen for vejledning om, hvordan Cozaar 2,5 mg/ml oral suspension fremstilles.
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: • 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: 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: • very rapid and irregular heartbeat (atrial fibrillation) brain attack (stroke),
Danish: • Meget hurtige og uregelmæssige hjerteslag (atrieflimren), slagtilfælde (hjernen)
English: At the end of three weeks, losartan administration once daily lowered trough blood pressure in a dosedependent manner.
Danish: Efter tre ugers administration af losartan én gang dagligt reduceredes det laveste blodtryk på en dosisafhængig måde.
English: COZAAR also contains methylhydroxybenzoate and propylhydroxybenzoate, which may cause allergic reactions (possibly delayed).
Danish: Cozaar indeholder også methylhydroxybenzoat og propylhydroxybenzoat, som kan give allergiske reaktioner (kan optræde efter behandlingen).
English: SPECIAL STORAGE CONDITIONS Store in the original container.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale flaske.
English: MSD Chibropharm GmbH Postfach 1202 D-85530 Haar, Germany
Danish: Tyskland MSD Chibropharm GmbH Postfach 1202 D-85530 Haar, Tyskland
English: To be prepared by medical or healthcare professionals only.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN Må kun tilberedes af lægen eller sundhedspersonalet.
English: The active metabolite is 10- to 40- times more active than Losartan on a weight for weight basis.
Danish: Den aktive metabolit er 10 til 40 gange mere aktiv sammenlignet med losartan.
English: Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien, Austria
Danish: Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien, Østrig
English: • One push-in bottle adaptor
Danish: • Et push-in tilpasningsstykke til flaske
English: PHARMACEUTICAL FORM Powder and solvent for oral suspension.
Danish: LÆGEMIDDELFORM Pulver og solvens til oral suspension.
English: Return the entire assembly to the upright position.
Danish: Vend hele anordningen tilbage i opretstående position.
English: Patients who weighted >20 kg 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 - <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: If you forget to take COZAAR
Danish: Hvis De har glemt at tage Cozaar
English: Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption 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: UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, Lithuania
Danish: UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, Litauen
English: The antihypertensive effect of losartan was established in a clinical study involving 177 hypertensive pediatric patients 6 to 16 years of age with a body weight > 20 kg and a glomerular filtration rate > 30 ml/ min/ 1.73 m2.
Danish: Cozaars antihypertensive virkning blev fastslået i en klinisk undersøgelse med 177 hypertensive pædiatriske patienter i alderen 6-16 år med en kropsvægt >20 kg og glomerulær filtrationshastighed >30 ml/min/1,73m2.
English: Compared to patients with normal renal function, the AUC for Losartan is about 2times higher in haemodialysis dialysis patients.
Danish: Sammenlignet med patienter med normal nyrefunktion er losartans AUC ca. 2 gange højere hos patienter i hæmodialyse.
English: It was found that concomitant treatment of losartan with rifampicine (inducer of metabolism 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: • Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with Angiotensinconverting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Danish: • Behandling af kronisk hjerteinsufficiens (hos patienter ≥60 år), når behandling med ACEhæmmere (angiotensinkonverterende enzymhæmmere) ikke anses for at være velegnet på grund af uforligelighed, især hoste, eller kontraindikation.
English: 12.5 mg and 50 mg (initiation pack)
Danish: 12.5 mg og 50 mg (initiationspakke)
English: HOW TO MEASURE AND GIVE A DOSE OF ORAL SUSPENSION
Danish: OPMÅLING OG INDGIVELSE AF EN DOSIS AF DEN ORALE SUSPENSION
English: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144 Rome, Italy
Danish: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.Viale Shakespeare 47, 00144 Rome, Italien
English: The usual initial dose of losartan in patients with heart failure is 12.5 mg once daily.
Danish: Den normale startdosis for losartan til patienter med hjerteinsufficiens er 12,5 mg én gang dagligt.
English: Both biliary and urinary excretions 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: PHARMACEUTICAL FORM AND CONTENTS 473 ml solvent
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 473 ml solvens
English: Important information about some of the ingredients of COZAAR COZAAR contains lactose monohydrate and sorbitol.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Cozaar Cozaar indeholder lactosemonohydrat.
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: COZAAR is used
Danish: Cozaar anvendes til
English: This leaflet was last approved in {MM/YYYY}
Danish: Denne indlægsseddel blev sidst revideret
English: Therefore, concomitant use is not recommended (see section 4.5).
Danish: Derfor frarådes samtidig anvendelse (se pkt.
English: • One 473 ml bottle of solvent
Danish: • En 473 ml flaske med solvens
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.
Danish: Forskellen i blodtryksstigning sammenlignet med placebo var størst i den gruppe, der fik middeldosis (6,70 mmHg middeldosis versus 5,38 mmHg høj dosis).
English: • Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment.
Danish: • Behandling af nyresygdom hos patienter med hypertension og type 2-diabetes mellitus med proteinuri ≥0,5 g/dag som del af en antihypertensiv behandling.
English: Reduction in the risk of stroke in hypertensive patients with left-ventricular hypertrophy documented by ECG
Danish: Reduktion af risikoen for stroke hos hypertensive patienter med hypertrofi af venstre ventrikel, som er dokumenteret ved EKG
English: Losartan suspension is a white to off-white liquid when reconstituted with the supplied solution.
Danish: Losartan suspension er en hvid til råhvid væske efter rekonstitution med den medfølgende opløsning.
English: Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide).
Danish: Losartan kan administreres sammen med andre antihypertensiva, især sammen med diuretika (f.eks. hydrochlorthiazid).
English: Concomitant use with other substances which may induce hypotension as an adverse reaction (like tricyclic antidepressants, antipsychotics, baclofen, and amifostine) may increase the risk of hypotension.
Danish: Samtidig anvendelse af andre lægemidler, der som bivirkning inducerer hypotension (f.eks. tricykliske antidepressiva, antipsykotika, baclofen, amifostin) kan øge risikoen for hypotension.
English: It is normal to have a small amount of residual powder adhering to the interior surfaces of the sachet.
Danish: Der vil normalt være en lille mængde pulver, som klæber til indersiden af brevet.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Angiotensin II antagonists, plain, ATC code: C09CA01 5.1 Pharmacodynamic properties
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-receptorantagonister, ATC-kode: C09CA01
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 Post-marketing experience
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.
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: Limited pharmacokinetic data are available in hypertensive children above one month of age (see section 5.2).
Danish: Der er begrænset farmakokinetisk dokumentation for hypertensive børn >1 måned (se pkt.
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: -It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 m2, as no data are available (see also section 4.4).
Danish: - Bør ikke gives til børn med glomerulær filtrationshastighed <30 ml/min/1,73 m2, da der ikke findes dokumentation herfor (se også pkt.
English: As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the renin angiotensin aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
Danish: Som følge af hæmningen af renin-angiotensinsystemet, er der rapporteret forandringer i nyrefunktionen herunder nyrefunktionsnedsættelse (især hos patienter hvis nyrefunktion er afhængig af renin angiotensin-aldosteronsystemet som patienter med svær hjerteinsufficiens eller tidligere nedsatnyrefunktion).