FrancophonIA/ELRC3.0 huggingface dataset:
English: This also applies to children.
Danish: Dette gælder også for børn.
English: (cannot be estimated from the available data)
Danish: (Kan ikke estimeres ud fra forhåndenværende data).
English: Stabilisation of the circulatory system should be given priority.
Danish: Stabilisering af kredsløbet bør prioriteres.
English: This is the indication currently proposed by the applicant and has been registered in 15 member states of the EU.
Danish: Det er denne indikation, som ansøgeren nu foreslår, og som er blevet er registreret i 15 medlemsstater i EU.
English: The clinical relevance of this effect is unknown.
Danish: Den kliniske relevans af denne virkning er ukendt.
English: Vital parameters should be corrected if necessary.
Danish: De vitale parametre bør korrigeres efter behov.
English: Patients were followed up for up to 4.6 years (3.4 years on average).
Danish: Patienterne blev fulgt i op til 4,6 år (i gennemsnit 3,4 år).
English: Do not take a double dose to make up for a forgotten tablet.
Danish: Tag ikke dobbelt dosis for at opveje den glemte tablet.
English: You may need urgent medical attention or hospitalisation.
Danish: De kan få brug for hurtig lægehjælp eller indlæggelse på hospital.
English: The mean length of follow up was 4.8 years.
Danish: Den gennemsnitlige opfølgningstid var 4,8 år.
English: The combination should be administered with caution, especially in the elderly.
Danish: Kombinationen bør anvendes med forsigtighed især hos ældre.
English: You should try to take your daily dose at about the same time each day.
Danish: De bør forsøge at tage Deres daglige dosis på samme tid hver dag.
English: Special precautionary measures (e.g. blood tests) may be appropriate.
Danish: Det kan være hensigtsmæssigt med særlige forholdsregler (f.eks. blodprøver).
English: Do not open the blister pack until you are ready to take the medicine.
Danish: Åbn ikke blisterpakningen før De er klar til at tage medicinen.
English: Afterwards, close monitoring of the vital parameters should be performed.
Danish: Derefter bør de vitale parametre monitoreres nøje.
English: The efficacy and safety are well established for the indication “treatment of essential hypertension”.
Danish: Virkningen og sikkerheden er godt underbygget for indikationen “behandling af essentiel hypertension”.
English: This was mainly attributable to a reduction of the incidence of stroke.
Danish: Dette skyldtes hovedsageligt en reduktion i incidensen af stroke.
English: These findings were regarded as clinically relevant for this group of patients.
Danish: Disse resultater blev anset for at være klinisk relevante for denne patientgruppe.
English: Blood pressure was significantly lowered to similar levels in the two groups.
Danish: Blodtrykket reduceredes signifikant til samme niveau i de to grupper.
English: Other warnings and precautions
Danish: Andre advarsler og forholdsregler
English: Overall, there was a dose-response.
Danish: Totalt set var der dosisrespons.
English: If you accidentally miss a daily dose, just take the next dose as normal.
Danish: Hvis De kommer til at glemme en daglig dosis, skal De blot tage næste dosis som normalt.
English: - the CHMP concluded that the Marketing Authorisation could be harmonised on the following indications:
Danish: - CHMP konkluderede, at markedsføringstilladelsen kunne harmoniseres for den følgende indikation:
English: ELITE I and ELITE II Study
Danish: ELITE I og II-undersøgelserne
English: • if you are, think you may be or are planning to become pregnant (see also “Pregnancy and breast-feeding”),
Danish: • De er gravid, tror De kan være gravid eller planlægger at blive gravid (se også "Graviditet og amning"),
English: 11415 Tallinn Estonia
Danish: 11415 Tallinn, Estland
English: 28027 Madrid
Danish: 28027 MADRID, Spanien
English: H-1123 Budapest
Danish: H-1123 Budapest, Ungarn
English: When comparing preschool children with adolescents these differences became statistically significant.
Danish: Når børn i førskolealderen blev sammenlignet med unge, blev disse forskelle statistisk signifikante.
English: Taking Cozaar with food and drink
Danish: Brug af Cozaar sammen med mad og drikke
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COZAAR AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF COZAAR OG TILKNYTTEDE NAVNE (SE BILAG I)
English: This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients.
Danish: Dette er en alvorlig men sjælden bivirkning, som rammer mere end 1 ud af 10.000 patienter men færre end 1 ud af 1.000 patienter.
English: Therefore, losartan should be used with caution in these patient groups.
Danish: Derfor bør losartan anvendes med forsigtighed til disse patientgrupper.
English: If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.
Danish: Hvis De har indtryk af, at virkningen af losartan er for stærk eller for svag, skal De tale med Deres læge eller apoteket.
English: You should not take losartan in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.
Danish: De bør ikke tage Cozaar i de første 12 uger af graviditeten, og De må overhovedet ikke tage det efter 13. uge, da brug under graviditet kan være skadeligt for barnet.
English: Very rare cases have also been reported with antiotensin II receptor antagonists.
Danish: Der er også rapporteret om meget sjældne tilfælde med antiotensin-II-receptorantagonister.
English: This results in an increase in blood pressure.
Danish: Dette medfører en stigning i blodtrykket.
English: Poland MSD Polska Sp. z o.o.
Danish: MSD Polska Sp. z o.o.
English: This medicinal product is authorized in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Medlemsstat
English: Bucharest Business Park Şos.
Danish: Bucharest Business Park
English: 28 day initiation pack
Danish: 28 dages startpakke
English: Lindenplatz 1 85540, Haar, Germany
Danish: Lindenplatz 1 85540, Haar, Tyskland
English: The volume of distribution of losartan is 34 litres.
Danish: Losartans fordelingsvolumen er 34 liter.
English: Furthermore, the study provided no information on the effect that higher doses of losartan (greater than 50mg) could have on improving efficacy.
Danish: Endvidere blev der med undersøgelsen ikke fremlagt nogen oplysninger om, hvorvidt højere doser losartan (større end 50 mg) kunne forbedre virkningen.
English: The systemic bioavailability of losartan tablets is approximately 33%.
Danish: Den systemiske biotilgængelighed af losartantabletter er ca. 33%.
English: The primary endpoint of this prospective study was the all-cause mortality.
Danish: Det primære effektmål for denne prospektive undersøgelse var mortalitet af enhver årsag.
English: Losartan is indicated for the treatment of hypertension.
Danish: Losartan er indiceret til behandling af hypertension.
English: An increased mortality was observed in ELITE II in the small subgroup (22% of all HF patients) taking beta-blockers at baseline.
Danish: Der sås en stigning i mortalitet i ELITE II i den lille undergruppe (22% af alle HF-patienter), der tog beta-blokkere ved baseline.
English: The CHMP considered that the data from these trials may not be sufficient to demonstrate the claimed benefit.
Danish: CHMP var af den opfattelse, at dataene fra disse undersøgelser muligvis ikke var tilstrækkelige til, at den påståede fordel kunne påvises.
English: The tablets should be swallowed with a glass of water.
Danish: Tabletterne bør sluges sammen med et glas vand.
English: 75114 Paris Cedex 08 France
Danish: 75114 Paris Cedex 08, Frankrig
English: Therefore, the use of Losartan tablets is not recommended.
Danish: Derfor kan anvendelse af losartantabletter ikke anbefales.
English: • if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
Danish: • De er overfølsom (allergisk) over for losartan eller et af de øvrige indholdsstoffer,
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Hvis De har yderligere spørgsmål om brugen af denne medicin, så spørg lægen eller på apoteket.
English: Use of losartan in children and adolescents
Danish: Anvendelse af losartan til børn og unge
English: Co-medication is not advisable.
Danish: Samtidig medicinering er ikke tilrådelig.
English: Important information about some of the ingredients of Cozaar
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Cozaar
English: Cozaar may be administered with or without food.
Danish: Cozaar kan administreres med eller uden mad.
English: Germany VARIPHARM ARZNEIMITTEL GmbH
Danish: VARIPHARM ARZNEIMITTEL GmbH
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - De produktresuméer, den etikettering og indlægsseddel, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på grundlag af den fremlagte dokumentation og den faglige drøftelse i udvalget.
English: Measures are depending on the time of drug intake and kind and severity of symptoms.
Danish: Forholdsreglerne afhænger af tidspunktet for indtagelse af medicinen samt symptomernes type og sværhedsgrad.
English: The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvensen af de nedenfor nævnte bivirkninger er defineret i henhold til følgende konvention: Meget almindelig (≥1/10); almindelig (≥1/100, <1/10); ikke almindelig (≥1/1.000, <1/100); sjælden (≥1/10.000, <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Danish: Epidemiologisk evidens for risiko for teratogenicitet efter eksponering for ACE-hæmmere i 1. trimester af graviditeten har ikke været konklusive; en lille risikostigning kan dog ikke udelukkes.
English: Like all medicines, Cozaar can cause side effects, although not everybody gets them.
Danish: Cozaar kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: No experience with overdose in man is available so far.
Danish: Der er indtil videre ingen erfaring med overdosering hos mennesker.
English: Take particular care if you are taking the following medicines while under treatment with Cozaar:
Danish: Vær særlig forsigtig, hvis De får den medicin, der nævnes nedenfor, mens De er i behandling med Cozaar:
English: Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen særlig risiko for mennesker på basis af konventionelle undersøgelser af generel farmakologi, genotoksicitet samt karcinogent potentiale.
English: Your doctor will decide on the appropriate dose of Cozaar, depending on your condition and whether you are taking other medicines.
Danish: Lægen bestemmer, hvilken dosis af Cozaar der er hensigtsmæssig for Dem, afhængigt af Deres tilstand, og om De tager anden medicin.
English: Sector 1, Bucureşti
Danish: Sector 1, Bucureşti, Rumænien
English: Losartan should not be initiated during pregnancy.
Danish: Behandling med losartan bør ikke initieres under graviditet.
English: It is important to continue taking Cozaar for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Danish: Det er vigtigt at fortsætte med at tage Cozaar, så længe lægen foreskriver det, det vil sikre en jævn kontrol af Deres blodtryk.
English: If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.
Danish: Hvis De kommer til at tage for mange tabletter, eller et barn sluger nogle tabletter, skal De straks kontakte lægen.
English: After discontinuation of Losartan, PRA and angiotensin II values fell within three days to the baseline values.
Danish: Efter seponering af losartan faldt PRA og angiotensin-II-værdierne inden for tre dage til værdierne ved baseline.
English: 00-867 Warsaw
Danish: 00-867 Warsaw, Polen
English: not known:
Danish: Ikke kendt:
English: It is important that you continue to take Cozaar until your doctor tells you otherwise.
Danish: Det er vigtigt, at De fortsætter med at tage Cozaar, indtil lægen siger noget andet.
English: Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.
Danish: Losartan anbefales ikke anvendt til børn under 6 år, da der foreligger begrænsede data for denne patientgruppe.
English: 1407 Sofia
Danish: 1407 Sofia, Bulgarien
English: • other blood pressure lowering medicines as they may additionally reduce your blood pressure.
Danish: • Anden blodtrykssænkende medicin da denne kan sænke Deres blodtryk yderligere.
English: In addition to the active metabolite, inactive metabolites are formed.
Danish: Ud over den aktive metabolit dannes inaktive metabolitter.
English: If you experience the following, stop taking losartan tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
Danish: Hvis De oplever følgende, skal De stoppe med at tage Cozaartabletter og straks fortælle lægen om det eller tage på skadestuen på det nærmeste hospital:
English: Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Danish: Selvom det bør overvejes, hvorvidt behandling med 25 mg skal initieres hos patienter over 75 år, er dosisjustering ikke nødvendig hos ældre.
English: Each pack contains a total of 35 tablets:
Danish: Hver pakke indeholder i alt 35 tabletter:
English: • reduced number of red blood cells (anaemia),
Danish: • Nedsat antal røde blodlegemer (anæmi)
English: • low blood pressure,
Danish: • Lavt blodtryk
English: Other antihypertensive agents may increase the hypotensive action of Losartan.
Danish: Andre antihypertensiva kan øge losartans hypotensive virkning.
English: Each pack contains a total of 28 tablets:
Danish: Hver pakke indeholder i alt 28 tabletter:
English: Cozaar is supplied in the following pack sizes:
Danish: Cozaar fås i følgende pakningsstørrelser:
English: Losartan is equally effective in males and females, and in younger (below the age of 65 years) and older hypertensive patients.
Danish: Losartan er lige effektiv hos mænd og kvinder samt hos yngre (<65 år) og ældre hypertensive patienter.
English: Do not use Cozaar after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke Cozaar efter den udløbsdato, der står på pakningen.
English: The primary endpoint did not show any statistically significant difference between Losartan and captopril in reducing all-cause mortality.
Danish: Det primære effektmål viste ingen statistisk signifikant forskel mellem losartan og captopril i reduktion af mortalitet af enhver årsag.
English: Losartan selectively blocks the AT1 receptor.
Danish: Losartan blokerer selektivt AT1-receptoren.
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Patienterne bør hydreres hensigtsmæssigt, og det bør overvejes at monitorere nyrefunktionen efter initiering af samtidig behandling samt periodisk herefter.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.
Danish: Selvom der ikke findes kontrollerede epidemiologiske data vedrørende risikoen ved angiotensin II receptorhæmmere (AIIRAer), kan de samme risici være forbundet med denne lægemiddelklasse.
English: Furthermore Losartan does not inhibit ACE (kininase II), the enzyme that degrades bradykinin.
Danish: Desuden hæmmer losartan ikke ACE (kininase II), enzymet som nedbryder bradykinin.
English: Long-term effects of losartan on growth, puberty and general development have not been studied.
Danish: De langsigtede virkninger af losartan på vækst, pubertet og den generelle udvikling blev ikke undersøgt.
English: If this combination proves essential, serum lithium level monitoring is recommended during concomitant use.
Danish: Hvis denne kombination viser sig at være essentiel, bør serum lithiumkoncentrationen monitoreres ved samtidig anvendelse.
English: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Losartan tablets.
Danish: I kontrollerede, kliniske undersøgelser var klinisk signifikante ændringer i standard laboratorieparametre sjældent associeret med administration af losartantabletter.
English: Losartan does not have an agonist effect nor does it block other hormone receptors or ion channels important in cardiovascular regulation.
Danish: Losartan har ikke en agonistvirkning eller blokerer andre hormonreceptorer eller ionkanaler, som er vigtige for den kardiovaskulære regulering.
English: Dosage should be adjusted according to blood pressure response.
Danish: Dosis bør justeres i henhold til blodtryksrespons.
English: Consequently, there is no potentiation of undesirable bradykininmediated effects.
Danish: Af denne grund finder ingen potensering af bradykinin-medierede virkninger sted.
English: All-cause mortality rate was not significantly different between the two treatment groups.
Danish: Ratio af mortalitet af enhver årsag var ikke signifikant forskellig mellem de to behandlingsgrupper.
English: Despite the marked decrease in blood pressure, Losartan had no clinically significant effects on heart rate.
Danish: På trods af det markante fald i blodtrykket havde losartan ingen klinisk signifikant virkning på hjertefrekvensen.
English: Exposure in infants/ toddlers was comparatively high.
Danish: Eksponeringen hos spædbørn/småbørn var relativt høj.
English: This composite endpoint can be considered as representative for CV morbidity and mortality, and has translated into this indication in many medicinal products that have been discussed in the CHMP (e.g. statins).
Danish: Dette sammensatte slutmål kan anses som repræsentativt for kardiovaskulær morbiditet og mortalitet og er blevet omsat til denne indikation i forbindelse med mange lægemidler, der er blevet drøftet af CHMP (f.eks. statiner).
English: The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy.
Danish: Maksimal antihypertensiv virkning opnås 3-6 uger efter initiering af behandling.
English: • inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
Danish: • Betændelse i blodkarrene (vasculitis, herunder Schönlein Henochs purpura)
English: Data in the pediatric population are limited.
Danish: Data for den pædiatriske population er begrænsede.
English: No difference in exposure was found with concomitantly 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: Cozaar is unlikely to affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at Cozaar vil påvirke Deres evne til at køre bil eller arbejde med maskiner.
English: Discontinuation of Losartan in hypertensive patients did not result in an abrupt rise in blood pressure (rebound).
Danish: Seponering af losartan hos hypertensive patienter medførte ikke en brat stigning af blodtrykket (rebound).
English: A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Danish: Skift til anden egnet behandling bør foretages før planlagt graviditet.
English: RENAAL-Study
Danish: RENAAL-undersøgelsen
English: Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.
Danish: Elektrolytforstyrrelser er almindeligt forekommende hos patienter med nyreinsufficiens, med eller uden diabetes, og bør behandles.
English: If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.
Danish: Hvis De oplever svimmelhed eller døsighed, bør De tale med Deres læge, før De foretager lignende aktiviteter.
English: Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor.
Danish: Medicin, der indeholder lithium, bør ikke tages sammen med losartan, uden at lægen overvåger behandlingen nøje.
English: Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.
Danish: Symptomer på overdosering er lavt blodtryk, øget hjerterytme, muligvis nedsat hjerterytme.
English: Pharmacotherapeutic group: Angiotensin II Receptor Antagonists, ATC code: C09CA01
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-receptorantagonister, ATC-kode: C09CA01
English: In this study 3152 patients with heart failure (NYHA Class II-IV) were followed for almost two years (median: 1.5 years) in order to determine whether Losartan is superior to captopril in reducing all cause mortality.
Danish: I denne undersøgelse blev 3152 patienter med hjerteinsufficiens (NYHA klasse II-IV) fulgt i næsten to år (median 1,5 år) for at undersøge, om losartan reducerede den totale mortalitet bedre end captopril.
English: Skanstes street 13, LV-1013, Riga
Danish: Skanstes street 13, LV-1013, Riga, Letland
English: After oral intake the administration of a sufficient dose of activated charcoal is indicated.
Danish: Efter peroral indtagelse er administration af en tilstrækkelig stor dosis aktivt kul indiceret.
English: Renal function should be regularly monitored during treatment with losartan as it may deteriorate.
Danish: Nyrefunktionen bør overvåges regelmæssigt under behandlingen med losartan, da den kan blive dårligere.
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: Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P.O.
Danish: Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P.O. Box 214
English: • to treat patients with high blood pressure (hypertension)
Danish: • at behandle patienter med forhøjet blodtryk (hypertension);
English: However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in particular during initiation of treatment or when the dose is increased.
Danish: Når man kører bil eller betjener maskiner, skal man dog tænke på, at svimmelhed eller døsighed lejlighedsvis kan forekomme i forbindelse med antihypertensiv behandling, i særdeleshed ved initiering af behandlingen, eller når dosis øges.
English: • if your liver function is impaired (see sections 2 "Do not take Losartan" and 3 ‘Dosage in special patient groups'),
Danish: • hvis Deres leverfunktion er nedsat (se afsnit 2 "Tag ikke Cozaar" og afsnit 3"Dosering til særlige patientgrupper"),
English: The results showed that the active metabolite is formed from losartan in all age groups.
Danish: Resultaterne viste, at den aktive metabolit dannes fra losartan i alle aldersgrupper.
English: After careful evaluation, the CHMP considered that this indication is acceptable.
Danish: Efter at have vurderet sagen nøje var CHMP af den opfattelse, at denne indikation kan accepteres.