FrancophonIA/ELRC3.0 huggingface dataset:
English: This generally has been true for other angiotensin II receptor (AT1) antagonists and angiotensin-converting enzyme inhibitors.
Danish: Dette har generelt været tilfældet for andre angiotensin II-receptor- (AT1) antagonister og angiotensin-konverterende enzyminhibitorer.
English: In seven double blind controlled studies, a total of 5,941 patients (3,672 given Edarbi, 801 given placebo, and 1,468 given active comparator) were evaluated.
Danish: I syv dobbeltblinde, kontrollerede studier blev i alt 5941 patienter vurderet (3672 fik Edarbi, 801 fik placebo og 1468 fik en aktiv komparator).
English: During controlled clinical studies in healthy subjects, once daily doses up to 320 mg of azilsartan medoxomil were administered for 7 days and were well tolerated.
Danish: I kontrollerede, kliniske studier med raske personer blev daglige doser på op til 320 mg azilsartan medoxomil administreret i 7 dage og var veltolererede.
English: There are no data from the use of azilsartan medoxomil in pregnant women.
Danish: Der foreligger ingen data om brugen af azilsartan medoxomil hos gravide kvinder.
English: Change from BL -2.1 -14.3 * -14.5 * -17.6 * -14.9 Study 2
Danish: Ændring fra BL -2,1 -14,3 * -14,5 * -17,6 * -14,9 Studie 2
English: Manufacturer: Takeda Ireland Limited, Bray Business Park, Kilruddery, Co. Wicklow, Ireland
Danish: Fremstiller: Takeda Ireland Limited, Bray Business Park, Kilruddery, Co. Wicklow, Irland
English: Takeda Ireland Ltd. Bray Business Park Kilruddery Co Wicklow Ireland
Danish: Takeda Ireland Ltd. Bray Business Park Kilruddery Co Wicklow Irland
English: Blood pressure reductions compared with placebo based on 24 hour mean blood pressure by ambulatory blood pressure monitoring (ABPM) and clinic blood pressure measurements at trough are shown in the table below for both studies.
Danish: Blodtryksreduktionerne sammenlignet med placebo baseret på 24-timers gennemsnitligt blodtryk ved ambulant blodtryksmåling (ABPM) og kliniske blodtryksmålinger for begge studier er vist i tabellen nedenfor.
English: There is no evidence of a teratogenic effect, but animal studies indicated some hazardous potential to the postnatal development of the offspring such as lower body weight, a slight delay in physical development (delayed incisor eruption, pinna detachment, eye opening), and higher mortality.
Danish: Der er ikke evidens for en teratogen effekt, men dyrestudier viste en potentiel risiko i forhold til den postnatale udvikling af afkommet, såsom lav legemsvægt, lettere forsinket fysisk udvikling (forsinket gennembrud af gnavertænder, frigørelse af det ydre øre, åbning af øjne) og højere mortalitet.
English: No dose adjustment is required in the black population, although smaller reductions in blood pressure are observed compared with a non-black population (see section 5.1).
Danish: Der er ikke behov for dosisjustering hos den negroide population, selvom der er observeret mindre blodtrykssænkende virkning hos denne population sammenlignet med den ikke-negroide population (se pkt.
English: Azilsartan is not removed by dialysis.
Danish: Azilsartan kan ikke fjernes ved dialyse.
English: Whilst there are no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Danish: Selvom der ikke findes kontrollerede epimiologiske data for angiotensin IIreceptorantagonister, kan der være en lignende risiko for denne lægemiddelklasse.
English: - The usual starting dose is 40 mg once a day.
Danish: - Den sædvanlige dosis er 40 mg én gang dagligt.
English: Blood creatinine increased Blood uric acid increased / Hyperuricemia
Danish: Forhøjet blodkreatinin Forhøjet urinsyre i blodet/hyperurikæmi
English: In rats and dogs, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Danish: I rotter og hunde blev der observeret forhøjet plasmareninaktivitet og hypertrofi/hyperplasi af de juxtaglomerulære nyreceller.
English: In these two studies, clinically important and most common adverse events included dizziness, headache and dyslipidemia.
Danish: I disse to studier omfattede klinisk vigtige og mest almindelige bivirkninger svimmelhed, hovedpine og dyslipædimi.
English: If you stop taking Edarbi
Danish: Hvis du holder op med at tage Edarbi
English: Azilsartan and M-II crossed the placenta and were found in the fetuses of pregnant rats and were excreted into the milk of lactating rats.
Danish: Azilsartan og M-II krydsede placenta og blev fundet i fostrene hos drægtige rotter og blev udskilt i mælken hos diegivende rotter.
English: Administration of Edarbi for up to 5 days in subjects with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment resulted in slight increase in azilsartan exposure (AUC increased by 1.3 to 1.6 fold, see section 4.2).
Danish: Administration af Edarbi i op til 5 dage hos patienter med mild (Child-Pugh A) eller moderat (Child-Pugh B) nedsat leverfunktion resulterede i en let stigning i azilsartaneksponering (AUC steg med 1,3 til 1,6 gange, se pkt.
English: Caution required with concomitant use
Danish: Forsigtighed bør udvises ved samtidig anvendelse
English: Coadministration of Edarbi 40 and 80 mg with a calcium channel blocker (amlodipine) or a thiazidetype diuretic (chlortalidone) resulted in additional blood pressure reductions compared with the other antihypertensive alone.
Danish: Samtidig administration af Edarbi 40 og 80 mg med en kalciumkanalblokker (amlodipin) eller et diuretikum af thiazid-typen (chlortalidon) resulterede i yderligere blodtryksreduktion sammenlignet med de andre antihypertensiva alene.
English: No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Danish: Der er ikke rapporteret signifikante interaktioner i studier med azilsartan medoxomil eller azilsartan administreret sammen med amlodipin, antacider, chlortalidon, digoxin, fluconazol, glyburid, ketoconazol, metformin og warfarin.
English: These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical significance.
Danish: Disse ændringer, der også er en klassevirkning for angiotensinkonverterende enzyminhibitorer og andre angiotensin II-receptorantagonister, forekommer ikke at have klinisk signifikans.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Edarbi in one or more subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af studier med Edarbi hos en eller flere undergrupper af den pædiatriske population med hypertension (se pkt.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Edarbi kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: In these clinical studies, adverse reactions associated with treatment with Edarbi were mostly mild or moderate, with an overall incidence similar to placebo.
Danish: I disse kliniske studier var bivirkningerne forbundet med behandling med Edarbi overvejende milde eller moderate, med en generel forekomst svarende til forekomsten for placebo.
English: 14, 28, 56 or 98 tablets; or
Danish: 14, 28, 56 eller 98 tabletter; eller
English: 14, 28, 30, 56, 90 or 98 tablets.
Danish: 14, 28, 30, 56, 90 eller 98 tabletter.
English: 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets
Danish: 14 tabletter 28 tabletter 30 tabletter 56 tabletter 90 tabletter 98 tabletter
English: The most common adverse reaction was dizziness.
Danish: Den mest almindelige bivirkning var svimmelhed.
English: Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Edarbi.
Danish: Din læge vil normalt anbefale, at du stopper med at tage dette lægemiddel, inden du bliver gravid, eller så snart du ved, at du er gravid.
English: Therefore, the use of Edarbi is not recommended in these patients.
Danish: Derfor bør Edarbi ikke anvendes til disse patienter.
English: C-labelled azilsartan medoxomil, approximately 55% of radioactivity was recovered in faeces and approximately 42% in urine, with 15% of the dose excreted in urine as azilsartan.
Danish: C-mærket azilsartan medoxomil blev ca. 55 % af radioaktiviteten genfundet i fæces og ca. 42 % i urinen.
English: Angiotensin II is the principal pressor agent of the RAAS, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.
Danish: Angiotensin II er det primære pressorstof af RAAS med virkninger, der omfatter vasokonstriktion, stimulering af syntese og frigivelse af aldosteron, hjertestimulering og renal reabsorption af natrium.
English: Blockade of the AT1 receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increases in plasma renin activity and angiotensin II circulating levels do not overcome the antihypertensive effect of azilsartan.
Danish: Blokering af AT1-receptoren hæmmer reguleringen af angiotensin IIs negative feedback på reninsekretionen, men de resulterende stigninger i plasmareninaktiviteten og det cirkulerende angiotensin II-niveau overvinder ikke azilsartans antihypertensive virkning.
English: The antihypertensive effect of azilsartan medoxomil occurred within the first 2 weeks of dosing with the full effect achieved by 4 weeks.
Danish: Den antihypertensive virkning af azilsartan medoxomil viste sig inden for de 2 første uger efter dosering, med fuld opnået virkning efter 4 uger.
English: Clinic SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) (LOCF) Study 1
Danish: KlinikSBP: LS middel ændring fra baseline (BL) til uge 6 (mm Hg) (LOCF) Studie 1
English: Doses were force-titrated at Week 2 from 20 to 40 mg and 40 to 80 mg for Edarbi, and 20 to 40 mg and 160 to 320 mg, respectively, for olmesartan medoxomil and valsartan
Danish: Doserne blev optitreret ved uge 2 fra 20 til 40 mg og 40 til 80 mg for Edarbi, og 20 til 40 mg og 160 til 320 mg for henholdsvis olmesartan medoxomil og valsartan
English: - have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Danish: - har sukkersyge eller nedsat nyrefunktion, og du også tager et blodtrykssænkende lægemiddel, der indeholder aliskiren
English: - The other ingredients are mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.
Danish: - Øvrige indholdsstoffer: mannitol, fumarsyre, natriumhydroxid, hydroxypropylcellulose, croscarmellosenatrium, mikrokrystallinsk cellulose og magnesiumstearat.
English: Swelling of the hands, ankles or feet is more common (in less than 1 in 10 users) when Edarbi is taken with amlodipine (a calcium channel blocker for treating hypertension) than when Edarbi is taken alone (less than 1 in 100 users).
Danish: Hævelser i hænder, ankler og fødder er mere almindelige (forekommer hos færre end 1 ud af 10 brugere), når Edarbi tages sammen med amlodipin (en kalciumkanalblokker til behandling af forhøjet blodtryk), end når Edarbi tages alene (forekommer hos færre end 1 ud af 100 brugere).
English: As with other angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors the antihypertensive effect was lower in black patients (usually a low-renin population).
Danish: Som det også er tilfældet for andre angiotensin II-receptorantagonister og angiotensin-konverterende enzyminhibitorer, var den antihypertensive virkning lavere hos negroide patienter (normalt en population med lav-renin tilstande).
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of lithium and angiotensin-converting enzyme inhibitors.
Danish: Der er rapporteret reversible stigninger i serum-lithiumkoncentrationerne samt toksicitet ved samtidig anvendelse af lithium og angiotensin-konverterende enzyminhibitorer.
English: Excessive blood pressure decreases in patients with ischaemic cardiomyopathy or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
Danish: Kraftigt blodtryksfald hos patienter med iskæmisk kardiomyopati eller iskæmisk cerebrovaskulær sygdom kan resultere i myokardieinfarkt eller apopleksi.
English: - The concomitant use of Edarbi with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.5 and 5.1).
Danish: - Samtidig brug af Edarbi og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR 60 ml/min/1,73m2) (se pkt.
English: Stop taking Edarbi and seek medical help immediately if you have any of the following allergic reactions, which occur rarely (may affect up to 1 in 1,000 people): - Difficulties in breathing, or swallowing, or swelling of the face, lips, tongue and/or throat
Danish: Stop med at tage Edarbi og kontakt omgående læge eller skadestue, hvis du får en eller flere af følgende overfølsomhedsreaktioner som forekommer sjældent (kan forekomme hos op til 1 ud af 1.000 personer): - Vejrtrækningsbesvær, eller synkebesvær, eller en hævelse i ansigt, læber, tunge og/eller svælg
English: Monitoring of potassium should be undertaken as appropriate.
Danish: Der bør foretages passende monitorering af kalium.
English: There was no evidence of QT/QTc prolongation at a dose of 320 mg of azilsartan medoxomil.
Danish: Der var ikke evidens for QT/QTc-forlængelse ved en dosis på 320 mg azilsartan medoxomil.
English: The blood pressure lowering effect of azilsartan medoxomil was also maintained throughout the 24 hour dosing interval.
Danish: Den blodtryksreducerende virkning af azilsartan medoxomil blev også opretholdt over hele doseringsintervallet på 24 timer.
English: Edarbi contains an active substance called azilsartan medoxomil and belongs to a class of medicines called angiotensin II receptor antagonists (AIIRAs).
Danish: Edarbi indeholder et aktivt stof, der kaldes azilsartan medoxomil og hører til en gruppe af lægemidler, der kaldes angiotensin-II receptorantagonister.
English: No data are available on the effect of azilsartan medoxomil on human fertility.
Danish: Der er ingen tilgængelige data om virkningen af azilsartan medoxomil på den humane fertilitet.
English: In the elderly, in patients with renal insufficiency, in diabetic patients and/or in patients with other co-morbidities, the risk of hyperkalaemia, which may be fatal, is increased.
Danish: Hos ældre patienter, patienter med nedsat nyrefunktion, diabetiske patienter og/eller patienter med andre komorbiditeter, er risikoen for hyperkalæmi, der kan være fatal, forhøjet.
English: Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark
Danish: Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Danmark
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om Edarbi findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Furthermore, concomitant use of angiotensin II receptor antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Danish: Ydermere kan samtidig brug af angiotensin II-receptorantagonister og NSAID medføre øget risiko for svækkelse af nyrefunktionen samt øgning af serumkalium.
English: Azilsartan medoxomil is an orally active prodrug that is rapidly converted to the active moiety, azilsartan, which selectively antagonises the effects of angiotensin II by blocking its binding to the AT1 receptor in multiple tissues (see section 5.2).
Danish: Azilsartan medoxomil er et oralt aktivt prodrug, der hurtigt omdannes til den aktive del, azilsartan, som selektivt antagoniserer virkningerne af angiotensin II ved at blokere bindingen heraf til AT1-receptoren i mange vævstyper (se pkt.
English: Azilsartan medoxomil has no or negligible influence on the ability to drive and use machines.
Danish: Azilsartan medoxomil påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 3 g/l and 1 volume percent, respectively) were observed in placebo-controlled monotherapy studies.
Danish: Det blev observeret små fald i hæmoglobin og hæmatokritværdier (gennemsnitligt fald på henholdsvis ca. 3 g/l og 1 volumenprocent) i placebokontrollerede monoterapistudier.
English: 24 Hour Mean SBP: LS Mean Change from Baseline (BL) to Week 6 (mm Hg) Study 1
Danish: 24-timers middel SBP: LS middel ændring fra baseline (BL) til uge 6 (mm Hg) Studie 1
English: Hypotension in volume- and /or salt-depleted patients In patients with marked volume- and/or salt-depletion (e.g. patients with vomiting, diarrhoea or taking high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Edarbi.
Danish: Hypotension hos volumen- og/eller saltdepleterede patienter Hos patienter med markant volumen- og saltdepletering (f.eks. patienter med opkastninger, diarré, eller patienter, som har taget høje doser diuretika), kan der forekomme symptomatisk hypotension efter initiering af behandling med Edarbi.
English: What Edarbi contains
Danish: Edarbi indeholder:
English: Consequently, uptitration of Edarbi and concomitant therapy may be needed more frequently for blood pressure control in black patients.
Danish: Der kan, som følge heraf, hyppigere være behov for optitrering af Edarbi samt samtidig behandling ved blodtrykskontrol hos negroide patienter.
English: In active-comparator studies with either valsartan or ramipril, the blood-pressure-lowering effect with Edarbi was sustained during long-term treatment.
Danish: I studier med aktive komparatorer med enten valsartan eller ramipril blev Edarbis antihypertensive virkning opretholdt ved langtidsbehandling.
English: Nonclinical studies demonstrated that azilsartan did not appear to affect male or female fertility in the rat (see section 5.3).
Danish: Nonkliniske studier viser, at azilsartan ikke synes at påvirke fertiliteten hos han- eller hunrotter (se pkt.
English: When Edarbi was coadministered with amlodipine, the frequency of peripheral oedema was increased from uncommon to common, but was lower than amlodipine alone.
Danish: Når Edarbi blev administreret samtidig med amlodipin, blev frekvensen af perifere ødemer forhøjet fra ikke almindelig til almindelig, men frekvensen var lavere end for amlodipin alene.
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Danish: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) var et studie, der skulle undersøge fordelen ved at tilføje aliskiren til standardbehandling med en ACEhæmmer eller en angiotensin II-receptorantagonist hos patienter med type 2-diabetes mellitus og kronisk nyresygdom, kardiovaskulær sygdom eller begge.
English: Monitoring of serum potassium should be undertaken as appropriate (see section 4.4).
Danish: Der bør foretages passende monitorering af serumkalium (se pkt.
English: Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Danish: Din læge vil eventuelt måle din nyrefunktion, dit blodtryk og elektrolytter (f.eks. kalium) i dit blod med jævne mellemrum
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere information om Edarbi på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: (angioedema) - Itching of the skin with raised lumps.
Danish: (angioødem) - Hudkløe med hævelser.
English: For Edarbi, olmesartan medoxomil and valsartan, respectively dizziness was observed at an incidence of 3.0%, 3.3% and 1.8%; headache at 4.8%, 5.5% and 7.6% and dyslipidemia at 3.5%, 2.4% and 1.1%.
Danish: Svimmelhed blev observeret med en hyppighed på 3,0 %, 3,3 % og 1,8 %, hovedpine med en hyppighed på 4,8 %, 5,5 % og 7,6 % og dyslipædimi med en hyppighed på 3,5 %, 2,4 % og 1,1 % for henholdsvis Edarbi, olmesartan medoxomil og valsartan.
English: Common side effects (may affect up to 1 in 10 people): - Dizziness - Diarrhoea - Increased blood creatine phosphokinase (an indicator of muscle damage).
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): - Svimmelhed - Diarré - Forhøjet blodkreatinfosfokinase (viser muskelskade).
English: Dose proportionality in exposure was established for azilsartan in the azilsartan medoxomil dose range of 20 mg to 320 mg after single or multiple dosing.
Danish: Dosisproportionaliteten ved eksponering blev fastslået for azilsartan i doseringsintervallet af azilsartan medoxomil fra 20 mg til 320 mg efter en enkelt- dosering eller efter flere doseringer.
English: The incidence of elevations in serum creatinine following treatment with Edarbi was similar to placebo in the randomised placebo-controlled monotherapy studies.
Danish: Incidensen af forhøjet serumkreatinin efter behandling med Edarbi svarede til placebo i de randomiserede, placebokontrollerede monoterapistudier.
English: Blood creatine phosphokinase increased
Danish: Forhøjet blodkreatininfosfokinase
English: When Edarbi was coadministered with chlortalidone, the frequencies of blood creatinine increased and hypotension were increased from uncommon to common.
Danish: Når Edarbi blev administreret samtidig med chlortalidon, forhøjedes frekvensen af blodkreatinin, og frekvensen af hypotension blev forhøjet fra ikke almindelig til almindelig.
English: Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day), and non-selective NSAIDs When angiotensin II receptor antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Danish: Nonsteroide antiinflammatoriske lægemidler (NSAID), inklusive selektive COX-2 hæmmere, acetylsalicylsyre > 3 g/dag) og nonselektive NSAID Når angiotensin II-receptorantagonister administreres samtidig med NSAID (f.eks. selektive COX-2 hæmmere, acetylsalicylsyre (> 3 g/dag) og nonselektive NSAID), kan den antihypertensive virkning svækkes.
English: As there is limited experience of use of Edarbi in patients with mild to moderate hepatic impairment close monitoring is recommended and consideration should be given to 20 mg as a starting dose (see section 5.2).
Danish: Da der er begrænset erfaring med brug af Edarbi til patienter med mild eller moderat nedsat leverfunktion, anbefales tæt monitorering, og det bør overvejes at give 20 mg som startdosis (se pkt.
English: In addition, plasma esterases are involved in the hydrolysis of azilsartan medoxomil to azilsartan.
Danish: Derudover er plasmaesteraser involveret i hydrolysen af azilsartan medoxomil til azilsartan.
English: In preclinical safety studies, azilsartan medoxomil and M-II, the major human metabolite, were examined for repeated-dose toxicity, reproduction toxicity, mutagenicity and carcinogenicity.
Danish: Azilsartan medoxomil og M-II, den største humane metabolit, blev undersøgt for toksicitet ved gentagne doser, reproduktionstoksicitet, mutagenicitet og carcinogenicitet i prækliniske sikkerhedsstudier.
English: Food does not affect the bioavailability of azilsartan (see section 4.2).
Danish: Føde påvirker ikke azilsartans biotilgængelighed(se pkt.