FrancophonIA/ELRC3.0 huggingface dataset:
English: - Second and third trimester of pregnancy (see sections 4.4 and 4.6).
Danish: - 2. og 3. trimester af graviditeten (se pkt.
English: These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed.
Danish: Disse studier viste ikke signifikant bedre effekt på renal og/eller kardiovaskulære mål og mortalitet sammenlignet med monoterapi, mens en øget risiko for hyperkaliæmi, akut nyrepåvirkning og/eller forhøjet blodtryk observeredes.
English: Edarbi has not been studied in patients with severe hepatic impairment.
Danish: Edarbi er ikke undersøgt hos patienter med svært nedsat leverfunktion.
English: If you forget to take Edarbi Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Coadministration of Edarbi with diuretics, such as chlortalidone, resulted in a greater incidence of creatinine elevations, an observation consistent with that of other angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors.
Danish: Samtidig administration af Edarbi med diuretika, såsom chlortalidon, resulterede i en større forekomst af kreatininforhøjelser, hvilket er en observation, der stemmer overens med observationen for andre angiotensin II-receptorantagonister og angiotensin-konverterende enzyminhibitorer.
English: Placebo at 0.05 level within the framework of the step-wise analysis † Significant difference vs. Comparator(s) at 0.05 level within the framework of the step-wise analysis # Maximum dose achieved in study 2.
Danish: OLM-M = olmesartan medoxomil, LS= least squares (mindste kvadraters metode), LOCF= Last observation Carried Forward (sidste udførte observation) * Signifikant forskel vs. placebo ved 0,05 niveau inden for rammerne af den trinvise analyse † Signifikant forskel vs. Komparator(er) ved 0,05 niveau inden for rammerne af den trinvise analyse # Maksimal dosis opnået i studie 2.
English: Angiotensin II is a substance which occurs naturally in the body and which causes the blood vessels to tighten, therefore increasing your blood pressure.
Danish: Angiotensin-II er et stof, der findes naturligt i kroppen, og som får blodårerne til at trække sig sammen.
English: Pharmacokinetics of azilsartan do not differ significantly between black and white populations.
Danish: Der er ikke en signifikant forskel i azilsartans farmakokinetik mellem negroide og ikke-negroide populationer.
English: Infants whose mothers have taken Angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har anvendt angiotensin II-receptorantagonister, bør observeres nøje for hypertension (se pkt.
English: Intravascular volume depletion
Danish: Nedsat intravaskulær volumen
English: Uncommon side effects (may affect up to 1 in 100 people): - Low blood pressure, which may make you feel faint or dizzy - Feeling tired - Swelling of the hands, ankles or feet (peripheral oedema) - Skin rash and itching - Nausea - Muscle spasms - Increased serum creatinine in the blood (an indicator of kidney function) - Increased uric acid in the blood.
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): - Lavt blodtryk, der kan bevirke, at du føler dig svag eller svimmel - Træthedsfølelse - Hævede hænder, ankler eller fødder (perifert ødem) - Hududslæt og kløe - Kvalme - Muskelspasmer - Forhøjet indhold af serumkreatinin i blodet (viser hvordan nyrerne fungerer) - Forhøjet indhold af urinsyre i blodet.
English: Hypovolemia should be corrected prior to administration of Edarbi, or the treatment should start under close medical supervision, and consideration can be given to a starting dose of 20 mg.
Danish: Hypovolæmi bør korrigeres før behandling med Edarbi, eller behandlingen bør starte under tæt lægelig overvågning.
English: You may feel faint or dizzy if you have taken more than you should.
Danish: Du kan føle dig svag eller svimmel, hvis du tager flere Edarbi tabletter, end du skal.
English: The tablets are white round debossed with “ASL” on one side and either “20”, “40” or “80” on the other.
Danish: Tabletterne er hvide, runde ogmærket med ”ASL” på den ene side og enten ”20”, ”40” eller ”80” på den anden side.
English: Following oral administration, azilsartan medoxomil is rapidly hydrolyzed to the active moiety azilsartan in the gastrointestinal tract and/or during absorption.
Danish: Efter oral administration hydrolyseres azilsartan medoxomil hurtigt til den aktive del azilsartan i mavetarm-kanalen og/eller under absorption.
English: Activated renin-angiotensin-aldosterone system (RAAS) In patients whose vascular tone and renal function depend predominantly on the activity of the RAAS (e.g. patients with congestive heart failure, severe renal impairment or renal artery stenosis), treatment with medicinal products that affect this system, such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists, has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.
Danish: Aktiveret renin-angiotensin-aldosteronsystem (RAAS) Hos patienter, hvis vaskulære tonus og nyrefunktion overvejende afhænger af aktiviteten af RAAS (f.eks. patienter med kongestivt hjertesvigt, svært nedsat nyrefunktion eller nyrearteriestenose), har behandling med lægemidler, som påvirker dette system, såsom angiotensin-konverterende enzym (ACE)inhibitorer og angiotensin II-receptorantagonister, været forbundet med akut hypotension, azotæmi, oliguri eller i sjældne tilfælde med akut nyresvigt.
English: However, there is no clinical experience in patients with severe renal impairment or end stage renal disease (see section 4.2).
Danish: Der er imidlertid ingen klinisk erfaring med patienter med svært nedsat nyrefunktion og terminal nyresygdom (se pkt.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Danish: Indehaver af markedsføringstilladelsen og fremstiller: Indehaver af markedsføringstilladelsen:
English: What you need to know before you take Edarbi
Danish: Det skal du vide, før du begynder at tage edarbi
English: As with other angiotensin II receptor antagonists the combination of lithium and Edarbi is not recommended (see section 4.5).
Danish: Som for andre angiotensin II-receptorantagonister frarådes kombinationen af lithium og Edarbi (se pkt.
English: Concomitant use not recommended
Danish: Samtidig anvendelse frarådes
English: Serum creatinine
Danish: Serumkreatinin
English: Edarbi is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Din læge vil sædvanligvis anbefale en anden behandling til dig, hvis du ønsker at amme dit barn, især hvis dit barn er nyfødt eller født for tidligt.
English: Near-maximal antihypertensive effect is evident at 2 weeks, with maximal effects attained by 4 weeks.
Danish: Næsten maksimal antihypertensiv virkning opnås efter 2 uger.
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Danish: Kaliumbesparende diuretika, kaliumtilskud, salterstatninger indeholdende kalium og andre stoffer, der kan øge kaliumniveauet
English: Based on experience with the use of other medicinal products that affect the RAAS, concomitant use of Edarbi with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (e.g. heparin) may lead to increases in serum potassium in hypertensive patients (see section 4.5).
Danish: Baseret på erfaringen med brug af andre lægemidler, der påvirker RAAS, kan samtidig anvendelse af Edarbi med kaliumbesparende diuretika, kaliumtilskud, salterstatninger indeholdende kalium eller andre lægemidler, der kan øge kaliumniveauet (f.eks. heparin) medføre stigninger i serumkalium hos hypertensive patienter (se pkt.
English: Edarbi is not recommended in early pregnancy, and must NOT be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Edarbi bør ikke anvendes tidligt i graviditeten, og Edarbi må IKKE anvendes, hvis du er længere end 3 måneder henne i graviditeten.
English: Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products (e.g. heparin) may increase potassium levels.
Danish: Samtidig brug af kaliumbesparende diuretika, kaliumtilskud, salterstatninger, der indeholder kalium, eller andre lægemidler (f.eks. heparin) kan øge kaliumniveauet.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately and, if appropriate, alternative therapy should be started.
Danish: I tilfælde af graviditet bør behandling med angiotensin II-receptorantagonister straks seponeres, og alternativ behandling påbegyndes.
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Danish: Behandling i 2. og 3. trimester med angiotensin II-receptorantagonister kan medføre human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, forsinkelse af knogledannelsen i kraniet) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi) (se pkt.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, plain, ATC Code: C09CA09
Danish: Farmakoterapeutisk klassifikation: Stoffer, der virker på renin-angiotensin-systemet, angiotensin IIantagonist, almindelig
English: Caution should be exercised in hypertensive patients with severe renal impairment, congestive heart failure or renal artery stenosis, as there is no experience of use of Edarbi in these patients (see sections 4.2 and 5.2).
Danish: Der bør udvises forsigtighed hos hypertensive patienter med svært nedsat nyrefunktion, kongestivt hjertesvigt eller nyrearteriestenose, da der ikke er erfaring med brug af Edarbi til disse patienter (se pkt.
English: No initial dose adjustment with Edarbi is necessary in elderly patients (see section 5.2), although consideration can be given to 20 mg as a starting dose in the very elderly (≥ 75 years), who may be at risk of hypotension.
Danish: 5.2), selvom det kan overvejes at give 20 mg som startdosis til de noget ældre patienter (≥ 75 år), der kan have risiko for hypotension.
English: Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.4 and 5.2).
Danish: Edarbi er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion, og derfor bør Edarbi ikke anvendes hos denne patientgruppe (se pkt.
English: In the repeated-dose toxicity studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters, changes in the kidney and renal haemodynamics,
Danish: I toksicitetsstudier med gentagne doser i normotensive dyr, frembringer eksponering, som kan sammenlignes med eksponeringen i det kliniske, terapeutiske interval, reduktion af de røde blodlegemer, ændringer i nyre- og leverhæmodynamik, såvel som forhøjet serumkalium.
English: Azilsartan medoxomil is rapidly hydrolysed to the active moiety azilsartan by esterases in the gastrointestinal tract and/or during drug absorption (see section 5.2).
Danish: Azilsartan medoxomil hydrolyseres hurtigt af esteraser til den aktive del af azilsartan i mave-tarmkanalen og/eller under optagelsen af medicin (se pkt.
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Du skal fortælle det til din læge, hvis du er gravid (eller kan være gravid/planlægger at blive gravid).
English: ACE inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.
Danish: ACE-hæmmere og angiotensin II-receptorantagonister bør derfor ikke anvendes samtidigt hos patienter med diabetisk nefropati.
English: In particular, tell your doctor if you are taking any of the following medicines: - Lithium (a medicine for mental health problems) - Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac or celecoxib
Danish: - Lithium (lægemiddel mod psykiske problemer) - Non-steroide anti-inflammatoriske lægemidler (NSAID), såsom ibuprofen, diclofenac eller celecoxib (smertestillende eller betændelseshæmmende lægemidler)
English: Edarbi 20 mg: Each tablet contains 20 mg azilsartan medoxomil (as potassium) Edarbi 40 mg: Each tablet contains 40 mg azilsartan medoxomil (as potassium) Edarbi 80 mg: Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Danish: Edarbi 20 mg: Hver tablet indeholder 20 mg azilsartan medoxomil (som kalium) Edarbi 40 mg: Hver tablet indeholder 40 mg azilsartan medoxomil (som kalium) Edarbi 80 mg: Hver tablet indeholder 80 mg azilsartan medoxomil (som kalium)
English: Dose dependent adverse events including dizziness, hypotension and serum creatinine elevations were more frequent with diuretic coadministration compared with Edarbi alone, while hypokalemia was less frequent compared with diuretic alone.
Danish: Dosisafhængige bivirkninger, herunder svimmelhed, hypotension og forhøjet serumkreatininniveau, forekom hyppigere med samtidig administration af et diuretikum sammenlignet med Edarbi alene.
English: Caution should be exercised in hypertensive patients with severe renal impairment and end stage renal disease as there is no experience of use of Edarbi in these patients (see sections 4.4 and 5.2).
Danish: Der bør udvises forsigtighed hos hypertensive patienter med svært nedsat nyrefunktion og terminal nyresygdom, da der ikke er erfaring med brug af Edarbi til disse patienter (se pkt.
English: The major metabolite in plasma is formed by Odealkylation, referred to as metabolite M-II, and the minor metabolite is formed by decarboxylation, referred to as metabolite M-I.
Danish: Den største metabolit i plasma dannes ved Odealkylering, denne kaldes metabolit M-II, og den mindste metabolit dannes ved decarboxylering, denne kaldes metabolit M-I. Systemisk eksponering for de større og mindre metabolitter hos mennesker var henholdsvis ca. 50 % og mindre end 1 % for eksponeringen af azilsartan.
English: Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Danish: Data fra kliniske studier har vist, at dobbelthæmning af RAAS gennem kombinationsbehandling med ACE-hæmmere, angiotensin II-receptorantagonister eller aliskiren, er forbundet med en højere hyppighed af bivirkninger som hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt) sammenlignet med brug af et enkelt RAAS-virkende lægemiddel (se pkt.
English: Other medicines and Edarbi Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger eller måske vil bruge anden medicin eller har brugt det for nylig.
English: Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis angiotensin II-receptorantagonister har været anvendt efter start af 2. trimester, bør nyrefunktionen og kraniet kontrolleres ved hjælp af ultralyd.
English: Talk to your doctor before taking Edarbi, especially if you - have kidney problems.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Edarbi, især hvis du: - har nyreproblemer - er i dialyse eller har fået en nyretransplantation for nylig
English: Pharmacokinetics of azilsartan do not differ significantly between males and females.
Danish: Der er ikke en signifikant forskel i azilsartans farmakokinetik hos mænd og kvinder.
English: Due to the lack of experience with concomitant use of azilsartan medoxomil and lithium, this combination is not recommended.
Danish: Denne kombination frarådes på grund af manglende erfaring med samtidig anvendelse af azilsartan medoxomil og lithium.
English: Adverse reactions were reported at a similar frequency for the Edarbi 20 mg dose as with the 40 and 80 mg doses in one placebo controlled study.
Danish: I et placebokontrolleret studie blev der indberettet samme hyppighed af bivirkninger ved Edarbi 20 mg dosis, som ved doser på 40 mg og 80 mg.
English: How to take Edarbi
Danish: Sådan skal du tage Edarbi
English: Edarbi is for oral use.
Danish: Edarbi skal tages gennem munden.
English: The elevations in serum creatinine during coadminstiration of Edarbi with diuretics were associated with larger blood pressure reductions compared with a single medicinal product.
Danish: Stigningerne i serum-kreatinin var forbundet med en større blodtryksreduktion ved samtidig administration af Edarbi og diuretika sammenlignet med administration af et enkelt lægemiddel alene.
English: - If you suffer from other coexisting illnesses such as severe kidney disease or heart failure your doctor will decide on the most appropriate starting dose.
Danish: - Din læge vil ordinere den bedst egnede startdosis, hvis du lider af andre sygdomme, såsom svær nyresygdom eller dårligt hjerte.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to angiotensin converting enzyme inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded.
Danish: Ud fra de epidemiologiske data, kan man ikke konkludere, at behandling med angiotensin-konverterende enzyminhibitorer i 1. trimester medfører en risiko for teratogenicitet.
English: - The active substance is azilsartan medoxomil (as potassium).
Danish: - Aktivt stof: azilsartan medoxomil (som kalium).
English: Tlf: + 47 6676 3030 infonorge@takeda.com
Danish: Takeda Nycomed AS Tlf: + 47 6676 3030 infonorge@takeda.com
English: White to nearly white round tablets, 7.6 mm in diameter, debossed “ASL” on one side and “40” on the other.
Danish: Hvide til næsten hvide, runde tabletter, 7,6 mm i diameter, præget med "ASL" på den ene side og "40" på den anden side.
English: Edarbi is not recommended in early pregnancy, and must NOT be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section "Pregnancy section and breast-feeding").
Danish: Edarbi kan skade dit barn alvorligt, hvis det anvendes i denne periode (se afsnittet "Graviditet og amning").
English: Aluminum blisters
Danish: Aluminiumblister Pakningsstørrelser:
English: Edarbi 20 mg tablets Edarbi 40 mg tablets Edarbi 80 mg tablets
Danish: Edarbi 20 mg tabletter Edarbi 40 mg tabletter Edarbi 80 mg tabletter
English: If you take too many tablets, or if someone else takes your medicine, contact your doctor immediately.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis du har taget for mange tabletter, eller hvis en anden har taget din medicin.
English: (medicines to relieve pain and inflammation) - Acetylsalicyclic acid if taking more than 3 g per day (medicine to relieve pain and inflammation) - Medicines that increase the amount of potassium in your blood; these include potassium supplements, potassium-sparing medicines (certain ‘water tablets') or salt substitutes containing potassium - Heparin (a medicine for thinning the blood) - Diuretics (water tablets) - Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan,
Danish: kaliumbesparende lægemidler (visse vanddrivende lægemidler) eller salterstatninger, som indeholder kalium - Heparin (blodfortyndende lægemiddel) - Diuretika (vanddrivende lægemidler) - Aliskiren eller andre blodtrykssænkende lægemidler (angiotensin-konverteringsenzym-hæmmere eller angiotensin-II-receptor-blokkere, såsom enalapril, lisinopril, ramipril eller valsartan, telmisartan, irbesartan).
English: Takeda UK Ltd Tel: +44 (0) 1628 537 900
Danish: Takeda UK Limited Tel: +44 (0) 1628 537 900
English: If blood pressure is not adequately controlled with Edarbi alone, additional blood pressure reduction can be achieved when this treatment is coadministered with other antihypertensive medicinal products,
Danish: Hvis blodtrykket ikke er tilstrækkeligt kontrolleret med Edarbi alene, kan der opnås yderligere blodtryksreduktion, når denne behandling administreres i kombination med andre antihypertensiva, herunder diuretika (såsom chlortalidon og hydrochlorthiazid) og calciumkanalblokkere (se pkt.
English: White to nearly white round tablets, 6.0 mm in diameter, debossed “ASL” on one side and “20” on the other.
Danish: Hvide til næsten hvide, runde tabletter, 6,0 mm i diameter, præget med ”ASL” på den ene side og ”20” på den anden side.
English: Edarbi 40 mg tablets
Danish: Edarbi 40 mg tabletter
English: What Edarbi is and what it is used for What you need to know before you take Edarbi How to take Edarbi
Danish: Det skal du vide, før du begynder at tage Edarbi Sådan skal du tage Edarbi Bivirkninger
English: White to nearly white round tablets, 9.6 mm in diameter, debossed “ASL” on one side and “80” on the other.
Danish: Hvide til næsten hvide, runde tabletter, 9,6 mm i diameter, præget med "ASL" på den ene side og "80" på den anden side
English: Special caution is indicated in patients suffering from aortic or mitral valve stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Der skal udvises ekstra forsigtighed hos patienter med aorta- eller mitralklapstenose eller hypertrofisk obstruktiv kardiomyopati.
English: Your doctor may increase this dose to a maximum of 80 mg once a day depending on blood pressure response.
Danish: Afhængigt af Edarbis påvirkning af dit blodtryk, kan din læge vælge at øge denne dosis til højst 80 mg én gang dagligt.
English: - For patients such as the very elderly (75 years and above) your doctor may recommend a lower starting dose of 20 mg once a day.
Danish: - Din læge kan anbefale en lavere startdosis på 20 mg én gang dagligt, specielt til ældre patienter (75 år og derover).
English: Edarbi 20 mg tablets
Danish: Edarbi 20 mg tabletter
English: Edarbi 80 mg tablets
Danish: Edarbi 80 mg tabletter
English: In the reproduction toxicity studies, there were no effects on male or female fertility.
Danish: Der sås ingen påvirkning af fertiliteten hos han- eller hunrotter i reproduktionsstudier.
English: The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: I 1. trimester kan behandling med angiotensin II-receptorantagonister ikke anbefales (se pkt.
English: Aluminum blisters integrated with desiccant.
Danish: Aluminiumblister med tørremiddel.
English: Edarbi 40 mg tablets Each tablet contains 40 mg of azilsartan medoxomil (as potassium).
Danish: Edarbi 40 mg tabletter Hver tablet indeholder 40 mg azilsartan medoxomil (som kalium).
English: - If you suffer from mild or moderate liver disease your doctor may recommend a lower starting dose of 20 mg once a day.
Danish: - Din læge kan anbefale en lavere startdosis på 20 mg én gang dagligt, hvis du lider af en mild eller moderat leversygdom.
English: Edarbi 40 mg tablets Azilsartan medoxomil
Danish: Edarbi 40 mg tabletter Azilsartan medoxomil
English: - have raised levels of potassium in your blood (as shown in blood tests).
Danish: - Lægemidler, der øger mængden af kalium i dit blod; disse lægemidler omfatter kaliumtilskud,