FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC also noted that the current clinical experience suggests that it is difficult to clearly separate patient populations where randomised clinical trials have shown serious harm from populations targeted by the approved indication.
Danish: Forslagene om at ændre indikationerne og kontraindikationerne vurderes ikke at kunne påvirke de ordinerende lægers adfærd i tilstrækkelig grad. PRAC bemærkede også, at aktuel klinisk erfaring viser, at det er vanskeligt at foretage en klar sondring mellem de patientpopulationer, hvor der i randomiserede kliniske studier er set alvorlig skade, og de populationer, der er omfattet af den godkendte indikation.
English: However, the available evidence shows that the non-adherence is not only due to a lack of awareness of the restrictions by prescribers, rendering further communication and education unlikely to be sufficiently effective.
Danish: Den tilgængelige evidens viser imidlertid, at den manglende overholdelse ikke kun skyldes de ordinerende lægers manglende bevidsthed om begrænsningerne.
English: In particular, the CMDh noted the results of a consultation of Member States where the suspension of the
Danish: • CMDh hæftede sig navnlig ved resultaterne af en høring af medlemsstaterne, hvor suspenderingen af markedsføringstilladelsen for HES-infusionsvæske, opløsning.
English: In view of the insight that the CMDh has on the national healthcare systems, it agreed that the following additional risk minimisation measures are feasible and likely to be effective to minimise the risk of using HES solutions for infusion in contraindicated populations: the inclusion of an emphasised warning on the SmPC, PL, primary and secondary packaging, the circulation of a targeted DHPC and the implementation of a controlled access program.
Danish: På baggrund af CMDh's indblik i de nationale sundhedssystemer fandt det, at følgende supplerende risikominimeringsforanstaltninger er gennemførlige og må forventes effektivt at ville minimere risikoen for, at HES-infusionsvæske, opløsning.
English: In order to prompt the attention of the recipients of the product information on the clinical situations above described, a warning to not use HES solutions for infusion in septic, renal impaired and critically ill patients should be mentioned at the top of the SmPC and PL.
Danish: Der anføres en advarsel om ikke at anvende HES-infusionsvæske, opløsning, hos patienter med sepsis, nedsat nyrefunktion eller kritisk sygdom, øverst i produktresuméet og indlægssedlen for at henlede opmærksomheden hos modtagerne af produktinformationen på de ovenfor beskrevne kliniske situationer.
English: The above training materials should be based on the following key elements: - the risks related to the use of HES solutions for infusion outside the terms of the MA, - a reminder of the indication, dose, duration of treatment and contraindications and the need to comply with the product information, - the new additional risk minimisation measures, - the results from the DUSs.
Danish: - en påmindelse om indikation, dosis, behandlingsvarighed, kontraindikationer og nødvendigheden af at overholde produktinformationen,
English: The focus for the drug utilisation studies (DUSs) has been to evaluate the adherence to the restrictions in use, implemented in the product information, concerning the indication, posology, and contraindication for HES solutions for infusion.
Danish: Fokus for studierne af lægemiddelanvendelsen har været at vurdere, om man overholder de begrænsninger af anvendelsen,der er anført i
English: Packaging Package size
Danish: Indgivelsesvej Emballage Pakningsstørrelse
English: - are more than 3 months pregnant.
Danish: - er mere end 3 måneder henne i graviditeten.
English: Elderly (65 years and over)
Danish: Ældre (65 år og derover)
English: You can take this medicine with or without food.
Danish: Du kan tage dette lægemiddel med eller uden mad.
English: Just take the next dose at the usual time.
Danish: Du skal blot tage den næste dosis til sædvanlig tid.
English: Date of first authorisation: 7 December 2011 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 7. december 2011 Dato for seneste fornyelse:
English: It is important to keep taking Edarbi every day at the same time.
Danish: Det er vigtigt, at fortsætte med at tage Edarbi på samme tidspunkt hver dag.
English: Elimination Following an oral dose of
Danish: Elimination Efter en oral dosis på
English: - have heart problems (including heart failure, recent heart attack).
Danish: - har hjerteproblemer (herunder dårligt hjerte, nyligt hjerteanfald)
English: However it should be taken into account that occasionally dizziness or tiredness may occur.
Danish: Man skal dog være opmærksom på, at der kan forekomme lejlighedsvis svimmelhed eller træthed.
English: See also information under the heading “Do not take Edarbi”.
Danish: Se også information under overskriften ”Tag ikke Edarbi”
English: Therefore, this medicine should not be given to children or adolescents.
Danish: Dette lægemiddel må derfor ikke bruges til børn eller unge.
English: Many of these elevations were transient or nonprogressive while subjects continued to receive treatment.
Danish: Mange af disse forhøjelser var forbigående eller ikke-progressive, mens patienterne fortsat modtog behandling.
English: Overall, 51% of patients were male and 26% were 65 years or older (5% ≥ 75 years); 67% were white and 19% were black.
Danish: 51 % af patienterne var mænd og 26 % var 65 år eller ældre (5 % ≥ 75 år); 67 % var hvide og 19 % var negroide.
English: The frequency of this effect is highest when amlodipine is taken alone.
Danish: Hyppigheden for denne virkning er størst, når amlodipin tages alene.
English: The incidence of adverse reactions with this treatment was not affected by gender, age, or race.
Danish: Incidensen af bivirkninger med denne behandling var ikke påvirket af køn, alder eller race.
English: (It is also better to avoid this medicine in early pregnancy - see pregnancy section).
Danish: (Du skal desuden helst undgå at tage dette lægemiddel tidligt i graviditeten - se afsnittet om graviditet.)
English: Take the tablet with plenty of water.
Danish: Tabletten skal synkes med rigeligt vand.
English: This medicine is used for treating high blood pressure (essential hypertension) in adult patients (over 18 years of age).
Danish: Denne medicin anvendes til behandling af forhøjet blodtryk (essentiel hypertension) hos voksne patienter (over 18 år).
English: Essential hypertension
Danish: Essentiel hypertension
English: If symptomatic hypotension should occur, supportive treatment should be instituted and vital signs monitored.
Danish: Hvis der skulle opstå symptomatisk hypotension, skal der iværksættes understøttende behandling, og de vitale tegn skal monitoreres.
English: The possibility of similar effects cannot be excluded with Edarbi.
Danish: Risikoen for tilsvarende virkninger med Edarbi kan ikke udelukkes.
English: The placebo-corrected trough-to-peak ratios for SBP and DBP were approximately 80% or higher.
Danish: Den placebokorrigerede trough-to-peak ratio for SBP og DBP var ca. 80 % eller højere.
English: Edarbi is indicated for the treatment of essential hypertension in adults.
Danish: Edarbi er indiceret til behandling af essentiel hypertension hos voksne.
English: Azilsartan is metabolised to two primary metabolites.
Danish: Azilsartan metaboliseres til to primære metabolitter.
English: Therefore do not stop taking Edarbi without first talking to your doctor about alternative treatment options.
Danish: Du må derfor ikke stoppe med at tage Edarbi uden først at talt med din læge om andre behandlingsmuligheder.
English: Additional information
Danish: Supplerende oplysninger
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt den {MM/YYYY}
English: The dose may be increased to a maximum of 80 mg once daily for patients whose blood pressure is not adequately controlled at the lower dose.
Danish: Dosis kan øges til maksimalt 80 mg én gang dagligt til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret ved den lavere dosis.
English: There is limited data on the use of Edarbi in children or adolescents under 18 years of age.
Danish: Der er begrænsede data vedrørende brug af Edarbi til børn eller unge under 18 år.
English: If you stop taking Edarbi, your blood pressure may increase again.
Danish: Hvis du holder op med at tage Edarbi, kan dit blodtryk stige igen.
English: In vitro studies indicated that interactions based on esterase inhibition are unlikely.
Danish: In vitro-studier indikerede, at interaktioner baseret på hæmning af esterase er usandsynlige.
English: Key Secondary End Point:
Danish: Centralt sekundært endepunkt:
English: These are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), including isolated reports.
Danish: Bivirkningerne er opdelt efter frekvens ud fra følgende konvention: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), herunder isolerede indberetninger.
English: In patients with mild, moderate, and severe renal impairment azilsartan total exposure (AUC) was +30%, +25% and +95% increased.
Danish: Hos patienter med mild, moderat og svært nedsat nyrefunktion var den totale azilsartaneksponering (AUC) forøget med +30 %, +25 % og +95 %.
English: Older people
Danish: Ældre
English: Pharmacokinetics of azilsartan do not differ significantly between young (age range 18-45 years) and elderly (age range 65-85 years) patients.
Danish: Azilsartans farmakokinetik adskiller sig ikke signifikant mellem yngre (aldersinterval 18-45 år) og ældre (aldersinterval 65-85 år) patienter.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene til fremsendelse af PSUR'er for dette lægemiddel er anført på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The major enzyme responsible for azilsartan metabolism is CYP2C9.
Danish: Det største enzym, der er ansvarligt for metabolisme af azilsartan, er CYP2C9.
English: Primary end point:
Danish: Primært endepunkt:
English: Beneficial effects of Edarbi on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Danish: De gavnlige virkninger af Edarbi på mortalitet og kardiovaskulær morbiditet og målorganskade kendes ikke på nuværende tidspunkt.
English: This effect is also seen with other inhibitors of the RAAS.
Danish: Denne virkning er også set med andre inhibitorer af RAAS.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Såfrem denne kombination skønnes nødvendig, tilrådes tæt monitorering af serum-lithiumniveauet.
English: - have severe liver disease.
Danish: - har en alvorlig leversygdom
English: Steady-state levels of azilsartan are achieved within 5 days and no accumulation in plasma occurs with repeated once-daily dosing.
Danish: Azilsartans steady-stateniveau opnås inden for 5 dage og der forekommer ingen ophobning i plasma ved gentagen dosering 1 gang dagligt.
English: Azilsartan is highly bound to plasma proteins (> 99%), mainly serum albumin.
Danish: Azilsartan er i høj grad bundet til plasmaproteiner (> 99 %), hovedsagelig til serumalbumin.
English: The safety and efficacy of Edarbi in children and adolescents aged 0 to < 18 years have not yet been established.
Danish: Edarbis sikkerhed og virkning hos børn og unge i alderen 0 til < 18 år er endnu ikke klarlagt.
English: Effect on cardiac repolarisation
Danish: Påvirkning af kardial repolarisering
English: Black population
Danish: Negroid population
English: Paediatric population The pharmacokinetics of azilsartan have not been studied in children under 18 years of age.
Danish: Pædiatrisk population Azilsartans farmakokinetik er ikke undersøgt hos børn under 18 år.
English: Edarbi is for oral use and may be taken with or without food (see section 5.2).
Danish: Edarbi er til oral brug og kan tages med eller uden mad (se pkt.
English: Change from BL -0.3
Danish: Ændring fra BL -0,3
English: No increase (+5%) was observed in end-stage renal disease patients who were dialysed.
Danish: Der blev ikke observeret en stigning (+5 %) hos patienter med terminal nyresygdom, der havde været i dialyse.
English: There is currently no experience on the use of Edarbi in patients who have recently undergone kidney transplantation.
Danish: Der er på nuværende tidspunkt ingen erfaring med anvendelse af Edarbi til patienter, der for nylig har fået foretaget en nyretransplantation.
English: These effects, which were prevented by oral saline supplementation, do not have clinical significance in treatment of hypertension.
Danish: Disse virkninger, der blev forebygget ved hjælp af oral saltvandstilskud, har ingen klinisk signifikans for behandlingen af hypertension.
English: Change from BL -1.8
Danish: Ændring fra BL -1,8
English: Characteristics in specific groups of patients
Danish: Karakteristika hos specifikke patientgrupper
English: Edarbi at doses of 20, 40 or 80 mg has been evaluated for safety in clinical studies in patients treated for up to 56 weeks.
Danish: Edarbi i doser à 20, 40 eller 80 mg er blevet undersøgt for sikkerhed i kliniske studier hos patienter behandlet i op til 56 uger.
English: Edarbi is provided in blisters with either 14 tablets or 15 tablets in cartons containing 14, 28, 56 or 98 tablets and blisters integrated with desiccant with either 14 tablets or 15 tablets in cartons containing 14, 28, 30, 56, 90 or 98 tablets.
Danish: Edarbi leveres i blisterpakninger med enten 14 eller 15 tabletter pakket i æsker, der indeholder 14, 28, 56 eller 98 tabletter, samt blisterpakninger med tørremiddel med enten 14 eller 15 tabletter pakket i æsker, der indeholder 14, 28, 30, 56, 90 eller 98 tabletter.
English: Edarbi can affect the way some other medicines work and some medicines can have an effect on Edarbi.
Danish: Edarbi kan påvirke den måde andre lægemidler virker på, og andre lægemidler kan påvirke den måde Edarbi virker på.
English: Edarbi was compared with placebo and active comparators in two 6 week randomised, double blind studies.
Danish: Edarbi blev sammenlignet med placebo og aktive komparatorer i to randomiserede, dobbeltblinde 6-ugers studier.
English: Edarbi blocks this effect so that the blood vessels relax, which helps lower your blood pressure.
Danish: Edarbi blokerer for denne virkning, således at blodkarrene kan slappe af, hvilket bidrager til at sænke dit blodtryk.
English: (haemoglobin).
Danish: (hæmoglobin).
English: Your doctor may need to change your dose and/or to take other precautions if you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Edarbi” and “Warnings and precautions”).
Danish: Det er muligt, at lægen er nødt til at ændre din dosis og/eller tage andre forholdsregler: Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Edarbi” og ”Advarsler og forsigtighedsregler”).
English: Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness.
Danish: Ud fra farmakologiske betragtninger vil de sandsynlige tegn på en overdosering være symptomatisk hypotension og svimmelhed.
English: The volume of distribution of azilsartan is approximately 16 litres.
Danish: Azilsartans fordelingsvolumen er ca. 16 liter.
English: However some people may feel tired or dizzy when taking this medicine and if this happens to you, do not drive or use any tools or machines.
Danish: Nogle kan dog føle sig trætte eller svimle, når de tager dette lægemiddel, og hvis du får disse symptomer, må du ikke køre bil, motorcykel, cykle eller anvende værktøj eller maskiner.
English: The estimated absolute oral bioavailability of azilsartan medoxomil based on plasma levels of azilsartan is approximately 60%.
Danish: Azilsartan medoxomils estimerede absolutte orale biotilgængelighed baseret på plasmaniveauet af azilsartan er ca. 60 %.
English: - have ever had a stroke.
Danish: - har eller tidligere har haft et slagtilfælde
English: The elimination half-life of azilsartan is approximately 11 hours and renal clearance is approximately 2.3 ml/min.
Danish: Eliminationshalveringstiden for azilsartan er ca. 11 timer og renal clearance er ca. 2,3 ml/min.
English: A similar effect may occur with angiotensin II receptor antagonists.
Danish: En tilsvarende virkning kan forekomme med angiotensin II-receptorantagonister.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Danish: Det er ikke nødvendigt at justere dosis til patienter med mild eller moderat nedsat nyrefunktion.
English: After oral administration of azilsartan medoxomil, peak plasma concentrations (Cmax) of azilsartan are reached within 1.5 to 3 hours.
Danish: Efter oral administration af azilsartan medoxomil nås azilsartans peak plasmakoncentration (Cmax) inden for 1,5 til 3 timer.
English: No dose adjustment is necessary based on race.
Danish: Der er ikke behov for dosisjustering på baggrund af race.
English: Edarbi had a lower incidence of cough (1.2%) compared with ramipril (8.2%).
Danish: Der var en lavere forekomst af hoste med Edarbi (1,2 %) sammenlignet med ramipril (8,2 %).
English: Dual blockade of the RAAS
Danish: Dobbelt hæmning af RAAS
English: No dose adjustment is necessary based on gender.
Danish: Der er ikke behov for dosisjustering på baggrund af køn.
English: Hemodialysis does not remove azilsartan from the systemic circulation.
Danish: Hæmodialyse fjerner ikke azilsartan fra den systemiske cirkulation.
English: Mannitol (E 421) Fumaric acid (E 297) Sodium hydroxide Hydroxypropylcellulose (E 463) Croscarmellose sodium Microcrystalline cellulose (E 460) Magnesium stearate (E 572)
Danish: Mannitol (E 421) Fumarsyre (E 297) Natriumhydroxid Hydroxypropylcellulose (E 463) Croscarmellosenatrium Mikrokrystallinsk cellulose(E 460) Magnesiumstearat (E 572)
English: The recommended starting dose is 40 mg once daily.
Danish: Den anbefalede startdosis er 40 mg én gang dagligt.
English: Following discontinuation of treatment, the majority of the elevations that had not resolved during treatment were reversible, with the creatinine levels of most subjects returning to baseline or near-baseline values.
Danish: Efter seponering af behandlingen var den overvejende del af forhøjelserne, der ikke var forsvundet under behandlingen, reversible, og kreatininniveauet for størstedelen af patienterne vendte tilbage til baseline- eller næsten til baselineniveauet.
English: Patients with primary hyperaldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the RAAS.
Danish: Patienter med primær hyperaldosteronisme vil normalt ikke respondere på antihypertensiva, som virker ved at hæmme RAAS.
English: Rare side effects (may affect up to 1 in 1,000 people): - Changes in blood test results including decreased levels of a protein in the red blood cells
Danish: Sjældne bivirkninger (kan forekomme hos 1 ud af 1.000 personer): - Ændringer i blodprøveresultater, herunder nedsat indhold af et protein i de røde blodceller
English: Adverse reactions based on pooled data (40 and 80 mg doses) are listed below according to system organ class and preferred terms.
Danish: Bivirkninger baseret på sammenfattede data (40 mg og 80 mg doser) er angivet i nedenstående tabel i henhold til systemorganklasse og foretrukne termer.
English: Rebound hypertension was not observed following abrupt cessation of Edarbi therapy after 6 months of treatment.
Danish: Der blev ikke observeret rebound-hypertension efter brat ophør med Edarbi efter 6 måneders behandling.
English: Edarbi may be less effective in lowering the blood pressure in black patients.
Danish: Edarbi kan være mindre effektivt til at sænke blodtrykket hos negroide patienter.
English: Store in the original package in order to protect from light and moisture.
Danish: Opbevares i den original pakning for at beskytte mod lys og fugt.
English: A reduction in your blood pressure will be measureable within 2 weeks of initiation of treatment and the full effect of your dose will be observed by 4 weeks.
Danish: En blodtryksreduktion vil være målbar inden for 2 uger efter behandlingsstart, og den fulde virkning af dosen vil kunne ses i løbet af 4 uger.
English: Do NOT take Edarbi if you - are allergic to azilsartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag IKKE Edarbi, hvis du - er allergisk over for azilsartan-medoxomil eller et af de øvrige indholdsstoffer i Edarbi (anført i punkt 6).
English: Additionally, Edarbi 80 mg resulted in significantly greater reductions in SBP than the highest approved doses of olmesartan medoxomil and valsartan.
Danish: Edarbi 80 mg resulterede endvidere i signifikant større reduktioner i SBP end de højeste godkendte doser af olmesartan medoxomil og valsartan.
English: Azilsartan and M-II showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Danish: Azilsartan og M-II viste ingen tegn på mutagenicitet og relevant klastogen aktivitet i in vitro- studier og ingen tegn på carcinogenicitet i rotter og mus.
English: Based on in vitro studies, carboxymethylenebutenolidase is involved in the hydrolysis in the intestine and liver.
Danish: Baseret på in vitro-studier, er carboxymethylenebutenolidase involveret i hydrolysen i tarmen og leveren.
English: Small mean increases of serum uric acid were observed with Edarbi (10.8 µmol/l) compared with placebo (4.3 µmol/l).
Danish: Der blev observeret en lille gennemsnitlig stigning af urinsyre i serum med Edarbi (10,8 µmol/l) sammenlignet med placebo (4,3 µmol/l).
English: Change from BL -1.4 -12.2 * -13.5 * -14.6 *† -12.6 Study 2
Danish: Ændring fra BL -1,4 -12,2 * -13,5 * -14,6 *† -12,6 Studie 2
English: No overall differences in safety and effectiveness were observed between elderly patients and younger patients, but greater sensitivity to blood pressure lowering effects in some elderly individuals cannot be ruled out (see section 4.2).
Danish: Der blev ikke observeret generelle forskelle i sikkerhed og virkning mellem ældre patienter og yngre patienter, men det kan ikke udelukkes, at nogle ældre er mere følsomme over for den blodtrykssænkende virkning (se pkt.
English: Protein binding is constant at azilsartan plasma concentrations well above the range achieved with recommended doses.
Danish: Proteinbindingen er konstant når plasmakoncentrationen af azilsartan er noget over det niveau, der blev opnået med de anbefalede doser.
English: M-I and M-II do not contribute to the pharmacologic activity of azilsartan medoxomil.
Danish: M-I og M-II bidrager ikke til azilsartan medoxomils farmakologiske aktivitet.
English: A thorough QT/QTc study was conducted to assess the potential of azilsartan medoxomil to prolong the QT/QTc interval in healthy subjects.
Danish: Der blev udført et indgående QT/QTc-studie for at vurdere azilsartan medoxomils potentiale for at forlænge QT/QTc-intervallet hos raske forsøgspersoner.
English: Edarbi is unlikely to have an effect on driving or using machines.
Danish: Det er usandsynligt, at Edarbi har en indvirkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: Therefore, adequate hydration and monitoring of renal function at the beginning of the treatment are recommended.
Danish: Det tilrådes derfor at sørge for adækvat hydrering samt monitorering af nyrefunktionen, når behandlingen initieres.