FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional wording separating the adverse events (AEs) findings from the CHARM programme was included as it illustrated that AE are more common in subjects who received other medicinal products which affect the renin-angiotensin system (RAS).
Danish: Yderligere formulering, som adskiller fundene af uønskede hændelser (AE'er) i CHARMprogrammet, blev inkluderet, fordi det illustrerer, at AE er mere almindeligt hos forsøgspersoner, som har fået andre lægemidler, som påvirker renin-angiotensin-systemet.
English: The area under the serum concentration versus time curve (AUC) of candesartan is not significantly affected by food.
Danish: Arealet under kurven, der viser serumkoncentration over tid (AUC) for candesartan, påvirkes ikke signifikant af fødeindtagelse.
English: Patients with such treatment should be monitored regularly and carefully.
Danish: Patienter i denne behandling bør monitoreres omhyggeligt og regelmæssigt.
English: Pharmacotherapeutic group: Angiotensin II antagonists, plain, ATC code: C09CA06
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-antagonist, ATC kode C09CA06
English: There is currently no data on the effect of candesartan on the progression to diabetic nephropathy.
Danish: Der foreligger for tiden ingen data vedrørende effekten af candesartan på progressionen til diabetisk nefropati.
English: A reference that candesartan can also be administrated with other antihypertensive agents was also included.
Danish: En reference om, at candesartan også kan administreres sammen med andre antihypertensive stoffer, blev også inkluderet.
English: • You can take Atacand with or without food.
Danish: • Du kan tage Atacand med eller uden mad.
English: Denmark AstraZeneca A/S Roskildevej 22
Danish: Danmark AstraZeneca A/S Roskildevej 22
English: Furthermore, candesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells.
Danish: Endvidere inducerede candersartan hyperplasi/hypertrofi af de juxtaglomerulære celler.
English: • if you are vomiting, have recently had severe vomiting, or have diarrhoea.
Danish: • hvis du kaster op, har kastet meget op for nylig eller har diarré.
English: Your resistance to infection may be decreased and you may notice tiredness, an infection or a fever.
Danish: Din modstandsdygtighed over for infektioner kan blive nedsat, og du bemærker måske træthed, infektion eller feber.
English: Very rare (affects less than 1 user in 10,000)
Danish: Meget sjældne bivirkninger (forekommer hos færre end 1 ud af 10.000)
English: There is no indication of serious or exaggerated first dose hypotension or rebound effect after cessation of treatment.
Danish: Der er ikke tegn på alvorlig eller kraftig hypotension efter første dosis eller rebound-effekt efter behandlingsophør.
English: • In some patients, such as those with liver problems, kidney problems or those who recently have lost body fluids, e.g., through vomiting or diarrhoea or by using water tablets, the doctor may prescribe a lower starting dose.
Danish: • Hos nogle patienter, f.eks. patienter med lever- eller nyreproblemer eller patienter, der for nylig har mistet væske ved f.eks. opkastning eller diarré eller ved at tage vanddrivende medicin, kan lægen ordinere en lavere startdosis.
English: No studies on the effects of candesartan on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af candesartans virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: The renal elimination of candesartan is both by glomerular filtration and active tubular secretion.
Danish: Den renale elimination af candesartan sker såvel via glomerulær filtration som via aktiv tubulær sekretion.
English: In patients with impaired hepatic function, the initial starting dose was changed from 2 mg to 4 mg.
Danish: Hos patienter med leverinsufficiens blev den indledende startdosis ændret fra 2 mg til 4 mg.
English: Atacand may also be administered with other antihypertensive agents.
Danish: Atacand kan også administreres sammen med andre antihypertensiva.
English: The major physiological effects of angiotensin II, such as vasoconstriction, aldosterone stimulation, regulation of salt and water homeostasis and stimulation of cell growth, are mediated via the type 1 (AT1) receptor.
Danish: De vigtigste fysiologiske virkninger af angiotensin II, såsom vasokonstriktion, aldosteronstimulering, regulering af salt- og vandbalancen og stimulering af cellevæksten, medieres via type I- (AT1-) receptoren.
English: Do not take Atacand
Danish: Tag ikke Atacand
English: The antihypertensive effect and tolerability of candesartan and losartan were compared in two randomised, double-blind studies in a total of 1,268 patients with mild to moderate hypertension.
Danish: Candesartans og losartans antihypertensive virkning og tolerabilitet blev sammenlignet i to randomiserede, dobbeltblindede forsøg hos i alt 1.268 patienter med let til moderat hypertension.
English: Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness.
Danish: Ud fra farmakologiske overvejelser vil hovedsymptomerne på overdosering sandsynligvis være hypotension og svimmelhed.
English: Atacand and associated names (see Annex I) 2 mg tablets Atacand and associated names (see Annex I) 4 mg tablets Atacand and associated names (see Annex I) 8 mg tablets Atacand and associated names (see Annex I) 16 mg tablets Atacand and associated names (see Annex I) 32 mg tablets
Danish: Atacand og tilhørende navne (se Bilag I) 2 mg tabletter Atacand og tilhørende navne (se Bilag I) 4 mg tabletter Atacand og tilhørende navne (se Bilag I) 8 mg tabletter Atacand og tilhørende navne (se Bilag I) 16 mg tabletter Atacand og tilhørende navne (se Bilag I) 32 mg tabletter
English: Atacand can be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.
Danish: Atacand kan tages sammen med anden hjertemedicin, og lægen vil beslutte, hvilken behandling der er bedst for dig.
English: The adverse experience profile of Atacand in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients.
Danish: Bivirkningsprofilen for Atacand hos patienter med hjerteinsufficiens stemte overens med lægemidlets farmakologi og patienternes sundhedsstatus.
English: Very rare Leukopenia, neutropenia and agranulocytosis
Danish: Leukopeni, neutropeni og agranulocytose
English: When candesartan cilexetil is used together with hydrochlorothiazide, the reduction in blood pressure is additive.
Danish: Når candesartancilexetil gives samtidig med hydrochlorthiazid, er blodtryksreduktionen additiv.
English: The table below presents adverse reactions from clinical trials and post-marketing experience.
Danish: Nedenstående tabel viser bivirkninger fra kliniske forsøg og erfaringer efter markedsføring.
English: After administration of a single dose of candesartan cilexetil, onset of antihypertensive effect generally occurs within 2 hours.
Danish: Efter indgift af en enkelt dosis candesartancilexetil indtræder den antihypertensive virkning sædvanligvis inden for 2 timer.
English: If this is severe then you may notice weakness, lack of energy, or muscle cramps.
Danish: Hvis dette er alvorligt, kan du mærke træthed, mangel på energi eller muskelkramper.
English: The safety and efficacy of Atacand in children aged between birth and 18 years have not been established in the treatment of hypertension and heart failure.
Danish: Sikkerhed og virkning af Atacand i behandlingen af hypertension og hjerteinsufficiens hos børn fra fødslen til 18 år er ikke fastlagt.
English: The symptomatic manifestations of overdose and recommendations on management if it occurs were included in this section.
Danish: Dette afsnit indeholdt de symptomatiske manifestationer af overdosis og anbefalinger om håndtering, hvis det forekommer.
English: Caution should be observed when initiating therapy and correction of hypovolemia should be attempted.
Danish: Der bør udvises forsigtighed ved behandlingens start, og det bør forsøges at korrigere for hypovolæmi.
English: The apparent volume of distribution of candesartan is 0.1 l/kg.
Danish: Det tilsyneladende fordelingsvolumen for candesartan er 0,1 1/kg.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Børn, hvis mødre har taget AIIRA'er, skal overvåges nøje for hypotension (se pkt.
English: These changes were considered to be caused by the pharmacological action of candesartan.
Danish: Disse ændringer antages at være fremkaldt af de farmakologiske virkninger af candesartan.
English: Germany AstraZeneca GmbH 22876 Wedel, Germany
Danish: Tyskland AstraZeneca GmbH 22876 Wedel, Germany
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: Epidemiologiske undersøgelser af risikoen for teratogenicitet ved behandling med ACE-hæmmere i første graviditetstrimester er inkonklusive, men en let forøget risiko kan ikke udelukkes.
English: Section 4.9 Overdose
Danish: Afsnit 4.9 Overdosering
English: • Changes in how your liver is working, including inflammation of the liver (hepatitis).
Danish: • Forandringer i leverfunktionen, inklusive leverbetændelse (hepatitis).
English: High blood pressure:
Danish: Forhøjet blodtryk:
English: A reduced amount of sodium in your blood.
Danish: Nedsat natriumniveau i blodet.
English: candesartan cilexetil
Danish: candesartancilexetil
English: The frequencies used in the tables throughout section 4.8 are: 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) and very rare
Danish: 4.8, er: Meget almindelig (≥1/10), Almindelig (≥1/100 til <1/10), Ikke almindelig (≥1/1000 til <1/100), Sjælden (≥1/10.000 til <1/1000) og Meget sjælden (<1/10.000).
English: Patients received candesartan cilexetil or placebo with other antihypertensive treatment added as needed.
Danish: Patienterne fik candesartancilexetil eller placebo sammen med anden antihypertensiv behandling, som blev tillagt efter behov.
English: In the elderly, the CHMP considered that no initial dose adjustment was needed in patients over 75 years of age.
Danish: CHMP mente ikke, at der var behov for en indledende dosisjustering hos ældre patienter over 75 år.
English: The beneficial effects of candesartan were consistent irrespective of age, gender and concomitant medication.
Danish: De gavnlige effekter af candesartan var de samme uanset alder, køn eller samtidig indtagelse af andre lægemidler.
English: In hypertension, candesartan causes a dose-dependent, long-lasting reduction in arterial blood pressure.
Danish: Ved hypertension forårsager candesartan en dosisafhængig, langvarig reduktion i det arterielle blodtryk.
English: No gender related differences in the pharmacokinetics of candesartan have been observed.
Danish: Der er ikke observeret nogen kønsrelateret forskel for candesartans farmakokinetik.
English: You can take Atacand with or without food.
Danish: Du kan tage Atacand sammen med eller uden mad.
English: Candesartan is mainly eliminated unchanged via urine and bile and only to a minor extent eliminated by hepatic metabolism (CYP2C9).
Danish: Candesartan elimineres overvejende uomdannet via urinen og galden og omdannes kun i ringe grad via levermetabolisme (CYP2C9).
English: Candesartan caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Danish: Candesartan forårsagede en reduktion i parametre for de røde blodlegemer (erytrocytter, hæmoglobin, hæmatokrit).
English: Germany Takeda Pharma GmbH Viktoriaallee 3-5
Danish: Tyskland Takeda Pharma GmbH Viktoriaallee 3-5
English: Evaluation of patients with heart failure should include periodic assessments of renal function, especially in elderly patients 75 years or older, and patients with impaired renal function.
Danish: Evaluering af patienter med hjerteinsufficiens bør omfatte regelmæssig vurdering af nyrefunktionen, især hos ældre patienter på 75 år eller derover og hos patienter med nedsat nyrefunktion.
English: Other sections of the SPC were harmonised accordingly.
Danish: Andre afsnit af produktresuméet blev harmoniseret i overensstemmelse hermed.
English: • if you are allergic (hypersensitive) to candesartan cilexetil or any of the other ingredients of Atacand (see section 6).
Danish: • hvis du er overfølsom (allergisk) over for candesartancilexetil eller et af de øvrige indholdsstoffer (se pkt.
English: Candesartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Danish: Candesartan binder ikke til og blokerer ikke andre af de hormonreceptorer eller ionkanaler, der vides at spille en vigtig rolle i den kardiovaskulære regulering.
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 være velhydrerede, og monitorering af nyrefunktionen bør overvejes efter opstart af samtidig behandling og herefter periodisk.
English: The dose may be adjusted according to response.
Danish: Dosis kan justeres efter respons.
English: Common Dizziness/vertigo, headache
Danish: Almindelig Svimmelhed/vertigo, hovedpine
English: In the elderly (over 65 years) Cmax and AUC of candesartan are increased by approximately 50% and 80%, respectively in comparison to young subjects.
Danish: Hos ældre (> 65 år) er Cmax og AUC for candesartan øget med henholdsvis ca. 50 % og 80 % i sammenligning med yngre forsøgspersoner.
English: However, patients treated with candesartan, an ACE inhibitor and a potassium sparing diuretic experienced increased risk of hyperkalaemia.
Danish: Patienter, som blev behandlet med candesartan, en ACE-hæmmer og et kaliumsparende diuretikum, oplevede imidlertid en øget risiko for hyperkaliæmi.
English: • if you have heart, liver or kidney problems, or are on dialysis.
Danish: • hvis du har hjerte-, lever- eller nyreproblemer eller er i dialysebehandling.
English: Detailed information on this product is available on the website of : {name of MS/Agency}
Danish: Yderligere information om dette lægemiddel er tilgængelig på {medlemslandets/lægemiddelagenturets navn} hjemmeside:
English: These events were more common in patients over 70 years of age, diabetics, or subjects who received other medicinal products which affect the renin-angiotensin-aldosterone system, in particular an ACE inhibitor and/or spironolactone.
Danish: Disse bivirkninger var hyppigere hos patienter over 70 år, hos diabetikere og hos patienter, som fik andre lægemidler, der påvirker renin-angiotensin-aldosteron-systemet, især en ACE-hæmmer og/eller spironolacton.
English: Very rare Increased liver enzymes, abnormal hepatic function or hepatitis
Danish: Stigning i leverenzymer, abnorm leverfunktion eller hepatitis
English: • difficulties in breathing, with or without swelling of the face, lips, tongue and/or throat
Danish: • vanskelighed ved at trække vejret med eller uden hævelse af ansigt, læber, tunge og/eller hals
English: C-labelled candesartan cilexetil, approximately 26% of the dose is excreted in the urine as candesartan and 7% as an inactive metabolite while approximately 56% of the dose is recovered in the faeces as candesartan and 10% as the inactive metabolite.
Danish: 26 % af dosis i urinen som candesartan og 7 % som en inaktiv metabolit, mens ca. 56 % af dosis genfindes i fæces som candesartan og 10 % som den inaktive metabolit.
English: Sections on use in special populations, such as elderly, patients with intravascular volume depletion, patients with impaired renal and hepatic function and patients of black ethnicity were also harmonised.
Danish: Afsnit om brug til særlige populationer som ældre, patienter med intravaskulær volumendepletering, patienter med nyre- og leverinsufficiens og etnisk sorte patienter blev også harmoniseret.
English: In these patients Atacand should be carefully titrated with thorough monitoring of blood pressure.
Danish: Hos disse patienter bør Atacand titreres forsigtigt med omhyggelig monitorering af blodtrykket.
English: Norway AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norway
Danish: AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norway
English: • treating high blood pressure (hypertension) in adult patients.
Danish: • behandling af for højt blodtryk (hypertension) hos voksne patienter
English: According to a meta-analysis, the average additional effect of a dose increase from 16 mg to 32 mg once daily was small.
Danish: I henhold til en meta-analyse er den gennemsnitlige additive effekt ved dosisøgning fra 16 mg til 32 mg én gang daglig lille.
English: • Back pain, pain in joints and muscles.
Danish: • Rygsmerter, smerter i led og muskler.
English: Based on the information provided, the CHMP endorsed the harmonised text for Angiotensin II receptor antagonists as the standard warning elaborated by the CHMP's Pharmacovigilance Working Party for all Angiotensin II receptor antagonists (AIIRAs): the use of AIIRAs in the first trimester of pregnancy is not recommended; the use of AIIRAs in the second and third trimester is contraindicated.
Danish: Baseret på den forelagte information har CHMP godkendt den harmoniserede tekst for angiotensin IIreceptorantagonister som standardadvarsel uddybet af CHMP's arbejdsgruppe vedrørende lægemiddelovervågning for alle angiotensin II-receptorantagonister (AIIRA): Brug af AIIRA'er anbefales ikke under graviditetens første trimester; brug af AIIRA'er er kontraindiceret under graviditetens andet og tredje trimester.
English: • Treatment of essential hypertension in adults.
Danish: • Behandling af essentiel hypertension hos voksne.
English: An initial dose of 4 mg once daily is recommended in patients with mild to moderate hepatic impairment.
Danish: En startdosis på 4 mg én gang daglig anbefales til patienter med let til moderat nedsat leverfunktion.
English: There is no experience regarding the administration of Atacand in patients with a recent kidney transplantation.
Danish: Der er ingen erfaring med anvendelse af Atacand hos patienter, der for nyligt har fået foretaget nyretransplantation.
English: Therapy should be adjusted according to blood pressure response.
Danish: Behandlingen bør justeres afhængigt af respons på blodtryk.
English: The candesartan serum concentrations increase linearly with increasing doses in the therapeutic dose range.
Danish: Serumkoncentrationen af candesartan stiger lineært med stigende doser inden for det terapeutiske dosisinterval.
English: When AIIRAs are administered simultaneously with non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Danish: Når AIIRA'er anvendes samtidigt med non-steroide antiinflammatoriske lægemidler (f.eks. selektive COX-2 hæmmere, acetylsalicylsyre (> 3 g/dag) og non-selektive NSAID'er), kan den antihypertensive virkning svækkes.
English: This is because Atacand, when combined with some anaesthetics, may cause a drop in blood pressure.
Danish: Det skyldes, at Atacand sammen med visse typer medicin til bedøvelse kan forårsage blodtryksfald.
English: Common Respiratory infection
Danish: Almindelig Luftvejsinfektion
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Danish: Reversible stigninger i serum-lithium-koncentrationer og toksicitet er blevet rapporteret ved samtidig brug af lithium og ACE-hæmmere.
English: The terminal t½ of candesartan was approximately doubled in patients with severe renal impairment.
Danish: Den terminale t½ for candesartan var omtrent fordoblet hos patienter med stærkt nedsat nyrefunktion.
English: Compounds which have been investigated in clinical pharmacokinetic studies include hydrochlorothiazide, warfarin, digoxin, oral contraceptives (i.e. ethinylestradiol/levonorgestrel), glibenclamide, nifedipine and enalapril.
Danish: De kemiske forbindelser, som er undersøgt i kliniske farmakokinetikstudier, inkluderer hydrochlorthiazid, warfarin, digoxin, orale kontraceptiva (dvs. ethinylestradiol/levonorgestrel), glibenclamid, nifedipin og enalapril.
English: If you stop taking Atacand
Danish: Hvis du holder op med at tage Atacand
English: Regarding concomitant therapy, according to the ESC heart failure guidelines (ESC HF, 2008), the current standard of care in patients is an adequate dose of a beta-blocker and an ACE inhibitor.
Danish: Vedrørende samtidig behandling er den aktuelle behandlingsstandard ifølge ESC's retningslinjer for hjerteinsufficiens (ESC HF, 2008) en passende dosis af en betablokker og en ACE-hæmmer.
English: • Low blood pressure.
Danish: • Lavt blodtryk.
English: Section 4.7 Effects on Ability to Drive and Use Machines
Danish: Afsnit 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner
English: Patients with primary hyperaldosteronism will not generally respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin-aldosterone system.
Danish: Patienter med primær hyperaldosteronisme responderer sædvanligvis ikke på antihypertensive lægemidler, der virker via hæmning af renin-angiotensin-aldosteron-systemet.
English: Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a role in the pathophysiology of hypertension, heart failure and other cardiovascular disorders.
Danish: Angiotensin II er det primære vasoaktive hormon i renin-angiotensin-aldosteron-systemet og spiller en rolle i patofysiologien for hypertension, hjerteinsufficiens og andre kardiovaskulære sygdomme.
English: Should these agents be less than effective, addition of an ARB or a potassium sparing diuretic should be considered.
Danish: Hvis disse stoffer ikke har tilstrækkelig effekt, kan det overvejes at tilføje en ARB eller kaliumsparende diuretikum.
English: The antihypertensive effect of candesartan is less pronounced in black patients than in non-black patients.
Danish: Den antihypertensive effekt af candesartan er lavere hos sorte patienter end hos ikke-sorte patienter.
English: No routine monitoring of laboratory variables is usually necessary for patients receiving Atacand.
Danish: Det er normalt ikke nødvendigt rutinemæssigt at monitorere laboratorieparametre hos patienter, der behandles med Atacand.
English: Atacand 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 pregnancy section).
Danish: Atacand anbefales ikke tidligt i graviditeten, og du må ikke tage Atacand, hvis du er mere end 3 måneder henne i graviditeten, da det kan skade dit barn alvorligt, hvis det bruges på dette stadium (se afsnittet om graviditet).
English: Common (affects 1 to 10 users in 100)
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 patienter):
English: However, the blood pressure response and the incidence of adverse events are similar after a given dose of Atacand in young and elderly patients (see section 4.2).
Danish: Alligevel er blodtryksreduktionen og hyppigheden af bivirkninger efter en given Atacanddosis ens hos yngre og ældre patienter (se pkt.
English: There is no effect on ACE and no potentiation of bradykinin or substance P. In controlled clinical trials comparing candesartan with ACE inhibitors, the incidence of cough was lower in patients receiving candesartan cilexetil.
Danish: Der er ingen virkning på ACE og ingen forstærkning af bradykinin eller substans P. I kontrollerede kliniske undersøgelser, hvor candesartan blev sammenlignet med ACE-hæmmere, var hyppigheden af hoste lavere hos patienter, der fik candesartancilexetil.