FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from the CHARM programme showed clear benefits with regard to cardiovascular (CV) mortality and morbidity for patients with heart failure on candesartan and concomitant medication.
Danish: Resultater fra CHARM-programmet viste tydelige fordele med hensyn til kardiovaskulær mortalitet og morbiditet for patienter med hjerteinsufficiens, som fik candesartan og samtidig medicin.
English: Therefore, Atacand should be carefully titrated with thorough monitoring of blood pressure in patients on haemodialysis.
Danish: Atacand bør derfor titreres forsigtigt med omhyggelig monitorering af blodtrykket hos patienter i hæmodialyse.
English: During dialysis the blood pressure may be particularly sensitive to AT1-receptor blockade as a result of reduced plasma volume and activation of the renin-angiotensin-aldosterone system.
Danish: Under dialyse kan blodtrykket være særligt følsomt over for AT1-receptorblokade på grund af reduceret plasmavolumen og aktivering af renin-angiotensin-aldosteron-systemet.
English: Atacand 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: Atacand anbefales ikke tidligt i graviditeten og må ikke tages, hvis du er mere end 3 måneder henne, da det kan skade dit barn alvorligt, hvis det anvendes efter den tredje måned i graviditeten).
English: Both the mortality and morbidity components of these composite endpoints contributed to the favourable effects of candesartan.
Danish: Både mortalitetsog morbiditetskomponenterne af disse sammensatte endepunkter bidrog til candesartans positive effekt.
English: Candesartan increases renal blood flow and either has no effect on or increases glomerular filtration rate while renal vascular resistance and filtration fraction are reduced.
Danish: Candesartan øger nyrernes blodgennemstrømning og er enten uden indflydelse på eller øger den glomerulære filtrationsrate, mens den renale karmodstand og filtrationsfraktion nedsættes.
English: It is rapidly converted to the active substance, candesartan, by ester hydrolysis during absorption from the gastrointestinal tract.
Danish: Det omdannes hurtigt til den aktive substans, candesartan, via ester-hydrolyse i forbindelse med absorption fra mave-tarm-kanalen.
English: The antihypertensive effect of candesartan may be enhanced by other medicinal products with blood pressure lowering properties, whether prescribed as an antihypertensive or prescribed for other indications.
Danish: Den antihypertensive virkning af candesartan kan forstærkes af lægemidler med blodtrykssænkende effekt, uansat om disse er ordineret som antihypertensiva eller til andre indikationer.
English: Data from in vitro and in vivo mutagenicity testing indicates that candesartan will not exert mutagenic or clastogenic activities under conditions of clinical use.
Danish: Data fra in vitro og in vivo mutagenicitetsforsøg tyder på, at candersartan ikke vil udøve mutagen eller lse.
English: For the purpose of harmonisation, the CHMP considered the national PI, answers provided by the marketing authorisation holder (MAH) and available scientific knowledge.
Danish: Til harmoniseringsformål har CHMP vurderet de nationale produktinformationer, svar fremlagt af indehaveren af markedsføringstilladelsen og den foreliggende faglige viden.
English: Alcohol may make you feel faint or dizzy.
Danish: Alkohol kan bevirke, at du bliver utilpas eller svimmel.
English: As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
Danish: Som for andre antihypertensive lægemidler kan en kraftig blodtryksreduktion hos patienter med iskæmisk hjertesygdom eller cerebrovaskulær iskæmisk lidelse resultere i myokardieinfarkt eller slagtilfælde.
English: Very rare Nausea
Danish: Meget sjælden
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Fortæl det til lægen, hvis du ammer eller skal til at begynde at amme.
English: In some patients whose blood pressure is not adequately controlled, the dose can be increased to 16 mg once daily and to a maximum of 32 mg once daily.
Danish: Hos nogle patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende, kan dosis øges til 16 mg én gang daglig og op til maksimalt 32 mg én gang daglig.
English: Foetotoxicity has been observed in late pregnancy (see section 4.6).
Danish: øtotoksicitet er observeret i den sene del af graviditeten (se pkt.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINE AGENCY
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: - An increased amount of potassium in your blood, especially if you already have kidney problems or heart failure.
Danish: Forhøjet kalium i blodet, især hvis du i forvejen har nyreproblemer eller hjertesvigt.
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Medmindre fortsat AIIRA-behandling anses for at være absolut nødvendig, bør patienter, der planlægger at blive gravide, skifte til alternativ antihypertensiv behandling med fastlagt sikkerhedsprofil ved brug under graviditet.
English: Patients on optimal CHF therapy at baseline were randomised to placebo or candesartan cilexetil (titrated from 4 mg or 8 mg once daily to 32 mg once daily or the highest tolerated dose, mean dose 24 mg) and followed for a median of 37.7 months.
Danish: Patienter i optimal CHF-behandling ved baseline blev randomiseret til placebo eller candesartancilexetil (titreret fra 4 mg eller 8 mg én gang daglig til 32 mg én gang daglig eller til højst tolererede dosis, gennemsnitsdosis var på 24 mg) og fulgt i en periode på gennemsnitligt 37,7 måned.
English: Patients who receive such combination therapy require careful and regular monitoring.
Danish: Patienter, som får denne kombinationsbehandling, skal monitoreres nøje og regelmæssigt.
English: The antagonism of the angiotensin II (AT1) receptors results in dose related increases in plasma renin levels, angiotensin I and angiotensin II levels, and a decrease in plasma aldosterone concentration.
Danish: Antagonismen af angiotensin II- (AT1-) receptorer resulterer i dosisrelaterede stigninger i plasma-renin-niveauerne, i angiotensin I- og angiotensin II-niveauerne og i et fald i plasma-aldosteron-koncentrationen.
English: In an open label clinical experience trial in 5,156 patients with diastolic hypertension, the blood pressure reduction during candesartan treatment was significantly less in black than non-black patients (14.4/10.3 mmHg vs 19.0/12.7 mmHg, p<0.0001/p<0.0001).
Danish: I et åbent klinisk forsøg med 5.156 patienter med diastolisk hypertension, var blodtryksreduktionen med candesartan-behandling signifikant lavere hos sorte end hos ikke-sorte patienter (14,4/10,3 mmHg versus 19,0/12,7 mmHg; p<0,0001/p<0,0001).
English: • Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
Danish: • Kaliumtilskud eller kaliumholdige salterstatninger (medicin, som øger kaliumniveauet i blodet).
English: A full contraindication in all trimesters of pregnancy and in lactation was previously included in the SPC.
Danish: Produktresuméet indeholdt tidligere en fuld kontraindikation i alle graviditetens trimestre og ved amning.
English: Following oral administration, candesartan cilexetil is converted to the active substance candesartan.
Danish: Efter oral indgift omdannes candersartancilexetil til den aktive substans candesartan.
English: The name of your medicine is Atacand.
Danish: Lægemidlets navn er Atacand.
English: Treatment with candesartan cilexetil resulted in improved NYHA functional class (p=0.008).
Danish: Behandling med candesartancilexetil resulterede i en forbedret NYHA-funktionsklasse (p=0,008).
English: In patients with mild to moderate renal impairment Cmax and AUC of candesartan increased during repeated dosing by approximately 50% and 70%, respectively, but t½ was not altered, compared to patients with normal renal function.
Danish: Hos patienter med let til moderat nedsat nyrefunktion steg Cmax og AUC for candesartan efter gentagne doseringer med henholdsvis ca. 50 % og 70 %, men t½ var uændret i sammenligning med patienter med normal nyrefunktion.
English: Evaluation of patients with heart failure should always comprise assessment of renal function including monitoring of serum creatinine and potassium.
Danish: Evaluering af patienter med hjerteinsufficiens bør altid inkludere vurdering af nyrefunktionen, herunder monitorering af serum-kreatinin og serum-kalium.
English: An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients with possible volume depletion (see section 4.4).
Danish: En startdosis på 4 mg kan overvejes hos patienter med risiko for hypotension, som for eksempel patienter med muligt nedsat intravaskulært volumen (se pkt.
English: This may make you feel faint or dizzy.
Danish: Kan bevirke, at du føler dig utilpas eller svimmel.
English: Section 4.6 Pregnancy and Lactation
Danish: Afsnit 4.6 Graviditet og amning
English: The posology for patients with heart failure was the same in all MSs.
Danish: Doseringen for patienter med hjerteinsufficiens var den samme i alle medlemsstater.
English: Some people may feel tired or dizzy when taking Atacand.
Danish: Nogle personer kan føle træthed og svimmelhed, når de er i behandling med Atacand.
English: Your doctor may increase your dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day.
Danish: Lægen kan øge dosis ved at fordoble den med intervaller på mindst 2 uger op til 32 mg én gang daglig.
English: Consequently, uptitration of Atacand and concomitant therapy may be more frequently needed for blood pressure control in black patients than in non-black patients (see section 5.1).
Danish: Som en konsekvens heraf kan der være større behov for optitrering af Atacand og anden samtidig behandling for at opnå blodtrykskontrol hos sorte patienter end hos ikke-sorte patienter (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING [Udfyldes nationalt]
English: Effects on the kidneys (such as interstitial nephritis, tubular distension, basophilic tubules; increased plasma concentrations of urea and creatinine) were induced by candesartan which could be secondary to the hypotensive effect leading to alterations of renal perfusion.
Danish: Virkninger på nyrerne (så som interstitiel nefritis, tubulær distension, basofile tubuli; øgede plasmakoncentrationer af urinstof og kreatinin) blev fremkaldt af candesartan og kunne være sekundære til den hypotensive effekt, der medfører ændring i den renale blodgennemstrømning.
English: Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Atacand.
Danish: Tilføjelse af hydrochlorthiazid til forskellige doser Atacand har vist en additiv antihypertensiv virkning.
English: Elderly population No initial dose adjustment is necessary in elderly patients.
Danish: Ældre Det er ikke nødvendigt at justere startdosis hos ældre patienter.
English: Medicinal products that block the renin-angiotensin-aldosterone system have less pronounced antihypertensive effect in black patients (usually a low-renin population) than in non-black patients.
Danish: Lægemidler, der hæmmer renin-angiotensin-aldosteron-systemet, har en mindre udtalt antihypertensiv virkning hos sorte patienter (en typisk lav-renin population) end hos ikke-sorte patienter.
English: {Name and address of the manufacturer} <{tel}> <{fax}> <{e-mail}>
Danish: Indehaver af markedsføringstilladelsen og fremstiller [Se Bilag I - Udfyldes nationalt] {Fremstillers navn og adresse} <{tlf}> <{fax}> <{e-mail}>
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Hvis samtidig behandling er nødvendig, anbefales omhyggelig monitorering af serum-lithium-niveauer.
English: • Heparin (a medicine for thinning the blood).
Danish: • Heparin (blodfortyndende medicin).
English: If this happens contact your doctor.
Danish: Tal med lægen, hvis du oplever dette.
English: There is limited experience in patients with very severe or end-stage renal impairment (Clcreatinine < 15 ml/min).
Danish: Der er begrænset erfaring hos patienter med meget alvorlig eller slutstadium af nyreinsufficiens (Clkreatinin < 15 ml/minut).
English: Treatment with candesartan cilexetil reduces mortality, reduces hospitalisation due to heart failure, and improves symptoms in patients with left ventricular systolic dysfunction as shown in the Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity (CHARM) programme.
Danish: Behandling med candesartancilexetil reducerer mortalitet, reducerer indlæggelser pga. hjerteinsufficiens og forbedrer symptomerne hos patienter med nedsat systolisk funktion af venstre ventrikel som vist i CHARM-programmet (Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity).
English: Candesartan was effective also in patients taking both beta-blockers and ACE inhibitors at the same time, and the benefit was obtained whether or not patients were taking ACE inhibitors at the target dose recommended by treatment guidelines.
Danish: Candesartan var ligeledes effektivt hos patienter, der tog både betablokkere og ACEhæmmere samtidig, og fordelen var til stede, uanset om patienterne fik de målsatte doser ACEhæmmere, som anbefales i behandlingsguidelines eller ej.
English: In particular, updates on the potential dose increase up to 32 mg, increased antihypertensive effect when candesartan is combined with other medicinal products, including hydrochlorothiazide and CCB such as amlodipine or felodipine were considered.
Danish: I særdeleshed blev opdateringer overvejet om en mulig dosisøgning op til 32 mg, øget antihypertensiv effekt, når candesartan gives i kombination med andre lægemidler, inklusive hydrochlorothiazid og calciumblokkere som amlodipin eller felodipin.
English: By this definition, the most commonly reported adverse reactions were dizziness/vertigo, headache and respiratory infection.
Danish: Ifølge denne definition var de hyppigst rapporterede bivirkninger svimmelhed, hovedpine og luftvejsinfektion.
English: • if you have severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder).
Danish: • hvis du har en alvorlig leversygdom eller galdevejstillukning (problemer med at udskille galde fra galdeblæren).
English: However, the CHMP/PhVWP report on the use of ACE inhibitors and Angiotensin II Receptor Antagonists (ARBs) during the 1st trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007)
Danish: CHMP/PhVWP's rapport om brug af ACE-hæmmere og angiotensin II-receptorantagonister (AIIRA'er) i graviditetens første trimester (EMEA/CHMP/PhVWP/474692/2007) tyder imidlertid på, at en kontraindikation i graviditetens første trimester ikke er retfærdiggjort.
English: The heart failure indication was approved in all MSs.
Danish: Indikationen hjerteinsufficiens var godkendt i alle medlemsstater.
English: Based on the above the CHMP considers the benefit/risk ratio of Atacand to be favourable and the harmonised PI to be approvable.
Danish: På baggrund af ovenstående anser CHMP benefit/risk-forholdet for Atacand for positivt og de harmoniserede produktinformationsdokumenter som egnede til godkendelse.
English: Fourteen patients needed to be treated for the duration of the study to prevent one patient from dying of a cardiovascular event or being hospitalised for treatment of heart failure.
Danish: Det er nødvendigt at behandle 14 patienter i hele studiets varighed for at forhindre én patient i at dø af en kardiovaskulær hændelse eller i at blive indlagt for behandling af hjerteinsufficiens.
English: You may notice tiredness, yellowing of your skin and the whites of your eyes and flu like symptoms.
Danish: Du bemærker eventuelt træthed, at din hud eller det hvide i dine øjne får en gullig farve eller influenzalignende symptomer.
English: However, it should be taken into account that occasionally dizziness or weariness may occur during treatment with Atacand.
Danish: Det bør dog tages i betragtning, at der kan optræde svimmelhed og træthed under behandlingen.
English: Candesartan does not inhibit ACE, which converts angiotensin I to angiotensin II and degrades bradykinin.
Danish: Candesartan hæmmer ikke ACE, som omdanner angiotensin I til angiotensin II og nedbryder bradykinin.
English: Results from two clinical studies investigating the pharmacokinetic (PK) profile of candesartan in patients with impaired hepatic function and the publication by Hoogkamer et al 1998, where a starting dose of 12 mg was used, indicate that mild to moderate hepatic impairment has no relevant effect on candesartan PK, and thus no dose adjustment is required.
Danish: Resultater fra to kliniske undersøgelser, som undersøgte den farmakokinetiske profil af candesartan hos patienter med leverinsufficiens, og publikationen af Hoogkamer et al 1998, hvor en startdosis på 12 mg blev anvendt, tyder på, at let til moderat leverinsufficiens ikke har nogen relevant effekt på farmakokinetikken for candesartan.
English: Patients with intravascular volume depletion
Danish: Patienter med nedsat intravaskulært volumen
English: It may also occur in hypertensive patients with intravascular volume depletion such as those receiving high dose diuretics.
Danish: Ligeledes kan der opstå hypotension hos hypertensive patienter med nedsat intravaskulært volumen, såsom patienter der behandles med høje doser diuretika.
English: The CHMP also agreed with the inclusion of a contraindication in patients with hypersensitivity to candersartan or to any of its excipients and in patients with severe hepatic impairment and/or cholestasis.
Danish: CHMP var også enige i inklusionen af en kontraindikation hos patienter med overfølsomhed over for candesartan eller over for et eller flere af hjælpestofferne og hos patienter med svært nedsat leverfunktion og/eller cholestase.
English: The effects of candesartan cilexetil 8-16 mg (mean dose 12 mg), once daily, on cardiovascular morbidity and mortality were evaluated in a randomised clinical trial with 4,937 elderly patients (aged 70-89 years; 21% aged 80 or above) with mild to moderate hypertension followed for a mean of 3.7 years (Study on COgnition and Prognosis in the Elderly).
Danish: Effekten af candesartancilexetil 8-16 mg (gennemsnitsdosis 12 mg) én gang daglig på kardiovaskulær morbiditet og mortalitet blev undersøgt i et randomiseret klinisk forsøg med 4.937 ældre patienter (alder 70-89 år; 21 % 80 år eller derover) med let til moderat hypertension, fulgt i gennemsnitligt 3,7 år (SCOPE: Study on Cognition and Prognosis in the Elderly).
English: [See Annex I - to be completed nationally]
Danish: [Se Bilag I - Udfyldes nationalt]
English: This placebo controlled, double-blind study programme in chronic heart failure (CHF) patients with NYHA functional class II to IV consisted of three separate studies: CHARM-Alternative (n=2,028) in patients with LVEF  40% not treated with an ACE inhibitor because of intolerance (mainly due to cough, 72%), CHARM-Added (n=2,548) in patients with LVEF  40% and treated with an ACE inhibitor, and CHARM-Preserved (n=3,023) in patients with LVEF > 40%.
Danish: CHARM var et placebo-kontrolleret, dobbeltblindet studieprogram hos patienter med kronisk hjerteinsufficiens (CHF), NYHA-funktionsklasse II til IV, og bestod af tre separate studier: CHARMAlternative (n=2.028) med patienter med LVEF ≤ 40 %, som pga. intolerans (hovedsageligt på grund af hoste, 72 %) ikke var i ACE-hæmmer behandling, CHARM-Added (n=2.548) med patienter med LVEF ≤ 40 % og behandlet med en ACE-hæmmer samt CHARM-Preserved (n=3.023) med patienter med LVEF > 40 %.
English: • swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing
Danish: • hævelse af ansigt, læber, tunge og/eller hals, hvilket kan give synkebesvær
English: Twenty-three patients needed to be treated for the duration of the study to prevent one patient from dying of a cardiovascular event or being hospitalised for treatment of heart failure.
Danish: Det er nødvendigt at behandle 23 patienter i hele studiets varighed for at forhindre én patient i at dø af en kardiovaskulær hændelse eller i at blive indlagt for behandling af hjerteinsufficiens.
English: In general, there were no clinically important influences of Atacand on routine laboratory variables.
Danish: Generelt havde Atacand ingen indflydelse af klinisk betydning på laboratorieværdier målt rutinemæssigt.
English: An increased antihypertensive effect is also seen when candesartan cilexetil is combined with amlodipine or felodipine.
Danish: En øget antihypertensiv virkning kan også ses, når candesartancilexetil gives samtidig med amlodipin eller felodipin.
English: In a 3-month clinical study in hypertensive patients with type 2 diabetes mellitus and microalbuminuria, antihypertensive treatment with candesartan cilexetil reduced urinary albumin excretion (albumin/creatinine ratio, mean 30%, 95%CI 15-42%).
Danish: I en 3-måneders klinisk undersøgelse af hypertensive patienter med type 2-diabetes og mikroalbuminuri nedsatte den antihypertensive behandling med candesartancilexetil udskillelsen af albumin i urinen (albumin/kreatinin-ratio, middelværdi: 30 % med 95 % konfidensinterval: 15-42 %).
English: The active ingredient is candesartan cilexetil.
Danish: Det aktive stof er candesartancilexetil.
English: The most commonly reported adverse reactions were hyperkalaemia, hypotension and renal impairment.
Danish: De hyppigst rapporterede bivirkninger var hyperkaliæmi, hypotension og nedsat nyrefunktion.
English: The trough blood pressure reduction (systolic/diastolic) was 13.1/10.5 mmHg with candesartan cilexetil 32 mg once daily and 10.0/8.7 mmHg with losartan potassium 100 mg once daily (difference in blood pressure reduction 3.1/1.8 mmHg, p<0.0001/p<0.0001).
Danish: Trough blodtryksreduktionen (systolisk/diastolisk) var 13,1/10,5 mmHg ved 32 mg candesartancilexetil én gang daglig og 10,0/8,7 mmHg ved 100 mg losartankalium én gang daglig (forskellen i blodtryksreduktion var 3,1/1,8 mmHg, p<0,0001/p<0,0001).
English: In preclinical safety studies candesartan had effects on the kidneys and on red cell parameters at high doses in mice, rats, dogs and monkeys.
Danish: I prækliniske sikkerhedsundersøgelser med høje doser påvirkede candesartan nyrerne og de røde blodlegemer hos mus, rotter, hunde og aber.
English: • Effects on how your kidneys work, especially if you already have kidney problems or heart failure.
Danish: • Påvirkning af nyrefunktionen, især hvis du allerede har nyreproblemer eller hjertesvigt.
English: As with ACE inhibitors, concomitant use of AIIRAs and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Danish: Som for ACE hæmmere kan samtidig anvendelse af AIIRA'er og NSAID'er medføre øget risiko for forværring af nyrefunktionen, inklusive mulig akut nyresvigt og en stigning i serum-kalium, især hos patienter med allerede nedsat nyrefunktion.
English: No initial dose adjustment is necessary for elderly patients or in patients with intravascular volume depletion or renal impairment or mild to moderate hepatic impairment.
Danish: Det er ikke nødvendigt at justere startdosis til ældre patienter eller til patienter med nedsat intravaskulært volumen, nyreinsufficiens eller let til moderat leverinsufficiens.
English: Total plasma clearance of candesartan is about 0.37 ml/min/kg, with a renal clearance of about 0.19 ml/min/kg.
Danish: Den totale plasma-clearance af candesartan er ca. 0,37 ml/min/kg med en renal clearance på ca.