FrancophonIA/ELRC3.0 huggingface dataset:
English: In the CHARM clinical programme, comparing Atacand in doses up to 32 mg (n=3,803) to placebo (n=3,796), 21.0% of the candesartan cilexetil group and 16.1% of the placebo group discontinued treatment because of adverse events.
Danish: I det kliniske studieprogram CHARM, hvor Atacand i doser op til 32 mg (n=3.803) blev sammenlignet med placebo (n=3.796), seponerede 21,0 % i candesartancilexetil-gruppen og 16,1 % i placebo-gruppen behandlingen på grund af bivirkninger.
English: Treatment with candesartan cilexetil resulted in improved NYHA functional class (p=0.020).
Danish: Behandling med candesartancilexetil resulterede i en forbedret NYHA funktionsklasse (p=0,020).
English: Common Hypotension
Danish: Almindelig Hypotension
English: AstraZeneca SA Theotokopoulou 4 & Astrnafton 151 25 Maroussi Greece
Danish: Grækenland AstraZeneca SA Theotokopoulou 4 & Astronafton 151 25 Maroussi Greece
English: Special patient populations
Danish: Særlige patientgrupper
English: Treatment of Hypertension
Danish: Behandling af hypertension
English: • Swelling of the face, lips, tongue and/or throat.
Danish: • Hævelse i ansigt, læber, tunge og/eller hals.
English: Aortic and mitral valve stenosis (obstructive hypertrophic cardiomyopathy) As with other vasodilators, special caution is indicated in patients suffering from haemodynamically relevant aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Stenose i aorta- og mitralklapper (obstruktiv hypertrofisk kardiomyopati) Som for andre vasodilatatorer er særlig forsigtighed indiceret hos patienter, der lider af hæmodynamisk relevant stenose i aorta- eller mitralklapper eller obstruktiv hypertrofisk kardiomyopati.
English: Section 4.1 Therapeutic indications
Danish: Afsnit 4.1 Terapeutiske indikationer
English: • Water tablets (diuretics).
Danish: • Vanddrivende medicin (diuretika).
English: Treatment of Heart Failure
Danish: Behandling af hjerteinsufficiens
English: Anaesthesia and surgery
Danish: Anæstesi og kirurgi
English: In conclusion, based on the assessment of the MAH proposal and responses, and following the discussions of the committee, the CHMP adopted harmonised sets of PI documents for Atacand and associated names.
Danish: CHMP vedtog således, baseret på bedømmelsen af forslag og svar fra indehaveren af markedsføringstilladelsen og efter drøftelser i udvalget, at harmonisere sæt af produktinformationsdokumenter for Atacand og tilknyttede navne.
English: Atacand can be administered with other heart failure treatment, including ACE inhibitors, beta-blockers, diuretics and digitalis or a combination of these medicinal products.
Danish: Atacand kan anvendes sammen med anden behandling mod hjerteinsufficiens, inkluderende ACEhæmmere, betablokkere, diuretika og digitalis eller en kombination af disse præparater.
English: Warnings regarding renal impairment, concomitant therapy with an ACE inhibitor in heart failure, haemodialysis, renal artery stenosis, kidney transplantation, hypotension, anaesthesia and surgery, aortic and mitral valve stenosis, primary hyperaldosteronism and hyperkalaemia were harmonised.
Danish: Advarsler vedrørende nyreinsufficiens, samtidig behandling med en ACE-hæmmer ved hjerteinsufficiens, hæmodialyse, nyrearteriestenose, nyretransplantation, hypotension, anæstesi og operation, aorta- og mitralklapstenose, primær hyperaldosteronisme og hyperkaliæmi blev harmoniseret.
English: The starting dose is 4 mg in patients with renal impairment, including patients on haemodialysis.
Danish: Startdosis er 4 mg til patienter med nedsat nyrefunktion, inklusive patienter i hæmodialyse.
English: As with other agents inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible patients treated with Atacand.
Danish: Som for andre lægemidler, der hæmmer renin-angiotensin-aldosteronsystemet, kan der forventes ændring i nyrefunktionen hos disponerede patienter, der behandles med Atacand.
English: As for other inhibitors of the renin-angiotensin-aldosterone system, small decreases in haemoglobin have been seen.
Danish: Som for andre hæmmere af renin-angiotensin-aldosteron-systemet er der set mindre fald i hæmoglobin.
English: Hyperkalaemia and renal impairment are common in patients treated with Atacand for the indication of heart failure.
Danish: Hyperkaliæmi og nedsat nyrefunktion er almindelig hos patienter, der behandles med Atacand på indikationen hjerteinsufficiens.
English: There is no experience in patients with severe hepatic impairment.
Danish: Der r ingen erfaringer hos patienter med stærkt nedsat leverfunktion.
English: In a pooled analysis of clinical trial data of hypertensive patients, adverse reactions with candesartan cilexetil were defined based on an incidence of adverse events with candesartan cilexetil at least 1% higher than the incidence seen with placebo.
Danish: I en samlet analyse af resultaterne fra kliniske forsøg med hypertensive patienter blev bivirkninger ved candesartancilexetil defineret på basis af en hyppighed, der var mindst 1 % højere for candesartancilexetil end for placebo.
English: There were 26.7 events per 1000 patient-years in the candesartan group versus 30.0 events per 1000 patient-years in the control group (relative risk 0.89, 95%CI 0.75 to 1.06, p=0.19).
Danish: Der var 26,7 hændelser pr. 1.000 patientår i candesartan-gruppen versus 30,0 hændelser pr. 1.000 patientår i kontrolgruppen (relativ risiko: 0,89; 95 % konfidensinterval: 0,75-1,06; p=0,19).
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels
Danish: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Bruxelles
English: Severe hepatic impairment and/or cholestasis.
Danish: Stærkt nedsat leverfunktion og/eller kolestase.
English: Therefore, periodic monitoring of serum potassium is recommended and the combination of an ACE inhibitor, a potassium-sparing diuretic and candesartan is not recommended and should be considered only after careful evaluation of the potential benefits and risks.
Danish: Derfor anbefales periodisk monitorering af serumkalium, og kombinationen af en ACE-hæmmer, et kaliumsparende diuretikum og candesartan kan ikke anbefales og bør kun overvejes efter nøje evaluering af de potentielle fordele og risici.
English: Exposure to AIIRA 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: Det er kendt, at AIIRA-behandling i andet og tredje trimester forårsager human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, forsinket ossifikation af kraniet) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi) (se pkt.
English: The AUC of candesartan in patients undergoing haemodialysis was similar to that in patients with severe renal impairment.
Danish: AUC for candesartan hos patienter i hæmodialyse var i samme størrelsesorden som den, der ses hos patienter med stærkt nedsat yrefunktion.
English: However, all-cause mortality was also assessed in pooled populations, CHARMAlternative and CHARM-Added, HR 0.88 (95%CI: 0.79 to 0.98, p=0.018) and all three studies, HR 0.91 (95%CI: 0.83 to 1.00, p=0.055).
Danish: Dog blev mortaliteten af alle årsager også opgjort i poolede data, CHARMAlternative og CHARM-Added, HR 0,88 (95 % konfidensinterval: 0,79-0,98; p=0,018) og alle tre studier, HR 0,91 (95 % konfidensinterval: 0,83-1,00; p=0,055).
English: Take special care with Atacand
Danish: Vær ekstra forsigtig med at tage Atacand
English: The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: Brug af AIIRA'er anbefales ikke i første trimester (se pkt.
English: It is acknowledged that there is limited data in this population, however, analysis of the primary composite endpoint, cardiovascular death or hospitalisation due to heart failure by NYHA class subgroups in the low EF trials (CHARMAlternative and CHARM-Added pooled, part of the CHARM programme), revealed Hazard Ratios (HR) below 1.0 in favour of candesartan compared to placebo in each of the NYHA subgroups.
Danish: Imidlertid viste en analyse af det primære sammensatte endpoint, kardiovaskulære dødsfald eller hospitalsindlæggelse på grund af hjerteinsufficiens hos NYHA-klassificerede undergrupper i undersøgelser med lav EF (CHARMAlternative og CHARM-Added pooled, en del af CHARM programmet) risikorater under 1,0 til fordel for candesartan sammenlignet med placebo i hver af NYHA-undergrupperne.
English: Hypertension indication
Danish: Indikationen hypertension
English: Up-titration to the target dose of 32 mg once daily (maximum dose) or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks.
Danish: Optitrering til måldosen på 32 mg én gang dagligt (maksimumdosis) eller den højeste tolererede dosis sker ved at fordoble dosis i intervaller på mindst 2 uger.
English: If this is severe you may notice tiredness, weakness, irregular heart beat or pins and needles.
Danish: Hvis dette er alvorligt, kan du mærke træthed, svaghedsfølelse, uregelmæssig hjerterytme eller en prikkende/sovende fornemmelse et sted på kroppen.
English: Both the mortality and morbidity (CHF hospitalisation) components of these composite endpoints contributed to the favourable effects of candesartan.
Danish: Både mortalitetsog morbiditets- (hospitalisering pga. kronisk hjerteinsufficiens) komponenterne af disse kombinerede endepunkter bidrog til candesartans positive effekt.
English: - the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
Danish: - Formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen.
English: Therefore, the use of Atacand is not recommended in this population.
Danish: Atacand anbefales derfor ikke til disse patienter.
English: A number of areas of disharmony were considered, in particular sections 4.1, 4.2, 4.3 and 4.4 of the summary of product characteristics (SPC).
Danish: 4.1, 4.2, 4.3 og 4.4 i produktresuméet.
English: Atacand contains candesartan cilexetil, an angiotensin receptor blocker (ARB), indicated for the treatment of essential hypertension in adults and of adult patients with heart failure and impaired left ventricle systolic function (left ventricular ejection fraction  40%) as add-on therapy to Angiotensin Converting Enzyme (ACE inhibitors) or when ACE inhibitors are not tolerated.
Danish: Atacand indeholder candesartan cilexetil, en angiotensinreceptorblokker (ARB), som er indiceret til behandling af essentiel hypertension hos voksne og voksne patienter med hjerteinsufficiens og systolisk dysfunktion i venstre ventrikel (venstre ventrikel ejektionsfraktion  40%), som tillægsbehandling til ACE-hæmmere (Angiotensin Converting Enzyme), eller når ACE-hæmmere ikke tåles.
English: The dose should be titrated according to response.
Danish: Dosis bør justeres efter respons.
English: Biotransformation and elimination
Danish: Metabolisme og elimination
English: Atacand contains lactose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactose.
English: Medicinal products that affect the renin-angiotensin-aldosterone system, including angiotensin II receptor antagonists (AIIRAs), may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Danish: Andre lægemidler, der påvirker renin-angiotensin-aldosteron-systemet, herunder angiotensin IIreceptor-antagonister (AIIRA), kan forårsage forhøjet serum-urinstof og serum-kreatinin hos patienter med bilateral nyrearteriestenose eller stenose i arterien til én nyre (hos patienter med kun en nyre).
English: Periodic monitoring of serum potassium is recommended.
Danish: Regelmæssig monitorering af serum-kalium anbefales.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Danish: Indehaver af markedsføringstilladelse
English: Bocskai út 134-146
Danish: AstraZeneca Kft. 1113 Budapest, Bocskai út 134-146 Hungary
English: Please tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately and, if appropriate, alternative therapy should be started.
Danish: Når graviditet er konstateret, bør behandling med AIIRA'er straks seponeres, og anden behandling bør iværksættes, hvis det skønnes hensigtsmæssigt.
English: In patients with CHF and depressed left ventricular systolic function (left ventricular ejection fraction, LVEF  40%), candesartan decreases systemic vascular resistance and pulmonary capillary wedge pressure, increases plasma renin activity and angiotensin II concentration, and decreases aldosterone levels.
Danish: Hos patienter med kronisk hjerteinsufficiens og nedsat systolisk funktion af venstre ventrikel (LVEF ≤ 40 %) mindsker candesartan den systemiske vaskulære modstand og lungearterie-indkilingstrykket, øger plasma-renin-aktiviteten og angiotension II-koncentrationen og nedsætter aldosteron-niveauet.
English: When Atacand is used in hypertensive patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended.
Danish: Når Atacand anvendes til hypertensive patienter med nedsat nyrefunktion, anbefales det at monitorere serum-kalium- og serum-kreatininniveauet regelmæssigt.
English: Hypotension may occur during anaesthesia and surgery in patients treated with angiotensin II antagonists due to blockade of the renin-angiotensin system.
Danish: Hos patienter behandlet med angiotension II-antagonister kan hypotension opstå under anæstesi og kirurgi på grund af blokering af renin-angiotension-systemet.
English: Periodic monitoring of serum creatinine and potassium is recommended (see section 4.4).
Danish: Regelmæssig monitorering af serum-kreatinin og serum-kalium anbefales (se pkt.
English: Up-titration to the target dose of 32 mg once daily (maximum dose) or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks (see section 4.4).
Danish: Titrering til måldosis på 32 mg én gang daglig (maksimaldosis) eller til den højst tolererede dosis foretages ved at fordoble dosis med intervaller på mindst 2 uger (se pkt.
English: Hypersensitivity to candesartan cilexetil or to any of the excipients.
Danish: Overfølsomhed over for candesartancilexetil eller over for et eller flere af hjælpestofferne.
English: Atacand is contraindicated in patients with severe hepatic impairment and/or cholestasis (see sections 4.3 and 5.2).
Danish: Atacand er kontraindiceret hos patienter med stærkt nedsat leverfunktion og/eller kolestase (se pkt.
English: Concomitant therapy with an ACE inhibitor in heart failure The risk of adverse reactions, especially renal function impairment and hyperkalaemia, may increase when Atacand is used in combination with an ACE inhibitor (see section 4.8).
Danish: Samtidig behandling med ACE-hæmmer ved hjerteinsufficiens Risikoen for bivirkninger, specielt nedsat nyrefunktion og hyperkaliæmi, kan være øget, når candesartan anvendes i kombination med en ACE-hæmmer (se pkt.
English: The combination of an ACE inhibitor, a potassium-sparing diuretic (e.g. spironolactone) and Atacand is not recommended and should be considered only after careful evaluation of the potential benefits and risks.
Danish: Kombination af en ACE-hæmmer, et kaliumbesparende diuretikum (for eksempel spironolacton) og Atacand anbefales ikke og bør kun overvejes efter omhyggelig evaluering af de mulige fordele og risici.
English: There is limited experience in patients with very severe or end-stage renal impairment (Clcreatinine < 15 ml/min) (see section 4.4).
Danish: Der er begrænset erfaring hos patienter med meget alvorlig eller slutstadium af nyreinsufficiens (kreatinin-clearance (Clkreatinin) <15 ml/minut) (se pkt.
English: If you take more Atacand than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.
Danish: Hvis du har taget for mange Atacand-tabletter Kontakt omgående lægen eller apoteket, hvis du har taget flere Atacand, end lægen har foreskrevet.
English: In line with the referred above, for heart failure patients treated with candesartan, hyperkalaemia may occur.
Danish: I overensstemmelse med ovenstående kan der opstå hyperkaliæmi hos patienter med hjerteinsufficiens, som behandles med candesartan.
English: Monitoring of potassium should be undertaken as appropriate.
Danish: Monitorering af serum-kalium bør foretages, når det er relevant.
English: Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Danish: Andet og tredje trimester af graviditeten (se pkt.
English: If you stop taking Atacand, your blood pressure may increase again.
Danish: Dit blodtryk kan stige igen, hvis du holder op med at tage Atacand.
English: Concomitant use of Atacand 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.
Danish: Samtidig anvendelse af Atacand og kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller andre lægemidler, der kan øge kaliumniveauerne (for eksempel heparin), kan medføre stigning i serum-kalium hos hypertensive patienter.
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: I tilfælde af eksponering for AIIRA'er i andet eller tredje graviditetstrimester anbefales det at foretage ultralydsscanning af nyrefunktion og kranie.
English: However, reference to an increased antihypertensive effect when candesartan cilexetil is combined with a CCB amlodipine or felodipine was not included in section 4.2 but rather in 5.1.
Danish: Henvisningen til en øget antihypertensiv effekt, når candesartan cilexetil kombineres med en CCB som amlodipin eller felodipin, var imidlertid ikke inkluderet i pkt.
English: Candesartan is not removed by haemodialysis.
Danish: Candesartan fjernes ikke ved hæmodialyse.
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 anvendelse af kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller andre lægemidler (for eksempel heparin) kan øge kaliumniveauerne.
English: • if you have ever had a stroke.
Danish: • hvis du på noget tidspunkt har haft en hjerneblødning.
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels
Danish: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Bruxelles Belgium
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Danish: Når graviditet er konstateret, bør behandling med AIIRA'er straks seponeres og anden behandling iværksættes, hvis det skønnes hensigtsmæssigt (se pkt.
English: Very rare Angioedema, rash, urticaria, pruritus
Danish: Angioødem, udslæt, urticaria, kløe
English: The use of AIIRAs in the second and third trimester is contraindicated.
Danish: AIIRA'er er kontraindiceret under andet og tredje trimester af graviditeten.
English: In two studies, both including patients with mild to moderate hepatic impairment, there was an increase in the mean AUC of candesartan of approximately 20% in one study and 80% in the other study (see section 4.2).
Danish: I to forsøg, begge med patienter med let til moderat nedsat leverfunktion, var der en stigning i gennemsnitlig AUC for candesartan på ca. 20 % i det ene forsøg og e
English: Very rare Back pain, arthralgia, myalgia
Danish: Rygsmerter, artralgi, myalgi
English: Heart failure:
Danish: Hjerteinsufficiens:
English: Withdrawals from treatment due to adverse events were similar with candesartan cilexetil (3.1%) and placebo (3.2%).
Danish: Den samlede hyppighed af bivirkninger viste ingen sammenhæng med dosis eller alder. Seponering af behandling på grund af bivirkninger var ens for candesartancilexetil (3,1 %) og placebo (3,2 %).
English: • The usual dose of Atacand is 8 mg once a day.
Danish: • Den sædvanlige dosis Atacand er 8 mg én gang dagligt.
English: DATE OF REVISION OF THE TEXT
Danish: NDRING AF TEKSTEN
English: Hypotension may occur during treatment with Atacand in heart failure patients.
Danish: Hypotension kan opstå hos patienter med hjerteinsufficiens i behandling med Atacand.
English: The recent ESH guidelines (Mancia et al 2007) and the Joint National Committee (JNC) VII guidelines (Chobanian et al 2003) for the treatment of hypertension state that the benefit may be substantial even when blood pressure reductions are small, and the initial blood pressure is below the traditional cut off defining hypertension.
Danish: Patienter, som reagerer på monoterapi med candesartan i lavere doser med nogen nedsættelse af blodtrykket, kan have yderligere gavn af den fulde dosis på 32 mg. Af de nye ESH-retningslinjer (Mancia et al 2007) og retningslinjerne fra Joint National Committee (JNC) VII (Chobanian et al 2003) for behandling af hypertension fremgår det, at der kan være tale om stor gavn, selvom blodtryksreduktionen er lille, og det indledende blodtryk ligger under den traditionelle grænse, som definerer hypertension.
English: Frequency Undesirable Effect
Danish: Hyppighed Bivirkning
English: Heart failure indication
Danish: Indikationen hjerteinsufficiens
English: Before you take, or whilst you are taking Atacand, tell your doctor.
Danish: Før og under behandling med Atacand skal du fortælle lægen:
English: Your doctor may want to see you more often and do some tests if you have any of these conditions.
Danish: Hvis noget af ovenstående gælder for dig, vil lægen eventuelt se dig oftere og tage nogle prøver.
English: (ACE inhibitors are a group of medicines used to treat heart failure).
Danish: ACE-hæmmere (hæmmer det angiotensinkonverterende enzym) er en gruppe lægemidler, der anvendes til at behandle hjerteinsufficiens.
English: The recommended initial dose and usual maintenance dose of Atacand is 8 mg once daily.
Danish: Anbefalet startdosis og sædvanlig vedligeholdelsesdosis er 8 mg Atacand én gang daglig.
English: AstraZeneca UK Limited 15 Stanhope Gate London W1K 1LN United Kingdom
Danish: Slovenien AstraZeneca UK Limited 15 Stanhope Gate
English: Monitoring of potassium should be undertaken as appropriate (see section 4.4).
Danish: Serum-kalium bør monitoreres, når det er relevant (se pkt.
English: Very rare Renal impairment, including renal failure in susceptible patients (see section 4.4)
Danish: Almindelig Nedsat nyrefunktion, herunder nyresvigt hos disponerede patienter (se pkt.
English: Very rare Dizziness, headache
Danish: Svimmelhed, hovedpine
English: The changes to the SPC have been taken into account in the amendments to the PL and labelling as appropriate.
Danish: Indlægsseddel og etikettering Ændringerne i indlægssedlen og etiketteringen tager højde for relevante ændringer i produktresuméet.
English: Common Renal impairment, including renal failure in susceptible patients (see section 4.4)
Danish: Nedsat nyrefunktion, herunder nyresvigt hos disponerede patienter (se pkt.
English: Very rare Hyponatraemia
Danish: Almindelig Hyperkaliæmi Meget sjælden