natgillin/translations-raw huggingface dataset:
Yderligere er der ingen åbenlys biologisk årsag til, at patienter, som er klassificeret i NYHA-klasse IV, skulle reagere anderledes på candesartan end andre patienter, for eksempel dem som er klassificeret i NYHA-klasse III.
Moreover, there is no obvious biological reason for patients classified in NYHA class IV to respond differently to candesartan than other patients such as those classified to NYHA class III.
celecoxib eller etoricoxib (medicin, som lindrer smerter og betændelseslignende tilstande).
celecoxib or etoricoxib (medicines to relieve pain and inflammation).
Candesartancilexetil er et prodrug egnet til oral anvendelse.
Candesartan cilexetil is a prodrug suitable for oral use.
Almirall, S.A. Ronda General Mitre, 151 08022 Barcelona Spain
Almirall, S.A. Ronda General Mitre, 151 08022 Barcelona
CHMP vurderede, at forholdet mellem fordele og risiko er positivt også for patienter i NYHA-klasse IV, og besluttede derfor ikke at udelukke disse patienter, som foreslået af European Society of Cardiology (ESC).
The CHMP considered that the benefit to risk ratio is positive also for patients in NYHA class IV and thus decided not to exclude these patients as recommended from the European Society of Cardiology (ESC).
Dette medvirker til, at dit blodtryk falder.
This helps to lower your blood pressure.
Candesartan er stærkt bundet til plasmaproteiner (> 99 %).
Candesartan is highly bound to plasma protein (more than 99%).
Særligt blev indikationerne og de tilhørende doseringsanbefalinger, kontraindikationer og særlige advarsler og forsigtighedsregler vedrørende brugen harmoniseret.
In particular, the indications and their associated posology recommendations, the contraindications and special warnings and precautions for use were harmonised.
Behandling med AIIRA'er bør ikke påbegyndes under graviditet.
AIIRAs should not be initiated during pregnancy.
Candesartan er en AIIRA, selektiv for AT1-receptorer, med kraftig binding til og langsom dissociation fra receptoren.
Candesartan is an AIIRA, selective for AT1 receptors, with tight binding to and slow dissociation from the receptor.
Den relative biotilgængelighed af tabletten sammenlignet med den orale opløsning er ca. 34 % med meget lille variabilitet.
The relative bioavailability of the tablet formulation compared with the same oral solution is approximately 34% with very little variability.
Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
If you forget to take Atacand Do not take a double dose to make up for a forgotten tablet.
Blodtrykket blev reduceret fra 166/90 til 145/80 mmHg i candesartan-gruppen og fra 167/90 til 149/82 mmHg i kontrolgruppen.
The blood pressure was reduced from 166/90 to 145/80 mmHg in the candesartan group, and from 167/90 to 149/82 mmHg in the control group.
• Acetylsalicylsyre (hvis du tager mere end 3 g dagligt) (medicin, som lindrer smerter og betændelseslignende tilstande).
• Acetylsalicylic acid (if you are taking more than 3 g each day) (medicine to relieve pain and inflammation).
Atacand kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Atacand can cause side effects, although not everybody gets them.
Tag altid Atacand nøjagtigt efter lægens anvisning.
Always take Atacand exactly as your doctor has told you.
Atacand bør tages én gang daglig med eller uden samtidig fødeindtagelse.
Atacand should be taken once daily with or without food.
CHMP mente, at sikkerhedsinformationen ved hypertension og kronisk hjerteinsufficiens skal fremgå separat.
The CHMP considered that the safety information in hypertension and chronic heart failure (CHF) should be presented separately.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Uperforeret folie (7, 14, 28, 56 og 98 tabletter)
Non-Perforated calendar foil (7, 14, 28, 56 and 98 tablets)
• Luftvejsinfektion.
• Respiratory infection.
• Non-steroide antiinflammatoriske stoffer (NSAID) så som ibuprofen, naproxen, diclofenac,
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac,
Den antihypertensive virkning skyldes en nedsat systemisk perifer modstand uden reflektorisk stigning i hjertefrekvensen.
The antihypertensive action is due to decreased systemic peripheral resistance, without reflex increase in heart rate.
• Svimmelhedsfølelse/snurrende fornemmelse.
• Feeling dizzy/spinning sensation.
Atacand anbefales ikke til mødre, som ammer, og lægen kan vælge en anden behandling til dig, hvis du ønsker at amme, især hvis dit barn er nyfødt eller født for tidligt.
Atacand is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Kliniske forsøg med hjerteinsufficiens inkluderede ikke patienter med serum-kreatinin > 265 mol/l (> 3 mg/dl).
Clinical trials in heart failure did not include patients with serum creatinine > 265 mol/l (> 3 mg/dl).
• alvorlig hudkløe (med hævelser af huden)
• severe itching of the skin (with raised lumps)
Biotilgængeligheden af candesartan påvirkes ikke af fødeindtagelse.
The bioavailability of candesartan is not affected by food.
Hvis dette ikke er tilstrækkeligt, bør plasmavolumen øges ved infusion af for eksempel isotonisk natriumchloridinfusionsvæske.
If this is not sufficient, plasma volume should be increased by infusion of, for example, isotonic saline solution.
• hvis du for nylig har fået transplanteret en nyre.
• if you have recently had a kidney transplant.
• Lithium (medicin mod psykiske lidelser).
• Lithium (a medicine for mental health problems).
Efter 6 måneders behandling havde 63 % af de patienter, som stadig fik candesartancilexetil (89 %), nået måldosis på 32 mg.
After 6 months of treatment 63% of the patients still taking candesartan cilexetil (89%) were at the target dose of 32 mg.
Baseret på in vitro data forventes det ikke, at der vil opstå nogen interaktion in vivo med lægemidler, hvis metabolisme afhænger af cytokrom P450-isoenzymerne CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A4.
Based on in vitro data, no interaction would be expected to occur in vivo with drugs whose metabolism is dependent upon cytochrome P450 isoenzymes CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4.
Den absolutte biotilgængelighed af candesartan er ca. 40 % efter en oral opløsning af candesartan cilexetil.
The absolute bioavailability of candesartan is approximately 40% after an oral solution of candesartan cilexetil.
• hvis du har lavt blodtryk.
• if you have low blood pressure.
Brug af candesartan samtidig med lithium anbefales ikke.
Use of candesartan with lithium is not recommended.
Imidlertid udelukkede den godkendte indikation i én medlemsstat patienter i New York Heart Association (NYHA)'s funktionsklasse IV.
However, the approved indication in one MS excluded patients falling in the New York Heart Association (NYHA) functional class IV.
Der var ingen tegn på unormal systemisk eller målorgantoksicitet ved klinisk relevante doser.
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
I individuelle rapporter om overdosering (med op til 672 mg candesartancilexetil) kom patienterne sig uden komplikationer.
In individual case reports of overdose (of up to 672 mg candesartan cilexetil) patient recovery was uneventful.
Den terminale t½ for candesartan er ca. 9 timer.
The terminal half-life of candesartan is approximately 9 hours.
Atacand kan påvirke den måde, anden medicin virker på, og anden medicin kan påvirke Atacand.
Atacand can affect the way some other medicines work and some medicines can have an effect on Atacand.
CHMP mente, at de foreliggende kliniske data understøtter en dosis af candesartan på op til 32 mg til behandling af hypertension.
The CHMP considered that the available clinical data support a dose of candesartan up to 32 mg for the treatment of hypertension.
Indikationen hypertension var godkendt i alle medlemsstater.
The hypertension indication was approved in all member states (MSs).
Du kan bemærke træthed, infektion eller feber.
You may notice tiredness, an infection or a fever.
• Patienter med sort hudfarve kan have mindre virkning af denne type medicin, når den gives som den eneste blodtryksbehandling, og disse patienter kan have behov for en større dosis.
• Some black patients may have a reduced response to this type of medicine, when given as the only treatment, and these patients may need a higher dose.
Det får dine blodårer til at slappe af og udvide sig.
It works by making your blood vessels relax and widen.
Candesartancilexetil én gang daglig giver en effektiv og jævn blodtryksreduktion over 24 timer med lille variation mellem den maksimale effekt og daleffekten i løbet af dosisintervallet.
Candesartan cilexetil once daily provides effective and smooth blood pressure reduction over 24 hours, with little difference between maximum and trough effects during the dosing interval.
Farmakokinetik hos særlige befolkningsgrupper
Pharmacokinetics in special populations
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.
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).
Arealet under kurven, der viser serumkoncentration over tid (AUC) for candesartan, påvirkes ikke signifikant af fødeindtagelse.
The area under the serum concentration versus time curve (AUC) of candesartan is not significantly affected by food.
Patienter i denne behandling bør monitoreres omhyggeligt og regelmæssigt.
Patients with such treatment should be monitored regularly and carefully.
Farmakoterapeutisk klassifikation: Angiotensin II-antagonist, ATC kode C09CA06
Pharmacotherapeutic group: Angiotensin II antagonists, plain, ATC code: C09CA06
Der foreligger for tiden ingen data vedrørende effekten af candesartan på progressionen til diabetisk nefropati.
There is currently no data on the effect of candesartan on the progression to diabetic nephropathy.
En reference om, at candesartan også kan administreres sammen med andre antihypertensive stoffer, blev også inkluderet.
A reference that candesartan can also be administrated with other antihypertensive agents was also included.
• Du kan tage Atacand med eller uden mad.
• You can take Atacand with or without food.
Danmark AstraZeneca A/S Roskildevej 22
Denmark AstraZeneca A/S Roskildevej 22
Endvidere inducerede candersartan hyperplasi/hypertrofi af de juxtaglomerulære celler.
Furthermore, candesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells.
• hvis du kaster op, har kastet meget op for nylig eller har diarré.
• if you are vomiting, have recently had severe vomiting, or have diarrhoea.
Din modstandsdygtighed over for infektioner kan blive nedsat, og du bemærker måske træthed, infektion eller feber.
Your resistance to infection may be decreased and you may notice tiredness, an infection or a fever.
Meget sjældne bivirkninger (forekommer hos færre end 1 ud af 10.000)
Very rare (affects less than 1 user in 10,000)
Der er ikke tegn på alvorlig eller kraftig hypotension efter første dosis eller rebound-effekt efter behandlingsophør.
There is no indication of serious or exaggerated first dose hypotension or rebound effect after cessation of treatment.
• 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.
• 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.
Der er ikke foretaget undersøgelser af candesartans virkning på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects of candesartan on the ability to drive and use machines have been performed.
Den renale elimination af candesartan sker såvel via glomerulær filtration som via aktiv tubulær sekretion.
The renal elimination of candesartan is both by glomerular filtration and active tubular secretion.
Hos patienter med leverinsufficiens blev den indledende startdosis ændret fra 2 mg til 4 mg.
In patients with impaired hepatic function, the initial starting dose was changed from 2 mg to 4 mg.
Atacand kan også administreres sammen med andre antihypertensiva.
Atacand may also be administered with other antihypertensive agents.
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.
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.
Tag ikke Atacand
Do not take Atacand
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.
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.
Ud fra farmakologiske overvejelser vil hovedsymptomerne på overdosering sandsynligvis være hypotension og svimmelhed.
Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness.
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
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
Atacand kan tages sammen med anden hjertemedicin, og lægen vil beslutte, hvilken behandling der er bedst for dig.
Atacand can be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.
Bivirkningsprofilen for Atacand hos patienter med hjerteinsufficiens stemte overens med lægemidlets farmakologi og patienternes sundhedsstatus.
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.
Leukopeni, neutropeni og agranulocytose
Very rare Leukopenia, neutropenia and agranulocytosis
Når candesartancilexetil gives samtidig med hydrochlorthiazid, er blodtryksreduktionen additiv.
When candesartan cilexetil is used together with hydrochlorothiazide, the reduction in blood pressure is additive.
Nedenstående tabel viser bivirkninger fra kliniske forsøg og erfaringer efter markedsføring.
The table below presents adverse reactions from clinical trials and post-marketing experience.
Efter indgift af en enkelt dosis candesartancilexetil indtræder den antihypertensive virkning sædvanligvis inden for 2 timer.
After administration of a single dose of candesartan cilexetil, onset of antihypertensive effect generally occurs within 2 hours.
Hvis dette er alvorligt, kan du mærke træthed, mangel på energi eller muskelkramper.
If this is severe then you may notice weakness, lack of energy, or muscle cramps.
Sikkerhed og virkning af Atacand i behandlingen af hypertension og hjerteinsufficiens hos børn fra fødslen til 18 år er ikke fastlagt.
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.
Dette afsnit indeholdt de symptomatiske manifestationer af overdosis og anbefalinger om håndtering, hvis det forekommer.
The symptomatic manifestations of overdose and recommendations on management if it occurs were included in this section.
Der bør udvises forsigtighed ved behandlingens start, og det bør forsøges at korrigere for hypovolæmi.
Caution should be observed when initiating therapy and correction of hypovolemia should be attempted.
Det tilsyneladende fordelingsvolumen for candesartan er 0,1 1/kg.
The apparent volume of distribution of candesartan is 0.1 l/kg.
Børn, hvis mødre har taget AIIRA'er, skal overvåges nøje for hypotension (se pkt.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Disse ændringer antages at være fremkaldt af de farmakologiske virkninger af candesartan.
These changes were considered to be caused by the pharmacological action of candesartan.
Tyskland AstraZeneca GmbH 22876 Wedel, Germany
Germany AstraZeneca GmbH 22876 Wedel, Germany
Epidemiologiske undersøgelser af risikoen for teratogenicitet ved behandling med ACE-hæmmere i første graviditetstrimester er inkonklusive, men en let forøget risiko kan ikke udelukkes.
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.
Afsnit 4.9 Overdosering
Section 4.9 Overdose
• Forandringer i leverfunktionen, inklusive leverbetændelse (hepatitis).
• Changes in how your liver is working, including inflammation of the liver (hepatitis).
Forhøjet blodtryk:
High blood pressure:
Nedsat natriumniveau i blodet.
A reduced amount of sodium in your blood.
candesartancilexetil
candesartan cilexetil
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).
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
Patienterne fik candesartancilexetil eller placebo sammen med anden antihypertensiv behandling, som blev tillagt efter behov.
Patients received candesartan cilexetil or placebo with other antihypertensive treatment added as needed.
CHMP mente ikke, at der var behov for en indledende dosisjustering hos ældre patienter over 75 år.
In the elderly, the CHMP considered that no initial dose adjustment was needed in patients over 75 years of age.
De gavnlige effekter af candesartan var de samme uanset alder, køn eller samtidig indtagelse af andre lægemidler.
The beneficial effects of candesartan were consistent irrespective of age, gender and concomitant medication.
Ved hypertension forårsager candesartan en dosisafhængig, langvarig reduktion i det arterielle blodtryk.
In hypertension, candesartan causes a dose-dependent, long-lasting reduction in arterial blood pressure.
Der er ikke observeret nogen kønsrelateret forskel for candesartans farmakokinetik.
No gender related differences in the pharmacokinetics of candesartan have been observed.
Du kan tage Atacand sammen med eller uden mad.
You can take Atacand with or without food.
Candesartan elimineres overvejende uomdannet via urinen og galden og omdannes kun i ringe grad via levermetabolisme (CYP2C9).
Candesartan is mainly eliminated unchanged via urine and bile and only to a minor extent eliminated by hepatic metabolism (CYP2C9).
Candesartan forårsagede en reduktion i parametre for de røde blodlegemer (erytrocytter, hæmoglobin, hæmatokrit).
Candesartan caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Tyskland Takeda Pharma GmbH Viktoriaallee 3-5
Germany Takeda Pharma GmbH Viktoriaallee 3-5
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.
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.
Andre afsnit af produktresuméet blev harmoniseret i overensstemmelse hermed.
Other sections of the SPC were harmonised accordingly.
• hvis du er overfølsom (allergisk) over for candesartancilexetil eller et af de øvrige indholdsstoffer (se pkt.
• if you are allergic (hypersensitive) to candesartan cilexetil or any of the other ingredients of Atacand (see section 6).
Candesartan binder ikke til og blokerer ikke andre af de hormonreceptorer eller ionkanaler, der vides at spille en vigtig rolle i den kardiovaskulære regulering.
Candesartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Patienterne bør være velhydrerede, og monitorering af nyrefunktionen bør overvejes efter opstart af samtidig behandling og herefter periodisk.
Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Dosis kan justeres efter respons.
The dose may be adjusted according to response.
Almindelig Svimmelhed/vertigo, hovedpine
Common Dizziness/vertigo, headache
Hos ældre (> 65 år) er Cmax og AUC for candesartan øget med henholdsvis ca. 50 % og 80 % i sammenligning med yngre forsøgspersoner.
In the elderly (over 65 years) Cmax and AUC of candesartan are increased by approximately 50% and 80%, respectively in comparison to young subjects.
Patienter, som blev behandlet med candesartan, en ACE-hæmmer og et kaliumsparende diuretikum, oplevede imidlertid en øget risiko for hyperkaliæmi.
However, patients treated with candesartan, an ACE inhibitor and a potassium sparing diuretic experienced increased risk of hyperkalaemia.
• hvis du har hjerte-, lever- eller nyreproblemer eller er i dialysebehandling.
• if you have heart, liver or kidney problems, or are on dialysis.
Yderligere information om dette lægemiddel er tilgængelig på {medlemslandets/lægemiddelagenturets navn} hjemmeside:
Detailed information on this product is available on the website of : {name of MS/Agency}
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.
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.
Stigning i leverenzymer, abnorm leverfunktion eller hepatitis
Very rare Increased liver enzymes, abnormal hepatic function or hepatitis
• vanskelighed ved at trække vejret med eller uden hævelse af ansigt, læber, tunge og/eller hals
• difficulties in breathing, with or without swelling of the face, lips, tongue and/or throat
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.
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.
Afsnit om brug til særlige populationer som ældre, patienter med intravaskulær volumendepletering, patienter med nyre- og leverinsufficiens og etnisk sorte patienter blev også harmoniseret.
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.
Hos disse patienter bør Atacand titreres forsigtigt med omhyggelig monitorering af blodtrykket.
In these patients Atacand should be carefully titrated with thorough monitoring of blood pressure.