FrancophonIA/ELRC3.0 huggingface dataset:
English: This conclusion was confirmed also in another study which looked at an even higher starting dose.
Danish: Denne konklusion blev også bekræftet i en anden undersøgelse af en endnu højere startdosis.
English: Sympathomimetic medicinal products may be administered if the above-mentioned measures are not sufficient.
Danish: Sympatomimetiske lægemidler kan gives, hvis ovennævnte tiltag ikke er tilstrækkelige.
English: • Changes in blood test results:
Danish: • Ændringer i blodprøver:
English: CARTON FOR BLISTER / CARTON FOR BOTTLE / LABEL FOR BOTTLE
Danish: KARTON TIL BLISTER / KARTON TIL FLASKE / ETIKET TIL FLASKE
English: All-cause mortality was not statistically significant when examined separately in each of the three CHARM studies.
Danish: Mortalitet af alle årsager var ikke statistisk signifikant, når den blev undersøgt separat i hver af de 3 CHARM-studier.
English: It also makes it easier for your heart to pump blood to all parts of your body.
Danish: Det gør det også lettere for dit hjerte at pumpe blod rundt i hele kroppen.
English: The estimated absolute bioavailability of the tablet is therefore 14%.
Danish: Den estimerede absolutte biotilgængelighed af tabletten er derfor 14 %.
English: The CHMP thus endorsed the wording “Essential hypertension”.
Danish: CHMP godkendte derfor ordlyden ”Essentiel hypertension”.
English: This is medicine is used for:
Danish: Medicinen anvendes til:
English: Most of the antihypertensive effect is attained within 4 weeks.
Danish: Størstedelen af den antihypertensive effekt opnås inden for 4 uger.
English: Atacand is indicated for the:
Danish: Atacand er indiceret til:
English: The presentation of results of a study in hypertension in the elderly was also harmonised.
Danish: Fremlæggelsen af resultater af en undersøgelse om hypertension hos ældre blev også harmoniseret.
English: There is no experience with the use of Atacand in children (below the age of 18 years).
Danish: Der er ingen erfaring med anvendelse af Atacand til børn (under 18 år).
English: • Do not use Atacand after the expiry date which is stated on the carton, blister pack or bottle.
Danish: • Brug ikke Atacand efter den udløbsdato, som står på pakningen, blisterpakningen eller flasken.
English: This is also the case for candesartan.
Danish: Dette gælder også for candesartan.
English: Just take the next dose as normal.
Danish: Tag den næste dosis på det sædvanlige tidspunkt.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ATACAND AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF ATACAND OG TILKNYTTEDE NAVNE (SE BILAG I)
English: The agreed indications were:
Danish: De vedtagne indikationer var:
English: Therefore Atacand should not be given to children.
Danish: Derfor bør Atacand ikke gives til børn.
English: Therefore do not stop taking Atacand without first talking to your doctor.
Danish: Derfor må du ikke holde op med at tage Atacand uden først at tale med lægen.
English: There was no evidence of carcinogenicity.
Danish: er var intet tegn på karcinogenicitet.
English: This is also confirmed in the recent meta-analysis by Law et al 2009, based on randomised trials.
Danish: Det bekræftes også i den seneste meta-analyse af Law et al 2009, som er baseret på randomiserede undersøgelser.
English: • This medicinal product does not require any special temperature storage conditions.
Danish: • Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Stop taking Atacand and seek medical help immediately if you have any of the following allergic reactions:
Danish: Hold op med at tage Atacand og søg øjeblikkelig lægehjælp, hvis du oplever nogle af følgende overfølsomhedsreaktioner:
English: Taking into account the inter-individual variability, a more than average effect can be expected in some patients.
Danish: Under hensynstagen til den inter-individuelle variation kan der hos nogle patienter forventes en effekt, som er større end den gennemsnitlige effekt.
English: If symptomatic hypotension should occur, symptomatic treatment should be instituted and vital signs monitored.
Danish: Hvis symptomgivende hypotension skulle opstå, bør symptomatisk behandlingen institueres og vitale tegn monitoreres.
English: This corresponds to a relative risk reduction of 15%.
Danish: Det svarer til en relativ risikoreduktion på 15 %.
English: In addition, there was no compelling indication that the results in any NYHA class subgroup were notably different from those described for the overall population.
Danish: Desuden var der ingen overbevisende indikation på, at resultaterne i nogen af de NYHA-klassificerede undergrupper var væsentlig anderledes end dem, som er beskrevet for den samlede population.
English: In particular, tell your doctor if you are using any of the following medicines:
Danish: Du skal især fortælle lægen, hvis du bruger noget af følgende medicin:
English: In the PostMarketing sub-section, the frequency “Very Rare” was replaced with the frequency “not known” as, for post marketing experience the frequency could not be estimated in accordance with the guideline on the SPC (September 2009).
Danish: I underafsnittet Efter Markedsføring blev hyppigheden ”Meget sjælden” erstattet med hyppigheden ”Ikke kendt”, da hyppigheden efter markedsføringen ikke kunne estimeres, og i overensstemmelse med retningslinjerne for produktresuméet (september 2009).
English: This corresponds to a relative risk reduction of 23%.
Danish: Det svarer til en relativ risikoreduktion på 23 %.
English: Regarding heart failure, the presentation of the results for the CHARM programme was harmonised.
Danish: Vedrørende hjerteinsufficiens blev fremlæggelsen af resultater fra CHARM-programmet harmoniseret.
English: Your doctor may occasionally do blood tests to check whether Atacand has had any effect on your blood (agranulocytosis).
Danish: Lægen vil måske tage blodprøver indimellem for at undersøge, om Atacand påvirker dit blod (agranulocytose).
English: Your doctor will normally advise you to stop taking Atacand before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Atacand.
Danish: Lægen vil normalt råde dig til at holde op med at tage Atacand, inden du bliver gravid, eller så snart du ved, at du er gravid, og vil råde dig til at tage anden medicin i stedet for Atacand.
English: • A reduction in your red or white blood cells.
Danish: • Fald i antallet af røde eller hvide blodlegemer.
English: A similar effect may occur with AIIRAs.
Danish: En tilsvarende virkning kan forekomme med AIIRA'er.
English: • if you have a disease of the adrenal gland called Conn's syndrome (also called primary hyperaldosteronism).
Danish: • hvis du har en sygdom i binyrerne, som kaldes Conn's syndrom (kaldes også primær hyperaldosteronisme).
English: This will help you to remember to take it.
Danish: Det vil hjælpe dig med at huske at tage tabletten.
English: Important information about some of the ingredients of Atacand Atacand contains lactose which is a type of sugar.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Atacand Atacand indeholder lactose, som er en sukkerart.
English: If you are using certain medicines, your doctor may need to do blood tests from time to time.
Danish: Hvis du tager visse typer medicin, vil lægen eventuelt tage blodprøver indimellem.
English: Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.
Danish: Selvom der ikke foreligger kontrollerede epidemiologiske data om risikoen ved AIIRA'er, kan der være lignende risici for denne gruppe lægemidler.
English: This section was shortened and harmonised taking into account the current scientific knowledge and in line with the discussions for other sections of the SPC.
Danish: Afsnittet blev forkortet og harmoniseret under hensyntagen til den eksisterende faglige viden og i overensstemmelse med drøftelserne af andre afsnit i produktresumeet.
English: • you must tell your doctor if you think you are (or might become) pregnant.
Danish: Du skal fortælle lægen, hvis du tror, du er (eller kan blive) gravid.
English: The SPC in one MS mentioned the addition of a calcium channel blocker (CCB) as an additional alternative strategy.
Danish: Produktresuméet i én medlemsstat nævnte tilføjelse af en calciumblokker (CCB) som en yderligere alternativ strategi.
English: Other possible side effects include:
Danish: Andre bivirkninger er:
English: Some studies support the addition of a calcium channel blocker (CCB), as additional strategy, (Farsang et al 2001, Morgan and Anderson 2002 and Lindholm et al 2003).
Danish: Nogle undersøgelser understøtter tilføjelse af en calciumblokker (CCB) som en yderligere strategi, (Farsang et al 2001, Morgan and Anderson 2002 og Lindholm et al 2003).
English: This belongs to a group of medicines called angiotensin II receptor antagonists.
Danish: Det tilhører en lægemiddelgruppe, der kaldes angiotensin II-receptor-antagonister.
English: Available interaction studies indicate no effect on CYP2C9 and CYP3A4.
Danish: Foreliggende interaktionsundersøgelser tyder ikke på nogen virkning på CYP2C9 og CYP3A4.
English: • When you are prescribed Atacand, discuss with your doctor before drinking alcohol.
Danish: • Når du får ordineret Atacand, skal du tale med lægen, inden du drikker alkohol.
English: There is no accumulation following multiple doses.
Danish: Der er ingen akkumulering efter gentagne doser.
English: In very rare cases, kidney failure may occur.
Danish: I meget sjældne tilfælde kan der forekomme nyresvigt.
English: No clinically significant pharmacokinetic interactions with these medicinal products have been identified.
Danish: Der er ikke påvist klinisk signifikante farmakokinetiske interaktioner med disse lægemidler.
English: The corresponding changes in patients with severe renal impairment were approximately 50% and 110%, respectively.
Danish: De tilsvarende ændringer hos patienter med stærkt nedsat nyrefunktion var henholdsvis ca. 50 % og 110 %.
English: Swallow the tablet with a drink of water.
Danish: Synk tabletten med vand.
English: In controlled clinical studies adverse reactions were mild and transient.
Danish: I kontrollerede kliniske undersøgelser var bivirkningerne milde og forbigående.
English: The patient should be placed supine with the legs elevated.
Danish: Patienten bør anbringes i liggende stilling med benene løftet.
English: Atacand may cause a reduction in number of white blood cells.
Danish: Atacand kan medføre et nedsat antal hvide blodlegemer.
English: The possibility of similar effects cannot be excluded with AIIRAs.
Danish: Muligheden for tilsvarende virkninger kan ikke udelukkes for AIIRA'er.
English: With continuous treatment, most of the reduction in blood pressure with any dose is generally attained within four weeks and is sustained during long-term treatment.
Danish: Ved fortsat behandling opnås størstedelen af blodtryksreduktionen, uanset dosis, i almindelighed i løbet af 4 uger og opretholdes under langtidsbehandling.
English: The mean peak serum concentration (Cmax) is reached 3-4 hours following tablet intake.
Danish: Den gennemsnitlige maksimale serumkoncentration (Cmax) nås i løbet af 3-4 timer efter tabletindtagelse.
English: • if you are more than 3 months pregnant (it is also better to avoid Atacand in early pregnancysee pregnancy section).
Danish: • hvis du er mere end 3 måneder henne i graviditeten (det er også bedre at undgå Atacand tidligt i graviditeten, se afsnittet om graviditet).
English: The 32 mg dose is supported by study results in hypertensive patients and by a recently published dose-response analysis by Karlson et al 2009.
Danish: Dosen på 32 mg understøttes af undersøgelsesresultater hos hypertensive patienter og af en dosisrespons-analyse af Karlson et al 2009, som er publiceret for nylig.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Medlemsland
English: If you are going to have an operation, tell your doctor or dentist that you are taking Atacand.
Danish: Hvis du skal opereres, skal du fortælle lægen eller tandlægen, at du tager Atacand.
English: Based on available data, including results from the CHARM study programme (Candesartan in Heart Failure: Assessment of Reduction in Mortality and morbidity) which included patients in NYHA functional class II to IV, the Committee noted there is no reason to exclude NYHA class IV patients.
Danish: På basis af tilgængelige data, herunder resultater fra undersøgelsesprogrammet CHARM (Candesartan in Heart Failure: Assessment of Reduction in Mortality and morbidity), som inkluderede patienter i NYHA-funktionsklasse II til IV, bemærkede udvalget, at der ikke er nogen grund til at udelukke patienter i NYHA-klasse IV.
English: Very rarely, hypotension may be severe such that it may warrant the use of intravenous fluids and/or vasopressors.
Danish: Meget sjældent kan hypotensionen være så alvorlig, at det nødvendiggør anvendelse af intravenøs væske og/eller vasopressorbehandling.
English: There was no statistically significant difference in the primary endpoint, major cardiovascular events (cardiovascular mortality, non-fatal stroke and non-fatal myocardial infarction).
Danish: Der var ingen statistisk signifikant forskel i det primære endepunkt, større kardiovaskulære hændelser (kardiovaskulær mortalitet, ikke-letalt slagtilfælde og ikke-letalt myokardieinfarkt).
English: It also has a role in the pathogenesis of end organ hypertrophy and damage.
Danish: Det har også en rolle i patogenesen af målorganets hypertrofi og beskadigelse.
English: This medicinal product was considered for SPC harmonisation and a referral was triggered in order to resolve divergences and harmonise the nationally authorised product information (PI) across Europe.
Danish: Dette lægemiddel blev overvejet til harmonisering af produktresuméet, og der blev foretaget en indbringelse for at løse spørgsmål om afvigelser og harmonisere de nationalt godkendte produktinformationer (PI) i Europa.
English: 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.
Danish: 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.
English: celecoxib or etoricoxib (medicines to relieve pain and inflammation).
Danish: celecoxib eller etoricoxib (medicin, som lindrer smerter og betændelseslignende tilstande).
English: Candesartan cilexetil is a prodrug suitable for oral use.
Danish: Candesartancilexetil er et prodrug egnet til oral anvendelse.
English: Almirall, S.A. Ronda General Mitre, 151 08022 Barcelona
Danish: Almirall, S.A. Ronda General Mitre, 151 08022 Barcelona Spain
English: 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).
Danish: 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).
English: This helps to lower your blood pressure.
Danish: Dette medvirker til, at dit blodtryk falder.
English: Candesartan is highly bound to plasma protein (more than 99%).
Danish: Candesartan er stærkt bundet til plasmaproteiner (> 99 %).
English: In particular, the indications and their associated posology recommendations, the contraindications and special warnings and precautions for use were harmonised.
Danish: Særligt blev indikationerne og de tilhørende doseringsanbefalinger, kontraindikationer og særlige advarsler og forsigtighedsregler vedrørende brugen harmoniseret.
English: AIIRAs should not be initiated during pregnancy.
Danish: Behandling med AIIRA'er bør ikke påbegyndes under graviditet.
English: Candesartan is an AIIRA, selective for AT1 receptors, with tight binding to and slow dissociation from the receptor.
Danish: Candesartan er en AIIRA, selektiv for AT1-receptorer, med kraftig binding til og langsom dissociation fra receptoren.
English: The relative bioavailability of the tablet formulation compared with the same oral solution is approximately 34% with very little variability.
Danish: Den relative biotilgængelighed af tabletten sammenlignet med den orale opløsning er ca. 34 % med meget lille variabilitet.
English: If you forget to take Atacand Do not take a double dose to make up for a forgotten tablet.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: 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.
Danish: Blodtrykket blev reduceret fra 166/90 til 145/80 mmHg i candesartan-gruppen og fra 167/90 til 149/82 mmHg i kontrolgruppen.
English: • Acetylsalicylic acid (if you are taking more than 3 g each day) (medicine to relieve pain and inflammation).
Danish: • Acetylsalicylsyre (hvis du tager mere end 3 g dagligt) (medicin, som lindrer smerter og betændelseslignende tilstande).
English: Like all medicines, Atacand can cause side effects, although not everybody gets them.
Danish: Atacand kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Always take Atacand exactly as your doctor has told you.
Danish: Tag altid Atacand nøjagtigt efter lægens anvisning.
English: Atacand should be taken once daily with or without food.
Danish: Atacand bør tages én gang daglig med eller uden samtidig fødeindtagelse.
English: The CHMP considered that the safety information in hypertension and chronic heart failure (CHF) should be presented separately.
Danish: CHMP mente, at sikkerhedsinformationen ved hypertension og kronisk hjerteinsufficiens skal fremgå separat.
English: Non-Perforated calendar foil (7, 14, 28, 56 and 98 tablets)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Uperforeret folie (7, 14, 28, 56 og 98 tabletter)
English: • Respiratory infection.
Danish: • Luftvejsinfektion.
English: • Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac,
Danish: • Non-steroide antiinflammatoriske stoffer (NSAID) så som ibuprofen, naproxen, diclofenac,
English: The antihypertensive action is due to decreased systemic peripheral resistance, without reflex increase in heart rate.
Danish: Den antihypertensive virkning skyldes en nedsat systemisk perifer modstand uden reflektorisk stigning i hjertefrekvensen.
English: • Feeling dizzy/spinning sensation.
Danish: • Svimmelhedsfølelse/snurrende fornemmelse.
English: 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.
Danish: 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.
English: Clinical trials in heart failure did not include patients with serum creatinine > 265 mol/l (> 3 mg/dl).
Danish: Kliniske forsøg med hjerteinsufficiens inkluderede ikke patienter med serum-kreatinin > 265 mol/l (> 3 mg/dl).
English: • severe itching of the skin (with raised lumps)
Danish: • alvorlig hudkløe (med hævelser af huden)
English: The bioavailability of candesartan is not affected by food.
Danish: Biotilgængeligheden af candesartan påvirkes ikke af fødeindtagelse.
English: If this is not sufficient, plasma volume should be increased by infusion of, for example, isotonic saline solution.
Danish: Hvis dette ikke er tilstrækkeligt, bør plasmavolumen øges ved infusion af for eksempel isotonisk natriumchloridinfusionsvæske.
English: • if you have recently had a kidney transplant.
Danish: • hvis du for nylig har fået transplanteret en nyre.
English: • Lithium (a medicine for mental health problems).
Danish: • Lithium (medicin mod psykiske lidelser).
English: After 6 months of treatment 63% of the patients still taking candesartan cilexetil (89%) were at the target dose of 32 mg.
Danish: Efter 6 måneders behandling havde 63 % af de patienter, som stadig fik candesartancilexetil (89 %), nået måldosis på 32 mg.
English: 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.
Danish: 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.
English: The absolute bioavailability of candesartan is approximately 40% after an oral solution of candesartan cilexetil.
Danish: Den absolutte biotilgængelighed af candesartan er ca. 40 % efter en oral opløsning af candesartan cilexetil.
English: • if you have low blood pressure.
Danish: • hvis du har lavt blodtryk.
English: Use of candesartan with lithium is not recommended.
Danish: Brug af candesartan samtidig med lithium anbefales ikke.
English: However, the approved indication in one MS excluded patients falling in the New York Heart Association (NYHA) functional class IV.
Danish: Imidlertid udelukkede den godkendte indikation i én medlemsstat patienter i New York Heart Association (NYHA)'s funktionsklasse IV.
English: There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Danish: Der var ingen tegn på unormal systemisk eller målorgantoksicitet ved klinisk relevante doser.
English: In individual case reports of overdose (of up to 672 mg candesartan cilexetil) patient recovery was uneventful.
Danish: I individuelle rapporter om overdosering (med op til 672 mg candesartancilexetil) kom patienterne sig uden komplikationer.
English: The terminal half-life of candesartan is approximately 9 hours.
Danish: Den terminale t½ for candesartan er ca. 9 timer.
English: Atacand can affect the way some other medicines work and some medicines can have an effect on Atacand.
Danish: Atacand kan påvirke den måde, anden medicin virker på, og anden medicin kan påvirke Atacand.
English: The CHMP considered that the available clinical data support a dose of candesartan up to 32 mg for the treatment of hypertension.
Danish: CHMP mente, at de foreliggende kliniske data understøtter en dosis af candesartan på op til 32 mg til behandling af hypertension.
English: The hypertension indication was approved in all member states (MSs).
Danish: Indikationen hypertension var godkendt i alle medlemsstater.
English: You may notice tiredness, an infection or a fever.
Danish: Du kan bemærke træthed, infektion eller feber.
English: • 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.
Danish: • 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.
English: It works by making your blood vessels relax and widen.
Danish: Det får dine blodårer til at slappe af og udvide sig.
English: 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.
Danish: 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.
English: Pharmacokinetics in special populations
Danish: Farmakokinetik hos særlige befolkningsgrupper