FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant treatment with baclofen, amifostin, tricyclic antidepressants or neuroleptics may lead to enhancement of the antihypertensive effect and may induce hypotension.
Danish: Samtidig behandling med baclofen, amifostin, tricykliske antidepressiva eller antipsykotika kan potensere den antihypertensive effekt og forårsage hypotension.
English: When indicated, induction of vomiting or gastric lavage should be considered.
Danish: • Hvis indiceret, skal fremkaldelse af opkastning eller ventrikelskylning overvejes.
English: The candesartan serum concentrations increase linearly with increasing doses in the therapeutic dose range.
Danish: Serumkoncentrationen af candesartan stiger lineært med stigende doser inden for det terapeutiske doseringsinterval.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimesters may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Danish: Som følge af hydrochlorthiazids farmakologiske virkningsmekanisme kan dets brug i andet og tredje trimester kompromittere den uteroplacentale perfusion og forårsage føtale og neonatale virkninger, som f.eks. icterus, forstyrrelser i elektrolytbalancen og trombocytopeni.
English: The antagonism of the 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: Antagonisme af AT1-receptorer resulterer i dosisrelateret stigning i plasma-reninniveauerne og i angiotensin Iog angiotensin II-niveauerne og i et fald i plasma-aldosteronkoncentrationen.
English: Based on pharmacological considerations, the main manifestation of an overdose of candesartan cilexetil is likely to be symptomatic hypotension and dizziness.
Danish: Ud fra farmakologiske overvejelser vil hovedsymptomerne på overdosering af candesartancilexetil sandsynligvis være symptomatisk hypotension og svimmelhed.
English: Compounds which have been investigated in clinical pharmacokinetic studies include warfarin, digoxin, oral contraceptives (i.e. ethinylestradiol/levonorgestrel), glibenclamide and nifedipine.
Danish: De stoffer, der er undersøgt i kliniske farmakokinetikstudier, inkluderer warfarin, digoxin, orale kontraceptiva (dvs. ethinylestradiol/levonorgestrel), glibenclamid og nifedipin.
English: [See Annex I - To be completed nationally] candesartan cilexetil/hydrochlorothiazide
Danish: [Se bilag I - udfyldes nationalt] candesartancilexetil/hydrochlorthiazid
English: There is no experience regarding the administration of Atacand Plus in patients with a recent kidney transplantation.
Danish: Der er ingen erfaring med indgift af Atacand Plus hos patienter, der for nyligt har fået foretaget en nyretransplantation.
English: Patients with primary hyperaldosteronism generally will not respond to antihypertensive agents acting through inhibition of the renin-angiotensin-aldosterone system.
Danish: Patienter med primær hyperaldosteronisme responderer sædvanligvis ikke på antihypertensiva, der virker via hæmning af renin-angiotensin-aldosteron-systemet.
English: This effect of hydrochlorothiazide seems to be less evident when combined with candesartan cilexetil.
Danish: Denne virkning af hydrochlorthiazid ser ud til at være mindre udtalt ved kombination med candesartancilexetil.
English: The table below presents adverse reactions with candesartan cilexetil from clinical trials and post marketing experience.
Danish: Nedenstående tabel viser bivirkningerne med candesartancilexetil fra kliniske forsøg og erfaringer efter markedsføring.
English: Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Danish: Antikolinergika (f.eks. atropin, biperiden) kan øge biotilgængeligheden af diuretika af thiazid-typen ved at reducere den gastrointestinale motilitet og mavens tømningshastighed.
English: Hydrochlorothiazide decreases plasma volume and extracellular fluid and reduces cardiac output and blood pressure.
Danish: Hydrochlorthiazid nedsætter plasmavolumen og mængden af ekstracellulær væske og nedsætter hjertets minutvolumen og blodtrykket.
English: This may make you feel faint or dizzy.
Danish: Det kan bevirke, at du føler dig utilpas eller svimmel.
English: swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing.
Danish: • hævelse af ansigt, læber, tunge, svælg og/eller hals, hvilket kan give synkebesvær.
English: Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Danish: Metformin skal anvendes med forsigtighed pga. risikoen for laktatacidose, der induceres af en eventuel nyreinsufficiens forårsaget af hydrochlorthiazid.
English: If this is severe then you may notice weakness, lack of energy, or muscle cramps.
Danish: Hvis det er stærkt nedsat, kan du eventuelt mærke en svaghedsfølelse, mangel på energi eller muskelkramper.
English: Hydrochlorothiazide is not metabolised and is excreted almost entirely as unchanged drug by glomerular filtration and active tubular secretion.
Danish: Hydrochlorthiazid metaboliseres ikke og udskilles næsten udelukkende som uomdannet lægemiddel via glomerulær filtration og aktiv tubulær sekretion.
English: Following oral administration, candesartan cilexetil is converted to the active substance candesartan.
Danish: Efter oral indgift omdannes candesartancilexetil til den aktive substans candesartan.
English: Hydrochlorothiazide The terminal t½ of hydrochlorothiazide is prolonged in patients with renal impairment.
Danish: Hydrochlorthiazid Den terminale t½ for hydrochlorthiazid er forlænget hos patienter med nedsat nyrefunktion.
English: It is not known to what extent hydrochlorothiazide is removed by haemodialysis.
Danish: Det vides ikke, i hvor stor udstrækning hydrochlorthiazid fjernes ved hæmodialyse.
English: cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperiodol)
Danish: cyamemazin, sulpirid, sultoprid, amisulprid, tiaprid, pimozid, haloperidol, droperiodol)
English: Cases of photosensitivity reactions have been reported during use of thiazide diuretics (see section 4.8).
Danish: Der er rapporteret tilfælde af lysfølsomhedsreaktioner under brugen af thiaziddiuretika (se pkt.
English: Toxic epidermal necrolysis, cutaneous lupus erythaematosus-like reactions, reactivation of cutaneous lupus erythaematosus
Danish: Sjælden Toksisk epidermal nekrolyse, kutane lupus erythematosuslignende reaktioner, reaktivering af kutan lupus erythematosus
English: The antihypertensive effect of Atacand Plus may be enhanced by other antihypertensives.
Danish: Atacand Pluss antihypertensive virkning kan forstærkes af andre antihypertensiva.
English: Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
Danish: • Kaliumtilskud eller kaliumholdige salterstatninger (medicin, der øger mængden af kalium i dit blod).
English: If you stop taking Atacand Plus, your blood pressure may increase again.
Danish: Hvis du holder op med at tage Atacand Plus Dit blodtryk kan stige igen, hvis du holder op med at tage Atacand Plus.
English: Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Danish: Thiazider bør anvendes med forsigtighed til patienter med nedsat leverfunktion eller progressiv leversygdom, da små ændringer i væske- og elektrolytbalancen kan udløse leverkoma.
English: Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Danish: Overfølsomhedsreaktioner over for hydrochlorthiazid kan forekomme hos patienter både med og uden allergi eller astma i anamnesen, men er dog mere sandsynlige hos patienter med de nævnte sygdomme i anamnesen.
English: Hydrochlorothiazide may increase the risk of acute renal insufficiency especially with high doses of iodinated contrast media.
Danish: Hydrochlorthiazid kan øge risikoen for akut nyreinsufficiens, især ved høje doser iodholdige kontrastmidler.
English: pentamidine, sparfloxacine, terfenadine, vincamine iv)
Danish: mizolastin, pentamidin, sparfloxacin, terfenadin, vincamin i.v.)
English: The terminal t½ of hydrochlorothiazide is approximately 8 hours.
Danish: Den terminale t½ for hydrochlorthiazid er ca. 8 timer.
English: Hydrochlorothiazide may cause the arterial response to pressor amines (e.g. adrenaline) to decrease but not enough to exclude a pressor effect.
Danish: Hydrochlorthiazid kan eventuelt få arterieresponset på pressoraminer (f.eks. adrenalin) til at falde, men ikke tilstrækkeligt til at udelukke en pressoreffekt.
English: Refractory hypokalaemia and hypercalcaemia.
Danish: Refraktær hypokaliæmi og hyperkalcæmi.
English: Atacand Plus is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Danish: Atacand Plus bør ikke tages tidligt i graviditeten og må ikke tages, hvis du er mere end 3 måneder henne, da det kan forårsage alvorlig skade på dit barn, hvis lægemidlet tages på dette tidspunkt (se afsnittet Graviditet).
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Fortæl din læge, hvis du ammer eller har planer om at amme.
English: Some of the side effects of Atacand Plus are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.
Danish: Nogle af Atacand Pluss bivirkninger skyldes candesartancilexetil, og andre skyldes hydrochlorthiazid.
English: There is no experience in patients with severe hepatic impairment.
Danish: Der er ingen erfaring hos patienter med stærkt nedsat leverfunktion.
English: It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide.
Danish: Det indeholder to aktive stoffer: Candesartancilexetil og hydrochlorthiazid.
English: The name of your medicine is Atacand Plus.
Danish: Lægemidlets navn er Atacand Plus.
English: Breathing difficulties (including lung inflammation and fluid in the lungs).
Danish: • Vejrtrækningsproblemer (inklusive en betændelsesreaktion og væske i lungerne).
English: The diuretic, natriuretic and antihypertensive effect of hydrochlorothiazide is blunted by NSAIDs.
Danish: Den diuretiske, natriuretiske og antihypertensive effekt af hydrochlorthiazid forringes af NSAID'er.
English: Nausea.
Danish: • Kvalme.
English: The terminal half-life (t½) of candesartan is approximately 9 hours.
Danish: Den terminale halveringstid (t½) for candesartan er ca. 9 timer.
English: Periodic determination of serum electrolytes should be performed at appropriate intervals.
Danish: Der skal foretages bestemmelse af serumelektrolytter med passende intervaller.
English: If this happens to you, do not drive or use any tools or machines.
Danish: Kør ikke bil eller motorcykel og lad være med at cykle og arbejde med værktøj eller maskiner, hvis dette er tilfældet for dig.
English: • Treatment of essential hypertension in adult patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy.
Danish: • Behandling af essentiel hypertension hos voksne patienter, hvis blodtryk ikke er optimalt kontrolleret med monoterapi med candesartancilexetil eller hydrochlorthiazid.
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'er), kan forhøje koncentrationen af urinstof i blodet og serumkreatinin hos patienter med bilateral nyrearteriestenose eller stenose i arterien til en solitær nyre.
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 poolet analyse af data fra kliniske forsøg med hypertensive patienter blev bivirkninger med candesartancilexetil defineret på basis af en bivirkningsfrekvens, der var mindst 1 % højere for candesartancilexetil end for placebo.
English: What Atacand Plus contains [To be completed nationally]
Danish: Atacand Plus indeholder [Udfyldes nationalt]
English: Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypercalcaemia, hypokalaemia, hyponatraemia, hypomagnesaemia and hypochloraemic alkalosis).
Danish: Thiazider, herunder hydrochlorthiazid, kan forårsage væske- eller elektrolytforstyrrelser (hyperkalcæmi, hypokaliæmi, hyponatriæmi, hypomagnesiæmi og hypokloræmisk alkalose).
English: Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended.
Danish: Dosistitrering med de individuelle komponenter (candesartancilexetil og hydrochlorthiazid) anbefales.
English: The potassium depleting effect of hydrochlorothiazide could be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid derivates, steroids, ACTH).
Danish: Hydrochlorthiazids kaliumnedsættende effekt kunne forventes at blive forstærket af andre lægemidler, der er forbundet med kaliumtab og hypokaliæmi (f.eks. andre kaliuretiske diuretika, laksantia, amphotericin B, carbenoxolon, benzylpenicillinnatrium, salicylsyrederivater, steroider, ACTH).
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with Angiotensin Converting Enzyme (ACE) inhibitors or hydrochlorothiazide.
Danish: Der er blevet rapporteret reversible stigninger i serum-lithium og -toksicitet ved samtidig indgift af lithium og ACE (Angiotensin Converting Enzyme)-hæmmere eller hydrochlorthiazid.
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 med ACE-hæmmere kan samtidig anvendelse af AIIRA'er og NSAID'er medføre en øget risiko for forværring af nyrefunktionen, inklusive risiko for akut nyresvigt og en stigning i serum-kalium, især hos patienter med allerede svækket nyrefunktion.
English: you have heart, liver or kidney problems.
Danish: - hvis du har problemer med hjerte, lever eller nyrer.
English: The bioavailability may decrease in patients with cardiac failure and pronounced oedema.
Danish: Biotilgængeligheden kan være lavere hos patienter med hjerteinsufficiens og udtalte ødemer.
English: you have persistently low levels of potassium in your blood.
Danish: - hvis du har vedvarende lavt kaliumindhold i blodet.
English: In clinical trials with candesartan cilexetil/hydrochlorothiazide, adverse reactions were limited to those that were reported previously with candesartan cilexetil and/or hydrochlorothiazide.
Danish: I kliniske forsøg med candesartancilexetil/hydrochlorthiazid var bivirkningerne begrænset til dem, der tidligere er rapporteret med candesartancilexetil og/eller hydrochlorthiazid.
English: Candesartan cilexetil is a prodrug which is rapidly converted to the active drug, candesartan, by ester hydrolysis during absorption from the gastrointestinal tract.
Danish: Candesartancilexetil er et prodrug, der hurtigt omdannes til den aktive substans, candesartan, via ester-hydrolyse under absorptionen fra mave-tarm-kanalen.
English: In preclinical safety studies candesartan itself 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: 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 det er tilfældet med andre vasodilatatorer, bør særlig forsigtighed udvises hos patienter, der lider af hæmodynamisk relevant stenose i aorta- eller mitralklapper eller af obstruktiv hypertrofisk kardiomyopati.
English: Detailed information on this medicinal product is available on the website of {name of MS/Agency}
Danish: Yderligere information om dette lægemiddel er tilgængelig på Lægemiddelstyrelsens hjemmeside http://www.dkma.dk.
English: Amphotericin (for the treatment of fungal infections).
Danish: • Amphotericin B (til behandling af svampeinfektioner).
English: Your doctor may prescribe Atacand Plus if your blood pressure has not been properly controlled by candesartan cilexetil or hydrochlorothiazide alone.
Danish: Din læge vil ordinere Atacand Plus, hvis dit blodtryk ikke har været ordentligt kontrolleret med candesartancilexetil eller hydrochlorthiazid alene.
English: Anticholinergic agents such as atropine and biperiden.
Danish: • Antikolinerg medicin såsom atropin og biperidin.
English: The pharmacokinetics in patients undergoing haemodialysis were similar to those in patients with severe renal impairment.
Danish: Farmakokinetikken hos patienter i hæmodialyse var som hos patienter med stærkt nedsat nyrefunktion.
English: Take special care with Atacand Plus Before you take, or whilst you are taking Atacand Plus, tell your doctor if:
Danish: Vær ekstra forsigtig med at tage Atacand Plus Før du tager, eller mens du tager Atacand Plus, skal du fortælle din læge: - hvis du har sukkersyge (diabetes).
English: Concomitant administration of candesartan cilexetil and hydrochlorothiazide has no clinically significant effect on the pharmacokinetics of either medicinal product.
Danish: Samtidige administration af candesartancilexetil og hydrochlorthiazid har ingen klinisk signifikant virkning på farmakokinetikken af hverken candesartancilexetil eller hydrochlorthiazid.
English: Treatment with a thiazide diuretic may impair glucose tolerance.
Danish: Behandling med et thiaziddiuretikum kan nedsætte glucosetolerancen.
English: Necrotising angiitis (vasculitis, cutaneous vasculitis)
Danish: Sjælden Nekrotiserende angiitis (vaskulitis, kutan vaskulitis)
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: Eksponering for AIIRA-behandling i andet og tredje trimester vides at inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, forsinket ossifikation af kraniet) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi) (se pkt.
English: No additional accumulation of hydrochlorothiazide occurs after repeated doses of the combination compared to monotherapy.
Danish: Der optræder ingen yderligere akkumulering af hydrochlorthiazid efter gentagne doser af kombinationen sammenlignet med monoterapi.
English: Damage to blood vessels causing red or purple dots in the skin.
Danish: • Skader på blodkar, der viser sig som røde eller lilla prikker på huden.
English: The candesartan cilexetil/hydrochlorothiazide combination 32 mg/25 mg was significantly more effective than the 32 mg/12.5 mg combination, and the overall mean blood pressure reductions were 16/10 mmHg and 13/9 mmHg, respectively.
Danish: Candesartancilexetil/hydrochlorthiazid-kombinationen 32 mg/25 mg var signifikant mere effektiv end kombinationen 32 mg/12,5 mg, og den samlede gennemsnitlige blodtryksreduktion var henholdsvis 16/10 mmHg og 13/9 mmHg.
English: Atacand Plus is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2 BSA) (see section 4.3).
Danish: Atacand Plus er kontraindiceret hos patienter med stærkt nedsat nyrefunktion (kreatinclearance < 30 ml/min/1,73 m2 legemsoverfladeareal) (se pkt.
English: Atacand Plus is contraindicated in patients with severe hepatic impairment and/or cholestasis (see section 4.3).
Danish: Atacand Plus er kontraindiceret hos patienter med stærkt nedsat leverfunktion og/eller kolestase (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS Non-Perforated foil, Perforated Foil
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Ikke-perforerede blisterkort, perforerede blisterkort
English: • Class III antiarrhythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide)
Danish: • Klasse III-antiarytmika (f.eks. amiodaron, sotalol, dofetilid, ibutilid)
English: you have severe liver disease or biliary obstruction (a problem with the drainage of bile from the gall bladder).
Danish: - hvis du har en alvorlig leversygdom eller blokering af galdevejene (problemer med at udskille galde fra galdeblæren).
English: The half-life of candesartan remains unchanged (approximately 9 h) after administration of candesartan cilexetil in combination with hydrochlorothiazide.
Danish: Halveringstiden for candesartan er uændret (ca. 9 timer) efter indgift af candesartancilexetil i kombination med hydrochlorthiazid.
English: Common Light-headedness, vertigo Rare
Danish: Almindelig Svimmelhed, vertigo Sjælden Paræstesier
English: Concomitant treatment with cyclosporine may increase the risk of hyperuricaemia and gout-type complications.
Danish: Samtidig behandling med ciclosporin kan øge risikoen for hyperurikæmi og arthritis urica-lignende komplikationer.
English: candesartan cilexetil/hydrochlorothiazide
Danish: candesartancilexetil/hydrochlorthiazid
English: Atacand Plus may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Atacand Plus at lower doses.
Danish: Atacand Plus kan administreres til patienter, hvis blodtryk ikke er optimalt kontrolleret med monoterapi med candesartancilexetil eller hydrochlorthiazid eller med Atacand Plus ved lavere doser.
English: Foetotoxicity has been observed in late pregnancy with candesartan.
Danish: Der er observeret føtotoksicitet, hvis candesartan administreres sent i graviditeten.
English: Renal impairment/kidney transplantation
Danish: Nedsat nyrefunktion/nyretransplantation
English: you must tell your doctor if you think you are (or might become) pregnant.
Danish: det er vigtigt, at du fortæller din læge, hvis du mener, du er (eller kunne blive) gravid.
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Det er vigtigt, at du fortæller din læge, hvis du mener, du er (eller kunne blive) gravid.
English: Concomitant use of Atacand Plus and potassium-sparing diuretics, potassium supplements or salt substitutes or other medicinal products that may increase serum potassium levels (e.g. heparin sodium) may lead to increases in serum potassium.
Danish: Samtidig brug af Atacand Plus og kaliumbesparende diuretika, kaliumtilskud eller salterstatning eller andre lægemidler, der kan øge kaliumniveauet i serum (f.eks. heparinnatrium), kan forårsage stigning i serum-kalium.
English: Thiazide diuretics may increase serum calcium levels due to decreased excretion.
Danish: Thiaziddiuretika kan øge calciumniveauet i serum på grund af formindsket udskillelse.
English: The main manifestation of an overdose of hydrochlorothiazide is acute loss of fluid and electrolytes.
Danish: Hovedsymptomerne på overdosering af hydrochlorthiazid er akut væske- og elektrolyttab.