FrancophonIA/ELRC3.0 huggingface dataset:
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients with aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som med alle andre vasodilatorer skal der udvises særlig forsigtighed over for patienter, der lider af aorta- eller mitralklapstenose eller obstruktiv hypertrofisk kardiomyopati.
English: Untreated acute-angle closure glaucoma can lead to permanent vision loss.
Danish: Ubehandlet lukketvinklet glaukom kan føre til permanent synstab.
English: Following oral administration of Imprida HCT in normal healthy adults, peak plasma concentrations of amlodipine, valsartan and hydrochlorothiazide are reached in 6-8 hours, 3 hours, and 2 hours, respectively.
Danish: Efter oral administration af Imprida HCT hos voskne raske personer, opnås peak plasma koncentrationer af amlodipin, valsartan og hydrochlorthiazid efter henholdsvis 6-8 timer, 3 timer, og 2 timer.
English: On average, in patients with mild to moderate chronic liver disease, exposure (measured by AUC values) to valsartan is twice that found in healthy volunteers (matched by age, sex and weight).
Danish: Hos patienter med mildt til moderat nedsat leverfunktion er den gennemsnitlige eksponering af valsartan (målt ved AUC-værdier) to gange højere end den, der er set hos raske frivillige (passet sammen efter alder, køn og vægt).
English: Increase of dose of probenecid or sulfinpyrazone may be necessary.
Danish: En øget dosis af probenecid eller sulfinpyrazon kan være
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Imprida HCT were dizziness and hypotension (0.7%).
Danish: De mest almindelige årsager til, at behandlingen blev afbrudt, var i dette kontrollerede kliniske forsøg med Imprida HCT svimmelhed og hypotension (0,7 %).
English: No dosage adjustment of Imprida HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion (GFR ≥30 ml/min/1,73 m
English: Since the three components are equally well tolerated in younger and elderly patients, normal dose regimens are recommended (see section 4.2).
Danish: Eftersom de tre aktive stoffer er lige veltolererede hos yngre og ældre patienter anbefales de normale doseringer.
English: There is no experience of overdose with Imprida HCT.
Danish: Der er ingen erfaring med overdosering af Imprida HCT.
English: Imprida HCT is used to treat high blood pressure in adult patients who are already taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances.
Danish: Imprida HCT bruges til at behandle forhøjet blodtryk hos voksne patienter, som allerede får amlodipin, valsartan og hydrochlorthiazid, og som kan drage fordel af at tage én tablet, som indeholder alle tre stoffer.
English: Patients with mild to moderate renal impairment may therefore receive the usual initial dose (see sections 4.2 and 4.4).
Danish: Patienter med mildt til moderat nedsat nyrefunktion kan derfor få normal startdosis (se pkt 4.2 og
English: In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve (AUC) and elimination half-life.
Danish: Amlodipins clearence har tendens til at falde hos ældre patienter, hvilket resulterer i øget areal under kurven (AUC) og øget eliminationshalveringstid.
English: Worsening of diabetic metabolic state
Danish: Forværring af den metaboliske tilstand ved diabetes
English: Based on the existing data with the components, the use of Imprida HCT is not recommended during first trimester and contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Danish: Baseret på eksisterende data med komponenterne anbefales brug af Imprida HCT ikke under første trimester og er kontraindiceret i graviditetens andet og tredje trimester.
English: Amlodipine should be used with caution together with CYP3A4 inducers.
Danish: Forsigtighed bør udvises ved samtidig anvendelse af amlodipin og CYP3A4-induktorer.
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and increases in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
Danish: Hos hypertensive patienter med normal nyrefunktion resulterede terapeutiske doser af amlodipin i en nedat renal vaskulær modstand og øget glomerulær filtrationshastighed og effektivt renal plasma flow, uden ændring i filtrationsfraktionen eller proteinuri.
English: Amlodipine Valsartan HCT
Danish: Amlodipin Valsartan HCT
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Medmindre fortsat behandling med AIIA vurderes at være nødvendig, bør patienter, som planlægger at blive gravide, skiftes til en alternativ hypertensionsbehandling med en dokumenteret sikkerhedsprofil til brug ved graviditet.
English: Concomitant administration of thiazide diuretics with substances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic
Danish: Administration af thiaziddiuretika samtidig med midler, som også har en blodtrykssænkende virkning (fx ved at reducere aktiviteten i det sympatiske centralnervesystem eller ved direkte vasodilatation) kan forstærke ortostatisk hypotension.
English: 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.
Danish: Epidemiologiske data angående risikoen for teratogenicitet efter eksponering af ACE-hæmmere under graviditetens første trimester er ikke entydige.
English: In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
Danish: Hos diabetespatienter kan dosisjustering af insulin eller orale antidiabetika være påkrævet.
English: Preclinical safety studies of up to 13 weeks in duration were conducted with amlodipine/valsartan/hydrochlorothiazide in rats.
Danish: Der blev udført prækliniske sikkerhedsstudier af op til 13 ugers varighed i rotter med amlodipin/valsartan/hydrochlorthiazid.
English: Due to the hydrochlorothiazide component, Imprida HCT is contraindicated in symptomatic hyperuricaemia.
Danish: På grund af indholdet af hydrochlorthiazid er Imprida HCT kontraindiceret ved symptomatisk hyperurikæmi.
English: In another rat study in which male rats were treated with amlodipine besilate for 30 days at a dose comparable with the human dose based on mg/kg, decreased plasma follicle-stimulating hormone and testosterone were found as well as decreases in sperm density and in the number of mature spermatids and Sertoli cells.
Danish: I et andet rottestudie, hvor hanrotter blev behandlet med amlodipinbesilat i 30 dage med en dosis sammenlignelig med doser til mennesker baseret på mg/kg, blev der fundet nedsat follikelstimulerende hormon og testosteron i plasma, nedsat spermdensitet samt nedsat antal modne spermatider og Sertoliceller.
English: In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Imprida HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Imprida HCT for clinical use in humans.
Danish: I prækliniske studier foretaget i adskillige dyrearter med amlodipin, valsartan, hydrochlorthiazid, valsartan/hydrochlorthiazid, amlodipin/valsartan og amlodipin/valsartan/hydrochlorthiazid (Imprida HCT), var der ikke bevis for systemisk toksicitet eller toksicitet i målorganet, der skadelig kunne påvirke udviklingen af Imprida HCT til kliniske forsøg med mennesker.
English: Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Danish: - Valsartan tilhører en gruppe stoffer, som kaldes ”angiotensin II-receptorantagonister”.
English: Periodic determination of serum electrolytes and potassium in particular should be performed at appropriate intervals to detect possible electrolyte imbalance, especially in patients with other risk factors such as impaired renal function, treatment with other medicinal products or history of prior electrolyte imbalances.
Danish: Der bør med passende intervaller foretages periodisk bestemmelse af serumelektrolytter og især kalium med henblik på at opdage elektrolytforstyrrelser, specielt hos patienter med andre risikofaktorer som nedsat nyrefunktion, behandling med andre lægemidler eller tidligere elektrolytforstyrrelser i anamnesen.
English: • fever, sore throat or mouth ulcers, more frequent infections (lack or low level of white blood cells)
Danish: • feber, ondt i halsen eller sår i munden, øget hyppighed af infektioner (manglende eller lavt antal hvide blodlegemer)
English: Fertility There are no clinical studies on fertility with Imprida HCT.
Danish: Fertilitet Der er ikke udført fertilitetsstudier med Imprida HCT.
English: if you experience dizziness and/or fainting during treatment with Imprida HCT, tell your doctor as soon as possible.
Danish: - hvis du bliver svimmel og/eller besvimer under behandlingen med Imprida HCT, skal du fortælle det til din læge med det samme.
English: You can take Imprida HCT with or without food.
Danish: - Du kan tage Imprida HCT sammen med eller uden mad.
English: The presence of valsartan in the triple combination attenuated the hypokalaemic effect of hydrochlorothiazide.
Danish: Til stedeværelsen af valsartan i trippelkombinationen mindskede den hypokaliæmiske virkning af hydrochlorthiazid.
English: Discomfort, malaise
Danish: Ubehag, utilpashed
English: It may be necessary to check the amount of potassium in your blood at regular intervals.
Danish: Det kan være nødvendigt, at din læge måler dit blods kaliumindhold med regelmæssige mellemrum.
English: Severe renal impairment (GFR <30 ml/min/1.73 m2), anuria and patients undergoing dialysis.
Danish: - Alvorligt nedsat nyrefunktion (GFR <30 ml/min/1,73 m2), anuri, og patienter i dialysebehandling.
English: Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Danish: Dosisjustering af urikosuriske lægemidler kan være nødvendig, da hydrochlorthiazid kan øge serumurinsyre.
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 fremkaldt af muligt funktionelt nyresvigt knyttet til hydrochlorthiazid.
English: • reduced appetite
Danish: • nedsat appetit
English: Hypromellose Titanium dioxide (E171) Macrogol 4000
Danish: Filmovertræk Hypromellose Titandioxid (E 171) Macrogol 4000
English: Thiazides reduce urinary calcium excretion and may cause intermittant and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Danish: Thiazider nedsætter calciumudskillelsen i urinen og kan forårsage en intermitterende og let stigning i serumcalcium uden tilstedeværelse af kendte calciummetabolismesygdomme.
English: if you have kidney problems, have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.
Danish: - hvis du har nyreproblemer, har fået en nyretransplantation eller har fået at vide, at du lider af forsnævring i nyrernes blodårer.
English: Monitoring of potassium should be undertaken as appropriate.
Danish: Monitorering af kalium bør ske efter behov.
English: Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.
Danish: - Refraktær hypokaliæmi, hyponatriæmi, hyperkalcæmi og symptomatisk hyperurikæmi.
English: • abnormal red blood cell test
Danish: • unormalt testresultat af røde blodlegemer
English: Absorption: After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6-12 hours.
Danish: Absorption: Efter oral administration af amlodipin alene i terapeutiske doser opnås maksimal plasmakoncentration af amlodipin efter 6-12 timer.
English: Valsartan and HCT
Danish: Valsartan og HCT
English: Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and
Danish: På grund af risiko for hypokaliæmi bør hydrochlorthiazid gives med forsigtighed sammen med lægemidler, der kan forårsage torsades de pointes især Klasse Ia og Klasse III antiarytmika og visse antipsykotika.
English: Imprida HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia.
Danish: Imprida HCT er kontraindiceret til patienter med hyperkalcæmi og bør kun anvendes efter korrektion af præeksisterende hyperkalcæmi.
English: Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia.
Danish: Overdosering af amlodipin kan resultere i udtalt perifer vasodilation og risiko for refleks-takykardi.
English: Elderly patients, particularly those taking the maximum dose of Imprida HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly.
Danish: Ældre patienter, især dem, der tager den højeste dosis af Imprida HCT (10 mg/320 mg/25 mg) skal regelmæssigt have deres blodtryk kontrolleret.
English: The safety profile of Imprida HCT presented below is based on clinical studies performed with Imprida HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Danish: Imprida HCT's sikkerhedsprofil, som er præsenteret herunder, er baseret på kliniske afprøvninger udført med Imprida HCT og de kendte sikkerhedsprofiler af de individuelle komponenter amlodipin, valsartan og hydrochlorthiazid.
English: Hypersensitivity to the active substances, to other sulphonamide derivatives, to dihydropyridine derivatives, or to any of the excipients.
Danish: - Overfølsomhed over for de aktive stoffer, andre sulfonamidderivater, dihydropyridinderivater eller over for et eller flere af hjælpestofferne.
English: If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of potassium plasma levels is
Danish: Hvis et lægemiddel, som påvirker kaliumniveauerne, vurderes nødvendigt i kombination med valsartan, bør kaliumindholdet i plasma jævnligt monitoreres.
English: • high level of calcium, fat or sodium in the blood
Danish: • højt indhold af calcium, fedt eller natrium i blodet
English: Uncommon • severely decreased urine output (decreased kidney function)
Danish: Ikke almindelig • meget nedsat vandladning (nedsat nyrefunktion)
English: Absorption: Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2-4 hours.
Danish: Absorption: Efter oral administration af valsartan alene opnås valsartans maksimale plasmakoncentration efter 2-4 timer.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: The amlodipine component of Imprida HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-komponenten i Imprida HCT hæmmer den transmembranale indstrømning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: Amlodipine belongs to a group of substances called “calcium channel blockers”.
Danish: - Amlodipin tilhører en gruppe stoffer, som kaldes ”calciumkanal-antagonister”.
English: Hydrochlorothiazide
Danish: Hydrochlorthiazid
English: Amlodipine stops calcium from moving into the blood vessel wall, which stops the blood vessels from tightening.
Danish: Amlodipin forhindrer calcium i at bevæge sig ind i muskelcellerne i blodårernes vægge, hvilket forhindrer, at blodårerne trækker sig sammen.
English: The combination resulted in expected reduction of red blood cell mass (erythrocytes, haemoglobin, haematocrit, and reticulocytes), increase in serum urea, increase in serum creatinine, increase in serum potassium, juxtaglomerular (JG) hyperplasia in the kidney and focal erosions in the glandular stomach in rats.
Danish: Kombinationen resulterede i en forventet reduktion af røde blodlegemer (erytrocytter, hæmoglobin, hæmatokrit og retikulocytter), stigning i serumurinstof, stigning i serumkreatinin, stigning i serumkalium, juxtaglomerulær (JG) hyperplasi i nyrerne og fokale erosioner i maveslimhinden hos rotter.
English: Treatment with hydrochlorothiazide should only be started after correction of pre-existing hyponatraemia.
Danish: Behandling med hydrochlorthiazid bør først initieres efter korrektion af allerede eksisterende hyponatriæmi.
English: The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, causing reductions in peripheral vascular resistance and in blood pressure.
Danish: Amlodipins antihypertensive virkning skyldes den direkte afslappende effekt på karvæggens glatte muskler, hvilket fører til nedsat perifer vaskulær modstand og nedsat blodtryk.
English: if you experience skin reactions such as rash after sun exposure.
Danish: - hvis du oplever hudreaktioner, som fx udslæt efter at have været i solen.
English: Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Danish: Behandling af essentiel hypertension som substitutionsbehandling til voksne patienter, hvis blodtryk er tilstrækkeligt kontrolleret med kombinationen af amlodipin, valsartan og hydrochlorthiazid (HCT), som enten tre individuelle formuleringer eller som kombinationsbehandling med to stoffer og én individuel formulering.
English: Risk factors for developing acute angle closure glaucoma may include a history of sulphonamide or penicillin allergy.
Danish: Risikofaktorer for at udvikle akut lukketvinklet glaukom kan inkludere sulfonamid- eller penicillinallergi i anamnesen.
English: Thiazide diuretics may precipitate azotaemia in patients with chronic kidney disease.
Danish: Thiaziddiuretika kan forårsage azotæmi hos patienter med kronisk nyresygdom.
English: Frequency Imprida HCT
Danish: Frekvens Imprida HCT
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget en AIIA, skal observeres nøje for hypotension (se pkt.
English: The concomitant use of CYP3A4 inducers (e.g. rifampicin, Hypericum perforatum) may give a lower plasma concentration of amlodipine.
Danish: Samtidig administration af CYP3A4-induktorer (f.eks. rifampicin, perikon) kan medføre lavere plasmakoncentration af amlodipin.
English: Information on Imprida HCT
Danish: Information om Imprida HCT
English: Abasia, gait disturbance
Danish: Abasi, gangforstyrrelse
English: Thiazide-induced hypokalaemia or hypomagnesaemia may occur as undesirable effects, favouring the onset of digitalis-induced cardiac arrhythmias.
Danish: Thiazidinduceret hypokaliæmi eller hypomagnesiæmi kan forekomme som uønskede virkninger, der kan fremprovokere digitalisinducerede hjertearytmier.
English: • low level of a certain type of white blood cell and blood platelet
Danish: • lavt antal af en bestemt type hvide blodlegemer og blodplader
English: Hypochloraemic alkalosis
Danish: Hypokloræmisk alkalose
English: Side effects reported with amlodipine or valsartan or hydrochlorothiazide alone, but not observed with Imprida HCT or observed in a higher frequency:
Danish: Bivirkninger, der er set ved brug af amlodipin, valsartan eller hydrochlorthiazid alene, men ikke ved brug af Imprida HCT eller er set med en højere hyppighed:
English: if you have liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the build up of bile in the liver (cholestasis).
Danish: - hvis du har en leversygdom, hvor de små galdegange i leveren er ødelagt (biliær cirrose), som fører til ophobning af galde i leveren (kolestase).
English: Elimination: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.
Danish: Udskillelse: Amlodipin udskilles bifasisk fra plasma med en terminal halveringstid på ca. 30 til 50 timer.
English: Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures.
Danish: Efter administration af terapeutiske doser til patienter med hypertension giver amlodipin en vasodilation, som resulterer i nedsat blodtryk i liggende og stående stilling.
English: Kidney transplantation
Danish: Nyretransplantation
English: Hypokalaemia may result in muscle spasms and or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain antiarrhythmic medicinal products.
Danish: Hypokaliæmi kan resultere i muskelkramper og/eller forstærke hjertearytmier forbundet med samtidig brug af digitalisglykosider eller visse anti-arytmiske lægemidler.
English: Medicinal products affecting serum sodium level
Danish: Lægemidler der påvirker serumnatrium
English: Other metabolic disturbances
Danish: Andre stofskifteforstyrrelser
English: The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of kaliuretic diuretics, corticosteroids, laxatives, adrenocorticotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G and salicylic acid derivatives or antiarrhythmics.
Danish: Hydrochlorthiazids hypokaliæmiske virkning kan øges af samtidig administration af kaliuretiske diuretika, kortikosteroider, laksantia, adrenokortikotrop hormon (ACTH), amphotericin, carbenoxolon, benzylpenicillin og salicylsyre-derivater eller antiarytmika.
English: The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Danish: Det er ikke fastlagt, i hvilket omfang hydrochlorthiazid kan fjernes ved hæmodialyse.
English: Linearity Amlodipine, valsartan and hydrochlorothiazide exhibit linear pharmacokinetics.
Danish: Linearitet Amlodipin, valsartan og hydrochlorthiazid udviser lineær farmakokinetik.
English: In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Danish: I et langtids-, placebo-kontrolleret studie (PRAISE-2) af amlodipin hos patienter med NYHA-klasse (New York Heart Association-klassificering) III- og IV-hjerteinsufficiens af non-iskæmisk ætiologi, blev amlodipin forbundet med øget forekomst af lungeødem.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and if appropriate, alternative therapy should be started.
Danish: Ved konstateret graviditet skal behandlingen med AIIA afbrydes med det samme, og om nødvendigt skal en anden behandling påbegyndes.