FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day.
Danish: Valsartan havde ingen ugunstige virkninger på reproduktionsevnen hos han- og hunrotter ved orale doser på op til 200 mg/kg/dag.
English: Valsartan is mostly eliminated unchanged via the bile, whereas amlodipine is extensively metabolised by the liver.
Danish: Valsartan udskilles hovedsageligt uforandret via galden, mens amlodipin i udtalt grad metaboliseres i leveren.
English: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Imprida HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).
Danish: Et statistisk signifikant større antal af patienterne opnåede blodtrykskontrol (<140/90 mmHg) med Imprida HCT (71 %) sammenlignet med hver af de tre tokombinationsbehandlinger (45-54 %) (p<0,0001).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Imprida HCT in all subsets of the paediatric population in essential hypertension.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Imprida HCT hos alle undergrupper af den pædiatriske population med essentiel hypertension (se pkt.
English: Hydrochlorothiazide crosses the placenta.
Danish: Hydrochlorthiazid krydser placenta.
English: if you have severe kidney problems or if you are having dialysis.
Danish: - hvis du har alvorlige nyrelidelser, eller hvis du er i dialysebehandling.
English: Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Danish: Valsartan er i høj grad bundet til serumproteiner (94-97 %), hovedsageligt serumalbumin.
English: Elimination: Hydrochlorothiazide is eliminated from plasma with a half-life averaging 6 to 15 hours in the terminal elimination phase.
Danish: Udskillelse: Hydrochlorthiazid elimineres fra plasma med en gennemsnitlig halveringstid på 6 til 15 timer i den terminale eliminationsfase.
English: Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
Danish: Administration af amlodipin sammen med grapefrugt eller grapefrugtjuice kan ikke anbefales, da biotilgængeligheden kan øges hos nogen patienter, hvilket kan resultere i en øget blodtrykssænkende effekt.
English: Clinical data are insufficient regarding the potential effect of amlodipine on fertility.
Danish: De kliniske data er utilstrækkelige til at afklare amlodipins potentielle virkning på fertiliteten.
English: In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or
Danish: I kliniske interaktionsstudier påvirkede amlodipin ikke farmakokinetikken af atorvastatin, digoxin, warfarin eller
English: If these medicinal products are to be prescribed with the amlodipine /valsartan /hydrochlorothiazide combination, monitoring of potassium plasma levels is advised.
Danish: Hvis disse lægemidler skal ordineres sammen med kombinationen amlodipin/valsartan/hydrochlorthiazid, tilrådes monitorering af plasmakalium-niveauer.
English: Furthermore, concomitant use of Imprida HCT and NSAIDs may lead to worsening of renal function and an increase in serum potassium.
Danish: Derudover kan samtidig brug af Imprida HCT og NSAID føre til en forværring af nyrefunktionen og en stigning i serumkalium.
English: Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
Danish: Tiden til maksimal plasmakoncentration af amlodipin er den samme for yngre og ældre patienter.
English: Absorption: The absorption of hydrochlorothiazide, after an oral dose, is rapid (Tmax about 2 hours).
Danish: Absorption: Efter en oral dosis absorberes af hydrochlorthiazid hurtigt (tmax omkring 2 timer).
English: Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to a week of treatment initiation.
Danish: Symptomerne omfatter akut nedsat syn og øjensmerter og opstår typisk inden for timer til en uge efter behandlingsstart.
English: Circulating hydrochlorothiazide is bound to serum proteins (40-70%), mainly serum albumin.
Danish: Cirkulerende hydrochlorthiazid er bundet til serumproteiner (40-70 %), hovedsagelig serumalbumin.
English: • decrease in vision or pain in your eyes due to high pressure (possible signs of acute angle closure glaucoma)
Danish: • nedsat syn eller øjensmerter på grund af højt tryk i øjet (mulige tegn på akut lukketvinklet glaukom)
English: As a result of all three mechanisms, the blood vessels relax and blood pressure is lowered.
Danish: Som et resultat af alle tre stoffers virkning, bliver blodårerne mere afslappede og blodtrykket sænkes.
English: Hyponatraemia, accompanied by neurological symptoms (nausea, progressive disorientation, apathy) has been observed.
Danish: Der er set tilfælde af hyponatriæmi, som var ledsaget af neurologiske symptomer (kvalme, progressiv desorientering, apati).
English: All changes were considered to be caused by the pharmacological action of valsartan which produces prolonged hypotension, particularly in marmosets.
Danish: Alle ændringer ansås for at være forårsaget af valsartans farmakologiske virkning, som især hos silkeaber giver forlænget hypotension.
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Fortæl din læge, hvis du ammer, eller hvis du skal starte med at amme.
English: Reproductive studies in rats and mice have shown delayed date of delivery, prolonged duration of labour and decreased pup survival at dosages approximately 50 times greater than the maximum recommended dosage for humans based on mg/kg.
Danish: Reproduktionsstudier med rotter og mus har vist forsinket fødsel, forlænget fødsel og nedsat overlevelse af afkommet ved doser ca. 50 gange højere end de maksimalt anbefalede doser til mennesker baseret på mg/kg.
English: If any of these apply to you, talk to your doctor.
Danish: Hvis noget af ovenstående gælder for dig, skal du fortælle det til din læge.
English: If excessive hypotension occurs with Imprida HCT, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Danish: Hvis der forekommer udtalt hypotension med Imprida HCT, skal patienten placeres i liggende rygstilling, og om nødvendigt skal der gives intravenøs infusion af normalt saltvand.
English: There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human dose of 10 mg on a mg/m basis).
Danish: Der sås ingen effekt på fertiliteten hos rotter behandlet med amlodipin (hanner i 64 dage og hunner i 14 dage før parring) ved doser op til 10 mg/kg/dag (8 gange* den maksimalt anbefalede dosis til mennesker på 10 mg baseret på mg/m2).
English: The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2.
Danish: Resultatet af et in vitro studie med humant levervæv indikerede, at valsartan er substrat for den hepatiske optagelsestransportør OATP1B1 og af den hepatiske effluxtransportør MRP2.
English: if you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water tablets”), especially if you suffer from asthma and allergies if you have been sick (vomiting or diarrhoea).
Danish: - hvis du har været overfølsom over for anden blodtrykssænkende medicin eller diuretika (en type medicin også kaldet ”vanddrivende tabletter”), specielt hvis du lider af astma og allergi.
English: Imprida HCT and older people (age 65 years and older) Imprida HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide.
Danish: Imprida HCT og ældre patienter (65 år og derover) Imprida HCT kan tages af patienter på 65 år og derover med samme dosis som for voksne patienter og på samme måde, som de allerede tager de tre stoffer, som kaldes amlodipin, valsartan og hydrochlorthiazid.
English: Clinically significant hypotension due to Imprida HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Danish: Klinisk signifikant hypotension pga. overdosering af Imprida HCT kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
English: Posology The recommended dose of Imprida HCT is one tablet per day, to be taken preferably in the morning.
Danish: Dosering Den anbefalede dosis af Imprida HCT er én tablet dagligt, som helst skal tages om morgenen.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended (see section 4.4).
Danish: Hvis kombinationen er en nødvendighed, anbefales tæt monitorering af lithiumniveauet i serum (se pkt.
English: In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death.
Danish: Hos patienter med alvorligt hjertesvigt, hvis nyrefunktion afhænger af renin-angiotensin-aldosteron-systemets aktivitet, er behandling med angiotensin-konverterende enzymhæmmere (ACE-hæmmere) og angiotensin-receptorantagonister blevet forbundet med oliguri og/eller progressiv azotæmi og (sjældent) med akut nyresvigt og/eller død.
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i den originale yderpakningpakning for at beskytte mod fugt.
English: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Danish: Behandling med angiotensin II-antagonister (AIIA) bør ikke påbegyndes under graviditet.
English: No information is available regarding the use of valsartan and/or amlodipine during breast-feeding.
Danish: Der foreligger ingen dokumentation vedrørende brug af valsartan og/eller amlodipin under amning.
English: In animal studies, reproductive toxicity was observed at high doses (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet ved høje doser (se pkt.
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Biotransformation: Hydrochlorothiazide is eliminated predominantly as unchanged compound.
Danish: Biotransformation: Hydrochlorthiazid udskilles hovedsagligt som uomdannet stof.
English: • medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
Danish: • medicin, som kan medføre ”torsades de pointes” (uregelmæssig hjerterytme), som fx antiarytmika (medicin, som bruges til behandling af hjerteproblemer) og visse antipsykotika;
English: if you have diabetes (high level of sugar in your blood).
Danish: - hvis du har højt blodsukker (diabetes).
English: • stomach discomfort after meal
Danish: • ubehag i maven efter et måltid
English: Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is not activated.
Danish: Patienter med primær hyperaldosteronisme bør ikke behandles med angiotensin II-antagonisten, valsartan, da deres renin-angiotensin-system er påvirket af den primære lidelse.
English: Respiratory distress, pulmonary oedema, pneumonitis
Danish: Respiratorisk distress, lungeødem, pneumonitis
English: Based on the pharmacological mechanism of action of hydrochlorothiazide, its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Danish: Baseret på hydrochlorthiazids farmakologiske virkningsmekanisme kan brug i andet og tredje trimester kompromittere den føto-placentale perfusion og forårsage føtale og neonatale effekter såsom icterus, forstyrrelse i elektrolytbalancen og trombocytopeni.
English: Pack sizes: 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
Danish: Pakningsstørrelser: 14, 28, 30, 56, 90, 98 eller 280 filmovertrukne tabletter.
English: • low blood pressure on standing up
Danish: • lavt blodtryk ved skift til stående stilling
English: • weakness, bruising, fever and frequent infections
Danish: • svaghed, blå mærker, feber og hyppige infektioner
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and hypovolaemia resulting from excessive diuresis.
Danish: Overdosering med hydrochlorthiazid er forbundet med elektrolytmangel (hypokaliæmi, hypokloræmi) og hypovolæmi, der er forårsaget af overdreven diurese.
English: To date there is no experience of the safe use of Imprida HCT in patients who have had a recent kidney transplantation.
Danish: På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Imprida HCT til patienter, som kort tid forinden har modtaget nyretransplantation.
English: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m basis) was close to the maximum tolerated dose for mice but not for rats.
Danish: Den højeste dosis (for mus lig med og for rotter 2 gange* den maksimalt anbefalede kliniske dosis på 10 mg baseret på mg/m2) var tæt på den maksimalt tolererede dosis for mus, men ikke for rotter.
English: Hypersensitivity reactions to hydrochlorothiazide are more likely in patients with allergy and asthma.
Danish: Risikoen for overfølsomhedsreaktioner over for hydrochlorthiazid er størst hos patienter med allergi eller astma.
English: Imprida HCT can be taken with or without food.
Danish: Imprida HCT kan tages sammen med eller uden mad.
English: Amlodipine bioavailability is unaffected by food ingestion.
Danish: Amlodipins biotilgængelighed er upåvirket af fødeindtagelse.
English: If any of the above applies to you, do not take Imprida HCT and talk to your doctor.
Danish: Hvis noget af ovenstående gælder for dig, må du ikke tage Imprida HCT, og du skal underrette din læge.
English: • ringing noise in ears
Danish: • ringen for ørerne
English: • severely decreased urine output (possible signs of renal disorder or renal failure)
Danish: • stærkt nedsat urinmængde (muligt tegn på nyresygdom eller nyresvigt)
English: Imprida HCT should be discontinued if hypercalcaemia develops during treatment.
Danish: Imprida HCT skal seponeres, hvis der udvikles hyperkalcæmi under behandlingen.
English: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers.
Danish: Der er rapporteret om reversible biokemiske ændringer i spermatozoers hoveder hos visse patienter, som blev behandlet med calciumantagonister.
English: The site of action of thiazide diuretics is primarily in the renal distal convoluted tubule.
Danish: Thiaziddiuretikas virkningssted er primært i de distale konvolute tubuli.
English: During repeated administration, the maximum reduction in blood pressure with any dose is generally attained within 2-4 weeks.
Danish: Ved gentagen dosering opnås den maksimale reduktion af blodtrykket normalt inden for 2-4 uger.
English: • worsening of the diabetic metabolic state
Danish: • forværring af den metaboliske tilstand ved diabetes
English: The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Danish: En sammentrækning af hjertemusklens og karvæggens glatte muskulatur er afhængig af ekstracellulære calciumioners vandring ind i disse celler gennem specifikke ionkanaler
English: In the 8-week controlled clinical study, no significant new or unexpected adverse reactions were observed with triple therapy treatment compared to the known effects of the monotherapy or dual therapy components.
Danish: I det kontrollerede kliniske forsøg af 8 ugers varighed blev der ikke set nogle nye signifikante eller uventede bivirkninger med tripelbehandlingen sammenlignet med den kendte virkning af monoterapien eller samtidig behandling med to af komponenterne.
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Du skal fortælle det til din læge, hvis du tror, du er gravid (eller planlægger at blive gravid).
English: Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”.
Danish: - Hydrochlorthiazid tilhører en gruppe stoffer, som kaldes ”thiazid-diuretika”.
English: Hydrochlorothiazide increases urine output, which also lowers blood pressure.
Danish: Hydrochlorthiazid øger udskillelsen af urin, hvilket ligeledes sænker blodtrykket.
English: This dose is 6 times the maximum recommended human dose on a mg/m basis
Danish: Denne dosis er 6 gange den maksimalt anbefalede humane dosis baseret på mg/m
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Danish: Intravenøs calciumglyconat kan være gavnlig til ophævelse af calciumkanalblokaden.
English: Imprida HCT 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 this stage (see section “Pregnancy and breastfeeding”).
Danish: Imprida HCT frarådes i den tidlige periode af graviditeten og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, da det kan forårsage alvorlig skade på dit barn, hvis det tages på dette tidspunkt (se afsnittet om ”Graviditet og amning”).
English: The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Imprida HCT are the same as when administered as individual dosage forms.
Danish: Absorptionshastigheden og absorptionsfraktionen af amlodipin, valsartan og hydrochlorthiazid fra Imprida HCT er de samme, som når de administreres som individuelle doseringer.
English: In marmosets at similar doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy which included raised urea and creatinine.
Danish: Hos silkeaber, som fik lignende doser, sås tilsvarende, men mere alvorlige ændringer, især i nyrerne, hvor der udvikledes nefropati, som omfattede forhøjet urinstof og kreatinin.
English: Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Danish: I studier med rotter og mus, der fik amlodipin i foderet i to år ved koncentrationer beregnet til at give daglige dosisniveauer på 0,5, 1,25 og 2,5 mg/kg, sås ingen tegn på karcinogenicitet.
English: Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure.
Danish: Angiotensin II produceres i kroppen og får blodårerne til at trække sig sammen, så blodtrykket øges.
English: Your doctor will normally advise you to stop taking Imprida HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Imprida HCT.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Imprida HCT, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
English: • allergic reaction including swelling deeper in the skin and difficulty breathing
Danish: • overfølsomhedsreaktion inklusive hævelse dybt i huden og vejrtrækningsbesvær
English: Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
Danish: Indgift af aktivt kul øjeblikkeligt eller op til 2 timer efter indtagelse af amlodipin har vist, at det signifikant nedsætter absorptionen af amlodipin hos raske frivillige.
English: Amlodipine
Danish: Amlodipin
English: • low blood pressure (feeling of faintness, light-headedness, sudden loss of consciousness)
Danish: • lavt blodtryk (følelse af at være ved at besvime, svimmelhed, pludselig besvimelse)
English: Imprida HCT is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Imprida HCT frarådes i den tidlige periode af graviditeten og må ikke tages, når du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på dit barn, hvis det tages efter tredje graviditetsmåned.
English: • pale skin, tiredness, breathlessness, dark-coloured urine (haemolytic anaemia, abnormal breakdown of red blood cells either in the blood vessels or elsewhere in the body)
Danish: • bleg hud, træthed, åndenød, mørkfarvet urin (hæmolytisk anæmi, unormal nedbrydning af røde blodlegemer i blodårerne eller andre steder i kroppen)
English: if you are taking medicines or substances that increase the amount of potassium in your blood.
Danish: - hvis du tager medicin eller andre stoffer, der øger indholdet af kalium i dit blod.
English: Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Danish: Markant hyperkalcæmi kan være tegn på skjult hyperparatyroidisme.
English: Amlodipine CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, ritonavir)
Danish: Amlodipin CYP3A4-hæmmere (dvs. ketoconazol, itraconazol, ritamovir)
English: • increased muscle stiffness
Danish: • øget muskelstivhed
English: No data are available on the use of Imprida HCT in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney.
Danish: Der er ingen tilgængelige data om brug af Imprida HCT til patienter med unilateral eller bilateral nyrearteriestenose eller stenose i en enkelt nyre.
English: Imprida HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single unit blisters.
Danish: Imprida HCT er tilgængelig i pakninger, der indeholder 14, 28, 30, 56, 90, 98 eller 280 filmovertrukne tabletter, i multipakninger med 280 tabletter (bestående af 4 kartoner, der hver indeholder 70 tabletter eller 20 kartoner, der hver indeholder 14 tabletter), og i hospitalspakninger med 56, 98 eller 280 tabletter i enkeltdosis-blistere.
English: Dose adjustment of the antidiabetic medicinal product may be necessary.
Danish: Det kan være nødvendigt at justere dosis af antidiabetika.
English: If photosensitivity reaction occurs during treatment with Imprida HCT, it is recommended to stop the treatment.
Danish: Hvis der opstår lysfølsomhedsreaktioner under behandlingen med Imprida HCT, anbefales det at seponere behandlingen.
English: • inability to either stand or walk in a normal manner
Danish: • svært ved at stå eller gå som normalt