FrancophonIA/ELRC3.0 huggingface dataset:
English: When driving vehicles or using machines it should be taken into account that occasionally dizziness or weariness may occur.
Danish: Når man fører motorkøretøjer eller betjener maskiner, skal man være opmærksom på, at der lejlighedsvis kan optræde svimmelhed eller træthed.
English: D-90429 Nürnberg Germany
Danish: D-90429 Nürnberg Tyskland
English: if you suffer from a disease called systemic lupus erythematosus (also called “lupus” or “SLE”).
Danish: - hvis du lider af sygdommen systemisk lupus erythematosus (også kaldet ”lupus” eller ”SLE”).
English: The increase in mean AUC is linear and dose proportional in the therapeutic range.
Danish: Stigningen i middel-AUC er lineær og proportional med dosis i det terapeutiske område.
English: Therefore, Imprida HCT is not recommended in this population.
Danish: Imprida HCT anbefales derfor ikke til denne population.
English: If you experience this symptom, do not drive or use tools or machines.
Danish: Hvis du oplever dette symptom, må du ikke køre bil eller betjene maskiner.
English: Amlodipine Grapefruit or grapefruit juice
Danish: Amlodipin Grapefrugt eller grapefrugtjuice
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelsen (Modul 1.8.1), er på plads og fungerer, før og mens produktet markedsføres.
English: One blister contains 7, 10 or 14 film-coated tablets.
Danish: Én blister indeholder 7, 10 eller 14 filmovertrukne tabletter.
English: • sugar in the urine
Danish: • sukker i urinen
English: As with many other medicines used to treat high blood pressure, this medicine may make you feel dizzy.
Danish: Som megen anden medicin, der bruges til behandling af forhøjet blodtryk, kan denne medicin få dig til at føle svimmelhed.
English: Known interactions with the following agents
Danish: Kendte interaktioner med følgende stoffer
English: In vitro studies with amlodipine have shown that approximately 97.5% of circulating drug is bound to plasma proteins.
Danish: In vitro-studier med amlodipin har vist, at ca. 97,5 % af det cirkulerende stof er bundet til plasmaproteiner.
English: This is especially important if you are using any of the medicines listed below:
Danish: Dette gælder især, hvis du tager medicin, som er anført herunder:
English: Primary hyperaldosteronism
Danish: Primær hyperaldosteronisme
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.
English: Mean absolute bioavailability is 23%.
Danish: Den gennemsnitlige absolutte biotilgængelighed er 23 %.
English: if you experience a decrease in vision or eye pain.
Danish: - hvis du oplever nedsat syn eller øjensmerter.
English: If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Danish: Hvis genoptagelse af behandling med diuretika skønnes nødvendig, anbefales det at beskytte eksponerede områder mod sol og kunstig UVA.
English: Distribution: Volume of distribution is approximately 21 l/kg.
Danish: Distribution: Fordelingsvolumen er omkring 21 l/kg.
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Danish: En hydroxymetabolit er blevet fundet i plasma ved lave koncentrationer (mindre end 10 % af valsartans AUC).
English: Caution required with concomitant use
Danish: Forsigtighed er påkrævet ved samtidig brug
English: Prompt medical or surgical treatment may need to be considered if the intraocular pressure remains uncontrolled.
Danish: Det kan være nødvendigt at overveje prompte medicinsk eller kirurgisk behandling, hvis det intraokulære tryk ikke kommer under kontrol.
English: This reduction in AUC is not, however, accompanied by a clinically significant reduction in the therapeutic effect, and valsartan can therefore be given either with or without food.
Danish: Denne reduktion af AUC er dog ikke ledsaget af klinisk signifikant nedsat terapeutisk effekt, og valsartan kan derfor gives med eller uden føde.
English: Not all pack sizes may be available in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført i dit land.
English: However, it is important to take into account that Imprida HCT may increase the hypotensive effect of other antihypertensive agents.
Danish: Det er imidlertid vigtigt at tage i betragtning, at Imprida HCT kan øge den hypotensive virkning af andre antihypertensive stoffer.
English: The most common signs and symptoms of overdose are nausea and somnolence.
Danish: De mest almindelige tegn og symptomer på overdosering er kvalme og døsighed.
English: The dose of Imprida HCT should be based on the doses of the individual components of the combination at the time of switching.
Danish: Doseringen af Imprida HCT skal baseres på doserne af de individuelle komponenter i kombinationen ved tidspunktet for omskiftningen.
English: if you have high levels of cholesterol or triglycerides in your blood.
Danish: - hvis du har et højt niveau af kolesterol eller triglycerider i blodet.
English: It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects.
Danish: Det er meget vigtigt, at du tager denne medicin nøjagtigt efter lægens anvisninger, hvis du vil opnå det bedste resultat og mindske risikoen for bivirkninger.
English: Very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000, not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Imprida HCT was studied in a double-blind, active controlled study in hypertensive patients.
Danish: Imprida HCT er blevet undersøgt i et dobbeltblindet, aktivt-kontrolleret studie hos hypertensive patienter.
English: Alcohol, barbiturates or narcotics
Danish: Alkohol, barbiturater og narkosemidler
English: • sad mood (depression)
Danish: • nedtrykthed (depression)
English: The renal clearance is composed of passive filtration and active secretion into the renal tubule.
Danish: Renal clearance består af passiv filtration og aktiv sekretion i de renale tubuli.
English: Renal dysfunction
Danish: Renal dysfunktion
English: Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus.
Danish: Amlodipin bør kun anvendes under graviditet, hvis der ikke findes et mere sikkert alternativ, og hvis selve sygdommen indebærer en større risiko for moderen og for fosteret.
English: Valsartan is an orally active, potent and specific angiotensin II receptor antagonist.
Danish: Valsartan er en oral, aktiv, potent og specifik angiotensin II-receptorantagonist.
English: Vitamin D and calcium salts
Danish: • D-vitamin og calciumsalte.
English: Before switching to Imprida HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Danish: Inden skift til Imprida HCT skal patienter være kontrolleret på stabile doser af monokomponenterne taget på samme tid.
English: Hydrochlorothiazide also accumulates in erythrocytes at approximately 3 times the level in plasma.
Danish: Hydrochlorthiazid akkumuleres også i erytrocytter, hvor niveauet af det er ca. 3 gange højere end i plasma.
English: OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Danish: YDERKARTON TIL MULTIPAKNING (MED BLUE BOX)
English: Like all medicines, Imprida HCT can cause side effects, although not everybody gets them.
Danish: Imprida HCT kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Thiazides should be discontinued before carrying out tests for parathyroid function.
Danish: Thiazider bør seponeres før udførelse af test for parathyreoidea-funktion.
English: Valsartan works by blocking the effect of angiotensin II.
Danish: Valsartan virker ved at blokere effekten af angiotensin II.
English: A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use.
Danish: En vasokonstriktor kan være gavnlig til genoprettelse af vaskulær tonus og blodtryk, forudsat at anvendelsen ikke er kontraindiceret.
English: If you forget to take a dose of this medicine, take it as soon as you remember and then take the next dose at its usual time.
Danish: Hvis du glemmer at tage din medicin, skal du tage den, så snart du kommer i tanke om det. Du skal tage din næste dosis på det sædvanlige tidspunkt.
English: Distribution: The apparent volume of distribution is 4-8 l/kg.
Danish: Distribution: Distributionsvolumenet er 4-8 l/kg.
English: It acts selectively on the receptor subtype AT1, which is responsible for the known actions of angiotensin II.
Danish: Den virker selektivt på AT1-receptor-subtypen, som er ansvarlig for angiotensin II's kendte virkninger.
English: Despite the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended.
Danish: Til trods for manglende erfaring med samtidig brug af valsartan og lithium frarådes denne kombination.
English: The usual dose of Imprida HCT is one tablet per day.
Danish: Den sædvanlige dosis af Imprida HCT er én tablet daglig.
English: The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Danish: Den primære behandling er seponering af hydrochlorthiazid så hurtigt som muligt.
English: Biotransformation: Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
Danish: Biotransformation: Amlodipin bliver i udstrakt grad (ca. 90 %) metaboliseret i leveren til inaktive metabolitter.
English: The use of Imprida HCT in children and adolescents under 18 years of age is not recommended.
Danish: Brug af Imprida HCT til børn og unge under 18 år frarådes.
English: It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine.
Danish: Det anbefales at begrænse dosis af simvastatin til 20 mg dagligt til patienter, som er i behandling med amlodipin.
English: Hypromellose Macrogol 4000
Danish: Filmovertræk Hypromellose Macrogol 4000
English: • urination at night
Danish: • vandladning om natten
English: Distribution: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Danish: Distribution: Steady-state fordelingsvolumen af valsartan efter intravenøs administration er omkring 17 liter, hvilket tyder på, at valsartan ikke fordeles i udtalt grad i væv.
English: Plasma concentrations correlate with effect in both young and elderly patients.
Danish: Plasmakoncentrationen korrelerer med virkningen hos både yngre og ældre patienter.
English: Do not take Imprida HCT with grapefruit or grapefruit juice.
Danish: Tag ikke Imprida HCT sammen med grapefrugt eller grapefrugtjuice.
English: Thiazides in high doses causing intense diuresis can inhibit milk production.
Danish: Thiazider i høje doser, der forårsager intens diurese, kan hæmme mælkeproduktionen.
English: Biotransformation: Valsartan is not transformed to a high extent as only about 20% of dose is recovered as metabolites.
Danish: Biotransformation: Valsartan omdannes ikke i stor grad, da kun omkring 20 % af dosis genfindes som metabolitter.
English: Some of these substances could interact with the hydrochlorothiazide component of Imprida HCT (see interactions related to HCT).
Danish: Nogle af disse substanser kan interagere med hydrochlorthiazidkomponenten i Imprida HCT (se interaktioner relateret til HCT)
English: • crushing/tight chest pain that gets worse or that does not go away
Danish: • trykkende/strammende brystsmerter, der bliver værre eller ikke går væk
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Danish: Erfaringerne med hydrochlorthiazid under graviditet, særligt i første trimester, er begrænsede.
English: Co-administration of multiple doses of 10 mg amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Danish: Samtidig administration af multiple doser af 10 mg amlodipin sammen med 80 mg simvastatin har resulteret i en 77% stigning i eksponeringen for simvastatin sammenlignet med simvastatin alene.
English: Using other medicines
Danish: Brug af anden medicin
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Imprida HCT.
Danish: Dette kan være symptomer på øget tryk i øjet og kan opstå inden for timer eller en uge efter indtagelse af Imprida HCT.
English: Ten per cent of original amlodipine and 60% of amlodipine metabolites are excreted in urine.
Danish: Ti procent uomdannet amlodipin og 60 % af amlodipin-metabolitterne udskilles i urinen.
English: MedDRA System Organ Class
Danish: Systemorganklasser i henhold til MedDRA
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Limited data suggest that the systemic clearance of hydrochlorothiazide is reduced in both healthy and hypertensive elderly subjects compared to young healthy volunteers.
Danish: Begrænsede data tyder på, at hydrochlorthiazids systemiske clearance er nedsat hos både raske og hypertensive ældre patienter sammenlignet med unge, raske frivillige.
English: • changes in blood tests for kidney function, increase of potassium in your blood, low level of red blood cells
Danish: • ændringer i blodprøveværdier for nyrefunktionen, forhøjet kaliumindhold i dit blod, lavt indhold af røde blodlegemer
English: Conversely, it is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazide-type diuretics.
Danish: Omvendt forventes det, at prokinetiske stoffer som cisaprid kan nedsætte biotilgængeligheden af thiaziddiuretika.
English: There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Danish: Der foreligger ingen data vedrørende virkningen af CYP3A4-induktorer på amlodipin.
English: The amlodipine/valsartan/hydrochlorothiazide combination was not tested for genotoxicity or carcinogenicity as there was no evidence of any interaction between these substances, which have been on the market for a long time.
Danish: Kombinationen af amlodipin/valsartan/hydrochlorthiazid blev ikke testet for genotoksicitet eller carcinogenicitet, da der ikke var evidens for interaktioner mellem disse stoffer, der har været på markedet længe.
English: There is no change in the kinetics of hydrochlorothiazide on repeated dosing, and accumulation is minimal when dosed once daily.
Danish: Der er ingen ændring i hydrochlorthiazids kinetik efter gentagen dosering, og akkumulationen er minimal ved daglig dosering.
English: Thiazides may alter glucose tolerance.
Danish: Thiazider kan ændre glucosetolerancen.
English: Systemic exposure to valsartan is slightly elevated in the elderly as compared to the young, but this has not been shown to have any clinical significance.
Danish: Systemisk eksponering af valsartan er lettere forhøjet hos ældre sammenlignet med yngre patienter, men dette har ikke vist at have nogen klinisk betydning.
English: Hypertrophy of the renal juxtaglomerular cells was also seen in both species.
Danish: Hypertrofi i de renale juxtaglomerulære celler sås også hos begge arter.
English: Elimination: Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug.
Danish: Udskillelse: Valsartan udskilles primært i fæces (omkring 83 % af dosis) og i urin (omkring 13 % af dosis) hovedsageligt som uomdannet stof.
English: Mutagenicity studies revealed no drug related effects at either the gene or chromosome levels.
Danish: Mutagenicitetsstudier viste ingen lægemiddelrelaterede virkninger på hverken gen- eller kromosomniveau.
English: PVC/PVDC perforated unit dose blisters for hospital use:
Danish: Perforerede PVC/PVDC-enkeltdosisblister til hospitalsbrug:
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Danish: Der er ingen kontrollerede epidemiologiske data angående risikoen ved brug af angiotensin II-antagonister (AIIA), men lignende risici eksisterer muligvis for denne gruppe af lægemidler.
English: Carcinogenesis, mutagenesis
Danish: Karcinogenicitet, mutagenicitet
English: This could result in sub-therapeutic effects of thiazide diuretics.
Danish: Dette kan resultere i en sub-terapeutisk effekt af thiaziddiuretika.
English: The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Imprida HCT.
Danish: Den fulde blodtrykssænkende effekt blev opnået 2 uger efter, at patienterne fik den maksimale dosis af Imprida HCT.
English: As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
Danish: Som det forventes for stoffer, hvor den renale udskillelse kun står for 30 % af den totale plasmaudskillelse, er der ikke set korrelation mellem nyrefunktion og valsartans systemiske eksponering.
English: The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc.
Danish: Den hyponatriæmiske virkning af diuretika kan forstærkes ved samtidig administration af lægemidler som antidepressiva, antipsykotika, antiepileptika osv.
English: • low level of blood platelets (sometimes with bleeding or bruising underneath the skin)
Danish: • lavt antal blodplader (sommetider med blødning eller blå mærker under huden)
English: Do not use any Imprida HCT pack that is damaged or shows signs of tampering.
Danish: Brug ikke pakninger med Imprida HCT, som er beskadiget eller viser tegn på at have været forsøgt åbnet.
English: Other possible side effects of Imprida HCT: Common
Danish: Andre mulige bivirkninger ved Imprida HCT: Almindelig:
English: If Imprida HCT is used during breast-feeding, doses should be kept as low as possible.
Danish: Hvis Imprida HCT anvendes under amning, bør dosis holdes så lav som muligt.
English: Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance).
Danish: Efter intravenøs administration er valsartans plasmaclearence omkring 2 l/t og dets renale clearence er 0,62 l/t (ca. 30 % af den totale clearence).
English: • increased sensitivity of skin to sun
Danish: • øget hudfølsomhed over for sol
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: KARTON TIL DELPAKNING (UDEN BLUE BOX)
English: These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data
Danish: Disse bivirkninger kan forekomme med bestemte hyppigheder, som er defineret på denne måde: Meget almindelig: forekommer hos flere end 1 ud af 10 patienter Almindelig: forekommer hos mellem 1 og 10 ud af 100 patienter Ikke almindelig: forekommer hos mellem 1 og 10 ud af 1.000 patienter Sjælden: forekommer hos mellem 1 og 10 ud af 10.000 patienter Meget sjælden: forekommer hos færre end 1 ud af 10.000 patienter Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data.
English: NSAIDS can attenuate the antihypertensive effect of both angiotensin II antagonists and hydrochlorothiazide when administered simultaneously.
Danish: NSAID kan svække den antihypertensive virkning af både angiotensin-II antagonister og hydrochlorthiazid, når de administreres samtidigt.
English: Do not use Imprida HCT after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke Imprida HCT efter den udløbsdato, der står på pakningen og blisteren efter ”Udløbsdato/EXP”.
English: (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Danish: (beregninger antager en oral dosis på 320 mg/dag og en patient på 60 kg).
English: Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Danish: Data fra dyreforsøg antyder, at amlodipin binder til både dihydropyridin og ikkedihydropyridin-bindingssteder.
English: Caution should be exercised in patients who have shown prior hypersensitivity to other angiotensin II receptor antagonists.
Danish: Der skal udvises forsigtighed hos patienter, der tidligere har udvist overfølsomhed over for andre angiotensin II-antagonister.
English: However, staggering the dosage of hydrochlorothiazide and resin such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins would potentially minimise the interaction.
Danish: Forskydning af doseringen af hydrochlorthiazid og anionbytter således, at hydrochlorthiazid gives mindst 4 timer før eller 4-6 timer efter indgift af anionbytter kan dog muligvis minimere interaktionen.
English: There is no experience on the use of Imprida HCT in pregnant women.
Danish: Der er ingen erfaringer med brug af Imprida HCT til gravide kvinder.
English: However, amlodipine, valsartan and hydrochlorothiazide have been tested individually for genotoxicity and carcinogenicity with negative results.
Danish: Amlodipin, valsartan og hydrochlorthiazid er dog blevet testet individuelt for genotoksicitet og carcinogenicitet med negative resultater.
English: Adverse reactions were generally mild and transient in nature and only infrequently required discontinuation of therapy.
Danish: Bivirkningerne var generelt af mild og forbigående karakter og krævede kun i sjældne tilfælde afbrydelse af behandlingen.
English: • spontaneous bleeding
Danish: • spontan blødning
English: Film-coated tablet (tablet)
Danish: Filmovertrukket tablet (tablet)
English: Alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Alternative behandlinger med bedre dokumenterede sikkerhedsprofiler ved amning er at foretrække, især ved amning af et nyfødt spædbarn eller et for tidligt født spædbarn.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere information om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http:/www.ema.europa.eu
English: Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40-60% in AUC.
Danish: Patienter med nedsat leverfunktion har nedsat udskillelse af amlodipin, hvilket medfører et øget AUC på ca. 40-60 %.
English: Not known • stiff limbs and trembling hands
Danish: Ikke kendt: • stivhed i benene og skælvende hænder
English: The safety of amlodipine in human pregnancy has not been established.
Danish: Sikkerheden af amlodipin under graviditet er ikke klarlagt.
English: Serum levels of calcium should be periodically monitored during treatment with thiazides.
Danish: Serumcalcium bør monitoreres regelmæssigt under behandling med thiazider.