FrancophonIA/ELRC3.0 huggingface dataset:
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 some antipsychotics.
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: There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Danish: Der har været isolerede rapporter om hæmolytisk anæmi, som er opstået ved samtidig brug af hydrochlorthiazid og methyldopa.
English: Approximate size: 15 mm (length) x 5.9 mm (width).
Danish: Størrelse: ca. 15 mm (længde) x 5,9 mm (bredde).
English: Biotransformation Hydrochlorothiazide is eliminated predominantly as unchanged compound.
Danish: Biotransformation Hydrochlorthiazid udskilles hovedsagligt som uomdannet stof.
English: • simvastatin (a medicine used to control high cholesterol levels);
Danish: • simvastatin (medicin som bruges til at behandle højt kolesterol);
English: Dafiro HCT can be taken with or without food.
Danish: Dafiro HCT kan tages sammen med eller uden mad.
English: • medicines to increase blood pressure such as adrenaline or noradrenaline;
Danish: • medicin, som bruges til at øge blodtrykket som fx adrenalin eller noradrenalin;
English: The absorption of hydrochlorothiazide, after an oral dose, is rapid (Tmax about 2 hours).
Danish: Efter en oral dosis absorberes af hydrochlorthiazid hurtigt (tmax omkring 2 timer).
English: If Dafiro HCT is used during breast-feeding, doses should be kept as low as possible.
Danish: Hvis Dafiro HCT anvendes under amning, bør dosis holdes så lav som muligt.
English: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dose recommendations have not been established.
Danish: Halveringstiden af amlodipin er forlænget og AUC større hos patienter med nedsat leverfunktion; der kan ikke gives nogen anbefaling vedrørende dosering.
English: There is no experience on the use of Dafiro HCT in pregnant women.
Danish: Der er ingen erfaringer med brug af Dafiro HCT til gravide kvinder.
English: Dafiro 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 perforated dose blisters.
Danish: Dafiro 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 perforerede enkeltdosis-blistere.
English: • medicines that may reduce the amount of sodium in your blood, such as antidepressants,
Danish: • medicin, som kan nedsætte mængden af natrium i dit blod, såsom antidepressiva, antopsykotika,
English: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Dafiro 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 Dafiro HCT (71 %) sammenlignet med hver af de tre tokombinationsbehandlinger (45-54 %) (p<0,0001).
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an ARB in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Danish: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) var et studie, der skulle undersøge fordelen ved at tilføje aliskiren til standardbehandling med en ACEhæmmer eller en ARB hos patienter med type 2-diabetes mellitus og kronisk nyresygdom, kardiovaskulær sygdom eller begge.
English: if you are taking any of the following medicines used to treat high blood pressure: an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Danish: - hvis du samtidig tager et af følgende lægemidler til behandling af for højt blodtryk: en ACE-hæmmer (f.eks. enelapril, lisinopril, ramipril), især, hvis du har nyreproblemer i forbindelse med sukkersyge aliskiren.
English: Furthermore, concomitant use of Dafiro HCT and NSAIDs may lead to worsening of renal function and an increase in serum potassium.
Danish: Derudover kan samtidig brug af Dafiro HCT og NSAID føre til en forværring af nyrefunktionen og en stigning i serumkalium.
English: Clinically significant hypotension due to Dafiro 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 Dafiro HCT kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
English: antipsychotics, antiepileptics;
Danish: antiepileptika;
English: • digoxin or other digitalis glycosides (medicines used to treat heart problems);
Danish: • digoxin og andre digitalisglykosider (medicin, som bruges til behandling af hjerteproblemer);
English: • muscle relaxants (medicines to relax the muscles which are used during operations);
Danish: • muskelrelaksantia (medicin, som bruges under operationer til at afslappe musklerne);
English: Dafiro HCT should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Danish: Dafiro HCT skal anvendes med forsigtighed ved behandling af hypertension hos patienter med unilateral eller bilateral nyrearteriestenose eller stenose i en enkelt nyre, da blod-urea og serumkreatinin kan stige hos disse patienter.
English: Elderly people (age 65 years and older)
Danish: Ældre (65 år og derover)
English: You can take Dafiro HCT with or without food.
Danish: - Du kan tage Dafiro HCT sammen med eller uden mad.
English: Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Danish: Data fra dyrestudier antyder, at amlodipin binder til både dihydropyridin og ikke- dihydropyridinbindingssteder.
English: Dafiro HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Danish: Dafiro HCT skal seponeres straks hos patienter, som udvikler angioødem, og behandlingen bør ikke genoptages.
English: Approximate size: 19 mm (length) x 7.5 mm (width).
Danish: Størrelse: ca. 19 mm (længde) x 7,5 mm (bredde).
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 studie 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: 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 hypotension.
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: Talk to your doctor or pharmacist before taking Dafiro HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
Danish: Kontakt lægen eller apotekspersonalet, før du tager Dafiro HCT - hvis du har et lavt niveau af kalium eller magnesium i blodet (med eller uden symptomer som fx muskelsvaghed, muskelkramper, unormal hjerterytme).
English: • dantrolene (infusion for severe body temperature abnormalities);
Danish: • dantrolen (infusion ved alvorligt forhøjet kropstemperatur);
English: • amantadine (anti-Parkinson therapy, also used to treat or prevent certain illnesses caused by viruses);
Danish: • amantadin (medicin til behandling af Parkinsons sygdom, bruges også til behandling af eller for at undgå visse virus-infektioner);
English: Based on the existing data with the components, the use of Dafiro 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 Dafiro HCT ikke under første trimester og er kontraindiceret i graviditetens andet og tredje trimester.
English: These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin;
Danish: Dette omfatter kaliumtilskud eller salterstatninger, der indeholder kalium, kaliumbesparende medicin og heparin;
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, other combinations, ATC code: C09DX01.
Danish: Farmakoterapeutisk klassifikation: Præparater der virker på renin-angiotensin systemet, angiotensin IIantagonister, andre kombinationer, ATC-kode: C09DX01.
English: • swelling of eyelids, face or lips
Danish: • hævede øjenlåg, ansigt eller læber
English: Stopping your treatment with Dafiro HCT may cause your disease to get worse.
Danish: Hvis du holder op med at tage Dafiro HCT, kan det resultere i, at din sygdom bliver værre.
English: Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Dafiro HCT.
Danish: Da thiazider nedsætter den renale clearance, kan risikoen for lithium-toksicitet muligvis være yderligere øget med Dafiro HCT.
English: To date there is no experience of the safe use of Dafiro HCT in patients who have had a recent kidney transplantation.
Danish: På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Dafiro HCT til patienter, som kort tid forinden har modtaget nyretransplantation.
English: The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Dafiro HCT are the same as when administered as individual dosage forms.
Danish: Absorptionshastigheden og absorptionsfraktionen af amlodipin, valsartan og hydrochlorthiazid fra Dafiro HCT er de samme, som når de administreres som individuelle doseringer.
English: Non-steroidal antiinflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), acetylsalicylic acid (>3 g/day), and nonselective NSAIDs
Danish: Non-steroid-antiinflammatorisk medicin (NSAID), inklusive selektive cyclooxygenase2-hæmmere (COX-2hæmmere), acetylsalicylsyre (>3 g/dag) og ikkeselektive NSAID
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 let 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: Patients taking hydrochlorothiazide should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions.
Danish: Patienter, der tager hydrochlorthiazid, skal informeres om risikoen for non-melanom hudkræft og have at vide, at de skal tjekke deres hud regelmæssigt for nye læsioner og straks kontakte lægen, hvis de observerer mistænkelige hudlæsioner.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Dafiro HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Dafiro HCT i alle undergrupper af den pædiatriske population med essentiel hypertension (se pkt.
English: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.
Danish: Amlodipin udskilles bifasisk fra plasma med en terminal halveringstid på ca. 30 til 50 timer.
English: Circulating hydrochlorothiazide is bound to serum proteins (40-70%), mainly serum albumin.
Danish: Cirkulerende hydrochlorthiazid er bundet til serumproteiner (4070 %), hovedsagelig serumalbumin.
English: Dafiro HCT should be discontinued if hypercalcaemia develops during treatment.
Danish: Dafiro HCT skal seponeres, hvis der udvikles hyperkalcæmi under behandlingen.
English: • ACE inhibitors or aliskiren -(see also information under the headings “Do not take Dafiro HCT” and “Warnings and precautions”) .
Danish: • ACE-hæmmere eller aliskiren (se også information under overskrifterne ”Tag ikke Dafiro HCT”
English: • cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
Danish: • cytotoksisk medicin (anvendes til behandling af kræft), som fx methotrexat eller cyclophosphamid;
English: Your doctor will normally advise you to stop taking Dafiro HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Dafiro HCT.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Dafiro HCT, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
English: Dafiro 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: Dafiro 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: In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Dafiro HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Dafiro 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 (Dafiro HCT), var der ikke bevis for systemisk toksicitet eller toksicitet i målorganet, der skadelig kunne påvirke udviklingen af Dafiro HCT til kliniske studier med mennesker.
English: • medicines that may increase blood sugar levels (beta blockers, diazoxide);
Danish: • medicin, som kan øge blodsukkeret (betablokkere, diazoxid);
English: if the level of calcium in your blood is too high despite treatment to reduce the calcium levels in your blood.
Danish: - hvis mængden af calcium i dit blod er højere end normalt, selvom du er i behandling for at nedsætte mængden af calcium i dit blod.
English: If you get these symptoms, stop taking Dafiro HCT and contact your doctor straight away.
Danish: Hvis du får disse symptomer, skal du stoppe med at tage Dafiro HCT og kontakte din læge med det samme.
English: Pain in extremity
Danish: Smerte i ekstremiteterne
English: • disorders combining rigidity, tremor and/or movement disorders
Danish: • en tilstand med stivhed, rysten og/eller bevægelsesforstyrrelser
English: Medicinal products used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol)
Danish: Lægemidler, der anvendes til behandling af arthritis urica (probenecid, sulfinpyrazon og allopurinol)
English: Following oral administration of Dafiro 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 Dafiro 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: The side effects reported with Dafiro HCT or one of its three active substances (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur with the use of Dafiro HCT.
Danish: De indberettede bivirkninger med Dafiro HCT eller en af dens tre aktive stoffer (amlodipin, valsartan og hydrochlorthiazid) er anført nedenfor og kan forekomme ved brug af Dafiro HCT.
English: • rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
Danish: • rifampicin (bruges fx til behandling af tuberkulose); erythromycin, clarithromycin (antibiotika)
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100000 mg) (see also section 4.4).
Danish: Der blev påvist en kumulativ dosis/respons relation med en justeret OR-værdi på 2,1 (95 % KI: 1,7-2,6), der steg til OR 3,9 (3,04,9) ved et stort forbrug (~25.000 mg) og OR 7,7 (5,7-10,5) ved den højeste kumulative dosis (~100.000 mg) (se også pkt.
English: Dafiro HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia.
Danish: Dafiro HCT er kontraindiceret til patienter med hyperkalcæmi og bør kun anvendes efter korrektion af præeksisterende hyperkalcæmi.
English: If photosensitivity reaction occurs during treatment with Dafiro HCT, it is recommended to stop the treatment.
Danish: Hvis der opstår lysfølsomhedsreaktioner under behandlingen med Dafiro HCT, anbefales det at seponere behandlingen.
English: Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2% versus 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001).
Danish: Blandt de sekundære endepunkter var incidensen af hjertesvigt (del af et sammensat kardiovaskulært endepunkt) signifikant højere i amlodipin-gruppen sammenlignet med chlorthalidon-gruppen (10,2 % versus 7,7 %; RR 1,38; 95 % KI [1,25-1,52]; p <0,001).
English: Haemodynamically unstable heart failure after acute myocardial infarction.
Danish: - Hæmodynamisk ustabil hjerteinsufficiens efter akut myokardieinfarkt.
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Dafiro HCT were dizziness and hypotension (0.7%).
Danish: De mest almindelige årsager til, at behandlingen blev afbrudt, var i dette kontrollerede kliniske studie med Dafiro HCT svimmelhed og hypotension (0,7 %).
English: Pressor amines (e.g. noradrenaline, adrenaline)
Danish: Karkontraherende aminer (fx noradrenalin, adrenalin)
English: • decreased number of white blood cells
Danish: • nedsat antal hvide blodlegemer
English: Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis).
Danish: - Obstruktion af venstre ventrikels udløb (f.eks. obstruktiv hypertrofisk kardiomyopati og udtalt aortastenose).
English: If any of the above applies to you, do not take Dafiro HCT and talk to your doctor.
Danish: Hvis noget af ovenstående gælder for dig, må du ikke tage Dafiro HCT, og du skal tale med din læge.
English: Elderly patients, particularly those taking the maximum dose of Dafiro 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 Dafiro HCT (10 mg/320 mg/25 mg) skal regelmæssigt have deres blodtryk kontrolleret.
English: Dafiro HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances.
Danish: Dafiro HCT bruges til at behandle forhøjet blodtryk hos voksne patienter, hvis blodtryk allerede er kontrolleret med amlodipin, valsartan og hydrochlorthiazid, og som kan drage fordel af at tage én tablet, som indeholder alle tre stoffer.
English: The safety profile of Dafiro HCT presented below is based on clinical studies performed with Dafiro HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Danish: Dafiro HCT's sikkerhedsprofil, som er præsenteret herunder, er baseret på kliniske afprøvninger udført med Dafiro HCT og de kendte sikkerhedsprofiler af de individuelle komponenter amlodipin, valsartan og hydrochlorthiazid.
English: The amlodipine component of Dafiro HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-komponenten i Dafiro HCT hæmmer den transmembranale indstrømning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of potassium plasma levels is advised.
Danish: Hvis et lægemiddel, som påvirker kaliumniveauerne, vurderes nødvendigt i kombination med valsartan, bør kaliumindholdet i plasma jævnligt monitoreres.
English: Due to the hydrochlorothiazide component, Dafiro HCT is contraindicated in symptomatic hyperuricaemia.
Danish: På grund af indholdet af hydrochlorthiazid er Dafiro HCT kontraindiceret ved symptomatisk hyperurikæmi.
English: There is no experience of overdose with Dafiro HCT.
Danish: Der er ingen erfaring med overdosering af Dafiro HCT.
English: Hypokalaemia may result in muscle spasms and or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Danish: Hypokaliæmi kan resultere i muskelkramper og/eller forstærke hjertearytmier forbundet med samtidig brug af digitalisglykosider eller visse anti-arytmiske lægemidler.
English: Dafiro HCT combines three antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines and hydrochlorothiazide belongs to the thiazide diuretics class of medicines.
Danish: Dafiro HCT kombinerer tre antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: amlodipin tilhører klassen kaldet calciumantagonister, valsartan tilhører klassen kaldet angiotensin II-antagonister og hydrochlorthiazid tilhører klassen kaldet thiazid-diuretika.
English: • medicines for the treatment of diabetes (oral agents such as metformin or insulins);
Danish: • medicin til behandling af sukkersyge (diabetes mellitus) (oral medicin, såsom metformin eller insulin);
English: 70x1 film-coated tablets.
Danish: 70x1 filmovertrukne tabletter.