FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) 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: Hæmmere af optagelsestransportøren (rifampicin, ciclosporin) eller effluxtransportøren (ritonavir) 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: 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: Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.
Danish: Almindelige anvendte antihypertensive stoffer (f.eks. alfablokkere, diuretika) og andre lægemidler, som kan forårsage hypotensive bivirkninger (f.eks. tricykliske antidepressiva, alfablokkere til behandling af benign prostata hyperplasi) kan øge kombinationens antihypertensive virkning.
English: Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Danish: Samtidig administration af lægemidler, som hæmmer optagelsestransportøren (rifampicin, ciclosporin) eller effluxtransportøren (ritonavir) kan øge den systemiske eksponering for valsartan.
English: Dafiro is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Danish: Dafiro er tilgængelig i pakninger indholdende 7, 14, 28, 30, 56, 90, 98 eller 280 tabletter og multipakninger, bestående af 4 kartoner med hver 70 tabletter, eller 20 kartoner med hver 14 tabletter.
English: Talk to your doctor before taking Dafiro: if you have been sick (vomiting or diarrhoea).
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Dafiro: - hvis du har været syg (opkastning eller diarré).
English: The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
Danish: Niveauet for ingen observerede bivirkninger (NOEL) på den føtale udvikling er set ved 3 (valsartan) og 4 (amlodipin) gange den kliniske eksponering (baseret på AUC).
English: Gingival hyperplasia
Danish: Gingival hyperplasi
English: If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Danish: Hvis der i kombination med valsartan udskrives et lægemiddel, som påvirker kaliumniveauet, bør kaliumindholdet i plasma monitoreres.
English: Confusion.
Danish: Konfusion.
English: Not known Toxic Epidermal Necrolysis * mostly consistent with cholestasis
Danish: Toksisk epidermal nekrolyse *oftest som følge af kolestase.
English: If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Danish: Hos patienter, der tager amlodipin, og som får bivirkninger som svimmelhed, hovedpine, træthed eller kvalme, kan reaktionsevnen blive påvirket.
English: In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with 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 ACE-hæmmere og angiotensin-receptorantagonister blevet forbundet med oliguri og/eller progressiv azotæmi og (sjældent) med akut nyresvigt og/eller død.
English: The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5%), type 2 diabetes (36.1%), high density lipoprotein - cholesterol <35 mg/dl or <0.906 mmol/l (11.6%), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9%), current cigarette smoking (21.9%).
Danish: Patienterne havde mindst én ekstra risikofaktor for koronar hjertelidelse fx tidligere myokardieinfarkt eller apopleksi (>6 måneder før inkludering) eller dokumenteret anden aterosklerotisk kardiovaskulær sygdom (tilsammen 51,5%), type 2-diabetes (36,1%), HDL-kolesterol <35 mg/dl (<0,906 mmol/l) (11,6%), venstre ventrikel-hypertrofi diagnosticeret ved elektrokardiogram eller ekkokardiografi (20,9%), aktuel cigaretrygning (21,9%).
English: Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young therefore caution is required when increasing the dosage.
Danish: Middel systemisk AUC af valsartan er 70% højere hos ældre end hos yngre.
English: ACE inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy.
Danish: ACE-hæmmere og ARBer bør ikke anvendes samtidigt hos patienter med diabetisk nefropati.
English: The safety and efficacy of Dafiro in children aged below 18 years have not been established.
Danish: Pædiatrisk population Dafiros sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
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: Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Danish: Der har været indrapporteret blodtrykspåvirkninger spændende fra udtalt og potentielt langvarigt systemisk hypotension til og inklusive shock med dødelig udgang.
English: Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans.
Danish: Amlodipin ændrer ikke sinusknudefunktionen eller den atrioventrikulære overledning hos levende dyr eller hos mennesker.
English: There are no available clinical data in severely renally impaired patients.
Danish: Der er ingen tilgængelige kliniske data fra patienter med alvorligt nedsat nyrefunktion.
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase 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 med øget glomerulær filtrationshastighed og effektivt renal plasma flow, uden ændring i filtrationsfraktionen eller proteinuri.
English: if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Danish: - hvis du har sukkersyge eller nedsat nyrefunktion, og du også tager et blodtrykssænkende lægemiddel, der indeholder aliskiren.
English: Heart failure/post-myocardial infarction
Danish: Hjertesvigt/post-myokardieinfarkt
English: Non cardiac chest pain
Danish: Ikke hjertebetinget brystsmerte
English: The combination of amlodipine and valsartan produces dose-related additive reduction in blood pressure across its therapeutic dose range.
Danish: Kombinationen af amlodipin og valsartan giver et dosisrelateret, additivt blodtryksfald i hele det terapeutiske dosisinterval.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan..
Danish: Der er rapporteret reversibelt forhøjede serumkoncentrationer og toksicitet af lithium ved administration af lithium sammen med angiotensin-konverteringsenzym (ACE)-hæmmere eller angiotensin II-antagonister, inklusive valsartan.
English: Caution required with concomitant use
Danish: Forsigtighed ved samtidig brug
English: if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors).
Danish: - hvis du har oplevet opsvulmen, særligt af ansigtet og halsen, mens du har taget anden medicin (inklusive ACE-hæmmere).
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 muskel, hvilket fører til nedsat perifer vaskulær modstand og nedsat blodtryk.
English: In elderly patients, caution is required when increasing the dosage.
Danish: Derfor kræves forsigtighed, når dosis øges.
English: Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (heparin, etc.) should be undertaken with caution and with frequent monitoring of potassium levels.
Danish: Samtidig brug af kaliumtilskud, kaliumbesparende diuretika, kaliumholdige salterstatninger eller anden medicin, som øger indholdet af kalium (heparin osv.), skal foretages med forsigtighed og under hyppig monitoriering af kaliumniveauet.
English: Interactions linked to valsartan
Danish: Interaktioner forbundet med valsartan
English: Esteve Pharmaceuticals, S.A. Tel: +34 93 446 60 00
Danish: Laboratorios Dr. Esteve, S.A. Tel: +34 93 446 60 00
English: The amlodipine component of Dafiro inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-delen af Dafiro hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: Summary of the safety profile
Danish: Resumé af bivirkningsprofilen
English: What Dafiro contains
Danish: Dafiro indeholder:
English: Monitoring of potassium levels and creatinine is advised in moderate renal impairment.
Danish: Det tilrådes at monitorere kaliumniveauet og kreatinin ved moderat nedsat nyrefunktion.
English: In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p <0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9%, respectively).
Danish: I kliniske studier, hvor valsartan blev sammenlignet med en ACE-hæmmer, var incidensen af tør hoste signifikant (p <0,05) mindre hos patienter i behandling med valsartan end hos patienter i behandling med en ACE-hæmmer (2,6% versus 7,9%, henholdsvis).
English: If any of the above applies to you, do not take Dafiro and talk to your doctor.
Danish: Hvis noget af ovenstående gælder for dig, må du ikke tage Dafiro, og du skal kontakte din læge.
English: There is evidence that the concomitant use of ACE inhibitors, ARBs or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Danish: Der er tegn på, at samtidig brug af ACE-hæmmere og ARBer eller aliskiren øger risikoen for hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt).
English: If any of these affect you severely, tell your doctor.
Danish: Hvis nogle af disse bivirkninger påvirker dig i alvorlig grad, skal du tale med din læge.
English: Other: dual blockade of the renin-angiotensin-aldosterone system (RAAS) Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an ARB.
Danish: Andet: dobbeltblokade af renin-anfiotensin-aldosteronsystemet (RAAS) Kombinationen af en ACE-hæmmer og en ARB er undersøgt i to store randomiserede, kontrollerede studier (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) og VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)).
English: Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Danish: Grundet risiko for hyperkaliæmi anbefales det, at samtidig indgift af calciumantagonister, såsom amlodipin, undgås hos patienter mistænkt for eller i behandling for malign hypertermi.
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 rapportering af pulmonært ødem.
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.
English: Exfoliative dermatitis
Danish: Eksfoliativ dermatitis
English: If you forget to take this medicine, take it as soon as you remember.
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 dit sædvanlige tidspunkt.
English: Hyperhidrosis
Danish: Hyperhidrose
English: Side effects reported with amlodipine or valsartan alone and either not observed with Dafiro or observed with a higher frequency than with Dafiro:
Danish: Bivirkninger, som er rapporteret ved behandling med valsartan og amlodipin alene, og som enten ikke er set ved behandling med Dafiro, eller som er set hyppigere end ved behandling med Dafiro:
English: A randomised double-blind morbidity-mortality study called the Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACEinhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild to moderate hypertension.
Danish: Et randomiseret, dobbeltblindet morbiditets-mortalitets studie kaldet ”Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial” (ALLHAT) blev gennemført for at sammenligne nye behandlinger: Amlodipin 2,5-10 mg/dag (calciumantagonist) eller lisinopril 10-40 mg/dag (ACEhæmmer) som førstevalgsbehandling i stedet for et thiaziddiuretikum, chlorthalidon 12,5-25 mg/dag ved let til moderat hypertension.
English: Valsartan has been studied in patients with post myocardial infarction and heart failure.
Danish: Valsartan er undersøgt til patienter med post-myokardieinfarkt og hjertesvigt.
English: As with other calcium channel blockers, haemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume.
Danish: Som med andre calciumantagonister har hæmodynamiske studier af hjertefunktionen i hvile og ved fysisk aktivitet (eller vedvarende aktivitet) hos patienter med normal ventrikelfunktion og i behandling med amlodipin, generelt vist en lille forøgelse i hjerteindekset uden signifikant indflydelse på dP/dt eller venstre ventrikels slutdiastoliske tryk eller volumen.
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Dafiro containing the same component doses.
Danish: Patienter, som får valsartan og amlodipin fra hver sin tablet/kapsel, kan for nemhedens skyld skifte til Dafiro med den samme dosis af hver komponent.
English: As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Danish: Som konsekvens af hæmningen af renin-angiotensin-aldosteron-systemet kan der sandsynligvis forekomme ændringer i nyrefunktionen hos særligt udsatte patienter.
English: However, there was no significant difference in all-cause mortality between amlodipine-based therapy and chlorthalidone-based therapy RR 0.96 95% CI [0.89-1.02] p=0.20.
Danish: Der var dog ingen signifikant forskel på mortalitet af alle årsager mellem amlodipin-baseret behandling og chlorthalidon-baseret behandling, RR 0,96; 95% KI [0,89-1,02]; p=0,20.
English: If you forget to take Dafiro
Danish: Hvis du har glemt at tage Dafiro
English: Common Common
Danish: Almindelig Almindelig
English: In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Danish: Der er ikke fundet klinisk signifikante interaktioner mellem valsartan monoterapi og følgende stoffer: cimetidin, warfarin, furosemid, digoxin, atenolol, indometacin, hydrochlorthiazid, amlodipin og glibenclamid.
English: In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene.
Danish: Hos dyr er der set letal ventrikelflimren og kardiovaskulært kollaps i forbindelse med hyperkaliæmi efter indgift af verapamil og dantrolen i.v.
English: if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.
Danish: - hvis du har fået en nyretransplantation, eller hvis du har fået at vide, at du har en forsnævring i blodtilførslen til nyrerne.
English: If you stop taking Dafiro
Danish: Hvis du holder op med at tage Dafiro
English: - Inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling of being very unwell.
Danish: - Betændelse i bugspytkirtlen, som kan give stærke smerter i maven og ryggen og få dig til at føle dig meget utilpas.
English: The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Danish: Brug af AIIA er kontraindiceret under andet og tredje trimester af graviditeten (se pkt.
English: There was no significant difference in the primary endpoint between amlodipine-based therapy and chlorthalidone-based therapy: risk ratio (RR) 0.98 95% CI (0.90-1.07) p=0.65.
Danish: Der var ingen signifikant forskel mellem amlodipin-baseret behandling og chlorthalidon-baseret behandling på det primære endepunkt: Risikoratio (RR) 0,98; 95% KI (0,90-1,07); p=0,65.
English: Pack sizes: 7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets and multipacks containing 280 (4x70 or 20x14) film-coated tablets.
Danish: Pakningsstørrelser: 7, 14, 28, 30, 56, 90, 98 eller 280 filmovertrukne tabletter og multipakninger, der indeholder 280 (4x70 eller 20x14) filmovertrukne tabletter.
English: In marmosets at comparable doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy including raised blood urea nitrogen and creatinine.
Danish: Hos silkeaber, som fik sammenlignelige doser, sås tilsvarende, men mere alvorlige ændringer, især i nyrerne, hvor der udvikledes nefropati, omfattende forhøjet carbamid og kreatinin.
English: Amlodipine can have mild or moderate influence on the ability to drive and use machines.
Danish: Amlodipin kan påvirke evnen til at føre motorkøretøj eller betjene maskiner i mindre til moderat grad.
English: • Concomitant use of Dafiro with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: • Samtidig brug af Dafiro og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: Det frarådes at bruge angiotensin II-antagonister (AIIA) under første trimester af graviditet (se pkt.
English: Amlodipine belongs to a group of substances called “calcium channel blockers”.
Danish: - Amlodipin tilhører en gruppe stoffer, som kaldes ”calcium-antagonister”.
English: • Severe hepatic impairment, biliary cirrhosis or cholestasis.
Danish: • Alvorligt nedsat leverfunktion, biliær cirrhose eller kolestase.
English: Confusion
Danish: Konfusion
English: Particular caution should be exercised when administering Dafiro to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Danish: Der bør udvises særlig forsigtighed, når Dafiro gives til patienter med let til moderat nedsat leverfunktion eller biliære obstruktive lidelser.
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Dafiro in placebo-controlled studies.
Danish: Under placebokontrollerede studier blev der set udtalt hypotension hos 0,4% af patienterne med ukompliceret hypertension, som blev behandlet med Dafiro.
English: Hepatic impairment Dafiro is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Nedsat leverfunktion Dafiro er kontraindiceret hos patienter med alvorligt nedsat leverfunktion (se pkt.
English: The addition of valsartan 160 mg produced an additional reduction in systolic/diastolic blood pressure of 2.9/2.1 mmHg compared to patients who remained on amlodipine 10 mg only.
Danish: Tillæg af valsartan 160 mg gav et yderligere nedsat systolisk/diastolisk blodtryk på henholdsvis 2,9/2,1 mmHg sammenlignet med patienter, som forblev på amlodipin 10 mg alene.
English: Other possible side effects of Dafiro:
Danish: Andre bivirkninger ved brug af Dafiro
English: What you need to know before you take Dafiro
Danish: Det skal du vide, før du begynder at tage Dafiro
English: Common Somnolence, dizziness, palpitations, abdominal pain, nausea, ankle swelling.
Danish: Almindelig Døsighed, svimmelhed, palpitationer, abdominalsmerter, kvalme, hævede ankler.
English: Caution should be exercised in patients with liver disease (see section 4.2).
Danish: Der skal udvises forsigtighed over for patienter med leverlidelser (se pkt.
English: ACE inhibitors and ARBs should therefore not be used concomitantly in patients with diabetic nephropathy (see section 4.4).
Danish: ACE-hæmmere og ARBer bør derfor ikke anvendes samtidigt hos patienter med diabetisk nefropati (se pkt.
English: 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. enalapril, lisinopril, ramipril), især hvis du har nyreproblemer i forbindelse med sukkersyge); aliskiren.