FrancophonIA/ELRC3.0 huggingface dataset:
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: Patients with hepatic impairment 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: Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Danish: Yderligere kan samtidig brug af angiotensin II-antagonister og NSAID føre til øget risiko for forværring af nyrefunktionen samt en øgning af serumkalium.
English: As with all other vasodilators, special caution is indicated in patients suffering from mitral stenosis or significant aortic stenosis that is not high grade.
Danish: Som med alle andre vasodilatorer skal der udvises særlig forsigtighed hos patienter, der lider af mitralklapstenose eller signifikant aortastenose, som ikke er af høj grad.
English: The recommended dose of Dafiro is one tablet per day.
Danish: Den anbefalede dosis af Dafiro er én tablet daglig.
English: Elimination: Valsartan shows multiexponential decay kinetics (t½α <1 h and t½ß about 9 h).
Danish: Elimination: Valsartan udviser multieksponentiel halveringskinetik (t½α <1 time og t½ß omkring 9 timer).
English: if you are allergic to valsartan or any of the other ingredients of Dafiro this medicine (listed in section 6).
Danish: - hvis du er allergisk over for valsartan eller et af de øvrige indholdsstoffer i Dafiro (angivet i punkt 6).
English: if you have liver or kidney problems.
Danish: - hvis du har problemer med lever eller nyrer.
English: The antihypertensive effect of a single dose of the combination persisted for 24 hours.
Danish: Den antihypertensive virkning af en enkelt kombinationsdosis varer over 24 timer.
English: Exceptional cases of extrapyramidal syndrome have been reported.
Danish: Der er set enkelte tilfælde af ekstrapyramidale symptomer.
English: Elimination: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.
Danish: Elimination: Amlodipin udskilles bifasisk fra plasma med en terminal halveringstid på ca. 30 til 50 timer.
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 kan eksistere for denne gruppe af lægemidler.
English: If you get these symptoms, stop taking Dafiro and contact your doctor straight away.
Danish: Hvis du får disse symptomer, skal du stoppe med at tage Dafiro og kontakte din læge med det samme.
English: Stopping your treatment with Dafiro may cause your disease to get worse.
Danish: Hvis du holder op med at tage Dafiro, kan det resultere i, at din sygdom bliver værre.
English: To date there is no experience of the safe use of Dafiro in patients who have had a recent kidney transplantation.
Danish: På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Dafiro til patienter, som kort tid forinden har modtaget nyretransplantation.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Danish: Valsartan bindes ikke til og blokerer ikke andre hormonreceptorer eller ionkanaler, der vides at have betydning for den kardiovaskulære regulering.
English: Do not take Dafiro if you are allergic to amlodipine or to any other calcium channel blockers.
Danish: Tag ikke Dafiro - hvis du er allergisk over for amlodipin eller andre calciumantagonister.
English: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue, has been reported in patients treated with valsartan.
Danish: Angioødem, herunder opsvulmning af larynx og glottis, som forårsager luftvejsobstruktion, og/eller hævelse af ansigt, læber, svælg og/eller tunge er blevet rapporteret hos patienter i behandling med valsartan.
English: * Mostly consistent with cholestasis
Danish: * Oftest som følge af kolestase
English: Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination.
Danish: Det anbefales at foretage individuel dosistitrering med de enkelte komponenter (dvs. amlodipin og valsartan), inden der skiftes til den faste kombination.
English: No drug-drug interaction studies have been performed with Dafiro and other medicinal products.
Danish: Der er ikke udført lægemiddelinteraktionsstudier med Dafiro og andre lægemidler.
English: 70 film-coated tablets.
Danish: 70 filmovertrukne tabletter.
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Medmindre fortsat behandling med AIIA vurderes til at være nødvendig, bør patienter, som planlægger at blive gravide, skiftes til en alternativ hypertensionsbehandling med en dokumenteret sikkerhedsprofil til brug ved graviditet.
English: if you have had heart failure or have experienced a heart attack.
Danish: - hvis du har haft hjertesvigt eller et hjerteanfald.
English: Amlodipine (mg)
Danish: Amlodipin (mg)
English: It acts selectively on the receptor subtype AT1, which is responsible for the known actions of angiotensin II.
Danish: Det virker selektivt på AT1-receptor subtypen, som er ansvarlig for angiotensin II's kendte virkninger.
English: 14 film-coated tablets.
Danish: 14 filmovertrukne tabletter.
English: Your doctor will normally advise you to stop taking Dafiro before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Dafiro.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Dafiro, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
English: Insomnia/sleep disorders
Danish: Insomni/søvnforstyrrelser
English: Dafiro 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 skal anvendes med forsigtighed v ed behandling af hypertension hos patienter med unilateral eller bilateral nyrearteriestenose eller stenose i en enkelt nyre, da blod-urea og serum-kreatinin kan stige hos disse patienter.
English: Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Danish: Calciumantagonister, herunder amlodipin, skal anvendes med forsigtighed til patienter med kongestiv hjerteinsufficiens, da de kan øge risikoen for fremtidige kardiovaskulære hændelser og død.
English: Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Danish: Amlodipin er undersøgt til patienter med kronisk stabil angina, vasospastisk angina og angiografisk dokumenteret koronarterielidelse.
English: Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Danish: Data fra dyrestudier tyder på, at amlodipin binder til både dihydropyridin og ikkedihydropyridin-bindingssteder.
English: Toxic Epidermal Necrolysis
Danish: Toksisk epidermal nekrolyse
English: If any of these cause you problems or if they last for more than one week, you should contact your doctor.
Danish: Hvis de bliver generende eller varer i mere end 1 uge, skal du kontakte lægen.
English: There is no experience of overdose with Dafiro.
Danish: Der er ingen erfaring med overdosering af Dafiro.
English: The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/valsartan combination.
Danish: Den gennemsnitlige incidens af perifert ødem fordelt ligeligt over alle doser var 5,1% med amlodipin/valsartan kombinationen.
English: If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Danish: Hvis dobbelthæmmende behandling anses for absolut nødvendig, bør dette kun ske under supervision af en speciallæge og under tæt monitorering af patientens nyrefunktion, elektrolytter og bloktryk.
English: The rate and extent of absorption of Dafiro are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Danish: Hastigheden og graden af Dafiro-absorptionen er ækvivalent med valsartans og amlodipins biotilgængelighed, når de gives som individuelle tabletter.
English: if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).
Danish: - hvis din læge har fortalt dig, at du har en forsnævring af hjerteklappen (kaldes ”aorta- eller mitralklapstenose”) eller at du har en unormal fortykkelse af hjertemusklen (kaldes ”obstruktiv hypertrofisk kardiomyopati”).
English: During repeated administration, the maximum reduction in blood pressure with any dose is generally attained within 2-4 weeks and is sustained during long-term therapy.
Danish: Ved gentagen dosering opnås den maksimale reduktion af blodtrykket inden for 2-4 uger, og den opretholdes ved vedvarende behandling.
English: PVC/PVDC perforated unit dose blisters.
Danish: PVC/PVDC perforeret enkeltdosisblister.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget en AIIA skal observeres tæt for hypotension (se pkt.
English: Consult a doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine: - Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing.
Danish: Kontakt straks lægen, hvis du får nogle af nedenstående meget sjældne bivirkninger: - Pludselig åndenød, brystsmerter, kortåndethed eller besvær med at trække vejret.
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: VA NEPHROND was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.
Danish: VA NEPHRON-D var et studie med patienter med type 2-diabetes mellitus og diabetisk nefropati.
English: • Haemodynamically unstable heart failure after acute myocardial infarction.
Danish: • Hæmodynamisk ustabil hjerteinsufficiens efter akut myokardieinfarkt.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, combinations; angiotensin II antagonists and calcium channel blockers, ATC code: C09DB01
Danish: Farmakoterapeutisk klassifikation: Midler der virker på renin-angiotensin-systemet; angiotensin-IIantagonister, kombinationer; angiotensin-II-antagonister og calciumkanal-blokkere, ATC-kode: C09DB01
English: Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events.
Danish: Pludselig seponering af valsartan har ikke været forbundet med rebound-hypertension eller andre uønskede kliniske hændelser.
English: Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Dafiro as well, even if not observed in clinical trials or during the post-marketing period.
Danish: Bivirkninger, som tidligere er indrapporteret for hver enkelt af de individuelle komponenter (amlodipin eller valsartan), kan også være potentielle bivirkninger med Dafiro, selv i de tilfælde, hvor de ikke er set i kliniske studier eller i perioden efter markedsføring.
English: Patients with high cardiovascular risks - heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one yearwere excluded.
Danish: Patienter med høje kardiovaskulære risici - hjertesvigt, type I- og dårligt kontrolleret type II-diabetes og en historie med myokardieinfarkt eller slagtilfælde inden for det sidste år - blev ekskluderet.
English: Adults with mild to moderate uncomplicated essential hypertension (mean sitting diastolic blood pressure 95 and <110 mmHg) were enrolled.
Danish: Voksne med let til moderat ukompliceret essentiel hypertension (middel siddende diastolisk blodtryk ≥95 og <110 mmHg) blev inkluderet.
English: Cellulose microcrystalline Crospovidone (type A) Silica, colloidal anhydrous Magnesium stearate
Danish: Cellulose, mikrokrystallinsk Crospovidon (type A) Silica, kolloid vandfri Magnesiumstearat
English: Peripheral oedema, a recognised side effect of amlodipine, was generally observed at a lower incidence in patients who received the amlodipine/valsartan combination than in those who received amlodipine alone.
Danish: Perifert ødem, en kendt bivirkning ved amlodipin, blev generelt observeret ved en lavere incidens hos patienter, som fik amlodipin/valsartan kombinationen end hos patienter, som fik amlodipin alene.
English: The half life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage 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: If hypotension occurs with Dafiro, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Danish: Hvis der forekommer hypotension med Dafiro, skal patienten placeres i liggende rygstilling, og om nødvendigt skal der gives intravenøs infusion af isotonisk natriumchlorid.
English: Dafiro combines two 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.
Danish: Dafiro kombinerer to antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: amlodipin tilhører klassen kaldet calciumantagonister og valsartan tilhører klassen kaldet angiotensin II-antagonister.
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 ACE-hæmmer eller en ARBer hos patienter med type 2-diabetes mellitus og kronisk nyresygdom, kardiovaskulær sygdom eller begge.
English: Dafiro was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Danish: Dafiro er også undersøgt i et aktivt kontrolleret studie med 130 hypertensive patienter med middel siddende diastolisk blodtryk ≥110 mmHg og <120 mmHg.
English: At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males.
Danish: Ved højere eksponering blev der set sårdannelse og erosion af maveslimhinden hos både han- og hunrotter.
English: Clinically significant hypotension due to Dafiro 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 med Dafiro kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
English: Very limited clinical data are available regarding amlodipine administration in patients with hepatic impairment.
Danish: Der er meget få tilgængelige kliniske data vedrørende amlodipin-administration til patienter med nedsat leverfunktion.
English: Dafiro tablets contain two substances called amlodipine and valsartan.
Danish: Dafiro tabletter indeholder to stoffer, som kaldes amlodipin og valsartan.
English: Patients taking Dafiro and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Danish: Patienter, som fører motorkøretøj eller betjener maskiner under behandling med Dafiro, skal være opmærksomme på, at der lejlighedsvis kan optræde svimmelhed eller træthed.
English: Amlodipine has been shown to pass into breast milk in small amounts.
Danish: Amlodipin har vist sig at udskilles i modermælk i små mængder.
English: For the single compounds there was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Danish: For de enkelte stoffer er der ingen evidens for mutagenicitet, clastogenicitet eller carcinogenicitet.
English: Frequency Dafiro Amlodipine Valsartan
Danish: Frekvens Dafiro Amlodipin Valsartan
English: Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin.
Danish: Valsartan hæmmer ikke ACE, også kendt som kininase II, som omdanner angiotensin I til angiotensin II og nedbryder bradykinin.
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for de aktive stoffer, over for dihydropyridinderivater eller over for et eller flere af hjælpestofferne anført i pkt.
English: Arrhythmias (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Danish: Arytmi (inklusive bradykardi, ventrikulær takykardi og atrieflimmer)
English: This means that both of these substances help to stop the blood vessels tightening.
Danish: Dette betyder, at begge stoffer forhindrer blodårerne i at trække sig sammen.
English: If you think you may be allergic, talk to your doctor before taking Dafiro.
Danish: Hvis du tror, du er allergisk, skal du tale med din læge, inden du tager Dafiro.
English: Following oral administration of Dafiro, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Danish: Efter oral administration af Dafiro opnås maksimal plasmakoncentration for valsartan og amlodipin efter henholdsvis 3 timer og 6-8 timer.
English: Amlodipine/Valsartan
Danish: Amlodipin/valsartan
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: The safety and efficacy of amlodipine in hypertensive crisis have not been established.
Danish: Amlodipins sikkerhed og effekt ved hypertensiv krise er ikke klarlagt.
English: In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.
Danish: I kliniske interaktionsstudier påvirkede amlodipin ikke farmakokinetikken af atorvastatin, digoxin, warfarin eller ciclosporin.
English: - Swelling of the tongue and throat which causes great difficulty breathing.
Danish: - Hævelse af tunge eller svælg, hvilket kan gøre det meget svært at trække vejret.
English: Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia.
Danish: Overdosering med amlodipin kan resultere i udtalt perifer vasodilation og risiko for refleks-takykardi.
English: • Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Danish: • Andet og tredje trimester af graviditet (se pkt.
English: 320 mg/day and a 60-kg patient).
Danish: 320 mg/dag til en patient, der vejer 60 kg).
English: In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Danish: I kliniske studier, hvor amlodipin blev givet i kombination med betablokkere til patienter med enten hypertension eller angina, er der ikke set bivirkninger på de elektrokardiografiske parametre.
English: No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat nyrefunktion (GFR >30 ml/min/1,73 m2).
English: Amlodipine and valsartan exhibit linear pharmacokinetics.
Danish: Amlodipin og valsartan udviser lineær farmakokinetik.
English: Multipack: 280 (4 packs of 70) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Danish: Multipakning: 280 (4 pakninger med 70) filmovertrukne tabletter Multipakning: 280 (20 pakninger med 14) filmovertrukne tabletter
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Giv din læge besked, hvis du ammer, eller hvis du skal starte med at amme.
English: Pack sizes: 56, 98 or 280 film-coated tablets.
Danish: Pakningsstørrelser: 56, 98 eller 280 filmovertrukne tabletter.
English: The major symptom of overdose with valsartan is possibly pronounced hypotension with dizziness.
Danish: Det væsentligste symptom på overdosering med valsartan er risikoen for udtalt hypotension med svimmelhed.
English: Abdominal discomfort, abdominal pain upper
Danish: Abdominalt ubehag, øvre abdominalsmerter
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs attenuation of the antihypertensive effect may occur.
Danish: Non-steroid-anti-inflammatorisk medicin (NSAID), inklusive selektive COX-2 hæmmere, acetylsalicylsyre (>3 g/dag) og ikke-selektive NSAID Når angiotensin II-antagonister gives samtidig med NSAID, kan der opstå svækkelse af den antihypertensive virkning.
English: The effect of amlodipine on infants is unknown.
Danish: Amlodipins virkning på spædbørn er ikke kendt.
English: Intrahepatic cholestasis, jaundice
Danish: Intrahepatisk kolestase, gulsot
English: All packs are available with standard blisters; the 56, 98 and 280 tablet packs are additionally available with perforated unit dose blisters.
Danish: Alle pakninger er tilgængelig i standard blisterstrips; desuden er 56, 98 og 280 tabletpakningerne også tilgængelig med perforeret enkeltdosisblister.
English: Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication particularly with strong CYP3A4 inducers (e.g. rifampicin, hypericum perforatum).
Danish: Blodtrykket skal derfor overvåges, og dosisjustering overvejes, både under og efter samtidig administration af andre lægemidler især kraftige CYP3A4-inducerende stoffer (fx rifampicin, perikon).