FrancophonIA/ELRC3.0 huggingface dataset:
English: The most important serious side effects are liver problems and thromboembolic complications (problems with clots in blood vessels).
Danish: De vigtigste alvorlige bivirkninger er leverproblemer og tromboemboliske komplikationer (problemer med blodpropper i blodkarrene).
English: The most common side effects with Revolade in adults with ITP (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea and abnormal blood levels of certain liver enzymes.
Danish: De hyppigste bivirkninger ved Revolade hos voksne med ITP (som optræder hos mere end 1 ud af 10 personer) er kvalme, diarré og et unormalt højt indhold af visse leverenzymer i blodet.
English: This study lasted 13 weeks and looked at the proportion of patients whose platelet count had increased to at least 50,000 per microlitre for at least 6 out of 8 weeks, between week 5 to 12 of the study in the absence of rescue medication.
Danish: Dette studie varede 13 uger og så nærmere på den andel af patienter, som havde et blodpladetal, der var steget til mindst 50.000 pr. mikroliter i mindst seks ud af otte uger i den studieperiode, der omfattede uge 5-12, uden redningsmedicin.
English: • primary immune thrombocytopenia (ITP), a disease in which the patient's immune system destroys platelets (components in the blood that help it to clot).
Danish: • primær immuntrombocytopeni (ITP), som er en tilstand, hvor patientens immunsystem ødelægger blodplader (bestanddele i blodet, som er vigtige for blodets evne til at størkne).
English: How is Revolade used?
Danish: Hvordan anvendes Revolade?
English: The dose depends on the patient's age and the disease for which Revolade is being used; it is adjusted as needed to maintain the appropriate platelet level.
Danish: Dosis afhænger af patientens alder og den sygdom, som Revolade bruges som behandling for.
English: In patients with thrombocytopenia and advanced chronic hepatitis C who are treated with interferon and Revolade, the most common side effects include headache, anaemia (low red blood cell counts), decreased appetite, cough, nausea, diarrhoea, high levels of bilirubin in the blood, hair loss, itching, muscle pain, fever, tiredness, flu-like illness, weakness, chills and swelling (because of build-up of water in the body).
Danish: Hos patienter med trombocytopeni og fremskreden kronisk hepatitis C, som behandles med interferon og Revolade, er de hyppigste bivirkninger bl.a. hovedpine, anæmi (et lavt antal røde blodlegemer), nedsat appetit, hoste, kvalme, diarré, høje niveauer af bilirubin i blodet, hårtab, kløe, muskelsmerter, feber, træthed, influenzalignende sygdom, svaghed, kulderystelser og hævelse (på grund af ophobning af vand i kroppen).
English: In children with ITP, the most common side effects include nose and throat infection, cough, fever, pain in the belly or in the mouth and throat, toothache and runny nose.
Danish: Hos børn med ITP er de hyppigste bivirkninger bl.a. næse- og halsinfektioner, hoste, feber, smerter i maven eller i munden og halsen, tandpine og løbende næse.
English: How does Revolade work?
Danish: Hvordan virker Revolade?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revolade have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Revolade.
English: In adults with severe aplastic anaemia the most common side effects include headache, dizziness, cough, pain in the belly or in the mouth and throat, nausea, diarrhoea, joint pain, pain in limbs, tiredness, fever and abnormal blood levels of certain liver enzymes.
Danish: Hos voksne med svær aplastisk anæmi er de hyppigste bivirkninger bl.a. hovedpine, svimmelhed, hoste, smerter i maven eller i munden og halsen, kvalme, diarré, ledsmerter, smerter i lemmerne, træthed, feber og et unormalt højt indhold af visse leverenzymer i blodet.
English: It is preferable to take your medicine at the same time each day.
Danish: - Det er at foretrække at tage din medicin på samme tidspunkt hver dag.
English: Date of first authorisation: 16 January 2007 Date of latest renewal: 21 November 2011
Danish: Dato for første markedsføringstilladelse: 16. januar 2007 Dato for seneste fornyelse: 21. november 2011
English: In some cases you may have to stop taking one of the medicines.
Danish: I nogle tilfælde kan det være nødvendigt at stoppe med at tage noget af medicinen.
English: There were only modest signs of maternal toxicity (moderate reduction of body weight) in this study.
Danish: Der var kun beskedne tegn på maternel toksicitet (moderat nedsættelse af kropsvægt) i dette studie.
English: Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
Danish: Afhængigt af hvordan du reagerer på behandlingen, kan lægen foreslå en højere eller lavere dosering.
English: Dantrolene (infusion)
Danish: Dantrolen (infusion)
English: Do not stop taking your medicine unless your doctor tells you to.
Danish: Stop ikke med at tage din medicin, medmindre din læge siger det.
English: This will help you get the best results and lower the risk of side effects.
Danish: Det vil hjælpe dig med at opnå den bedste virkning og mindske risikoen for bivirkninger.
English: See also information under the heading “Do not take Dafiro”.
Danish: Se også information under overskriften ”Tag ikke Dafiro”.
English: Distribution: Volume of distribution is approximately 21 l/kg.
Danish: Fordeling: Fordelingsvolumen er omkring 21 l/kg.
English: This medicine may make you feel dizzy.
Danish: Denne medicin kan få dig til at føle svimmelhed.
English: D-90429 Nuremberg Germany
Danish: D-90429 Nürnberg Tyskland
English: if you have severe low blood pressure (hypotension).
Danish: - hvis du har meget lavt blodtryk (hypotension).
English: In two long-term follow-up studies the effect of Dafiro was maintained for over one year.
Danish: I to langtids-og opfølgningsstudier blev effekten af Dafiro opretholdt i over et år.
English: A total of 33,357 hypertensive patients aged 55 or older were randomised and followed for a mean of 4.9 years.
Danish: I alt 33.357 hypertensive patienter på 55 år eller ældre blev randomiseret og fulgt i gennemsnitligt 4,9 år.
English: A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people).
Danish: Nogle få patienter har oplevet nedenstående alvorlige bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer).
English: It is recommended to take Dafiro with some water.
Danish: Det anbefales at tage Dafiro med lidt vand.
English: So, if you are not sure how this medicine will affect you, do not drive, use machinery, or do other activities that you need to concentrate on.
Danish: Hvis du ikke er sikker på, hvordan denne medicin påvirker dig, må du ikke køre bil, betjene maskiner eller udføre andre aktiviteter, som kræver din koncentration.
English: Mean absolute bioavailability is 23%.
Danish: Den gennemsnitlige absolutte biotilgængelighed er 23%.
English: Your doctor may need to change your dose and/or to take other precautions.
Danish: Det er muligt, at lægen er nødt til at ændre din dosis og/eller tage andre forholdssregler.
English: Dafiro with food and drink
Danish: Dafiro sammen med mad og drikke
English: You should never take Dafiro again.
Danish: Du bør aldrig tage Dafiro igen.
English: Treatment can be continued once blood pressure has been stabilised.
Danish: Behandlingen kan fortsættes, når blodtrykket igen er blevet stabiliseret.
English: Both of these substances help to control high blood pressure.
Danish: Begge disse stoffer hjælper med at kontrollere højt blodtryk.
English: Thrombocytopenia, sometimes with purpura
Danish: Trombocytopeni, sommetider med purpura
English: Rare (may affect up to 1 in 1,000 people): Confusion.
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer): Forvirring.
English: • Shock (including cardiogenic shock).
Danish: • Shock, herunder kardiogent shock.
English: Stevens-Johnson syndrome
Danish: Stevens-Johnsons syndrom -
English: Peripheral neuropathy, neuropathy
Danish: Perifer neuropati, neuropati
English: % of patients who experienced peripheral oedema
Danish: % patienter, som oplevede perifert ødem
English: Your doctor may also check your kidney function.
Danish: Lægen vil muligvis også undersøge din nyrefunktion.
English: Grapefruit or grapefruit juice
Danish: Grapefrugt eller grapefrugtjuice
English: Absolute bioavailability has been calculated as between 64% and 80%.
Danish: Den absolutte biotilgængelighed er beregnet til at være mellem 64% og 80%.
English: Similar outcomes have been reported with valsartan.
Danish: Tilsvarende udfald er blevet rapporteret med valsartan.
English: Novartis Farmacéutica SA Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
Danish: Novartis Farmacéutica SA Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spanien
English: Placebo-controlled trials
Danish: Placebokontrollerede studier
English: Paediatric population (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Danish: Pædiatrisk population (under 18 år) Der er ingen farmakokinetiske data tilgængelige for den pædiatriske population.
English: Dafiro is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Dafiro frarådes i den tidlige periode af graviditeten (de første 3 måneder), og må ikke tages, hvis du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på din baby, hvis det tages efter tredje måned af graviditeten.
English: The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3-7%, with a maximum of 15%.
Danish: Den andel af moderens dosis, der overføres til spædbarnet, er blevet estimeret til at ligge i et interkvartilområdet på 3-7% med et maksimum på 15%.
English: Use in patients with hypertension
Danish: Anvendelse til patienter med hypertension
English: Additional information on the individual components
Danish: Yderligere information om de individuelle komponenter
English: MedDRA System organ class
Danish: MedDRA organklasse
English: PVC/PVDC blisters.
Danish: PVC/PVDC blister.
English: However, if it is almost time for your next dose, skip the dose you missed.
Danish: Hvis det næsten er tid til din næste dosis, skal du springe den dosis over, som du glemte at tage.
English: Clinical monitoring and dose adjustment may thus be required.
Danish: Monitorering og dosisjustering kan være nødvendig.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: • Severe hypotension.
Danish: • Svær hypotension.
English: Correction of this condition prior to administration of Dafiro or close medical supervision at the start of treatment is recommended.
Danish: Det anbefales, at denne tilstand korrigeres før administration af Dafiro, eller at der foretages tæt medicinsk overvågning ved behandlingens start.
English: Follow your doctor's instructions for the starting dose carefully.
Danish: Følg nøje lægens anvisning vedrørende startdosis.
English: Dafiro and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Danish: Dafiro og ældre patienter (65 år og derover) Din læge bør udvise forsigtighed, når dosis øges.
English: Over 1,400 hypertensive patients received Dafiro once daily in two placebo-controlled trials.
Danish: Mere end 1.400 hypertensive patienter har fået Dafiro en gang daglig i to placebokontrollerede studier.
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: Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Danish: Valsartan er i høj grad bundet til serumproteiner (94-97%), hovedsageligt serumalbumin.
English: If you have taken too many tablets of Dafiro, or if someone else has taken your tablets, consult a doctor immediately.
Danish: Hvis du har taget for mange Dafiro-tabletter, eller hvis andre har taget dine tabletter, skal du kontakte en læge med det samme.
English: This can affect how well you can concentrate.
Danish: Det kan påvirke din koncentrationsevne.
English: One blister contains 7, 10 or 14 film-coated tablets.
Danish: En blister indeholder 7, 10 eller 14 filmovertrukne tabletter.
English: You can take Dafiro with or without food.
Danish: - Du kan tage Dafiro med eller uden mad.
English: Do not use this medicine after the expiry date which is stated on the carton and blister.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: - Swelling of eyelids, face or lips.
Danish: - Hævede øjenlåg, ansigt eller læber.
English: In double-blind, controlled clinical trials, the incidence of peripheral oedema by dose was as follows:
Danish: I dobbeltblindede, kontrollerede kliniske studier var incidensen af perifert ødem fordelt på dosis følgende:
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE inhibitors and ARBs.
Danish: På baggrund af de fælles farmakodynamiske egenskaber er disse resultater også relevante for andre ACE-hæmmere og ARBer.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Danish: Alder, køn, race eller body mass indeks (≥30 kg/m 2, <30 kg/m 2) havde ingen indflydelse på Dafiros virkning.
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: Do not exceed the prescribed dose.
Danish: Du må ikke tage mere end den foreskrevne dosis.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apotekspersonalet til råds, før du tager nogen former for lægemidler.
English: The following side effects have been reported.
Danish: Følgende bivirkninger er set.
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Dafiro.
Danish: Hvis der samtidig gives et diuretikum, kan risikoen for lithiumtoksicitet muligvis være yderligere øget med Dafiro.
English: Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Danish: Det anbefales derfor at monitorere nyrefunktionen i begyndelsen af behandlingen og at sørge for passende hydrering af patienten.
English: Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000-fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Danish: Valsartan udviser ikke partiel agonistaktivitet på AT1-receptoren og har en meget højere (ca. 20.000 gange) affinitet for AT1-receptoren end for AT2-receptoren.
English: Adverse reactions have been ranked under headings of frequency using the following convention: 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: Bivirkningerne er opstillet efter frekvens ved anvendelse af følgende definition: 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: Urticaria and other forms of rash
Danish: Urticaria og andre former for udslæt
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: Approximate size: 14.2 mm (length) x 5.7 mm (width).
Danish: Størrelse: ca. 14,2 mm (længde) x 5,7 mm (bredde).
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: Approximate size: diameter 8.20 mm.
Danish: Størrelse: ca. 8,20 mm i diameter.
English: Do not take Dafiro with grapefruit or grapefruit juice.
Danish: Tag ikke Dafiro sammen med grapefrugt eller grapefrugtjuice.
English: To be taken into account with concomitant use
Danish: Bør tages i betragtning ved samtidig brug
English: Additional information on the combination
Danish: Yderligere information for kombinationen
English: Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug.
Danish: Valsartan udskilles primært i fæces (omkring 83% af dosis) og i urin (omkring 13% af dosis) hovedsageligt som uomdannet stof.
English: Interactions common to the combination
Danish: Almindelige interaktioner med kombinationen
English: Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function.
Danish: Evaluering af patienter med hjertesvigt eller post-myokardieinfarkt bør altid indeholde en vurdering af nyrefunktionen.
English: if you have a condition affecting the renal glands called “primary hyperaldosteronism”.
Danish: - hvis du har en tilstand, som påvirker binyrerne, og som kaldes ”primær hyperaldosteroisme”.
English: Swallow the tablets with a glass of water.
Danish: - Tag tabletten sammen med vand.
English: Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
Danish: Indgift af aktivt kul til raske frivillige øjeblikkeligt eller op til 2 timer efter indtagelse af amlodipin har vist, at det signifikant nedsætter absorptionen af amlodipin.
English: Some of these patients previously experienced angioedema with other medicinal products, including ACE inhibitors.
Danish: Nogle af disse patienter havde tidligere udviklet angioødem ved behandling med andre lægemidler, herunder ACE-hæmmere.
English: if you suffer from heart failure after a heart attack.
Danish: - hvis du lider af hjertesvigt efter et hjerteanfald.
English: The safety of Dafiro has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Danish: Dafiros sikkerhed er blevet evalueret i fem kontrollerede kliniske studier med 5.175 patienter, hvoraf 2.613 modtog valsartan i kombination med amlodipin.
English: When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered.
Danish: Når det er klinisk relevant, kan et direkte skift fra monoterapi til den faste kombination overvejes.
English: Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.
Danish: Da der ikke er nogen effekt på ACE og ingen potensering af bradykinin eller substans P, er det usandsynligt, at angiotensin II-antagonister kan forbindes med hoste.
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: Fordeling: 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: Interactions linked to amlodipine
Danish: Interaktioner forbundet med amlodipin
English: The primary endpoint was a composite of fatal coronary heart disease or non-fatal myocardial infarction.
Danish: Det primære endepunkt var sammensat af dødelig koronarsygdom eller ikke-dødeligt myokardieinfarkt.
English: Children and adolescents The use of Dafiro in children and adolescents is not recommended (aged below 18 years old).
Danish: Børn og unge Brug af Dafiro til børn og unge frarådes (under 18 år).
English: Therefore, careful monitoring of serum lithium levels is recommended during concomitant use.
Danish: Tæt monitorering af lithiumkoncentrationen i serum anbefales derfor ved samtidig brug.
English: Do not use any Dafiro pack that is damaged or shows signs of tampering.
Danish: Brug ikke pakninger med Dafiro, som er beskadiget eller viser tegn på åbning.
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: As a result, the blood vessels relax and blood pressure is lowered.
Danish: Som et resultat, bliver blodårerne mere afslappede, og blodtrykket sænkes.
English: The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Danish: Kombinationen af disse stoffer har en additiv virkning ved i større grad at nedsætte blodtrykket end hver komponent alene.
English: if you have severe liver problems or bile problems such as biliary cirrhosis or cholestasis.
Danish: - hvis du har alvorlige leverlidelser eller galdeproblemer som f.eks. biliær cirrhose eller cholestasi.
English: Dafiro should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Danish: Dafiro skal seponeres straks hos patienter, som udvikler angioødem, og behandlingen bør ikke genoptages.
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: Dafiro has not been studied in any patient population other than hypertension.
Danish: Dafiro er ikke undersøgt i andre patientgrupper end hypertension.
English: The usual dose of Dafiro is one tablet per day.
Danish: Den sædvanlige dosis af Dafiro er én tablet daglig.
English: Liver function test abnormal, including blood bilirubin increase
Danish: Unormale leverfunktionstests, inklusive forhøjet bilirubin i blodet
English: Abrupt withdrawal of Dafiro has not been associated with a rapid increase in blood pressure.
Danish: Pludselig seponering af Dafiro er ikke blevet forbundet med hurtig blodtryksstigning.
English: Some side effects can be serious and need immediate medical attention:
Danish: Bivirkninger, som kan være alvorlige, og som kræver, at du straks søger læge:
English: Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
Danish: Patienter med primær hyperaldosteronisme bør ikke behandles med angiotensin II-antagonisten, valsartan, da deres renin-angiotensin-system er påvirket af den primære lidelse.