FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of pneumonia in patients with asthma was common at the higher dose.
Danish: Hyppigheden af pneumoni hos astmapatienter var almindelig ved den højeste dosering.
English: Do not use Relvar Ellipta if you are allergic to fluticasone furoate, vilanterol or any other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Relvar Ellipta - hvis du er allergisk over for fluticasonfuroat, vilanterol eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: The enhanced anti-inflammatory effect of the LABA component was similar to that obtained with other ICS/LABA combinations.
Danish: Den forbedrede antiinflammatoriske virkning af LABA komponenten svarede til den, der blev opnået med andre ICS/LABA kombinationer.
English: These were randomised controlled studies in patients with a clinical diagnosis of COPD.
Danish: Disse var randomiserede, kontrollerede studier gennemført hos patienter med en klinisk KOL-diagnose.
English: Administration of fluticasone furoate/vilanterol to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Danish: Administration af fluticasonfuroat/vilanterol til gravide kvinder bør kun overvejes, hvis den forventede fordel for moderen opvejer enhver mulig risiko for fostret.
English: The allergen was house dust mite, cat dander, or birch pollen; the selection was based on individual screening tests.
Danish: Allergenet var husstøvmide, katteskæl eller birkepollen, der blev valgt på baggrund af en individuel screeningtest.
English: In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of fractures was <1%, and usually associated with trauma.
Danish: I en samlet analyse af 11 studier med astmapatienter (7.034 patienter) var forekomsten af frakturer <1 % og oftest forbundet med et traume.
English: Just follow these step-by-step instructions.
Danish: Bare følg denne trinvise brugervejledning.
English: Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists.
Danish: Beta2-adrenerge blokkere kan svække eller antagonisere virkningen af beta2-adrenerge agonister.
English: 12 month studies
Danish: 12-måneders studier
English: *, ** See below ‘Description of selected adverse reactions'
Danish: *, ** Se nedenfor 'Beskrivelse af udvalgte bivirkninger'
English: The MAH shall perform the required Pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Administration of fluticasone furoate combined with vilanterol did not result in any significant new toxicity.
Danish: Administration af fluticasonfuroat i kombination med vilanterol resulterede ikke i signifikant ny toksicitet.
English: In HZA106837 the primary endpoint was the time to first severe asthma exacerbation.
Danish: I HZA106837 var det primære endepunkt tid til første svære astmaeksacerbation.
English: Fluticasone furoate was not teratogenic in rats or rabbits, but delayed development in rats and caused abortion in rabbits at maternally toxic doses.
Danish: Fluticasonfuroat var ikke teratogent hos rotter eller kaniner, men forsinkede udviklingen hos rotter og medførte abort hos kaniner ved maternelt toksiske doser.
English: Corticosteroids also help to prevent attacks of asthma and aggravation of COPD.
Danish: Kortikosteroider er også med til at forebygge astma-anfald og forværring af KOL.
English: ritonavir or cobicistat, to treat HIV infections.
Danish: • ritonavir eller cobicistat, der bruges til behandling af hiv-infektioner.
English: Candidiasis of mouth and throat
Danish: Candidiasis i mund og svælg
English: They reduce the swelling and irritation in the small air passages in the lungs and so gradually ease breathing problems.
Danish: De mindsker hævelse og irritation i de små luftveje i lungerne og letter derved gradvist vejrtrækningsproblemer.
English: Six month studies
Danish: 6-måneders studier
English: Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet ved eksponeringer, der ikke er klinisk relevante (se pkt.
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Relvar Ellipta.
Danish: Lægen kan vælge at følge dig tæt, hvis du tager et af disse lægemidler, da de kan øge bivirkningerne af Relvar Ellipta.
English: Relvar Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD and asthma.
Danish: Relvar Ellipta skal tages hver dag og ikke kun, når du har problemer med vejrtrækningen eller andre symptomer på KOL og astma.
English: These studies included measures of lung function, dyspnoea and moderate and severe exacerbations.
Danish: Disse studier omfattede måling af lungefunktion, dyspnø og moderate og svære eksacerbationer.
English: This should be treated immediately with a short-acting inhaled bronchodilator.
Danish: Dette bør omgående behandles med en korttidsvirkende inhalationsbronkodilatator.
English: Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Danish: Brug ikke dette lægemiddel, hvis du er gravid, med mindre din læge siger, at du kan.
English: • increased cough or increased breathing difficulties
Danish: • tiltagende hoste eller tiltagende vejrtrækningsproblemer.
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Danish: Systemiske bivirkninger kan opstå efter inhalation af alle typer af kortikosteroider, specielt ved høje doser givet i længere perioder.
English: Serial FEV1 measurements were compared with pre-allergen challenge values taken after saline inhalation (baseline).
Danish: Serielle FEV1-målinger blev sammenlignet med de værdier, der blev målt inden allergeneksponering efter inhalation af saltvandsopløsning (baseline).
English: However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic.
Danish: Patienten bør dog informeres om, at regelmæssig daglig brug er nødvendig for at kontrollere astmasymptomerne, og at brugen skal fortsætte, selv når patienten ikke har symptomer.
English: Each delivered dose contains approximately 25 mg of lactose (as monohydrate).
Danish: Hver afgivet dosis indeholder ca. 25 mg lactose (som monohydrat).
English: However, other corticosteroids and beta2-agonists are detected in human milk (see section 5.3).
Danish: Andre kortikosteroider og beta2-agonister kan dog spores i human mælk (se pkt.
English: Interaction with CYP3A4 inhibitors
Danish: Interaktion med CYP3A4-hæmmere
English: Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
Danish: Øget brug af korttidsvirkende bronkodilatatorer til symptomlindring indikerer dårligere sygdomskontrol, og patienten bør undersøges af en læge.
English: Tell your doctor or pharmacist if you are taking any of these medicines.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du tager et eller flere af disse lægemidler.
English: LIST OF EXCIPIENTS Also contains lactose and magnesium stearate.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også lactose og magnesiumstearat.
English: In vitro plasma protein binding in human plasma of fluticasone furoate and vilanterol was high, on average >99.6% and 93.9%, respectively.
Danish: In vitro human plasmaproteinbinding af fluticasonfuroat og vilanterol var høj: I gennemsnit henholdsvis > 99,6 % og 93,9 %.
English: The adjusted mean treatment difference of -37 mL between the groups was not statistically significant (p=0.162).
Danish: Den justerede gennemsnitlige behandlingsforskel på -37 ml imellem grupperne var ikke statistisk signifikant (p = 0,162).
English: - The other ingredients are lactose monohydrate (See section 2) and magnesium stearate.
Danish: - Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2) og magnesiumstearat.
English: Moderate/ severe exacerbations were defined as worsening symptoms that required treatment with oral corticosteroids and/or antibiotics or in-patient hospitalisation.
Danish: Moderate/svære eksacerbationer var defineret som symptomforværring, der krævede behandling med orale kortikosteroider og/eller antibiotika eller hospitalsindlæggelse.
English: 184/22 micrograms
Danish: 184/22 mikrogram
English: Patients should be regularly reassessed by a healthcare professional so that the strength of fluticasone furoate/vilanterol they are receiving remains optimal and is only changed on medical advice.
Danish: Patienterne skal jævnligt kontrolleres af en læge/sygeplejerske, så den styrke fluticasonfuroate/vilanterol, de får, forbliver optimal, og kun ændres efter lægens anvisning.
English: Neither fluticasone furoate nor vilanterol trifenatate had any adverse effects on fertility or pre- and post-natal development in rats.
Danish: Hverken fluticasonfuroat eller vilanteroltrifenatat havde nogen negative virkninger på fertiliteten eller den præ- og postnatale udvikling hos rotter.
English: If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief.
Danish: Hvis der opstår symptomer i perioden mellem doserne, bør en korttidsvirkende beta2-agonist inhaleres for akut lindring.
English: Tell your doctor as soon as possible if you develop any of these symptoms.
Danish: Kontakt lægen så hurtigt som muligt, hvis du får et eller flere af disse symptomer.
English: If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol).
Danish: Hvis du får et anfald af den type, skal du inhalere et lægemiddel med hurtig virkning (f.eks. salbutamol).
English: In genetic toxicity studies, vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic indicating that vilanterol (as trifenatate) does not represent a genotoxic hazard to humans.
Danish: I genetiske toksicitetsstudier var vilanterol (som alfa-phenylcinnamat) og triphenyleddikesyre ikke genotoksiske, hvilket indikerer, at vilanterol (som trifenatat) ikke udgør nogen genotoksisk fare for mennesker.
English: Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid undesirable effects, in which case patients should be monitored for systemic corticosteroid undesirable effects.
Danish: Samtidig administration bør undgås medmindre fordelene overstiger den øgede risiko for systemiske kortikosteroide bivirkninger, i sådanne tilfælde bør patienten monitoreres for systemiske kortikosteroide bivirkninger.
English: Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g. eosinophils, macrophages, lymphocytes) and mediators (e.g. cytokines and chemokines involved in inflammation).
Danish: Det er vist, at kortikosteroider har en lang række effekter på mange forskellige celletyper (f.eks. eosinofile celler, makrofager og lymfocytter) og på mediatorer (f.eks. cytokiner og kemokiner involveret i inflammation).
English: There is no relevant use of Relvar Ellipta in the paediatric population for the indication of COPD.
Danish: Det er ikke relevant at anvende Relvar Ellipta i den pædiatriske population på indikationen KOL.
English: There are no or limited data from the use of fluticasone furoate and vilanterol trifenatate in pregnant women.
Danish: Der er ingen eller begrænsede data fra anvendelse af fluticasonfuroat og vilanteroltrifenatat til gravide kvinder.
English: Pneumonia (infection of the lung) (common side effect, may affect up to 1 in 10 people) Tell your doctor if you have any of the following while taking Relvar Ellipta - they could be symptoms of a lung infection:
Danish: Lungebetændelse (pneumoni) (almindelig bivirkning, kan forekomme hos op til 1 ud af 10 personer) Kontakt lægen, hvis du oplever nogle af følgende symptomer, mens du tager Relvar Ellipta - det kan være tegn på lungebetændelse:
English: Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids.
Danish: Fluticasonfuroat tilhører en gruppe lægemidler, som hedder kortikosteroider, men som ofte bare kaldes steroider.
English: Very common Rare
Danish: Meget almindelig Sjælden
English: In HZA106837 all patients had at least one exacerbation that required treatment with oral corticosteroids in the year prior to visit 1.
Danish: I HZA106837 havde alle patienterne oplevet mindst én eksacerbation, der krævede kortikosteroidbehandling, i året inden besøg 1.
English: Slide the cover down until you hear a ‘click'.
Danish: Træk beskyttelseshætten ned, indtil du hører et 'klik'.
English: The incidence of cardiovascular history/risk factors was similar across the treatment groups with patients most commonly suffering from hypertension (46%), followed by hypercholesterolemia (29%) and diabetes mellitus (12%).
Danish: Forekomsten af kardiovaskulære hændelser i anamnesen/risikofaktorer var ens på tværs af behandlingsgrupperne, hvor patienterne oftest led af hypertension (46 %) efterfulgt af hyperkolesterolæmi (29 %) og diabetes mellitus (12 %).
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate the adverse reactions of fluticasone furoate/vilanterol.
Danish: Samtidig administration af andre sympatomimetika (alene eller som del af kombinationsbehandling) kan forstærke bivirkningerne af fluticasonfuroat/vilanterol.
English: Extrasystoles Palpitations Tachycardia
Danish: Ekstrasystoler Palpitationer Takykardi
English: Systemic corticosteroid effects
Danish: Systemiske kortikosteroidbivirkninger
English: • Slide the cover down until you hear a “click”.
Danish: • Træk beskyttelseshætten ned, indtil du hører et 'klik'.
English: The COPD clinical development programme included a 12-week (HZC113107), two 6-month (HZC112206, HZC112207), two one-year (HZC102970, HZC102871), and one >1 year study (SUMMIT).
Danish: Det kliniske udviklingsprogram vedrørende KOL omfattede et 12-ugers (HZC113107), to 6-måneders (HZC112206, HZC112207), to 1-års (HZC102970, HZC102871) og et >1 års studie (SUMMIT).
English: Vilanterol trifenatate was not teratogenic in rats.
Danish: Vilanteroltrifenatat var ikke teratogent hos rotter.
English: Adjusted mean change from baseline in trough FEV1 was also evaluated as a secondary endpoint.
Danish: Den justerede gennemsnitlige ændring i trough-FEV1 i forhold til baseline blev også vurderet som et sekundært endepunkt.
English: Subjects used salbutamol on an as-needed basis throughout the studies.
Danish: Patienterne anvendte salbutamol efter behov igennem studierne.
English: Do not give this medicine to children under the age of 12 years for the treatment of asthma, or in children and adolescents of any age for the treatment of COPD.
Danish: Giv ikke denne medicin til behandling af astma hos børn under 12 år eller til behandling af KOL hos børn og unge, uanset alder.
English: Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Danish: Øgede niveauer af cyklisk AMP medfører afslapning af den glatte muskulatur i bronkierne og hæmmer frigivelsen af mediatorer fra celler ved akut overfølsomhed, særligt fra mastcellerne.
English: These synergistic interactions are reflected in enhanced anti-inflammatory activity, which has been demonstrated in vitro and in vivo in a range of inflammatory cells relevant to the pathophysiology of both asthma and COPD.
Danish: Disse synergistiske interaktioner afspejles i en øget antiinflammatorisk effekt, der er påvist i in vitro og in vivo studier med en række inflammatoriske celler, der er relevante for patofysiologien ved både astma og KOL.
English: Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Danish: Eventuelle systemiske virkninger kan omfatte Cushings syndrom, cushingoide træk, binyrebarksuppression, nedsat knoglemineraltæthed, væksthæmning hos børn og unge, katarakt og glaukom og sjældnere en række psykiske eller adfærdsrelaterede bivirkninger, inklusive psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depression eller aggression (specielt hos børn).
English: Oral corticosteroids and antibiotics were allowed for the acute treatment of COPD exacerbations with specific guidelines for use.
Danish: Orale kortikosteroider og antibiotika var tilladte til akut behandling af KOLeksacerbationer i henhold til specifikke retningslinjer vedrørende brugen.
English: PHARMACEUTICAL FORM AND CONTENTS 30 doses
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 doser
English: Subjects had moderate COPD (mean percent post-bronchodilator screening FEV1 of 60% [SD = 6%]), and a history of, or an increased risk of cardiovascular disease.
Danish: Personerne havde moderat KOL (gennemsnitlig procent post-bronkodilatator screening FEV1 på 60 % [SD = 6 %], og en fortid med, eller en øget risiko for kardiovaskulær sygdom.
English: The increase in vilanterol exposure was not associated with an increase in beta2-agonist related systemic effects on heart rate, blood potassium or QTcF interval.
Danish: Den øgede eksponering af vilanterol var ikke forbundet med en stigning i beta2-agonist-relaterede systemiske virkninger på hjertefrekvens, blodkalium eller QTcF-interval.
English: Relvar Ellipta contains lactose
Danish: Relvar Ellipta indeholder lactose
English: Prior to randomization, subjects were required to discontinue previous COPD medications used at baseline, which included long-acting bronchodilators plus inhaled corticosteroids (28%), long-acting bronchodilators alone (11%) and inhaled corticosteroids alone (4%).
Danish: Inden randomisering blev personerne bedt om at afbryde behandling med tidligere KOL medicin, der blev anvendt ved baseline, dette omfattede langtidsvirkende bronkodilatatorer samt inhalerede kortikosteroider (28 %), langtidsvirkende bronkodilatatorer alene (11 %) og inhalerede kortikosteroider alene (4 %).
English: All subjects were using an ICS (Inhaled corticosteroid) with or without LABA for at least 12 weeks prior to visit 1.
Danish: Alle patienter havde anvendt et inhalationssteroid (ICS) sammen med eller uden en LABA i mindst 12 uger inden besøg 1.
English: Patients with asthma should be given the strength of Relvar Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease.
Danish: Astmapatienter bør behandles med den styrke af Relvar Ellipta, der indeholder den dosis fluticasonfuroat (FF), der passer til patientens sværhedsgrad af sygdommen.
English: Given this low oral bioavailability, systemic exposure for fluticasone furoate and vilanterol following inhaled administration is primarily due to absorption of the inhaled portion of the dose delivered to the lung.
Danish: Som konsekvens af denne lave orale biotilgængelighed kan den systemiske eksponering af fluticasonfuroat og vilanterol efter inhalation primært tilskrives absorption af en del af den dosis, der leveres til lungerne.
English: Paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing.
Danish: Der kan forekomme paradoks bronkospasme med akut øget hvæsen efter indtagelse af dosis.
English: Close the inhaler and rinse your mouth
Danish: Luk inhalatoren og skyl munden
English: The effects of haemodialysis have not been studied.
Danish: Effekten af hæmodialyse er ikke blevet undersøgt.
English: Fluticasone furoate and vilanterol represent two classes of medications (a synthetic corticosteroid and a selective, long-acting beta2-receptor agonist).
Danish: Fluticasonfuroat og vilanterol repræsenterer to klasser af lægemidler (et syntetisk kortikosteroid og en selektiv, langtidsvirkende beta2-receptor agonist).
English: Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity.
Danish: Fluticasonfuroat er et syntetisk trifluorineret kortikosteroid med potent antiinflammatorisk effekt.
English: 14 doses
Danish: 14 doser
English: Similar effects in reduction of moderate and severe exacerbations were observed in this subgroup as compared with the overall population.
Danish: I denne undergruppe af patienter blev der set den samme effekt på reduktion af moderate og svære eksacerbationer som i den samlede population.
English: However, there was no evidence that this higher vilanterol Cmax resulted in clinically significant effects on heart rate.
Danish: Der var dog ingen evidens for, at det forhøjede vilanterol-Cmax havde klinisk signifikant effekt på hjertefrekvensen.
English: Check with your doctor before you use this medicine if you think any of these applies to you.
Danish: Kontakt lægen, før du begynder at tage dette lægemiddel, hvis du tror, at noget af det ovenstående gælder for dig.
English: When you take the inhaler out of its tray, it will be in the ‘closed' position.
Danish: Når du tager inhalatoren ud af bakken, er den i en ”lukket” position.
English: Patients usually experience an improvement in lung function within 16-17 minutes of inhaling Relvar Ellipta.
Danish: Patienter oplever normalt en forbedring af lungefunktionen i løbet af 16-17 minutter efter inhalation af Relvar Ellipta.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ETIKET TIL BAKKE
English: Both studies had a 4 week run-in period during which all subjects received open-label salmeterol/FP 50/250 twice daily to standardise COPD pharmacotherapy and stabilise disease prior to randomisation to blinded study medication for 52 weeks.
Danish: I begge studier var der en 4-ugers indkøringsperiode, hvor alle patienterne åbent fik salmeterol/FP 50/250 to gange daglig for at standardisere KOL-behandlingen og for at stabilisere sygdommen inden randomisering til blindet studiemedicin i 52 uger.
English: Do not use this medicine after the expiry date which is stated on the pack after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: After inhalation, patients should rinse their mouth with water without swallowing.
Danish: Efter inhalation skal patienten skylle munden med vand uden at synke det.
English: Fluticasone furoate is primarily metabolised through hydrolysis of the S-fluoromethyl carbothioate group to metabolites with significantly reduced corticosteroid activity.
Danish: Fluticasonfuroat metaboliseres primært ved hydrolyse af S-fluorometylkarbotioat-gruppen til metabolitter med signifikant reduceret kortikosteroid-aktivitet.
English: Fluticasone furoate/vilanterol should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Danish: Fluticasonfuroat/vilanterol bør administreres med forsigtighed hos patienter med lungetuberkulose og hos patienter med kroniske eller ubehandlede infektioner.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere information om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu