FrancophonIA/ELRC3.0 huggingface dataset:
English: At screening, the mean pre-bronchodilator FEV1 was 42.6% and 43.6% predicted, and the mean reversibility was 15.9% and 12.0% in HZC112206 and HZC112207, respectively.
Danish: Ved screeningen var den gennemsnitlige præ-bronkodilatoriske FEV1-værdi 42,6 % og 43,6 % af den forventede værdi, og den gennemsnitlige reversibilitet var 15,9 % og 12,0 % i henholdsvis HZC112206 og HZC112207.
English: There is no specific treatment for an overdose with fluticasone furoate/vilanterol.
Danish: Der findes ingen specifik behandling af overdosering med fluticasonfuroat/vilanterol.
English: These include: beta-blockers, such as metoprolol, used to treat high blood pressure or a heart condition.
Danish: • betablokkere, såsom metoprolol, der bruges til behandling af for højt blodtryk eller hjertesygdom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 14 doses
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 14 doser
English: Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use.
Danish: Inhalatoren skal opbevares i den forseglede bakke for at beskytte mod fugt, og skal først tages ud umiddelbart før første brug.
English: Pneumonia in patients with asthma
Danish: Pneumoni hos astmapatienter
English: If you want to clean the mouthpiece, use a dry tissue, before closing the cover.
Danish: Hvis du vil rengøre mundstykket, så brug en tør serviet, før du lukker beskyttelseshætten.
English: There was no evidence for age to affect the pharmacokinetics of fluticasone furoate in subjects with COPD while there was an increase (37%) in AUC (0-24) of vilanterol over the observed age range of 41 to 84 years.
Danish: Der var ingen evidens for, at alder påvirker farmakokinetikken af fluticasonfuroat hos patienter med KOL, hvorimod der blev set en stigning (37 %) i AUC (0-24) af vilanterol i det observerede aldersinterval fra 41 til 84 år.
English: Molecular interactions occur between corticosteroids and LABAs, whereby steroids activate the beta2receptor gene, increasing receptor number and sensitivity and LABAs prime the glucocorticoid receptor for steroid-dependent activation and enhance cell nuclear translocation.
Danish: Der opstår molekylære interaktioner mellem kortikosteroider og LABA'er, hvorved steroiderne aktiverer beta2-receptorgenet og øger antallet af receptorer og receptorfølsomheden, og LABA'er aktiverer glukokortikoidreceptorerne under tilstedeværelse af steroid og styrker cellens nukleære translokation.
English: Vilanterol belongs to a group of medicines called long acting bronchodilators.
Danish: Vilanterol tilhører en gruppe lægemidler, der kaldes langtidsvirkende bronkodilatatorer.
English: Nasopharyngitis Paradoxical bronchospasm Oropharyngeal pain Sinusitis
Danish: Nasopharyngitis Paradoks bronkospasme Orofaryngeal smerte Sinuitis
English: No dose adjustment is required for patients with renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: All-cause mortality was: fluticasone furoate/vilanterol, 6.0%; placebo, 6.7%; fluticasone furoate, 6.1%; vilanterol, 6.4%.
Danish: Total mortalitet var: fluticasonfuroat/vilanterol, 6,0 %; placebo, 6,7 %; fluticasonfuroat, 6,1 %; vilanterol, 6,4 %.
English: Fluticasone furoate and vilanterol are both substrates of P-glycoprotein (P-gp).
Danish: Fluticasonfuroat og vilanterol er begge substrater for P-glykoprotein (P-gp).
English: Inhale your medicine
Danish: Inhalér din medicin
English: Vilanterol is primarily metabolised by O-dealkylation to a range of metabolites with significantly reduced 1- and 2-agonist activity.
Danish: Vilanterol metaboliseres primært via O-dealkylering til en række metabolitter med signifikant lavere β1- og β2-agonist-aktivitet.
English: Cardiovascular effects
Danish: Kardiovaskulær effekt
English: A severe asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Danish: Svær astmaeksacerbation var defineret som astmaforværring, der krævede brug af systemiske kortikosteroider i mindst 3 dage, hospitalsindlæggelse eller besøg på skadestue på grund af astma, der krævede behandling med systemiske kortikosteroider.
English: There have been reports of increases in blood glucose levels in diabetic patients and this should be considered when prescribing to patients with a history of diabetes mellitus.
Danish: Der er rapporter om øget blodglucoseniveau hos diabetespatienter, og dette skal der tages hensyn til, når Relvar Ellipta udskrives til patienter med diabetes mellitus i anamnesen.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Relvar Ellipta.
Danish: Der kan ses kardiovaskulære effekter, såsom hjertearytmier, f.eks. supraventrikulær takykardi og ekstrasystoli, med sympatomimetika, inklusive Relvar Ellipta.
English: There was no evidence for age (12-84) to affect the pharmacokinetics of fluticasone furoate and vilanterol in subjects with asthma.
Danish: Der var ingen evidens for, at alder (12-84) påvirker farmakokinetikken af fluticasonfuroat og vilanterol hos patienter med astma.
English: The most commonly reported adverse reactions with fluticasone furoate and vilanterol were headache and nasopharyngitis.
Danish: De hyppigst rapporterede bivirkninger for fluticasonfuroat og vilanterol var hovedpine og nasopharyngitis.
English: How to prepare a dose
Danish: Sådan skal du klargøre en dosis
English: Don't open the tray until you are ready to start using your new inhaler.
Danish: Du må ikke åbne bakken, før du er klar til at begynde at bruge din nye inhalator.
English: What is the Ellipta inhaler?
Danish: Hvad er en Ellipta-inhalator?
English: The step-by-step instructions shown below for the 30-dose Ellipta inhaler (30 day supply) also apply to the 14-dose Ellipta inhaler (14 day supply).
Danish: Den trinvise brugervejledning, der er vist nedenfor for Ellipta-inhalatoren med 30 doser (30 dages forbrug), gælder også for Ellipta-inhalatoren med 14 doser (14 dages forbrug).
English: The apparent plasma elimination half-life of vilanterol following single inhaled administration of fluticasone furoate/vilanterol was, on average, 2.5 hours.
Danish: Den tilsyneladende halveringstid for eliminationen af vilanterol i plasma efter en enkelt administration af inhaleret fluticasonfuroat/vilanterol var i gennemsnit 2,5 timer.
English: Caution is advised when co-administering with strong CYP 3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol.
Danish: Der bør udvises forsigtighed ved samtidig administration af potente CYP3A4-hæmmere (f.eks. produkter, der indeholder ketoconazol, ritonavir og cobicistat), da der er mulighed for øget systemisk eksponering af både fluticasonfuroat og vilanterol.
English: If patients are inadequately controlled on Relvar Ellipta 92/22 micrograms, the dose can be increased to 184/22 micrograms, which may provide additional improvement in asthma control.
Danish: Hvis patienten ikke er velkontrolleret på Relvar Ellipta 92/22 mikrogram, kan dosis øges til 184/22 mikrogram, der kan give en yderligere forbedring af astmakontrollen.
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of treatment with Relvar Ellipta.
Danish: Patienterne skal informeres om at fortsætte behandlingen og søge læge, hvis astmasymptomerne ikke kan kontrolleres efter opstart af behandling med Relvar Ellipta, eller hvis de forværres.
English: Patients usually experience an improvement in lung function within 15 minutes of inhaling Relvar Ellipta.
Danish: Patienten oplever normalt en forbedring af lungefunktionen i løbet af 15 minutter efter inhalation af Relvar Ellipta.
English: Studies versus salmeterol/fluticasone propionate combinations
Danish: Studier versus kombinationer af salmeterol/fluticasonpropionat
English: Studies in subjects with mild, moderate and severe hepatic impairment showed an increase in systemic exposure to fluticasone furoate (both Cmax and AUC) (see section 5.2).
Danish: Studier med personer med let, moderat og svær leverinsufficiens viste en stigning i den systemiske eksponering af fluticasonfuroat (både Cmax og AUC) (se pkt.
English: Allergen challenge study
Danish: Allergenbelastningsstudie
English: The use of concurrent inhaled long-acting bronchodilators (beta2-agonist and anticholinergic), ipratropium/salbutamol combination products, oral beta2-agonists, and theophylline preparations were not allowed during the treatment period.
Danish: Samtidig brug af inhalerede langtidsvirkende bronkodilatatorer (beta2-agonister og antikolinergika), kombinationspræparater med ipratropium/salbutamol, orale beta2-agonister og theophyllinpræparater var ikke tilladt i behandlingsperioden.
English: P value (95% CI)
Danish: P-værdi (95 % konfidensinterval)
English: • patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.
Danish: • hos patienter, der allerede er tilstrækkelig kontrolleret på både inhalationssteroid og langtidsvirkende beta2-agonist.
English: HZC102970 and HZC102871 integrated
Danish: HZC102970 og HZC102871 samlet
English: Talk to your doctor before you use Relvar Ellipta: if you have liver disease, as you may be more likely to have side effects.
Danish: Kontakt lægen, før du tager Relvar Ellipta: - hvis du har en leversygdom, da det kan øge risikoen for bivirkninger.
English: if you think the above applies to you, don't use Relvar Ellipta until you have checked with your doctor.
Danish: Hvis du tror, at ovenstående gælder for dig, må du ikke tage Relvar Ellipta, før du har talt med lægen.
English: The co-primary endpoints in both studies were weighted mean FEV1 from zero to 4 hours post-dose at Day 168 and change from baseline in pre-dose trough FEV1 at Day 169.
Danish: De sammensatte primære endepunkter for begge studier var vægtet gennemsnitligt FEV1 i de første 4 timer efter dosering på dag 168 og ændring i forhold til baseline i trough-FEV1 inden dosering på dag 169.
English: Rinsing your mouth out with water immediately after using Relvar Ellipta may help stop this side effect developing.
Danish: Hvis du skyller munden med vand, og spytter vandet ud, umiddelbart efter, du har taget Relvar Ellipta, kan det være med til at forebygge, at du får denne bivirkning.
English: HZC112206 and HZC112207 were 24 week randomised, double-blind, placebo controlled, parallel group studies comparing the effect of the combination to vilanterol and FF alone and placebo.
Danish: HZC112206 og HZC112207 var randomiserede, dobbeltblindede, placebokontrollerede, parallelgruppestudier af 24 ugers varighed, der sammenlignede effekten af kombinationen i forhold til vilanterol og FF alene og placebo.
English: Effects seen following inhalation administration of fluticasone furoate in combination with vilanterol in rats were similar to those seen with fluticasone furoate alone.
Danish: De effekter, der blev set efter inhalation af fluticasonfuroat i kombination med vilanterol hos rotter, var de samme som dem, der blev set med fluticasonfuroat alene.
English: The inhaler contains two aluminium foil laminate strips of 14 or 30 doses.
Danish: Inhalatoren indeholder to laminerede aluminiumsfolie-strips med enten 14 eller 30 doser.
English: In a placebo-controlled study in subjects with moderate COPD and a history of, or an increased risk of cardiovascular disease, there was no increase in the risk of cardiovascular events in patients receiving fluticasone furoate/vilanterol compared with placebo (see section 5.1).
Danish: I et placebokontrolleret studie hos personer med moderat KOL og en fortid med, eller en forøget risiko for kardiovaskulær sygdom, var der ingen stigning i risikoen for kardiovaskulære hændelser hos patienter, der fik fluticasonfuroat/vilanterol sammenlignet med placebo (se pkt.
English: The results of both studies showed that treatment with fluticasone furoate/vilanterol 92/22 micrograms once daily resulted in a lower annual rate of moderate/severe COPD exacerbations compared with vilanterol (Table 2).
Danish: Resultaterne fra begge studier viste, at behandling med fluticasonfuroat/vilanterol 92/22 mikrogram en gang daglig resulterede i en lavere årlig rate af moderate/svære KOL-eksacerbationer sammenlignet med vilanterol (tabel 2).
English: Animal studies showed no effect of fluticasone furoate/vilanterol trifenatate on fertility (see section 5.3).
Danish: Dyrestudier viste ingen effekt af fluticasonfuroat/vilanteroltrifenatat på fertilitet (se pkt.
English: If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your quick-acting inhaler (e.g. salbutamol), then seek medical advice.
Danish: Hvis du får hvæsende vejrtrækning eller åndenød eller udvikler andre symptomer på et astma-anfald, skal du inhalere et lægemiddel med hurtig virkning (f.eks. salbutamol) og derefter søge lægehjælp.
English: The pharmacokinetics of fluticasone furoate/vilanterol in patients less than 12 years of age has not been studied.
Danish: Farmakokinetikken af fluticasonfuroat/vilanterol hos patienter under 12 år er ikke blevet undersøgt.
English: The device does not need to be stored in the foil laminate tray once it has been opened.
Danish: Det er ikke nødvendigt at opbevare inhalatoren i bakken af laminatfolie efter åbning.
English: Driving and using machines This medicine is unlikely to affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at dette lægemiddel vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Relvar Ellipta is for inhalation use.
Danish: Relvar Ellipta er til inhalations brug.
English: Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough.
Danish: Symptomerne kommer og går og omfatter åndenød, hvæsende vejrtrækning, trykken for brystet og hoste.
English: If you have any of the following symptoms after taking Relvar Ellipta stop taking this medicine and tell your doctor immediately.
Danish: Hvis du oplever nogle af de følgende symptomer efter at have taget Relvar Ellipta, skal du stoppe med at tage medicinen og straks kontakte lægen.
English: Fluticasone furoate was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in rats or mice at exposures similar to those at the maximum recommended human dose, based on AUC.
Danish: Fluticasonfuroat var ikke genotoksisk i en række standardstudier og ikke karcinogent ved livslang inhalationsbehandling hos rotter og mus ved eksponeringer, der svarer til dem, der opnås hos mennesker ved den maksimalt anbefalede dosis, baseret på AUC.
English: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
Danish: Der er set en øget forekomst af pneumoni, herunder pneumoni, der krævede hospitalsindlæggelse, hos KOLpatienter, der fik kortikosteroider til inhalation.
English: The pharmacologic effects of beta2-adrenoceptor agonist active substances, including vilanterol trifenatate, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Danish: De farmakologiske effekter af beta2-agoniste aktive substanser, herunder vilanteroltrifenatat, kan i det mindste delvist tilskrives stimulering af intracellulær adenylatcyklase, som er det enzym, der katalyserer omdannelsen af adenosintrifosfat (ATP) til cyklisk-3',5'-adenosinmonofosfat (cyklisk AMP).
English: The effective half-life for accumulation of vilanterol, as determined from inhalation administration of repeat doses of vilanterol 25 micrograms, is 16.0 hours in subjects with asthma and 21.3 hours in subjects with COPD.
Danish: Den effektive halveringstid for akkumulering af vilanterol, bestemt efter inhalation af gentagne doser af vilanterol 25 mikrogram, er 16,0 timer hos patienter med astma og 21,3 timer hos patienter med KOL.
English: Clinical pharmacology studies with a specific P-gp inhibitor and fluticasone furoate have not been conducted.
Danish: Der er ikke udført klinisk farmakologiske studier med en specifik P-gp-hæmmer og fluticasonfuroat.
English: During clinical studies, pneumonia and fractures were more frequently commonly observed in patients with COPD.
Danish: I de kliniske studier blev pneumoni og frakturer set hyppigere hos KOL-patienter.
English: Always use this medicine exactly as your doctor has told you to.
Danish: Tag altid dette lægemiddel nøjagtigt efter lægens anvisning.
English: - Contact your doctor if you experience increased thirst, frequent urination or unexplained tiredness
Danish: - Kontakt din læge hvis du oplever øget tørst, hypige vandlandninger eller uforklarlig træthed (tegn på højt blodsukker).
English: In the asthma clinical development program a total of 7,034 patients were included in an integrated assessment of adverse reactions.
Danish: I det kliniske udviklingsprogram med astmapatienter blev der i alt inkluderet 7.034 patienter, som danner basis for en samlet vurdering af bivirkninger.
English: If you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia.
Danish: Hvis du tager dette lægemiddel mod KOL, kan du have en øget risiko for at få lungebetændelse.
English: Time to first exacerbation: Hazard ratio (95% CI) % risk reduction p-value p<0.001
Danish: Hazard ratio konfidensinterval) Risikoreduktion i % P-værdi p < 0,001
English: An overdose of fluticasone furoate/vilanterol may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Danish: En overdosis af fluticasonfuroat/vilanterol kan medføre tegn og symptomer som følge af de enkelte indholdsstoffers virkninger, inklusive symptomer, som ses ved overdosering med andre beta2-agonister, og som stemmer overens med de kendte klasseeffekter af inhalationssteroider (se pkt.
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Danish: Ved symptomer som sløret syn eller andre synsforstyrrelser bør det overvejes at henvise patienten til oftalmolog med henblik på vurdering af de mulige årsager; disse kan være grå stær, glaukom eller sjældne sygdomme såsom central serøs korioretinopati (CSCR), som er indberettet efter brug af systemiske og topikale kortikosteroider.
English: The lost dose will be securely held inside the inhaler, but it will no longer be available.
Danish: En dosis, der er gået tabt, vil blive tilbageholdt i inhalatoren, men den vil ikke længere være tilgængelig.
English: If the inhaler cover is opened and closed without inhaling the medicine, the dose will be lost.
Danish: Hvis beskyttelseshætten på inhalatoren åbnes og lukkes, uden at medicinen inhaleres, vil dosis gå tabt.
English: The increase in fluticasone furoate exposure was associated with a 27% reduction in 0-24 hours weighted mean serum cortisol.
Danish: Den øgede eksponering af fluticasonfuroat var forbundet med en reduktion på 27 % i vægtet gennemsnit af serumkortisol i løbet af de første 24 timer.
English: Relvar Ellipta should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing longacting beta2-adrenergic agonists.
Danish: Relvar Ellipta bør ikke anvendes i kombination med andre langtidsvirkende beta2-agonister eller lægemidler, der indeholder langtidsvirkende beta2-agonister.
English: ketoconazole, to treat fungal infections.
Danish: • ketoconazol, der bruges til behandling af svampeinfektioner.
English: For an elderly subject (aged 84 years) with low bodyweight (35 kg) vilanterol AUC (0-24) is predicted to be 35% higher than the population estimate (subject with COPD aged 60 years and bodyweight of 70 kg), whilst Cmax was unchanged.
Danish: Hos en ældre patient (på 84 år) med lav legemsvægt (35 kg) forventes AUC (0-24) af vilanterol at være 35 % højere end den generelle population (KOL-patienter på 60 år med en legemsvægt på 70 kg), hvorimod Cmax var uændret.
English: Do not breathe out into the inhaler.
Danish: Ånd ikke ud i inhalatoren.
English: United Kingdom.
Danish: Storbritannien.
English: long-acting beta2-adrenergic agonists, such as salmeterol
Danish: • langtidsvirkende beta2-agonister, såsom salmeterol.
English: The precise mechanism through which fluticasone furoate affects asthma and COPD symptoms is not known.
Danish: Den præcise mekanisme bag fluticasonfuroats effekt på astma- og KOL-symptomer kendes ikke.
English: Description of selected adverse reactions *Pneumonia (see section 4.4)
Danish: Beskrivelse af udvalgte bivirkninger *Pneumoni (se pkt.
English: However, fluticasone furoate/vilanterol should be used with caution in patients with severe cardiovascular disease or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.
Danish: Fluticasonfuroat/vilanterol bør dog anvendes med forsigtighed hos patienter med svær kardiovaskulær sygdom eller hjerterytmeforstyrrelser, tyreotoksikose, ukorrigeret hypokaliæmi og hos patienter disponeret for lave serumkaliumniveauer.
English: It may not be possible to taste or feel the medicine, even when using the inhaler correctly.
Danish: Det er ikke sikkert, at du kan smage eller mærke medicinen, selvom inhalatoren anvendes korrekt.
English: In the COPD clinical development programme a total of 6,237 subjects were included in an integrated assessment of adverse reactions.
Danish: I det kliniske udviklingsprogram med KOL blev der i alt inkluderet 6.237 patienter, som danner basis for en samlet vurdering af bivirkninger.
English: Relvar Ellipta has been shown to reduce flare-ups and symptoms of asthma.
Danish: Det er påvist, at Relvar Ellipta reducerer opblussen af og symptomer på astma.
English: For patients with moderate to severe hepatic impairment, the 92/22 micrograms dose should be used and patients should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Danish: Hos patienter med moderat til svær leverinsufficiens bør styrken på 92/22 mikrogram anvendes, og patienterne bør monitoreres for bivirkninger relateret til kortikosteroiders systemiske virkninger (se pkt.
English: • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Danish: • Hvis dosistælleren ikke tæller nedad, når du hører 'klikket', vil inhalatoren ikke afgive medicin.
English: There is insufficient information on the excretion of fluticasone furoate or vilanterol trifenatate and/or metabolites in human milk.
Danish: Data for udskillelse af fluticasonfuroat eller vilanteroltrifenatat og/eller metabolitter i human mælk er utilstrækkelige.
English: Chronic obstructive pulmonary disease (COPD) is a serious, long term lung disease where the airways become inflamed and thickened.
Danish: Kronisk obstruktiv lungesygdom (KOL) er en alvorlig, langvarig lungesygdom, hvor luftvejene bliver irriterede (inflammation) og fortykkede.
English: Overall, across the two studies combined 2009 (62%) patients had cardiovascular history/risk factors at screening.
Danish: På tværs af de to studier var der samlet set 2.009 (62 %) af patienterne, der havde kardiovaskulære hændelser i anamnesen eller risikofaktorer herfor ved screeningen.