FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was annual rate of on-treatment moderate and severe exacerbations in subjects treated with FF/UMEC/VI compared with FF/VI and UMEC/VI.
Danish: Det primære endepunkt var den årlige hyppighed af moderate og svære eksacerbationer under behandling hos forsøgspersoner behandlet med FF/UMEC/VI sammenlignet med FF/VI og UMEC/VI.
English: Uncommon side effects (may affect up to 1 in 100 people): • skin rash (hives) or redness
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): • udslæt (nældefeber) eller hudrødme
English: The mean annual rate of exacerbations was 0.91, 1.07 and 1.21 for FF/UMEC/VI, FF/VI, and UMEC/VI respectively.
Danish: Den gennemsnitlige årlige hyppighed af eksacerbationer var 0,91, 1,07 og 1,21 for henholdsvis FF/UMEC/VI, FF/VI og UMEC/VI.
English: Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Anoro Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Danish: Indsendelse af den endelige rapport for det kliniske observationssikkerhedsstudie (kohorte) efter godkendelsen (PAS - Post-Authorisation Safety), der skal kvantificere incidensen og sammenlignende sikkerhed for udvalgte kardiovaskulære og cerebrovaskulære bivirkninger hos KOL-patienter forbundet med Anoro Ellipta i sammenligning med tiotropium (studie 201038), i henhold til den protokol, der er aftalt med PRAC.
English: ∗ A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did not achieve statistical significance.
Danish: ∗ En statistisk testprocedure med trinvis reduktion blev benyttet i dette studie, og denne sammenligning lå under en sammenligning, hvor der ikke blev opnået statistisk signifikans.
English: 55 micrograms/22 micrograms
Danish: 55 mikrogram/22 mikrogram
English: Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors on airway smooth muscle.
Danish: Umeclidinium udøver sin bronkodilaterende aktivitet ved kompetitivt at hæmme binding af acetylcholin til muskarinreceptorer på luftvejenes glatte muskulatur.
English: There was no evidence for tachyphylaxis in the effect of ANORO ELLIPTA over time.
Danish: Der var ingen tegn på takyfylaksi for effekten af Anoro Ellipta over tid.
English: • infection of the upper airways.
Danish: • infektion i de øvre luftveje.
English: The increase in vilanterol exposure was not associated with an increase in beta-adrenergic agonist related systemic effects on heart rate, blood potassium or QT interval (corrected using the Fridericia method).
Danish: Den øgede eksponering af vilanterol var ikke forbundet med en stigning i beta-adrenerge agonistrelaterede systemisk virkning på hjertefrekvens, blodkalium eller QT-intervallet (korrigeret ved brug af Fridericias metode).
English: If you think this applies to you, don't use this medicine until you have checked with your doctor.
Danish: Hvis du tror, at dette gælder for dig, må du ikke tage dette lægemiddel, før du har talt med lægen.
English: Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine and faeces.
Danish: Den primære eliminering af vilanterol var ved metabolisering efterfulgt af udskillelse af metabolitter i urinen og fæces.
English: The results were similar to those for the ANORO ELLIPTA dose and provided additional supportive evidence for the efficacy of ANORO ELLIPTA.
Danish: Resultaterne var sammenlignelige med resultater for Anoro Ellipta dosis og gav yderligere understøttende evidens for virkningen af Anoro Ellipta.
English: Umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.
Danish: Umeclidinium/vilanterol påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
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 mastceller.
English: The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, 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 virkninger af beta2-agonister, herunder vilanterol, 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: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Danish: Stop med at tage denne medicin, og søg omgående lægehjælp, da du kan have en alvorlig lidelse, der kaldes paradoksal bronkospasme.
English: Umeclidinium/vilanterol should not be used in patients with asthma since it has not been studied in this patient population.
Danish: Umeclidinium/vilanterol bør ikke anvendes til patienter med astma, da det ikke er undersøgt hos denne patientpopulation.
English: Following repeat dosing of inhaled vilanterol, steady state was achieved within 6 days with up to 2.4-fold accumulation.
Danish: Efter gentagen dosering af vilanterol som inhalation blev steady state nået inden for 6 dage med en akkumulation på op til 2,4 gange.
English: Concomitant administration of strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin) may inhibit the metabolism of, and increase the systemic exposure to, vilanterol.
Danish: Samtidig administration af potente CYP3A4hæmmere (f.eks. ketoconazol, clarithromycin, itraconazol, ritonavir, telithromycin) kan hæmme metabolisering af vilanterol, og øge den systemiske eksponering.
English: The absolute bioavailability of inhaled umeclidinium was on average 13% of the dose, with negligible contribution from oral absorption.
Danish: Den absolutte biotilgængelighed af inhaleret umeclidinium var i gennemsnit 13 % af dosis, med et ubetydeligt bidrag fra oral absorption.
English: When umeclidinium and vilanterol were administered in combination by the inhaled route, the pharmacokinetics of each component was similar to those observed when each active substance was administered separately.
Danish: Når umeclidinium og vilanterol blev administreret i kombination via inhalation, var farmakokinetikken for hver komponent tilsvarende farmakokinetikken for de aktive stoffer, når de blev administreret hver for sig.
English: Not for acute use Umeclidinium/vilanterol is not indicated for the treatment of acute episodes of bronchospasm.
Danish: Ikke til akut anvendelse Umeclidinium/vilanterol er ikke indiceret til behandling af akutte tilfælde af bronkospasmer.
English: If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:
Danish: Hvis dine KOL-symptomer (åndenød, hvæsende vejrtræning, hoste) ikke aftager, eller hvis de bliver værre, eller hvis du oftere inhalerer et lægemiddel med hurtig virkning:
English: Both umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp).
Danish: Umeclidinium og vilanterol er begge substrater for transportproteinet P-glykoprotein (P-gp).
English: The primary metabolic routes for vilanterol are O-dealkylation to a range of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity.
Danish: De primære metaboliseringsveje for vilanterol er O-dealkylering til en række metabolitter med signifikant nedsat beta1- og beta2-agonist-aktivitet.
English: Umeclidinium is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Danish: Umeclidinium er en langtidsvirkende muskarinreceptorantagonist (også kaldet et antikolinergikum).
English: In the other two active-comparator studies, a similar proportion of patients achieved at least the MCID with ANORO ELLIPTA and tiotropium; 49% and 54% for ANORO ELLIPTA 55/22 micrograms and 52% and 55% for tiotropium.
Danish: I de to andre studier med aktiv komparator opnåede en tilsvarende andel af patienterne som minimum MCID med Anoro Ellipta og tiotropium; 49 % og 54 % for Anoro Ellipta 55/22 mikrogram og 52 % og 55 % for tiotropium.
English: ANORO ELLIPTA contains two active substances umeclidinium bromide and vilanterol.
Danish: Anoro Ellipta indeholder to aktive stoffer umeclidiniumbromid og vilanterol.
English: It is not known whether the ingredients of ANORO ELLIPTA can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Anoro Ellipta går over i modermælken.
English: In vitro plasma protein binding in human plasma was on average 94%.
Danish: In vitro var human plasmaproteinbinding i gennemsnit 94 %.
English: The ELLIPTA inhaler contains pre-dispensed doses and is ready to use.
Danish: Ellipta inhalatoren indeholder afdelte doser og er klar til brug.
English: Lung function, symptomatic and health related quality of life outcomes at Week 24 Treatment comparisons with ANORO
Danish: Lungefunktion, symptomatiske og helbredsrelateret livskvalitets resultater ved uge 24
English: Following intravenous administration to healthy volunteers, the mean volume of distribution was 86 litres.
Danish: Efter intravenøs administration til raske personer var det gennemsnitlige distributionsvolumen 86 liter.
English: Umeclidinium/vilanterol should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Danish: Umeclidinium/vilanterol bør anvendes med forsigtighed hos patienter med konvulsive sygdomme eller tyrotoksidose, samt hos patienter, der er usædvanligt responsive over for beta2-adrenerge agonister.
English: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland GlaxoSmithKline (Ireland) Limited logo
Danish: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irland GlaxoSmithKline (Ireland) Limited logo
English: In nonclinical studies with umeclidinium and vilanterol, alone and in combination, findings were those typically associated with the primary pharmacology of either muscarinic receptor antagonists or beta2-adrenergic agonists respectively and/or local irritancy.
Danish: I non-kliniske studier med umeclidinium og vilanterol, alene og i kombination, var resultaterne i overensstemmelse med dem, der typisk forbindes med den primære farmakologi af enten muskarinreceptorantagonister eller beta2-agonister, og/eller lokal irritation.
English: The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium and vilanterol was assessed in healthy volunteers.
Danish: Effekten af den moderate P-gp-hæmmer verapamil (240 mg én gang daglig) på farmakokinetikken af umeclidinium og vilanterol ved steady state blev bestemt hos raske personer.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ANORO ELLIPTA in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Anoro Ellipta i alle undergrupper af den pædiatriske population ved indikationen KOL (se pkt.
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Danish: Beta2-adrenerge agonister kan medføre signifikant hypokaliæmi hos visse patienter med potentiale for at udvikle kardiovaskulære bivirkninger.
English: Eye problems during treatment with ANORO ELLIPTA
Danish: Øjenproblemer under behandling med Anoro Ellipta
English: Following intravenous administration to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Danish: Efter intravenøs administration til raske personer var det gennemsnitlige distributionsvolumen ved steady state 165 liter.
English: ANORO ELLIPTA demonstrated improvements in lung function (as defined by change from baseline in trough FEV1) in several studies.
Danish: Anoro Ellipta viste forbedringer af lungefunktion (defineret som ændring i forhold til baseline i troughFEV1) i flere studier.
English: In the second study, the treatment difference in EET between ANORO ELLIPTA 55/22 micrograms and placebo was 21.9 seconds (p=0.234) at Week 12.
Danish: I det andet studie var behandlingsforskellen i EET mellem Anoro Ellipta 55/22 mikrogram og placebo 21,9 sekunder (p = 0,234) ved uge 12.
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 1.8-fold accumulation.
Danish: Efter gentagen dosering af umeclidinium som inhalation blev steady state nået inden for 7 til 10 dage med en akkumulation på 1,5 til 1,8 gange.
English: Headache Tremor Dysgeusia Dizziness
Danish: Hovedpine Tremor Dysgeusi Svimmelhed
English: Therefore, no clinically relevant pro-arrhythmic potential related to QT-interval prolongations was observed with umeclidinium/vilanterol 113/22 micrograms.
Danish: Der blev derfor ikke observeret noget klinisk relevant potentiale for proarytmi relateret til forlængelse af QT-intervallet med umeclidinium/vilanterol 113/22 mikrogram.
English: It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Danish: Umeclidinium udviser langsom reversibilitet ved undertypen af humane muskarinreceptorer, M3, in vitro og har en langvarig virkning in vivo, når det administreres direkte til lungerne i prækliniske modeller.
English: If you are breastfeeding, you must check with your doctor before you use ANORO ELLIPTA.
Danish: Hvis du ammer, skal du tale med lægen, før du begynder at tage Anoro Ellipta.
English: ANORO ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing.
Danish: Anoro Ellipta må ikke anvendes til lindring af pludselige anfald af åndenød eller hvæsende vejrtrækning.
English: Lactose monohydrate Magnesium stearate
Danish: Lactosemonohydrat Magnesiumstearat
English: A decision must be made whether to discontinue breast-feeding or to discontinue umeclidinium/vilanterol therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med umeclidinium/vilanterol skal seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: • difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention.
Danish: • besværet og smertefuld vandladning - dette kan være tegn på tilstopning i blæren eller urinretention.
English: Intraocular pressure increased
Danish: Øget intraokulært tryk
English: medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems ketoconazole or itraconazole, to treat fungal infections clarithromycin or telithromycin, to treat bacterial infections ritonavir, to treat HIV infection medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids) other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. tiotropium, indacaterol.
Danish: medicin, som kaldes betablokkere (såsom propranolol), til behandling af forhøjet blodtryk eller andre hjerteproblemer ketoconazol eller itraconazol, til behandling af svampeinfektioner clarithromycin eller telithromycin, til behandling af bakterieinfektioner ritonavir, til behandling af hiv-infektion medicin der nedsætter mængden af kalium i dit blod, såsom diuretika (vanddrivende tabletter) eller visse lægemidler til behandling af astma (f.eks. methylxanthine eller steroider) andre langtidsvirkende lægemidler, som minder om Anoro Ellipta, til behandling af vejrtrækningsproblemer, f.eks. tiotropium eller indacaterol.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium/vilanterol.
Danish: Der kan ses kardiovaskulære virkninger, såsom hjertearytmier, f.eks. atrieflimren og takykardi, efter administration af muskarinreceptorantagonister og sympatomimetika, herunder umeclidinium/vilanterol.
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution (see section 4.4).
Danish: Samtidig hypokaliæmisk behandling med methylxanthin-derivater, steroider eller ikke-kaliumbesparende diuretika kan medføre mulighed for hypokaliæmisk virkning af beta2-adrenerge agonister, og skal derfor anvendes med forsigtighed (se pkt.
English: Following oral administration to healthy male volunteers, total radioactivity was excreted primarily in faeces (92% of the administered radiolabelled dose or 99% of the recovered radioactivity) by 168 hours post-dose.
Danish: Efter oral administration til raske mænd blev den samlede radioaktivitet primært udskilt i fæces (92 % af den administrerede radioaktivt mærkede dosis eller 99 % af genfunden radioaktivitet) 168 timer efter dosering.
English: Use of rescue medication3
Danish: Brug af anfaldsmedicin3
English: A study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium.
Danish: Et studie med personer, der er dårlige til at metabolisere på grund af manglende CYP2D6-aktivitet, viste, at der ikke var en klinisk signifikant effekt af genetisk CYP2D6-polymorfisme på den systemiske eksponering over for umeclidinium.
English: ANORO ELLIPTA also demonstrated a greater increase from baseline in the proportion of days when no rescue medication was needed in all three studies (average within the range 17.6% to 21.5%) compared with tiotropium (average within the range 11.7% to 13.4%).
Danish: Anoro Ellipta viste også en større stigning fra baseline i antal dage uden behov for anfaldsmedicin i alle tre studier (gennemsnit indenfor intervallet 17,6-21,5 %) sammenlignet med tiotropium (gennemsnit indenfor intervallet 11,7-13,4 %).
English: Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol, which could lead to an increase in the potential for adverse reactions.
Danish: Det tilrådes at udvise forsigtighed, når umeclidinium/vilanterol administreres samtidigt med ketoconazol og andre kendte potente CYP3A4-hæmmere, da der derved er mulighed for en øget systemisk eksponering af vilanterol, som kan medføre en større risiko for bivirkninger.
English: Upon initiation of treatment with umeclidinium/vilanterol plasma glucose should be monitored more closely in diabetic patients.
Danish: Ved initiering af behandling med umeclidinium/vilanterol, bør plasmaglukose monitoreres tættere hos diabetespatienter.
English: A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium and vilanterol were similar between COPD patients 65 years and older and those younger than 65 years of age.
Danish: En populationsfarmakokinetisk analyse viste, at farmakokinetikken af umeclidinium og vilanterol hos KOLpatienter på 65 år og derover svarede til farmakokinetikken hos KOL-patienter under 65 år.
English: Co-administration with ketoconazole (400 mg) in healthy volunteers increased mean vilanterol AUC(0-t) and Cmax, 65% and 22% respectively.
Danish: Samtidig administration med ketoconazol (400 mg) hos raske personer øgede vilanterols gennemsnitlige AUC(0-t) og Cmax, med henholdsvis 65 % og 22 %.
English: Mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo was 224 ml (p<0.001∗) at Week 24.
Danish: De gennemsnitlige forbedringer i FEV1 inden for de første 6 timer efter dosering, i forhold til placebo, var 224 ml (p < 0,001*) ved uge 24.
English: Although no formal in vivo drug interaction studies have been performed, inhaled umeclidinium/vilanterol has been used concomitantly with other COPD medicinal products including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.
Danish: Selvom der ikke er udført formelle interaktionsstudier in vivo, er inhaleret umeclidinium/vilanterol blevet anvendt samtidigt med andre lægemidler mod KOL, herunder korttidsvirkende sympatomimetiske bronkodilatatorer og inhalationssteroider, uden klinisk evidens for interaktion mellem lægemidlerne.
English: It is unknown whether umeclidinium or vilanterol are excreted in human milk.
Danish: Det vides ikke om umeclidinium eller vilanterol udskilles i human mælk.
English: When given subcutaneously there were no effects at 36-times the human clinical exposure of vilanterol 22 micrograms, based on AUC.
Danish: Ved subkutan administration var der ingen virkninger ved 36 gange human klinisk eksponering over for vilanterol 22 mikrogram, baseret på AUC.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på den fremstillere, der er ansvarlig for batchfrigivelse
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your ANORO ELLIPTA inhaler:
Danish: Hvis du får trykken for brystet, hoste, hvæsende vejrtrækning eller åndenød, umiddelbart efter at du har brugt din Anoro Ellipta inhalator:
English: There are no data from the use of umeclidinium/vilanterol in pregnant women.
Danish: Der er ingen data fra anvendelse af umeclidinium/vilanterol til gravide kvinder.
English: Plasma metabolic profiles following oral administration of vilanterol in a human radiolabel study were consistent with high first-pass metabolism.
Danish: Efter oral administration af vilanterol i et studie med radioaktiv mærkning hos mennesker, var de metaboliske profiler i plasma i overensstemmelse med en høj first-pass-metabolisme.
English: In inhalation studies in rabbits, vilanterol caused effects similar to those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation) at 6-times the human clinical exposure based on AUC.
Danish: I inhalationsstudier med kaniner medførte vilanterol virkninger, der lignede de virkninger, der ses med andre beta2-agonister (ganespalte, åbne øjenlåg, sammenvoksning ved sternum og abnormt bøjede lemmer/malrotation) ved 6 gange human klinisk eksponering, baseret på AUC.
English: 3) Inhale your medicine • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Danish: 3) Inhalér din medicin • Hold inhalatoren væk fra munden og foretag den dybeste udånding, du finder behagelig.
English: Vilanterol plasma elimination half-life following inhaled dosing for 10 days averaged 11 hours.
Danish: Halveringstiden for elimination af vilanterol i plasma efter dosering via inhalation i 10 dage, var i gennemsnit 11 timer.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine:
Danish: Hvis du får trykken for brystet, hoste, hvæsende vejrtrækning eller åndenød, umiddelbart efter, at du har brugt denne medicin:
English: To use ANORO ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler.
Danish: Anoro Ellipta tages ved at indånde medicinen ned i dine lunger gennem munden ved hjælp af Ellipta-inhalatoren.