FrancophonIA/ELRC3.0 huggingface dataset:
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 or cobicistat, to treat HIV infection medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets)
Danish: - betablokkere (f.eks. propranolol) til behandling af højt blodtryk eller andre hjerteproblemer - ketoconazol og itraconazol til behandling af svampeinfektioner - clarithromycin og telithromycin til behandling af bakterieinfektioner - ritonavir og cobicistat til behandling af hiv-infektion - lægemidler, der sænker kaliumindholdet i dit blod, f.eks. vanddrivende midler
English: In IMPACT, Trelegy Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
Danish: I IMPACT medførte Trelegy Ellipta en signifikant forbedring (p < 0,001) i lungefunktionen sammenlignet med FF/VI og UMEC/VI over en 52-ugers periode (se tabel 2).
English: In vitro plasma protein binding in human plasma was on average 94%.
Danish: In vitro-plasmaproteinbindingen i humant plasma var i gennemsnit 94 %.
English: Vilanterol plasma elimination half-life following inhaled dosing for 10 days averaged 11 hours.
Danish: Vilanterols plasmahalveringstiden efter inhalation i 10 dage var 11 timer i gennemsnit.
English: Plasma clearance following intravenous administration was 65.4 litres/hour.
Danish: Plasmaclearance efter intravenøs administration var 65,4 liter pr. time.
English: Cough Oropharyngeal pain
Danish: Hoste Oropharyngeale smerter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1236/001
English: White powder in a light grey inhaler (Ellipta) with a beige mouthpiece cover and a dose counter.
Danish: Hvidt pulver i lysegrå inhalator (Ellipta) med en beige beskyttelseshætte over mundstykket og en dosistæller.
English: Multipacks containing 90 (3 inhalers of 30) doses (90 day supply) are also available.
Danish: Multipakninger med 90 (3 inhalatorer med 30) doser (til 90 dages forbrug) fås også.
English: Beta2-adrenergic agonists may produce transient hyperglycaemia in some patients.
Danish: Beta2-adrenerge agonister kan medføre kortvarig hyperglykæmi hos nogle patienter.
English: The effects of race, gender and weight on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were also evaluated in the population pharmacokinetic analysis.
Danish: Virkningerne af race, køn og vægt på farmakokinetikken af fluticasonfuroat, umeclidinium og vilanterol blev ligeledes vurderet i populationsfarmakokinetikanalysen.
English: Therefore, Trelegy Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.
Danish: Trelegy Ellipta bør derfor anvendes med forsigtighed til patienter med ustabil eller livstruende kardiovaskulær sygdom.
English: Pharmacological and toxicological effects seen with fluticasone furoate, umeclidinium or vilanterol in nonclinical studies were those typically associated with glucocorticoids, muscarinic receptor antagonists, or beta2-adrenergic receptor agonists.
Danish: De farmakologiske og toksikologiske effekter, der blev set med fluticasonfuroat, umeclidinium og vilanterol i prækliniske studier, var typisk de samme, som normalt ses med glukokortikoider, muskarine receptorantagonister og beta2-adrenerge receptoragonister.
English: In IMPACT, treatment with Trelegy Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
Danish: I IMPACT reducerede behandlingen med Trelegy Ellipta den årlige frekvens af svære eksacerbationer (dvs. der krævede hospitalsindlæggelse eller resulterede i død) med 13 % sammenlignet med FF/VI (95 % CI: -1, 24; p = 0,064).
English: Don't use this medicine if you are breastfeeding unless your doctor tells you that you can.
Danish: Undlad at bruge lægemidlet, hvis du ammer, medmindre lægen siger, at du kan bruge det.
English: The apparent plasma elimination half-life of fluticasone furoate following inhaled administration of fluticasone furoate/vilanterol was, on average, 24 hours.
Danish: Fluticasonfuroats tilsyneladende plasmahalveringstiden efter inhalation af fluticasonfuroat/vilanterol var 24 timer i gennemsnit.
English: IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Trelegy Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Danish: IMPACT (CTT116855) var et 52-ugers studie (n = 10.355), der sammenlignede Trelegy Ellipta (92/55/22 mikrogram) med fluticasonfuroat/vilanterol 92/22 mikrogram (FF/VI) og umeclidinium/vilanterol 55/22 mikrogram (UMEC/VI).
English: In a total of 1810 patients with advanced COPD (mean post-bronchodilator screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Trelegy Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
Danish: Hos i alt 1.810 patienter med fremskreden KOL (gennemsnitlig postbronkodilator FEV1 ved screening på 45 % af det forventede, standardafvigelse (SD) 13 %), hvoraf 65 % havde haft en moderat/svær eksacerbation af KOL i året før indtrædelse i studiet (studie CTT116853), blev der indberettet en højere forekomst af pneumonitilfælde op til 24 uger hos patienter, der fik Trelegy Ellipta (20 patienter, 2 %), end hos patienter, der fik budesonid/formoterol (7 patienter, < 1 %).
English: No clinically relevant effects on plasma glucose were observed in clinical studies with fluticasone furoate/umeclidinium/vilanterol at the recommended therapeutic dose.
Danish: Der er ikke observeret klinisk relevante effekter på plasmaglucose i kliniske studier med fluticasonfuroat/umeclidinium/vilanterol ved den anbefalede terapeutiske dosis.
English: Plasma clearance of vilanterol following intravenous administration was 108 litres/hour.
Danish: Plasmaclearance for vilanterol efter intravenøs administration var 108 liter pr. time.
English: Co-administration of Trelegy Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Danish: Administration af Trelegy Ellipta samtidig med andre langtidsvirkende muskarine antagonister eller langtidsvirkende beta2-adrenerge agonister er ikke blevet undersøgt og anbefales ikke, da det kan forstærke bivirkningerne (se pkt.
English: Following intravenous administration of vilanterol to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Danish: Efter intravenøs administration af vilanterol til frivillige raske forsøgspersoner var den gennemsnitlige fordelingsvolumen ved steady-state 165 liter.
English: Vilanterol had no adverse effect on preor post-natal development in rats.
Danish: Vilanterol havde ingen negative virkninger på den præ- eller postnatale udvikling hos rotter.
English: In vitro plasma protein binding in human plasma of fluticasone furoate was high, on average >99.6%.
Danish: Fluticasonfuroats in vitro-plasmaproteinbinding i humant plasma var høj - i gennemsnit > 99,6 %.
English: In IMPACT, Trelegy Ellipta significantly reduced (p<0.001) the use of rescue medication (occasions per day) at each 4-week time period compared with FF/VI and UMEC/VI.
Danish: I IMPACT medførte Trelegy Ellipta en signifikant reduktion (p < 0,001) i brugen af akutmedicin (tilfælde pr. dag) i hver periode på 4 uger sammenlignet med FF/VI og UMEC/VI.
English: Trelegy Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Danish: Trelegy Ellipta bør anvendes med forsigtighed hos patienter med snævervinklet glaukom eller urinretention.
English: The medicine may not be tasted or felt, even when using the inhaler correctly.
Danish: Det er ikke sikkert, at du kan smage eller mærke lægemidlet, selvom inhalatoren anvendes korrekt.
English: What Trelegy Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Danish: Trelegy Ellipta indeholder De aktive stoffer er fluticasonfuroat, umeclidiniumbromid og vilanterol.
English: • inflammation of the sinuses
Danish: • inflammation i bihulerne
English: b) How to inhale the medicinal product
Danish: b) Sådan inhaleres lægemidlet
English: No effect of verapamil was observed on umeclidinium or vilanterol Cmax.
Danish: Der blev ikke observeret nogen virkning af verapamil på Cmax af umeclidinium eller vilanterol.
English: 1 inhaler of 30 doses
Danish: 1 inhalator med 30 doser
English: Trelegy Ellipta contains lactose
Danish: Trelegy Ellipta indeholder lactose
English: Trelegy Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Danish: Trelegy Ellipta bør administreres med forsigtighed til patienter med lungetuberkulose og til patienter med kroniske eller ubehandlede infektioner.
English: Respiratory, thoracic & mediastinal disorders
Danish: Luftveje, thorax og mediastinum
English: • Put the mouthpiece between your lips, and close your lips firmly around it. Don't block the air vent with your fingers.
Danish: • Placer mundstykket mellem læberne, og luk læberne godt sammen omkring mundstykket.
English: • Rinse your mouth with water after you have used the inhaler, do not swallow.
Danish: • Skyl munden med vand uden at synke det, efter at du har brugt inhalatoren.
English: Each blister in one strip contains fluticasone furoate, each blister in the other strip contains umeclidinium (as bromide) and vilanterol (as trifenatate).
Danish: Den ene blister indeholder fluticasonfuroat og den anden blister indeholder umeclidinium (som bromid) og vilanterol (som trifenatat).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 14 doser
English: The following instructions for the 30 dose (30 day supply) Ellipta inhaler also apply to the 14 dose (14 day supply) Ellipta inhaler.
Danish: Følgende vejledning til Ellipta-inhalatoren med 30 doser (30 dages forbrug) gælder også for Elliptainhalatoren med 14 doser (14 dages forbrug).
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Danish: Datoen "Kasseres senest" er 6 uger efter den dag, hvor bakken åbnes.
English: If you forget to use Trelegy Ellipta
Danish: Hvis du har glemt at bruge Trelegy Ellipta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1236/003
English: c) Close the inhaler and rinse your mouth
Danish: c) Luk inhalatoren, og skyl munden
English: Rinse your mouth with water after you have used the inhaler, do not swallow.
Danish: Skyl munden med vand uden at synke det, efter at du har brugt inhalatoren.
English: There were no effects on development in rats at exposures 6.6fold the human clinical exposure at a daily dose of 92 micrograms, based on AUC.
Danish: Der var ingen effekt på udviklingen hos rotter ved eksponeringer, der var 6,6 gange højere end dem, der opnås hos mennesker ved en daglig dosis på 92 mikrogram, baseret på AUC.
English: Write the date that the inhaler should be discarded on the label and carton in the space provided.
Danish: Datoen for, hvornår inhalatoren skal kasseres, skal angives på etiketten og æsken i det dertil beregnede felt.
English: The effects of age on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were evaluated in the population pharmacokinetic analysis.
Danish: Alderens indvirkning på farmakokinetikken af fluticasonfuroat, umeclidinium og vilanterol blev evalueret i populationsfarmakokinetikanalysen.
English: In FULFIL, Trelegy Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
Danish: I FULFIL medførte Trelegy Ellipta et signifikant fald i risikoen for en moderat/svær eksacerbation sammenlignet med BUD/FOR over 24 uger (33 %; 95% CI: 12; 48; p =
English: Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Trelegy Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months.
Danish: Studie 200812 var et 24-ugers non-inferiorstudie (n = 1.055), der sammenlignede Trelegy Ellipta (92/55/22 mikrogram) med FF/VI (92/22 mikrogram) + UMEC (55 mikrogram), der blev administreret samtidig som en multi-inhalatorbehandling én gang dagligt hos patienter med moderate eller svære eksacerbationer inden for de seneste 12 måneder.
English: Plasma clearance following intravenous administration was 151 litres/hour.
Danish: Plasmaclearance efter intravenøs administration var 151 liter pr. time.
English: The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
Danish: Placer mundstykket mellem læberne, og luk læberne godt sammen omkring mundstykket.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with P-gp inhibitors.
Danish: Ud fra disse ændringers betydning forventes der ingen klinisk relevante lægemiddelinteraktioner, når fluticasonfuroat/umeclidinium/vilanterol administreres samtidig med P-gp-hæmmere.
English: There are no data on the effects of fluticasone furoate/umeclidinium/vilanterol on human fertility.
Danish: Der foreligger ingen data om virkningen af fluticasonfuroat/umeclidinium/vilanterol på fertiliteten hos mennesker.
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 of 1.4- or 2.9-fold, respectively, those seen in humans at a daily dose of 92 micrograms fluticasone furoate, based on AUC.
Danish: Fluticasonfuroat var ikke genotoksisk i en række standardstudier og ikke karcinogent ved livslang inhalationsbehandling hos rotter og mus ved eksponeringer henholdsvis 1,4 eller 2,9 gange højere end dem, der opnås hos mennesker ved en daglig dosis på 92 mikrogram fluticasonfuroat, baseret på AUC.
English: If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use.
Danish: Hvis inhalatoren opbevares på køl, skal den ligge ved stuetemperatur i mindst én time før brug.
English: There was no increase in tumour incidence in rats or mice at exposures 0.9- or 22-fold, respectively, the human clinical exposure of vilanterol at a daily dose of 22 micrograms based on AUC.
Danish: Der var ingen stigning i forekomsten af tumorer hos rotter eller mus ved eksponeringer, der var henholdsvis 0,9 og 22 gange højere end dem, der opnås hos mennesker ved en daglig dosis på 22 mikrogram vilanterol, baseret på AUC.
English: Don't open the inhaler until you are ready to inhale a dose of medicine.
Danish: Inhalatoren må ikke åbnes, før du er klar til at inhalere en dosis af lægemidlet.
English: Further management should be clinically indicated or as recommended by the national poisons centre, where available.
Danish: Yderligere behandling gives efter klinisk behov eller i henhold til den nationale giftcentrals anbefalinger (www.giftlinjen.dk).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Dette lægemiddel må ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp lactase deficiency) eller glucose-/galactosemalabsorption.
English: In FULFIL, Trelegy Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
Danish: I FULFIL medførte Trelegy Ellipta en signifikant reduktion (p < 0,001) i brugen af akutmedicin mellem uge 1-24 sammenlignet med BUD/FOR (behandlingsforskel: -0,2 tilfælde pr. dag; 95 % CI:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (ENKELTPAKNINGER)
English: In IMPACT, Trelegy Ellipta prolonged the time to first moderate/severe exacerbation and significantly decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
Danish: I IMPACT medførte Trelegy Ellipta en signifikant forlængelse i tiden til første moderate/svære eksacerbation og et signifikant fald (p < 0,001) i risikoen for moderate/svære eksacerbationer målt ved tid til første eksacerbation, sammenlignet med både FF/VI (14,8 %; 95 % CI: 9,3; 19,9) og UMEC/VI (16,0 %; 95% CI: 9,4; 22,1).
English: At weeks 49-52, the treatment difference was -0.28 (95% CI: -0.37, -0.19) when compared with FF/VI and -0.30 (95% CI: -0.41, -0.19) with UMEC/VI.
Danish: I uge 49-52 var behandlingsforskellen -0,28 (95 % CI: -0,37; -0,19) når sammenlignet med FF/VI og -0,30 (95 % CI:0,41; -0,19) når sammenlignet med UMEC/VI.
English: Trelegy Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0).
Danish: Trelegy Ellipta medførte en signifikant forbedring (p < 0,001) i helbredsrelateret livskvalitet (målt ved hjælp af SGRQ-score [St. George's Respiratory Questionnaire]) i både FULFIL (uge 24) når sammenlignet med BUD/FOR (-2,2 enheder; 95 % CI: -3,5; -1,0) og IMPACT (uge 52) når sammenlignet med FF/VI (-1,8 enheder; 95 % CI: -2,4; -1,1) og UMEC/VI (-1,8 enheder; 95 % CI:
English: GlaxoSmithKline Trading Services Limited Currabinny
Danish: GlaxoSmithKline Trading Services Limited.
English: In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Trelegy Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
Danish: I IMPACT var andelen af respondenter også signifikant højere (p < 0,001) for Trelegy Ellipta (36 %) sammenlignet med FF/VI (29 %; OR 1,36; 95 % CI: 1,19; 1,55) og UMEC/VI (30 %; OR 1,33; 95 % CI: 1,13; 1,57).
English: The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta compared with BUD/FOR (47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94).
Danish: Andelen af respondenter i uge 21-24 var signifikant højere (p < 0,001) for patienter behandlet med Trelegy Ellipta sammenlignet med BUD/FOR (henholdsvis 47 % og 37 %; OR 1,59; 95 % CI: 1,30; 1,94).
English: If you store in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use.
Danish: Hvis du opbevarer inhalatoren på køl, skal den ligge ved stuetemperatur i mindst én time før brug.
English: In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Trelegy Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
Danish: I et 52-ugers studie med i alt 10.355 KOL-patienter og moderate eller svære eksacerbationer inden for de seneste 12 måneder (gennemsnitlig postbronkodilator FEV1 ved screening på 46 % af forventede, standardafvigelse (SD) 15 %) (studie CTT116855) var forekomsten af pneumoni på 8 % (317 patienter) for Trelegy Ellipta (n = 4.151), 7 % (292 patienter) for fluticasonfuroat/vilanterol (n = 4.134) og 5 % (97 patienter) for umeclidinium/vilanterol (n = 2.070).
English: For fluticasone furoate, patients with moderate hepatic impairment showed up to three times higher systemic exposure (FF 184 micrograms); therefore, patients with severe hepatic impairment received half the dose (FF 92 micrograms).
Danish: I forbindelse med fluticasonfuroat viste patienter med moderat nedsat leverfunktion op til 3 gange så høj systemisk eksponering (FF 184 mikrogram).
English: In IMPACT, Trelegy Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
Danish: I IMPACT medførte Trelegy Ellipta en statistisk signifikant reduktion i det gennemsnitlige antal natlige opvågninger som følge af KOL sammenlignet med FF/VI (-0,05; 95 % CI: -0,08; -0,01; p = 0,005) og med UMEC/VI (-0,10; 95 % CI: -0,14; -0,05; p < 0,001) i uge 49 til 52.
English: a) Prepare a dose
Danish: a) Sådan skal du klargøre en dosis
English: Following repeat dosing of inhaled umeclidinium/vilanterol, steady state was achieved within 6 days with up to 1.5-fold accumulation.
Danish: Efter gentaget inhalation af umeclidinium/vilanterol blev der opnået steady-state inden for 6 dage med en akkumulering på op til 1,5 gange.
English: Treatment with Trelegy Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Danish: Behandling med Trelegy Ellipta medførte en signifikant reduktion i den årlige frekvens af svære eksacerbationer med 34 % sammenlignet med UMEC/VI (95 % CI: 22,44; p
English: When given subcutaneously there were no effects at exposures 62-fold the human clinical exposure at a daily dose of 22 micrograms, based on AUC.
Danish: Ved subkutan administration var der ingen effekter ved eksponeringer, der var 62 gange højere end dem, der opnås hos mennesker ved en daglig dosis på 22 mikrogram, baseret på AUC.
English: 2 years Shelf-life after opening the tray: 6 weeks
Danish: Opbevaringstid efter anbrud af bakken: 6 uger
English: Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation
Danish: Efter gentaget inhalation af fluticasonfuroat/vilanterol blev der opnået steady-state inden for 6 dage med en akkumulering på op til 1,6 gange.
English: Animal studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see section 5.3).
Danish: Dyreforsøg viser ingen effekt af fluticasonfuroat, umeclidinium eller vilanterol på fertiliteten hos mennesker (se pkt.
English: The third study included safety data from 4,151 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with two active comparators (study CTT116855, IMPACT).
Danish: Det tredje studie omfattede sikkerhedsdata fra 4.151 KOL-patienter, der fik fluticasonfuroat/umeclidinium/vilanterol 92/55/22 mikrogram én gang dagligt i op til 52 uger, med to aktive komparatorer (studie CTT116855, IMPACT).
English: Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose of 55 micrograms umeclidinium, based on AUC respectively.
Danish: Umeclidinium var ikke genotoksisk i en række standardstudier og ikke karcinogent ved livslang inhalationsbehandling hos mus og rotter ved eksponeringer på henholdsvis ≥ 20 og ≥ 17 gange højere end dem, der opnås hos mennesker ved en daglig dosis på 55 mikrogram umeclidinium, baseret på AUC.