natgillin/translations-raw huggingface dataset:
Undlad at bruge lægemidlet, hvis du ammer, medmindre lægen siger, at du kan bruge det.
Don't use this medicine if you are breastfeeding unless your doctor tells you that you can.
Fluticasonfuroats tilsyneladende plasmahalveringstiden efter inhalation af fluticasonfuroat/vilanterol var 24 timer i gennemsnit.
The apparent plasma elimination half-life of fluticasone furoate following inhaled administration of fluticasone furoate/vilanterol was, on average, 24 hours.
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).
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).
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 %).
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%).
Der er ikke observeret klinisk relevante effekter på plasmaglucose i kliniske studier med fluticasonfuroat/umeclidinium/vilanterol ved den anbefalede terapeutiske dosis.
No clinically relevant effects on plasma glucose were observed in clinical studies with fluticasone furoate/umeclidinium/vilanterol at the recommended therapeutic dose.
Plasmaclearance for vilanterol efter intravenøs administration var 108 liter pr. time.
Plasma clearance of vilanterol following intravenous administration was 108 litres/hour.
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.
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).
Efter intravenøs administration af vilanterol til frivillige raske forsøgspersoner var den gennemsnitlige fordelingsvolumen ved steady-state 165 liter.
Following intravenous administration of vilanterol to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Vilanterol havde ingen negative virkninger på den præ- eller postnatale udvikling hos rotter.
Vilanterol had no adverse effect on preor post-natal development in rats.
Fluticasonfuroats in vitro-plasmaproteinbinding i humant plasma var høj - i gennemsnit > 99,6 %.
In vitro plasma protein binding in human plasma of fluticasone furoate was high, on average >99.6%.
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.
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.
Trelegy Ellipta bør anvendes med forsigtighed hos patienter med snævervinklet glaukom eller urinretention.
Trelegy Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Det er ikke sikkert, at du kan smage eller mærke lægemidlet, selvom inhalatoren anvendes korrekt.
The medicine may not be tasted or felt, even when using the inhaler correctly.
Trelegy Ellipta indeholder De aktive stoffer er fluticasonfuroat, umeclidiniumbromid og vilanterol.
What Trelegy Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
• inflammation i bihulerne
• inflammation of the sinuses
b) Sådan inhaleres lægemidlet
b) How to inhale the medicinal product
Der blev ikke observeret nogen virkning af verapamil på Cmax af umeclidinium eller vilanterol.
No effect of verapamil was observed on umeclidinium or vilanterol Cmax.
1 inhalator med 30 doser
1 inhaler of 30 doses
Trelegy Ellipta indeholder lactose
Trelegy Ellipta contains lactose
Trelegy Ellipta bør administreres med forsigtighed til patienter med lungetuberkulose og til patienter med kroniske eller ubehandlede infektioner.
Trelegy Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Luftveje, thorax og mediastinum
Respiratory, thoracic & mediastinal disorders
• Placer mundstykket mellem læberne, og luk læberne godt sammen omkring mundstykket.
• Put the mouthpiece between your lips, and close your lips firmly around it. Don't block the air vent with your fingers.
• Skyl munden med vand uden at synke det, efter at du har brugt inhalatoren.
• Rinse your mouth with water after you have used the inhaler, do not swallow.
Den ene blister indeholder fluticasonfuroat og den anden blister indeholder umeclidinium (som bromid) og vilanterol (som trifenatat).
Each blister in one strip contains fluticasone furoate, each blister in the other strip contains umeclidinium (as bromide) and vilanterol (as trifenatate).
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 14 doser
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Følgende vejledning til Ellipta-inhalatoren med 30 doser (30 dages forbrug) gælder også for Elliptainhalatoren med 14 doser (14 dages forbrug).
The following instructions for the 30 dose (30 day supply) Ellipta inhaler also apply to the 14 dose (14 day supply) Ellipta inhaler.
Datoen "Kasseres senest" er 6 uger efter den dag, hvor bakken åbnes.
The “Discard by” date is 6 weeks from the date of opening the tray.
Hvis du har glemt at bruge Trelegy Ellipta
If you forget to use Trelegy Ellipta
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c) Luk inhalatoren, og skyl munden
c) Close the inhaler and rinse your mouth
Skyl munden med vand uden at synke det, efter at du har brugt inhalatoren.
Rinse your mouth with water after you have used the inhaler, do not swallow.
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.
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.
Datoen for, hvornår inhalatoren skal kasseres, skal angives på etiketten og æsken i det dertil beregnede felt.
Write the date that the inhaler should be discarded on the label and carton in the space provided.
Alderens indvirkning på farmakokinetikken af fluticasonfuroat, umeclidinium og vilanterol blev evalueret i populationsfarmakokinetikanalysen.
The effects of age on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were evaluated in the population pharmacokinetic analysis.
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 =
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).
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.
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.
Plasmaclearance efter intravenøs administration var 151 liter pr. time.
Plasma clearance following intravenous administration was 151 litres/hour.
Placer mundstykket mellem læberne, og luk læberne godt sammen omkring mundstykket.
The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
Ud fra disse ændringers betydning forventes der ingen klinisk relevante lægemiddelinteraktioner, når fluticasonfuroat/umeclidinium/vilanterol administreres samtidig med P-gp-hæmmere.
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.
Der foreligger ingen data om virkningen af fluticasonfuroat/umeclidinium/vilanterol på fertiliteten hos mennesker.
There are no data on the effects of fluticasone furoate/umeclidinium/vilanterol on human fertility.
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.
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.
Hvis inhalatoren opbevares på køl, skal den ligge ved stuetemperatur i mindst én time før brug.
If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use.
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.
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.
Inhalatoren må ikke åbnes, før du er klar til at inhalere en dosis af lægemidlet.
Don't open the inhaler until you are ready to inhale a dose of medicine.
Yderligere behandling gives efter klinisk behov eller i henhold til den nationale giftcentrals anbefalinger (www.giftlinjen.dk).
Further management should be clinically indicated or as recommended by the national poisons centre, where available.
Dette lægemiddel må ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp lactase deficiency) eller glucose-/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
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:
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).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (ENKELTPAKNINGER)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS)
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).
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).
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.
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.
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:
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).
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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).
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).
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).
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).
Hvis du opbevarer inhalatoren på køl, skal den ligge ved stuetemperatur i mindst én time før brug.
If you store in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use.
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).
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).
I forbindelse med fluticasonfuroat viste patienter med moderat nedsat leverfunktion op til 3 gange så høj systemisk eksponering (FF 184 mikrogram).
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).
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.
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.
a) Sådan skal du klargøre en dosis
a) Prepare a dose
Efter gentaget inhalation af umeclidinium/vilanterol blev der opnået steady-state inden for 6 dage med en akkumulering på op til 1,5 gange.
Following repeat dosing of inhaled umeclidinium/vilanterol, steady state was achieved within 6 days with up to 1.5-fold accumulation.
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
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).
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.
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.
Opbevaringstid efter anbrud af bakken: 6 uger
2 years Shelf-life after opening the tray: 6 weeks
Efter gentaget inhalation af fluticasonfuroat/vilanterol blev der opnået steady-state inden for 6 dage med en akkumulering på op til 1,6 gange.
Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation
Dyreforsøg viser ingen effekt af fluticasonfuroat, umeclidinium eller vilanterol på fertiliteten hos mennesker (se pkt.
Animal studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see section 5.3).
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).
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).
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.
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.
Efter intravenøs administration af fluticasonfuroat til frivillige raske forsøgspersoner var den gennemsnitlige fordelingsvolumen ved steady-state 661 liter.
Following intravenous dosing of fluticasone furoate to healthy volunteers, the mean volume of distribution at steady state of 661 litres.
FEV1 = forceret ekspiratorisk volumen i første sekund; l = liter; LS = mindste kvadrater; SE = standardfejl; n = antal i intention to treat; CI = konfidensinterval, a Statistisk signifikant behandlingsforskel for FF/UMEC/VI ift.
FEV1=forced expiratory volume in 1 second; L=litres; LS=least squares; SE= standard error, N=number in the intent-totreat population; CI= confidence interval, a Statistically significant treatment difference for FF/UMEC/VI vs. BUD/FOR also observed at the other assessment timepoints (weeks 2, 4 and 12).
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Dette svarer til en afdelt dosis på 100 mikrogram fluticasonfuroat, 74,2 mikrogram umeclidiniumbromid svarende til 62,5 mikrogram umeclidinium og 25 mikrogram vilanterol (som trifenatat).
This corresponds to a pre-dispensed dose of 100 micrograms fluticasone furoate, 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Det skal du vide, før du begynder at bruge Trelegy Ellipta
What you need to know before you use Trelegy Ellipta
In vitro-studier har vist, at vilanterol primært metaboliseres af cytokrom P450 3A4 (CYP3A4) og er et substrat for P-gp-transporteren.
In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Det andet studie omfattede sikkerhedsdata fra 527 KOL-patienter, der fik fluticasonfuroat/umeclidinium/vilanterol (92/55/22 mikrogram) og 528 KOL-patienter, der fik fluticasonfuroat/vilanterol (92/22 mikrogram) + umeclidinium (55 mikrogram) én gang dagligt i op til 24 uger (studie 200812).
The second study included safety data from 527 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol (92/55/22 micrograms) and 528 patients with COPD who received fluticasone furoate/vilanterol (92/22 micrograms) + umeclidinium (55 micrograms) once daily for up to 24 weeks (study 200812).
Den indeholder afmålte doser og er klar til brug med det samme.
The Ellipta inhaler contains pre-dispensed doses and is ready to use.
Fluticasonfuroat, umeclidinium og vilanterol havde ingen bivirkninger på fertiliteten blandt hanrotter og hunrotter.
Fluticasone furoate, umeclidinium and vilanterol did not have any adverse effects on male or female fertility in rats.
Det er ikke nødvendigt at kontrollere, om Trelegy Ellipta-inhalatoren virker korrekt, før du bruger den første gang.
The first time you use Trelegy Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
I IMPACT var andelen af patienter, der var CAT-respondenter i uge 52, signifikant højere (p < 0,001) for patienter behandlet med Trelegy Ellipta (42 %) sammenlignet med FF/VI (37 %; OR 1,24; 95 % CI: 1,14; 1,36) og UMEC/VI (36 %; OR 1,28; 95 % CI: 1,15; 1,43).
In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
In vitro-studier har vist, at umeclidinium primært metaboliseres af cytokrom P450 2D6 (CYP2D6) og er et substrat for P-gp-transporteren.
In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter.
In vitro-studier har vist, at fluticasonfuroat primært metaboliseres af cytokrom P450 3A4 (CYP3A4) og er et substrat for P-gp-transporteren.
In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
For yderligere oplysning om håndtering af inhalatoren, se pkt.
For further instructions on handling the device, see section 6.6.
Det første studie omfattede sikkerhedsdata fra 911 KOL-patienter, der har fået fluticasonfuroat/umeclidinium/vilanterol 92/55/22 mikrogram én gang dagligt i op til 24 uger, hvoraf 210 patienter fik fluticasonfuroat/umeclidinium/vilanterol 92/55/22 mikrogram én gang dagligt i op til 52 uger, med en aktiv komparator (studie CTT116853, FULFIL).
The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).