FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no specific treatment for an overdose with Temybric Ellipta.
Danish: Der findes ingen specifik behandling af overdosering med Temybric Ellipta.
English: Don't use Temybric Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Temybric Ellipta: - hvis du er allergisk over for fluticasonfuroat, umeclidinium, vilanterol eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: One fatal case of pneumonia was reported in a patient who received Temybric Ellipta.
Danish: Der blev indberettet et tilfælde af dødelig pneumoni hos en patient, der fik Temybric Ellipta.
English: Temybric Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Danish: Temybric Ellipta skal bruges hver dag og ikke kun, når du har problemer med vejrtrækningen eller andre symptomer på KOL.
English: Eye problems during treatment with Temybric Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Temybric Ellipta:
Danish: Øjenproblemer ved behandling med Temybric Ellipta Hvis du oplever smerter eller ubehag i øjnene, midlertidigt sløret syn, synlige haloer eller farvede billeder såvel som røde øjne ved behandling med Temybric Ellipta:
English: The other ingredients are lactose monohydrate (see section 2 under ‘Temybric Ellipta contains lactose') and magnesium stearate.
Danish: De øvrige indholdsstoffer er lactosemonohydrat (se punkt 2 ”Temybric Ellipta indeholder lactose”) og magnesiumstearat.
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Temybric Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Danish: Der opstod pneumoni, som krævede hospitalsindlæggelse, hos 1 % af de patienter, der fik Temybric Ellipta, og hos < 1 % af de patienter, der fik budesonid/formoterol op til 24 uger.
English: The most frequently reported adverse reactions with Temybric Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Danish: De hyppigst indberettede bivirkninger ved brug af Temybric Ellipta var nasopharyngitis (7 %), hovedpine (5 %) og infektion i de øvre luftveje (2 %).
English: Tabulated summary of adverse reactions The safety profile of Temybric Ellipta is based on three phase III clinical studies.
Danish: Tabel over bivirkninger Sikkerhedsprofilen for Temybric Ellipta er baseret på tre kliniske fase III-studier.
English: Treatment with Temybric Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Danish: Behandling med Temybric Ellipta skal stoppes omgående, hvis der opstår paradoks bronkospasme.
English: Upon initiation of treatment with Temybric Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Danish: Ved initiering af behandling med Temybric Ellipta, bør plasmaglucose monitoreres tættere hos diabetespatienter.
English: Rinsing your mouth out with water immediately after using Temybric Ellipta may help prevent this side effect.
Danish: Hvis du skyller munden med vand og spytter vandet ud, umiddelbart efter at du har brugt Temybric Ellipta, kan det være med til at forebygge denne bivirkning
English: The recommended and maximum dose is one inhalation of Temybric Ellipta 92/55/22 micrograms once daily, at the same time each day.
Danish: Den anbefalede og maksimale dosis er én inhalation med Temybric Ellipta 92/55/22 mikrogram én gang dagligt på samme tidspunkt hver dag.
English: Don't use Temybric Ellipta if you already use these medicines.
Danish: Du må ikke bruge Temybric Ellipta, hvis du allerede bruger et eller flere af disse lægemidler.
English: The fluticasone furoate/vilanterol component of Temybric Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Danish: Fluticasonfuroat/vilanterol-komponenten i Temybric Ellipta er blevet vurderet hos patienter med alle sværhedsgrader af nedsat leverfunktion (Child-Pugh A, B eller C).
English: In Study 200812, Temybric Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
Danish: I studie 200812 var Temybric Ellipta non-inferior sammenlignet med FF/VI + UMEC, som blev administreret samtidig i to inhalatorer, i forbedringen fra FEV1-baseline i uge 24.
English: Temybric Ellipta is for inhalation use only.
Danish: Temybric Ellipta er kun beregnet til inhalation.
English: The efficacy of Temybric Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Danish: Virkningen af Temybric Ellipta (92/55/22 mikrogram), der administreres én gang dagligt, er blevet evalueret hos patienter med en klinisk KOL-diagnose i to studier med aktiv kontrol og i et enkelt, noninferiorstudie.
English: In FULFIL, bronchodilatory effects with Temybric Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24).
Danish: I FULFIL var de bronkodilatoriske virkninger med Temybric Ellipta evidente på den første behandlingsdag og blev opretholdt i løbet af behandlingsperioden på 24 uger (ændringerne i forhold til baseline i FEV1 var 90-222 ml på dag 1 og 160-339 ml i uge 24).
English: Temybric Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Danish: Temybric Ellipta bruges til at behandle kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: Patients should not stop therapy with Temybric Ellipta without physician supervision since symptoms may recur after discontinuation.
Danish: Patienten bør ikke stoppe behandlingen med Temybric Ellipta uden samråd med lægen, da symptomerne kan vende tilbage efter seponering.
English: Once the tray is opened Temybric Ellipta is ready to use.
Danish: Når bakken er åbnet er Temybric Ellipta klar til brug.
English: Talk to your doctor before using Temybric Ellipta - if you have asthma (Don't use Temybric Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
Danish: Kontakt lægen, før du bruger Temybric Ellipta - hvis du har astma (Temybric Ellipta må ikke bruges til at behandle astma) - hvis du har hjerteproblemer eller højt blodtryk - hvis du har leverproblemer - hvis du har lungetuberkulose (TB) eller langvarige eller ubehandlede infektioner - hvis du har et problem med øjnene kaldet snævervinklet glaukom - hvis du har forstørret prostata, besvær med at tisse eller en blokering i blæren - hvis du lider af epilepsi - hvis du har problemer med skjoldbruskkirtlen - hvis du har lavt kaliumindhold i blodet - hvis du har diabetes - hvis du oplever sløret syn eller andre synsforstyrrelser.
English: In the event of deterioration of COPD during treatment with Temybric Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Danish: Hvis KOL-tilstanden forværres under behandling med Temybric Ellipta, skal der foretages en ny vurdering af patienten og af KOL-behandlingsmetoden.
English: In FULFIL, Temybric Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Danish: I FULFIL forbedrede Temybric Ellipta daglige symptomer på KOL som vurderet ved E-RS: Samlet KOL score sammenlignet med BUD/FOR (fald på ≥ 2 enheder fra baseline).
English: Temybric Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Danish: Temybric Ellipta medførte en signifikant forbedring (p < 0,001) i lungefunktionen (defineret ved en gennemsnitlig ændring fra FEV1-baseline i uge 24) (se tabel 1), og forbedringen blev opretholdt i undergruppen af patienter, der fortsatte behandlingen til uge 52.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Temybric 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 Temybric Ellipta i alle undergrupper af den pædiatriske population ved KOL (se pkt.
English: Caution should be exercised when Temybric Ellipta is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Danish: Der bør udvises forsigtighed, når Temybric Ellipta anvendes sammen med andre lægemidler, der også potentielt kan forårsage hypokalæmi (se pkt.
English: Use Temybric Ellipta regularly
Danish: Brug Temybric Ellipta regelmæssigt
English: Other medicines and Temybric Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Temybric Ellipta Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Temybric Ellipta inhaler:
Danish: Hvis du får trykken for brystet, hoste, hvæsende vejrtrækning eller åndenød umiddelbart efter at have brugt Temybric Ellipta-inhalatoren:
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Temybric Ellipta - these could be symptoms of a lung infection:
Danish: Lungebetændelse (pneumoni) hos KOL-patienter (almindelig bivirkning) Kontakt lægen, hvis du får et eller flere af følgende symptomer, mens du bruger Temybric Elliptadet kan være symptomer på lungebetændelse:
English: A decision must be made whether to discontinue breast-feeding or to discontinue Temybric Ellipta 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 eller behandling med Temybric Ellipta skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Trough FEV1 (L) at Week 24, LS mean change from baseline (SE)a
Danish: Trough FEV1 (l) i uge 24, gennemsnitlig LSændring fra baseline (SE)a
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with Temybric Ellipta at the recommended therapeutic dose.
Danish: Der er ikke observeret klinisk relevante hypokalæmieffekter i kliniske studier med Temybric Ellipta ved den anbefalede terapeutiske dosis.
English: The incidence of pneumonia with Temybric Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Danish: Forekomsten af pneumoni ved brug af Temybric Ellipta er sammenlignelig med den forekomst, der blev observeret i fluticasonfuroat/vilanterol (FF/VI) 100/25gruppen i kliniske FF/VI-studier af KOL.
English: Temybric Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
Danish: Temybric Ellipta er indiceret til vedligeholdelsesbehandling hos voksne patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), som ikke er velkontrolleret med en kombination af inhalationssteroid og en langtidsvirkende beta2-agonist eller en kombination af en langtidsvirkende beta2-agonist og en langtidsvirkende muskarin-antagonist (for effekt på symptomkontrol og forebyggelse af eksacerbationer, se pkt.
English: Temybric Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Danish: Temybric Ellipta indeholder tre aktive stoffer ved navn fluticasonfuroat, umeclidinium og vilanterol.
English: If you are breast-feeding, you must check with your doctor before you use Temybric Ellipta.
Danish: Hvis du ammer, skal du tale med lægen, før du bruger Temybric Ellipta.
English: Temybric Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Danish: Temybric Ellipta bør bruges med forsigtighed hos patienter med krampelidelser eller tyreotoksikose og hos patienter, der reagerer i usædvanlig høj grad på beta2-adrenerge agonister.
English: Temybric Ellipta contains lactose
Danish: Temybric Ellipta indeholder lactose
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Temybric Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
Danish: Letal pneumoni forekom hos 12 af 4.151 patienter (3,5 pr. 1.000 patientår), som fik Temybric Ellipta, 5 af 4.134 patienter (1,7 pr. 1.000 patientår), som fik fluticasonfuroat/vilanterol og 5 af 2.070 patienter (2.9 pr. 1.000 patientår), som fik umeclidinium/vilanterol.
English: Patients with moderate to severe hepatic impairment receiving Temybric Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Danish: Patienter med moderat til svært nedsat leverfunktion, som får Temybric Ellipta, bør monitoreres for bivirkninger relateret til kortikosteroiders systemiske virkninger (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1378/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1378/001
English: Temybric Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Danish: Temybric Ellipta kan ikke anvendes til lindring af pludselige anfald af åndenød eller hvæsende vejrtrækning.
English: INFORMATION IN BRAILLE temybric ellipta
Danish: INFORMATION I BRAILLESKRIFT temybric ellipta
English: In IMPACT, Temybric 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 Temybric 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: Co-administration of Temybric 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 Temybric 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: 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 Temybric 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 Temybric Ellipta (20 patienter, 2 %), end hos patienter, der fik budesonid/formoterol (7 patienter, < 1 %).
English: What Temybric Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Danish: Temybric Ellipta indeholder De aktive stoffer er fluticasonfuroat, umeclidiniumbromid og vilanterol.
English: In IMPACT, treatment with Temybric 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 Temybric 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: Therefore, Temybric Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.
Danish: Temybric Ellipta bør derfor anvendes med forsigtighed til patienter med ustabil eller livstruende kardiovaskulær sygdom.
English: IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Temybric 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 Temybric Ellipta (92/55/22 mikrogram) med fluticasonfuroat/vilanterol 92/22 mikrogram (FF/VI) og umeclidinium/vilanterol 55/22 mikrogram (UMEC/VI).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1378/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1378/003
English: In IMPACT, Temybric 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 Temybric 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: Temybric Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Danish: Temybric Ellipta bør administreres med forsigtighed til patienter med lungetuberkulose og til patienter med kroniske eller ubehandlede infektioner.
English: Temybric Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Danish: Temybric Ellipta bør anvendes med forsigtighed hos patienter med snævervinklet glaukom eller urinretention.
English: Treatment with Temybric 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 Temybric Ellipta medførte en signifikant reduktion i den årlige frekvens af svære eksacerbationer med 34 % sammenlignet med UMEC/VI (95 % CI: 22,44; p <0,001).
English: Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Temybric 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 Temybric 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: If you forget to use Temybric Ellipta
Danish: Hvis du har glemt at bruge Temybric Ellipta
English: In FULFIL, Temybric 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 Temybric 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: In FULFIL, Temybric 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 Temybric 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: Temybric 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: Temybric 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: The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Temybric 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 Temybric Ellipta sammenlignet med BUD/FOR (henholdsvis 47 % og 37 %; OR 1,59; 95 % CI: 1,30; 1,94).
English: In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Temybric 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 Temybric 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: In IMPACT, Temybric 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 Temybric 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: 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 Temybric 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 Temybric Ellipta (n = 4.151), 7 % (292 patienter) for fluticasonfuroat/vilanterol (n = 4.134) og 5 % (97 patienter) for umeclidinium/vilanterol (n = 2.070).