FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Trelegy Ellipta naqqas sinifikament ir-riskju ta' taħrix moderat/sever meta mqabbel ma' BUD/FOR matul 24 ġimgħa (33%; 95% CI: 12, 48; p=0.004).
English: Trelegy 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).
Maltese: Trelegy Ellipta huwa indikat bħala kura ta' manteniment f'pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD, chronic obstructive pulmonary disease) moderat sa sever li ma jiġux ikkurati b'mod adegwat b'kombinazzjoni ta' kortikosterojde li jittieħed man-nifs u agonista-β2 li jaġixxi fit-tul jew kombinazzjoni ta' agonista-β2 li jaġixxi fit-tul u agonista-β2 li jaġixxi fit-tul muskariniku (għall-effetti dwar il-kontroll tassintomi u prevenzjoni ta' taħrix ara sezzjoni 5.1).
English: FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Trelegy Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Maltese: FULFIL (CTT116853) kien studju ta' 24 ġimgħa (N=1,810), b'estensjoni sa 52 ġimgħa f'subsett ta' individwi (n=430), li qabbel Trelegy Ellipta (92/55/22 mikrogramma) ma' budesonide/formoterol 400/12il mikrogramma (BUD/FOR) mogħti darbtejn kuljum.
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).
Maltese: Il-kura bi Trelegy Ellipta naqqset sinifikament ir-rata annwali ta' taħrix sever b'34 % meta mqabbel ma' UMEC/VI (95% CI: 22, 44; p<0.001).
English: Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g. eosinophils, macrophages, lymphocytes) and mediators (e.g. cytokines and chemokines) involved in inflammation.
Maltese: Il-kortikosterojdi ntwerew li għandhom firxa wiesgħa ta' azzjonijiet fuq diversi tipi ta' ċelloli (eż. eosinofili, makrofaġi, limfoċiti) u medjaturi (eż. ċitokini u kemokini) involuti fl-infjammazzjoni.
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).
Maltese: 001) għal Trelegy Ellipta (36%) meta mqabbel ma' FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) u UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
English: Multipack of 90 (3 packs of 30) dose inhalers.
Maltese: Pakkett multiplu ta' inalatur ta' 90 (3 pakketti ta' 30) doża.
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Maltese: M'hemmx evidenza klinika konklussiva għal differenzi bejn klassi u oħra fid-daqs tar-riskju tal-pulmonite fost il-prodotti kortikosterojdi li jittieħdu bin-nifs.
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 and vilanterol, respectively.
Maltese: L-effetti kardjovaskulari, bħal arritmiji kardijaċi, eż. fibrillazzjoni atrijali u takikardija, jistgħu jidhru wara lgħoti ta' riċetturi muskariniċi antagonisti u simpatomimetiċi, inkluż umeclidinium u vilanterol, rispettivament.
English: No dosage adjustment is required in patients over 65 years (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti ta' aktar minn 65 sena (ara sezzjoni 5.2).
English: Following intravenous dosing of fluticasone furoate to healthy volunteers, the mean volume of distribution at steady state of 661 litres.
Maltese: Wara dożaġġ ġol-vini ta' fluticasone furoate lil voluntiera b'saħħithom, il-volum medju ta' distribuzzjoni flistat fiss kien ta' 661 litru.
English: Contents of the pack and other information Step-by-step instructions
Maltese: Kontenut tal-pakkett u informazzjoni oħra Struzzjonijiet pass wara pass
English: The pre-specified non-inferiority margin was 50 mL.
Maltese: Il-marġini tan-noninferjorità speċifikat minn qabel kien 50 mL.
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).
Maltese: Fi studju ta' 52 ġimgħa, b'total ta' 10,355 pazjent b'COPD u storja ta' taħrix moderat jew sever fi żmien it12-il xahar ta' qabel (skrinjar wara l-bronkodilatur medju FEV1 ta' 46 % tal-previst, SD 15%) (studju CTT116855), l-inċidenza ta' pulmonite kienet 8 % (317-il pazjent) għal Trelegy Ellipta (n = 4,151), 7% (292 individwu) għal fluticasone furoate/vilanterol (n = 4,134), u 5 % (97 individwu) għal umeclidinium/vilanterol (n = 2,070).
English: Lung function endpoint in FULFIL
Maltese: End-point tal-funzjoni tal-pulmun f'FULFIL
English: Significant reductions were observed over all other timepoints for UMEC/VI (p<0.001) and for the all but two of the of timepoints for FF/VI (p≤0.021).
Maltese: Ġie osservat tnaqqis sinifikament fil-punti ta' żmien l-oħra kollha għal UMEC/VI (p<0.001) u għall-punti ta' żmien kollha ħlief tnejn għal FF/VI (p≤0.021).
English: GlaxoSmithKline, s.r.o.
Maltese: Česká republika GlaxoSmithKline, s.r.o.
English: In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Maltese: Studji in vitro wrew li fluticasone furoate jiġi metabolizzat primarjament miċ-ċitokromu P450 3A4 (CYP3A4) u huwa substrat għat-trasportatur tal-P-gp.
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).
Maltese: George's [SGRQ]) kemm f'FULFIL (ġimgħa 24) meta mqabbel ma' BUD/FOR (-2.2 unitajiet; 95% CI: -3.5, -1.0) u IMPACT (ġimgħa 52) meta mqabbel ma' FF/VI (-1.8 unitajiet; 95% CI: -2.4, -1.1) u UMEC/VI (-1.8 unitajiet; 95% CI: -2.6, -1.0).
English: Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (LABA).
Maltese: Vilanterol huwa riċettur agonist adrenerġiku selettiv ta' beta2, li jaġixxi fit-tul (LABA).
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.
Maltese: Leffett tal-inibitur moderat tal-P-gp, verapamil (240 mg darba kuljum), fuq il-farmakokinetika fi stat fiss ta' umeclidinium u vilanterol ġie vvalutat f'voluntiera b'saħħithom.
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%).
Maltese: F'total ta' 1810 pazjenti b'COPD avvanzat (skrinjar wara l-bronkodilatur medju FEV1 ta' 45 % tal-previst, devjazzjoni standard (SD, standard deviation) 13 %), 65 % minnhom esperjenzaw taħrix tas-COPD moderat/sever fis-sena preċedenti qabel id-dħul fl-istudju (studju CTT116853), kien hemm inċidenza ogħla ta' avvenimenti ta' pulmonite rrappurtati sa 24 ġimgħa f'pazjenti li kienu qed jirċievu Trelegy Ellipta (20 pazjent, 2 %) milli f'pazjenti li kienu qed jirċievu budesonide/formoterol (7 pazjenti, <1 %).
English: Following intravenous administration of umeclidinium to healthy volunteers, the mean volume of distribution was 86 litres.
Maltese: Wara għoti ġol-vini ta' umeclidinium lil voluntiera b'saħħithom, il-volum medju ta' distribuzzjoni kien ta' 86 litru.
English: In IMPACT, over 52 weeks, Trelegy Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
Maltese: F'IMPACT, matul 52 ġimgħa, Trelegy Ellipta naqqas sinifikament ir-rata annwali ta' taħrix moderat/sever bi 15 % (95% CI:10, 20) meta mqabbel ma' FF/VI (rata; 0.91 vs 1.07 avvenimenti għal kull sena ta' pazjent) u b'25% (95% CI: 19, 30) meta mqabbel ma' UMEC/VI (rata; 0.91 vs 1.21 avvenimenti għal kull sena ta' pazjent).
English: The absolute bioavailability of fluticasone furoate when administrated as fluticasone furoate/vilanterol by inhalation was 15.2%, primarily due to absorption of the inhaled portion of the dose delivered to the lung, with negligible contribution from oral absorption.
Maltese: Il-bijodisponibbiltà assoluta ta' fluticasone furoate meta mogħti bħala fluticasone furoate/vilanterol permezz ta' teħid bin-nifs kienet ta' 15.2 %, primarjament minħabba l-assorbiment tal-proporzjon tad-doża meħud bin-nifs imwassal lill-pulmun, b'kontribuzzjoni negliġibbli minn assorbiment orali.
English: The increase in fluticasone furoate exposure was associated with a 27% reduction in 0-24 hours weighted mean serum cortisol.
Maltese: Iż-żieda fl-esponiment għal fluticasone furoate kienet assoċjata ma' tnaqqis ta' 27 % filmedja peżata ta' cortisol fis-seru fuq perjodu ta' 0-24 siegħa.
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.
Maltese: Studju 200812 kien studju ta' 24 ġimgħa, ta' non-inferjorità (N=1,055) li qabbel Trelegy Ellipta (92/55/22 mikrogramma) ma' FF/VI (92/22 mikrogramma) + UMEC (55 mikrogramma), mogħti flimien darba kuljum bħala terapija ta' ħafna inalaturi f'pazjenti bi storja ta' taħrix moderat jew sever fi żmien 12il xahar.
English: At study entry, the most common COPD medications reported in the FULFIL and IMPACT studies were ICS +LABA+LAMA (28%, 34% respectively), ICS+LABA (29%, 26% respectively), LAMA+LABA (10%, 8% respectively) and LAMA (9%, 7% respectively).
Maltese: Mad-dħul fl-istudju, il-medikazzjonijiet tas-COPD l-aktar komuni li ġew irrappurtati fl-istudji FULFIL u IMPACT kienu ICS +LABA+LAMA (28%, 34% rispettivament), ICS+LABA (29%, 26% rispettivament),
English: 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).
Maltese: It-tieni studju inkluda dejta dwar is-sigurtà minn 527 pazjent b'COPD li rċivew fluticasone furoate/umeclidinium/vilanterol (92/55/22 mikrogramma) u 528 pazjent b'COPD li rċivew fluticasone furoate/vilanterol (92/22 mikrogramma) + umeclidinium (55 mikrogramma) darba kuljum sa 24 ġimgħa (studju 200812).
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).
Maltese: Il-proporzjon ta' rispondenti matul ġimgħat 21-24 kien sinifikament ogħla (p<0.001) għal pazjenti kkurati bi Trelegy meta mqabbel ma' BUD/FOR (47% u 37% rispettivament; OR 1.59; 95% CI: 1.30, 1.94).
English: In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter.
Maltese: Studji in vitro wrew li umeclidinium jiġi metabolizzat primarjament miċ-ċitokromu P450 2D6 (CYP2D6) u huwa substrat għat-trasportatur tal-P-gp.
English: Multipacks containing 90 (3 inhalers of 30) doses (90 day supply) are also available.
Maltese: Huma disponibbli wkoll pakketti multipli li fihom 90 (3 inalaturi ta' 30) doża (provvista ta' 90 jum).
English: Adverse reactions detected during these clinical trials are listed by MedDRA system organ class.
Maltese: Ir-reazzjonijiet avversi li ġew osservati waqt dawn il-provi kliniċi huma elenkati mis-sistema tal-klassifika tal-organi MedDRA.
English: Following intravenous administration, the elimination phase half-life averaged 15.1 hours.
Maltese: Wara għoti ġol-vini, il-fażi tal-eliminazzjoni tal-half-life kienet ta' medja ta' 15.1 sigħat.
English: • inflammation of the sinuses
Maltese: • infjammazzjoni tas-sinusis
English: In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Maltese: Studji in vitro wrew li vilanterol jiġi metabolizzat primarjament miċ-ċitokromu P450 3A4 (CYP3A4) u huwa substrat għat-trasportatur tal-P-gp.
English: In vitro plasma protein binding in human plasma of fluticasone furoate was high, on average >99.6%.
Maltese: Ittwaħħil ta' fluticasone furoate mal-proteini tal-plażma in vitro fil-plażma tal-bniedem kien għoli, bħala medja >99.6 %.
English: Following intravenous administration of vilanterol to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Maltese: Wara għoti ġol-vini ta' vilanterol lil voluntiera b'saħħithom, il-volum medju ta' distribuzzjoni fl-istat fiss kien ta' 165 litru.
English: The decrease in serum potassium is usually transient, not requiring supplementation.
Maltese: It-tnaqqis fil-potassju fis-serum huwa normalment temporanju, u ma jkunx jeħtieġ supplimentazzjoni.
English: Following oral administration, fluticasone furoate was eliminated in humans mainly by metabolism with metabolites being excreted almost exclusively in faeces, with <1% of the recovered radioactive dose eliminated in the urine.
Maltese: Wara għoti orali, fluticasone furoate kien eliminat fil-bnedmin prinċipalment permezz tal-metaboliżmu bilmetaboliti jitneħħew kważi esklussivament fl-ippurgar, b'<1 % tad-doża radjuattiva rkuprata tiġi eliminata fl-awrina.
English: A higher percentage of patients receiving Trelegy Ellipta responded with a clinically meaningful improvement in SGRQ total score in FULFIL at week 24 compared with BUD/FOR (50% and 41% respectively), odds ratios of response vs. non-response (OR) (1.41; 95% CI: 1.16, 1.70) and in IMPACT at week 52 compared with FF/VI and UMEC/VI (42%, 34% and 34% respectively), OR vs. FF/VI (1.41; 95% CI:1.29, 1.55) and OR vs. UMEC/VI (1.41; 95% CI: 1.26, 1.57); all treatment comparisons were statistically significant (p<0.001).
Maltese: Perċentwali ogħla ta' pazjenti li rċivew Trelegy Ellipta rrispondew b'titjib klinikament sinifikanti fil-punteġġ totali ta' SGRQ f'FULFIL f'ġimgħa 24 meta mqabbel ma' BUD/FOR (50% u 41% rispettivament), proporzjonijiet ta' probabbiltà ta' rispons kontra nuqqas ta' rispons (OR) (1.41; 95% CI: 1.16, 1.70) u f'IMPACT f'ġimgħa 52 meta mqabbel ma' FF/VI u UMEC/VI (42%, 34% u 34% rispettivament), OR vs.
English: The absolute bioavailability of inhaled umeclidinium was on average 13%, with negligible contribution from oral absorption.
Maltese: Il-bijodisponibilità assoluta ta' umeclidinium li jittieħed mannifs kienet bħala medja 13 %, b'kontribuzzjoni negliġibbli mill-assorbiment orali.
English: Breathlessness was measured using the Transition Dyspnoea Index (TDI) focal score at week 24 in FULFIL and week 52 in IMPACT (a subset of patients, n=5,058).
Maltese: Il-qtugħ ta' nifs tkejjel mill-punteġġ fokali tal-Indiċi tad-Dispnea ta' Tranżizzjoni (TDI) f'ġimgħa 24 f'FULFIL u ġimgħa 52 f' IMPACT (subsett ta' pazjenti, n=5,058).
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.
Maltese: F'IMPACT, Trelegy Ellipta naqqas sinifikament in-numru medju ta' qawmien billejl minħabba COPD meta mqabbel ma' FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) u ma' UMEC/VI (-0.10; 95% CI: -0.
English: 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).
Maltese: LS=l-inqas kaxxi; SE= errur standard, N=numru fl-intenzjoni li jikkura l-popolazzjoni; CI= interval ta' kunfidenza, a Differenza fil-kura statistikament sinifikanti għal FF/UMEC/VI vs.
English: 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).
Maltese: Din tikkorrispondi għal doża lesta minn qabel ta' 100 mikrogramma fluticasone furoate, 74.2 mikrogramma umeclidinium bromide ekwivalenti għal 62.5 mikrogramma umeclidinium u 25 mikrogramma vilanterol (bħala trifenatate).
English: Adults
Maltese: Pożoloġija Adulti
English: In FULFIL, based upon data up to 24 weeks, Trelegy Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
Maltese: F'FULFIL, abbażi ta' dejta sa 24 ġimgħa, Trelegy Ellipta naqqas sinifikament (p=0.002) ir-rata annwali ta' taħrix moderat/sever b'35 % (95% CI: 14, 51) meta mqabbel ma' BUD/FOR.
English: When fluticasone furoate, umeclidinium and vilanterol were administered in combination by the inhaled route from a single inhaler in healthy subjects, the pharmacokinetics of each component were similar to those observed when each active substance was administered either as fluticasone furoate/vilanterol combination or as an umeclidinium/vilanterol combination or umeclidinium monotherapy.
Maltese: Meta fluticasone furoate, umeclidinium u vilanterol ingħataw f'kombinazzjoni mir-rotta li tittieħed bin-nifs minn inalatur wieħed f'individwi b'saħħithom, il-farmakokinetika ta' kull komponent kienet simili għal dik osservata meta kull sustanza attiva ngħataw jew bħala kombinazzjoni ta' fluticasone furoate/vilanterol jew bħala kombinazzjoni ta' umeclidinium/vilanterol jew monoterapija bi umeclidinium.
English: TQT studies for FF/VI and umeclidinium/vilanterol (UMEC/VI) did not show clinically relevant effects on QT interval at clinical doses of FF, UMEC and VI.
Maltese: L-istudji tat-TQT għal FF/VI u umeclidinium/vilanterol (UMEC/VI) ma wrewx effetti klinikament relevanti fuq l-intervall QT b'dożi kliniċi ta' FF, UMEC u VI.
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.
Maltese: Ma kien hemm l-ebda effett fuq l-iżvilupp fil-firien b'esponimenti 6.6 darbiet l-esponiment kliniku tal-bniedem b'doża ta' kuljum ta' 92 mikrogramma, abbażi tal-AUC.
English: NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Maltese: Trelegy Ellipta 92/55/22 mcg trab li jittieħed man-nifs fluticasone furoate/umeclidinium/vilanterol
English: No clinically relevant effects on the QTc interval were observed on review of centrally read ECGs from 911 subjects with COPD exposed to fluticasone furoate/umeclidinium/vilanterol for up to 24 weeks, or in the subset of 210 subjects exposed for up to 52 weeks.
Maltese: Ma ġie osservat l-ebda effett klinikament relevanti fuq l-intervall QTc abbażi ta' reviżjoni ta' ECGs moqrija ċentralment minn 911-il individwu b'COPD esposti għal fluticasone furoate/umeclidinium/vilanterol sa 24 ġimgħa, jew fis-subset ta' 210 individwu esposti sa 52 ġimgħa.
English: In FULFIL, bronchodilatory effects with Trelegy 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).
Maltese: F'FULFIL, l-effetti bronkodilatorji bi Trelegy Ellipta kienu evidenti fl-ewwel jum ta' kura u nżammu matul il-perjodu ta' kura ta' 24 ġimgħa (il-bidliet medji mil-linja bażi f'FEV1 kienu 90-222 mL f'jum 1 u 160-339 mL f'ġimgħa 24).
English: Health-Related Quality of Life
Maltese: GĦAMLA KWALITATTIVA
English: 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).
Maltese: 001) għal pazjenti kkurati bi Trelegy Ellipta (42%) meta mqabbel ma' FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) u UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
English: In 113 East Asian subjects with COPD (Japanese and East Asian Heritage), who received FF/UMEC/VI from a single inhaler (27% subjects), fluticasone furoate AUC(ss) estimates were on average 30% higher compared with Caucasian subjects.
Maltese: F'113-il individwu mil-Lvant tal-Asja b'COPD (Wirt Ġappuniż u mil-Lvant tal-Asja), li rċivew FF/UMEC/VI minn inalatur wieħed (27% tal-individwi), l-istimi tal-AUC(ss) ta' fluticasone furoate kienu bħala medja 23% sa 30% ogħla meta mqabbla ma' individwi Kawkasi.
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Trading Services Limited GSK Logo
Maltese: GlaxoSmithKline Trading Services Limited.
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).
Maltese: It-tielet studju inkluda dejta dwar is-sigurtà minn 4,151 pazjent b'COPD li rċivew fluticasone furoate/umeclidinium/vilanterol 92/55/22 mikrogramma darba kuljum sa 52 ġimgħa, b'żewġ komparaturi attivi (studju CTT116855, IMPACT).
English: The steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Maltese: Il-farmakokinetika fi stat fiss ta' umeclidinium ġiet ivvalutata f'voluntiera b'saħħithom neqsin minn CYP2D6 (metabolizzaturi dgħajfa).
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Maltese: Jista' jiġi rrappurtat disturb fil-vista b'użu tal-kortikosterojdi sistemiċi u topiċi.
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.
Maltese: L-effetti farmakoloġiċi u tossikoloġiċi li dehru bi fluticasone furoate, umeclidinium jew vilanterol fi studji mhux kliniċi kienu dawk tipikament assoċjati mal-kortikosterojdi, mal-antagonisti tar-riċetturi muskariniċi, jew mal-agonisti tar-riċetturi beta adrenerġiċi.
English: At screening, the mean post-bronchodilator percent predicted FEV1 was 45% and 65% of patients reported a history of one or more moderate/severe exacerbation in the past year.
Maltese: Waqt l-iskrinjar, l-FEV1 medju wara l-bronkodilatur kien ta' 45 % tal-previst u 65 % tal-pazjenti rrappurtaw storja ta' taħrix wieħed jew aktar moderat/sever fissena mgħoddija.
English: Umeclidinium and vilanterol belong to a group of medicines called bronchodilators.
Maltese: Umeclidinium u vilanterol jagħmlu parti minn grupp ta' mediċini li jissejjaħ bronkodilaturi.