FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of the cardiovascular composite event with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.93; 95% CI: 0.75 to 1.14), fluticasone furoate (HR 1.03; 95% CI: 0.83 to 1.28) or vilanterol (HR 0.94; 95% CI: 0.76 to 1.16).
Maltese: Ir-riskju tal-avveniment kompost kardjovaskulari ma' fluticasone furoate/vilanterol ma kienx ferm differenti meta mqabbel mal-plaċebo (HR 0.93; 95% CI: 0.75 sa 1.14), fluticasone furoate (HR 1.03; 95% CI: 0.83 sa 1.28) jew vilanterol (HR 0.94; 95% CI: 0.76 sa 1.16).
English: Barnard Castle,
Maltese: Harmire Road, Barnard Castle, County Durham
English: Fluticasone furoate/vilanterol 92/22 micrograms increased trough FEV1 by 46 mL compared to vilanterol (95% CI: 8, 83mL, p= 0.017).
Maltese: Fluticasone furoate/vilanterol 92/22 mikrogramma żied il-FEV1 minimu b'46 mL meta mqabbel ma' vilanterol (95% CI: 8, 83mL, p= 0.017).
English: At the 24-week time point FF and FP increased trough FEV1 by 146 mL (95% CI 36, 257 mL, p=0.009) and 145 mL (95% CI 33, 257 mL, p=0.011) respectively compared to placebo.
Maltese: żiedu l-FEV1 minimu b'146 mL (95% CI 36, 257 mL, p=0.009) u 145 mL (95% CI 33, 257 mL, p=0.011)
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Maltese: GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, L-Irlanda
English: Weighted Mean Serial FEV1 over 0-24 hours post-dose Treatment difference
Maltese: FEV1 Serjali Medju Peżat fuq perjodu ta' 0-24 siegħa wara d-doża
English: HZC112206 evaluated the efficacy of fluticasone furoate/vilanterol 46 /22 micrograms [n=206] and fluticasone furoate/vilanterol 92/22 micrograms [n=206] compared with FF 92 micrograms [n=206], vilanterol 22 micrograms [n=205] and placebo [n = 207], all administered once daily.
Maltese: HZC112206 evalwa l-effikaċja ta' fluticasone furoate/vilanterol 46 mikrogramma/22 mikrogramma [n=206] u fluticasone furoate/vilanterol 92/22 mikrogramma [n=206]) meta mqabbla ma' FF (92 mikrogramma [n=206]),
English: The adjusted mean treatment difference of -37 mL between the groups was not statistically significant (p=0.162).
Maltese: Id-differenza medja aġġustata tal-kuri, ta' -37 mL, bejn il gruppi ma kinitx statistikament sinifikanti (p=0.162).
English: FF and FP both increased the percentage of 24 hour rescue free periods by 14.8% (95% CI 6.9, 22.7, p<0.001) and 17.9% (95% CI 10.0, 25.7, p<0.001) respectively versus placebo.
Maltese: FF u FP it-tnejn żiedu l-perċentwal ta' perjodi ta' 24 siegħa ħielsa minn salvataġġ b'14.8% (95% CI 6.9, 22.7, p<0.001) u 17.9% (95% CI 10.0, 25.7, p<0.001) rispettivament kontra l-plaċebo.
English: A randomised, double-blind, parallel group, 24 week study (201378) was conducted to demonstrate noninferiority (using a margin of -100 mL for trough FEV1) of fluticasone furoate/vilanterol 92/22 once daily to salmeterol/FP 50/250 twice daily in adults and adolescents whose asthma was well controlled following 4 weeks of treatment with open-label salmeterol/FP 50/250 twice daily (N=1504).
Maltese: Sar studjurandomised, double-blind, ta' grupp parallel, ta' 24 ġimgħa (201378) biex jintwera n-nuqqas ta' inferjorità (bl-użu ta' marġini ta' -100 mL għall-FEV1 minimu) ta' fluticasone furoate/vilanterol 92/22 darba kuljum għal salmeterol/FP 50/250 darbtejn kuljum fl-adulti u fl-adolexxenti li l-ażżma tagħhom kienet ikkontrollata tajjeb wara 4 ġimgħat ta' kura b'salmeterol/FP 50/250 open-label darbtejn kuljum (N=1504).
English: The maximum recommended dose is Relvar Ellipta 184/22 micrograms once daily.
Maltese: Id-doża massima rakkomandata hi Relvar Ellipta 184/22 mikrogramma darba kuljum.
English: Adults and adolescents aged 12 years and over
Maltese: Adulti u adolexxenti minn 12-il sena 'l fuq
English: Vilanterol trifenatate is a selective long-acting, beta2-adrenergic agonist (LABA).
Maltese: Vilanterol trifenatate huwa agonist adrenerġiku selettiv, li jaħdem fit-tul, ta' beta2 (LABA).
English: There were no clinically relevant effects of the fluticasone furoate/vilanterol combination on beta-adrenergic systemic effects (heart rate or serum potassium) in subjects with mild or moderate hepatic impairment (vilanterol, 22 micrograms) or with severe hepatic impairment (vilanterol, 12.5 micrograms) compared with healthy subjects.
Maltese: Ma kienx hemm effetti klinikament rilevanti tal-kombinazzjoni ta' fluticasone furoate/vilanterol fuq l-effetti sistemiċi beta-adrenerġiċi (ir-rata tal-qalb jew il-potassju fis-serum) f'individwi b'indeboliment tal-fwied ħafif jew moderat (vilanterol, 22 mikrogramma) jew b'indeboliment tal-fwied sever (vilanterol, 12.5
English: *, ** See below ‘Description of selected adverse reactions'
Maltese: *, ** Ara ‘Deskrizzjoni ta' reazzjonijiet avversi magħżula' hawn isfel Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids.
Maltese: Fluticasone furoate jappartjeni għal grupp ta' mediċini msejħa kortikosterojdi, ħafna drabi msejħa sempliċement sterojdi.
English: HZC112207 evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=204] and fluticasone furoate/vilanterol 184/22 micrograms [n=205] compared with FF 92 micrograms [n=204], FF 184 micrograms [n=203] and vilanterol 22 micrograms [n=203] and placebo [n = 205], all administered once daily.
Maltese: evalwa l-effikaċja ta' fluticasone furoate/vilanterol 92/22 mikrogramma [n=204] u fluticasone furoate/vilanterol (184/22 mikrogramma [n=205]) meta mqabbla ma' FF (92 mikrogramma [n=204], 184 mikrogramma [n=203]) u vilanterol (22 mikrogramma [n=203]) u l-plaċebo (n = 205), kollha mogħtija darba kuljum.
English: The bronchoprotective effect of fluticasone furoate/vilanterol 92/22 micrograms on the early and late asthmatic response to inhaled allergen was evaluated in a repeat dose, placebo-controlled four-way crossover study (HZA113126) in patients with mild asthma.
Maltese: L-effett bronkoprotettiv ta' fluticasone furoate/vilanterol 92/22 mikrogramma fuq ir-rispons ażżmatiku bikri u tard għal allerġen meħud man-nifs ġie evalwat fi studju four-way crossover, b'dożi ripetuti, ikkontrollat bil-plaċebo (HZA113126) f'pazjenti li kellhom ażżma ħafifa.
English: The oral bioavailability of both fluticasone furoate and vilanterol was low, on average 1.26% and <2%, respectively.
Maltese: Il-bijodisponibilità orali kemm ta' fluticasone furoate kif ukoll ta' vilanterol kienet baxxa, medja ta' 1.26% u <2%, rispettivament.
English: Gender, weight and BMI
Maltese: Sess tal-persuna, piż u BMI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 92/22 micrograms
Maltese: TIKKETTA TAL-PAKKETT (BIL-KAXXA L-BLU- PAKKETT MULTIPLU) 92/22 mikrogramma
English: P value (95% CI)
Maltese: Differenza bejn il-kuri Valur p (95% CI)
English: Subjects had moderate COPD (mean percent post-bronchodilator screening FEV1 of 60% [SD = 6%]), and a history of, or an increased risk of cardiovascular disease.
Maltese: L-individwi kellhom COPD moderata (FEV tal-iskrinjar wara l-bronkodilatur perċentwal medju, ta' 60% [SD = 6%], u storja ta', u riskju akbar ta' mard kardjovaskulari.
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucosegalactose malabsorption should not use this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jużaw din il-mediċina.
English: The ratio of the exacerbation rate for fluticasone furoate/vilanterol 92/22 micrograms versus FF 92 was 0.755 (95% CI 0.603, 0.945).
Maltese: mikrogramma kontra FF 92 kien ta' 0.755 (95% CI 0.603, 0.945).
English: Fluticasone furoate and vilanterol are substrates for P-glycoprotein (P-gp), however, concomitant administration of fluticasone furoate/vilanterol with P-gp inhibitors is considered unlikely to alter fluticasone furoate or vilanterol systemic exposure since they are both well absorbed molecules.
Maltese: Fluticasone furoate u vilanterol huma substrati għall-glikoproteina-P (P-gp), madankollu, l-għoti fl-istess ħin ta' fluticasone furoate/vilanterol ma' inibituri tal-P-gp mhuwiex meqjus probabbli li jibdel l-esponiment sistemiku għal fluticasone furoate jew vilanterol billi t-tnejn huma molekuli assorbiti tajjeb.
English: In the 12 months prior to the study, 61% of subjects reported no COPD exacerbations and 39% of subjects reported ≥1 moderate/severe COPD exacerbation.
Maltese: Fit-12-il xahar ta' qabel l-istudji, 61% talindividwi ma rrapportaw l-ebda taħrix tal-COPD u 39% tal-individwi rrapportaw ≥1 taħrix moderat/sever talCOPD.
English: There is no additional benefit of the 184/22 micrograms dose compared to the 92/22 micrograms dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions (see sections 4.4 and 4.8).
Maltese: M'hemm l-ebda benefiċċju addizzjonali tad doża ta' 184/22 mikrogramma meta mqabbel mad-doża ta' 92/22 mikrogramma u hemm riskju potenzjal akbar ta' pulmonite u ta' reazzjonijiet avversi relatati mal-kortikosterojdi sistemiċi (ara sezzjonijiet 4.4 u
English: Allergic reactions to Relvar Ellipta are rare (may affect up to 1 in 1,000 people).
Maltese: Reazzjonijiet allerġiċi għal Revinty Ellipta huma rari (jista jaffettwa sa persuna 1 minn 1,000 ).
English: In the asthma clinical development program a total of 7,034 patients were included in an integrated assessment of adverse reactions.
Maltese: Fil-programm ta' żvilupp kliniku dwar lażżma, total ta' 7,034 pazjent kienu inklużi f'valutazzjoni integrata tar-reazzjonijiet avversi.
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Maltese: Il-fatturi ta' riskju għal pulmonite f'pazjenti b'COPD jinkludu t-tipjip, età avvanzata, indiċi tal-massa tal ġisem (BMI) baxx u COPD severa.
English: See section 4 for information on symptoms to look out for while you are using this medicine.
Maltese: Ara sezzjoni 4 għal informazzjoni dwar is-sintomi li għandek toqgħod attent għalihom waqt li tkun qed tuża din il-mediċina.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Harmire Road,
Maltese: Glaxo Operations UK Limited (li tinnegozja bħala Glaxo Wellcome Operations),
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 184/22 micrograms
Maltese: TIKKETTA TAL-PAKKETT (BIL-KAXXA L-BLU- PAKKETT MULTIPLU) 184/22 mikrogramma
English: Multipack of 3 x 30 dose Inhalers.
Maltese: Pakkett multiplu ta' 3 Inalaturi ta' 30 doża kull wieħed.
English: The exposureadjusted rates (per 1000 treatment years) for all fracture events were 13.6, 12.8, 13.2, 11.5 respectively; fractures commonly associated with ICS use were 3.4, 3.9, 2.4, 2.1 respectively.
Maltese: Ir-rati aġġustati għall-esponiment (għal kull 1000 sena ta' kura) għall-avvenimenti kollha ta' ksur kienu 13.6, 12.8, 13.2, 11.5 rispettivament; ksur assoċjat b'mod komuni mal-użu tal-ICS kien 3.4, 3.9, 2.4, 2.1 rispettivament.
English: HZC112206 and HZC112207 were 24 week randomised, double-blind, placebo controlled, parallel group studies comparing the effect of the combination to vilanterol and FF alone and placebo.
Maltese: Studji ta' sitt xhur HZC112206 u HZC112207 kienu studji double-blind, randomizzati, bi gruppi paralleli, ikkontrollati bil plaċebo, li qabblu l-effett tal-kombinazzjoni ma' vilanterol u FF waħedhom u l-plaċebo.
English: At Day 169 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean trough FEV1 by 129 mL (95% CI: 91, 167 mL, p<0.001) and 83 mL (95% CI: 46, 121mL, p<0.001) respectively compared to placebo.
Maltese: F'Jum 169 fluticasone furoate/vilanterol 92/22 mikrogramma u vilanterol żiedu l-FEV1 minimu medju aġġustat b'129 mL (95% CI: 91, 167 mL, p<0.001) u 83 mL (95% CI: 46, 121mL, p<0.001) rispettivament meta mqabbla mal-plaċebo.
English: There was no evidence for age (12-84) to affect the pharmacokinetics of fluticasone furoate and vilanterol in subjects with asthma.
Maltese: Ma kien hemm l-ebda evidenza li l-età (12-84) taffettwa l-farmakokinetika ta' fluticasone furoate u vilanterol f'individwi bl-ażżma.
English: At Day 168 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean weighted mean FEV1 over 0-4 hours by 193mL (95% CI: 156, 230 mL, p<0.001) and 145 mL (95% CI: 108, 181 mL, p<0.001) respectively compared to placebo.
Maltese: F'Jum 168 fluticasone furoate/vilanterol 92/22 mikrogramma u vilanterol żiedu l-FEV1 medju peżat aġġustat fuq perjodu ta' 0-4 sigħat b'193mL (95% CI: 156, 230 mL, p<0.001) u 145 mL (95% CI: 108, 181 mL, p<0.001) rispettivament meta mqabbla mal-plaċebo.
English: The increase in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (Child-Pugh B; fluticasone furoate/vilanterol 184/22 micrograms) was associated with an average 34% reduction in serum cortisol compared with healthy subjects.
Maltese: Iż-żieda fl-esponiment sistemiku għal fluticasone furoate f'individwi b'indeboliment tal-fwied moderat (Child-Pugh B; fluticasone furoate/vilanterol 184/22 mikrogramma ) kienet assoċjata ma' tnaqqis medju ta' 34% fil-cortisol fis-serum meta mqabbel ma' individwi b'saħħithom.
English: Vilanterol is primarily metabolised by O-dealkylation to a range of metabolites with significantly reduced 1- and 2-agonist activity.
Maltese: Vilanterol huwa metabolizzat prinċipalment permezz ta' dealkilazzjoni-O f'firxa ta' metaboliti b'attività agonista ta' β1- u β2 konsiderevolment imnaqqsa.
English: The enhanced anti-inflammatory effect of the LABA component was similar to that obtained with other ICS/LABA combinations.
Maltese: L-effett anti-infjammatorju mtejjeb tal-komponent LABA kien simili għal dak miksub f'kombinazzjonijiet ICS/LABA oħrajn.
English: Consistent with findings for other beta2 agonists, in lifetime inhalation studies vilanterol trifenatate caused proliferative effects in the female rat and mouse reproductive tract and rat pituitary gland.
Maltese: B'mod konsistenti mas-sejbiet għal agonisti beta2 oħra, fi studji tal-inalazzjoni tul il-ħajja, vilanterol trifenatate kkawża effetti proliferattivi fl-apparat riproduttiv tal-firien u l-ġrieden nisa u fil-glandola pitwatarja tal-firien.
English: For an elderly subject (aged 84 years) with low bodyweight (35 kg) vilanterol AUC (0-24) is predicted to be 35% higher than the population estimate (subject with COPD aged 60 years and bodyweight of 70 kg), whilst Cmax was unchanged.
Maltese: Għal persuna anzjana (età ta' 84 sena) b'piż tal-ġisem baxx (35 kg), l-AUC (0-24) ta' vilanterol huwa previst li tkun 35% ogħla mill-istima għall-popolazzjoni (persuna b'COPD ta' 60 sena u piż tal-ġisem ta' 70 kg), filwaqt li s-Cmax ma nbidlitx.
English: Clinical pharmacology studies with a specific P-gp inhibitor and fluticasone furoate have not been conducted.
Maltese: Ma sarux studji kliniċi tal-farmakoloġija b'inibitur speċifiku tal-P-gp u fluticasone furoate.
English: The adjusted mean change from baseline in trough FEV1 on Day 85 was 111 mL in the fluticasone furoate/vilanterol group and 88 mL in the salmeterol/FP group; the 23 mL (95% CI: -20, 66) difference between the treatment groups was not clinically meaningful or statistically significant (p=0.294).
Maltese: Il-bidla medja aġġustata mil-linja bażi fil-FEV1 minimu f'Jum 85 kienet ta' 111 mL filgrupp li ħa fluticasone furoate/vilanterol u 88 mL fil-grupp li ħa FP/salmeterol; id-differenza ta' 23 mL (95% CI: -20, 66) bejn il-gruppi ta' kura ma kinitx klinikament importanti jew statistikament sinifikanti (p=0.294).
English: Similar effects in reduction of moderate and severe exacerbations were observed in this subgroup as compared with the overall population.
Maltese: Effetti simili fit-tnaqqis ta' taħrix moderat u sever kienu osservati f'dan is-sottogrupp meta mqabbel mal-popolazzjoni ġenerali.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tas-suq għas-sottomissjoni ta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u aġġornamenti sussegwenti jigu ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: 1 inhaler of 30 doses.
Maltese: Inalatur 1 ta' 30 doża.
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% fil-medja peżata ta' cortisol fis-serum fuq perjodu ta' 0-24 siegħa.
English: • cough
Maltese: **Ksur
English: There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females) and 1091 subjects with COPD (340 females).
Maltese: Ma kien hemm l-ebda evidenza li s-sess, il-piż jew il-BMI jaffettwaw il-farmakokinetika ta' vilanterol fuq il bażi ta' analiżi farmakokinetika tal-popolazzjoni fi 856 individwu bl-ażżma (500 mara) u 1091 individwu b'COPD (340 mara).
English: An overdose of fluticasone furoate/vilanterol may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Maltese: Doża eċċessiva ta' fluticasone furoate/vilanterol tista' tipproduċi sinjali u sintomi minħabba l-azzjonijiet talkomponenti individwali, inklużi dawk li jidhru b'doża eċċessiva ta' agonisti beta2 oħra u konsistenti maleffetti magħrufa tal-kategorija ta' kortikosterojdi li jittieħdu man-nifs (ara sezzjoni 4.4).
English: Other medicines and Relvar Ellipta
Maltese: Mediċini oħra u Relvar Ellipta
English: The step-by-step instructions shown below for the 30-dose Ellipta inhaler (30 day supply) also apply to the 14-dose Ellipta inhaler (14 day supply).
Maltese: L-istruzzjonijiet pass pass murija hawn taħt għall-inalatur Ellipta ta'30 doża (provvista ta' 30 ġurnata) japplikaw ukoll għad-doża Ellipta inalatur ta' 14-il doża (provvista ta' 14-il ġurnata).
English: Subjects randomised to once-daily FF/VI maintained lung function comparable with those randomised to twice-daily salmeterol/FP [difference in trough FEV1 of +19 mL (95% CI: -11, 49)].
Maltese: Il pazjenti randomised għal FF/VI darba kuljum żammew funzjoni tal-pulmun komparabbli ma' dawk li ġew randomised għal salmeterol/FP darbtejn kuljum [differenza fl-FEV1 minimu ta' +19 mL (95% CI: -11, 49)]. Monoterapija bi fluticasone furoate
English: Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (up to three-fold as measured by AUC(0-24)) in subjects with hepatic impairment (Child-Pugh A, B or C) compared with healthy subjects.
Maltese: Wara għoti ripetut ta' fluticasone furoate/vilanterol għal 7 ijiem, kien hemm żieda fl-esponiment sistemiku għal fluticasone furoate (sa tliet darbiet aktar kif imkejjel mill-AUC(0-24)) f'individwi b'indeboliment talfwied (Child-Pugh A, B jew C) meta mqabbel ma' individwi b'saħħithom.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Relvar Ellipta.
Maltese: Jistgħu jidhru effetti kardjovaskulari, bħal arritmiji tal-qalb, eż. takikardija sopraventrikolari u extrasistoli, bi prodotti mediċinali simpatomimetiċi fosthom Relvar Ellipta.
English: Cardioselective beta-blocking medicinal products should be used with caution in patients with a history of bronchospasm.
Maltese: Prodotti mediċinali ta' imblokk beta kardjoselettiv għandhom jintużaw bil-kawtela f'pazjenti bi storja ta' bronkospażmu.
English: In inhalation studies in rabbits, vilanterol trifenatate caused effects similar to those seen with other beta2 agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation).
Maltese: Fi studji tal-inalazzjoni fil-fniek, vilanterol trifenatate kkawża effetti simili għal dawk li dehru b'agonisti beta2 oħra (palat mixquq, kpiepel tal-għajnejn miftuħin, fużjoni sternebrali u liwja/rotazzjoni ħażina tad-dirgħajn u r-riġlejn).
English: In patients with a cardiovascular history/risk factors, fluticasone furoate/vilanterol 92/22 micrograms resulted in a significantly lower annual rate of moderate/severe COPD exacerbations compared with vilanterol (adjusted mean annual rates of 0.83 and 1.18 respectively, 30% reduction (95% CI 16, 42%, p<0.001)).
Maltese: F'pazjenti bi storja/fatturi ta' riskju kardjovaskulari, fluticasone furoate/vilanterol 92/22 mikrogramma rriżulta f'rata annwali konsiderevolment aktar baxxa ta' taħrix moderat/sever tal-COPD meta mqabbel ma' vilanterol (rati annwali medji aġġustati ta' 0.83 u 1.18 rispettivament, tnaqqis ta' 30% (95% CI 16, 42%,
English: Studies > 1 year duration
Maltese: Studji > durata ta' sena
English: County Durham DL12 8DT,
Maltese: DL12 8DT, Ir-Renju Unit.
English: There was no evidence for age to affect the pharmacokinetics of fluticasone furoate in subjects with COPD while there was an increase (37%) in AUC (0-24) of vilanterol over the observed age range of 41 to 84 years.
Maltese: Ma kien hemm l-ebda evidenza li l-età taffettwa l-farmakokinetika ta' fluticasone furoate f'individwi b'COPD filwaqt li kien hemm żieda (37%) fl-AUC (0-24) ta' vilanterol matul il-firxa osservata ta' etajiet minn
English: Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was no significant increase in systemic exposure to vilanterol (Cmax and AUC) in subjects with mild, moderate, or severe hepatic impairment (Child-Pugh A, B or C).
Maltese: Wara għoti ripetut ta' fluticasone furoate/vilanterol għal 7 ijiem, ma kien hemm l-ebda żieda sinifikanti flesponiment sistemiku għal vilanterol (Cmax u AUC) f'individwi b'indeboliment tal-fwied ħafif, moderat, jew sever (Child-Pugh A, B jew C).
English: In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI 184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group.
Maltese: F'analiżi integrata taż-żewġ studji ripetuti ta' sena b'COPD moderat sa sever (skrinjar wara l-bronkodilatur imbassar medju FEV1 ta' 45%, devjazzjoni standard (SD) 13%) b'taħrix fis-sena ta' qabel (n = 3255), in numru ta' episodji ta' pulmonite għal kull 1000 pazjent sena kien 97.9 b'FF/VI 184/22, 85.
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English: In a placebo-controlled study in subjects with moderate COPD and a history of, or an increased risk of cardiovascular disease, there was no increase in the risk of cardiovascular events in patients receiving fluticasone furoate/vilanterol compared with placebo (see section 5.1).
Maltese: Fi studju kkontrollat bi plaċebo f'individwi b'COPD moderata, bi storja ta', jew b'riskju akbar ta' mard kardjovaskulari, ma kienx hemm żieda fir-riskju ta' avvenimenti kardjovaskulari f'pazjenti li kienu qegħdin jirċievu fluticasone furoate/vilanterol meta mqabbel ma' plaċebo (ara s-sezzjoni 5.1).