FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of cases are self-limited but severe exacerbations, including fatal outcomes, may occur after discontinuation of treatment for hepatitis B. Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of treatment for hepatitis B. If appropriate, resumption of hepatitis B therapy may be warranted.
Maltese: Il-funzjoni tal-fwied għandha tkun immonitorjata f'intervalli ripetuti kemm b'segwitu kliniku kif ukoll fil-laboratorju għal mill-inqas 6 xhur wara li titwaqqaf il-kura għallepatite B.
English: Tenofovir alafenamideh (40 mg orally, q.d.)
Maltese: Tenofovir alafenamideh (40 mg mogħti mill-ħalq, q.d.)
English: • Swelling of the face, lips, tongue or throat (angioedema)
Maltese: • Nefħa fil-wiċċ, fix-xufftejn, fl-ilsien jew fil-griżmejn (anġjoedema)
English: • antibiotics used to treat bacterial infections including tuberculosis, containing:
Maltese: • antibijotiċi li jintużaw għall-kura ta' infezzjonijiet batteriċi li jinkludu t-tuberkulożi, li fihom:
English: Tenofovir alafenamidec (10 mg orally, q.d.)
Maltese: Tenofovir alafenamidec (10 mg mogħti mill-ħalq, q.d.)
English: Treatment outcomes of Study 108 and Study 110 through Week 48 are presented in Table 3 and Table 4.
Maltese: Ir-riżultati tal-kura tal-Istudju 108 u l-Istudju 110 f'Ġimgħa 48 huma ppreżentati fitTabella 3 u t-Tabella 4.
English: Tenofovir ↔ Cmax 1.10 (0.96, 1.25)
Maltese: ↔ Cmax 1.10 (0.96, 1.25) ↑ AUC 1.25 (1.06, 1.47)
English: Tenofovir alafenamidec (10 mg orally, s.d.)
Maltese: Tenofovir alafenamidec (10 mg mogħti mill-ħalq, s.d.)
English: Medicinal products that are P-gp inducers (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital or St. John's wort) are expected to decrease plasma concentrations of tenofovir alafenamide, which may lead to loss of therapeutic effect of Vemlidy.
Maltese: Il-prodotti mediċinali li huma indutturi tal-P-gp (eż. rifampicin, rifabutin, carbamazepine, phenobarbital jew St.
English: Tenofovir alafenamidef (25 mg orally, q.d.)
Maltese: Tenofovir alafenamidef (25 mg mogħti mill-ħalq, q.d.)
English: Recommendation concerning co-administration with Vemlidy
Maltese: Mediċini oħra u Vemlidy
English: Tenofovir alafenamide ↑ Cmax 1.77 (1.28, 2.44)
Maltese: ↑ Cmax 1.77 (1.28, 2.44) ↑ AUC 1.91 (1.55, 2.35)
English: In the open-label phase, the median change in eGFR from Week 96 to Week 120 was -0.6 mL/min in patients who remained on Vemlidy, compared to +1.8 mL/min in patients who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
Maltese: Fil-fażi open-label, il-bidla medja fl-eGFR minn Ġimgħa 96 sa Ġimgħa 120 kienet ta' -0.6 mL/min f'pazjenti li baqgħu fuq Vemlidy, meta mqabbla ma' +1.8 mL/min f'pazjenti li qalbu minn tenofovir disoproxil fumarate għal Vemlidy f'Ġimgħa 96.
English: • If it is less than 18 hours after you usually take Vemlidy, take it as soon as you can, and then take your next dose at its regular time.
Maltese: • Jekk għaddew iktar minn 18-il siegħa minn meta normalment tiegħu Vemlidy, tiħux id-doża li tkun qbiżt.
English: Vemlidy [Outer packaging only]
Maltese: INFORMAZZJONI BIL-BRAILLE Vemlidy [Ippakkjar ta' barra biss]
English: Tenofovir alafenamidec (25 mg orally, s.d.)
Maltese: Tenofovir alafenamidec (25 mg mogħti mill-ħalq, s.d.)
English: Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Maltese: Gilead Sciences Poland Sp. z o.o. Tel: + 48 (0) 22 262 8702
English: Tenofovir alafenamidec (25 mg orally, q.d.)
Maltese: Tenofovir alafenamidec (25 mg mogħti mill-ħalq, q.d.)
English: Tenofovir ↓ Cmax 0.75 (0.67, 0.86)
Maltese: ↓ Cmax 0.75 (0.67, 0.86) ↔ AUC 0.80 (0.73, 0.87) ↔ Cmin 0.
English: • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or until there is loss of efficacy (see section 4.4).
Maltese: • F'pazjenti HBeAg pożittivi mingħajr ċirrożi, il-kura għandha tingħata għallinqas għal 6-12-il xahar wara serokonverżjoni għal HBe (telf ta' HBeAg u telf ta' HBV DNA bi skoperta anti-HBe) tkun ikkonfermata jew sakemm ikun hemm serokonverżjoni għal HBs jew sakemm ikun hemm telf ta' effikaċja (ara sezzjoni 4.4).
English: Acute exacerbation of hepatitis has been reported in patients who have discontinued treatment for hepatitis B, usually in association with rising HBV DNA levels in plasma.
Maltese: Epatite li tirkadi b'mod akut ġiet irrappurtata f'pazjenti li waqqfu t-trattament għall-epatite B, ġeneralment assoċjata ma' livelli li qed jogħlew tal-HBV DNA fil-plażma.
English: Medicinal products that may affect tenofovir alafenamide
Maltese: Prodotti mediċinali li jistgħu jaffettwaw tenofovir alafenamide
English: You must continue to take precautions to avoid this.
Maltese: Għandhom ikomplu jintużaw prekawzjonijiet adattati.
English: Vemlidy met the non-inferiority criteria in achieving HBV DNA less than 29 IU/mL when compared to tenofovir disoproxil fumarate.
Maltese: Vemlidy issodisfa l-kriterji ta' nuqqas ta' inferjorità fil-kisba ta' HBV DNA ta' inqas minn 29 IU/mL meta mqabbel ma' tenofovir disoproxil fumarate.
English: ↔ Cmin 1.18 (1.06, 1.31) Cobicistat ↔ Cmax 0.96 (0.92, 1.00)
Maltese: ↔ Cmax 1.00 (0.86, 1.16) ↔ AUC 0.96 (0.89, 1.03)
English: On days of haemodialysis, Vemlidy should be administered after completion of haemodialysis treatment (see section 5.2).
Maltese: Fil-jiem tal-emodijalisi, Vemlidy għandu jingħata wara li titlesta l-kura tal-emodijalisi (ara sezzjoni 5.2).
English: At Week 96, viral suppression as well as biochemical and serological responses were maintained with continued tenofovir alafenamide treatment (see Table 5).
Maltese: F'Ġimgħa 96, is-soppressjoni virali kif ukoll ir-rispons bijokimiku u seroloġiku nżammu bil-kura kontinwa b'tenofovir alafenamide (ara Tabella 5).
English: Co-administration of strong inhibitors of P-gp with Vemlidy is not recommended.
Maltese: • Treddax matul il-kura b'Vemlidy.
English: Tenofovir ↑ Cmax 1.62 (1.56, 1.68)
Maltese: ↑ Cmax 1.32 (1.17, 1.48) ↑ AUC 1.52 (1.43, 1.61)
English: e The population used for serology analysis included only patients with antigen (HBeAg) positive and antibody (HBeAb) negative or missing at baseline.
Maltese: e Il-popolazzjoni użata għall-analiżi tas-seroloġija kienet tinkludi biss pazjenti pożittivi għall-antiġen (HBeAg) u negattivi għall-antikorpi (HBeAb) jew b'antikorpi nieqsa fil-linja bażi.
English: If you accidentally take more than the recommended dose of Vemlidy you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Maltese: Jekk aċċidentalment tieħu aktar mid-doża rakkomandata ta' Vemlidy tista' tkun f'riskju akbar li jkollok effetti sekondarji b'din il-mediċina (ara sezzjoni 4, Effetti sekondarji possibbli).
English: Tenofovir alafenamide ↑ Cmax 2.19 (1.72, 2.79)
Maltese: ↑ Cmax 2.19 (1.72, 2.79) ↑ AUC 1.47 (1.17, 1.85)
English: No special hazard for humans was revealed in conventional studies of carcinogenic potential with tenofovir disoproxil (as fumarate) and toxicity to reproduction and development with tenofovir disoproxil (as fumarate) or tenofovir alafenamide.
Maltese: Ebda periklu speċjali għall-bnedmin ma kien żvelat fi studji konvenzjonali tal-potenzjal karċinoġeniku b'tenofovir disoproxil (bħala fumarate) u tal-effett tossiku fuq ir-riproduzzjoni u l-iżvilupp b'tenofovir disoproxil (bħala fumarate) jew tenofovir alafenamide.
English: • Periodic Safety Update reports
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: e Study conducted with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fixed-dose combination tablet.
Maltese: e L-istudju twettaq bil-pillola kombinata ta' doża fissa ta' elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide.
English: ↔ Cmin 1.02 (0.98, 1.07) Sofosbuvir ↔ Cmax 0.96 (0.89, 1.04)
Maltese: ↔ Cmax 1.02 (0.96, 1.09) ↔ AUC 0.99 (0.92, 1.07) ↔ Cmin 0.97 (0.82, 1.15)
English: The binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Maltese: L-irbit ta' tenofovir alafenamide mal-proteini tal-plażma umana fil-kampjuni miġbura matul l-istudji kliniċi kien ta' madwar 80%.
English: The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and/or OATP1B3.
Maltese: Id-distribuzzjoni ta' tenofovir alafenamide fil-ġisem tista' tkun affettwata mill-attività ta' OATP1B1 u/jew OATP1B3.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women.
Maltese: M'hemmx dejta jew hemm dejta limitata (inqas minn 300 riżultat ta' tqala) dwar l-użu ta' tenofovir alafenamide f'nisa tqal.
English: ↔ Cmin 0.97 (0.82, 1.15) Cobicistat ↔ Cmax 1.06 (1.00, 1.12)
Maltese: ↔ Cmax 0.95 (0.86, 1.05) ↔ AUC 1.01 (0.97, 1.06)
English: Nephrotoxicity
Maltese: Carrigtohill
English: Tenofovir alafenamide ↑ Cmax 1.24 (0.88, 1.74)
Maltese: ↑ Cmax 1.24 (0.88, 1.74) ↑ AUC 1.19 (0.96, 1.48)
English: In patients with hepatitis B, Vemlidy controls the infection by stopping the virus from multiplying.
Maltese: F'pazjenti bl-epatite B, Vemlidy jikkontrolla l-infezzjoni billi jwaqqaf il-virus milli jimmultiplika.
English: No dose adjustment of Vemlidy is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Maltese: L-ebda aġġustament fid-doża ta' Vemlidy ma hu meħtieġ f'pazjenti li għandhom indeboliment talfwied (ara sezzjonijiet 4.4 u 5.2).
English: ↔ Cmin 1.01 (0.95, 1.09) Voxilaprevir ↔ Cmax 0.96 (0.84, 1.11)
Maltese: ↔ Cmax 1.05 (0.96, 1.16) ↔ AUC 1.01 (0.94, 1.07) ↔ Cmin 1.01 (0.95, 1.09)
English: Therapy should be initiated by a physician experienced in the management of chronic hepatitis B.
Maltese: Jekk xieraq, tista' tkun meħtieġa tkomplija tat-terapija għall-epatite B.
English: The primary efficacy endpoint in both studies was the proportion of patients with plasma HBV DNA levels below 29 IU/mL at Week 48.
Maltese: L-iskop finali tal-effikaċja primarja fiż-żewġ studji kien il-proporzjon ta' pazjenti b'livelli ta' HBV DNA tal-plażma taħt 29 IU/mL f'Ġimgħa 48.
English: Patients with liver disease, who are treated for hepatitis B with antiviral medicines, have a higher risk of severe and potentially fatal liver complications.
Maltese: Pazjenti li għandhom mard talfwied, li huma kkurati għall-epatite B bil-mediċini antivirali, għandhom riskju ogħla ta' kumplikazzjonijiet severi jew potenzjalment fatali tal-fwied.
English: Differences in pharmacokinetics according to gender were not considered to be clinically relevant.
Maltese: Differenzi fil-farmakokinetika skont is-sess tal-persuna ma ġewx ikkunsidrati li huma klinikament rilevanti.
English: Co-administration of Vemlidy with medicinal products that inhibit P-gp and BCRP may increase plasma concentrations of tenofovir alafenamide.
Maltese: L-għoti flimkien ta' Vemlidy ma' prodotti mediċinali li jinibixxu P-gp u BCRP jista' jżid ilkonċentrazzjonijiet ta' tenofovir alafenamide fil-plażma.
English: Elebrato vs.
Maltese: Tqabbil Trelegy vs.
English: Use Elebrato Ellipta regularly
Maltese: Uża Elebrato Ellipta regolarment
English: The most frequently reported adverse reactions with Elebrato Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktkar mod frekwenti b'Elebrato Ellipta kienu nażofarinġite (7%), uġigħ ta' ras (5%) u infezzjoni fl-apparat respiratorju ta' fuq (2%).
English: What Elebrato Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Maltese: Is-sustanzi attivi huma fluticasone furoate, umeclidinium bromide u vilanterol.
English: Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Elebrato Ellipta jintuża għall-kura ta' mard kroniku ostruttiv tal-pulmuni (COPD) fl-adulti.
English: IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Elebrato Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Maltese: IMPACT (CTT116855) kien studju ta' 52 ġimgħa (N=10,355), li qabbel Elebrato Ellipta (92/55/22 mikrogramma) ma' fluticasone furoate/vilanterol 92/22 mikrogramma (FF/VI) u umeclidinium/vilanterol 55/22 mikrogramma (UMEC/VI).
English: EU/1/17/1237/002
Maltese: EU/1/17/1236/001 EU/1/17/1236/002
English: The other ingredients are lactose monohydrate (see section 2 under ‘Elebrato Ellipta contains lactose') and magnesium stearate.
Maltese: L-ingredjenti l-oħra huma lactose monohydrate (ara sezzjoni 2 taħt ‘Elebrato Ellipta fih lactose') u magnesium stearate.
English: The fluticasone furoate/vilanterol component of Elebrato Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Maltese: Il-komponent fluticasone furoate/vilanterol ta' Elebrato Ellipta ġie vvalutat f'pazjenti bis-severitajiet kollha ta' indebboliment tal-fwied (Child-Pugh A, B jew C).
English: In FULFIL, Elebrato Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Maltese: F'FULFIL, Elebrato Ellipta tejjeb is-sintomi ta' kuljum ta' COPD kif ivvalutat mill-punteġġ totali ta' E-RS: COPD, meta mqabbel ma' BUD/FOR (tnaqqis ta' ≥2 unitajiet mil-linja bażi).
English: Elebrato 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: Elebrato 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 tas-sintomi u prevenzjoni ta' taħrix ara sezzjoni 5.1).
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Elebrato 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.
Maltese: Pulmonite fatali seħħet fi 12 minn 4,151 pazjent (3.5 għal kull 1,000 snin ta' pazjent) li rċivew Elebrato Ellipta, 5 minn 4,134 pazjent (1.7 għal kull 1,000 snin ta' pazjent) li rċivew fluticasone furoate/vilanterol, u 5 minn 2,070 pazjent (2.9 għal kull 1,000 snin ta' pazjent) li rċivew umeclidinium/vilanterol.
English: Treatment with Elebrato 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 Elebrato Ellipta naqqset sinifikament ir-rata annwali ta' taħrix sever b'34 % meta mqabbel ma' UMEC/VI (95% CI: 22, 44; p<0.001).
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 Elebrato 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 Elebrato Ellipta (92/55/22 mikrogramma) ma' budesonide/formoterol 400/12il mikrogramma (BUD/FOR) mogħti darbtejn kuljum.
English: In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Elebrato 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 Elebrato 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: In FULFIL, Elebrato 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: Elebrato 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: Following oral administration of radiolabelled vilanterol, 70% of the radiolabel was excreted in urine and 30% in faeces.
Maltese: Wara għoti orali ta' vilanterol radjutikkettat, 70% tar-radjutikketta ġie eliminat fl-awrina u 30 % fl-ippurgar.
English: In a total of 1810 patients with advanced COPD (mean post bronchodilatory 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 Elebrato 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 Elebrato Ellipta (20 pazjent, 2 %) milli f'pazjenti li kienu qed jirċievu budesonide/formoterol (7 pazjenti, <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 Elebrato 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 Elebrato 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: The incidence of pneumonia with Elebrato Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Maltese: L-inċidenza ta' pulmonite b'Elebrato Ellipta hija kumparabbli ma' dik osservata fil-fergħa fluticasone furoate/vilanterol (FF/VI) 100/25 tal-istudji kliniċi ta' FF/VI fis-COPD.
English: Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Elebrato 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 Elebrato 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: Elebrato 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: NAME OF THE MEDICINAL PRODUCT Elebrato Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Maltese: Elebrato Ellipta 92/55/22 mcg trab li jittieħed man-nifs fluticasone furoate/umeclidinium/vilanterol
English: In IMPACT, over 52 weeks, Elebrato 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, Elebrato 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: In IMPACT, Elebrato 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, Elebrato 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: The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Elebrato 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: A higher percentage of patients receiving Elebrato 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 Elebrato Ellipta rrispondew b'titjib klinikament sinifikanti filpunteġġ 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: In IMPACT, Elebrato Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
Maltese: 001) il-funzjoni tal-pulmun meta mqabbel ma' FF/VI u UMEC/VI fuq perjodu ta' 52 ġimgħa (Ara Tabella 2).
English: In FULFIL, based upon data up to 24 weeks, Elebrato 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, Elebrato 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: In FULFIL, bronchodilatory effects with Elebrato 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 Elebrato 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).