FrancophonIA/ELRC3.0 huggingface dataset:
English: At Week 52, a statistically significant improvement in the least-squares (LS) mean change from baseline in trough FEV1 was observed for FF/UMEC/VI compared with FF/VI (mean change: +94 mL vs. -3 mL; treatment difference: 97 mL; 95% CI: 85, 109; p<0.001).
Maltese: F'Ġimgħa 52, ġie osservat titjib statistikament sinifikanti fil-bidla medja tal-inqas kwadri (LS) mil-linja bażi tal-FEV1 minimu għal FF/UMEC/VI meta mqabbel ma' FF/VI (bidla medja: +94 mL vs. -3 mL; differenza fit-trattament: 97 mL; 95% CI: 85, 109; p<0.
English: In two 12-week, placebo controlled studies (200109 and 200110), the addition of Rolufta Ellipta to fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 154; p<0.001 and 122 mL 95% CI: 91, 152; p<0.001).
Maltese: F'żewġ studji fuq 12-il ġimgħa, ikkontrollati bi plaċebo (200109 u 200110), iż-żieda ta' Rolufta Ellipta ma' fluticasone furoate/vilanterol (FF/VI) (92/22 mikrogramma) darba kuljum f'pazjenti adulti b'dijanjożi klinika ta' COPD, irriżultat f'titjib statistikament u klinikament sinifikanti fil-punt ta' tmiem primarju l-aktar baxx ta' FEV1 fil-Jum 85 meta mqabbel mal-plaċebo flimkien ma' FF/VI (124 mL 95% CI: 93, 154; p<0.001 u 122 mL 95%CI:
English: Following intravenous administration to healthy subjects, the mean volume of distribution was 86 litres.
Maltese: Wara l-għoti ġol-vina lil individwi b'saħħithom, il-volum medju ta' distribuzzjoni kien ta' 86 litru.
English: This medicine is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Din il-mediċina tintuża biex tikkura l-marda kronika ostruttiva tal-pulmun (COPD) fl-adulti.
English: This includes 576 patients who received the recommended dose of 55 micrograms once daily.
Maltese: Dan kien jinkludi 576 pazjent li rċevew id-doża rakkomandata ta' 55 mikrogramma darba kuljum.
English: Infections and infestations
Maltese: Infezzjonijiet u infestazzjonijiet
English: Subjects with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein binding between subjects with moderate hepatic impairment and healthy volunteers.
Maltese: Indeboliment epatiku Individwi b'indeboliment epatiku moderat (Child-Pugh tal-Klassi B) ma wrew l-ebda evidenza ta' żieda fl espożizzjoni sistemika għal umeclidinium bromide (Cmax u AUC), u l-ebda evidenza ta' tibdil fl-irbit tal proteini bejn individwi b'indeboliment epatiku moderat u voluntiera b'saħħithom.
English: Multipack of 3 x 30 dose inhalers.
Maltese: Pakkett multiplu ta' 3 inalaturi ta' 30 doża kull wieħed.
English: Following repeat dosing of inhaled umeclidinium bromide, steady state was achieved within 7 to 10 days with 1.5 to 1.8-fold accumulation.
Maltese: l-istat stabbli nkiseb wara 7 sa 10 ijiem b'akkumulazzjoni ta' 1.5 sa 1.8 darbiet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 55 micrograms
Maltese: KARTUNA TA' BARRA (PAKKETTI SINGOLI) 55 mikrogramma
English: • rash
Maltese: • raxx.
English: MARKETING AUTHORISATION HOLDER
Maltese: KONDIZZJONIJIET U REKWIŻITI
English: The steady-state pharmacokinetics of umeclidinium bromide were assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Maltese: Il-farmakokinetika ta' umeclidinium bromide fi stat stabbli ġiet evalwata f'voluntiera b'saħħithom nieqsa minn CYP2D6 (metabolizzaturi dgħajfa).
English: Description
Maltese: LISTA
English: Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Maltese: 55 mikrogramma ta' umeclidinium (ekwivalenti għal 65 mikrogramma ta' umeclidinium bromide).
English: A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium bromide are similar between COPD patients 65 years and older and those younger than 65 years of age.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni wriet li l-farmakokinetiċi ta' umeclidinium bromide huma simili bejn pazjenti b'COPD ta' aktar minn 65 sena u dawk ta' anqas minn 65 sena.
English: Instructions for use:
Maltese: Armi sa:
English: PHARMACEUTICAL FORM AND CONTENTS
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: The tray contains a desiccant sachet, to reduce moisture.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
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 Irekwiżiti għas-sottomissjoni tar-rapporti perjodiċi ta 'aġġornament għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kull aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiċi
English: Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Maltese: Rolufta Ellipta 55 mcg trab li jittieħed man-nifs. umeclidinium (umeclidinium bromide)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattosju, defiċjenza ta' Lapp lactase jew malassorbiment tal-glukosju-galattosju m'għandhomx jieħdu dan il-prodott mediċinali.
English: COPD exacerbations
Maltese: Aggravar ta' COPD
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: See section 4.8 for how to report adverse reactions.
Maltese: Ara sezzjoni 4.8 dwar kif għandhom jiġu rappurtati reazzjonijiet avversi.
English: Rash
Maltese: Raxx
English: Multipacks containing 90 (3 inhalers of 30) doses are also available.
Maltese: Pakketti multipli li fihom 90 (3 inalaturi x 30) doża huma disponibbli wkoll.
English: • itching • skin rash (hives) or redness
Maltese: • ħakk • raxx tal-ġilda (ħorriqija) jew ħmura
English: Mechanism of action
Maltese: Darba kuljum
English: Following oral administration to healthy male subjects, total radioactivity was excreted primarily in faeces (92% of the administered radiolabelled dose or 99% of the recovered radioactivity) by 168 hours post-dose.
Maltese: Wara l-għoti orali lil individwi maskili b'saħħithom, ir-radjuattività totali kienet primarjament eliminata fl-ippurgar (92% tad-doża radjuttikkettata mogħtija jew 99% tar-radjuattività rkuprata) 168 siegħa wara d-doża.
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered radioactivity) was excreted in faeces by 192 hours post-dose.
Maltese: Wara l-għoti ġol-vina, madwar 58% tad-doża radjuttikkettata mogħtija (jew 73% tar-radjuattività rkuprata) ġiet eliminata fl-ippurgar 192 siegħa wara d-doża.
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Rolufta Ellipta (38%) compared with placebo (15%) in the 12-week study.
Maltese: Il-proporzjon ta' pazjenti li rrispondew b'mill-inqas id-differenza minima klinikament importanti (MCID) ta' unità 1 fil-punteġġ fokali tad-TDI fil-Ġimgħa 12 kien akbar għal Rolufta Ellipta (38%) meta mqabbel ma' plaċebo (15%) fl-istudju fuq 12-il ġimgħa.
English: Other medicinal products for COPD
Maltese: Prodotti mediċinali oħra għal COPD
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma jurux effetti ħżiena diretti jew indiretti fuq is-sistema riproduttiva (ara 5.3).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX - MULTIPACK) 55 micrograms
Maltese: KARTUNA TA' BARRA INTERMEDJA (MINGĦAJR KAXX BLU - PAKKETT MULTIPLU BISS) 55 mikrogramma
English: Nasopharyngitis Upper respiratory tract infection Urinary tract infection Sinusitis
Maltese: Infezzjoni fl-apparat urinarju Sinusite
English: Acute symptoms should be treated with an inhaled short-acting bronchodilator.
Maltese: Sintomi akuti għandhom jiġu ttrattati bi bronkodilatur li jittieħed man-nifs li jaħdem malajr.
English: Other antimuscarinics
Maltese: Antimuskariniċi oħra
English: GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Maltese: Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: An overdose of umeclidinium bromide will likely produce signs and symptoms consistent with the known inhaled muscarinic antagonist adverse effects (e.g. dry mouth, visual accommodation disturbances and tachycardia).
Maltese: Doża eċċessiva ta' umeclidinium bromide x'aktarx tipproduċi sinjali u sintomi konsistenti mal-effetti avversi magħrufa ta' antagonisti muskariniċi li jittieħdu man-nifs (eż. ħalq xott, disturbi fl-akkomodazzjoni viżwali u takikardja).
English: Following repeat doses of umeclidinium 500 micrograms once daily for 10 days, no clinically relevant effect on prolongation of QT interval (corrected using the Fridericia method) or effects on heart rate were observed.
Maltese: umeclidinium 500 mikrogramma darba kuljum għal 10 ijiem, ma kien osservat l-ebda effett klinikament rilevanti fuq it-titwil tal-intervall QT (ikkorreġut bl-użu tal-metodu Fridericia) jew effetti fuq ir-rata tal-qalb.
English: Paediatric population
Maltese: Popolazzjoni pedjatrika
English: The safety profile of umeclidinium bromide was evaluated from 1663 patients with COPD who received doses of 55 micrograms or greater for up to one year.
Maltese: Il-profil tas-sigurtà ta' umeclidinium bromide ġie vvalutat minn 1663 pazjent b'COPD li rċevew dożi ta' 55 mikrogramma jew aktar sa sena.
English: In nonclinical studies with umeclidinium bromide, findings were those typically associated with the primary pharmacology of muscarinic receptor antagonists and/or local irritancy.
Maltese: Fi studji li mhumiex kliniċi b'umeclidinium bromide, is-sejbiet kienu dawk tipikament assoċjati mal-farmakoloġija primarja ta' antagonisti tar-riċettur muskariniku u/jew irritanza lokali.
English: Umeclidinium bromide exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic cholinergic receptors on airway smooth muscle.
Maltese: Umeclidinium bromide jeżerċita l-attività bronkodilatorja tiegħu billi b'mod kompetittiv jinibixxi l-irbit ta' acetylcholine ma' riċetturi kolinerġiċi muskariniċi fuq il muskoli lixxi tal-passaġġi tal-arja.
English: Patients receiving Rolufta Ellipta had a higher percentage of days when no rescue medication was needed (on average 31.1%) compared with placebo (on average 21.7%).
Maltese: Il-pazjenti li kienu qed jirċievu Rolufta Ellipta kellhom perċentwal ogħla ta' ġranet fejn ma kienx hemm il-ħtieġa li jieħdu mediċina ta' salvataġġ (medja ta' 31.1%) meta mqabbla ma' plaċebo (medja ta' 21.7%).
English: Desiccant
Maltese: Disurja
English: See package leaflet for further information
Maltese: Sorsi oħra ta' informazzjoni
English: EXPIRY DATE
Maltese: Data mistennija
English: Other medicines and Rolufta Ellipta
Maltese: Mediċina oħra u Rolufta Ellipta
English: Rolufta Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12-week pivotal study.
Maltese: Rolufta Ellipta wera titjib statistikament sinifikanti akbar mil-linja bażi fl-FEV1 medju peżat wara 0-6 sigħat wara d-doża fil-Ġimgħa 12 meta mqabbel ma' plaċebo (166 ml (p<0.001)) fl-istudju pivotali fuq 12-il ġimgħa.
English: Administration of umeclidinium bromide may produce paradoxical bronchospasm that may be lifethreatening.
Maltese: L-għoti ta' umeclidinium bromide jista' jipproduċi bronkospażmu paradossali li jista' jkun ta' periklu għallħajja.
English: It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity across multiple muscarinic cholinergic receptor subtypes.
Maltese: Huwa derivattiv ta' quinuclidine li huwa antagonista tar-riċettur muskariniku b'attività fuq bosta sottotipi ta' riċetturi kolinerġiċi muskariniċi.
English: Do not store above 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: Frequency
Maltese: Frekwenza
English: Umeclidinium bromide has not been evaluated in subjects with severe hepatic impairment.
Maltese: Umeclidinium bromide ma ġiex ivvalutat f'individwi b'indeboliment epatiku sever.
English: In the 24-week placebo-controlled study in patients with symptomatic COPD, Rolufta Ellipta reduced the risk of a moderate/severe COPD exacerbation by 40% compared with placebo (analysis of time to first exacerbation; Hazard Ratio 0.6; 95% CI: 0.4, 1.0, p=0.035*).
Maltese: Fl-istudju fuq 24-ġimgħa kkontrollat bi plaċebo f'pazjeni b'COPD sintomatiku, Rolufta Ellipta naqqas ir riskju ta' aggravar ta' COPD moderat/sever b'40 % meta mqabbel ma' plaċebo (analiżi taż-żmien għallewwel aggravar; Proporzjoni tal-Periklu ta' 0.6; 95% CI: 0.4, 1.0, p=0.035*)).Il-probabbiltà ta' aggravar f'pazjenti li kienu qed jirċievu Rolufta Ellipta fil-ġimgħa 24 kienet ta' 8.9% meta mqabbla ma' 13.7% għall plaċebo.
English: Rolufta Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Maltese: George's (SGRQ) kif indikat bi tnaqqis fil-punteġġ totali ta' SGRQ fil-Ġimgħa 12 meta mqabbla ma' plaċebo (-7.90 unità, p≤0.001) fl-istudju fuq 12-il ġimgħa.
English: The short duration of these two studies and limited number of exacerbation events, preclude any conclusion regarding additional effect of Rolufta Ellipta on COPD exacerbation rate.
Maltese: Il-perjodu qasir ta' dawn iż-żewġ studji u n-numru limitat ta' avvenimenti ta' aggravar, jipprekludi kwalunkwe konklużjoni dwar l-effett addizzjonali ta' Rolufta Ellipta fuq ir-rata ta' aggravar ta' COPD.
English: • cough
Maltese: • sogħla
English: Breast-feeding
Maltese: IL-PROVVISTA
English: Characteristics in specific groups of subjects or patients
Maltese: Karatteristiċi fi gruppi speċifiċi ta' individwi jew pazjenti
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Maltese: Kull inalazzjoni waħdanija tipprovdi doża mogħtija (id-doża li toħroġ mill-biċċa tal-ħalq tal-inalatur) ta' 55 mikrogramma ta' umeclidinium (ekwivalenti għal 65 mikrogramma ta' umeclidinium bromide).
English: A study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium bromide.
Maltese: polimorfiżmu ġenetiku ta' CYP2D6 fuq l-espożizzjoni sistemika għal umeclidinium bromide.
English: Constipation Dry mouth common Uncommon
Maltese: Effetti sekondarji mhux komuni
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Maltese: Rolufta Ellipta 55 mikrogramma trab li jittieħed man-nifs, lest minn qabel umeclidinium (umeclidinium bromide)
English: Urinary elimination accounted for 22% of the administered radiolabelled dose by 168 hours (27% of recovered radioactivity).
Maltese: 168 siegħa (27% tar-radjuattività rkuprata).
English: 24-Week Study Treatment difference1 95% Confidence interval p-value
Maltese: Studju fuq 24-Ġimgħa Differenza fil-kura1
English: OTHER
Maltese: Kontra
English: Cough
Maltese: Jew
English: GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Maltese: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
English: Umeclidinium bromide is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Maltese: Umeclidinium bromide huwa antagonist tar-riċettur muskariniku li jaġixxi fit-tul (imsejjaħ ukoll bħala antikolinerġiku).
English: Ellipta 1 inhaler of 30 doses.
Maltese: Qabel ma jintuża l-inalatur turi eżattament 30 dożi.
English: • common cold
Maltese: • riħ komuni
English: A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Rolufta Ellipta (1.0 units, p<0.001) in the 24-week study.
Maltese: Titjib statistikament sinifikanti meta mqabbel ma' plaċebo fil-punteġġ fokali tat-TDI fil-Ġimgħa 24 intwera għal Rolufta Ellipta(1.0 unità,
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed
Maltese: TIKKETTA TAL-INALATUR 55 mikrogramma
English: In the 24-week study treatment with Rolufta Ellipta, the mean (SD) change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period was -1.4 (0.20) for placebo and -1.7 (0.16) for Rolufta Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276).
Maltese: għal plaċebo u ta' -1.7 (0.16) għal Rolufta Ellipta (Differenza = -0.3; 95%CI:
English: Allergic reactions are uncommon (may affect up to 1 in 100 people).
Maltese: Reazzjonijet allerġiċi mhumiex komuni (jistgħu jaffettwaw sa 1 minn kull 100).
English: • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Maltese: • Jekk il-counter tad-dożi ma jonqosx 'l isfel malli tisma l-“klikk”, l-inalatur ma jagħtix ilmediċina.
English: • Dizziness
Maltese: Bijotrasformazzjoni
English: Rolufta Ellipta demonstrated a greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 24 compared with placebo (150 ml, p<0.001*) in the 24-week pivotal study.
Maltese: Rolufta Ellipta wera titjib akbar mil-linja bażi fl-FEV1 medju peżat wara 0-6 sigħat wara d-doża filĠimgħa 24 meta mqabbel ma' plaċebo (150 ml; p<0.
English: Symptomatic outcomes
Maltese: Eżiti sintomatiċi
English: • constipation.
Maltese: • stitikezza.
English: BATCH NUMBER
Maltese: NUMRU TAL-LOTT
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Rolufta Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Maltese: Bl-istess mod, kien hemm proporzjon akbar ta' pazjenti li kisbu mill-inqas l-MCID għal Rolufta Ellipta 55 mikrogramma fil-Ġimgħa 24 (44%) meta mqabbla ma' plaċebo (34%) fl istudju fuq 24-ġimgħa.
English: Health-related quality of life:
Maltese: GĦAMLA KWALITATTIVA
English: 12-Week Study Treatment difference1 95% Confidence interval p-value
Maltese: Intervall ta' fiduċja ta' 95%
English: In the 12-week study, Rolufta Ellipta statistically significantly reduced the use of rescue medication with salbutamol compared with placebo (on average a reduction of 0.7 puffs per day over Weeks 1-12, p=0.025) and demonstrated a higher percentage of days when no rescue medication was needed (on average 46.3%) compared with placebo (on average 35.2%; no formal statistical analysis was performed on this endpoint).
Maltese: salvataġġ b'salbutamol meta mqabbel ma' plaċebo (tnaqqis b'medja ta' 0.7 puffs kuljum matul il-Ġimgħat 112, p=0.025) u wera perċentwal ogħla ta' ġranet meta ma kienx hemm il-ħtieġa ta' xi mediċina ta' salvataġġ (medja ta' 46.3%) meta mqabbel ma' plaċebo (medja ta' 35.2%; l-ebda analiżi statistika formali ma twettqet fuq dan l-endpoint).
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: NUMRU(I)
English: Nervous system disorders
Maltese: Fibrillazzjoni atrijali
English: Although no formal in vivo interaction studies have been performed, inhaled umeclidinium bromide has been used concomitantly with other COPD medicinal products including short and long acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of interactions.
Maltese: Għalkemm ma sar l-ebda studju formali in vivo dwar l-interazzjoni, umeclidinium bromide li jittieħed mannifs intuża flimkien ma' prodotti mediċinali oħra għal COPD inklużi bronkodilaturi simpatomimetiċi li jaġixxu malajr u fuq żmien twil u kortikosterojdi li jittieħdu man-nifs mingħajr evidenza klinika ta'
English: Rolufta Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators.
Maltese: Rolufta Ellipta fih is-sustanza attiva umeclidinium bromide, li tagħmel parti minn grupp ta' mediċini magħrufa bħala bronkodilaturi.
English: Following inhaled administration of umeclidinium bromide in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Maltese: Wara l-għoti ta' umeclidinium bromide man-nifs lil voluntiera b'saħħithom, is-Cmax seħħ wara 5 sa 15-il minuta.
English: Breathlessness:
Maltese: Reazzjonijiet allerġiċi
English: The clinical efficacy of Rolufta Ellipta administered once daily was evaluated in 904 adult patients who received umeclidinium bromide or placebo from two pivotal Phase III clinical studies with a clinical diagnosis of COPD; a 12-week study (AC4115408) and a 24-week study (DB2113373).
Maltese: studju fuq 12-il ġimgħa (AC4115408) u studju fuq 24-ġimgħa (DB2113373).
English: Effects on lung function
Maltese: Effetti fuq il-funzjoni tal-pulmun
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Maltese: Id-data “Armi sa” hija 6 ġimgħat mid-data meta tkun ftaħt it-trej.
English: Pivotal Efficacy Studies:
Maltese: Studji Pivotali tal-Effikaċja:
English: Stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma.
Maltese: Ieqaf uża din il-mediċina u fittex għajnuna medika minnufih, dawn jistgħu jkunu sinjali ta' attakk akut ta' glawkoma b'angolu dejjaq.
English: Vision blurred
Maltese: KONKLUŻJONIJIET XJENTIFIĊI
English: Elderly
Maltese: Fażi
English: GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com
Maltese: Tel: + 370 5 264 90 00 info.lt@gsk.com
English: In a Phase III, 6-month study (DB2113373) Rolufta Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p<0.001*).
Maltese: Fi studju tal-Fażi III, li dam għaddej 6 xhur (DB2113373), Rolufta Ellipta ipprovda titjib klinikament sinifikanti fuq plaċebo fil-funzjoni tal-pulmun (kif imkejjel bil-volum tal-arja sfurzat 'l barra f'sekonda 1
English: How to store Rolufta Ellipta
Maltese: Kif taħżen Rolufta Ellipta
English: PHARMACEUTICAL FORM
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at Week 12 was not demonstrated for Rolufta Ellipta (1.0 units, p=0.05).
Maltese: Fl-istudju fuq 12-il ġimgħa, ma ntweriex titjib statistikament sinifikanti meta mqabbel ma' plaċebo fil punteġġ fokali tat-TDI fil-Ġimgħa 12 għal Rolufta Ellipta (1.0 unità, p=0.05).
English: Carton
Maltese: Sentejn
English: The mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo were 130 ml (p<0.001*) at Week 24.
Maltese: It-titjib massimu medju fl-FEV1 fl-ewwel 6 sigħat wara l-għoti ta' doża meta mqabbel ma' plaċebo kien ta' 130 ml (p<0.