FrancophonIA/ELRC3.0 huggingface dataset:
English: Summary of the safety profile The most frequently reported adverse reaction with umeclidinium/vilanterol was nasopharyngitis (9%).
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjoni avversa rrappurtata l-aktar ta' spiss b'umeclidinium/vilanterol kienet ir-rinofarinġite (9%).
English: For pharmacokinetic purposes each component can therefore be considered separately.
Maltese: Għal skopijiet farmakokinetiċi, kull komponent għalhekk jista' jiġi kkunsidrat separatament.
English: Urinary elimination accounted for 22% of the administered radiolabelled dose by 168 hours (27% of recovered radioactivity).
Maltese: It-tneħħija fl-awrina ammontat għal 22% tad-doża radjutikkettata mogħtija sa 168 siegħa (27% tar radjuattività rkuprata).
English: ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Maltese: ANORO ELLIPTA jintuża għall-kura ta' mard kroniku ostruttiv tal-pulmuni (COPD) fl-adulti.
English: ELLIPTA 55/22 mcg
Maltese: Tqabbil bejn il-kuri b'ANORO ELLIPTA 55/22 mcg
English: Co-administration with ketoconazole (400 mg) in healthy volunteers increased mean vilanterol AUC(0-t) and Cmax, 65% and 22% respectively.
Maltese: (400 mg) f'voluntiera b'saħħithom żied l-AUC(0-t) u s-Cmax, medji ta' vilanterol b'65% u 22% rispettivament.
English: Common Common Uncommon Rare
Maltese: Komuni Komuni Mhux komuni Rari
English: Nasopharyngitis Pharyngitis
Maltese: .1 Proprjetajiet farmakodinamiċi
English: A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium and vilanterol were similar between COPD patients 65 years and older and those younger than 65 years of age.
Maltese: Analiżi farmakokinetika tal-popolazzjoni wriet li l-farmakokinetika ta' umeclidinium u vilanterol kienet simili bejn pazjenti b'COPD li kellhom 65 sena u aktar u dawk li kellhom inqas minn 65 sena.
English: Umeclidinium/vilanterol is a combination inhaled long-acting muscarinic receptor antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA).
Maltese: Umeclidinium/vilanterol huwa antagonist tar-riċetturi muskariniċi li jaħdem fit-tul/agonist beta2-adrenerġiku li jaħdem fit-tul (LAMA/LABA) kombinat li jittieħed man-nifs.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Maltese: Glaxo Operations UK Limited (jinnegozja bħala Glaxo Wellcome Operations) Priory Street
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Harmire Road
Maltese: Glaxo Operations UK Limited (jinnegozja bħala Glaxo Wellcome Operations) Harmire Road
English: Following oral administration of radiolabelled vilanterol, mass balance showed 70% of the radiolabel in urine and 30% in faeces.
Maltese: vilanterol radjutikkettat, il-bilanċ tal-massa wera 70% tar-radjutikketta fl-awrina u 30% fl-ippurgar.
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 24 was greater for ANORO ELLIPTA (58%) compared with placebo (41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).
Maltese: ta' punteġġ fokali TDI ta' unità 1 f'Ġimgħa 24 kien akbar għal ANORO ELLIPTA (58%) meta mqabbel mal-plaċebo (41%) u kull komponent tal-monoterapija (53% għal umeclidinium u 51% għal vilanterol ).
English: The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption.
Maltese: Ilbijodisponibilità assoluta ta' vilanterol li jittieħed man-nifs kienet ta' 27%, b'kontribuzzjoni negliġibbli millassorbiment orali.
English: This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Maltese: 74.2 mikrogramma umeclidinium bromide ekwivalenti għal 62.5 mikrogramma ta' umeclidinium u
English: The clinical efficacy of umeclidinium/vilanterol administered once daily was evaluated in eight Phase III clinical studies in 6,835 adult patients with a clinical diagnosis of COPD; 5,618 patients from five 6-month studies (two placebo-controlled and three active [tiotropium]-comparator controlled), 655 patients from two 3-month exercise endurance/lung function studies and 562 patients from a 12-month supportive study.
Maltese: III fuq 6,835 pazjent adult b'dijanjosi klinika ta' COPD; 5,618 pazjent minn ħames studji ta' sitt xhur (żewġ provi kkontrollati bi plaċebo u tliet provi kkontrollati b'sustanza attiva [tiotropium] ta' tqabbil), 655 pazjent minn żewġ studji ta' 3 xhur dwar il-felħan għall-eżerċizzju/funzjoni tal-pulmuni u 562 pazjent minn studju ta' appoġġ ta' 12-il xahar.
English: In the first study, ANORO ELLIPTA 55/22 micrograms demonstrated a statistically significant and clinically relevant improvement (based on a minimal clinically important difference (MCID) between 45 to 85 seconds) over placebo in exercise endurance time (EET) obtained 3 hours after dosing at Week 12 (69.4 seconds [p=0.003]).
Maltese: Fl-ewwel studju, ANORO ELLIPTA 55/22 mikrogramma wera titjib statistikament sinifikanti u t-titjib klinikament rilevanti (abbażi ta' differenza minima klinikament importanti (MCID) bejn 45 għal 85 sekonda) fuq plaċebo fil-ħin ta' felħan għall-eżerċizzju (EET) miksub 3
English: The decrease in serum potassium is usually transient, not requiring supplementation.
Maltese: It-tnaqqis fil-potassju fis-serum huwa normalment temporanju,
English: Difference in the mean number of puffs per day over Weeks 1-24
Maltese: Differenza fl-għadd medju ta' nefħiet kuljum matul il-Ġimgħat 1-24
English: The tray contains a desiccant sachet, to reduce moisture.
Maltese: Żommu fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: The maximum mean difference in prolongations of QT interval (corrected using the Fridericia method, QTcF) from placebo after baseline-correction was 4.3 (90% CI=2.2 to 6.4) milliseconds seen 10 minutes after administration with umeclidinium/vilanterol 113/22 micrograms and 8.2 (90% CI=6.2 to 10.2) milliseconds seen 30 minutes after administration with umeclidinium/vilanterol 500/100 micrograms.
Maltese: CI=2.2 sa 6.4) millisekondi li dehret 10 minuti wara l-għoti ma' umeclidinium/vilanterol 113/22 mikrogramma u 8.2 (90% CI=6.2 sa 10.2) millisekondi li dehret 30 minuta wara l-għoti ma' umeclidinium/vilanterol 500/100 mikrogramma.
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 huwa metabolizzat primarjament miċ-ċitokromu P450 3A4 (CYP3A4) u huwa substrat għat-trasportatur tal-P-gp.
English: Oropharyngeal pain Dysphonia
Maltese: Popolazzjoni pedjatrika
English: ANORO ELLIPTA has also shown an 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 24 compared with placebo and each monotherapy component (see Table 1).
Maltese: George's Respiratory Questionnaire (SGRQ) kif indikat minn tnaqqis fil-punteġġ totali tal-SGRQ f'Ġimgħa 24 meta mqabbel mal-plaċebo u kull komponent tal-monoterapija (ara Tabella 1).
English: Consistent with findings for other beta2-adrenergic agonists, in lifetime inhalation studies, vilanterol trifenatate caused proliferative effects in the female rat and mouse reproductive tract and in the rat pituitary gland.
Maltese: B'mod konsistenti mas-sejbiet għal agonisti beta2-adrenerġiċi oħra, fi studji tal-inalazzjoni tul ilħajja, vilanterol trifenatate kkawża effetti proliferattivi fl-apparat riproduttiv tal-firien u l-ġrieden nisa u fil glandola pitwitarja tal-firien.
English: Common Common Common Common Common
Maltese: Komuni Komuni Komuni Komuni Komuni
English: triple combinations with corticosteroids, ATC code: R03AL03
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tal-arja, adrenerġiċi f'kombinazzjoni ma' antikolinerġiċi inkl. kombinazzjonijiet trippli bil-kortikosterojdi, Kodiċi ATC: R03AL03
English: The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Maltese: L-effetti farmakoloġiċi tal-agonisti beta2-adrenerġiċi, inkluż vilanterol, huma tal-anqas parzjalment attribwibbli lill-istimulazzjoni tal-adenylate cyclase ġoċ-ċelloli, l-enzima li tikkatalizza l-konverżjoni ta'
English: Placebo (N = 280) ANORO ELLIPTA (N =
Maltese: Plaċebo (N = 280)
English: The results were similar to those for the ANORO ELLIPTA dose and provided additional supportive evidence for the efficacy of ANORO ELLIPTA.
Maltese: kienu simili għal dawk tad-doża ta' ANORO ELLIPTA u pprovdew evidenza addizzjonali ta' appoġġ għalleffikaċja ta' ANORO ELLIPTA.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 55 micrograms/22 micrograms
Maltese: KARTUNA TA' BARRA (PAKKETTI SINGOLI) 55 mikrogramma/22 mikrogramma
English: A study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium.
Maltese: Studju fuq metabolizzaturi ħżiena ta' CYP2D6 ma wera l-ebda evidenza ta' effett klinikament sinifikanti tal-polimorfiżmu ġenetiku ta' CYP2D6 fuq l-esponiment sistemiku għal umeclidinium.
English: ANORO ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) compared with placebo (see Table 1).
Maltese: ANORO ELLIPTA wera tnaqqis statistikament sinifikanti u klinikament importanti fil-qtugħ ta' nifs kif evalwat minn żieda fil-punteġġ fokali TDI f'Ġimgħa 24 (end-point sekondarju prinċipali) meta mqabbel malplaċebo (ara Tabella 1).
English: ANORO ELLIPTA demonstrated improvements in lung function (as defined by change from baseline in trough FEV1) in several studies.
Maltese: ANORO ELLIPTA wera titjib fil-funzjoni tal-pulmun (kif definit mill-bidla mil-linja bażi fl-inqas livell talFEV1) f'diversi studji.
English: Vilanterol is a substrate of cytochrome P450 3A4 (CYP3A4).
Maltese: Interazzjonijiet metaboliċi u bbażati fuq it-trasportaturi Vilanterol huwa substrat taċ-ċitokromu P450 3A4 (CYP3A4).
English: In inhalation studies in rabbits, vilanterol caused effects similar to those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation) at 6-times the human clinical exposure based on AUC.
Maltese: Fi studji tal-inalazzjoni fil-fniek, vilanterol ikkawża effetti simili għal dawk li dehru b'agonisti beta2-adrenerġiċi oħra (palat mixquq, kpiepel tal-għajnejn miftuħin, fużjoni sternebrali u liwja/rotazzjoni ħażina tad-dirgħajn u r-riġlejn) b'esponiment 6 darbiet ogħla mill-esponiment kliniku fil-bniedem fuq il-bażi tal-AUC.
English: ANORO ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: ANORO ELLIPTA hu indikat bħala kura regolari bi bronkodilatur sabiex jittaffew is-sintomi f'pazjenti adulti b'mard kroniku ostruttiv tal-pulmuni (COPD).
English: Verapamil, a moderate CYP3A4 inhibitor, did not significantly affect the pharmacokinetics of vilanterol.
Maltese: Verapamil, inibitur moderat ta' CYP3A4, ma affettwax b'mod sinifikanti l-farmakokinetika ta' vilanterol.
English: Multipacks containing 90 (3 inhalers of 30) doses are also available.
Maltese: Huma disponibbli wkoll pakketti multipli li fihom 90 (3 inalaturi ta' 30) doża.
English: ANORO ELLIPTA 55/22 micrograms also showed statistically significant improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 in the first study (inspiratory capacity: 237 ml and 316 ml respectively, residual volume: -466 ml and -643 ml respectively and functional residual capacity: -351 ml and -522 ml respectively; all p<0.001).
Maltese: ANORO ELLIPTA 55/22 mikrogramma wera wkoll titjib statistikament sinifikanti meta mqabbel malplaċebo fil-bidla mil-linja bażi fil-kejl tal-volum tal-pulmun fl-inqas livell u 3 sigħat wara d-doża f'Ġimgħa 12 fl-ewwel studju (kapaċità ispiratorja: 237 ml u 316 ml rispettivament, volum residwu: -466 ml u -643 ml rispettivament u kapaċità residwa funzjonali:
English: A higher dose of umeclidinium/vilanterol (113/22 micrograms) was also studied in a 24-week placebo controlled clinical study and in two of the three 24-week active-controlled studies.
Maltese: Doża ogħla ta' umeclidinium/vilanterol (113/22 mikrogramma) ġiet studjata wkoll fi studju kliniku ikkontrollat bi plaċebo ta' 24 ġimgħa u fi tnejn mit-tliet studji attivi-ikkontrollati ta' 24 ġimgħa.
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 jnaqqasx b'1 malli tisma' l-“klikk”, l-inalatur ma jagħtikx ilmediċina.
English: The maximum mean difference in heart rate from placebo after baseline-correction was 8.4 (90% CI=7.0 to 9.8) beats/minute and 20.3 (90% CI=18.9 to 21.7) beats/minute seen 10 minutes after administration of umeclidinium/vilanterol 113/22 micrograms and 500/100 micrograms respectively.
Maltese: Id-differenza massima medja fir-rata tal-qalb mill-plaċebo wara korrezzjoni fil-linja bażi kienet ta' 8.4 (90% CI=7.0 għal 9.8) taħbitiet/minuta u 20.3 (90% CI=18.9 għal 21.7) taħbita/minuta li dehret 10 minuti wara l-għoti ta' umeclidinium/ vilanterol
English: The steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Maltese: Il-farmakokinetika fissa ta' umeclidinium ġiet valutata f'voluntiera b'saħħithom neqsin minn CYP2D6 (metabolizzaturi ħżiena).
English: Treatment with umeclidinium/vilanterol should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Maltese: Il-kura b'umeclidinium/vilanterol għandha titwaqqaf immedjatament jekk iseħħ bronkospażmu paradossali u jekk ikun meħtieġ, tinbeda terapija alternattiva.
English: Other antimuscarinics and sympathomimetics
Maltese: Antimuskariniċi u simpatomimetiċi oħra
English: Glaucoma
Maltese: SGRQ
English: Uncommon side effects (may affect up to 1 in 100 people): • skin rash (hives) or redness
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): raxx tal-ġilda (ħorriqija) jew ħmura
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 55 micrograms/22 micrograms
Maltese: TIKKETTA TAL-PAKKETT (BIL-KAXXA L-BLU- PAKKETT MULTPLU) 55 mikrogramma/22 mikrogramma
English: Characteristics in specific groups of healthy volunteers or patients
Maltese: Karatteristiċi fi gruppi speċifiċi ta' voluntiera b'saħħithom jew pazjenti
English: In the other two active-comparator studies, a similar proportion of patients achieved at least the MCID with ANORO ELLIPTA and tiotropium; 49% and 54% for ANORO ELLIPTA 55/22 micrograms and 52% and 55% for tiotropium.
Maltese: Fiż-żewġ studji l-oħra bis-sustanza attiva ta' tqabbil, proporzjon simili ta' pazjenti kisbu mill-anqas il-MCID b'ANORO ELLIPTA u tiotropium; 49% u 54% għal ANORO ELLIPTA
English: The increase in vilanterol exposure was not associated with an increase in beta-adrenergic agonist related systemic effects on heart rate, blood potassium or QT interval (corrected using the Fridericia method).
Maltese: Iż-żieda fl-esponiment għal vilanterol ma kinitx assoċjata ma' żieda fl-effetti sistemiċi fuq ir-rata tal-qalb, il potassju fid-demm jew l-intervall QT (korrett bl-użu tal-metodu ta' Fridericia) relatati mal-agonisti beta adrenerġiċi.
English: When umeclidinium and vilanterol were administered in combination by the inhaled route, the pharmacokinetics of each component was similar to those observed when each active substance was administered separately.
Maltese: Meta umeclidinium u vilanterol ingħataw flimkien bit-teħid man-nifs, il-farmakokinetika ta' kull komponent kienet simili għal dik osservata meta kull sustanza attiva ngħatat separatament.
English: Following intravenous administration to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Maltese: Wara għoti fil-vini lil voluntiera b'saħħithom, il-volum medju ta' distribuzzjoni fl-istat fiss kien ta' 165 litru.
English: There are no data on the effects of umeclidinium/vilanterol on human fertility.
Maltese: M'hemmx dejta dwar l-effetti ta' umeclidinium/vilanterol fuq il-fertilità tal-bniedem.
English: In genetic toxicity studies, vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic indicating that vilanterol (as trifenatate) does not represent a genotoxic hazard to humans.
Maltese: Fi studji dwar it-tossiċità ġenetika, vilanterol (bħala alpha-phenylcinnamate) u l-aċidu trifenilaċetiku ma kinux ġenotossiċi, li jindika li vilanterol (bħala trifenatate) ma jirrappreżentax periklu ġenotossiku għallbnedmin.
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT), 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate/severe exacerbations in the prior 12 months were randomised (1:2:2) to receive umeclidinium/vilanterol (UMEC/VI 55/22 micrograms), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 92/55/22 micrograms), or fluticasone furoate/vilanterol (FF/VI 92/22 micrograms) administered once daily as a single inhaler.
Maltese: biex jirċievu umeclidinium/vilanterol (UMEC/VI 55/22 mikrogramma), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 92/55/22 mikrogramma), jew fluticasone furoate/vilanterol (FF/VI 92/22 mikrogramma) mogħti darba kuljum bħala inalatur wieħed.
English: The absolute bioavailability of inhaled umeclidinium was on average 13% of the dose, with negligible contribution from oral absorption.
Maltese: Ilbijodisponibilità assoluta ta' umeclidinium li jittieħed man-nifs kienet bħala medja 13% tad-doża, b'kontribuzzjoni negliġibbli mill-assorbiment orali.
English: In one 6-month Phase III study, ANORO ELLIPTA demonstrated statistically significant improvements in trough FEV1 (primary endpoint) at Week 24 compared with placebo and each monotherapy component treatment arm.
Maltese: Fi studju wieħed tal-Fażi 3 ta' 6-xhur, ANORO ELLIPTA wera titjib statistikament sinifikanti fl-inqas livell tal-FEV1 (endpoint primarju) f'Ġimgħa 24 meta mqabbel ma' plaċebo u kull fergħa ta' kura b'komponent tal-monoterapija.
English: ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol
Maltese: ANORO ELLIPTA 55 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel umeclidinium/vilanterol
English: In the second study, ANORO ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual capacity: -238 ml and -302 ml respectively); all p<0.001∗).
Maltese: Fit-tieni studju, ANORO ELLIPTA 55/22 mikrogramma wera titjib meta mqabbel mal-plaċebo fil-bidla mil-linja bażi fil-kejl tal-volum tal-pulmun fl-inqas livell u 3 sigħat wara d-doża f'Ġimgħa 12 (kapaċità ispiratorja: 198 ml u 238 ml rispettivament, volum residwu: -295 ml u -351 ml rispettivament u kapaċità residwa funzjonali:
English: Co-administration of umeclidinium/vilanterol with other long-acting muscarinic antagonists, long-acting beta2-adrenergic agonists or medicinal products containing either of these agents has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions (see sections 4.4 and 4.9).
Maltese: L-għoti fl-istess ħin ta' umeclidinium/vilanterol ma' antagonisti muskariniċi li jaħdmu fit-tul oħra, agonisti beta2-adrenerġiċi li jaħdmu fit-tul jew prodotti mediċinali li fihom xi waħda minn dawn is-sustanzi ma ġiex studjat u mhuwiex rakkomandat minħabba l-potenzjal ta' reazzjonijiet avversi magħrufa b'antagonisti muskariniċi jew b'agonisti beta2-adrenerġiċi (ara sezzjonijiet 4.4 u 4.9).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose 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 dan il prodott mediċinali. 4.5
English: SGRQ Total Score
Maltese: Punteġġ Totali tal
English: Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms vilanterol (as trifenatate).
Maltese: Kull doża mogħtija fiha 55 mikrogramma umeclidinium (ekwivalenti għal 65 mikrogramma ta' umeclidinium bromide) u 22 mikrogramma vilanterol (bħala trifenatate).
English: No clinically relevant effects on plasma glucose were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose.
Maltese: Fi studji kliniċi b'umeclidinium/vilanterol ma kienu osservati l-ebda effetti klinikament rilevanti fuq ilglukosju fil-plasma fid-doża terapewtika rakkomandata.
English: Excipients: lactose and magnesium stearate See package leaflet for further information
Maltese: Eċċipjenti: lactose u magnesium stearate
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Harmire Road
Maltese: (li tinnegozja bħala Glaxo Wellcome Operations) Harmire Road
English: The maximum dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily.
Maltese: Id-doża massima hija inalazzjoni waħda ta' ANORO ELLIPTA 55/22 mikrogramma darba kuljum.
English: Following oral administration to healthy male volunteers, 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 għoti orali lil voluntiera rġiel b'saħħithom, ir-radjuattività totali tneħħiet primarjament fl-ippurgar (92% tad-doża radjutikkettata mogħtija jew 99% tar-radjuattività rkuprata) sa 168
English: The recommended dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily.
Maltese: Id-doża rakkomandata hija inalazzjoni waħda ta' ANORO ELLIPTA 55/22 mikrogramma darba kuljum.
English: ANORO ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Maltese: ANORO ELLIPTA naqqas l-użu tal-medikazzjoni ta' salvataġġ b'salbutamol matul il-Ġimgħat 1-24 meta mqabbel mal-plaċebo u umeclidinium (ara Tabella 1) u wera żieda mil-linja bażi fil-proporzjon ta' ġranet meta ma kienet meħtieġa l-ebda medikazzjoni ta' salvataġġ (medja ta' 11.1%) meta mqabbel ma' tnaqqis mil-linja bażi fuq plaċebo (medja ta' 0.9%).
English: Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Maltese: Pazjenti b'mard kardjovaskulari klinikament sinifikanti li mhux ikkontrollat kienu esklużi mill-istudji kliniċi.
English: Use ANORO ELLIPTA regularly
Maltese: Uża ANORO ELLIPTA b'mod regolari
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Maltese: (li tinnegozja bħala as Glaxo Wellcome Operations) Priory Street
English: Although no formal in vivo drug interaction studies have been performed, inhaled umeclidinium/vilanterol has been used concomitantly with other COPD medicinal products including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.
Maltese: Għalkemm ma sarux studji formali in vivo tal-interazzjoni bejn il-mediċini, umeclidinium/vilanterol li jittieħed man-nifs intuża b'mod konkomitanti ma' prodotti mediċinali oħra għal COPD fosthom bronkodilaturi simpatomimetiċi li jaħdmu għal qasir żmien u kortikosterojdi li jittieħdu man-nifs, mingħajr evidenza klinika ta' interazzjonijiet bejn il-mediċini.