FrancophonIA/ELRC3.0 huggingface dataset:
English: Vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic indicating that vilanterol (as trifenatate) does not represent a genotoxic hazard to humans.
Maltese: Vilanterol (bħala alpha-phenylcinnamate) u l-aċidu trifenilaċetiku ma kellhomx effett tossiku fuq il-ġeni, li jindika li vilanterol (bħala trifenatate) ma jirrappreżentax periklu ġenotossiku għall-bnedmin.
English: Following oral administration, 92% of the administered radiolabelled dose was excreted primarily in faeces.
Maltese: Wara għoti orali, 92 % tad-doża radjutikkettata mogħtija kienet eliminat primarjament fl-ippurgar.
English: Vilanterol was not teratogenic in rats.
Maltese: Vilanterol ma kienx teratoġeniku fil-firien.
English: At screening, the mean post-bronchodilator percent predicted FEV1 was 46% and over 99% of patients reported a history of one or more moderate/severe exacerbation in the past year.
Maltese: Waqt l-iskrinjar, l-FEV1 medju wara lbronkodilatur kien ta' 46 % tal-previst u aktar minn 99 % tal-pazjenti rrappurtaw storja ta' taħrix wieħed jew aktar moderat/sever fis-sena mgħoddija.
English: However, studies have been conducted with fluticasone furoate/vilanterol and umeclidinium/vilanterol.
Maltese: Madankollu, saru studji bi fluticasone furoate/vilanterol u umeclidinium/vilanterol.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics including triple combinations with corticosteroids, ATC code: R03AL08.
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tal-arja, adrenerġiċi flimkien ma' antikolinerġiċi inkluż kombinazzjonijiet trippli ma' kortikosterojdi, Kodiċi ATC:
English: In FULFIL, Trelegy Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
Maltese: F'FULFIL, Trelegy Ellipta naqqas sinifikament (p<0.001) l-użu ta' medikazzjoni ta' salvataġġ bejn ġimgħat 1-24 meta mqabbel ma' BUD/FOR (differenza fil-kura: -0.2 okkażjonijiet għal kull jum; 95% CI: -0.3, -0.1).
English: In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Trelegy Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
Maltese: 001) għal Trelegy Ellipta meta mqabbel ma' BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
English: Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation
Maltese: Wara dożaġġ ripetut ta' fluticasone furoate /vilanterol miġbud bin-nifs, listat fiss inkiseb fi żmien 6 ijiem b'sa akkumulazzjoni ta' 1.6 darba
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 talġisem (BMI) baxx u COPD severa.
English: The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).
Maltese: L-ewwel studju inkluda dejta dwar is-sigurtà minn 911-il pazjent b'COPD li rċivew fluticasone furoate/umeclidinium/vilanterol 92/55/22 mikrogramma, darba kuljum, sa 24 ġimgħa, li minnhom 210 pazjent irċivew fluticasone furoate/umeclidinium/vilanterol 92/55/22 mikrogramma darba kuljum sa 52 ġimgħa, b'komparatur attiv (studju CTT116853, FULFIL).
English: Cough Oropharyngeal pain
Maltese: Popolazzjoni pedjatrika
English: Systemic exposure to the metabolites is low.
Maltese: L-esponiment sistemiku għall-metaboliti huwa baxx.
English: Read the package leaflet before use.
Maltese: Aħżen fil‑pakkett oriġinali sabiex tilqa' mill‑umdità.
English: In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or lower) at week 24, was significantly higher (p<0.001) for patients treated with Trelegy Ellipta compared with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
Maltese: F'FULFIL, il-proporzjon ta' pazjenti li kienu rispondenti għal CAT (definiti bħal 2 unitajiet taħt il-linja bażi jew aktar baxx) kien f'ġimgħa 24, kien sinifikament ogħla (p<0.001) għal pazjenti kkurati bi Trelegy Ellipta meta mqabbel ma' BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
English: Viral respiratory tract infection
Maltese: Infezzjoni tal-pulmun
English: • flu (influenza)
Maltese: • influwenza
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Maltese: L-agonisti beta2 adrenerġiċi jistgħu jipproduċu ipokalimja sinifikanti f'xi pazjenti, li kapaċi tikkawża effetti kardjovaskulari avversi.
English: In Study 200812, Trelegy Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
Maltese: Fi studju 200812, Trelegy Ellipta kien noninferjuri meta mqabbel ma' FF/VI+UMEC, mogħti flimkien f'żewġ inalaturi, fit-titjib mil-linja bażi f'FEV1 minimu f'Ġimgħa 24.
English: Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Maltese: Trelegy Ellipta 92 mikrogramma/55 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel fluticasone furoate/umeclidinium/vilanterol
English: Other sources of information
Maltese: Sorsi oħra ta᾽ informazzjoni
English: The following instructions for the 30 dose (30 day supply) Ellipta inhaler also apply to the 14 dose (14 day supply) Ellipta inhaler.
Maltese: L-istruzzjonijiet li ġejjin għall-inalatur Ellipta ta' 30 doża (provvista ta' 30 jum) japplikaw ukoll għallinalatur Ellipta ta' 14-il doża (provvista ta' 14-il jum).
English: The primary metabolic routes for umeclidinium are oxidative (hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not been established.
Maltese: Ir-rotot metaboliċi primarji għal umeclidinium huma ossidattivi (idroksilazzjoni, dealkilazzjoni-O) segwiti mill-konjugazzjoni (glukuronidazzjoni, eċċ.), li jirriżultaw f'firxa ta' metaboliti li jew ikollhom attività farmakoloġika mnaqqsa jew li għalihom ma ġietx stabbilita l-attività farmakoloġika.
English: Co-administration of Trelegy Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Maltese: Antimuskariniċi oħra li jaġixxu fit-tul u agonisti beta2 adrenerġiċi li jaġixxu fit-tul L-għoti flimkien ta' Trelegy Ellipta ma' antimuskariniċi li jaġixxu fit-tul u agonisti beta2 adrenerġiċi li jaġixxu fit-tul ma ġiex studjat u mhuwiex rakkomandat peress li dan jista' jkollu potenzjal għal reazzjonijiet avversi (ara sezzjoni 4.8 u sezzjoni 4.9).
English: The effects of race, gender and weight on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were also evaluated in the population pharmacokinetic analysis.
Maltese: L-effetti tar-razza, tas-sess u tal-piż fuq il-farmakokinetika ta' fluticasone furoate, umeclidinium u vilanterol ġew evalwati wkoll fl-analiżi farmakokinetika tal-popolazzjoni.
English: LIST OF EXCIPIENTS Also contains lactose and magnesium stearate.
Maltese: Fih ukoll lattożju u magnesium stearate.
English: Plasma clearance of vilanterol following intravenous administration was 108 litres/hour.
Maltese: It-tneħħija ta' vilanterol mill-plażma wara għoti ġol-vini kienet ta' 108 litri/siegħa.
English: The effect of fluticasone furoate/umeclidinium/vilanterol on the QT interval has not been evaluated in a thorough QT (TQT) study.
Maltese: L-effett ta' fluticasone furoate/umeclidinium/vilanterol fuq l-intervall QT ma ġiex ivvalutat fi studju komprensiv tal-QT (TQT).
English: Fluticasone furoate was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in rats or mice at exposures of 1.4- or 2.9-fold, respectively, those seen in humans at a daily dose of 92 micrograms fluticasone furoate, based on AUC.
Maltese: Fluticasone furoate ma kellux effett tossiku fuq il-ġeni f'batterija standard ta' studji u ma kienx karċinoġeniku fi studji ta' teħid bin-nifs tul il-ħajja fil-firien jew fil-ġrieden b'esponimenti ta' 1.4- jew 2.9darbiet, rispettivament, dawk li dehru fil-bnedmin bid-doża ta' kuljum ta' 92 mikrogramma fluticasone furoate, abbażi tal-AUC.
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
English: Covariate analysis showed higher FF apparent clearance (42%) when comparing FF/VI to FF/UMEC/VI; however, this is not considered clinically relevant.
Maltese: Analiżi kovarjata uriet tneħħija apparenti ta' FF ogħla (42%) meta mqabbel ma' FF/VI sa FF/UMEC/VI; madankollu, dan ma tqiesx bħala klinikament rilevanti.
English: Package leaflet: Information for the patient Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Maltese: Informazzjoni għall-pazjent Trelegy Ellipta 92 mikrogramma/55 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel fluticasone furoate/umeclidinium/vilanterol
English: The efficacy of Trelegy Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Maltese: L-effikaċja ta' Trelegy Ellipta (92/55/22 mikrogramma) mogħti bħala kura ta' darba kuljum ġiet ivvalutata f'pazjenti b'dijanjożi klinika ta' COPD f'żewġ studji kkontrollati attivi u fi studju wieħed mhux ta' inferjorità.
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 li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din ilmediċina.
English: Umeclidinium is a long-acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Maltese: Umeclidinium huwa antagonist tar-riċettur muskariniku li jaħdem fit-tul (imsejjaħ ukoll antikolinerġiku).
English: In vitro protein binding studies between subjects with severe renal impairment and healthy volunteers were conducted, and no clinically significant evidence of altered protein binding was seen.
Maltese: Saru studji ta' twaħħil tal-proteina in vitro bejn individwi b'indeboliment tal-kliewi sever u voluntiera b'saħħithom, u ma dehret l-ebda evidenza klinikament sinifikanti ta' twaħil tal-proteina.
English: The patient should be assessed and alternative therapy instituted if necessary.
Maltese: Il-pazjent għandu jiġi vvalutat u għandha tingħata terapija alternattiva jekk din tkun meħtieġa.
English: • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Maltese: • Jekk il-kontatur tad-dożi ma jnaqqasx b'1 malli tisma' l-“klikk”, l-inalatur ma jagħtikx ilmediċina.
English: Step-by-step instructions
Maltese: Relatata mas-Saħħa
English: Each blister in one strip contains fluticasone furoate, each blister in the other strip contains umeclidinium (as bromide) and vilanterol (as trifenatate).
Maltese: Kull folja fi strixxa waħda fiha fluticasone furoate, kull folja fl-istrixxa l-oħra fiha umeclidinium (bħala bromide) u vilanterol (bħala trifenatate).
English: There are no data on the effects of fluticasone furoate/umeclidinium/vilanterol on human fertility.
Maltese: M'hemmx dejta dwar l-effetti ta' fluticasone furoate/umeclidinium/vilanterol fuq il-fertilità tal-bniedem.
English: Talk to your doctor before using Trelegy Ellipta - if you have asthma (Don't use Trelegy Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
Maltese: - jekk għandek l-ażżma (Tużax Trelegy Ellipta biex tikkura l-ażżma) - jekk għandek problemi fil-qalb jew pressjoni tad-demm għolja - jekk għandek problemi fil-fwied - jekk għandek it-tuberkulożi (TB) tal-pulmun, jew kwalunkwe infezzjoni li ilha preżenti jew li ma ġietx ikkurata għal żmien twil - jekk għandek problema fl-għajnejn imsejħa glawkoma tal-angolu dejjaq. - jekk għandek prostata mkabbra, diffikultà biex tgħaddi l-awrina jew imblokk fil-bużżieqa tal awrina tiegħek - jekk tbati minn epilessija - jekk għandek problemi fil-glandola tat-tirojde - jekk għandek livell ta' potassju baxx fid-demm tiegħek - jekk għandek storja ta' dijabete - Jekk tesperjenza vista mċajpra jew disturbi viżivi oħrajn
English: In terms of other patient characteristics, a study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium.
Maltese: F'termini ta' karatteristiċi oħra tal-pazjent, studju fuq metabolizzaturi dgħajfa ta' CYP2D6 ma wera l-ebda evidenza ta' effett klinikament sinifikanti tal-polimorfiżmu ġenetiku ta' CYP2D6 fuq l-esponiment sistemiku għal umeclidinium.
English: Stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma.
Maltese: Tibqax tuża din il-mediċina u fittex għajnuna medika immedjatament, dawn jistgħu jkunu sinjali ta' attakk akut ta' glawkoma b'angolu dejjaq.
English: • hoarseness
Maltese: • sogħla
English: Trelegy Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Maltese: 001) il-funzjoni tal-pulmun (kif definite minn bidla medja mil-linja bażi f'FEV1 minimu f'ġimgħa 24) (ara Tabella 1) u t-titjib inżamm f'subsett ta' pazjenti li komplew il-kura sa ġimgħa 52.
English: BATCH NUMBER
Maltese: Qawmien billejl
English: Systemic drug levels (steady state Cmax and AUC) of FF, UMEC and VI following FF/UMEC/VI in one inhaler (triple combination) were within the range of those observed following FF/VI + UMEC as two inhalers, dual combinations (FF/VI and UMEC/VI), as well as individual single inhalers (FF, UMEC and VI).
Maltese: FF/VI + UMEC bħala żewġ inalaturi kombinazzjonijiet doppji (FF/VI u UMEC/VI) kif ukoll inalaturi waħdiena individwali (FF, UMEC u VI).
English: Lung Function
Maltese: Funzjoni tal-Pulmun
English: Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Maltese: Kull doża mogħtija fiha 92 mikrogramma ta' fluticasone furoate, 55mikrogramma ta' umeclidinium (ekwivalenti għal 65 mikrogramma ta' umeclidinium bromide) u 22 mikrogramma ta' vilanterol (bħala trifenatate).
English: Uncommon side effects These may affect up to 1 in 100 people:
Maltese: Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa persuna 1 minn kull 100:
English: INFORMATION IN BRAILLE trelegy ellipta
Maltese: Jekk tinsa tuża Trelegy Ellipta
English: Your Trelegy Ellipta inhaler carton contains
Maltese: X'inhu Trelegy Ellipta u għalxiex jintuża
English: Clinically significant drug interactions mediated by fluticasone furoate/umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Maltese: Fi studji kliniċi bi fluticasone furoate/umeclidinium/vilanterol ma ġie osservat l-ebda effett klinikament relevanti fuq ilglukożju fil-plażma bid-doża terapewtika rakkomandata.
English: In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, based on AUC).
Maltese: Fi studju qabel u wara t-twelid, l-għoti taħt ilġilda ta' umeclidinium lill-firien irriżulta f'żieda fil-piż tal-ġisem tal-omm u konsum tal-ikel aktar baxxi u f'piżijiet tal-ġisem ftit imnaqqsa fil-frieħ ta' qabel il-ftim fin-nisa li ngħataw doża ta' 180 mikrogramma/kg/jum (madwar 61 darba l-esponiment kliniku tal-bniedem ta' umeclidinium bid-doża ta' kuljum ta' 55 mikrogramma, abbażi tal-AUC).
English: This will make it less likely that you will develop a sore mouth or throat as side effects.
Maltese: Dan se jagħti inqas probabbiltà li tiżviluppa ħalq misluħ jew uġigħ fil-griżmejn bħala effetti sekondarji.
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 2-fold accumulation.
Maltese: Wara dożaġġ ripetut ta' umeclidinium li jittieħed man-nifs, stat fiss inkiseb fi żmien 7 sa 10 ijiem b'akkumulazzjoni 1.5 sa darbtejn akbar.
English: PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Fluticasone furoate is a corticosteroid with potent anti-inflammatory activity.
Maltese: Fluticasone furoate huwa kortikosterojde b'attività anti-infjammatorja b'saħħitha.
English: In IMPACT, treatment with Trelegy Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
Maltese: F'IMPACT, il-kura bi Trelegy Ellipta naqqset ir-rata annwali ta' taħrix sever (jiġifieri, li jeħtieġ dħul flisptar jew li jirriżulta f'mewt) bi 13 % meta mqabbel ma' F/VI (95% CI: -1, 24; p=0.064).
English: For fluticasone furoate, patients with moderate hepatic impairment showed up to three times higher systemic exposure (FF 184 micrograms); therefore, patients with severe hepatic impairment received half the dose (FF 92 micrograms).
Maltese: Għal fluticasone furoate, pazjenti b'indeboliment talfwied moderat urew esponiment sistemiku sa tliet darbiet ogħla (FF 184 mikrogramma); għalhekk, pazjenti b'indeboliment tal-fwied sever irċivew nofs id-doża (FF
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms of vilanterol (as trifenatate).
Maltese: Kull inalazzjoni tipprovdi doża lesta (id-doża li toħroġ mill-biċċa tal-ħalq) ta' 92 mikrogramma fluticasone furoate, 65 mikrogramma umeclidinium bromide ekwivalenti għal 55 mikrogramma umeclidinium u 22 mikrogramma vilanterol (bħala trifenatate).
English: Trelegy Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Maltese: Tużax Trelegy Ellipta jekk diġà qiegħed tuża dawn il-mediċini.
English: The inhaler contains two aluminium foil laminate blister strips that deliver a total of 14 or 30 doses (14 or 30 day supply).
Maltese: L-inalatur fih żewġ strixxi folji ta' laminat tal-fojl tal-aluminju li jagħtu total ta' 14 jew 30 doża (provvista ta' 14 jew 30 jum).
English: Don't use Trelegy Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tużax Trelegy Ellipta: - jekk inti allerġiku għal fluticasone furoate, umeclidinium, vilanterol jew għal xi sustanza oħra ta' din il-mediċina (elenkata fis-sezzjoni 6).
English: What Trelegy Ellipta looks like and contents of the pack The Ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter.
Maltese: Fi studji kliniċi b'Trelegy Ellipta ma ġie osservat l-ebda effett klinikament relevanti ta' ipokalimja bid-doża terapewtika rakkomandata.
English: Fluticasone furoate and vilanterol are rapidly cleared by extensive first pass metabolism mediated by enzyme CYP3A4.
Maltese: Fluticasone furoate u vilanterol jitneħħew malajr permezz ta' metaboliżmu estensiv tal-ewwel passaġġ medjat mill-enzima CYP3A4.
English: Patients with moderate to severe hepatic impairment receiving Trelegy Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Maltese: Pazjenti b'indebboliment tal-fwied moderat sa sever li jkunu qed jirċievu Trelegy Ellipta għandhom jiġu mmonitorjati għal reazzjonijiet avversi relatati mal-kortikosterojdi (ara sezzjoni 5.2).
English: • cough
Maltese: Ksur
English: At weeks 49-52, the treatment difference was -0.28 (95% CI: -0.37, -0.19) when compared with FF/VI and -0.30 (95% CI: -0.41, -0.19) with UMEC/VI.
Maltese: FF/VI (14.8%; 95% CI: 9.3, 19.9) kif ukoll UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
English: • Take one long, steady, deep breath in.
Maltese: • Iġbed b'nifs wieħed twil, sod u fond.
English: Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose of 55 micrograms umeclidinium, based on AUC respectively.
Maltese: Umeclidinium ma kellux effett tossiku fuq il-ġeni f'batterija standard ta' studji u ma kienx karċinoġeniku fi studji ta' teħid bin-nifs tul il-ħajja fil-firien jew fil-ġrieden b'esponimenti  20 jew  17-il darba talesponiment kliniku tal-bniedem bid-doża ta' kuljum ta' 55 mikrogramma umeclidinium, abbażi tal-AUC rispettivament.
English: Pack sizes of 14 or 30 dose inhalers.
Maltese: Daqsijiet tal-pakkett ta' inalatur ta' 14 jew 30 doża.
English: This medicine is subject to additional monitoring.
Maltese: Dan il‑prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: However, other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk.
Maltese: Madankollu, kortikosterjodi, agonisti muskariniċi u agonisti beta2 adrenerġiċi huma misjuba fil-ħalib tas-sider tal-bniedem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/003
Maltese: EU/1/17/1236/001 EU/1/17/1236/002 EU/1/17/1236/003
English: Following repeat dosing of inhaled umeclidinium/vilanterol, steady state was achieved within 6 days with up to 1.5-fold accumulation.
Maltese: Wara dożaġġ ripetut ta' vilanterol li jittieħed man-nifs, stat fiss inkiseb fi żmien 6 ijiem b'akkumulazzjoni sa 1.5 darbiet akbar.
English: Pregnancy
Maltese: Inalatur
English: There was no increase in tumour incidence in rats or mice at exposures 0.9- or 22-fold, respectively, the human clinical exposure of vilanterol at a daily dose of 22 micrograms based on AUC.
Maltese: Ma kien hemm l-ebda żieda fl-inċidenza ta' tumuri fil-firien u l-ġrieden b'esponimenti 0.9 jew 22 darba ripsettivament, mill-esponiment kliniku tal-bniedem ta' vilanterol b'doża ta' kuljum ta' 22 mikrogramma, abbażi tal-AUC.
English: Use of Rescue Medication
Maltese: TAL-PRODOTT MEDIĊINALI
English: Dose counter
Maltese: 14-il doża