FrancophonIA/ELRC3.0 huggingface dataset:
English: Children under 6 years of age: The experience in children under the age of 6 years is limited (see section 5.1 and 5.2).
Maltese: L-esperjenza fi tfal ta' taħt 6 snin hija limitata (ara sezzjonijiet 5.1 u 5.2).
English: The medicinal product is available in three pack sizes: 30, 60 and 120 sprays.
Maltese: Il-prodott mediċinali jinsab f'pakketti ta' tliet daqsijiet: 30, 60 u 120 sprejjaturi.
English: INFORMATION IN BRAILLE alisade
Maltese: INFORMAZZJONI BIL-BRAILLE
English: MARKETING AUTHORISATION HOLDER Glaxo Group Ltd
Maltese: Glaxo Group Ltd
English: Adults and Adolescents (12 years and over)
Maltese: Adulti u adolexxenti (12-il sena u ikbar)
English: Distribution: The plasma protein binding of fluticasone furoate is greater than 99 %.
Maltese: Dak li jeħel mal-proteini tad-demm fi fluticasone furoate hu aktar minn 99 %.
English: These effects vary between patients and different corticosteroids (see section 5.2).
Maltese: Dawn l-effetti jvarjaw bejn pazjenti u corticosteroids differenti (ara sezzjoni 5.2).
English: The other ingredients are glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.
Maltese: Is-sustanzi l-oħra huma glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, ilma purifikat.
English: Alisade is available in pack sizes 30, 60 and 120 sprays.
Maltese: Alisade ikun f'pakketti ta' 30, 60 u 120 sprejjaturi.
English: Luxembourg/Luxemburg GlaxoSmithKline s.a./n.v.
Maltese: GlaxoSmithKline s.a./n.v.
English: The values are similar to those seen in adults (12+) where median concentrations in those subjects with quantifiable levels were 15.4 pg/ml and 21.8 pg/ml at 55 micrograms and 110 micrograms, respectively.
Maltese: konċentrazzjonijiet f'dawk il-persuni b'livelli kwantifikabbli kienet ta' 15.4 pg/ml u 21.8 pg/ml wara doża ta' 55 mikrogrammi u 110 mikrogrammi, rispettivament.
English: This may result in a higher frequency of systemic adverse events (see section 4.2 and 5.2).
Maltese: Dan jista' jwassal għal frekwenza ogħla ta' effetti mhux mixtieqa (ara sezzjonijiet 4.2 u 5.2).
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version GM2006/00247/05 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: L-MAH jimpenja ruħu li jwettaq l-istudji u l-attivitajiet addizzjonali ta' farmakoviġilanza dettaljati filPjan ta' Farmakoviġilanza, kif miftiehem fil-verżjoni GM2006/00247/05 tal-Pjan dwar il-Maniġġjar ta' Riskju (RMP), preżentat fit-Taqsima 1.8.2 ta' l-Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq u fl-aġġornamenti sussegwenti tal-RMP mifthema mas-CHMP.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini (EMEA): http://www.emea.europa.eu/
English: In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three days with no adverse systemic effects observed (see section 5.2).
Maltese: Fi studju dwar bijodisponibilta`, ittieħdu dożi fl-imnieħer sa 2640 mikrogrammi kuljum għal tlett ijiem mingħajr ma ġew osservati ebda effetti sistemiċi avversi (ara sezzjoni 5.2).
English: Taking nasal glucocorticoids (such as Alisade):
Maltese: It-teħid ta' glucocorticoids mill-imnieħer (bħal Alisade):
English: Median fluticasone furoate concentrations in those subjects with quantifiable levels at 55 micrograms were 18.4 pg/ml and 18.9 pg/ml for 2-5 yrs and 6-11 yrs, respectively.
Maltese: 55 mikrogrammi, kienet ta' 18.4 pg/ml u 18.9 pg/ml għal sentejn sa 5 snin u għal 6 snin sa 11-il sena, rispettivament.
English: Post-hoc analysis over 6 and 12 weeks in the same study, as well as 6-week HPA axis safety study, supported the efficacy of fluticasone furoate nasal spray 110 micrograms once daily.
Maltese: Analiżi post-hoc matul 6 u 12-il ġimgħa fl-istess studju, kif ukoll studju ta' 6 ġimgħat dwar sigurta` ta' HPA axis, urew tisħiħ fl effikaċja ta' 110 mikrogrammi ta' sprej nażali fluticasone furoate darba kuljum.
English: Seasonal Allergic Rhinitis in adults and adolescents Compared with placebo, fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms (comprising rhinorrhoea, nasal congestion, sneezing and nasal itching) and ocular symptoms (comprising itching/burning, tearing/watering and redness of the eyes) in all 4 studies.
Maltese: Meta mqabbla ma' plaċebo, 110 mikrogrammi kuljum ta' l-isprej nażali fluticasone furoate tejbu ssintomi nażali (li jinkludu rinorrea, konġestjoni nażali, għatis u ħakk fl-imnieħer) u sintomi fl-għajnejn (li jinkludu ħakk/ħruq, dmugħ u ħmura fl-għajnejn) f'kull wieħed mill-erba' studji.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna
English: BATCH NUMBER LOT {Number}
Maltese: NUMRU TAL-LOTT LOTT (Numru)
English: Česká republika GlaxoSmithKline s.r.o.
Maltese: Slovenská republika GlaxoSmithKline Slovakia s. r. o.
English: 7 If your dose is two sprays in each nostril repeat steps 4 to 6.
Maltese: 7 Jekk id-doża tiegħek hija żewġ sprejjaturi f'kull imnifsejn irrepeti passi 4 sa 6.
English: Absorption: Fluticasone furoate undergoes incomplete absorption and extensive first-pass metabolism in the liver and gut resulting in negligible systemic exposure.
Maltese: Fluticasone furoate jiġi assorbit mhux kompletament u metabolizzat b'mod first-pass estensivament fil-fwied u l-imsaren li jirriżulta f'esponiment sistemiku negliġibbli.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each spray delivers 27.5 micrograms of fluticasone furoate
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull sprejjatura fiha 27.5 mikrogrammi ta' fluticasone furoate
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/474/001
Maltese: FIS-SUQ EU/1/08/474/001
English: Therefore moderate hepatic impairment is not predicted to result in a clinically relevant effect for the normal adult dose.
Maltese: Għaldaqstant indeboliment moderat tal-fwied mhuwiex mistenni li għandu jirriżulta f'xi effett klinikament rilevanti fl-użu ta' doża normali għal adulti.
English: Alisade 27.5 micrograms per spray nasal spray suspension Fluticasone furoate
Maltese: Alisade 27.5 mikrogrammi/sprejjatura ta' suspensjoni għal użu bħala sprej fl-imnieħer Fluticasone furoate
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Glaxo Group Ltd
Maltese: FIS-SUQ Glaxo Group Ltd
English: This is important as Alisade is a thick suspension that becomes liquid when you shake it well - see picture b. It will only spray when it becomes liquid.
Maltese: Dan huwa importanti peress li Alisade huwa suspensjoni magħquda li ssir likwida meta tħawwdu sew - ara stampa b. Ser jisprejja biss meta jsir likwidu.
English: A 6-week study that assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily on adrenal function in children aged 2 to 11 years showed that there was no significant effect on 24hour serum cortisol profiles, compared with placebo.
Maltese: Studju ta' 6 ġimgħat li fih saret stima ta' l-effett ta' 110 mikrogrammi ta' sprej nażali fluticasone furoate darba kuljum fuq il-funzjoni adrenali fi tfal ta' bejn sentejn u 11-il sena wera li ma kien hemm ebda effett sinifikanti fuq il-profili ta' serum cortisol f'24 siegħa, meta mqabbel ma' plaċebo.
English: In the majority of patients fluticasone furoate is not quantifiable (< 10 pg/ml) following intranasal dosing of 110 micrograms once daily.
Maltese: Fil-maġġoranza ta' pazjenti fluticasone furoate ma jistax jiġi kwantifikat (< 10 pg/mL) wara dożaġġ fl imnieħer ta' 110 mikrogrammi darba kuljum.
English: • Alisade comes in a brown bottle.
Maltese: • Alisade jiġi fi flixkun kannella.
English: {MM/YYYY}
Maltese: • KUNDIZZJONIJIET OĦRA
English: once every day.
Maltese: 6 ġimgħat kontinwament.
English: Adults, adolescents (12 years and over) and children (6 - 11 years)
Maltese: Adulti u adolexxenti (minn 12-il sena ‘l fuq) u tfal (minn 6 snin sa 11-il sena).
English: Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.
Maltese: It-trattament b'dożi ta' corticosteroids nażali akbar minn dawk rakkomandati jista' jirriżulta' f'soppressjoni adrenali klinika ta' ċerta sinifikanza.
English: Fluticasone furoate nasal spray significantly improved the patients' perception of overall response to therapy, and the patients' disease-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire - RQLQ), in all 4 studies.
Maltese: L-isprej nażali fluticasone furoate għamel titjib sinifikanti f'dik li hi perċezzjoni tal-pazjenti tar rispons ġenerali għat-terapija, u f'dik li hi kwalita` ta' ħajja relattiva għall-marda (Kwistjonarju dwar Kwalita` tal-Ħajja b'Rinokonġuntivite -RQLQ), f'kull wieħed mill-erba' studji.
English: GlaxoSmithKline d.o.o.
Maltese: GlaxoSmithKline s.r.o.
English: How to store Alisade
Maltese: Tużax Alisade
English: Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, co-administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.
Maltese: CYP3A4, mhuwiex rakkomandat li jingħata flimkien ma' ritonavir minħabba r-riskju ta' esponiment sistemiku akbar ta' fluticasone furoate.
English: Important information about some of the ingredients of Alisade Alisade contains benzalkonium chloride.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Alisade Alisade fih benzalkonium chloride.
English: Each spray delivers 27.5 micrograms of fluticasone furoate.
Maltese: Kull doża/sprejjatura toħroġ madwar 27.5 mikrogrammi ta' fluticasone furoate.
English: If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone furoate.
Maltese: Jekk jidher li għal xi raġuni l-funzjoni adrenali ddgħajfet, għandha tingħata attenzjoni meta pazjenti jaqilbu minn trattament bi sterojdi sistemiċi għal wieħed bi fluticasone furoate.
English: Results from a placebo-controlled knemometry study of fluticasone furoate nasal spray 110 micrograms once daily revealed no clinically relevant effects on short-term lower leg growth rate in children (6 to 11 years).
Maltese: Riżultati minn studju dwar nemometrija kontrollat bi plaċebo b'110 mikrogrammi ta' sprej nażali ta' fluticasone furoate darba kuljum ma wrew ebda effetti klini ċi rilevanti fl-iżvilupp f'perijodu qasir talparti t'isfel tas-saqajn fi tfal (6 snin sa 11-il sena).
English: Renal Impaired Patients: No dose adjustment is required in this population (see section 5.2).
Maltese: M'hemmx bżonn ta'aġġustament ta' dożi f'din il-popolazzjoni (ara sezzjoni 5.2).
English: Fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms as well as patients' perception of overall response to therapy compared to placebo in three studies.
Maltese: 110 mikrogrammi kuljum ta' sprej nażali fluticasone furoate ġabu titjib sinifikanti tas-sintomi flgħajnejn kif ukoll f'dik li hi perċezzjoni tal-pazjenti tal-kwalita` ta' ħajja relattiva għall-marda (RQLQ) meta mqabbla ma' plaċebo fi studju wieħed.
English: Fluticasone furoate 110 micrograms once daily was not associated with hypothalamicpituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects.
Maltese: Jekk ikun jidher il-bżonn ta' dożi akbar minn dawk rakkomandati, għandha tiġi kkunsidrata żieda fil-kopertura sistemika ta' corticosteroid matul perijodi ta' stress jew f'każ ta' xi operazzjoni mhux ur ġenti. 110 mikrogrammi ta' fluticasone furoate darba kuljum ma ġewx assoċjati ma' hypothalamic-pituitary-adrenal (HPA) axis suppression f'suġġetti adulti, adolexxenti jew pedjatriċi.
English: Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate (see section 4.5).
Maltese: L-amministrazzjoni flimkien ma' ritonavir mhux rakkomandat minħabba r-riskju li jiżdied l-ammont ta' fluticasone furoate fid-demm (ara sezzjoni 4.5).
English: NAME OF THE MEDICINAL PRODUCT Alisade 27.5 micrograms/spray nasal spray suspension Fluticasone furoate
Maltese: Alisade 27.5 mikrogrammi/ sprejjatura ta' suspensjoni li jintuża bħala sprej fl-imnieħer Fluticasone furoate
English: The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms).
Maltese: Id-doża rakkomandata għall-bidu hi ta' żewġ sprejjaturi (27.5 mikrogrammi ta' fluticasone furoate f'kull sprejjatura li tiġi attwata) f'kull minħar darba kuljum (doża totali tal-ġurnata,
English: • steroid tablets or injected steroids
Maltese: • tas-sintomi ta' rinite allerġika .
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Maltese: • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL-FORNIMENT U L-UŻU IMPOSTI FUQ ID-DETENTUR TA' L AWTORIZZAZZJONI GĦAT-TQEGĦID FISSUQ
English: If the level is very low there may not be enough left to work the nasal spray.
Maltese: possibilment titnaqqas għal sprejjatura waħda f'kull minħar darba kuljum.
English: Alisade works to decrease inflammation caused by allergy (rhinitis).
Maltese: Tużax Alisade wara d-data ta' l-iskadenza li tidher fuq it-tikketta u fuq il-kaxxa.
English: Alisade nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over.
Maltese: Alisade sprej nażali jintuża fit-trattament ta' sintomi ta' rinite allerġika inklużi mnieħer imblukkat jew inixxi, għatis, u għajnejn idemmgħu u ħakk fl-għajnejn fl-adulti u fit-tfal ta' 6 snin u l-fuq.
English: This leaflet was last approved in {MM/YYYY}.
Maltese: Id-data ta' skadenza tirreferi għal l-aħħar ġurnata ta' dak ix-xahar.
English: EXPIRY DATE EXP {MM/YYYY]
Maltese: Kodi ċi ATC:
English: ÔSee Step-by-step guide to using the nasal spray, after Section 6.
Maltese:  Ara Gwida pass wara pass dwar kif għandek tuża l-isprej għall-imnieħer, wara Sezzjoni 6.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Maltese: • Meta s-sintomi jkunu kontrollati tista' tnaqqas id-doża għal sprejjatura waħda f'kull minħar, darba kuljum.
English: Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Maltese: Tel: + 421 (0)2 49 10 33 11 recepcia.sk@gsk.com
English: Barnard Castle, County Durham DL12 8DT United Kingdom
Maltese: Barnard Castle, County Durham DL12 8DT Ir-Renju Unit
English: Supraventricular extrasystoles Palpitations
Maltese: Ekstrasistoli supraventrikulari Palpitazzjonijiet
English: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland GlaxoSmithKline (Ireland) Limited logo
Maltese: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irlanda GlaxoSmithKline (Ireland) Limited logo
English: • painful and frequent urination (may be signs of a urinary tract infection)
Maltese: • awrina frekwenti u bl-uġigħ (jistgħu jkunu sinjali ta' infezzjoni fl-apparat urinarju)
English: 55 micrograms/22 micrograms
Maltese: 55 mikrogramma/22 mikrogramma
English: ANORO ELLIPTA (N = 454) versus tiotropium 18 mcg (N = 451) (Study ZEP117115)
Maltese: ANORO ELLIPTA (N = 454) kontra tiotropium 18 mcg (N = 451) (Studju ZEP117115)
English: Beta-adrenergic blockers
Maltese: Imblokkaturi beta-adrenerġiċi
English: Atrial fibrillation Supraventricular tachycardia Rhythm idioventricular Tachycardia
Maltese: Fibrillazzjoni atrijali Takikardija sopraventrikolari Ritmu idjoventrikulari Takikardija
English: Uncommon Rare
Maltese: Rari Rari
English: Treatment difference1 (95% confidence intervals, p-value) Trough FEV1 (ml)
Maltese: Differenza bejn il-kuri1 (95% intervall ta' kunfidenza, valur-p) L-anqas livell tal-FEV1 (ml)
English: Concomitant administration of strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin) may inhibit the metabolism of, and increase the systemic exposure to, vilanterol.
Maltese: CYP3A4 (eż. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin) jista' jinibixxi l metaboliżmu ta', u jżid l-esponiment sistemiku għal, vilanterol.
English: By Q3 2024
Maltese: Sa Q3
English: versus
Maltese: kontra
English: The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Maltese: polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate u stainless steel.
English: Date of first authorisation: 08 May 2014 Date of latest renewal: 15 January 2019
Maltese: Data tal-aħħar tiġdid: 15 ta' Jannar 2019
English: The active substances are umeclidinium bromide and vilanterol.
Maltese: Is-sustanzi attivi huma umeclidinium bromide u vilanterol.
English: ANORO ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol
Maltese: ANORO ELLIPTA 55/22 mcg trab li jittieħed man-nifs umeclidinium/vilanterol
English: The other ingredients are lactose monohydrate (see section 2 under ‘ANORO ELLIPTA contains lactose') and magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate (ara sezzjoni 2 taħt “ANORO ELLIPTA fih il-lactose”) u magnesium stearate.
English: Following intravenous administration to healthy volunteers, the mean volume of distribution was 86 litres.
Maltese: Wara għoti fil-vini lil voluntiera b'saħħithom, il-volum medju ta' distribuzzjoni kien ta' 86 litru.
English: In the other two studies, the risk of a moderate/severe COPD exacerbation was increased by 20% and 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 and HR 1.9; 95% CI: 1.0, 3.6; p=0.062 respectively).
Maltese: 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 u HR 1.9; 95% CI: 1.0, 3.6; p=0.062 rispettivament).
English: Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (beta2-adrenergic agonist).
Maltese: Vilanterol huwa agonist selettiv li jaħdem fit-tul, tar-riċetturi beta2-adrenerġiċi (agonist beta2-adrenerġiku).
English: In the second study, the treatment difference in EET between ANORO ELLIPTA 55/22 micrograms and placebo was 21.9 seconds (p=0.234) at Week 12.
Maltese: EET bejn ANORO ELLIPTA 55/22 mikrogramma u l-plaċebo kienu ta' 21.9 sekondi (p=0.234)
English: • hoarseness.
Maltese: • sturdament.
English: ANORO ELLIPTA (N = 207) versus tiotropium 18 mcg (N = 203) (Study DB2113360)
Maltese: ANORO ELLIPTA (N = 207) kontra tiotropium 18 mcg (N = 203) (Studju DB2113360) ANORO ELLIPTA (N = 217) kontra tiotropium 18 mcg (N = 215) (Studju DB2113374)
English: Therefore, no clinically relevant pro-arrhythmic potential related to QT-interval prolongations was observed with umeclidinium/vilanterol 113/22 micrograms.
Maltese: Għalhekk, ma kien osservat l-ebda potenzjal proarritmiku klinikament rilevanti relatat mat-titwil fl-intervall QT b'umeclidinium/vilanterol 113/22 mikrogramma.
English: In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
Maltese: Studji in vitro wrew li umeclidinium huwa metabolizzat primarjament miċ-ċitokromu P450 2D6 (CYP2D6) u huwa substrat għat-trasportatur tal-glikoproteina P (P-gp).
English: The comparison of FF/UMEC/VI to FF/VI and UMEC/VI resulted in a statistically significant 14.8% reduction in risk of a moderate/severe exacerbation (based on analysis of time to first exacerbation) (Hazard Ratio 0.85; 95% CI: 0.80, 0.91; p<0.001) and 16.0% reduction in risk of a moderate/severe exacerbation respectively (based on analysis of time to first exacerbation) (Hazard Ratio 0.84; 95% CI: 0.78, 0.91; p<0.001).
Maltese: It-tqabbil ta' FF/UMEC/VI ma' FF/VI u UMEC/VI rriżulta fi tnaqqis statistikament sinifikanti ta' 14.8% firriskju ta' taħrix moderat/sever (abbażi tal-analiżi taż-żmien għall-ewwel taħrix) (Proporzjon ta' Periklu 0.85; 95% CI: 0.80, 0.91; p<0.001) u tnaqqis ta' 16.0% fir-riskju ta' taħrix moderat/sever rispettivament (abbażi tal-analiżi taż-żmien għall-ewwel taħrix) (Proporzjon ta' Periklu 0.84; 95% CI: 0.78, 0.91; p<0.001).
English: Both umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp).
Maltese: Kemm umeclidinium kif ukoll vilanterol huma substrati tat-trasportatur tal-glikoproteina P (P-gp).
English: In a 24-week placebo-controlled study in patients with symptomatic COPD, ANORO ELLIPTA reduced the risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis of time to first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121).
Maltese: Fi studju ta' 24 ġimgħa kkontrollat bil-plaċebo f'pazjenti b'COPD sintomatiku, ANORO ELLIPTA naqqas ir-riskju ta' taħrix tas-COPD moderat/sever b'50% meta mqabbel ma' plaċebo (abbażi tal-analiżi tas-żmien għall-ewwel taħrix: Proporzjon ta' Periklu (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); b'20% meta mqabbel ma' umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); u b'30% meta mqabbel ma' vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121).
English: EU/1/14/898/001 1 inhaler of 7 doses EU/1/14/898/002 1 inhaler of 30 doses
Maltese: EU/1/14/898/002 1 inalatur ta' 30 doża
English: An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual components' actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry mouth, visual accommodation disturbances and tachycardia) or those with overdose of other beta2-adrenergic agonists (e.g. arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
Maltese: Doża eċċessiva ta' umeclidinium/vilanterol probabbilment tipproduċi sinjali u sintomi minħabba l-azzjonijiet tal-komponenti individwali, konsistenti mar-reazzjonijiet avversi magħrufa tal-antagonisti muskariniċi li jittieħdu man-nifs (eż. ħalq xott, disturbi tal-akkomodazzjoni viżwali u takidardija) jew dawk b'doża eċċessiva ta' agonisti beta2-adrenerġiċi oħra (eż. arritmiji, rogħda, uġigħ ta' ras, palpitazzjonijiet, dardir, ipergliċemija u ipokalimja).
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 1.8-fold accumulation.
Maltese: Wara dożaġġ ripetut ta' umeclidinium li jittieħed mannifs, stat fiss inkiseb fi żmien 7 sa 10 ijiem b'akkumulazzjoni 1.5 sa 1.8 darbiet akbar.
English: Renal impairment
Maltese: Rogħda Disgewżja
English: It is a quinuclidine derivative with activity across multiple muscarinic receptor subtypes.
Maltese: Huwa derivattiv ta' quinuclidine b'attività fost bosta sottotipi ta' riċetturi muskariniċi.
English: Anaphylaxis, angioedema, and urticaria
Maltese: Anafilassi, anġjoedema u urtikarja
English: • awareness of heart beat (palpitations)
Maltese: • tkun konxju tar-rata ta' taħbit tal-qalb (palpitazzjonijiet)
English: 1 inhaler of 7 doses 1 inhaler of 30 doses
Maltese: 1 inalatur ta' 7 dożi
English: The safety profile of ANORO ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Maltese: Il-profil tas-sigurtà ta' ANORO ELLIPTA huwa bbażat fuq l-esperjenza tas-sigurtà b'umeclidinium/vilanterol u l-komponenti individwali mill-programm ta' żvilupp kliniku li fih ħadu sehem 6,855 pazjent b'COPD u minn rapportar spontanju.