FrancophonIA/ELRC3.0 huggingface dataset:
English: For trough FEV1 subjects in the fluticasone furoate/vilanterol group achieved a LS mean change from baseline of 281 mL and subjects in the salmeterol/FP group a change of 300 mL; (the difference in adjusted mean of -19 mL (95%CI:-0.073, 0.034) was not statistically significant (p=0.485).
Maltese: Għall-FEV1 minimu, il-pazjenti fil-grupp li ngħata fluticasone furoate/vilanterol kisbu bidla medja fil-LS mil-linja bażi ta' 281 mL u l-pazjenti fil-grupp li ngħata salmeterol/FP kisbu bidla ta' 300 mL; (id-differenza fil-medja aġġustata ta' -19 mL (95%CI:-0.073, 0.034) ma kinitx statistikament sinifikanti (p=0.485).
English: • skin rash (hives) or redness
Maltese: • raxx tal-ġilda (ħorriqija) jew ħmura
English: The 92/22 micrograms strength is used for the regular treatment of chronic obstructive pulmonary disease (COPD) in adults, and asthma in adults and adolescents 12 years and over.
Maltese: Il-qawwa ta' 92/22 mikrogramma tintuża għall-kura regolari ta' mard kroniku ostruttiv tal-pulmuni (COPD) fl-adulti, u ażżma f'persuni adulti u tfal ta' 'l fuq minn 12-il sena.
English: Relvar Ellipta 184/22 micrograms is not indicated for patients with COPD.
Maltese: Relvar Ellipta 184/22 mhuwiex indikat għal pazjenti b'COPD.
English: Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity.
Maltese: Fluticasone furoate huwa kortikosterojd sintetiku trifluworinat b'attività antiinfjammatorja b'saħħitha.
English: The pharmacologic effects of beta2-adrenoceptor agonist active substance, including vilanterol trifenatate, 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: huma tal-anqas parzjalment attribwibbli lill-istimulazzjoni tal-adenylate cyclase ġoċ-ċelloli, l-enzima li tikkatalizza l-konverżjoni ta' adenosine triphosphate (ATP) fi 3',5'-adenosine monophosphate ċikliku (AMP
English: Prescribers should be aware that in patients with asthma, fluticasone furoate (FF) 100 micrograms once daily is approximately equivalent to fluticasone propionate (FP) 250 micrograms twice daily, while FF 200 micrograms once daily is approximately equivalent to FP 500 micrograms twice daily.
Maltese: Min jordnah għandu jkun konxju li f'pazjenti bl-ażma, fluticasone furoate (FF) 100 mikrogrammi darba kuljum huwa bejn wieħed u ieħor ekwivalenti għal fluticasone propionate (FP) 250 mikrogramma darbtejn kuljum, filwaqt li FF 200 mikrogramma darba kuljum huma bejn wieħed u ieħor ekwivalenti għal FP 500 mikrogrammi darbtejn kuljum.
English: Vilanterol trifenatate was not teratogenic in rats.
Maltese: Vilanterol trifenatate ma kienx teratoġeniku fil-firien.
English: The primary endpoint was all-cause mortality and a secondary endpoint was a composite of cardiovascular events (on-treatment cardiovascular death, myocardial infarction, stroke, unstable angina, or transient ischemic attack).
Maltese: avvenimenti kardjovaskulari (mewt kardjovaskulari waqt il-kura, infart mijokardjali, puplesija, anġina instabbli, jew attakk tranżitorju iskemiku).
English: HZA106837 was of variable treatment duration (from a minimum of 24 weeks to a maximum of 76 weeks with the majority of patients treated for at least 52 weeks).
Maltese: HZA106837 kien studju b'tul tal-kura varjabbli (minn minimu ta' 24 ġimgħa sa massimu ta' 76 ġimgħa, bilmaġġoranza tal-pazjenti kkurati għal mill-anqas 52 ġimgħa).
English: long-acting beta2-adrenergic agonists, such as salmeterol
Maltese: L-effetti farmakoloġiċi tas- sustanzi attivi agonisti tal-adrenoriċetturi beta2, inkluż vilanterol trifenatate,
English: Studies in subjects with mild, moderate and severe hepatic impairment showed an increase in systemic exposure to fluticasone furoate (both Cmax and AUC) (see section 5.2).
Maltese: Studji fuq individwi b'indeboliment tal-fwied ħafif, moderat u sever urew żieda fl-esponiment sistemiku għal fluticasone furoate (kemm Cmax kif ukoll AUC) (ara sezzjoni 5.2).
English: 184 micrograms [n=194]) both administered once daily compared with FP 500 micrograms twice daily [n=195].
Maltese: 184/22 mikrogramma [n=197] u FF 184 mikrogramma [n=194]), it-tnejn mogħtija darba kuljum meta mqabbel ma' fluticasone propionate (FP) 500 mikrogramma darbtejn kuljum [n=195].
English: In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of fractures was <1%, and usually associated with trauma.
Maltese: F'analiżi integrata ta' 11-il studju dwar l-ażżma (7,034 pazjent), l-inċidenza tal-ksur kienet ta' <1%, u ġeneralment kienet assoċjata ma' trawma.
English: Adjusted mean treatment increases from baseline in weighted mean 0-24 hours FEV1 of 341 mL (fluticasone furoate/vilanterol) and 377 mL (salmeterol/FP) demonstrated an overall improvement in lung function over 24 hours for both treatments.
Maltese: (fluticasone furoate/vilanterol) u 377 mL (salmeterol/FP) urew titjib ġenerali fil-funzjoni tal-pulmun fuq perjodu ta' 24 siegħa għaż-żewġ trattamenti.
English: These were randomised controlled studies in patients with a clinical diagnosis of COPD.
Maltese: Dawn kienu f'pazjenti b'dijanjosi klinika ta' COPD.
English: Pharmacotherapeutic group: Drugs for obstructive airways diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics ATC code: R03AK10.
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tal-arja, adrenerġiċi flimkien ma' kortikosterojdi jew mediċini oħra, esklużi antikolinerġiċi, Kodiċi ATC:
English: In subjects with COPD estimates of fluticasone furoate AUC(0-24) for East Asian, Japanese and South East Asian subjects (13-14% subjects) were on average 23% to 30% higher compared with Caucasian subjects.
Maltese: Ġappuniżi u min-Nofsinhar tal-Asja (13-14% tal-individwi) kienu bħala medja 23% sa 30% ogħla meta mqabbla ma' individwi
English: In HZA106827/HZA106829 the co-primary efficacy endpoints were change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the treatment period in all subjects and weighted mean serial FEV1 over 0-24 hours post-dose calculated in a subset of subjects at the end of the treatment period.
Maltese: Fl-istudju HZA106827/HZA106829 l-endpoints ko-primarji tal-effikaċja kienu l-bidla mil-linja bażi fl-inqas livell tal-FEV1 fil-viżta klinika (qabel il-bronkodilatur u qabel id-doża) fit-tmiem tal-perjodu ta' kura fil pazjenti kollha u l-FEV1 serjali medju peżat fuq perjodu ta' 0-24 siegħa wara d-doża, ikkalkulata f'subsett ta' pazjenti fit-tmiem tal-perjodu ta' kura.
English: Fluticasone furoate/vilanterol 92/22 micrograms provided significantly greater protection against allergen-induced bronchial hyper-reactivity compared with monotherapies FF and vilanterol as assessed on Day 22 by methacholine challenge.
Maltese: mikrogramma pprovda protezzjoni konsiderevolment akbar kontra r-reattività eċċessiva tal-bronki kkawżata mill-allerġeni meta mqabbel ma' monoterapiji b'FF u vilanterol kif valutat f'Jum 22 permezz ta' esponiment għal methacholine.
English: Description of selected adverse reactions *Pneumonia (see section 4.4)
Maltese: *Pulmonite (ara s-sezzjoni 4.4)
English: Patients were randomized to receive fluticasone furoate/vilanterol 92/22 micrograms, FF 92 micrograms, vilanterol 22 micrograms or placebo once daily for 21 days followed by challenge with allergen 1 hour after the final dose.
Maltese: Il-pazjenti kienu randomizzati sabiex jirċievu fluticasone furoate/vilanterol 92/22 mikrogramma , FF 92 mikrogramma, vilanterol 22 mikrogramma jew plaċebo darba kuljum għal 21 jum segwiti minn esponiment għal allerġen siegħa qabel id-doża finali.
English: One inhalation of Relvar Ellipta 92/22 micrograms once daily.
Maltese: Relvar Ellipta 92/22 µg
English: In an integrated analysis of both studies, fluticasone furoate/vilanterol 92/22 micrograms showed clinically meaningful improvements in lung function.
Maltese: F'analiżi integrata taż-żewġ studji, fluticasone furoate/vilanterol 92/22 mikrogramma wera titjib klinikament sinifikanti fil-funzjoni tal-pulmun.
English: In subjects with asthma, estimates of fluticasone furoate AUC(0-24) for East Asian, Japanese and South East Asian subjects (12-13% of subjects) were on average 33% to 53% higher compared with other racial groups.
Maltese: F'individwi bl-ażżma, l-istimi tal-AUC(0-24) ta' fluticasone furoate għal individwi mil-Lvant tal-Asja, Ġappuniżi u min-Nofsinhar tal-Asja (12-13% tal-individwi) kienu bħala medja 33% sa 53% ogħla meta mqabbla ma' gruppi razzjali oħra.
English: The higher strength of Relvar Ellipta (184 micrograms fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.
Maltese: Il-qawwa aktar għolja ta' Relvar Ellipta (184 mikrogrammi fluticasone furoate u 22 mikrogramma ta' vilanterol) mhijiex adatta għall-kura ta' COPD.
English: Vilanterol belongs to a group of medicines called long acting bronchodilators.
Maltese: Vilanterol jappartjeni għal grupp ta' mediċini msejħa bronkodilaturi li jaħdmu fit-tul.
English: On average, vilanterol Cmax is predicted to be 220 to 287% higher and AUC(0-24) comparable for those subjects from an Asian heritage compared with subjects from other racial groups.
Maltese: Bħala medja, is-Cmax ta' vilanterol hija prevista li tkun 220 sa 287% ogħla u l-AUC(0-24) komparabbli għal dawk l-individwi ta' nisel Asjatiku meta mqabbel ma' individwi minn gruppi razzjali oħra.
English: The “Discard by” date is 6 weeks from the date you opened the tray.
Maltese: Id-data "Armi minn" hija ta' 6 ġimgħat mid-data li tkun fetħet it-trej.
English: In a 24 week study (HZA113091) in adult and adolescent patients with uncontrolled persistent asthma both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the evening and salmeterol/FP 50/250 micrograms given twice daily demonstrated improvements from baseline in lung function.
Maltese: Fi studju ta' 24 ġimgħa (HZA113091) f'pazjenti adulti u adolexxenti li kellhom ażżma persistenti mhux ikkontrollata, kemm Relvar Ellipta 92/22 mikrogramma mogħti darba kuljum filgħaxija kif ukoll salmeterol/FP 50/220 mikrogrammi mogħti darbtejn kuljum urew titjib mil-linja bażi fil-funzjoni tal-pulmun.
English: For patients with moderate or severe hepatic impairment the maximum dose is 92/22 micrograms (see section 4.4).
Maltese: Għal pazjenti b'indeboliment tal-fwied moderat jew sever, id-doża massima hija 92/22 mikrogramma (ara sezzjoni 4.4).
English: If patients are inadequately controlled on Relvar Ellipta 92/22 micrograms, the dose can be increased to 184/22 micrograms, which may provide additional improvement in asthma control.
Maltese: Jekk il-pazjenti ma jkunux ikkontrollati adegwatament b'Relvar Ellipta 92/22 mikrogramma , id-doża tista' tiżdied għal 184/22 mikrogramma , li jista' jipprovdi titjib addizzjonali fil-kontroll tal-ażżma.
English: • muscle spasms
Maltese: • uġigħ fid-dahar
English: Fluticasone furoate and vilanterol represent two classes of medications (a synthetic corticosteroid and a selective, long-acting beta2-receptor agonist).
Maltese: Fluticasone furoate u vilanterol jirrappreżentaw żewġ kategoriji ta' medikazzjonijiet (kortikosterojd sintetiku u agonist li jaħdem fit-tul tar-riċetturi beta2).
English: Although there were more fractures in the Relvar Ellipta groups compared with the vilanterol 22 micrograms group, fractures typically associated with corticosteroid use (e.g., spinal compression/thoracolumbar vertebral fractures, hip and acetabular fractures) occurred in <1% of the Relvar Ellipta and vilanterol treatment arms.
Maltese: Għalkemm kien hemm aktar ksur fil gruppi li ħadu Relvar Ellipta meta mqabbel mal-grupp li ħa vilanterol 22 mikrogramma, ksur tipikament assoċjat mal-użu ta' kortikosterojdi (eż. kompressjoni spinali/ksur fil-partijiet toraċiċi u lombari tas-sinsla, ksur fil-ġenbejn u aċetubulari) seħħ f'<1% tal-gruppi li ngħataw Relvar Ellipta u vilanterol.
English: Dysphonia
Maltese: Disfonija
English: Following oral administration, fluticasone furoate was eliminated in humans mainly by metabolism with metabolites being excreted almost exclusively in faeces, with <1% of the recovered radioactive dose eliminated in the urine.
Maltese: Wara għoti orali, fluticasone furoate kien eliminat fil-bniedem prinċipalment permezz tal-metaboliżmu, bilmetaboliti jitneħħew kważi esklussivament fl-ippurgar, b'<1% tad-doża radjuattiva rkuprata tiġi eliminata fl awrina.
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 għall bnedmin.
English: 1 inhaler of 14 doses 1 inhaler of 30 doses
Maltese: Inalatur 1 ta' 30 doża
English: Inhalation powder, pre-dispensed.
Maltese: Tarmix mediċini mal-ilma tad-dranaġġ.
English: In HZA106837 the primary endpoint was the time to first severe asthma exacerbation.
Maltese: Fl-istudju HZA106837, l-endpoint primarju kien iż-żmien salewwel taħrix sever tal-ażżma.
English: The incidence of cardiovascular history/risk factors was similar across the treatment groups with patients most commonly suffering from hypertension (46%), followed by hypercholesterolemia (29%) and diabetes mellitus (12%).
Maltese: L-inċidenza ta' storja/fatturi ta' riskju kardjovaskulari kienet simili bejn il-gruppi ta' kura, bil-pazjenti fis-sottogrupp tal-istorja/fatturi ta' riskju kardjovaskulari jbatu l-aktar minn pressjoni għolja (46%), segwita mill-iperkolesterolemija (29%) u d-dijabete mellitus (12%).
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Maltese: Jista' jiġi rrappurtat disturb fil-vista bl-użu sistemiku u topiku ta' kortikosterojdi.
English: This will make it less likely to develop a sore mouth or throat as side effects.
Maltese: Dan inaqqas il-probabbiltà li tiżviluppa mard tal-ħalq jew tal-gerżuma bħala effetti sekondarji.
English: Desiccant
Maltese: Dessikant
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 il-mediċina.
English: if you have thyroid gland problems.
Maltese: jekk għandek problemi bil-glandola tat-tirojde.
English: There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females) and 1225 subjects with COPD (392 females).
Maltese: III minn 1213-il individwu bl-ażżma (712-il mara) u 1225 individwu b'COPD (392 mara).
English: Moderate/ severe exacerbations were defined as worsening symptoms that required treatment with oral corticosteroids and/or antibiotics or in-patient hospitalisation.
Maltese: Taħrix moderat/sever kien definit bħala deterjorament tas-sintomi li kien jeħtieġ trattament b'kortikosterojdi orali u/jew antibijotiċi jew rikoveru tal-pazjent l-isptar.
English: • blurred vision
Maltese: • rogħda
English: - For the 184/22 dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Maltese: - Għad-doża 184/22: kull inalazzjoni waħda tipprovdi doża mogħtija (id-doża li toħroġ mill-biċċa talħalq) ta'184 mikrogrammi ta' fluticasone furoate u 22 mikrogramma ta 'vilanterol (bħala trifenatate).
English: This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Maltese: Din tikkorrispondi għal doża lesta minn qabel ta' 200 mikrogramma ta' fluticasone furoate u 25 mikrogramma vilanterol (bħala trifenatate).
English: These synergistic interactions are reflected in enhanced anti-inflammatory activity, which has been demonstrated in vitro and in vivo in a range of inflammatory cells relevant to the pathophysiology of both asthma and COPD.
Maltese: Dawn l-interazzjonijiet sinerġistiċi huma riflessi f'żieda fl-attività antiinfjammatorja, li ġiet murija in vitro u in vivo f'firxa ta' ċelloli infjammatorji rilevanti għall-patofiżjoloġija kemm tal-ażżma kif ukoll tal-COPD.
English: Both studies had a 4 week run-in period during which all subjects received open-label salmeterol/FP 50/250 twice daily to standardise COPD pharmacotherapy and stabilise disease prior to randomisation to blinded study medication for 52 weeks.
Maltese: Iż-żewġ studji kellhom perjodu ta' twassil għalihom ta' 4 ġimgħat li matulu l-pazjenti kollha ngħataw salmeterol/FP 50/250 open-label darbtejn kuljum biex tiġi standardizzata l-farmakoterapija għal COPD u biex tiġi stabbilizzata l-marda qabel ir-randomizzazzjoni għall-medikazzjoni blinded tal-istudju għal 52 ġimgħa.
English: What Relvar Ellipta contains - The active substances are fluticasone furoate and vilanterol.
Maltese: - Is-sustanzi attivi huma fluticasone furoate u vilanterol.
English: Fluticasone furoate and vilanterol are both rapidly cleared by extensive first pass metabolism mediated by the liver enzyme CYP3A4.
Maltese: Fluticasone furoate u vilanterol, it-tnejn jitneħħew malajr permezz ta' metaboliżmu estensiv tal-ewwel passaġġ medjat mill-enzima tal-fwied CYP3A4.
English: In an integrated analysis of HZC102970 and HZC102871 at week 52, an improvement was seen when comparing the fluticasone furoate/vilanterol 92/22 micrograms versus vilanterol 22 micrograms in adjusted mean trough FEV1 (42 mL 95% CI: 19, 64mL, p<0.001).
Maltese: L-istudji HZC102970 u HZC102871 kienu studji double-blind, randomizzati, bi gruppi paralleli, ta' 52 ġimgħa li qabblu l-effett ta' fluticasone furoate/vilanterol 184/22 mikrogramma , fluticasone furoate/vilanterol 92/22 mikrogramma , fluticasone furoate/vilanterol 46/22 mikrogramma ma' vilanterol 22
English: - For the 92/22mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Maltese: - Għad-doża ta' 92 / 22mcg: kull inalazzjoni waħdanija tipprovdi doża mogħtija (id-doża li toħroġ millbiċċa tal-ħalq) ta' 92 mikrogramma ta' fluticasone furoate u 22 micrograms ta' vilanterol (bħala trifenatate).
English: LIST OF EXCIPIENTS Also contains lactose and magnesium stearate.
Maltese: Fih ukoll lactose u magnesium stearate.
English: A clinical pharmacology study in healthy subjects with co-administered vilanterol and the potent P-gp and moderate CYP3A4 inhibitor verapamil did not show any significant effect on the pharmacokinetics of vilanterol.
Maltese: Studju kliniku tal farmakoloġija fuq individwi b'saħħithom, fejn dawn ingħataw vilanterol flimkien mal-inbitur qawwi tal-P-gp u moderat ta' CYP3A4, verapamil, ma wera l-ebda effett sinifikanti fuq il-farmakokinetika ta' vilanterol.
English: Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with fluticasone furoate/vilanterol.
Maltese: Intużat dejta minn provi kliniċi kbar dwar l-ażżma u COPD biex tiġi determinata l-frekwenza tarreazzjonijiet avversi assoċjati ma' fluticasone furoate/vilanterol.
English: Forty four percent of patients in the fluticasone furoate/vilanterol 92/22 micrograms group were well controlled (ACQ7 ≤0.75) at end of treatment compared to 36% of subjects in the FF 92 micrograms group (p<0.001 95% CI 1.23, 1.82).
Maltese: Erbgħa u erbgħin fil-mija tal-pazjenti fil-grupp li ħadu Relvar Ellipta 92/22 kienu kkontrollati tajjeb (ACQ7 ≤0.75) fl-aħħar tal-kura meta mqabbel ma' 36% tal-pazjenti fil-grupp li ħa FF 92 mikrogramma (p<0.001 95% CI 1.23, 1.82).
English: The primary efficacy endpoint was change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the treatment period.
Maltese: L-endpoint primarju tal-effikaċja kien il-bidla mil-linja bażi fil-FEV1 minimu tal-viżta klinika (qabel il-bronkodilatur u qabel id-doża) fit-tmiem tal-perjodu ta' kura.
English: Asthma-related adverse events and exacerbations may occur during treatment with fluticasone furoate/vilanterol.
Maltese: Jista' jkun hemm avvenimenti avversi u taħrix relatati mal-ażżma waqt il-kura bi fluticasone furoate/vilanterol.
English: There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females).
Maltese: Ma kien hemm l-ebda evidenza li s-sess, il-piż jew il-BMI jaffettwaw il-farmakokinetika ta' vilanterol fuq il bażi ta' analiżi farmakokinetika tal-popolazzjoni fi 856 individwu bl-ażżma (500 mara).
English: How to store Relvar Ellipta
Maltese: Kif tuża Relvar Ellipta
English: No risk factors were identified.
Maltese: Ma kinux identifikati fatturi ta' riskju.
English: This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Maltese: Din tikkorrispondi għal doża lesta minn qabel ta' 100 mikrogramma ta' fluticasone furoate u 25 mikrogramma vilanterol (bħala trifenatate).
English: Adjusted mean treatment increases from baseline in weighted mean 0-24 hours FEV1 of 130 mL (fluticasone furoate/vilanterol) and 108 mL (salmeterol/FP) demonstrated an overall improvement in lung function over 24 hours for both treatments.
Maltese: FEV1 medju peżat fuq perjodu ta' 0-24 sigħat, ta' 130 mL (fluticasone furoate/vilanterol) u 108 mL
English: The absolute bioavailability for fluticasone furoate and vilanterol when administered by inhalation as fluticasone furoate/vilanterol was on average 15.2% and 27.3%, respectively.
Maltese: Il-bijodisponibilità assoluta għal fluticasone furoate/vilanterol meta mogħtija b'inalazzjoni bħala fluticasone furoate/vilanterol kienet bħala medja 15.
English: The apparent plasma elimination half-life of vilanterol following single inhaled administration of fluticasone furoate/vilanterol was, on average, 2.5 hours.
Maltese: Il-half-life apparenti tal-eliminazzjoni ta' vilanterol mill-plażma wara għoti wieħed man-nifs ta' fluticasone furoate/vilanterol kienet, bħala medja, 2.5 sigħat.
English: Immediate breathing difficulties after using Relvar Ellipta are rare.
Maltese: Id-diffikultajiet immedjati tan-nifs wara l-użu ta' Relvar Ellipta huma rari.
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/vilanterol
Maltese: Relvar Ellipta 184 mikrogramma/22 mikrogramma trab li jittieħed man-nifs fluticasone furoate/vilanterol
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 92 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Maltese: Relvar Ellipta 92 mikrogramma/22 mikrogramma trab li jittieħed man-nifs fluticasone furoate/vilanterol
English: Each delivered dose contains 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Maltese: mikrogramma ta' fluticasone furoate u 22 mikrogramma ta' vilanterol (bħala trifenatate).
English: The effective half-life for accumulation of vilanterol, as determined from inhalation administration of repeat doses of vilanterol 25 micrograms, is 16.0 hours in subjects with asthma and 21.3 hours in subjects with COPD.
Maltese: Il-half-life effettiva għall-akkumulazzjoni ta' vilanterol, kif stabbilita permezz tal-għoti bit-teħid man-nifs ta' dożi ripetuti ta' vilanterol 25 mikrogramma, hija ta' 16.0-il siegħa f'individwi bl-ażżma u ta' 21.3 sigħat f'individwi b'COPD.