FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Relvar Ellipta (92/22 micrograms once daily).
Slovenian: Če imate zmerno ali hudo bolezen jeter, vam bo zdravnik odmerek omejil na manjšo jakost zdravila Relvar Ellipta (92/22 mikrogramov enkrat na dan); če imate težave s srcem ali visok krvni tlak;
English: Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus.
Slovenian: Med njenimi simptomi so kratka sapa, kašelj, nelagodje v prsih in izkašljevanje sluzi.
English: The use of concurrent inhaled long-acting bronchodilators (beta2-agonist and anticholinergic), ipratropium/salbutamol combination products, oral beta2-agonists, and theophylline preparations were not allowed during the treatment period.
Slovenian: Med obdobjem zdravljenja ni bila dovoljena sočasna uporaba inhaliranih dolgodelujočih bronhodilatatorjev (agonistov adrenergičnih receptorjev beta2, antiholinergikov), kombiniranih zdravil z ipratropijem in salbutamolom, peroralnih agonistov adrenergičnih receptorjev beta2 in pripravkov teofilina.
English: Relvar Ellipta has been shown to reduce flare-ups of COPD symptoms.
Slovenian: Dokazano je, da zdravilo Relvar Ellipta zmanjša pogostnost poslabšanj simptomov KOPB.
English: If you want to clean the mouthpiece, use a dry tissue, before closing the cover.
Slovenian: Če želi bolnik očistiti ustnik, mora uporabiti suho krpico, preden zapre pokrovček.
English: There were no effects on development in rats at exposures approximately 3-times greater than those at the maximum recommended human dose, based on AUC.
Slovenian: Pri podganah ob izpostavljenostih, ki so bile približno 3-krat večje od izpostavljenosti (na podlagi AUC) med uporabo največjega priporočenega odmerka za človeka, ni vplival na razvoj.
English: Do not stop using Relvar Ellipta without advice
Slovenian: Ne prenehajte uporabljati zdravila Relvar Ellipta, ne da bi vam to naročil zdravnik.
English: FF/VI 92/22 Once Daily vs FF 92 Once Daily
Slovenian: FF/VI 92/22 1-krat/dan v prim.
English: FF and FP both increased the percentage of 24 hour rescue free periods by 14.8% (95% CI 6.9, 22.7, p<0.001) and 17.9% (95% CI 10.0, 25.7, p<0.001) respectively versus placebo.
Slovenian: Oba, FF in FP, sta povečala odstotek 24-urnih obdobij brez rešilnega zdravila, in sicer FF za 14,8 % (95 % IZ od 6,9 do 22,7, p < 0,001) in FP za 17,9 % (95 % IZ od 10,0 do 25,7, p < 0,001) v primerjavi s placebom.
English: In HZA106837 the risk of experiencing a severe asthma exacerbation in patients receiving fluticasone furoate/vilanterol 92/22 micrograms was reduced by 20% compared with FF 92 micrograms alone (hazard ratio 0.795, p=0.036 95% CI 0.642, 0.985).
Slovenian: V HZA106837 se je tveganje za hudo poslabšanje astme pri prejemnikih flutikazonfuroata/vilanterola 92/22 mikrogramov zmanjšalo za 20 % v primerjavi z 92 mikrogrami samega FF (razmerje ogroženosti 0,795, p = 0,036, 95 % IZ: 0,642, 0,985).
English: If you forget to use Relvar Ellipta Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne uporabite dvojnega odmerka, da bi nadomestili pozabljenega.
English: The safety and efficacy of fluticasone furoate/vilanterol in children under the age of 12 years has not yet been established.
Slovenian: Varnost in učinkovitost zdravila Relvar Ellipta pri otrocih, mlajših od 12 let, še nista ugotovljeni.
English: Both fluticasone furoate/vilanterol 92/22 micrograms and FF 92 micrograms virtually abolished the late asthmatic response compared with vilanterol alone.
Slovenian: 92/22 mikrogramov kot 92 mikrogramov FF sta v primerjavi s samim vilanterolom praktično odpravila pozni astmatični odziv.
English: A 24 week randomised, double-blind placebo controlled study (FFA112059) evaluated the safety and efficacy of FF 92 micrograms once daily [n= 114] and FP 250 micrograms twice daily [n=114] versus placebo [n=115] in adult and adolescent patients with persistent asthma.
Slovenian: Monoterapija s flutikazonfuroatom24-tedenska randomizirana, dvojno slepa, s placebom kontrolirana študija (FFA112059) je ocenila varnost in učinkovitost 92 mikrogramov FF enkrat na dan [n = 114] in 250 mikrogramovov FP dvakrat na dan [n = 114] v primerjavi s placebom [n = 115] pri odraslih in mladostnikih s persistentno astmo.
English: In a placebo-controlled study in subjects with moderate COPD and a history of, or an increased risk of cardiovascular disease, there was no increase in the risk of cardiovascular events in patients receiving fluticasone furoate/vilanterol compared with placebo (see section 5.1).
Slovenian: S placebom kontrolirana študija pri bolnikih z zmerno KOPB, ki so imeli kardiovaskularno bolezen kdaj v preteklosti ali so imeli večje tveganje za takšno bolezen, ni pokazala, da bi se tveganje za kardiovaskularne dogodke pri prejemnikih kombinacije flutikazonfuroat/vilanterol povečalo v primerjavi s prejemniki placeba
English: Vision blurred (see section 4.4)
Slovenian: *Pljučnica (glejte poglavje 4.4)
English: Driving and using machines This medicine is unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Relvar Ellipta vplivalo na sposobnost upravljanja vozil in strojev.
English: Fluticasone furoate and vilanterol are both rapidly cleared by extensive first pass metabolism mediated by the liver enzyme CYP3A4.
Slovenian: Flutikazonfuroat in vilanterol se oba hitro očistita z obsežno presnovo prvega prehoda z jetrnim encimom
English: In patients with a cardiovascular history/risk factors, fluticasone furoate/vilanterol 92/22 micrograms resulted in a significantly lower annual rate of moderate/severe COPD exacerbations compared with vilanterol (adjusted mean annual rates of 0.83 and 1.18 respectively, 30% reduction (95% CI 16, 42%, p<0.001)).
Slovenian: Pri bolnikih s kardiovaskularno anamnezo/dejavniki tveganja je flutikazonfuroat/vilanterol 92/22 mikrogramov dosegel značilno manjši letni delež zmernih/hudih poslabšanj KOPB kot vilanterol (korigirana povprečna letna deleža 0,83 in 1,18, 30 % zmanjšanje, 95 % IZ: 16, 42 %,
English: Change from Baseline in Percentage of Symptom-Free 24-hour Periods Treatment difference
Slovenian: Sprememba odstotka 24-urnih obdobij brez simptomov glede na izhodišče Razlika zdravljenj
English: Adjusted mean change from baseline in trough FEV1 was also evaluated as a secondary endpoint.
Slovenian: Kot sekundarni opazovani dogodek je bila ocenjena tudi korigirana povprečna sprememba najnižjega FEV1 glede na izhodišče.
English: Overall, the greatest effects on the early asthmatic response were seen with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 micrograms or vilanterol 22 micrograms alone.
Slovenian: V celoti so največje učinke na zgodnji astmatični odziv zabeležili s flutikazonfuroatom/vilanterolom 92/22 mikrogramov v primerjavi z 92 mikrogrami FF ali 22 mikrogrami vilanterola, uporabljenih samih.
English: EXP In use shelf-life: 6 weeks.
Slovenian: EXP: Rok uporabnosti po prvem odprtju: 6 tednov.
English: For severe pneumonia the corresponding number of events per 1000 patient years were 33.6, 35.5, and 7.6 respectively, while for serious pneumonia the corresponding events per 1000 patient years were 35.1 for FF/VI 184/22, 42.9 with FF/VI 92/22, 12.1 with VI 22.
Slovenian: Za hudo pljučnico je bilo ustrezno število pljučnic na 1000 bolnik-let 33,6, 35,5 in 7,6, za resno pljučnico pa je bilo ustrezno število pljučnic na 1000 bolnik-let 35,1 s FF/VI 184/22, 42,9 s FF/VI 92/22 in 12,1 z VI 22.
English: There was no effect of race on pharmacokinetic parameter estimates of vilanterol in subjects with COPD.
Slovenian: Pri preiskovancih s KOPB rasa ni vplivala na ocene farmakokinetičnih parametrov vilanterola.
English: Always use this medicine exactly as your doctor has told you to.
Slovenian: Zelo pomembno je, da to zdravilo uporabljate vsak dan, kot vam je naročil zdravnik.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Relvar Ellipta.
Slovenian: Med uporabo simpatikomimetičnih zdravil, vključno z zdravilom Relvar Ellipta, se lahko pojavijo kardiovaskularni učinki, npr. motnje srčnega ritma, kakršne so supraventrikularna tahikardija in ekstrasistole.
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Slovenian: Glaxo Operations UK Ltd. (posluje kot Glaxo Wellcome Operations) Priory Street
English: The pharmacokinetics of fluticasone furoate/vilanterol in patients less than 12 years of age has not been studied.
Slovenian: Farmakokinetika zdravila Relvar Ellipta pri bolnikih, mlajših od 12 let, ni raziskana.
English: At screening, the mean pre-bronchodilator FEV1 was 42.6% and 43.6% predicted, and the mean reversibility was 15.9% and 12.0% in HZC112206 and HZC112207, respectively.
Slovenian: Ob presejanju je bil povprečni FEV1 pred bronhodilatatorjem v HZC112206 42,6 % predvidenega in povprečna reverzibilnost 15,9 % napovedane, v
English: Hold the inhaler away from your mouth and breathe out as far as is comfortable.
Slovenian: Bolnik naj drži inhalator odmaknjen od ust in izdihne čim bolj globoko, a ne toliko, da bi bilo neprijetno.
English: • patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.
Slovenian: • bolniki, ki imajo bolezen ustrezno urejeno ob uporabi inhalacijskih kortikosteroidov in dolgodelujočih agonistov adrenergičnih receptorjev beta2.
English: The risk of the cardiovascular composite event with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.93; 95% CI: 0.75 to 1.14), fluticasone furoate (HR 1.03; 95% CI: 0.83 to 1.28) or vilanterol (HR 0.94; 95% CI: 0.76 to 1.16).
Slovenian: Tveganje za sestavljeni kardiovaskularni dogodek se s kombinacijo flutikazonfuroat/vilanterol ni značilno razlikovalo od placeba (RO 0,93, 95 % IZ: 0,75 do 1,14), flutikazonfuroata (RO 1,03, 95 % IZ: 0,83 do 1,28) ali vilanterola (RO 0,94, 95 % IZ: 0,76 do 1,16).
English: SUMMIT was a multi-centre, randomised, double-blind study evaluating the effect on survival of fluticasone furoate/vilanterol 92/22 micrograms compared with placebo in 16,485 subjects.
Slovenian: Študije, ki so trajale več kot 1 leto Študija SUMMIT je bila multicentrična, randomizirana dvojno slepa študija, ki je pri 16.485 bolnikih ocenjevala vpliv kombinacije flutikazonfuroat/vilanterol 92/22 mikrogramov v primerjavi s placebom na preživetje.
English: Change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period was a powered secondary.
Slovenian: Sprememba odstotka 24-urnih obdobij brez rešilnega zdravila med 24-tedenskim zdravljenjem glede na izhodišče je bil sekundarni opazovani dogodek, za ugotavljanje katerega je bila določena moč.
English: HZA106829 was 24 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 184/22 micrograms [n=197] and FF
Slovenian: HZA106829 je trajala 24 tednov in je ocenila učinkovitost flutikazonfuroata/vilanterola 184/22 mikrogramov
English: Put the mouthpiece between your lips and close your lips firmly around it.
Slovenian: • Ustnik namestite čvrsto med ustnici.
English: It is packaged in a foil laminate tray with a peelable foil lid.
Slovenian: Nahaja se v embalaži iz laminatne folije, zaprti s pokrovom iz folije.
English: Both fluticasone furoate and vilanterol have a low association with red blood cells.
Slovenian: Tako flutikazonfuroat kot vilanterol imata nizko povezanost z eritrociti.
English: HZC102970 and HZC102871 integrated
Slovenian: HZC102970 in HZC102871 skupaj vilanterol (n = 409)
English: At the 24-week time point FF and FP increased trough FEV1 by 146 mL (95% CI 36, 257 mL, p=0.009) and 145 mL (95% CI 33, 257 mL, p=0.011) respectively compared to placebo.
Slovenian: za 146 ml (95 % IZ od 36 do 257 ml, p = 0,009) in FP za 145 ml (95 % IZ od 33 do 257 ml, p = 0,011) v primerjavi s placebom.
English: Use this medicine for as long as your doctor recommends.
Slovenian: Zdravilo Relvar Ellipta uporabljajte toliko časa, kot vam svetuje vaš zdravnik.
English: Neither fluticasone furoate nor vilanterol trifenatate had any adverse effects on fertility or pre- and post-natal development in rats.
Slovenian: Niti flutikazonfuroat niti vilanterolijev trifenatat pri podganah nista imela neželenih učinkov na plodnost,
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.
Slovenian: Pri KOPB je bila ocenjena AUC(0-24) flutikazonfuroata za preiskovance iz vzhodne Azije, Japonske in jugovzhodne Azije (13-14 % preiskovancev) v povprečju za 23 do 30 % večja kot pri belcih.
English: Mortality risk with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.88; 95% CI: 0.74 to 1.04; p=0.137), fluticasone furoate (HR 0.96; 95% CI: 0.81 to 1.15; p=0.681) or vilanterol (HR 0.91; 95% CI: 0.77 to 1.09; p=0.299).
Slovenian: Tveganje umrljivosti se s kombinacijo flutikazonfuroat/vilanterol ni značilno razlikovalo od placeba (RO [razmerje ogroženosti] 0,88, 95 % IZ: 0,74 do 1,04, p = 0,137), flutikazonfuroata (RO 0,96, 95 % IZ: 0,81 do 1,15, p = 0,681) ali vilanterola (RO 0,91, 95 % IZ: 0,77 do 1,09, p = 0,299).
English: However, fluticasone furoate/vilanterol should be used with caution in patients with severe cardiovascular disease or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.
Slovenian: Vendar je treba pri bolnikih s hudo kardiovaskularno boleznijo ali motnjami srčnega ritma, hipertiroidizmom, nekorigirano hipokaliemijo ali pri bolnikih, ki so nagnjeni k nizkim vrednostim kalija v serumu, flutikazonfuroat/vilanterol uporabljati previdno.
English: When given subcutaneously there were no effects at exposures 84-times greater than those at the maximum recommended human dose, based on AUC.
Slovenian: Med subkutano uporabo ob izpostavljenostih, 84-krat večjih od izpostavljenosti (na podlagi AUC) med uporabo največjega priporočenega odmerka za človeka,
English: Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (up to three-fold as measured by AUC(0-24)) in subjects with hepatic impairment (Child-Pugh A, B or C) compared with healthy subjects.
Slovenian: Po ponavljajočem se odmerjanju flutikazonfuroata/vilanterola 7 dni se je sistemska izpostavljenost flutikazonfuroatu pri preiskovancih z okvaro jeter (Child-Pugh A, B in C) povečala (do trikrat, merjeno z
English: A randomised, double-blind, parallel group, 24 week study (201378) was conducted to demonstrate noninferiority (using a margin of -100 mL for trough FEV1) of fluticasone furoate/vilanterol 92/22 once daily to salmeterol/FP 50/250 twice daily in adults and adolescents whose asthma was well controlled following 4 weeks of treatment with open-label salmeterol/FP 50/250 twice daily (N=1504).
Slovenian: Randomizirano, dvojno slepo 24-tedensko študijo vzporednih skupin (201378) so izvedli za ugotavljanje neinferiornosti (z uporabo meje -100 mL za najnižji FEV1) kombinacije flutikazonfuroat/vilanterol 92/22 mikrogramov enkrat na dan v primerjavi s kombinacijo salmeterol/FP 50/250 mikrogramov dvakrat na dan pri odraslih in mladostnikih, ki so imeli astmo dobro urejeno po 4 tednih zdravljenja (po shemi odprtega načrta zdravljenja) s kombinacijo salmeterol/FP 50/250 mikrogramov dvakrat na dan (N = 1504).
English: • voice disorders
Slovenian: • motnje glasu,
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).
Slovenian: Integrirana analiza HZC102970 in HZC102871 52. teden je pokazala izboljšanje korigiranega povprečnega najmanjšega FEV1 s flutikazonfuroatom/vilanterolom 92/22 mikrogramov v primerjavi z 22 mikrogrami vilanterola (42 ml, 95 % IZ: 19, 64 ml, p < 0,001).
English: Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
Slovenian: Na voljo sta dve različni jakosti zdravila Relvar Ellipta: flutikazonfuroat 92 mikrogramov/vilanterol 22 mikrogramov in flutikazonfuroat 184 mikrogramov/vilanterol 22 mikrogramov.
English: Gender, weight and BMI
Slovenian: Spol, telesna masa in ITM
English: Change from Baseline in Percentage of Rescue-Free 24-hour Periods Treatment difference
Slovenian: Sprememba odstotka 24-urnih obdobij brez rešilnega zdravila glede na izhodišče Razlika zdravljenj
English: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Slovenian: Bolezni imunskega sistema preobčutliivostne reakcije, vključno z anafilakso, angioedemom,
English: If stored in a refrigerator, the inhaler should be allowed to return to room temperature for at least an hour before use.
Slovenian: Če je zdravilo shranjeno v hladilniku, je treba inhalator vsaj eno uro pred uporabo pustiti zunaj, da se ogreje na sobno temperaturo.
English: Improvements were also seen in this subgroup at week 52 when comparing the fluticasone furoate/vilanterol 92/22 micrograms vs. vilanterol 22 micrograms in adjusted mean trough FEV1 (44 mL 95% CI: 15, 73mL, (p=0.003)).
Slovenian: Izboljšanje so v tej podskupini zabeležili tudi 52. teden, ko so primerjali korigirani povprečni najnižji FEV1 s flutikazonfuroatom/vilanterolom 92/22 mikrogramov in z 22 mikrogrami vilanterola (44 ml, 95 % IZ: 15, 73 ml, (p = 0,003))
English: The European Medicines Agency has waived the obligation to submit the results of studies with Relvar Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Slovenian: Ellipta za vse skupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI 184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group.
Slovenian: V integrirani analizi dveh repliciranih enoletnih študij pri zmerni do hudi KOPB (povprečni predvideni FEV1 po bronhodilatatorju ob presejanju 45 %, standardni odklon 13 %) s poslabšanjem v predhodnem letu (n = 3255) je bilo število pljučnic na 1000 bolnik-let v skupini s FF/VI 184/22 97,9, v skupini s FF/VI 92/22 85,7 in v skupini z VI 22 42,3.
English: Pack sizes of 14 or 30 dose Inhalers.
Slovenian: Velikost pakiranja je inhalator s 14 ali 30 odmerki.
English: The ratio of the exacerbation rate for fluticasone furoate/vilanterol 92/22 micrograms versus FF 92 micrograms was 0.755 (95% CI 0.603, 0.945).
Slovenian: Razmerje deležev poslabšanj z flutikazonfuroatom/vilanterolom 92/22 mikrogramov in s FF 92 mikrogramov je bilo 0,755 (95 % IZ 0,603, 0,945).
English: This leaflet
Slovenian: Opazovani dogodek
English: • infection of the nose sinuses or throat
Slovenian: • srbenje nosu, izcedek iz nosu ali zamašen nos,
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).
Slovenian: Kar zadeva najnižji FEV1, so preiskovanci v skupini s flutikazonfuroatom/vilanterolom dosegli povprečno spremembo (po metodi NK) glede na izhodišče 281 ml in v skupini s salmeterolom/FP spremembo 300 ml (razlika v korigiranem povprečju 19 ml (95 % IZ: -0,073, 0,034) ni bila statistično značilna (p = 0,485)).
English: Pneumonia in patients with COPD
Slovenian: Pljučnica pri bolnikih s KOPB
English: Change from baseline in the percentage of rescue-free 24 hour periods during treatment was a powered secondary endpoint.
Slovenian: Sprememba odstotka 24-urnih obdobij brez rešilnega zdravila med zdravljenjem je bila sekundarni opazovani dogodek, za ugotavljanje katerega je bila določena moč.
English: • awareness of heart beat (palpitations)
Slovenian: • neprijetni občutki ob hitrem ali močnem utripanju srca (palpitacije),
English: Following oral administration, vilanterol was eliminated mainly by metabolism followed by excretion of metabolites in urine and faeces approximately 70% and 30% of the radioactive dose respectively in a human radiolabel study conducted by the oral route.
Slovenian: V študiji radioaktivno označenega, peroralno uporabljenega zdravila pri človeku se je vilanterol odstranil predvsem s presnovo, ki ji je sledilo izločanje presnovkov: približno 70 % radioaktivnega odmerka v urinu in približno 30 % v blatu.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Harmire Road,
Slovenian: Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations), Harmire Road,
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) and 1091 subjects with COPD (340 females).
Slovenian: Populacijska farmakokinetična analiza podatkov 856 preiskovancev z astmo (500 žensk) in 1091
English: You do not need to prepare Relvar Ellipta in any special way, not even the first time you use it.
Slovenian: Inhalatorja ni potrebno posebej pripraviti za uporabo, niti ko zdravilo Relvar Ellipta uporabite prvič.
English: • Rinse your mouth with water after you have used the inhaler, do not swallow.
Slovenian: • Po uporabi inhalatorja si usta splaknite z vodo, vode ne pogoltnite.
English: This represents a 25% reduction in the rate of severe asthma exacerbations for subjects treated with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 micrograms(p=0.014).
Slovenian: To pomeni 25 % zmanjšanje deleža hudih poslabšanj astme pri preiskovancih, zdravljenih z flutikazonfuroatom/vilanterolom 92/22 mikrogramov, v primerjavi s prejemniki FF 92 mikrogramov (p = 0,014).
English: Rinsing your mouth out with water immediately after using Relvar Ellipta may help stop this side effect developing.
Slovenian: Nastanek tega učinka lahko pomaga preprečiti izpiranje ust z vodo takoj po uporabi zdravila Relvar Ellipta.
English: The COPD clinical development programme included a 12-week (HZC113107), two 6-month (HZC112206, HZC112207), two one-year (HZC102970, HZC102871), and one >1 year study (SUMMIT).
Slovenian: (HZC112206, HZC112207), dve 1-letni (HZC102970, HZC102871) in eno več kot 1 leto trajajočo študijo (SUMMIT).To so bile randomizirane kontrolirane študije pri bolnikih s klinično diagnozo KOPB.
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.
Slovenian: Absolutna biološka uporabnost za flutikazonfuorat in vilanterol v obliki inhaliranega flutikazonfuroata/vilanterola je bila v povprečju 15,2 % (za prvega) in 27,3 % (za drugega).
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
English: Fluticasone furoate/vilanterol
Slovenian: Tako flutikazonfuroat/vilanterol
English: Take it back to a pharmacist for advice.
Slovenian: Bolnik naj ga nese k farmacevtu in se posvetuje z njim.
English: In-use shelf-life after opening the tray: 6 weeks.
Slovenian: Rok uporabnosti po prvem odprtju embalaže: 6 tednov.