FrancophonIA/ELRC3.0 huggingface dataset:
English: In two replicate 12 month studies in a total of 3,255 patients with COPD the incidence of bone fractures overall was low in all treatment groups, with a higher incidence in all Revinty Ellipta groups (2%) compared with the vilanterol 22 micrograms group (<1%).
Slovenian: V dveh repliciranih 12-mesečnih študijah pri skupno 3.255 bolnikih s KOPB je bila celotna incidenca zlomov kosti majhna v vseh terapevtskih skupinah, a je bila večja v vseh skupinah z zdravilom Revinty Ellipta (2 %) kot v skupini s 22 mikrogrami vilanterola (< 1 %).
English: If your symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often contact your doctor as soon as possible.
Slovenian: Če se vaši simptomi (zasoplost, piskajoče dihanje, kašelj) ne izboljšajo ali se poslabšajo, ali če uporabljate vaš kratkodelujoči inhalator pogosteje:
English: Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
Slovenian: Zdravilo Revinty Ellipta je indicirano za simptomatsko zdravljenje odraslih s KOPB, ki imajo FEV1 < 70 % predvidenega normalnega (po bronhodilatatorju), z anamnezo poslabšanj kljub rednemu zdravljenju z bronhodilatatorjem.
English: Patients usually experience an improvement in lung function within 16-17 minutes of inhaling Revinty Ellipta.
Slovenian: Bolnikom se pljučna funkcija po navadi izboljša v 16 do 17 minutah po inhaliranju zdravila Revinty Ellipta.
English: if you have ever been told you have diabetes or high blood sugar.
Slovenian: če so vam kdaj povedali, da imate sladkorno bolezen ali povišan sladkor v krvi; če imate težave s ščitnico;
English: If you use more Revinty Ellipta than you should
Slovenian: Če ste uporabili večji odmerek zdravila Revinty Ellipta, kot bi smeli
English: *, ** See below ‘Description of selected adverse reactions' *Pneumonia (see section 4.4)
Slovenian: *, ** Glejte spodaj "Opis izbranih neželenih učinkov" Opis izbranih neželenih učinkov
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, prenatalni ali postnatalni razvoj.
English: Although there were more fractures in the Revinty 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 Revinty Ellipta and vilanterol treatment arms.
Slovenian: Čeprav je bilo v skupinah z zdravilom Revinty Ellipta več zlomov kot v skupini z 22 mikrogrami vilanterola, so se zlomi, ki so tipično povezani z uporabo kortikosteroidov (npr. spinalna kompresija/torakolumbalni zlomi vretenc, zlomi kolka in acetabula), tako v krakih z zdravilom Revinty Ellipta kot z vilanterolom pojavili pri < 1 %.
English: Patients usually experience an improvement in lung function within 15 minutes of inhaling Revinty Ellipta.
Slovenian: Bolnikom se pljučna funkcija po navadi izboljša v 15 minutah po inhaliranju zdravila Revinty Ellipta.
English: There is no relevant use of Revinty Ellipta in the paediatric population for the indication of COPD.
Slovenian: Zdravilo Revinty Ellipta ni primerno za uporabo v pediatrični populaciji za indikacijo KOPB.
English: Revinty Ellipta contains two active substances: fluticasone furoate and vilanterol.
Slovenian: Zdravilo Revinty Ellipta vsebuje dve zdravilni učinkovini: flutikazonfuroat in vilanterol.
English: What you need to know before you use Revinty Ellipta 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Revinty Ellipta 3.
English: long-acting beta2-adrenergic agonists, such as salmeterol
Slovenian: dolgodelujoči agonisti adrenergičnih receptorjev beta2, kot npr. salmeterol.
English: The bronchoprotective effect of fluticasone furoate/vilanterol 92/22 micrograms on the early and late asthmatic response to inhaled allergen was evaluated in a repeat dose, placebo-controlled four-way crossover study (HZA113126) in patients with mild asthma.
Slovenian: Študija provokacije z alergenom Bronhoprotektivni vpliv flutikazonfuroata/vilanterola 92/22 mikrogramov na zgodnji in pozni astmatični odziv na inhalirani alergen so ocenili v štirismerni navzkrižni, s placebom kontrolirani študiji ponavljajočih se odmerkov (HZA113126) pri bolnikih z blago astmo.
English: What Revinty Ellipta is and what it is used for
Slovenian: Kaj je zdravilo Revinty Ellipta in za kaj ga uporabljamo
English: Revinty Ellipta is for inhalation use only.
Slovenian: Zdravilo Revinty Ellipta je namenjeno samo za inhalacijsko uporabo.
English: All patients were required to have a smoking history of at least 10 pack years; a post-salbutamol FEV1/FVC ratio less than or equal to 0.70; post-salbutamol FEV1 less than or equal to 70% predicted and have a Modified Medical Research Council (mMRC) dyspnea score 2 (scale 0-4) at screening.
Slovenian: Vsi bolniki so morali imeti anamnezo kajenja vsaj 10 škatlic-let, razmerje FEV1/FVC po salbutamolu manj ali enako 0,70, FEV1 po salbutamolu manj ali enako 70 % predvidenega ter oceno mMRC (Modified Medical
English: If you have any of the following symptoms after taking Revinty Ellipta stop taking this medicine and tell your doctor immediately.
Slovenian: Če imate po jemanju zdravila Revinty Ellipta katerega koli od naslednjih simptomov, zdravilo takoj nehajte uporabljati in nemudoma obvestite svojega zdravnika:
English: The higher strength of Revinty Ellipta (184 micrograms fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.
Slovenian: Višja jakost zdravila Revinty Ellipta (184 mikrogramov flutikazonfuroata in 22 mikrogramov vilanterola) ni primerna za zdravljenje KOPB.
English: If patients are inadequately controlled on Revinty Ellipta 92/22 micrograms, the dose can be increased to 184/22 micrograms, which may provide additional improvement in asthma control.
Slovenian: Če bolniki z zdravilom Revinty Ellipta 92/22 mikrogramov bolezni nimajo ustrezno urejene, pride v poštev zvišanje odmerka na 184/22 mikrogramov; to lahko prinese dodatno izboljšanje urejenosti astme.
English: Use Revinty Ellipta at the same time each day as it is effective over 24 hours It is very important that you use this medicine every day, as instructed by your doctor.
Slovenian: Zdravilo Revinty Ellipta uporabljajte vsak dan ob istem času, saj učinkuje 24 ur.
English: There is no additional benefit of the 184/22 micrograms dose compared to the 92/22 micrograms dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions (see sections 4.4 and 4.8).
Slovenian: mikrogramov v primerjavi z odmerkom 92/22 mikrogramov nima dodatnih koristi, obstaja pa lahko večje tveganje za pljučnico in sistemske neželene učinke, povezane s kortikosteroidi (glejte poglavji 4.4 in 4.8).
English: Following intravenous dosing, both fluticasone furoate and vilanterol are extensively distributed with average volumes of distribution at steady state of 661 L and 165 L, respectively.
Slovenian: Po intravenski uporabi se flutikazonfuroat in vilanterol obširno porazdelita; povprečni volumen porazdelitve v stanju dinamičnega ravnovesja je za flutikazonfuroat 661 l in za vilanterol 165 l.
English: Revinty Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Slovenian: Zdravila Revinty Ellipta se ne sme uporabljati za olajšanje nenadnega napada težkega dihanja ali piskanja.
English: Other medicines and Revinty Ellipta
Slovenian: Druga zdravila in zdravilo Revinty Ellipta
English: Revinty Ellipta should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing longacting beta2-adrenergic agonists.
Slovenian: Zdravila Revinty Ellipta se ne sme uporabljati skupaj z drugimi dolgodelujočimi agonisti adrenergičnih receptorjev beta2 ali z zdravili, ki vsebujejo dolgodelujoče agoniste adrenergičnih receptorjev beta2.
English: if you have tuberculosis (TB) of the lung, or any long standing or untreated infections.
Slovenian: če imate težave s srcem ali visok krvni tlak; če imate pljučno tuberkulozo (TB) ali katerokoli dolgotrajno nezdravljeno okužbo;
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicinesn.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo; Če niste prepričani, kaj vsebuje vaše zdravilo se posvetujte z zdravnikom ali farmacevtom.
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.
Slovenian: Druge posebne skupine bolnikov Pri astmi je bila ocenjena AUC(0-24) flutikazonfuroata za preiskovance iz vzhodne Azije, Japonske in jugovzhodne Azije (12-13 % preiskovancev) v povprečju za 33 do 53 % večja kot pri drugih rasnih skupinah.
English: One inhalation of Revinty Ellipta 92/22 micrograms once daily.
Slovenian: Ena inhalacija zdravila Revinty Ellipta 92/22 mikrogramov enkrat na dan.
English: If your breathing or wheezing gets worse straight after using Revinty Ellipta, stop using it and get medical help immediately.
Slovenian: Če se vam dihanje ali piskanje takoj po uporabi zdravila Revinty Ellipta poslabša, zdravilo nehajte uporabljati in nemudoma poiščite zdravniško pomoč.
English: Revinty Ellipta has been shown to reduce flare-ups and symptoms of asthma.
Slovenian: Dokazano je, da zdravilo Revinty Ellipta zmanjša pogostnost poslabšanj in simptomov astme.
English: The adjusted mean treatment difference of -37 mL between the groups was not statistically significant (p=0.162).
Slovenian: Korigirana povprečna razlika med zdravljenjema 37 ml med skupinama ni bila statistično značilna (p =
English: Revinty Ellipta 184/22 micrograms is not indicated for patients with COPD.
Slovenian: Zdravilo Revinty Ellipta 184/22 mikrogramov ni indicirano pri bolnikih s KOPB.
English: In a placebo-controlled study (SUMMIT) in subjects with moderate COPD (mean percent postbronchodilator screening FEV1 of 60%, SD 6%), and a history of, or an increased risk of cardiovascular disease, the incidence of pneumonia with FF/VI, FF, VI and placebo was: adverse events (6%, 5%, 4%, 5%); serious adverse events (3%, 4%, 3%, 3%); adjudicated on treatment deaths due to pneumonia (0.3%, 0.2%, 0.1%, 0.2%); the exposure adjusted rates (per 1000 treatment years) were: adverse events (39.5, 42.4, 27.7, 38.4); serious adverse events (22.4, 25.1, 16.4, 22.2); adjudicated on-treatment deaths due to pneumonia (1.8, 1.5, 0.9, 1.4) respectively.
Slovenian: V študiji, kontrolirani s placebom (SUMMIT), pri bolnikih z zmerno KOPB (povprečni odstotek predvidenega FEV1 po bronhodilatatorju ob presejanju 60 %, standardni odklon 6 %), ki so imeli kardiovaskularno bolezen kdaj v preteklosti ali so imeli večje tveganje za takšno bolezen, je bila pojavnost pljučnice s FF/VI, FF, VI in placebom: neželeni učinki (6 %, 5 %, 4 %, 5 %), resni neželeni učinki (3 %, 4 %, 3 %, 3 %), presojene smrti zaradi pljučnice med zdravljenjem (0,3 %, 0,2 %, 0,1 %, 0,2 %); za izpostavljenost prilagojeni deleži (na 1000 bolnik-let zdravljenja) so bili: neželeni učinki (39,5, 42,4, 27,7, 38,4), resni neželeni učinki (22,4, 25,1, 16,4, 22,2), presojene smrti zaradi pljučnice med zdravljenjem (1,8,
English: If you are breast-feeding, check with your doctor before you use Revinty Ellipta.
Slovenian: Če dojite, se posvetujte z zdravnikom, preden uporabite zdravilo Revinty Ellipta.
English: What you need to know before you use Revinty Ellipta
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Revinty Ellipta
English: The maximum recommended dose is Revinty Ellipta 184/22 micrograms once daily.
Slovenian: Največji priporočeni odmerek zdravila Revinty Ellipta je 184/22 mikrogramov enkrat na dan.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Revinty Ellipta in one or more subsets of the paediatric population in asthma (see section 4.2 for information on paediatric use).
Slovenian: Revinty Ellipta za eno ali več skupin pediatrične populacije pri astmi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: How to use Revinty Ellipta See ‘Step-by-step instructions' after section 6 of this leaflet for full information.
Slovenian: Kako uporabiti inhalator Za celotne informacije glejte Navodila, ki so za poglavjem 6 tega navodila za uporabo.
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.
Slovenian: Flutikazonfuroat/vilanterol 92/22 mikrogramov je prinesel bistveno večjo zaščito pred bronhialno hiperreaktivnostjo, povzročeno z alergeni, kot monoterapiji s FF oziroma vilanterolom, ocenjeno
English: • infection of the nose sinuses or throat
Slovenian: • okužba obnosnih votlin (sinusov) ali žrela,
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 Revinty Ellipta pri otrocih, mlajših od 12 let, še nista ugotovljeni.
English: • awareness of heart beat (palpitations)
Slovenian: • neprijetni občutki ob hitrem ali močnem utripanju srca (palpitacije)
English: Both fluticasone furoate/vilanterol 92/22 micrograms and FF 92 micrograms virtually abolished the late asthmatic response compared with vilanterol alone.
Slovenian: Tako flutikazonfuroat/vilanterol 92/22 mikrogramov kot 92 mikrogramov FF sta v primerjavi s samim vilanterolom praktično odpravila pozni astmatični odziv.
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of treatment with Revinty Ellipta.
Slovenian: Bolnikom je treba naročiti, naj v primeru, da simptomi astme po uvedbi zdravila Revinty Ellipta niso obvladani ali se poslabšajo, zdravljenje nadaljujejo, a naj se hkrati posvetujejo z zdravnikom.
English: You do not need to prepare Revinty Ellipta in any special way, not even the first time you use it.
Slovenian: Inhalatorja ni potrebno posebej pripraviti za uporabo, niti ko zdravilo Revinty Ellipta uporabite prvič.
English: If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Revinty Ellipta (92/22 micrograms once daily).
Slovenian: če imate bolezen jeter, ker lahko obstaja večja verjetnost, da boste imeli neželene učinke; Če imate zmerno ali hudo bolezen jeter, vam bo vaš zdravnik omejil odmerek na nižjo jakost zdravila Revinty Ellipta (92/22 mikrogramov enkrat na dan).
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 %, p < 0,001).
English: How to store Revinty Ellipta 6.
Slovenian: Shranjevanje zdravila Revinty Ellipta 6.
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
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 =
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 Revinty Ellipta vplivalo na sposobnost upravljanja vozil in strojev.
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
English: The pharmacokinetics of fluticasone furoate/vilanterol in patients less than 12 years of age has not been studied.
Slovenian: Farmakokinetika zdravila Revinty Ellipta pri bolnikih, mlajših od 12 let, ni raziskana.
English: If you forget to use Revinty Ellipta Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne uporabite dvojnega odmerka, da bi nadomestili pozabljenega.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Revinty Ellipta.
Slovenian: Med uporabo simpatikomimetičnih zdravil, vključno z zdravilom Revinty Ellipta, se lahko pojavijo kardiovaskularni učinki, npr. motnje srčnega ritma, kakršne so supraventrikularna tahikardija in ekstrasistole.
English: Revinty Ellipta has been shown to reduce flare-ups of COPD symptoms.
Slovenian: Dokazano je, da zdravilo Revinty Ellipta zmanjša pogostnost poslabšanj simptomov KOPB.
English: Vilanterol trifenatate is a selective long-acting, beta2-adrenergic agonist (LABA).
Slovenian: Vilanterolijev trifenatat je selektiven, dolgodelujoč agonist adrenergičnih receptorjev beta2 (LABA - longacting, beta2-adrenergic agonist).
English: Two different strengths of Revinty 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 Revinty Ellipta: flutikazonfuroat 92 mikrogramov/vilanterol 22 mikrogramov in flutikazonfuroat 184 mikrogramov/vilanterol 22 mikrogramov.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Revinty 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: Fluticasone furoate/vilanterol 92/22 micrograms increased trough FEV1 by 46 mL compared to vilanterol (95% CI: 8, 83mL, p= 0.017).
Slovenian: Flutikazonfuroat/vilanterol 92/22 mikrogramov je povečal najnižji FEV1 v primerjavi z vilanterolom za 46 ml (95 % IZ: 8, 83 ml, p = 0,017).
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).
Slovenian: 44 % bolnikov v skupini s flutikazonfuroatom/vilanterolom 92/22 mikrogramov je imelo na koncu zdravljenja dobro urejeno bolezen (ACQ7 ≤ 0,75); v skupini z 92 mikrogrami FF je bilo takšnih 36 % (p < 0,001, 95 % IZ od 1,23 do
English: This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Slovenian: To ustreza odmerjenemu odmerku 200 mikrogramov flutikazonfuorata in 25 mikrogramov vilanterola (v obliki trifenatata).
English: Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Slovenian: Če ste noseči, tega zdravila ne uporabljajte, razen, če vam je tako svetoval zdravnik.
English: United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Slovenian: United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk.com to navodilo za uporabo škatla pokrov embalaže inhalator vrečka s sušilom embalaža vrečka s sušilom
English: Do not stop using Revinty Ellipta without advice
Slovenian: Ne prenehajte uporabljati zdravila Revinty Ellipta, ne da bi vam to naročil zdravnik.
English: You can also report side effects directly via the national reporting system listed in Appendix V .
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S poročanjem o neželenih učinkih lahko prispevate k boljši obveščenosti glede varnosti tega zdravila.
English: Use this medicine for as long as your doctor recommends.
Slovenian: Zdravilo Revinty Ellipta uporabljajte toliko časa, kot vam svetuje vaš zdravnik.
English: 0.19 in the FF 92 micrograms group (approximately 1 in every 5 years) and 0.14 in the fluticasone furoate/vilanterol 92/22 micrograms group (approximately 1 in every 7 years).
Slovenian: Delež hudih poslabšanj astme na bolnika na leto je bil v skupini z 92 mikrogrami FF 0,19 (približno 1 na 5 let) in v skupini z flutikazonfuroatom/vilanterolom 92/22 mikrogramov 0,14 (približno 1 na 7 let).
English: How to use Revinty Ellipta
Slovenian: Kako uporabljati zdravilo Revinty Ellipta
English: Asthma Revinty Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:
Slovenian: Zdravilo Revinty Ellipta je indicirano za redno zdravljenje astme pri odraslih in mladostnikih, starih 12 let ali več, za katere je primerna uporaba kombiniranega zdravila (dolgodelujočega agonista adrenergičnih receptorjev beta2 in inhalacijskega kortikosteroida): • bolniki, ki bolezni nimajo ustrezno urejene ob uporabi inhalacijskih kortikosteroidov in inhalacijskih kratkodelujočih agonistov adrenergičnih receptorjev beta2 ''po potrebi'';
English: Revinty Ellipta contains lactose
Slovenian: Zdravilo Revinty Ellipta vsebuje laktozo.
English: Multipacks contain 3 x 30 dose inhalers.
Slovenian: Revinty Ellipta z več inhalatorji vsebuje 3 inhalatorje s 30 odmerki.
English: Prepare a dose Wait to open the cover until you are ready to take your dose.
Slovenian: Pokrovček odprite šele, kot ste pripravljeni, da vzamete odmerek.
English: Based on in vitro data, the major routes of metabolism of both fluticasone furoate and vilanterol in human are mediated primarily by CYP3A4.
Slovenian: Na podlagi podatkov in vitro poteka pri človeku glavna pot presnove obeh, flutikazonfuroata in vilanterola,
English: At Day 168 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean weighted mean FEV1 over 0-4 hours by 193mL (95% CI: 156, 230 mL, p<0.001) and 145 mL (95% CI: 108, 181 mL, p<0.001) respectively compared to placebo.
Slovenian: Na 168. dan je flutikazonfuroat/vilanterol 92/22 mikrogramov povečal korigirani povprečni uteženi povprečni FEV1 v obdobju 0-4 ure za 193 ml (95 % IZ:156, 230 ml, p < 0,001) in vilanterol za 145 ml (95 %
English: NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
Slovenian: IME ZDRAVILA Revinty Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
English: These include: beta-blockers, such as metoprolol, used to treat high blood pressure or a heart condition.
Slovenian: Med takšnimi so: antagonisti adrenergičnih receptorjev beta, npr. metoprolol, ki se uporablja za zdravljenje visokega krvnega tlaka ali bolezni srca, ketokonazol za zdravljenje glivičnih okužb, ritonavir ali kobicistat za zdravljenje okužb z virusom HIV,