FrancophonIA/ELRC3.0 huggingface dataset:
English: If the dose counter does not count down as you hear the ‘click', the inhaler will not deliver medicine.
Slovenian: Če se število na števcu odmerkov ne zmanjša, ko se zasliši ''klik'', inhalator ne bo oddal zdravila.
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.
Slovenian: Klinična farmakološka študija s sočasno uporabo vilanterola in verapamila, ki je močan zaviralec P-gp in zmeren zaviralec CYP3A4, pri zdravih preiskovancih ni pokazala pomembnega vpliva na farmakokinetiko vilanterola.
English: There is insufficient information on the excretion of fluticasone furoate or vilanterol trifenatate and/or metabolites in human milk.
Slovenian: Dojenje Podatkov o izločanju flutikazonfuroata oziroma vilanterolijevega trifenatata in/ali njunih presnovkov v materinem mleku pri človeku ni dovolj.
English: The most commonly reported adverse reactions with fluticasone furoate and vilanterol were headache and nasopharyngitis.
Slovenian: Najpogosteje zabeležena neželena učinka flutikazonfuroata in vilanterola sta bila glavobol in nazofaringitis.
English: If you have any of the following symptoms after taking Relvar Ellipta stop taking this medicine and tell your doctor immediately.
Slovenian: Če imate po jemanju zdravila Relvar Ellipta katerega koli od naslednjih simptomov, zdravilo takoj nehajte uporabljati in nemudoma obvestite svojega zdravnika:
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: Porazdelitev 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: What Relvar Ellipta is and what it is used for
Slovenian: Kaj je zdravilo Relvar Ellipta in za kaj ga uporabljamo
English: Close the inhaler and rinse your mouth
Slovenian: Zaprite inhalator in si splaknite usta.
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.
Slovenian: Jakost 92/22 mikrogramov se uporablja za zdravljenje kronične obstruktivne pljučne bolezni (KOPB) pri odraslih in za zdravljenje astme pri odraslih in mladostnikih, starih 12 let ali več.
English: Tel: + 420 222 001 111 cz.info@gsk.com
Slovenian: Tel: + 420 222 001 111 gsk.czmail@gsk.com
English: Take one long, steady, deep breath in.
Slovenian: Naredi naj en dolg, enakomeren, globok vdih.
English: Use Relvar 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 Relvar Ellipta uporabljajte vsak dan ob istem času, saj učinkuje 24 ur.
English: In inhalation studies in rabbits, vilanterol trifenatate caused effects similar to those seen with other beta2 agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation).
Slovenian: V inhalacijskih študijah pri podganah je povzročil podobne učinke, kot se pojavljajo z drugimi agonisti adrenergičnih receptorjev beta2 (palatoshiza, odprte veke, sternebralna fuzija in fleksura/malrotacija udov).
English: Relvar Ellipta should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing longacting beta2-adrenergic agonists.
Slovenian: Zdravila Relvar Ellipta se ne sme uporabljati skupaj z drugimi dolgodelujočimi agonisti adrenergičnih receptorjev beta2 ali z zdravili, ki vsebujejo dolgodelujoče agoniste adrenergičnih receptorjev beta2.
English: Read this before you start
Slovenian: Pred začetkom uporabe preberite ta navodila.
English: Don't open the inhaler until you are ready to inhale a dose of medicine.
Slovenian: Ne odpirajte inhalatorja, dokler niste pripravljeni za vdihanje odmerka zdravila.
English: The effects of age on the pharmacokinetics of fluticasone furoate and vilanterol were determined in phase III studies in COPD and asthma.
Slovenian: Vplive starosti na farmakokinetiko flutikazonfuroata in vilanterola so preučili v študijah III. faze pri KOPB
English: Exposure-adjusted all-cause mortality per 100 patients/year (%/yr) was: fluticasone furoate/vilanterol, 3.1 %/yr; placebo, 3.5 %/yr; fluticasone furoate, 3.2 %/yr; and vilanterol, 3.4 %/yr.
Slovenian: Za izpostavljenost korigirana umrljivost zaradi vseh vzrokov na 100 bolnik-let (%/bl) je bila med uporabo flutikazonfuroata/vilanterola 3,1 %/leto, placeba 3,5 %/leto, flutikazonfuroata 3,2 %/leto in vilanterola 3,4 %/leto.
English: There was no evidence for age (12-84) to affect the pharmacokinetics of fluticasone furoate and vilanterol in subjects with asthma.
Slovenian: Izsledki niso pokazali, da bi starost (od 12 do 84 let) pri preiskovancih z astmo vplivala na farmakokinetiko flutikazonfuroata in vilanterola.
English: The 184/22 micrograms strength is not approved for the treatment of COPD.
Slovenian: Jakost 184/22 mikrogramov ni odobrena za zdravljenje KOPB.
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.
Slovenian: Po peroralni uporabi se flutikazonfuroat pri človeku odstrani predvsem s presnovo; presnovki se izločijo skoraj samo v blatu in < 1 % najdenega radioaktivnega odmerka se je izločil v urinu.
English: Subjects randomised to once-daily FF/VI maintained lung function comparable with those randomised to twice-daily salmeterol/FP [difference in trough FEV1 of +19 mL (95% CI: -11, 49)].
Slovenian: Preiskovanci, randomizirani na kombinacijo FF/VI enkrat na dan, so ohranili pljučno funkcijo primerljivo preiskovancem, randomiziranim na kombinacijo salmeterol/FP dvakrat na dan [razlika v najnižjem FEV1 +19 mL (95 % IZ: -11, 49)].
English: If you have further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: • Take one long, steady, deep breath in.
Slovenian: • Naredi naj en dolg, enakomeren, globok vdih.
English: Sympathomimetic medicinal products
Slovenian: Simpatikomimetična zdravila
English: Relvar Ellipta has been shown to reduce flare-ups and symptoms of asthma.
Slovenian: Dokazano je, da zdravilo Relvar Ellipta zmanjša pogostnost poslabšanj in simptomov astme.
English: For patients with moderate to severe hepatic impairment, the 92/22 micrograms dose should be used and patients should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Slovenian: Bolniki z okvaro jeter Pri bolnikih z zmerno do hudo okvaro jeter je treba uporabiti odmerek 92/22 mikrogramov in bolnike je treba kontrolirati glede sistemskih neželenih učinkov, povezanih s kortikosteroidi (glejte poglavje 5.2).
English: • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Slovenian: • Medtem ko inhalator držite še odmaknjen od ust, izdihnite čim bolj globoko, a ne toliko, da bi bilo neprijetno.
English: Co-administration increased mean vilanterol AUC(0-t) and Cmax 65% and 22%, respectively.
Slovenian: Sočasna uporaba je povečala povprečno AUC(0-t) vilanterola za 65 % in njegovo Cmax za 22 %.
English: When the inhaler is taken out of its tray, it will be in the ‘closed' position.
Slovenian: Ko bolnik vzame inhalator iz embalaže, bo le-ta v položaju ''zaprto''.
English: Fluticasone furoate
Slovenian: Flutikazonfuroat
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, predvsem preko CYP3A4.
English: 1 inhaler of 30 doses.
Slovenian: 1 inhalator s 30 odmerki.
English: Other medicines and Relvar Ellipta
Slovenian: Druga zdravila in zdravilo Relvar Ellipta
English: It should be administered at the same time of the day, each day.
Slovenian: Zdravilo je treba uporabljati vsak dan ob istem času.
English: What you need to know before you use Relvar Ellipta
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Relvar Ellipta
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: 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: if you experience blurred vision or other visual disturbances.
Slovenian: če se vam pojavi zamegljen vid.
English: Relvar Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Slovenian: Zdravila Relvar Ellipta se ne sme uporabljati za olajšanje nenadnega napada težkega dihanja ali piskanja.
English: Weighted Mean Serial FEV1 over 0-24 hours post-dose Treatment difference
Slovenian: Uteženi povprečni zaporedni FEV1 v 0-24 urah po odmerku
English: Vilanterol trifenatate is a selective long-acting, beta2-adrenergic agonist (LABA).
Slovenian: Vilanterolijev trifenatat je selektiven, dolgodelujoč agonist adrenergičnih receptorjev beta2 (LABA - long acting, beta2-adrenergic agonist).
English: Relvar Ellipta 184/22 micrograms is not indicated for patients with COPD.
Slovenian: Zdravilo Relvar Ellipta 184/22 mikrogramov ni indicirano pri bolnikih s KOPB.
English: The rate of severe asthma exacerbations per patient per year was 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: PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za inhaliranje, odmerjeni
English: FF/VI 184/22 Once Daily vs FF 184 Once Daily
Slovenian: FF/VI 184/22 1-krat/dan v prim.
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: 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, 1,5, 0,9, 1,4) v tem zaporedju.
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.
Slovenian: Bolnike so randomizirali na prejemanje 92/22 mikrogramov flutikazonfuroata/vilanterola, 92 mikrogramov FF, 22 mikrogramov vilanterola ali placeba enkrat na dan za 21 dni; temu je sledila provokacija z alergenom 1 uro po zadnjem odmerku.
English: The maximum recommended dose is Relvar Ellipta 184/22 micrograms once daily.
Slovenian: Največji priporočeni odmerek zdravila Relvar Ellipta je 184/22 mikrogramov enkrat na dan.
English: How to use Relvar 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: Interaction with P-glycoprotein inhibitors
Slovenian: Medsebojno delovanje z zaviralci P-glikoproteina
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Slovenian: za inhaliranje POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
English: Time to first exacerbation: Hazard ratio (95% CI) % risk reduction p-value p<0.001
Slovenian: Čas do prvega poslabšanja: Razmerje ogroženosti (95 % IZ) % zmanjšanja tveganja
English: Dose-normalised fluticasone furoate systemic exposure was similar in subjects with moderate and severe hepatic impairment (Child-Pugh B or C).
Slovenian: Na odmerek normalizirana sistemska izpostavljenost flutikazonfuroatu je bila pri preiskovancih z zmerno in hudo okvaro jeter (Child-Pugh B ali C) podobna.
English: If your breathing or wheezing gets worse straight after using Relvar Ellipta, stop using it and get medical help immediately.
Slovenian: Če se vam dihanje ali piskanje takoj po uporabi zdravila Relvar Ellipta poslabša, zdravilo nehajte uporabljati in nemudoma poiščite zdravniško pomoč.
English: How to store Relvar Ellipta 6.
Slovenian: Shranjevanje zdravila Relvar Ellipta 6.
English: Finally, the exposure-adjusted cases of fatal pneumonia were 8.8 for FF/VI 184/22 versus 1.5 for FF/VI 92/22 and 0 for VI 22.
Slovenian: In navsezadnje, glede na izpostavljenost korigirano število pljučnic s smrtnim izidom je bilo 8,8 s FF/VI 184/22, 1,5 s FF/VI 92/22 in 0 z VI 22.
English: One inhalation of Relvar Ellipta 92/22 micrograms once daily.
Slovenian: Ena inhalacija zdravila Relvar Ellipta 92/22 mikrogramov enkrat na dan.
English: Co-administration increased mean fluticasone furoate AUC(0-24) and Cmax by 36% and 33%, respectively.
Slovenian: Sočasna uporaba je povečala povprečno AUC(0-24) flutikazonfuroata za 36 % in njegovo Cmax za 33 %.
English: United Kingdom.
Slovenian: Velika Britanija
English: The adjusted mean change from baseline in trough FEV1 on Day 85 was 111 mL in the fluticasone furoate/vilanterol group and 88 mL in the salmeterol/FP group; the 23 mL (95% CI: -20, 66) difference between the treatment groups was not clinically meaningful or statistically significant (p=0.294).
Slovenian: Korigirana povprečna sprememba najnižjega FEV1 glede na izhodišče je bila 85. dan 111 ml v skupini s flutikazonfuroatom/vilanterolom in 88 ml v skupini s salmeterolom/FP; razlika 23 ml (95 % IZ: -20, 66) med terapevtskima skupinama ni bila ne klinično pomembna ne statistično značilna (p = 0,294).
English: The incidence of pneumonia in patients with asthma taking fluticasone furoate/vilanterol 184/22 micrograms was numerically higher compared with those receiving fluticasone furoate/vilanterol 92/22 micrograms or placebo (see section 4.8).
Slovenian: Incidenca pljučnice je bila številsko večja pri bolnikih z astmo, ki so jemali flutikazonfuroat/vilanterol 184/22 mikrogramov, kot pri tistih, ki so jemali flutikazonfuroat/vilanterol 92/22 mikrogramov ali placebo (glejte poglavje 4.8).
English: This will make it less likely to develop a sore mouth or throat as side effects.
Slovenian: Tako bo manj verjetno, da se kot neželen učinek pojavi bolečina v ustih ali žrelu.
English: There are no or limited data from the use of fluticasone furoate and vilanterol trifenatate in pregnant women.
Slovenian: Podatkov o uporabi flutikazonfuroata in vilanterolijevega trifenatata pri nosečnicah je malo ali jih ni.
English: White powder in a light grey inhaler with a yellow mouthpiece cover and a dose counter.
Slovenian: Bel prašek v svetlo sivem inhalatorju z rumenim pokrovčkom ustnika in števcem odmerkov.
English: Do not breathe out into the inhaler.
Slovenian: Ne izdihnite v inhalator.
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Relvar Ellipta.
Slovenian: Če jemljete katero od teh zdravil, vas bo zdravnik morda skrbno spremljal, kajti ta zdravila lahko povečajo neželene učinke zdravila Relvar.
English: Slide the cover upwards as far as it will go to cover the mouthpiece.
Slovenian: Pokrovček mora potisniti navzgor, kolikor daleč gre, da pokrije ustnik.
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: 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: What is the Ellipta inhaler?
Slovenian: Navodila po korakih Kaj je inhalator Ellipta?
English: No dose adjustment is required for patients with renal impairment.
Slovenian: Bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
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
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 Research Council) ≥ 2 (lestvica 0-4) o presejanju.
English: No comparative studies versus salmeterol/FP or versus other established bronchodilators have been conducted to appropriately compare the effects on COPD exacerbations.
Slovenian: Primerjalnih študij s salmeterolom/FP ali drugimi uveljavljenimi bronhodilatatorji za ustrezno primerjavo vpliva na poslabšanja KOPB niso izvedli.
English: How to inhale the medicine
Slovenian: Kako vdihniti zdravilo
English: In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of pneumonia per 1000 patient years was 18.4 for FF/VI 184/22 versus 9.6 for FF/VI 92/22 and 8.0 in the placebo group.
Slovenian: V integrirani analizi 11 študij pri astmi (7.034 bolnikov) je bila incidenca pljučnice na 1000 bolnik-let v skupini s FF/VI 184/22 18,4, s FF/VI 92/22 9,6 in s placebom 8,0.
English: If you accidentally take more Relvar Ellipta than your doctor has instructed, talk to your doctor or pharmacist.
Slovenian: Če ste uporabili večji odmerek zdravila Relvar Ellipta, kot bi smeli Če pomotoma uporabite večji odmerek zdravila Relvar Ellipta, kot vam je naročil zdravnik, se posvetujte z zdravnikom ali farmacevtom.
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 Relvar Ellipta.
Slovenian: Bolnikom je treba naročiti, naj v primeru, da simptomi astme po uvedbi zdravila Relvar Ellipta niso obvladani ali se poslabšajo, zdravljenje nadaljujejo, a naj se hkrati posvetujejo z zdravnikom.
English: If you are breast-feeding, check with your doctor before you use Relvar Ellipta.
Slovenian: Če dojite, se posvetujte z zdravnikom, preden uporabite zdravilo Relvar Ellipta.
English: A repeat dose CYP3A4 drug interaction study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and the strong CYP3A4 inhibitor ketoconazole (400mg).
Slovenian: Pri zdravih preiskovancih so izvedli študijo medsebojnega delovanja ponavljajočih se odmerkov kombinacije flutikazonfuroat/vilanterol (184/22 mikrogramov) in močnega zaviralca CYP3A4 ketokonazola (400 mg).
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Slovenian: Pri sistemski in topični uporabi kortikosteroidov lahko poročajo o motnjah vida.
English: No comparative studies versus salmeterol/FP or versus other ICS/LABA combinations have been conducted to appropriately compare the effects on asthma exacerbations.
Slovenian: Primerjalnih študij s salmeterolom/FP ali drugimi kombinacijami ICS/LABA za ustrezno primerjavo vpliva na poslabšanje astme niso izvedli.
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.
Slovenian: V študijah HZA106827/HZA106829 sta bila soprimarna opazovana dogodka učinkovitosti sprememba najnižjega FEV1 na ambulantnem obisku (pred bronhodilatatorjem in pred odmerkom) ob koncu zdravljenja v primerjavi z izhodiščem pri vseh bolnikih ter uteženega zaporednega povprečnega FEV1 v 0-24 urah po odmerku, izračunanega pri podskupini preiskovancev ob koncu zdravljenja.
English: • becoming very wheezy, coughing or having difficulty in breathing
Slovenian: • piskanje, kašelj ali težave pri dihanju,
English: The incidence of pneumonia in patients with asthma was common at the higher dose.
Slovenian: Z višjim odmerkom je bila incidenca pljučnice pri bolnikih z astmo pogosta.
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 22. dan z metaholinskim testom.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Relvar Ellipta in one or more subsets of the paediatric population in asthma (see section 4.2 for information on paediatric use).
Slovenian: Ellipta za eno ali več skupin pediatrične populacije pri astmi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: 95% CI p-value % reduction (95% CI)
Slovenian: Razmerje v primerjavi z VI 95 % IZ Vrednost p % zmanjšanja (95 % IZ)
English: • inflammation of the sinuses
Slovenian: • vnetje obnosnih votlin (sinusov),
English: 14 doses
Slovenian: 14 odmerkov
English: The results of both studies showed that treatment with fluticasone furoate/vilanterol 92/22 micrograms once daily resulted in a lower annual rate of moderate/severe COPD exacerbations compared with vilanterol (Table 2).
Slovenian: Rezultati obeh študij so pokazali, da je bil letni delež zmernih/hudih poslabšanj KOPB med zdravljenjem s flutikazonfuroatom/vilanterolom 92/22 mikrogramov enkrat na dan manjši kot med zdravljenjem z vilanterolom (Preglednica 2).
English: The Ellipta inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture.
Slovenian: Inhalator Ellipta se nahaja v embalaži iz laminatne folije, ki vsebuje vrečko s sušilom za zmanjšanje vlažnosti.
English: In HZA106837 patients were randomised to receive either fluticasone furoate/vilanterol 92/22 micrograms [n=1009] or FF 92 micrograms [n=1010] both administered once daily.
Slovenian: Bolniki v HZA106837 so bili randomizirani na prejemanje bodisi flutikazonfuroata/vilanterola 92/22 mikrogramov [n = 1009] bodisi FF 92 mikrogramov [n = 1010]; oba sta bila uporabljena enkrat na dan.