natgillin/translations-raw huggingface dataset:
This leaflet was last revised in <{MM/YYYY}> 
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> Drugi viri informacij
Excipients with known effect: 
Pomožna(e) snov(i) z znanim učinkom:
The precise mechanism through which fluticasone furoate affects asthma and COPD symptoms is not known. 
Natančen mehanizem, po katerem flutikazonfuroat vpliva na simptome astme in KOPB, ni znan.
Adverse reactions are listed by system organ class and frequency. 
Neželeni učinki so navedeni po organskih sistemih in pogostnosti.
Vilanterol trifenatate 
Vilanterolijev trifenatat
Vilanterol trifenatate was not teratogenic in rats. 
Vilanterolijev trifenatat pri podganah ni bil teratogen.
Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g. eosinophils, macrophages, lymphocytes) and mediators (e.g. cytokines and chemokines involved in inflammation). 
Dokazano je, da imajo kortikosteroidi širok spekter vplivov na več vrst celic (npr. na eozinofilce, makrofage, limfocite) in mediatorjev (npr. na citokine in kemokine, ki sodelujejo pri vnetju).
In the asthma clinical development program a total of 7,034 patients were included in an integrated assessment of adverse reactions. 
V programu kliničnega razvoja pri astmi je bilo v integrirano oceno neželenih učinkov vključenih skupno 7.034 bolnikov.
With the exception of pneumonia and fractures, the safety profile was similar in patients with asthma and COPD. 
Z izjemo pljučnice in zlomov so bile varnostne značilnosti pri bolnikih z astmo in KOPB podobne.
Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see section 5.3). 
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri izpostavljenostih, ki niso klinično pomembne (glejte poglavje 5.3).
Patients with asthma should be given the strength of Relvar Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. 
Bolniki z astmo morajo dobiti tisto jakost zdravila Relvar Ellipta, ki vsebuje odmerek flutikazonfuroata (FF), ustrezen izrazitosti njihove bolezni.
In HZA106837 the primary endpoint was the time to first severe asthma exacerbation. 
V študiji HZA106837 je bil primarni opazovani dogodek čas do prvega hudega poslabšanja astme.
If you open and close the cover without inhaling the medicine, you will lose the dose. 
Če odprete in zaprete pokrovček, ne da bi vdihnili zdravilo, boste izgubili odmerek.
PHARMACEUTICAL FORM AND CONTENTS 30 doses 
FARMACEVTSKA OBLIKA IN VSEBINA 30 odmerkov
This should be treated immediately with a short-acting inhaled bronchodilator. 
Takšno stanje je treba nemudoma zdraviti s hitrodelujočim inhalacijskim bronhodilatatorjem.
Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists. 
Antagonisti adrenergičnih receptorjev beta2 lahko oslabijo ali antagonizirajo učinek agonistov adrenergičnih receptorjev beta2.
Vilanterol belongs to a group of medicines called long acting bronchodilators. 
Vilanterol spada v skupino zdravil, imenovanih dolgodelujoči bronhodilatatorji.
Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucosegalactose malabsorption should not use this medicinal product. 
Bolniki z redko dedno intoleranco za galaktozo, popolno zmanjšano aktivnostjo laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
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). 
Študije pri bolnikih z blago, zmerno in hudo okvaro jeter so pokazale večjo sistemsko izpostavljenost flutikazonfuroatu (tako Cmax kot AUC) (glejte poglavje 5.2).
COPD (Chronic Obstructive Pulmonary Disease) 
KOPB (kronična obstruktivna pljučna bolezen)
Fluticasone furoate/vilanterol should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections. 
Flutikazonfuroat/vilanterol je treba uporabljati previdno pri bolnikih s pljučno tuberkulozo in bolnikih s kroničnimi ali nezdravljenimi okužbami.
- The other ingredients are lactose monohydrate (See section 2) and magnesium stearate. 
- Pomožni snovi sta laktoza monohidrat (glejte poglavje 2) in magnezijev stearat.
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. 
Ti sinergistični učinki se izražajo z močnejšim protivnetnim delovanjem, ki je bilo in vitro in in vivo dokazano pri celi vrsti vnetnih celic, pomembnih tako za patofiziologijo astme kot KOPB.
Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate the adverse reactions of fluticasone furoate/vilanterol. 
Sočasna uporaba drugih simpatikomimetičnih zdravil (samih ali kot sestavin kombiniranega zdravljenja) lahko stopnjuje neželene učinke flutikazonfuroata/vilanterola.
Paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. 
Pojavi se lahko paradoksni bronhospazem s takojšnjim pojačanjem piskajočega dihanja po uporabi zdravila.
However, there was no evidence that this higher vilanterol Cmax resulted in clinically significant effects on heart rate. 
Vendar ni dokazov, da bi ta večja Cmax vilanterola klinično pomembno vplivala na srčno frekvenco.
• sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). 
• boleče, dvignjene lehe v ustih ali žrelu, ki jih povzroča glivična okužba (kandidoza),
In the COPD clinical development programme a total of 6,237 subjects were included in an integrated assessment of adverse reactions. 
V programu kliničnega razvoja pri KOPB je bilo v integrirano oceno neželenih učinkov vključenih skupno 6.237 preiskovancev.
Table 1 - Results of primary and key secondary endpoints in HZA106827 and HZA106829 
Rezultati primarnega in ključnih sekundarnih opazovanih dogodkov v HZA106827 in
INFORMATION IN BRAILLE relvar ellipta 184:22 
PODATKI V BRAILLOVI PISAVI relvar ellipta 184:22
Clinical pharmacology studies with a specific P-gp inhibitor and fluticasone furoate have not been conducted. 
Kliničnih farmakoloških študij s specifičnim zaviralcem P-gp in flutikazonfuroatom niso izvedli.
• Slide the cover down until you hear a “click”. 
• Potisnite pokrovček dol, dokler ne zaslišite "klik".
It relaxes the muscles of the small air passages in the lungs. 
Sprosti mišice v malih dihalnih poteh v pljučih.
Relvar Ellipta should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. 
Uporabo zdravila Relvar Ellipta je treba takoj prekiniti, bolnika pregledati in uvesti drugo zdravljenje, če je potrebno.
Interaction with CYP3A4 inhibitors 
Medsebojno delovanje z zaviralci CYP3A4
Pharmacotherapeutic group: Drugs for obstructive airways diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics ATC code: R03AK10. 
Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni; adrenergiki v kombinaciji s kortikosteroidi ali drugimi učinkovinami razen antiholinergikov, oznaka ATC: R03AK10.
If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol). 
Če se vam pojavi takšen napad, morate uporabiti hitrodelujoč inhalator (npr. salbutamol).
Subjects used salbutamol on an as-needed basis throughout the studies. 
Preiskovanci so ves čas študij uporabljali salbutamol po potrebi.
Do not give this medicine to children under the age of 12 years for the treatment of asthma, or in children and adolescents of any age for the treatment of COPD. 
Tega zdravila ne smete dajati za zdravljenje astme otrokom, mlajšim od 12 let, ali za zdravljenje KOPB otrokom in mladostnikom ne glede na starost.
INFORMATION IN BRAILLE relvar ellipta 92:22 
PODATKI V BRAILLOVI PISAVI relvar ellipta 92:22
If you feel you are getting breathless or wheezy more often than normal, or if you are using your quickacting inhaler more than usual, see your doctor. 
Če se vam zasoplost ali piskajoče dihanje pojavlja pogosteje kot po navadi, ali če svoj hitrodelujoči inhalator uporabljate pogosteje kot po navadi, obiščite svojega zdravnika.
LIST OF EXCIPIENTS Also contains lactose and magnesium stearate. 
SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo in magnezijev stearat.
Asthma is a serious, long term lung disease where the muscles surrounding the smaller airways become tight (bronchoconstriction) and swollen and irritated (inflammation). 
Astma je resna, dolgotrajna bolezen pljuč, ki se pojavi, če se mišice, ki obdajajo manjše dihalne poti, skrčijo (bronhokonstrikcija) ter otečejo in so razdražene (vnetje).
Molecular interactions occur between corticosteroids and LABAs, whereby steroids activate the beta2receptor gene, increasing receptor number and sensitivity and LABAs prime the glucocorticoid receptor for steroid-dependent activation and enhance cell nuclear translocation. 
Med kortikosteroidi in LABA prihaja do molekulskih medsebojnih delovanj, pri čemer steroidi aktivirajo gen za beta2-receptor ter povečajo število in občutljivost receptorjev, LABA pa pripravijo glukokortikoidne receptorje na aktiviranje s steroidi in povečajo celično jedrno translokacijo.
Component of a multipack, can't be sold separately. 
Sestavina pakiranja z več inhalatorji, ni za ločeno prodajo.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 
Če se pri bolniku pojavijo simptomi, kot so zamegljen vid ali druge motnje vida, ga je potrebno upoštevati za napotitev k oftalmologu zaradi ovrednotenja možnih vzrokov, ki lahko vključujejo katarakto, glavkom ali redke bolezni, kot je centralna serozna horioretinopatija, o katerih so poročali po sistemski in topični uporabi kortikosteroidov.
Allergen challenge study 
Študija provokacije z alergenom
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). 
Primarni opazovani dogodek je bila umrljivost zaradi vseh vzrokov, sekundarni opazovani dogodek pa so sestavljali kardiovaskularni dogodki (kardiovaskularna smrt med zdravljenjem, miokardni infarkt, možganska kap, nestabilna angina pektoris ali tranzitorna ishemična ataka).
After inhalation, patients should rinse their mouth with water without swallowing. 
Po inhalaciji morajo bolniki splakniti usta z vodo, vode ne smejo pogoltniti.
In vitro plasma protein binding in human plasma of fluticasone furoate and vilanterol was high, on average >99.6% and 93.9%, respectively. 
Vezava na plazemske beljakovine v človeški plazmi in vitro je bila visoka: flutikazonfuroata v povprečju > 99,6 % in vilanterola v povprečju
Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. 
Flutikazonfuroat je sintetičen trifluoriran kortikosteroid z močnim protivnetnim delovanjem.
During clinical studies, pneumonia and fractures were more frequently commonly observed in patients with COPD. 
Med kliničnimi študijami so pljučnico in zlome pogosteje zabeležili pri bolnikih s KOPB.
When you first use the Ellipta inhaler you do not need to check that it is working properly, and you do not need to prepare it for use in any special way. 
Ko prvič uporabite inhalator Ellipta, vam ni treba preverjati, ali deluje pravilno in vam ga tudi ni treba posebej pripravljati za uporabo.
It will only be effective as long as you are using it. Do not stop unless your doctor advises you to, even if you feel better. 
Ne nehajte ga uporabljati, če vam tega ne svetuje zdravnik, tudi če se počutite bolje.
If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your quick-acting inhaler (e.g. salbutamol), then seek medical advice. 
Če se vam pojavi piskajoče dihanje ali zasoplost ali kakšni drugi simptomi napada astme, uporabite svoj hitrodelujoči inhalator (npr. salbutamol) in nato poiščite zdravniški nasvet.
P value (95% CI) 
Vrednost p (95 % IZ)
• pain and irritation in the back of the mouth and throat 
• bolečine in draženje v zadnjem delu ust in v žrelu,
Multipack: 90 (3 packs of 30) doses 
Pakiranje z več inhalatorji: 90 (3 pakiranja po 30) odmerkov
Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use. 
Inhalator hranite v zaprti embalaži za zaščito pred vlago in ga odprite tik pred prvo uporabo.
HZC112206 and HZC112207 were 24 week randomised, double-blind, placebo controlled, parallel group studies comparing the effect of the combination to vilanterol and FF alone and placebo. 
Študiji HZC112206 in HZC112207 sta bili 24-tedenski randomizirani, dvojno slepi, s placebom kontrolirani študiji vzporednih skupin, ki sta primerjali vpliv kombinacije z vplivi vilanterola in FF samih ter placeba.
The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled. 
Izgubljeni odmerek bo varno shranjen v inhalatorju, vendar ne bo več na voljo za inhalacijo.
• high temperature (fever) 
• zvišana telesna temperatura (vročina),
Cardioselective beta-blockade should only be considered for profound vilanterol overdose effects that are clinically concerning and unresponsive to supportive measures. 
Kardioselektivna blokada beta pride v poštev le pri zelo izrazitih učinkih prevelikega odmerjanja vilanterola, ki so klinično zaskrbljujoči in se ne odzivajo na podporne ukrepe.
14 doses 30 doses 
14 odmerkov 30 odmerkov
- Contact your doctor if you experience increased thirst, frequent urination or unexplained tiredness 
- Posvetujte se s svojim zdravnikom, če se vam pojavi povečana žeja, pogosto uriniranje ali nepojasnjena utrujenost (znaki povišanega sladkorja v krvi).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 14 doses 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 14 odmerkov
You may not be able to taste or feel the medicine, even when you are using the inhaler correctly. 
Zdravila morda ne boste ne okusili, ne občutili, tudi če inhalator uporabljate pravilno.
This will make it less likely that you will develop a sore mouth or throat as side effects. 
Tako bo manj verjetno, da se vam kot neželen učinek pojavi vnetje ust ali žrela.
Visual disturbance 
Motnje vida
Animal studies showed no effect of fluticasone furoate/vilanterol trifenatate on fertility (see section 5.3). 
Študije na živalih niso pokazale, da bi flutikazonfuroat/vilanterol vplival na plodnost (glejte poglavje 5.3).
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to medical prescription. 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
Pneumonia in patients with asthma 
Pljučnica pri bolnikih z astmo
The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel. 
Inhalator je večdelni pripomoček, izdelan iz polipropilena, polietilena velike gostote, polioksimetilena, polibutilentereftalata, akrilonitril butadienstirena, polikarbonata in nerjavečega jekla.
The 184/22 micrograms strength is used to treat asthma in adults and adolescents aged 12 years and older. 
Jakost 184/22 mikrogramov se uporablja za zdravljenje astme pri odraslih in mladostnikih, starih 12 let in več.
• Remove the inhaler from your mouth. 
• Inhalator naj vzame iz ust.
The safety and efficacy of Relvar Ellipta in children under 12 years of age has not yet been established in the indication for asthma. 
Varnost in učinkovitost zdravila Relvar Ellipta pri otrocih, mlajših od 12 let, za indikacijo astme še nista ugotovljeni.
All-cause mortality was: fluticasone furoate/vilanterol, 6.0%; placebo, 6.7%; fluticasone furoate, 6.1%; vilanterol, 6.4%. 
Umrljivost zaradi vseh vzrokov je bila med uporabo flutikazonfuroata/vilanterola 6,0 %, placeba 6,7 %, flutikazonfuroata 6,1 % in vilanterola 6,4 %.
Do not use this medicine after the expiry date which is stated on the pack after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Fluticasone furoate was not teratogenic in rats or rabbits, but delayed development in rats and caused abortion in rabbits at maternally toxic doses. 
Flutikazonfuroat pri podganah in kuncih ni bil teratogen, a je pri podganah upočasnil razvoj, pri kuncih pa je v maternalnih toksičnih odmerkih povzročil splave.
Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician. 
Če bolnikova uporaba kratkodelujočih bronhodilatatorjev za olajšanje narašča, to kaže na slabšanje urejenosti bolezni in bolnikovo stanje je treba znova oceniti.
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. 
Vilanterolijev trifenatat Študije genotoksičnosti kažejo, da vilanterol (v obliki alfa-fenilcinamata) in trifenilocetna kislina nista genotoksična, to kaže, da vilanterol (v obliki trifenatata) za človeka ne pomeni genotoksične nevarnosti.
Chronic obstructive pulmonary disease (COPD) is a serious, long term lung disease where the airways become inflamed and thickened. 
Kronična obstruktivna pljučna bolezen (KOPB) je resna, kronična pljučna bolezen, kjer se dihalne poti vnamejo in zadebelijo.
All subjects were using an ICS (Inhaled corticosteroid) with or without LABA for at least 12 weeks prior to visit 1. 
Vsi preiskovanci so vsaj 12 tednov pred 1. obiskom uporabljali inhalirani kortikosteroid (ICS) z LABA ali brez njega.
The MAH shall perform the required Pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
There have been reports of increases in blood glucose levels in diabetic patients and this should be considered when prescribing to patients with a history of diabetes mellitus. 
Opisani so primeri zvišane koncentracije glukoze v krvi pri sladkornih bolnikih; to morate upoštevati, če zdravilo predpišete bolnikom z anamnezo sladkorne bolezni.
Caution is advised when co-administering with strong CYP 3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol. 
Previdnost je potrebna med sočasno uporabo z močnimi zaviralci CYP3A4 (npr. ketokonazol, ritonavir, zdravila, ki vsebujejo kobicistat), ker obstaja možnost večje sistemske izpostavljenosti flutikazonfuroatu in vilanterolu.
Relvar 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. 
Zdravilo Relvar 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.
The step-by-step instructions shown below for the 30-dose Ellipta inhaler (30 day supply) also apply to the 14-dose Ellipta inhaler (14 day supply). 
Spodnja navodila za inhalator Ellipta s 30 odmerki (30-dnevna zaloga) veljajo tudi za inhalator Ellipta s 14 odmerki (14-dnevna zaloga).
However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic. 
Vendar je treba bolnikom povedati, da je za vzdrževanje nadzora nad simptomi astme potrebna redna vsakodnevna uporaba in da morajo zdravilo uporabljati tudi, ko nimajo simptomov.
Oral corticosteroids and antibiotics were allowed for the acute treatment of COPD exacerbations with specific guidelines for use. 
Za akutno zdravljenje poslabšanj KOPB je bila dovoljena uporaba peroralnih kortikosteroidov in antibiotikov s specifičnimi smernicami za njihovo uporabo.
There is no specific treatment for an overdose with fluticasone furoate/vilanterol. 
Specifičnega zdravljenja za preveliko odmerjanje flutikazonfuroata/vilanterola ni.
Just follow these step-by-step instructions. 
Samo upoštevajte spodnja navodila.
Fluticasone furoate and vilanterol are substrates for P-glycoprotein (P-gp), however, concomitant administration of fluticasone furoate/vilanterol with P-gp inhibitors is considered unlikely to alter fluticasone furoate or vilanterol systemic exposure since they are both well absorbed molecules. 
Flutikazonfuroat in vilanterol sta substrata P-glikoproteina (P-gp), vendar ni verjetno, da bi sočasna uporaba flutikazonfuroata/vilanterola z zaviralci P-gp spremenila sistemsko izpostavljenost flutikazonfuroata ali vilanterola, ker se obe molekuli dobro absorbirata.
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). 
Med možnimi sistemskimi učinki so Cushingov sindrom, Cushingoidne značilnosti, supresija nadledvičnih žlez, zmanjšanje mineralne gostote kosti, upočasnitev rasti pri otrocih in mladostnikih, katarakta in glavkom ter, redkeje, različni psihološki ali vedenjski učinki, med njimi psihomotorična hiperaktivnost, motnje spanja,
However, other corticosteroids and beta2-agonists are detected in human milk (see section 5.3). 
Se pa v materinem mleku pri človeku pojavijo drugi kortikosteroidi in agonisti adrenergičnih receptorjev beta2 (glejte poglavje 5.3).
In an integrated analysis of both studies, fluticasone furoate/vilanterol 92/22 micrograms showed clinically meaningful improvements in lung function. 
V integrirani analizi obeh študij je flutikazonfuroat/vilanterol 92/22 mikrogramov pokazal klinično pomembno izboljšanje pljučne funkcije.
Given this low oral bioavailability, systemic exposure for fluticasone furoate and vilanterol following inhaled administration is primarily due to absorption of the inhaled portion of the dose delivered to the lung. 
Glede na majhno peroralno biološko uporabnost je sistemska izpostavljenost flutikazonfuroatu in vilanterolu po inhaliranju v prvi vrsti posledica absorpcije inhaliranega dela odmerka, ki pride v pljuča.
What Relvar Ellipta is and what it is used for 2. 
Kaj je zdravilo Relvar Ellipta in za kaj ga uporabljamo 2.
What you need to know before you use Relvar Ellipta 3. 
Kaj morate vedeti, preden boste uporabili zdravilo Relvar Ellipta 3.
The increase in vilanterol exposure was not associated with an increase in beta2-agonist related systemic effects on heart rate, blood potassium or QTcF interval. 
Večje izpostavljenosti vilanterolu ni spremljalo povečanje z agonistom adrenergičnih receptorjev beta2 povezanih sistemskih učinkov na srčno frekvenco, raven kalija v krvi ali interval QTcF.
Overall, across the two studies combined 2009 (62%) patients had cardiovascular history/risk factors at screening. 
V celoti je imelo ob presejanju kardiovaskularno anamnezo/dejavnike tveganja v obeh študijah skupaj 2009 (62 %) bolnikov.