natgillin/translations-raw huggingface dataset:
In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Trelegy Ellipta and budesonide/formoterol arms was equal at 2%. 
V podskupini 430 bolnikov, zdravljenih do 52 tednov, je bila pojavnost pljučnic tako v skupini z zdravilom Trelegy Ellipta kot v skupini s kombinacijo budezonid/formoterol enaka in je znašala 2 %.
The inhaler should be held away from the mouth breathing out as far as is comfortable, but not breathing out into the inhaler. 
Bolnik naj drži inhalator odmaknjen od ust in izdihne čim bolj globoko, ne da bi bilo neprijetno, vendar ne sme izdihniti v inhalator.
Patients with moderate to severe hepatic impairment receiving Trelegy Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2). 
Bolnike z zmerno do hudo okvaro jeter, ki prejemajo zdravilo Trelegy Ellipta, je treba nadzorovati glede sistemskih neželenih učinkov, povezanih s kortikosteroidi (glejte poglavje 5.2).
The efficacy of Trelegy Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study. 
Učinkovitost zdravila Trelegy Ellipta (92/55/22 mikrogramov) enkrat na dan so ovrednotili na bolnikih s klinično diagnozo KOPB v dveh z zdravilno učinkovino kontroliranih študijah in v eni študiji neinferiornosti.
If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice. 
Če se število na števcu odmerkov ne zmanjša, ko se zasliši "klik", inhalator ne bo oddal odmerka; bolnik naj ga nese k farmacevtu in se z njim posvetuje.
Following oral administration of radiolabelled vilanterol, 70% of the radiolabel was excreted in urine and 30% in faeces. 
Po peroralni uporabi radioaktivno označenega vilanterola se je 70 % radioaktivno označenega odmerka izločilo v urinu in 30 % v blatu.
The incidence of pneumonia with Trelegy Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD. 
Pojavnost pljučnice z zdravilom Trelegy Ellipta je primerljiva tisti, ki so jo opažali v skupini s kombinacijo flutikazonfuroat/vilanterol (FF/VI) 100/25 kliničnih študij FF/VI pri KOPB.
Fluticasone furoate and vilanterol are rapidly cleared by extensive first pass metabolism mediated by enzyme CYP3A4. 
Flutikazonfuroat in vilanterol se oba hitro očistita z obsežno presnovo prvega prehoda z encimom CYP3A4.
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. 
Po peroralni uporabi se je flutikazonfuroat pri človeku odstranil predvsem s presnovo; presnovki se izločijo skoraj samo v blatu in < 1 % najdenega radioaktivnega odmerka se je izločil v urinu.
In FULFIL, Trelegy Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline). 
V študiji FULFIL je zdravilo Trelegy Ellipta izboljšalo dnevne simptome KOPB, ocenjene z E-RS: celotna ocena KOPB, v primerjavi z BUD/FOR (zmanjšanje izhodiščne vrednosti za ≥ 2 enoti).
Animal studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see section 5.3). 
Študije na živalih ne kažejo učinkov flutikazonfuroata, umeklidinija ali vilanterola na plodnost samcev ali samic (glejte poglavje 5.3).
Don't use this medicine if you are pregnant unless your doctor tells you that you can. 
Če ste noseči, ne uporabljajte tega zdravila, razen če vam zdravnik naroči, da ga lahko uporabljate.
The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). 
Farmakološke učinke agonistov adrenergičnih receptorjev beta2, tudi vilanterola, je mogoče vsaj deloma pripisati stimulaciji znotrajcelične adenilat-ciklaze, tj. encima, ki katalizira pretvorbo adenozin trifosfata (ATP) v ciklični 3',5'
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 14 odmerkov
Pneumonia 
Pljučnica
Treatment difference (95% CI) Comparison with BUD/FOR 
Razlika med zdravljenji (95% IZ) Primerjava zdravila Trelegy s FF/VI
In the event of deterioration of COPD during treatment with Trelegy Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken. 
Če se KOPB med zdravljenjem z zdravilom Trelegy Ellipta poslabša, je treba znova oceniti tako bolnika kot shemo zdravljenja KOPB.
What Trelegy Ellipta is and what it is used for 2. 
Kaj je zdravilo Trelegy Ellipta in za kaj ga uporabljamo 2.
Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (LABA). 
Vilanterol je selektiven, dolgodelujoč agonist adrenergičnih receptorjev beta2 (LABA).
There was no significant increase in systemic exposure to vilanterol. 
Sistemska izpostavljenost vilanterolu ni bila pomembno večja.
Consistent with findings for other beta2 agonists, in lifetime inhalation studies vilanterol trifenatate caused proliferative effects in the female rat and mouse reproductive tract and rat pituitary gland. 
Skladno z izsledki, dobljenimi za druge agoniste adrenergičnih receptorjev beta2, je vilanterolijev trifenatat v študijah vseživljenjskega vdihavanja povzročil proliferacijske učinke v reproduktivnem traktu podganjih in mišjih samic ter v podganji hipofizi.
Stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma. 
Nemudoma nehajte uporabljati to zdravilo in nemudoma poiščite zdravniško pomoč, kajti to so lahko znaki akutnega napada glavkoma z ozkim zakotjem.
It is unknown whether fluticasone furoate, umeclidinium, vilanterol or their metabolites are excreted in human milk. 
Ni znano, ali se flutikazonfuroat, umeklidinij, vilanterol ali njihovi presnovki pri človeku izločajo v materinem mleku.
At screening, the mean post-bronchodilator percent predicted FEV1 was 46% and over 99% of patients reported a history of one or more moderate/severe exacerbation in the past year. 
Ob presejanju je bil povprečni FEV1 po bronhodilatatorju 46 % predvidenega in več kot 99 % bolnikov je navajalo eno ali več zmernih ali hudih poslabšanj v preteklem letu.
Trelegy Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists. 
Zdravilo Trelegy Ellipta je treba uporabljati previdno pri bolnikih s konvulzivnimi motnjami ali tirotoksikozo in pri bolnikih, ki so nenavadno odzivni na agoniste adrenergičnih receptorjev beta2.
2) Prepare a dose 
Pripravite odmerek
Plasma clearance following intravenous administration was 65.4 litres/hour. 
Očistek iz plazme po intravenski uporabi je bil 65,4 l/uro.
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.
Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine and faeces. 
Primarna pot odstranjevanja vilanterola je presnova, ki ji sledi izločanje presnovkov v urinu in blatu.
There is no relevant use of Trelegy Ellipta in the paediatric population (under 18 years of age) for the indication of COPD. 
Pediatrična populacija V pediatrični populaciji (mlajši od 18 let) zdravilo Trelegy Ellipta nima relevantne uporabe za indikacijo
In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, based on AUC). 
V pre- in postnatalni študiji je subkutano dajanje umeklidinija pri podganah povzročilo manjše maternalno povečanje telesne mase in uživanje hrane ter rahlo manjšo telesno maso mladičev pred odstavitvijo pri samicah-materah, ki so dobivale odmerek 180 mikrogramov/kg/dan (to je na podlagi AUC približno 61-kratnik klinične izpostavljenosti pri človeku med uporabo dnevnega odmerka 55 mikrogramov).
Following oral inhalation, umeclidinium and vilanterol act locally on airways to produce bronchodilation by separate mechanisms and fluticasone furoate reduces inflammation. 
Po peroralni inhalaciji umeklidinij in vilanterol delujeta lokalno na dihala in vsak po svojem mehanizmu povzročita bronhodilatacijo, flutikazonfuroat pa zmanjša vnetje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI)
Umeclidinium plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours, with 3% to 4% active substance excreted unchanged in urine at steady-state. 
Plazemski eliminacijski razpolovni čas umeklidinija po 10-dnevni inhalacijski uporabi je bil v povprečju 19 ur; v stanju dinamičnega ravnovesja se je od 3 do 4 % učinkovine izločilo nespremenjene v urinu.
1) Read this before you start 
Pred začetkom uporabe preberite ta navodila
Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray. 
Ko je embalaža odprta, lahko inhalator uporabljate do 6 tednov; to obdobje začne teči z dnem,
Systemic drug levels (steady state Cmax and AUC) of FF, UMEC and VI following FF/UMEC/VI in one inhaler (triple combination) were within the range of those observed following FF/VI + UMEC as two inhalers, dual combinations (FF/VI and UMEC/VI), as well as individual single inhalers (FF, UMEC and VI). 
Sistemske koncentracije (Cmax in AUC v stanju dinamičnega ravnovesja) FF, UMEC in VI so bile po uporabi FF/UMEC/VI v enem inhalatorju (trojna kombinacija) znotraj razponov, opaženih po uporabi dveh inhalatorjev FF/VI + UMEC, dvojnih kombinacij (FF/VI in UMEC/VI), ali posameznih enojnih inhalatorjev (FF, UMEC in VI).
• faster heart beat 
• hitrejše bitje srca,
There have been reports of increases in blood glucose levels in diabetic patients treated with fluticasone furoate/umeclidinium/vilanterol 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, ki so se zdravili s kombinacijo flutikazonfuroat/umeklidinij/vilanterol; to morate upoštevati, če zdravilo predpišete bolnikom z anamnezo sladkorne bolezni.
Following oral administration, 92% of the administered radiolabelled dose was excreted primarily in faeces. 
Po peroralni uporabi se je 92 % uporabljenega radioaktivno označenega odmerka izločilo predvsem v blatu.
medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems ketoconazole or itraconazole, to treat fungal infections clarithromycin or telithromycin, to treat bacterial infections ritonavir or cobicistat, to treat HIV infection medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) 
zdravila, imenovana blokatorji beta (npr. propranolol), za zdravljenje visokega krvnega tlaka in drugih težav s srcem, ketokonazol ali itrakonazol za zdravljenje glivnih okužb, klaritromicin ali telitromicin za zdravljenje bakterijskih okužb, ritonavir ali kobicistat za zdravljenje okužbe z virusom HIV,
Trelegy Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. 
Zdravila Trelegy Ellipta se ne sme uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
Trelegy Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1). 
4.1 Terapevtske indikacije Zdravilo Trelegy Ellipta je indicirano za vzdrževalno zdravljenje odraslih bolnikov z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), ki niso zadostno zdravljeni s kombinacijo inhalacijskega kortikosteroida in dolgodelujočega agonista adrenergičnih receptorjev β2 ali s kombinacijo dolgodelujočega agonista adrenergičnih receptorjev β2 in dolgodelujočega antagonista muskarinskih receptorjev (za učinke na obvladanje simptomov in preprečevanje poslabšanj glejte poglavje 5.1).
The effect of fluticasone furoate/umeclidinium/vilanterol on the QT interval has not been evaluated in a thorough QT (TQT) study. 
Učinka kombinacije flutikazonfuroat/umeklidinij/vilanterol na interval QT niso ocenili v podrobni študiji QT
Vilanterol plasma elimination half-life following inhaled dosing for 10 days averaged 11 hours. 
Plazemski eliminacijski razpolovni čas vilanterola po 10-dnevni inhalacijski uporabi je bil v povprečju 11 ur.
In vitro plasma protein binding in human plasma of fluticasone furoate was high, on average >99.6%. 
In vitro je bila vezava flutikazonfuroata na plazemske beljakovine v človeški plazmi velika, v povprečju > 99,6 %.
Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. 
Agonisti adrenergičnih receptorjev beta2 lahko nekaterim bolnikom povzročijo pomembno hipokaliemijo s posledičnimi neželenimi kardiovaskularnimi učinki.
The date should be added as soon as the inhaler has been removed from the tray. 
Ta datum je treba zapisati takoj, ko inhalator vzame iz embalaže.
Following intravenous administration, approximately 58% of the administered radiolabelled dose was excreted in faeces and approximately 22% of the administered radiolabelled dose was excreted in urine. 
Po intravenski uporabi se je približno 58 % uporabljenega radioaktivno označenega odmerka izločilo v blatu in približno 22 % v urinu.
What you need to know before you use Trelegy Ellipta 3. 
Kaj morate vedeti, preden boste uporabili zdravilo Trelegy Ellipta 3.
At screening, the mean post-bronchodilator percent predicted FEV1 was 45% and 65% of patients reported a history of one or more moderate/severe exacerbation in the past year. 
Ob presejanju je bil povprečni FEV1 po bronhodilatatorju 45 % predvidenega in 65 % bolnikov je navajalo eno ali več zmernih ali hudih poslabšanj v preteklem letu.
Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics including triple combinations with corticosteroids, ATC code: R03AL08. 
Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, adrenergiki v kombinaciji z antiholinergiki, vključno s kortikosteroidi v trojnih kombinacijah.
Symptom Relief 
Lajšanje simptomov
Therefore, Trelegy Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease. 
Zato je treba zdravilo Trelegy Ellipta previdno uporabljati pri bolnikih, ki imajo kakšno nestabilno ali življenjsko ogrožujočo kardiovaskularno bolezen.
METHOD AND ROUTE(S) OF ADMINISTRATION Inhalation use, 
POSTOPEK IN POT(I) UPORABE ZDRAVILA za inhaliranje
When fluticasone furoate, umeclidinium and vilanterol were administered in combination by the inhaled route from a single inhaler in healthy subjects, the pharmacokinetics of each component were similar to those observed when each active substance was administered either as fluticasone furoate/vilanterol combination or as an umeclidinium/vilanterol combination or umeclidinium monotherapy. 
Če je bila kombinacija flutikazonfuroata, umeklidinija in vilanterola pri zdravih preiskovancih uporabljena iz enega inhalatorja, je bila farmakokinetika vsake posamezne sestavine podobna, kot če je bila zdravilna učinkovina uporabljena ali v kombinaciji flutikazonfuroat/vilanterol ali umeklidinij/vilanterol ali v monoterapiji z umeklidinijem.
The following instructions for the 30 dose (30 day supply) Ellipta inhaler also apply to the 14 dose (14 day supply) Ellipta inhaler. 
Naslednja navodila za uporabo inhalatorja Ellipta s 30 odmerki (30-dnevna zaloga) veljajo tudi za inhalator Ellipta s 14 odmerki (14-dnevna zaloga).
The active substances are present as a white powder in separate blister strips inside the inhaler. 
Zdravilne učinkovine so v inhalatorju prisotne kot bel prašek v ločenih pretisnih trakovih.
Co-administration increased mean vilanterol AUC(0-t) and Cmax by 65% and 22%, respectively. 
Sočasna uporaba je povečala povprečno AUC(0-t) vilanterola za 65 % in njegovo Cmax za 22 %.
• Remove the inhaler from the mouth. 
• Inhalator naj vzame iz ust.
Fluticasone furoate/umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Kombinacija flutikazonfuroat/umeklidinij/vilanterol nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
The effects of race, gender and weight on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were also evaluated in the population pharmacokinetic analysis. 
Vpliv rase, spola in telesne mase na farmakokinetiko flutikazonfuroata, umeklidinija in vilanterola so ocenili v populacijski farmakokinetični analizi.
Multipacks containing 90 (3 inhalers of 30) doses (90 day supply) are also available. 
Na voljo so tudi pakiranja z več inhalatorji, ki vsebujejo 90 (3 inhalatorji po 30) odmerkov (zaloga za 90 dni).
However, studies have been conducted with fluticasone furoate/vilanterol and umeclidinium/vilanterol. 
Toda izvedli so študije s kombinacijama flutikazonfuroat/vilanterol in umeklidinij/vilanterol.
Use Trelegy Ellipta regularly 
Zdravilo Trelegy Ellipta uporabljajte redno
The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption. 
Absolutna biološka uporabnost inhaliranega vilanterola je bila 27 %; prispevek peroralne absorpcije je bil zanemarljiv.
In COPD the muscles around the airways tighten, making breathing difficult. 
Pri KOPB se mišice, ki obdajajo dihalne poti, skrčijo in tako povzročijo težko dihanje.
Pack sizes of 14 or 30 dose inhalers. 
Velikost pakiranja je inhalator s 14 ali 30 odmerki.
In Study 200812, Trelegy Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24. 
V študiji 200812 je bilo zdravilo Trelegy Ellipta neinferiorno v primerjavi s sočasno uporabljeno kombinacijo dveh inhalatorjev FF/VI+UMEC, kar zadeva izboljšanje najnižjega FEV1 od izhodišča do 24. tedna.
Fluticasone furoate had no adverse effect on pre- or post-natal development in rats. 
Flutikazonfuroat ni škodljivo vplival na pre- in postnatalni razvoj pri podganah.
Other medicines and Trelegy Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Breathlessness was measured using the Transition Dyspnoea Index (TDI) focal score at week 24 in FULFIL and week 52 in IMPACT (a subset of patients, n=5,058). 
Težko dihanje so merili s skupno oceno indeksa dispneje skozi čas (Transition Dyspnoea Index, TDI) v študiji FULFIL po 24 tednih in v študiji IMPACT po 52 tednih (podskupina bolnikov, n = 5058).
However, studies have been conducted with fluticasone furoate/vilanterol and umeclidinium/vilanterol that showed no evidence of an increase in systemic exposure to fluticasone furoate, umeclidinium or vilanterol. 
Toda izvedene so bile študije s kombinacijama flutikazonfuroat/vilanterol in umeklidinij/vilanterol; te študije niso pokazale večje sistemske izpostavljenosti flutikazonfuroatu, umeklidiniju ali vilanterolu.
4.4 Special warnings and precautions for use 
4.4 Posebna opozorila in previdnostni ukrepi Astma
Fluticasone furoate/umeclidinium/vilanterol is a combination of inhaled synthetic corticosteroid, long-acting muscarinic receptor antagonist and long-acting beta2-adrenergic agonist (ICS/LAMA/LABA). 
Mehanizem delovanja Kombinacija flutikazonfuroat/umeklidinij/vilanterol je kombinacija inhalacijskega sinteznega kortikosteroida, dolgodelujočega antagonista muskarinskih receptorjev in dolgodelujočega agonista adrenergičnih receptorjev beta2 (IGK/LAMA/LABA).
Plasma clearance of vilanterol following intravenous administration was 108 litres/hour. 
Plazemski očistek vilanterola je po intravenski uporabi 108 litrov/uro.
Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors on airway smooth muscle. 
Deluje bronhodilatacijsko s kompetitivnim zavrtjem vezave acetilholina na muskarinske receptorje gladkih mišic dihal.
No dosage adjustment is required in patients with mild, moderate or severe hepatic impairment. 
Bolnikom z blago, zmerno ali hudo okvaro jeter odmerka ni treba prilagoditi.
The effects of age on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were evaluated in the population pharmacokinetic analysis. 
Vplive starosti na farmakokinetiko kombinacije flutikazonfuroata, umeklidinija in vilanterola so ocenili v populacijski farmakokinetični analizi.
Treatment with Trelegy Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001). 
Zdravljenje z zdravilom Trelegy Ellipta je značilno zmanjšalo letni delež hudih poslabšanj za 34 % v primerjavi z UMEC/VI (95 % IZ: 22, 44; p < 0,001).
The primary metabolic routes for vilanterol are O-dealkylation to a range of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity. 
Primarna pot presnove vilanterola je O-dealkilacija v številne presnovke z bistveno manjšo agonistično aktivnostjo na adrenergičnih receptorjih beta1 in beta2.
The absolute bioavailability of inhaled umeclidinium was on average 13%, with negligible contribution from oral absorption. 
Absolutna biološka uporabnost inhaliranega umeklidinija je bila v povprečju 13 %; prispevek peroralne absorpcije je bil zanemarljiv.
Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with P-gp inhibitors. 
Glede na velikost teh sprememb ni pričakovati klinično pomembnih medsebojnih delovanj zdravil, če je kombinacija flutikazonfuroat/umeklidinij/vilanterol uporabljena sočasno z zaviralci P-gp.
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
Uncommon side effects These may affect up to 1 in 100 people: 
Pojavijo se lahko pri največ 1 od 100 bolnikov:
4) Close the inhaler and rinse your mouth 
Zaprite inhalator in si splaknite usta
Trelegy Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol. 
Zdravilo Trelegy Ellipta vsebuje tri zdravilne učinkovine: flutikazonfuroat, umeklidinij in vilanterol.
In IMPACT, Trelegy Ellipta significantly reduced (p<0.001) the use of rescue medication (occasions per day) at each 4-week time period compared with FF/VI and UMEC/VI. 
V študiji IMPACT je zdravilo Trelegy Ellipta značilno bolj zmanjšalo (p < 0,001) uporabo rešilnega zdravila (dogodki na dan) v vsakem 4-tedenskem obdobju kot FF/VI in UMEC/VI.