FrancophonIA/ELRC3.0 huggingface dataset:
English: Consistent with findings for other beta2-adrenergic agonists, in lifetime inhalation studies, vilanterol trifenatate caused proliferative effects in the female rat and mouse reproductive tract and in the rat pituitary gland.
Slovenian: Skladno z izsledki pri drugih agonistih adrenergičnih receptorjev beta2 je vilanterol v študijah vseživljenjskega vdihavanja povzročil proliferacijske učinke v reproduktivnem traktu podganjih in mišjih samic ter v podganji hipofizi.
English: The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
Slovenian: Izgubljeni odmerek bo varno shranjen v inhalatorju, vendar vam ne bo več na voljo za vdihanje.
English: Although no formal in vivo drug interaction studies have been performed, inhaled umeclidinium/vilanterol has been used concomitantly with other COPD medicinal products including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.
Slovenian: Čeprav še ni bilo uradnih študij medsebojnega delovanja z drugimi zdravili in vivo, so kombinacijo umeklidinij/vilanterol za inhaliranje že uporabljali sočasno z drugimi zdravili za KOPB, vključno s kratkodelujoči simpatomimetični bronhodilatatorji in inhalacijski kortikosteroidi, vendar kliničnih dokazov za medsebojno delovanje z drugimi zdravili ni.
English: Verapamil, a moderate CYP3A4 inhibitor, did not significantly affect the pharmacokinetics of vilanterol.
Slovenian: Verapamil, zmerni zaviralec CYP3A4, ni pomembno vplival na farmakokinetiko vilanterola.
English: In inhalation studies in rabbits, vilanterol caused effects similar to those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation) at 6-times the human clinical exposure based on AUC.
Slovenian: V inhalacijskih študijah pri zajcih je imel podobne učinke, kot se pojavljajo z drugimi agonisti adrenergičnih receptorjev beta2 (palatoshiza, odprte veke, sternebralna fuzija in fleksura/malrotacija udov), in sicer ob izpostavljenosti, ki je na osnovi AUC ustrezala 6-kratni klinični izpostavljenosti pri človeku.
English: ANORO ELLIPTA contains two active substances umeclidinium bromide and vilanterol.
Slovenian: Zdravilo ANORO ELLIPTA vsebuje dve učinkovini, umeklidinijev bromid in vilanterol.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in CYP2D6 activity (poor metabolisers).
Slovenian: Glede na velikost teh sprememb ni pričakovati klinično pomembnih medsebojnih delovanj zdravil, če je kombinacija umeklidinij/vilanterol uporabljena sočasno z zaviralci CYP2D6 ali pri bolnikih z genetskim pomanjkanjem aktivnosti CYP2D6 (slabi metabolizatorji).
English: Paradoxical bronchospasm
Slovenian: Pogostnost paradoksni bronhospazem redki
English: When umeclidinium and vilanterol were administered in combination by the inhaled route, the pharmacokinetics of each component was similar to those observed when each active substance was administered separately.
Slovenian: Če sta bila umeklidinij in vilanterol uporabljena skupaj v inhalaciji, je bila farmakokinetika vsakega od njiju podobna, kot če sta bila uporabljena vsak posamezno.
English: Plasma clearance of vilanterol following intravenous administration was 108 litres/hour.
Slovenian: Plazemski očistek vilanterola je bil po intravenski uporabi 108 litrov/uro.
English: A dose-dependent increase in heart rate was also observed.
Slovenian: Opazovali so tudi povečanje hitrosti srčnega utripa glede na odmerek.
English: In vitro plasma protein binding in human plasma was on average 94%.
Slovenian: Vezava na plazemske beljakovine v človeški plazmi in vitro je bila v povprečju 94 %.
English: Umeclidinium is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Slovenian: Umeklidinij je dolgodelujoč antagonist muskarinskih receptorjev (imenovani tudi antiholinergiki).
English: Other medicinal products for COPD
Slovenian: Druga zdravila za KOPB
English: It is unknown whether umeclidinium or vilanterol are excreted in human milk.
Slovenian: Ni znano, ali se umeklidinij ali vilanterol pri človeku izloča v materino mleko.
English: There is no relevant use of ANORO ELLIPTA in the paediatric population (under 18 years of age) for the indication of COPD.
Slovenian: Zdravilo ANORO ELLIPTA za indikacijo KOPB v pediatrični populaciji (mlajši od 18 let) nima relevantne uporabe.
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Slovenian: Agonisti adrenergičnih receptorjev beta2 lahko nekaterim bolnikom povzročijo precejšnjo hipokaliemijo, ki lahko izzove neželene kardiovaskularne učinke.
English: Vilanterol 22 mcg (N = 421)
Slovenian: 22 µg vilanterola (N = 421)
English: Administration of umeclidinium/vilanterol may produce paradoxical bronchospasm that may be lifethreatening.
Slovenian: Paradoksni bronhospazem Uporaba kombinacije umeklidinij/vilanterol lahko povzroči paradoksni bronhospazem, ki je lahko smrtno nevaren.
English: Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors on airway smooth muscle.
Slovenian: Umeklidinij deluje bronhodilatacijsko s kompetitivnim zavrtjem vezave acetilholina na muskarinske receptorje gladkih mišic v dihalih.
English: Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine and faeces.
Slovenian: Primarna pot odstranjevanja vilanterola je s presnovo, ki ji sledi izločanje presnovkov v urinu in blatu.
English: Don't open the tray until you are ready to start using your new inhaler.
Slovenian: Ne odpirajte embalaže, dokler niste pripravljeni na začetek uporabe vašega novega inhalatorja.
English: Urinary elimination accounted for 22% of the administered radiolabelled dose by 168 hours (27% of recovered radioactivity).
Slovenian: V urinu se je v obdobju do 168 ur izločilo 22 % uporabljenega radioaktivno označenega odmerka (27 % najdene radioaktivnosti).
English: These include:
Slovenian: Med takimi so:
English: - if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder
Slovenian: če imate povečano prostato, težave pri odvajanju urina ali zaporo v mehurju, če imate epilepsijo,
English: The instructions for use of the inhaler provided below can be used for either the 30-dose inhaler (30 day supply) or the 7-dose inhaler (7 day supply).
Slovenian: Spodaj navedena navodila za uporabo inhalatorja veljajo za inhalator s 30 odmerki (30-dnevna zaloga) in za inhalator s 7 odmerki (7-dnevna zaloga).
English: An approximately 1.4-fold increase in umeclidinium AUC was observed with no effect on vilanterol AUC.
Slovenian: Opazili so približno 1,4-kratno povečanje AUC umeklidinija in nobenega vpliva na AUC
English: Multipack: 90 (3 packs of 30) doses
Slovenian: Skupno pakiranje: 90 odmerkov - 3 x 30 odmerkov
English: Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use.
Slovenian: Inhalator hranite v zaprti embalaži za zagotovitev zaščite pred vlago in jo odprite šele tik pred prvo uporabo.
English: Vilanterol is a substrate of cytochrome P450 3A4 (CYP3A4).
Slovenian: Vilanterol je substrat citokroma P450 3A4 (CYP3A4).
English: 2 years In-use shelf-life after opening the tray: 6 weeks
Slovenian: 2 leti Rok uporabnosti po prvem odprtju: 6 tednov.
English: In nonclinical studies with umeclidinium and vilanterol, alone and in combination, findings were those typically associated with the primary pharmacology of either muscarinic receptor antagonists or beta2-adrenergic agonists respectively and/or local irritancy.
Slovenian: Izsledki nekliničnih študij z umeklidinijem in vilanterolom, uporabljenima posamično ali v kombinaciji, so bili takšni, kot so značilno povezani s primarno farmakologijo antagonistov muskarinskih receptorjev ali agonistov adrenergičnih receptorjev beta2 in/ali lokalnim draženjem.
English: It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Slovenian: M3 človeških muskarinskih receptorjev in vitro je njegovo delovanje počasi reverzibilno, in vivo pa je dolgotrajno, če je v predkliničnih modelih uporabljen neposredno na pljučih.
English: Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (beta2-adrenergic agonist).
Slovenian: Vilanterol je selektiven, dolgodelujoč agonist adrenergičnih receptorjev beta2 (beta2 adrenergični agonist).
English: ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Slovenian: Zdravilo ANORO ELLIPTA se uporablja za zdravljenje kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
English: Upon initiation of treatment with umeclidinium/vilanterol plasma glucose should be monitored more closely in diabetic patients.
Slovenian: Po uvedbi zdravljenja s kombinacijo umeklidinij/vilanterol je treba sladkornim bolnikom natančneje kontrolirati glukozo v plazmi.
English: In the event of deterioration of COPD during treatment with umeclidinium/vilanterol, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Slovenian: Če se stanje KOPB med zdravljenjem s kombinacijo umeklidinij/vilanterol poslabša, je treba znova oceniti tako bolnika kot shemo zdravljenja KOPB.
English: ANORO ELLIPTA demonstrated improvements in lung function (as defined by change from baseline in trough FEV1) in several studies.
Slovenian: Zdravilo ANORO ELLIPTA je izboljšalo pljučno funkcijo (opredeljeno kot spremembo najnižjega FEV1 od izhodišča) v več kliničnih študijah.
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT), 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate/severe exacerbations in the prior 12 months were randomised (1:2:2) to receive umeclidinium/vilanterol (UMEC/VI 55/22 micrograms), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 92/55/22 micrograms), or fluticasone furoate/vilanterol (FF/VI 92/22 micrograms) administered once daily as a single inhaler.
Slovenian: V randomizirani, dvojno slepi 52-tedenski študiji (CTT116855, IMPACT), ki je zajela 10.355 odraslih bolnikov s simptomatsko KOPB in anamnezo 1 ali več zmernih/hudih poslabšanj v predhodnih 12 mesecih, so bolnike randomizirali (1:2:2) tako, da so prejemali umeklidinij/vilanterol (UMEC/VI 55/22 mikrogramov), flutikazonfuroat/umeklidinij/vilanterol (FF/UMEC/VI 92/55/22 mikrogramov) ali flutikazonfuroat/vilanterol (FF/VI 92/22 mikrogramov) enkrat na dan v enem inhalatorju.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with P-gp inhibitors.
Slovenian: Glede na velikost teh sprememb ni pričakovati klinično pomembnih medsebojnih delovanj zdravil, če je kombinacija umeklidinij/vilanterol uporabljena sočasno z zaviralci P-gp.
English: Barnard Castle, County Durham DL12 8DT United Kingdom
Slovenian: County Durham DL12 8DT
English: From the three active-comparator studies in patients with symptomatic COPD, the risk of a moderate/severe COPD exacerbation compared with tiotropium was reduced by 50% in one study (HR 0.5; 95% CI: 0.3, 1.0; p=0.044).
Slovenian: V treh študijah z aktivno primerjalno učinkovino pri bolnikih s simptomatsko KOPB se je tveganje za zmerno/hudo poslabšanje KOPB v primerjavi s tiotropijem v eni študiji zmanjšalo za 50 % (ROg 0,5; 95 % IZ: 0,3; 1,0, p = 0,044).
English: If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Slovenian: Če inhalator hranite v hladilniku, naj bo na sobni temperaturi vsaj eno uro, preden ga uporabite.
English: If you stop using ANORO ELLIPTA
Slovenian: Če ste prenehali uporabljati zdravilo ANORO ELLIPTA
English: Contents of the pack and other information What ANORO ELLIPTA contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo ANORO ELLIPTA
English: Other medicines and ANORO ELLIPTA
Slovenian: Druga zdravila in zdravilo ANORO ELLIPTA
English: What ANORO ELLIPTA is and what it is used for What ANORO ELLIPTA is
Slovenian: Kaj je zdravilo ANORO ELLIPTA in za kaj ga uporabljamo Kaj je zdravilo ANORO ELLIPTA
English: There are no data from the use of umeclidinium/vilanterol in pregnant women.
Slovenian: O uporabi kombinacije umeklidinij/vilanterol pri nosečnicah ni podatkov.
English: An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual components' actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry mouth, visual accommodation disturbances and tachycardia) or those with overdose of other beta2-adrenergic agonists (e.g. arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
Slovenian: Preveliko odmerjanje kombinacije umeklidinij/vilanterol bo verjetno povzročilo znake in simptome, ki so posledica delovanja vsake od obeh sestavin in so skladni z znanimi neželenimi učinki inhalacijskih muskarinskih antagonistov (npr. suhost ust, motnje akomodacije vida in tahikardija) ter s prevelikim odmerjanjem drugih agonistov adrenergičnih receptorjev beta2 (npr. aritmije, tremor, glavobol, palpitacije,
English: Therefore, umeclidinium/vilanterol should be used with caution in patients with severe cardiovascular disease.
Slovenian: Zato je treba kombinacijo umeklidinij/vilanterol pri bolnikih s hudo kardiovaskularno boleznijo uporabljati previdno.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ANORO ELLIPTA in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Slovenian: ELLIPTA za vse podskupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: ANORO ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing.
Slovenian: Zdravila ANORO ELLIPTA se ne sme uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
English: Inhalation powder, pre-dispensed 1 inhaler of 30 doses
Slovenian: prašek za inhaliranje, odmerjeni 1 inhalator s 30 odmerki.
English: To use ANORO ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler.
Slovenian: Zdravilo ANORO ELLIPTA uporabite tako, da ga s pomočjo inhalatorja ELLIPTA skozi usta vdihnete v pljuča.
English: Animal studies indicate no effects of umeclidinium or vilanterol on fertility.
Slovenian: Študije na živalih ne kažejo, da bi umeklidinij ali vilanterol vplivala na plodnost.
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 24 was greater for ANORO ELLIPTA (58%) compared with placebo (41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).
Slovenian: Delež bolnikov, ki so se odzvali z vsaj minimalno klinično pomembno razliko (MCID) 1 enoto fokalnega seštevka TDI po 24 tednih, je bil večji pri zdravljenju z zdravilom ANORO ELLIPTA (58 %) kot pri dajanju placeba (41 %) ali vsake od obeh sestavin v monoterapiji (53 % za umeklidinij in 51 % za vilanterol).
English: Atrial fibrillation Supraventricular tachycardia Rhythm idioventricular Tachycardia
Slovenian: Srčne bolezni atrijska fibrilacija supraventrikularna tahikardija idioventrikularni ritem tahikardija supraventrikularne ekstrasistole palpitacije občasni občasni občasni občasni občasni občasni
English: Don't use this medicine if you are breast-feeding unless your doctor tells you that you can.
Slovenian: Tega zdravila ne uporabljajte, če dojite, razen če vam zdravnik naroči, da ga lahko uporabljate.
English: Co-administration with ketoconazole (400 mg) in healthy volunteers increased mean vilanterol AUC(0-t) and Cmax, 65% and 22% respectively.
Slovenian: Sočasna uporaba s 400 mg ketokonazola je pri zdravih prostovoljcih povečala povprečno AUC(0-t) vilanterola za 65 % in njegovo Cmax za 22 %.
English: Not for acute use Umeclidinium/vilanterol is not indicated for the treatment of acute episodes of bronchospasm.
Slovenian: Kombinacija umeklidinij/vilanterol ni indicirana za zdravljenje akutnih epizod bronhospazma.
English: White powder in a light grey inhaler (ELLIPTA) with a red mouthpiece cover and a dose counter.
Slovenian: Bel prašek v svetlo sivem inhalatorju (ELLIPTA) z rdečim pokrovčkom ustnika in števcem odmerkov.
English: The comparison of FF/UMEC/VI to FF/VI and UMEC/VI resulted in a statistically significant 14.8% reduction in risk of a moderate/severe exacerbation (based on analysis of time to first exacerbation) (Hazard Ratio 0.85; 95% CI: 0.80, 0.91; p<0.001) and 16.0% reduction in risk of a moderate/severe exacerbation respectively (based on analysis of time to first exacerbation) (Hazard Ratio 0.84; 95% CI: 0.78, 0.91; p<0.001).
Slovenian: Primerjava FF/UMEC/VI s FF/VI oziroma UMEC/VI je pokazala statistično značilno 14,8-odstotno zmanjšanje tveganja za zmerno/hudo poslabšanje (na podlagi analize časa do prvega poslabšanja) (razmerje ogroženosti 0,85; 95 % IZ: 0.80; 0,91, p<0,001) oziroma 16,0-odstotno zmanjšanje tveganja za zmerno/hudo poslabšanje (na podlagi analize časa do prvega poslabšanja) (razmerje ogroženosti 0,84; 95 % IZ: 0,78, 0,91,
English: Umeclidinium/vilanterol is a combination inhaled long-acting muscarinic receptor antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA).
Slovenian: Umeklidinij/vilanterol je kombinacija inhalacijskega dolgodelujočega antagonista muskarinskih receptorjev in dolgodelujočega agonista adrenergičnih receptorjev beta2 (LAMA/LABA).
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered radioactivity) was excreted in faeces by 192 hours post-dose.
Slovenian: Po intravenski uporabi se je približno 58 % uporabljenega radioaktivno označenega odmerka (oziroma 73 % najdene radioaktivnosti) pojavilo v blatu do
English: Umeclidinium/vilanterol has not been evaluated in patients with severe hepatic impairment.
Slovenian: Kombinacije umeklidinij/vilanterol niso ocenili pri bolnikih s hudo okvaro jeter.
English: Use ANORO ELLIPTA regularly
Slovenian: Zdravilo ANORO ELLIPTA uporabljajte redno
English: • swelling, sometimes of the face or mouth (angioedema)
Slovenian: • otekanje, včasih obraza ali ust (angioedem), • piskanje, kašelj ali težave pri dihanju,
English: ELLIPTA has not been studied in patients with severe hepatic impairment and should be used with caution.
Slovenian: Uporaba zdravila ANORO ELLIPTA ni raziskana pri bolnikih s hudo okvaro jeter, zato ga je pri takšnih bolnikih treba uporabljati previdno.
English: The recommended dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily.
Slovenian: Priporočeni odmerek je ena inhalacija zdravila ANORO ELLIPTA 55/22 mikrogramov enkrat na dan.
English: Hyperglycaemia Beta2-adrenergic agonists may produce transient hyperglycemia in some patients.
Slovenian: Agonisti adrenergičnih receptorjev beta2 lahko pri nekaterih bolnikih povzročijo prehodno hiperglikemijo.
English: Following intravenous administration to healthy volunteers, the mean volume of distribution was 86 litres.
Slovenian: Povprečni volumen porazdelitve po intravenski uporabi je bil pri zdravih prostovoljcih 86 litrov.
English: ANORO ELLIPTA 55/22 micrograms also showed statistically significant improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 in the first study (inspiratory capacity: 237 ml and 316 ml respectively, residual volume: -466 ml and -643 ml respectively and functional residual capacity: -351 ml and -522 ml respectively; all p<0.001).
Slovenian: Zdravilo ANORO ELLIPTA 55/22 mikrogramov je v prvi študiji v primerjavi s placebom po 12 tednih tudi statistično značilno izboljšalo spremembo od izhodišča v merah pljučnega volumna pri najnižji koncentraciji in 3 ure po odmerku (inspiratorna kapaciteta: 237 ml oziroma 316 ml, rezidualni volumen: -466 ml oziroma643 ml in funkcionalna rezidualna kapaciteta: -351 ml oziroma -522 ml, vse p < 0,001).
English: Following intravenous administration to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Slovenian: Povprečni volumen porazdelitve po intravenski uporabi je bil pri zdravih prostovoljcih v stanju dinamičnega ravnovesja 165 litrov.
English: If possible, show them the inhaler, the package or this leaflet.
Slovenian: Če je mogoče, mu pokažite inhalator zdravila ANORO ELLIPTA, ovojnino ali to navodilo.
English: There are no data on the effects of umeclidinium/vilanterol on human fertility.
Slovenian: Podatkov o vplivu kombinacije umeklidinij/vilanterol na plodnost pri človeku ni.
English: Excipient with known effect Each delivered dose contains approximately 25 mg of lactose (as monohydrate).
Slovenian: En oddani odmerek vsebuje približno 25 mg laktoze (v obliki laktoze monohidrata).
English: Following inhaled administration of vilanterol in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Slovenian: Pri zdravih prostovoljcih je bila Cmax po inhaliranju vilanterola dosežena v 5 do 15 minutah.
English: The maximum dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily.
Slovenian: Največji odmerek je ena inhalacija zdravila ANORO ELLIPTA 55/22 mikrogramov enkrat na dan.
English: Concomitant administration of strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin) may inhibit the metabolism of, and increase the systemic exposure to, vilanterol.
Slovenian: ketokonazola, klaritromicina, itrakonazola, ritonavirja, telitromicina) lahko zavre presnovo vilanterola in poveča sistemsko izpostavljenost temu zdravilu.
English: When given subcutaneously there were no effects at 36-times the human clinical exposure of vilanterol 22 micrograms, based on AUC.
Slovenian: Subkutano dajanje ni povzročilo učinkov ob izpostavljenosti, ki je bila na osnovi AUC 36-kratnik klinične izpostavljenosti pri človeku z odmerkom 22 mikrogramov vilanterola.
English: Mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo was 224 ml (p<0.001∗) at Week 24.
Slovenian: Po 24 tednih je bilo povprečno največje izboljšanje FEV1 v prvih 6 urah po uporabi odmerka v primerjavi s placebom za 224 ml (p < 0.001∗).
English: In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
Slovenian: Študije in vitro so pokazale, da se umeklidinij presnavlja predvsem s citokromom P450 2D6 (CYP2D6) in da je substrat transporterja P-glikoproteina (P-gp).
English: Co-administration of umeclidinium/vilanterol with other long-acting muscarinic antagonists, long-acting beta2-adrenergic agonists or medicinal products containing either of these agents has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions (see sections 4.4 and 4.9).
Slovenian: Sočasne uporabe kombinacije umeklidinij/vilanterol in drugih dolgodelujočih muskarinskih antagonistov, dolgodelujočih agonistov adrenergičnih receptorjev beta2 ali zdravil, ki vsebujejo katero od teh učinkovin, niso preučevali in zato te uporabe ne priporočajo, ker lahko poveča znane neželene učinke inhalacijskih muskarinskih antagonistov ali agonistov adrenergičnih receptorjev beta2 (glejte poglavji 4.4 in 4.9).