FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substances are present as a white powder in separate blister strips inside the inhaler.
Slovenian: Zdravilne učinkovine so v inhalatorju prisotne kot bel prašek v ločenih pretisnih trakovih.
English: Co-administration increased mean vilanterol AUC(0-t) and Cmax by 65% and 22%, respectively.
Slovenian: Sočasna uporaba je povečala povprečno AUC(0-t) vilanterola za 65 % in njegovo Cmax za 22 %.
English: • Remove the inhaler from the mouth.
Slovenian: • Inhalator naj vzame iz ust.
English: Fluticasone furoate/umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.
Slovenian: 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.
English: The effects of race, gender and weight on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were also evaluated in the population pharmacokinetic analysis.
Slovenian: Vpliv rase, spola in telesne mase na farmakokinetiko flutikazonfuroata, umeklidinija in vilanterola so ocenili v populacijski farmakokinetični analizi.
English: Multipacks containing 90 (3 inhalers of 30) doses (90 day supply) are also available.
Slovenian: Na voljo so tudi pakiranja z več inhalatorji, ki vsebujejo 90 (3 inhalatorji po 30) odmerkov (zaloga za 90 dni).
English: However, studies have been conducted with fluticasone furoate/vilanterol and umeclidinium/vilanterol.
Slovenian: Toda izvedli so študije s kombinacijama flutikazonfuroat/vilanterol in umeklidinij/vilanterol.
English: Use Trelegy Ellipta regularly
Slovenian: Zdravilo Trelegy Ellipta uporabljajte redno
English: The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption.
Slovenian: Absolutna biološka uporabnost inhaliranega vilanterola je bila 27 %; prispevek peroralne absorpcije je bil zanemarljiv.
English: In COPD the muscles around the airways tighten, making breathing difficult.
Slovenian: Pri KOPB se mišice, ki obdajajo dihalne poti, skrčijo in tako povzročijo težko dihanje.
English: Pack sizes of 14 or 30 dose inhalers.
Slovenian: Velikost pakiranja je inhalator s 14 ali 30 odmerki.
English: 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.
Slovenian: 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.
English: Fluticasone furoate had no adverse effect on pre- or post-natal development in rats.
Slovenian: Flutikazonfuroat ni škodljivo vplival na pre- in postnatalni razvoj pri podganah.
English: Other medicines and Trelegy Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Toda izvedene so bile študije s kombinacijama flutikazonfuroat/vilanterol in umeklidinij/vilanterol; te študije niso pokazale večje sistemske izpostavljenosti flutikazonfuroatu, umeklidiniju ali vilanterolu.
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Astma
English: 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).
Slovenian: Mehanizem delovanja Kombinacija flutikazonfuroat/umeklidinij/vilanterol je kombinacija inhalacijskega sinteznega kortikosteroida, dolgodelujočega antagonista muskarinskih receptorjev in dolgodelujočega agonista adrenergičnih receptorjev beta2 (IGK/LAMA/LABA).
English: Plasma clearance of vilanterol following intravenous administration was 108 litres/hour.
Slovenian: Plazemski očistek vilanterola je po intravenski uporabi 108 litrov/uro.
English: Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors on airway smooth muscle.
Slovenian: Deluje bronhodilatacijsko s kompetitivnim zavrtjem vezave acetilholina na muskarinske receptorje gladkih mišic dihal.
English: No dosage adjustment is required in patients with mild, moderate or severe hepatic impairment.
Slovenian: Bolnikom z blago, zmerno ali hudo okvaro jeter odmerka ni treba prilagoditi.
English: The effects of age on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were evaluated in the population pharmacokinetic analysis.
Slovenian: Vplive starosti na farmakokinetiko kombinacije flutikazonfuroata, umeklidinija in vilanterola so ocenili v populacijski farmakokinetični analizi.
English: 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).
Slovenian: 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).
English: The primary metabolic routes for vilanterol are O-dealkylation to a range of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity.
Slovenian: Primarna pot presnove vilanterola je O-dealkilacija v številne presnovke z bistveno manjšo agonistično aktivnostjo na adrenergičnih receptorjih beta1 in beta2.
English: The absolute bioavailability of inhaled umeclidinium was on average 13%, with negligible contribution from oral absorption.
Slovenian: Absolutna biološka uporabnost inhaliranega umeklidinija je bila v povprečju 13 %; prispevek peroralne absorpcije je bil zanemarljiv.
English: 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.
Slovenian: Glede na velikost teh sprememb ni pričakovati klinično pomembnih medsebojnih delovanj zdravil, če je kombinacija flutikazonfuroat/umeklidinij/vilanterol uporabljena sočasno z zaviralci P-gp.
English: Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri izpostavljenostih, ki niso klinično pomembne
English: Uncommon side effects These may affect up to 1 in 100 people:
Slovenian: Pojavijo se lahko pri največ 1 od 100 bolnikov:
English: 4) Close the inhaler and rinse your mouth
Slovenian: Zaprite inhalator in si splaknite usta
English: Trelegy Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Slovenian: Zdravilo Trelegy Ellipta vsebuje tri zdravilne učinkovine: flutikazonfuroat, umeklidinij in vilanterol.
English: 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.
Slovenian: 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.
English: The apparent plasma elimination half-life of fluticasone furoate following inhaled administration of fluticasone furoate/vilanterol was, on average, 24 hours.
Slovenian: Povprečni navidezni plazemski eliminacijski razpolovni čas flutikazonfuroata po inhalacijski uporabi kombinacije flutikazonfuroat/vilanterol je bil 24 ur.
English: An approximately 1.3-fold increase in umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax.
Slovenian: Pri 16-krat večjem odmerku se je AUC umeklidinija povečala za približno 1,3-krat, vpliva na Cmax umeklidinija pa ni bilo.
English: Eye problems during treatment with Trelegy Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Trelegy Ellipta:
Slovenian: Težave z očmi med zdravljenjem z zdravilom Trelegy Ellipta Če se vam med zdravljenjem z zdravilom Trelegy Ellipta pojavijo bolečine ali nelagodje v očesu, prehodno zamegljen vid, odsevi okrog stvari ali obarvane slike ter pordele oči:
English: In 113 East Asian subjects with COPD (Japanese and East Asian Heritage), who received FF/UMEC/VI from a single inhaler (27% subjects), fluticasone furoate AUC(ss) estimates were on average 30% higher compared with Caucasian subjects.
Slovenian: Ocenjena AUC(0-24) flutikazonfuroata je bila pri 113 preiskovancih s KOPB iz vzhodne Azije (japonskega in jugovzhodnoazijskega porekla), ki so prejemali FF/UMEC/VI v enem inhalatorju (27 % preiskovancev) v povprečju za 30 % večja kot pri belcih.
English: FEV1=forced expiratory volume in 1 second; L=litres; LS=least squares; SE= standard error, N=number in the intent-totreat population; CI= confidence interval, a Statistically significant treatment difference for FF/UMEC/VI vs. BUD/FOR also observed at the other assessment timepoints (weeks 2, 4 and 12).
Slovenian: FEV1 = volumen izdihanega zraka v 1. sekundi forsiranega izdiha; L = liter; mNK = metoda najmanjših kvadratov; SN = standardna napaka, N = število bolnikov v populaciji z namenom zdravljenja; IZ = interval zaupanja, a Statistično značilna razlika med zdravljenjema s kombinacijama FF/UMEC/VI in BUD/FOR je bila opazna tudi v drugih časovnih točkah opazovanja (2., 4. in 12. teden).
English: INFORMATION IN BRAILLE trelegy ellipta
Slovenian: PODATKI V BRAILLOVI PISAVI trelegy ellipta
English: PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek za inhaliranje, odmerjeni.
English: Beta2-adrenergic agonists may produce transient hyperglycaemia in some patients.
Slovenian: Agonisti adrenergičnih receptorjev beta2 lahko nekaterim bolnikom povzročijo prehodno hiperglikemijo.
English: Vision blurred (see section 4.4)
Slovenian: Očesne bolezni zamegljen vid (glejte poglavje 4.4)
English: FEV1= forced expiratory volume in 1 second; L= litres; LS=least squares; SE= standard error; N= number in the intentto-treat population; CI= confidence interval; a Statistically significant treatment differences for FF/UMEC/VI vs. FF/VI and FF/UMEC/VI vs. UMEC/VI were also observed at the other assessment timepoints (Weeks 4, 16, 28, and 40).
Slovenian: FEV1 = volumen izdihanega zraka v 1. sekundi forsiranega izdiha; L = liter; mNK = metoda najmanjših kvadratov; SN = standardna napaka, N = število bolnikov v populaciji z namenom zdravljenja; IZ = interval zaupanja, a Statistično značilne razlike med zdravljenji s kombinacijami FF/UMEC/VI in FF/VI ter FF/UMEC/VI in UMEC/VI so bile opazne tudi v drugih časovnih točkah opazovanja (4.. 16., 28. in 40. teden).
English: What you need to know before you use Trelegy Ellipta
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Trelegy Ellipta
English: Lung function endpoint in FULFIL
Slovenian: Opazovani dogodek pljučne funkcije v študiji FULFIL
English: Fluticasone furoate, umeclidinium and vilanterol did not have any adverse effects on male or female fertility in rats.
Slovenian: Flutikazonfuroat, umeklidinij in vilanterol niso neugodno vplivali na plodnost podganjih samcev ali samic.
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 2-fold accumulation.
Slovenian: Po večkratnem odmerjanju inhaliranega umeklidinija je bilo stanje dinamičnega ravnovesja doseženo v 7 do 10 dneh; kopičenje je bilo od 1,5- do
English: FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Trelegy Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Slovenian: Študija FULFIL (CTT116853) je bila 24 tednov trajajoča študija (N = 1810) s podaljšanjem do 52 tednov v podskupini preiskovancev (n = 430), v kateri so primerjali zdravilo Trelegy Ellipta (92/55/22 mikrogramov) s kombinacijo budezonid/formoterol 400/12 mikrogramov (BUD/FOR) dvakrat na dan.
English: If you store in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use.
Slovenian: Če imate zdravilo shranjeno v hladilniku, ga vsaj eno uro pred uporabo pustite, da se ogreje na sobno temperaturo.
English: Trelegy Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Slovenian: Zdravilo Trelegy Ellipta je treba uporabljati previdno pri bolnikih s pljučno tuberkulozo in pri bolnikih s kroničnimi ali nezdravljenimi okužbami.
English: White powder in a light grey inhaler (Ellipta) with a beige mouthpiece cover and a dose counter.
Slovenian: Bel prašek v svetlosivem inhalatorju (Ellipta) s pokrovčkom ustnika bež barve in števcem odmerkov.
English: In IMPACT, treatment with Trelegy Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
Slovenian: V študiji IMPACT je zdravljenje z zdravilom Trelegy Ellipta zmanjšalo letni delež hudih poslabšanj (tj. poslabšanj, ki so zahtevala sprejem v bolnišnico ali so se končala s smrtnim izidom) za 13 % v primerjavi s FF/VI (95 % IZ: -1, 24; p = 0,064).
English: The inhaler should not be shaken.
Slovenian: Inhalatorja ne sme stresati.
English: Vilanterol had no adverse effect on preor post-natal development in rats.
Slovenian: Vilanterol ni škodljivo vplival na pre- in postnatalni razvoj pri podganah.
English: In IMPACT, Trelegy Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
Slovenian: V študiji IMPACT je zdravilo Trelegy Ellipta značilno izboljšalo (p < 0,001) pljučno funkcijo v primerjavi s kombinacijo FF/VI in UMEC/VI v obdobju 52 tednov (glejte Preglednico 2).
English: There were no effects on development in rats at exposures 6.6fold the human clinical exposure at a daily dose of 92 micrograms, based on AUC.
Slovenian: Pri podganah ni bilo vplivov na razvoj ob izpostavljenostih, ki so bile na podlagi AUC 6,6-kratnik klinične izpostavljenosti pri človeku med uporabo dnevnega odmerka 92 mikrogramov.
English: For further instructions on handling the device, see section 6.6.
Slovenian: Za nadaljnja navodila o ravnanju z inhalatorjem glejte poglavje 6.6. 4.3 Kontraindikacije
English: Trelegy Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Slovenian: Za kaj uporabljamo zdravilo Trelegy Ellipta Zdravilo Trelegy Ellipta uporabljamo za zdravljenje kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
English: Don't use this medicine if you are breastfeeding unless your doctor tells you that you can.
Slovenian: Če dojite, ne uporabljajte tega zdravila, razen če vam zdravnik naroči, da ga lahko uporabljate.
English: Supraventricular tachyarrhythmia Tachycardia
Slovenian: Srčne bolezni supraventrikularna tahiaritmija tahikardija atrijska fibrilacija občasni
English: In vitro plasma protein binding in human plasma was on average 89%.
Slovenian: Vezava na beljakovine v človeški plazmi in vitro je bila v povprečju 89 %.
English: Administration of combined fluticasone furoate, umeclidinium and vilanterol to dogs did not result in any significant new toxicity or any major exacerbation of expected findings associated with fluticasone furoate, umeclidinium or vilanterol alone.
Slovenian: umeklidinija in vilanterola pri psih ni povzročila pomembnih novih toksičnih učinkov; prav tako ni povzročila nobenih večjih poslabšanj pričakovanih izsledkov, povezanih z uporabo samega flutikazonfuroata, umeklidinija ali vilanterola.
English: If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).
Slovenian: Če se vam pojavi takšen napad, morate uporabiti hitrodelujoč inhalator za olajšanje (na primer salbutamol).
English: Fluticasone furoate was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in rats or mice at exposures of 1.4- or 2.9-fold, respectively, those seen in humans at a daily dose of 92 micrograms fluticasone furoate, based on AUC.
Slovenian: Flutikazonfuroat ni bil genotoksičen v standardni skupini študij in ni bil kancerogen v študijah vseživljenjskega vdihavanja pri podganah (1,4-kratnik) ali miših (2,9-kratnik) ob izpostavljenostih, ki so na podlagi AUC podobne kot med uporabo dnevnega odmerka 92 mikrogramov flutikazonfuroata pri človeku.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS)
Slovenian: ZUNANJA OVOJNINA (POSAMIČNA PAKIRANJA)
English: In a total of 1810 patients with advanced COPD (mean post-bronchodilator screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Trelegy Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
Slovenian: predvidenega, standardni odklon (SD) 13 %), od katerih jih je 65 % imelo zmerno/hudo poslabšanje KOPB v letu pred vstopom v študijo (študija CTT116853), so do 24. tedna ugotovili večjo pojavnost pljučnic med prejemniki zdravila Trelegy Ellipta (20 bolnikov, 2 %) kot med prejemniki kombinacije budezonid/formoterol (7 bolnikov, < 1 %).
English: The Ellipta inhaler consists of a light grey body, beige mouthpiece cover and a dose counter, packed into a foil laminate tray containing a desiccant sachet.
Slovenian: Inhalator Ellipta sestavljajo svetlo sivo telo, pokrovček ustnika bež barve in števec odmerkov; inhalator se nahaja v embalaži iz laminatne folije, ki vsebuje vrečko s sušilom.
English: If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use.
Slovenian: Če je zdravilo shranjeno v hladilniku, ga vsaj eno uro pred uporabo pustite zunaj, da se ogreje na sobno temperaturo.
English: In vitro plasma protein binding in human plasma was on average 94%.
Slovenian: Vezava na beljakovine v človeški plazmi in vitro je bila v povprečju 94 %.
English: At weeks 49-52, the treatment difference was -0.28 (95% CI: -0.37, -0.19) when compared with FF/VI and -0.30 (95% CI: -0.41, -0.19) with UMEC/VI.
Slovenian: V tednih 49-52 je bila razlika med zdravljenjema -0,28 (95 % IZ: -0,37, -0,19) v primerjavi s FF/VI in -0,30 (95 % IZ: -0,41, -0,19) v primerjavi z UMEC/VI.
English: In FULFIL, Trelegy Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
Slovenian: V študiji FULFIL je zdravilo Trelegy Ellipta med 1. in 24. tednom značilno bolj zmanjšalo (p < 0,001) uporabo rešilnega zdravila kot BUD/FOR (razlika med zdravljenjema: -0,2 dogodka na dan; 95 % IZ: -0,3,
English: c) Close the inhaler and rinse your mouth
Slovenian: c) Bolnik naj zapre inhalator in si splakne usta
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Trelegy Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
Slovenian: ki so prejemali zdravilo Trelegy Ellipta, pri 5 od 4134 bolnikov (1,7 na 1000 bolnik-let), ki so prejemali kombinacijo flutikazonfuroat/vilanterol in pri 5 od 2070 bolnikov (2,9 na 1000 bolnik-let), ki so prejemali kombinacijo umeklidinij/vilanterol.
English: The step-by-step instructions for use of the inhaler provided below can be used for either the 30-dose (30 day supply) or the 14-dose (14 day supply) Ellipta inhaler.
Slovenian: Spodaj navedena navodila po korakih za uporabo inhalatorja veljajo tako za inhalator Ellipta s 30 odmerki (30-dnevna zaloga) kot za inhalator Ellipta s 14 odmerki (14-dnevna zaloga).
English: In FULFIL, Trelegy Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
Slovenian: V študiji FULFIL je zdravilo Trelegy Ellipta značilno zmanjšalo tveganje za zmerno ali hudo poslabšanje v primerjavi z BUD/FOR v 24 tednih (33 %; 95 % IZ: 12, 48; p = 0,004).
English: Trelegy Ellipta contains lactose
Slovenian: Zdravilo Trelegy Ellipta vsebuje laktozo
English: There are no data on the effects of fluticasone furoate/umeclidinium/vilanterol on human fertility.
Slovenian: Podatkov o vplivu kombinacije flutikazonfuroat/umeklidinij/vilanterol na plodnost pri človeku ni.
English: In IMPACT, Trelegy Ellipta prolonged the time to first moderate/severe exacerbation and significantly decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
Slovenian: V študiji IMPACT je zdravilo Trelegy Ellipta podaljšalo čas do prvega zmernega ali hudega poslabšanja in značilno zmanjšalo (p < 0,001) tveganje za zmerno ali hudo poslabšanje, merjeno s časom do prvega poslabšanja, tako v primerjavi s FF/VI (14,8 %; 95 % IZ: 9,3, 19,9) kot z UMEC/VI (16,0 %; 95% IZ: 9,4,
English: There is no specific treatment for an overdose with Trelegy Ellipta.
Slovenian: Za preveliko odmerjanje zdravila Trelegy Ellipta ni specifičnega zdravljenja.
English: If you are breast-feeding, you must check with your doctor before you use Trelegy Ellipta.
Slovenian: Če dojite, se morate pred uporabo zdravila Trelegy Ellipta posvetovati z zdravnikom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trelegy 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: Your Trelegy Ellipta inhaler carton contains
Slovenian: Škatla vašega inhalatorja Trelegy Ellipta vsebuje
English: Co-administration of Trelegy Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Slovenian: Druge dolgodelujoče antimuskarinske učinkovine in dolgodelujoči agonisti adrenergičnih receptorjev beta2 Sočasna uporaba zdravila Trelegy Ellipta z drugimi dolgodelujočimi muskarinskimi antagonisti ali dolgodelujočimi agonisti adrenergičnih receptorjev beta2 ni raziskana in ni priporočljiva, ker lahko poveča neželene učinke (glejte poglavji 4.8 in 4.9).
English: Comparison Trelegy vs. UMEC/VI
Slovenian: Primerjava zdravila Trelegy z UMEC/VI
English: However, other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk.
Slovenian: Vendar so v materinem mleku ugotovili druge kortikosteroide, muskarinske antagoniste in agoniste adrenergičnih receptorjev beta2.
English: Trelegy Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z zmerno do hudo okvaro jeter je treba zdravilo Trelegy Ellipta uporabljati previdno (glejte poglavji 4.4 in 5.2).