FrancophonIA/ELRC3.0 huggingface dataset:
English: These belong to a group of medicines called bronchodilators.
Slovenian: Učinkovini spadata v skupino zdravil, ki jih imenujemo bronhodilatatorji.
English: - if you are allergic to umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na umeklidinij, vilanterol ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: You only need to inhale once a day because the effect of this medicine lasts for 24 hours.
Slovenian: Ena inhalacija zdravila na dan zadostuje, ker učinki zdravila trajajo 24 ur.
English: COPD is a long-term condition characterised by breathing difficulties that slowly get worse.
Slovenian: KOPB je dolgotrajna bolezen, za katero so značilne težave z dihanjem, ki se počasi slabšajo.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika zdraviti podporno in ga po potrebi ustrezno spremljati.
English: Other antimuscarinics and sympathomimetics
Slovenian: Druga antimuskarinska zdravila in simpatikomimetiki
English: These studies were not specifically designed to evaluate the effect of treatments on COPD exacerbations and patients were withdrawn from the study if an exacerbation occurred.
Slovenian: Te študije niso bile posebej načrtovane za oceno učinka zdravljenja na poslabšanja KOPB in v primeru poslabšanja so bolnike umaknili iz študije.
English: There was no attenuation of the bronchodilator effect over time.
Slovenian: Bronhodilatacijski učinek se s časom ni zmanjševal.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10);
Slovenian: Pogostnost neželenih učinkov je opredeljena z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti
English: Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Slovenian: Bolniki s klinično pomembnimi neurejenimi kardiovaskularnimi boleznimi niso bili vključeni v klinične študije.
English: Treatment difference1 (95% confidence intervals, p-value) Trough FEV1 (ml)
Slovenian: Razlika zdravljenj1 (95% interval zaupanja, p-vrednost) Najnižji FEV1 (ml)
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs.
Slovenian: To zdravilo prepreči skrčenje teh mišic v pljučih ter s tem olajša vdihavanje in izdihavanje zraka.
English: No dose adjustment is required in patients over 65 years.
Slovenian: Bolnikom, starejšim od 65 let, odmerka ni treba prilagoditi.
English: Improvement in EET compared with placebo was seen at Day 2 and was sustained at Week 6 and Week 12.
Slovenian: Izboljšanje EET v primerjavi s placebom je bilo opazno že drugi dan in se je ohranilo 6. in 12. teden.
English: Tell your doctor or pharmacist if you are taking any of these.
Slovenian: Zdravniku ali farmacevtu povejte, če jemljete katero od teh zdravil.
English: • increase of the measured eye pressure
Slovenian: • povišan izmerjeni očesni tlak,
English: The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed in the integration of five 24-week studies and in the 12-month safety study.
Slovenian: Pogostnosti, pripisane neželenim učinkom, navedenim v spodnji preglednici, vključujejo grobe incidenčne stopnje, ugotovljene z združitvijo podatkov petih 24-tedenskih študij in 12-mesečne študije varnosti.
English: (<1/10,000) and not known (cannot be estimated from available data).
Slovenian: in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Use of rescue medication3
Slovenian: Uporaba rešilnega zdravila3
English: Use of rescue medication
Slovenian: Uporaba rešilnega zdravila
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Slovenian: (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000)
English: ANORO ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation.
Slovenian: Zdravilo ANORO ELLIPTA je treba uporabljati vsak dan ob istem času, za ohranjanje bronhodilatacije.
English: If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:
Slovenian: Če se simptomi KOPB (težko dihanje, piskajoče dihanje, kašelj) ne izboljšajo ali se poslabšajo ali če uporabljate svoj hitrodelujoči inhalator pogosteje:
English: Use this medicine for as long as your doctor recommends.
Slovenian: To zdravilo uporabljajte toliko časa, kot vam priporoča vaš zdravnik.
English: • difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention.
Slovenian: • težave in bolečina pri uriniranju - to so lahko znaki obstrukcije sečnega mehurja ali zastoja urina.
English: Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju, embalaži ali inhalatorju poleg oznake »EXP«.
English: Immediate breathing difficulties after using ANORO ELLIPTA are rare.
Slovenian: Takojšnje težko dihanje po uporabi zdravila ANORO ELLIPTA je redko.
English: Metabolic and transporter based interactions
Slovenian: Presnovne interakcije in interakcije na podlagi transporterjev
English: Following oral administration of radiolabelled vilanterol, mass balance showed 70% of the radiolabel in urine and 30% in faeces.
Slovenian: Po peroralni uporabi radioaktivno označenega vilanterola je masno ravnotežje pokazalo 70 % radioaktivnega označenja v urinu in 30 % v blatu.
English: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Slovenian: Prenehajte uporabljati to zdravilo in nemudoma poiščite zdravniško pomoč, ker gre lahko za resno stanje, imenovano paradoksni bronhospazem.
English: SGRQ Total Score
Slovenian: SGRQ Celotni seštevek
English: It is not known whether the ingredients of ANORO ELLIPTA can pass into breast milk.
Slovenian: Ni znano, ali lahko sestavine zdravila ANORO ELLIPTA prehajajo v materino mleko.
English: Pooled data from Study DB2113360 and Study DB2113374
Slovenian: Združeni podatki študije DB2113360 in študije DB2113374
English: Concurrent use of either non-selective or selective beta-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Slovenian: Sočasni uporabi z zaviralci adrenergičnih receptorjev beta (tako neselektivnih kot selektivnih) se je treba izogibati, razen če obstajajo nujni razlogi za njihovo uporabo.
English: Toxicity to reproduction
Slovenian: Reproduktivna toksičnost
English: The other ingredients are lactose monohydrate (see section 2 under ‘ANORO ELLIPTA contains lactose') and magnesium stearate.
Slovenian: Drugi sestavini zdravila sta laktoza monohidrat (glejte poglavje 2 "Zdravilo ANORO ELLIPTA vsebuje laktozo") in magnezijev stearat.
English: Umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.
Slovenian: Kombinacija umeklidinij/vilanterol nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: If you forget to use ANORO ELLIPTA Don't inhale an extra dose to make up for a forgotten dose.
Slovenian: Če ste pozabili uporabiti zdravilo ANORO ELLIPTA Ne vdihnite dodatnega odmerka, da bi nadomestili pozabljenega.
English: Umeclidinium/vilanterol should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Slovenian: Kombinacijo umeklidinij /vilanterol se sme med nosečnostjo uporabljati le, če je pričakovana korist za mater večja od možnega tveganja za plod.
English: A decision must be made whether to discontinue breast-feeding or to discontinue umeclidinium/vilanterol therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja s kombinacijo umeklidinij/vilanterol, upoštevajoč koristi dojenja za otroka in koristi zdravljenja za žensko.
English: The mean annual rate of exacerbations was 0.91, 1.07 and 1.21 for FF/UMEC/VI, FF/VI, and UMEC/VI respectively.
Slovenian: Povprečni letni delež poslabšanj je bil 0,91; 1,07 oziroma 1,21 za FF/UMEC/VI, FF/VI oziroma UMEC/VI.
English: If you think this applies to you, don't use this medicine until you have checked with your doctor.
Slovenian: Če menite, da omenjeno velja za vas, ne uporabite zdravila, dokler se ne posvetujete s svojim zdravnikom.
English: A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium and vilanterol were similar between COPD patients 65 years and older and those younger than 65 years of age.
Slovenian: Analiza populacijske farmakokinetike je pokazala, da sta farmakokinetika umeklidinija in farmakokinetika vilanterola pri bolnikih s KOPB, starih 65 let ali več, podobni kot pri bolnikih, mlajših od 65 let.
English: If you have any of the following symptoms after taking ANORO ELLIPTA stop using this medicine and tell your doctor immediately.
Slovenian: Če imate po jemanju zdravila ANORO ELLIPTA katerega koli od naslednjih simptomov, zdravilo takoj nehajte uporabljati in nemudoma obvestite svojega zdravnika.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobnejše informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: TDI Focal Score
Slovenian: TDI Fokalni seštevek
English: EU/1/14/898/001 1 inhaler of 7 doses EU/1/14/898/002 1 inhaler of 30 doses
Slovenian: EU/1/14/898/001 1 inhalator s 7 odmerki EU/1/14/898/002 1 inhalator s 30 odmerki
English: Step-by-step instructions What is the inhaler?
Slovenian: Navodila za uporabo Kaj je inhalator?
English: Caution should be exercised when umeclidinium/vilanterol is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Slovenian: Previdnost je potrebna, če je kombinacija umeklidinij/vilanterol uporabljena z drugimi zdravili, ki tudi lahko povzročijo hipokaliemijo (glejte poglavje 4.5).
English: Plasma clearance following intravenous administration was 151 litres/hour.
Slovenian: Plazemski očistek po intravenski uporabi je bil 151 litrov/uro.
English: It will only be effective as long as you are using it. Don't stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.
Slovenian: Čeprav se počutite bolje, ne nehajte uporabljati zdravila, če vam tega ne svetuje vaš zdravnik, kajti simptomi se vam lahko poslabšajo.
English: Don't use ANORO ELLIPTA if you already use these medicines.
Slovenian: Ne uporabite zdravila ANORO ELLIPTA, če ste že vzeli katero od teh zdravil.
English: Talk to your doctor before using this medicine: - if you have asthma (Don't use ANORO ELLIPTA to treat asthma)
Slovenian: Pred začetkom uporabe tega zdravila se posvetujte z zdravnikom: če imate astmo (zdravila ANORO ELLIPTA ne uporabljajte za zdravljenje astme),
English: Uncommon side effects (may affect up to 1 in 100 people): • skin rash (hives) or redness
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): • kožni izpuščaj (koprivnica) ali rdečina.
English: A population pharmacokinetic analysis showed that no dose adjustment is required for umeclidinium or vilanterol based on the effect of age, race, gender, inhaled corticosteroid use, or weight.
Slovenian: Analiza populacijske farmakokinetike je pokazala, da odmerka umeklidinija ali vilanterola ni treba prilagoditi glede na starost, raso, spol, uporabo inhalacijskih kortikosteroidov ali telesno maso.
English: The results were similar to those for the ANORO ELLIPTA dose and provided additional supportive evidence for the efficacy of ANORO ELLIPTA.
Slovenian: Rezultati so bili podobni rezultatom z odmerkom v zdravilu ANORO ELLIPTA in dodatno potrjujejo učinkovitost zdravila ANORO ELLIPTA.
English: The inhaler contains two aluminium foil laminate blisters of 7 or 30 doses.
Slovenian: Inhalator vsebuje dva pretisna omota iz aluminijaste laminatne folije s 7 ali 30 odmerki.
English: It is unlikely that ANORO ELLIPTA will affect your ability to drive or use machines.
Slovenian: Ni verjetno, da bi zdravilo ANORO ELLIPTA vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: The primary endpoint was annual rate of on-treatment moderate and severe exacerbations in subjects treated with FF/UMEC/VI compared with FF/VI and UMEC/VI.
Slovenian: Primarni opazovani dogodek je bil letni delež zmernih in hudih poslabšanj med zdravljenjem pri bolnikih, zdravljenih s FF/UMEC/VI v primerjavi s FF/VI oziroma UMEC/VI.
English: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland GlaxoSmithKline (Ireland) Limited logo
Slovenian: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irska GlaxoSmithKline (Ireland) Limited logo
English: Following repeat dosing of inhaled vilanterol, steady state was achieved within 6 days with up to 2.4-fold accumulation.
Slovenian: Po večkratnem odmerjanju inhaliranega vilanterola je bilo stanje dinamičnega ravnovesja doseženo v 6 dneh; kopičenje je bilo do 2,4-kratno.
English: Following oral inhalation both compounds act locally on airways to produce bronchodilation by separate mechanisms.
Slovenian: Po peroralni inhalaciji obe sestavini delujeta lokalno na dihala in po ločenih mehanizmih povzročita bronhodilatacijo.
English: A study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium.
Slovenian: Študija slabih metabolizatorjev s CYP2D6 ni pokazala klinično pomembnega vpliva genetskega polimorfizma CYP2D6 na sistemsko izpostavljenost umeklidiniju.
English: 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.
Slovenian: V študijah genotoksičnosti vilanterol (v obliki alfa-fenil-cinamata) in 3-fenil ocetna kislina za človeka nista bila genotoksična, kar kaže na to, da vilanterol (v obliki trifenatata) ne predstavlja genotoksične nevarnosti za človeka.
English: Medicinal products containing beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol.
Slovenian: Zdravila, ki vsebujejo zaviralce adrenergičnih receptorjev beta, lahko oslabijo ali antagonizirajo učinek agonistov adrenergičnih receptorjev beta2, kakršen je vilanterol.
English: 55 micrograms/22 micrograms
Slovenian: 55 mikrogramov/22 mikrogramov
English: Placebo (N = 280) ANORO ELLIPTA (N =
Slovenian: s placebom (N = 280) ANORO ELLIPTA (N =
English: Improvements in TDI focal score compared with each monotherapy component and tiotropium were not statistically significant (see Table 1).
Slovenian: Izboljšanje fokalnega seštevka TDI v primerjavi z vsako od sestavin v monoterapiji in v primerjavi s tiotropijem ni bilo statistično značilno (glejte preglednico 1).
English: Exercise endurance and lung volumes
Slovenian: Obremenitvena vzdržljivost in pljučni volumen
English: Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant after administration of vilanterol (see section 5.3).
Slovenian: Študije na živalih so po uporabi vilanterola pokazale toksične učinke na sposobnost razmnoževanja pri izpostavljenostih, ki niso klinično pomembne (glejte poglavje 5.3).
English: The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
Slovenian: Ustnik namestite med ustnici in ju nato trdno stisnite okrog njega.
English: The increase in vilanterol exposure was not associated with an increase in beta-adrenergic agonist related systemic effects on heart rate, blood potassium or QT interval (corrected using the Fridericia method).
Slovenian: Večje izpostavljenosti vilanterolu ni spremljalo povečanje z agonistom adrenergičnih receptorjev beta povezanih sistemskih učinkov na srčno frekvenco, raven kalija v krvi ali interval QT (korigiran po Fridericijevi metodi).
English: Both umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp).
Slovenian: Umeklidinij in vilanterol sta substrata P-glikoproteinskega transporterja (P-gp).
English: It is a quinuclidine derivative with activity across multiple muscarinic receptor subtypes.
Slovenian: Je derivat kvinuklidina, ki deluje na številnih podtipih muskarinskih receptorjev.
English: Umeclidinium/vilanterol should not be used in patients with asthma since it has not been studied in this patient population.
Slovenian: Kombinacije umeklidinij/vilanterol se ne sme uporabljati pri bolnikih z astmo, ker ta kombinacija pri tej populaciji bolnikov ni raziskana.
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 1.8-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 1,8-kratno.
English: • decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).
Slovenian: • zmanjšan vid ali bolečina v očeh zaradi povišanega tlaka (možni znaki glavkoma),
English: Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Anoro Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Slovenian: Opazovalna kohortna raziskava za določitev incidence in primerjalne varnosti za izbrane kardiovaskularne in cerebrovaskularne dogodke pri bolnikih s KOPB z zdravilom Anoro Ellipta v primerjavi s tiotropijem (raziskava 201038), po porotokolu, ki ga je potrdil PRAC.
English: The ELLIPTA inhaler contains pre-dispensed doses and is ready to use.
Slovenian: Inhalator Ellipta vsebuje odmerjene odmerke in je pripravljen za uporabo.
English: What you need to know before you use ANORO ELLIPTA Do not use ANORO ELLIPTA:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo ANORO ELLIPTA Ne uporabljajte zdravila ANORO ELLIPTA:
English: In the other two active-comparator studies, a similar proportion of patients achieved at least the MCID with ANORO ELLIPTA and tiotropium; 49% and 54% for ANORO ELLIPTA 55/22 micrograms and 52% and 55% for tiotropium.
Slovenian: V drugih dveh študijah z aktivno primerjalno učinkovino je podoben delež bolnikov dosegel vsaj MCID z zdravilom ANORO ELLIPTA kot s tiotropijem: 49 % oz. 54 % z zdravilom ANORO ELLIPTA 55/22 mikrogramov in 52 % oz. 55 % s tiotropijem.
English: If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost.
Slovenian: Če pokrovček inhalatorja odprete in zaprete, ne da bi vdihnili zdravilo, bo odmerek izgubljen.
English: If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).
Slovenian: Če se vam pojavi tak napad, morate uporabiti hitrodelujoči inhalator za olajšanje (kot je salbutamol).
English: ANORO ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo ANORO ELLIPTA je indicirano za vzdrževalno bronhodilatacijsko zdravljenje za olajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
English: Eye problems during treatment with ANORO ELLIPTA
Slovenian: Težave z očmi med zdravljenjem z zdravilom ANORO ELLIPTA
English: If you become wheezy or breathless, use your quick-acting reliever inhaler (such as salbutamol), then seek medical advice.
Slovenian: Če se vam pojavi piskajoče ali težko dihanje, uporabite svoj hitrodelujoči inhalator za olajšanje (kot je salbutamol) in nato poiščite zdravniški nasvet.
English: The safety profile of ANORO ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Slovenian: Varnostne značilnosti zdravila ANORO ELLIPTA temeljijo na izkušnjah z varnostjo kombinacije umeklidinij/vilanterol in s posameznima sestavinama iz programa kliničnega razvoja, ki je zajel 6.855
English: Umeclidinium 55 mcg (N = 418)
Slovenian: 55 µg umeklidinija (N = 418)
English: When you take the inhaler out of its tray, it will be in the ‘closed' position.
Slovenian: Ko inhalator vzamete iz embalaže, je v položaju "zaprto".
English: The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium and vilanterol was assessed in healthy volunteers.
Slovenian: Vpliv verapamila, zmernega zaviralca P-gp, v odmerku 240 mg enkrat na dan, na farmakokinetiko umeklidinija in vilanterola v stanju dinamičnega ravnovesja so ocenili pri zdravih prostovoljcih.
English: Umeclidinium/vilanterol should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Slovenian: Kombinacijo umeklidinij/vilanterol je potrebno previdno uporabljati pri bolnikih s konvulzivnimi motnjami ali tirotoksikozo ter pri bolnikih, ki so neobičajno odzivni na agoniste adrenergičnih receptorjev beta2.
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution (see section 4.4).
Slovenian: Sočasno hipokaliemično zdravljenje z metilksantinskimi derivati, steroidi ali diuretiki, ki ne ohranjajo kalija, lahko stopnjuje možni hipokaliemični učinek agonistov adrenergičnih receptorjev beta2, zato je pri uporabi potrebna previdnost (glejte poglavje 4.4).
English: In the second study, the treatment difference in EET between ANORO ELLIPTA 55/22 micrograms and placebo was 21.9 seconds (p=0.234) at Week 12.
Slovenian: V drugi študiji je bila razlika EET med zdravilom ANORO ELLIPTA 55/22 mikrogramov in placebom 21,9 sekunde (p = 0,234) v 12. tednu.
English: ANORO ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Slovenian: Zdravilo ANORO ELLIPTA je zmanjšalo uporabo rešilnega zdravila s salbutamolom tekom 1.-24. tedna v primerjavi s placebom in umeklidinijem (glejte preglednico 1) ter je doseglo zvišanje deleža dni glede na izhodišče, ko ni bilo treba uporabiti rešilnega zdravila (v povprečju 11,1 %) v primerjavi z znižanjem deleža glede na izhodišče pri placebu (v povprečju 0,9 %).
English: Following oral administration to healthy male volunteers, total radioactivity was excreted primarily in faeces (92% of the administered radiolabelled dose or 99% of the recovered radioactivity) by 168 hours post-dose.
Slovenian: Po peroralni uporabi pri zdravih moških prostovoljcih se je celotna radioaktivnost v 168 urah po odmerku izločila v prvi vrsti v blatu (92 % uporabljenega radioaktivno označenega odmerka in 99 % najdene radioaktivnosti).
English: If you use more ANORO ELLIPTA than you should
Slovenian: Če ste uporabili večji odmerek zdravila ANORO ELLIPTA, kot bi smeli