FrancophonIA/ELRC3.0 huggingface dataset:
English: The largest time-matched difference versus placebo was 4.62 ms (90% CI 0.40, 8.85 ms), the largest time-matched decrease was -2.71 ms (90% CI -6.97, 1.54 ms), indicating that Ultibro Breezhaler had no relevant impact on the QT interval, as was expected by the properties of its components.
Slovenian: Pri meritvi ob istem času je bila največja razlika v primerjavi z uporabo placeba 4,62 ms (90-odstotni IZ 0,40, 8,85 ms), največje skrajšanje intervala v primerjavi z uporabo placeba pa je bilo -2,71 ms (90-odstotni IZ -6,97, 1,54 ms), kar kaže na to, da zdravilo Ultibro Breezhaler nima pomembnega vpliva na interval QT, kot je bilo pričakovati že na podlagi lastnosti njegovih učinkovin.
English: Increased heart rates were apparent in dogs at all doses of Ultibro Breezhaler and each monotherapy component.
Slovenian: Pri psih so opažali zvišanje srčne frekvence pri vseh odmerkih zdravila Ultibro Breezhaler in vsake posamezne učinkovine v monoterapiji.
English: What Ultibro Breezhaler is and what it is used for
Slovenian: Kaj je zdravilo Ultibro Breezhaler in za kaj ga uporabljamo
English: At 52 weeks, the reduction compared to fluticasone/salmeterol was statistically significant (LS mean treatment difference -1.3, p=0.003).
Slovenian: Po 52 tednih je bilo znižanje ocene v primerjavi z uporabo kombinacije flutikazon/salmeterol statistično značilno (razlika med obema načinoma zdravljenja po metodi najmanjših kvadratov: -1,3, p=0,003).
English: Ultibro Breezhaler also statistically significantly reduced the annualised rate of all COPD exacerbations (mild, moderate or severe) by 15% as compared to glycopyrronium (p=0.001) and 14% as compared to tiotropium (p=0.002).
Slovenian: Poleg tega je zdravilo Ultibro Breezhaler statistično značilno zmanjšalo letno pogostnost vseh poslabšanj KOPB (blagih, zmernih ali hudih) za 15 % v primerjavi z glikopironijem (p=0,001) in za 14 % v primerjavi s tiotropijem (p=0,002).
English: You may taste the medicine as you inhale.
Slovenian: Med vdihom lahko začutite okus zdravila.
English: The pharmacological effects of beta2-adrenoceptor agonists, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP).
Slovenian: Indakaterol je dolgodelujoči agonist beta-2 adrenergičnih receptorjev, ki se odmerja enkrat na dan. Farmakološko delovanje agonistov beta-2 adrenergičnih receptorjev, med katere sodi tudi indakaterol, je vsaj deloma mogoče pripisati stimulaciji znotrajcelične adenilat-ciklaze, encima, ki katalizira pretvorbo adenozin-trifosfata (ATP) v ciklični adenozin-3',5'-monofosfat (ciklični AMP).
English: Step 2a:
Slovenian: Korak 2a:
English: Read the leaflet before use.
Slovenian: Pred uporabo preberite navodilo za uporabo.
English: Treatment difference
Slovenian: Razlika med načini zdravljenja
English: The combination of indacaterol and glycopyrronium in Ultibro Breezhaler showed a rapid onset of action within 5 minutes after dosing.
Slovenian: Pokazalo se je, da ima kombinacija indakaterola in glikopironija v zdravilu Ultibro Breezhaler hiter začetek delovanja, saj začne delovati že v 5 minutah po odmerjanju.
English: • combination of sore throat and runny nose - these may be signs of nasopharyngitis.
Slovenian: • kombinacija vnetega žrela in izcedka iz nosu - to sta lahko znaka nazofaringitisa
English: In vitro metabolism studies showed consistent metabolic pathways for glycopyrronium bromide between animals and humans.
Slovenian: V študijah presnove in vitro se je pokazalo, da so presnovne poti glikopironijevega bromida enake pri živalih in pri ljudeh.
English: • dental caries.
Slovenian: • zobna gniloba
English: Mean renal clearance of glycopyrronium following inhalation was in the range of 17.4 and 24.4 litres/h.
Slovenian: Po inhaliranju zdravila je povprečni ledvični očistek glikopironija znašal med 17,4 l/h in 24,4 l/h.
English: In vitro investigations further indicated that indacaterol is a low affinity substrate for the efflux pump P-gp.
Slovenian: V in vitro raziskavah so ugotovili tudi, da je indakaterol substrat izlivne črpalke P-gp, a z majhno afiniteto.
English: In vivo, M9 is formed from the swallowed dose fraction of inhaled glycopyrronium bromide.
Slovenian: In vivo M9 nastane iz tiste frakcije inhaliranega glikopironijevega bromida, ki jo oseba pogoltne.
English: Clinically relevant effects of hypokalaemia have not been observed in clinical studies of Ultibro Breezhaler at the recommended therapeutic dose (see section 5.1).
Slovenian: V kliničnih študijah pri uporabi zdravila Ultibro Breezhaler v priporočenem terapevtskem odmerku niso opažali klinično pomembnih učinkov hipokaliemije (glejte poglavje 5.1).
English: Time to first pneumonia was prolonged with Ultibro Breezhaler compared to fluticasone/salmeterol (p=0.013).
Slovenian: Čas do pojava prve pljučnice je bil pri uporabi zdravila Ultibro Breezhaler daljši kot pri uporabi kombinacije flutikazon/salmeterol (p=0,013).
English: A population pharmacokinetic analysis of data in COPD patients after inhalation of Ultibro Breezhaler indicated no significant effect of age, gender and (lean body) weight on the systemic exposure to indacaterol and glycopyrronium.
Slovenian: Populacijska farmakokinetična analiza podatkov pri bolnikih s KOPB je pokazala, da starost, spol in (pusta) telesna masa ne vplivajo na sistemsko izpostavljenost indakaterolu in glikopironiju po inhaliranju zdravila Ultibro Breezhaler.
English: The number of all COPD exacerbations/patient-years was 3.34 for Ultibro Breezhaler (2,893 events), 3.92 for glycopyrronium (3,294 events) and 3.89 for tiotropium (3,301 events).
Slovenian: Število vseh poslabšanj KOPB na bolnika-leto je znašalo 3,34 pri uporabi zdravila Ultibro Breezhaler (2.893 poslabšanj), 3,92 pri uporabi glikopironija (3.294 poslabšanj) in 3,89 pri uporabi tiotropija (3.301 poslabšanj).
English: Indacaterol, one of the active substances in Ultibro Breezhaler, may prevent labour due to its effect on the uterus.
Slovenian: Indakaterol, ki je ena od učinkovin v zdravilu Ultibro Breezhaler, lahko zaradi svojega delovanja na maternico zavira porod.
English: • headache.
Slovenian: • glavobol
English: There were no relevant effects of Ultibro Breezhaler on mean heart rate over 24 h and heart rate assessed after 30 minutes, 4 h and 24 h.
Slovenian: V obdobju 24 ur ni prišlo do pomembnega učinka zdravila Ultibro Breezhaler na povprečno srčno frekvenco, niti na izmerjene frekvence v času 30 minut, 4 ure in 24 ur po odmerjanju.
English: When indacaterol and glycopyrronium are administered together in Ultibro Breezhaler, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve smooth muscle relaxation.
Slovenian: Indakaterol in glikopironij imata pri hkratnem odmerjanju v obliki zdravila Ultibro Breezhaler aditivni učinek, saj z različnima mehanizmoma delujeta na različne receptorje in preko različnih biokemičnih poti omogočata relaksacijo gladkih mišic.
English: In the 52-week study comparing Ultibro Breezhaler (n=1,675) and fluticasone/salmeterol (n=1,679), Ultibro Breezhaler met the primary study objective of non-inferiority in rate of all COPD exacerbations (mild, moderate or severe) compared to fluticasone/salmeterol.
Slovenian: V 52-tedenski študiji, v kateri so primerjali zdravilo Ultibro Breezhaler (n=1.675) in kombinacijo flutikazon/salmeterol (n=1.679) so v okviru primarnega cilja študije dokazali neinferiornost zdravila Ultibro Breezhaler v primerjavi s kombinacijo flutikazon/salmeterol glede vpliva na pogostnost vseh poslabšanj KOPB (blagih, zmernih ali hudih).
English: Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ultibro Breezhaler.
Slovenian: Poročali so o primerih takojšnje preobčutljivostne reakcije po odmerjanju indakaterola oziroma glikopironija, ki sta učinkovini zdravila Ultibro Breezhaler.
English: They have the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap.
Slovenian: Na telesu kapsule imajo pod dvema modrima črtama modro tiskano oznako zdravila “IGP110.50”, na pokrovčku pa črno tiskan zaščitni znak družbe ( ).
English: The inhaler provided with each new prescription should be used.
Slovenian: Vedno je treba uporabiti inhalator, ki je priložen novemu pakiranju zdravila.
English: Pierce and release
Slovenian: • srbenje ali izpuščaj
English: Metabolism and nutrition disorders Hyperglycaemia and diabetes mellitus
Slovenian: Presnovne in prehranske motnje hiperglikemija in sladkorna bolezen pogosti
English: The capsules must always be stored in the original blister to protect from moisture and only removed immediately before use.
Slovenian: Za zagotovitev zaščite pred vlago je treba kapsule vedno shranjevati v originalnem pretisnem omotu in jih vzeti iz njega šele tik pred uporabo.
English: How to inhale Ultibro Breezhaler - Ultibro Breezhaler is for inhalation use.
Slovenian: Kako inhalirati zdravilo Ultibro Breezhaler - Zdravilo Ultibro Breezhaler je namenjeno inhaliranju.
English: The highest dose level of 464 micrograms/86 micrograms Ultibro Breezhaler also showed a higher proportion of absolute QTcF values >450 ms (12.2% vs. 5.7% for placebo).
Slovenian: Pri najvišji ravni odmerka zdravila Ultibro Breezhaler (464 mikrogramov/86 mikrogramov) se je povečal tudi delež tistih bolnikov z absolutnim trajanjem intervala QTcF več kot 450 ms (12,2 % v primerjavi s 5,7 % pri uporabi placeba).
English: Heart rate in COPD patients at supratherapeutic dose levels was investigated.
Slovenian: Pri bolnikih s KOPB so raziskovali srčno frekvenco pri uporabi supraterapevtskih odmerkov.
English: Talk to your doctor, pharmacist or nurse before using Ultibro Breezhaler if any of the following applies to you: - you have asthma - this medicine should not be used as a treatment for asthma.
Slovenian: Pred začetkom uporabe zdravila Ultibro Breezhaler se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če kaj od navedenega velja za vas: - če imate astmo - tega zdravila ne smete uporabljati za zdravljenje astme, - če imate težave s srcem, - če imate epileptične napade ali krče, - če imate težave s ščitnico (hipertiroidizem),
English: Oxidative metabolites were found in incubations with recombinant CYP1A1, CYP2D6, and CYP3A4.
Slovenian: Pri inkubaciji z rekombinantnimi CYP1A1, CYP2D6 in CYP3A4 so odkrili oksidativne presnovke.
English: Steady state concentrations of indacaterol were achieved within 12 to 15 days following once-daily administration.
Slovenian: Indakaterol je dosegel koncentracijo dinamičnega ravnovesja v 12 do 15 dneh enkrat dnevnega odmerjanja.
English: Each capsule contains 110 microgram indacaterol and 50 microgram glycopyrronium.
Slovenian: Ena kapsula vsebuje 110 mikrogramov indakaterola in 50 mikrogramov glikopironija.
English: Effects on the cardiovascular system attributable to the beta2-agonistic properties of indacaterol included tachycardia, arrhythmias and myocardial lesions in dogs.
Slovenian: Pri psih so med učinki na kardiovaskularni sistem, ki jih ima indakaterol zaradi svojega agonističnega delovanja na beta-2 receptorje, opažali tahikardijo, aritmije in poškodbe miokarda.
English: Anticholinergics
Slovenian: Antiholinergična zdravila
English: A moderate mean increase in total systemic exposure (AUClast) of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease.
Slovenian: Opažali so zmerno povečanje povprečne celotne sistemske izpostavljenosti do zadnje merljive koncentracije (AUClast), in sicer do 1,4-kratno povečanje pri bolnikih z blago in zmerno okvaro ledvic in do 2,2-kratno povečanje pri bolnikih s hudo okvaro ledvic oziroma s končno ledvično odpovedjo.
English: Serum potassium and blood glucose
Slovenian: Koncentraciji kalija v serumu in glukoze v krvi
English: Studies in subjects with severe hepatic impairment were not performed.
Slovenian: Pri bolnikih s hudo okvaro jeter niso izvajali študij.
English: - Peel the backing away from the blister to open it - do not push the capsule through the foil.
Slovenian: - Z enote pretisnega omota odlepite zaščitno plast - kapsul ne potiskajte skozi folijo.
English: If you forget to inhale a dose at the usual time, inhale one as soon as possible that day.
Slovenian: Če ste pozabili uporabiti zdravilo Ultibro Breezhaler Če pozabite inhalirati odmerek ob običajnem času, ga inhalirajte čimprej istega dne.
English: Fertility and pre- and post-natal development were not affected in rats.
Slovenian: Pri podganah ni vplival na plodnost ter na prenatalni in postnatalni razvoj.
English: Up to 23% of the delivered dose was found in urine as parent drug.
Slovenian: V urinu so prestregli do 23 % prejetega odmerka v obliki nespremenjene učinkovine.
English: Step 1c:
Slovenian: Korak 1c:
English: Steady-state exposure to indacaterol after Ultibro Breezhaler inhalation was either similar or slightly lower than systemic exposure after indacaterol monotherapy product inhalation.
Slovenian: Izpostavljenost indakaterolu v stanju dinamičnega ravnovesja je bila po inhaliranju zdravila Ultibro Breezhaler bodisi podobna ali nekoliko nižja od sistemske izpostavljenosti indakaterolu po inhaliranju zdravila, ki vsebuje samo indakaterol.
English: Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency.
Slovenian: Indakaterol je delni agonist humanih beta-2 adrenergičnih receptorjev, ki deluje že v nanomolarni koncentraciji.
English: • eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes - these may be signs of glaucoma.
Slovenian: • bolečina ali ščemenje v očeh, začasno zamegljen vid, zaznavanje svetlobnih ali živobarvnih kolobarjev okrog luči v povezavi s pordelostjo oči - to so lahko znaki glavkoma;
English: Lean body weight (which is a function of weight and height) was identified as a covariate.
Slovenian: Pokazalo se je, da je pusta telesna masa (ki je funkcija telesne mase in telesne višine) moteča spremenljivka.
English: The number of moderate or severe COPD exacerbations/patient-years was 0.98 for Ultibro Breezhaler (1,265 events) and 1.19 for fluticasone/salmeterol (1,452 events).
Slovenian: Število zmernih oziroma hudih poslabšanj KOPB na bolnika-leto je znašalo 0,98 pri uporabi zdravila Ultibro Breezhaler (1.265 poslabšanj) in 1,19 pri uporabi kombinacije flutikazon/salmeterol (1.452 poslabšanj).
English: Ultibro Breezhaler further showed superiority in reducing the annualised rate of all exacerbations by 11% versus fluticasone/salmeterol (p=0.003).
Slovenian: Poleg tega so dokazali superiornost zdravila Ultibro Breezhaler, ki je zmanjšalo letno pogostnost vseh poslabšanj za 11 % v primerjavi s kombinacijo flutikazon/salmeterol (p=0,003).
English: Genotoxicity studies did not reveal any mutagenic or clastogenic potential.
Slovenian: V študijah genotoksičnosti se ni pokazalo, da bi bil indakaterol lahko mutagen ali klastogen.
English: Over 26 weeks, Ultibro Breezhaler statistically significantly reduced the use of rescue medication (salbutamol) by 0.96 puffs per day (p<0.001) compared to placebo, 0.54 puffs per day (p<0.001) compared to tiotropium and 0.39 puffs per day (p=0.019) compared to fluticasone/salmeterol.
Slovenian: V 26 tednih zdravljenja je zdravilo Ultibro Breezhaler statistično značilno zmanjšalo uporabo hitrega olajševalca (salbutamola) za 0,96 vpihov na dan v primerjavi s placebom (p<0,001), za 0,54 vpihov na dan v primerjavi s tiotropijem (p <0,001) in za 0,39 vpihov na dan (p=0,019) v primerjavi s kombinacijo flutikazon/salmeterol.
English: Step 1b: Open inhaler
Slovenian: Korak 1b: Odprite inhalator.
English: Only use the capsules with the inhaler provided in this pack (Ultibro
Slovenian: Kapsule uporabljajte samo z inhalatorjem, ki je priložen v škatli (inhalator
English: Genotoxicity studies did not reveal any mutagenic or clastogenic potential for glycopyrronium bromide.
Slovenian: V študijah genotoksičnosti se ni pokazalo, da bi bil glikopironijev bromid lahko mutagen ali klastogen.
English: Close the inhaler and replace the cap.
Slovenian: Zaprite inhalator in ga pokrijte s pokrovčkom.
English: • irregular heartbeat.
Slovenian: • nepravilno bitje srca.
English: In another study comparing Ultibro Breezhaler (n=258) and fluticasone/salmeterol (n=264), for 26 weeks, the number of moderate or severe COPD exacerbations/patient-years was 0.15 versus 0.18 (18 events versus 22 events), respectively (p=0.512), and the number of all COPD exacerbations/patients-years (mild, moderate or severe) was 0.72 versus 0.94 (86 events versus 113 events), respectively (p=0.098).
Slovenian: V drugi študiji, v kateri so zdravilo Ultibro Breezhaler (n=258) primerjali s kombinacijo flutikazon/salmeterol (n=264) 26 tednov, je bilo število zmernih ali hudih poslabšanj KOPB na bolnika-leto 0,15 v primerjavi z 0,18 (18 poslabšanj v primerjavi z 22 poslabšanji; p=0,512), število vseh poslabšanj KOPB na bolnika-leto (blagih, zmernih ali hudih) pa je znašalo 0,72 v primerjavi z 0,94, (86 poslabšanj v primerjavi s 113 poslabšanji; p=0,098).
English: As it contains indacaterol and glycopyrronium, the type and severity of adverse reactions associated with each of these components may be expected in the combination.
Slovenian: Ker zdravilo vsebuje indakaterol in glikopironij, je mogoče pri njegovi uporabi pričakovati enako vrsto in izraženost neželenih učinkov kot pri uporabi posameznih učinkovin.
English: Indacaterol
Slovenian: Indakaterol
English: The largest time-matched heart rate increase compared to placebo was +5.69 bpm (90% CI [2.71, 8.66]), the largest decrease was -2.51 bpm (90% CI [-5.48, 0.47]).
Slovenian: V primerjavi s placebom se je srčna frekvenca pri meritvi ob istem času povečala za največ 5,69 utripov na minuto (90-odstotni IZ [2,71; 8,66]) in zmanjšala za največ 2,51 utripov na minuto (90-odstotni IZ [-5,48; 0,47]).
English: However, the occurrence of dizziness may influence the ability to drive and use machines (see section 4.8).
Slovenian: Zdravilo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev, v primeru pojavljanja omotičnosti pa vendarle lahko vpliva na sposobnost vožnje in upravljanja strojev (glejte poglavje 4.8).
English: At 26 weeks (primary endpoint), Ultibro Breezhaler increased trough FEV1 by 80 ml in patients (Ultibro Breezhaler n=82; placebo n=42) with the lowest degree of reversibility (<5%) (p=0.053) and by 220 ml in those patients (Ultibro Breezhaler n=392, placebo n=190) with a higher degree of reversibility at baseline (≥5%) compared to placebo (p<0.001).
Slovenian: Po 26 tednih je zdravilo Ultibro Breezhaler pri bolnikih z najnižjo stopnjo reverzibilnosti ob izhodišču (<5 %) (Ultibro Breezhaler n=82; placebo n=42) povečalo najnižjo vrednost FEV1 (kar je bil primarni cilj opazovanja) za 80 ml (p=0,053), pri bolnikih z višjo stopnjo reverzibilnosti ob izhodišču (≥5 %) (Ultibro Breezhaler n=392, placebo n=190) pa za 220 ml v primerjavi s placebom (p<0,001).
English: - Please read the instructions at the end of this leaflet for more information on how to use the inhaler.
Slovenian: - Več o uporabi inhalatorja boste našli v navodilih na koncu tega Navodila za uporabo.
English: No data are available in patients with urinary retention, therefore Ultibro Breezhaler should be used with caution in these patients.
Slovenian: O uporabi pri bolnikih z zastojem urina ni na voljo nobenih podatkov, zato je pri uporabi zdravila Ultibro Breezhaler pri teh bolnikih potrebna previdnost.
English: In this pack, you will find a device called an inhaler together with capsules in blister strips.
Slovenian: Pakiranje vsebuje inhalator skupaj s kapsulami v pretisnih omotih.
English: Step 3b:
Slovenian: Korak 3b:
English: The effects on heart rate for Ultibro Breezhaler increased in magnitude and duration when compared with the changes observed for each component alone consistent with an additive response.
Slovenian: Učinek zdravila Ultibro Breezhaler na srčno frekvenco je bil večji in dolgotrajnejši v primerjavi z učinki vsake posamezne učinkovine, kar kaže na aditivno delovanje.
English: The number of all COPD exacerbations/patient-years was 3.59 for Ultibro Breezhaler (4,531 events) and 4.03 for fluticasone/salmeterol (4,969 events).
Slovenian: Število vseh poslabšanj KOPB na bolnika-leto je znašalo 3,59 pri uporabi zdravila Ultibro Breezhaler (4.531 poslabšanj) in 4,03 pri uporabi kombinacije flutikazon/salmeterol (4.969 poslabšanj).
English: Improvements versus indacaterol and glycopyrronium were 0.26 and 0.21, respectively.
Slovenian: Izboljšanje v primerjavi z uporabo indakaterola je znašalo 0,26, v primerjavi z uporabo glikopironija pa 0,21.
English: Post-dose trough FEV1 (least squares mean) at day 1 and week 26 (primary endpoint)
Slovenian: Najnižje vrednosti FEV1 po odmerjanju (metoda povprečja najmanjših kvadratov) prvega dne in po 26 tednih zdravljenja (primarni cilj opazovanja)
English: The number of moderate or severe COPD exacerbations/patient-years was 0.94 for Ultibro Breezhaler (812 events), 1.07 for glycopyrronium (900 events) and 1.06 for tiotropium (898 events).
Slovenian: V obdobju zdravljenja je bilo število zmernih ali hudih akutnih poslabšanj KOPB na bolnika-leto 0,94 pri uporabi zdravila Ultibro Breezhaler (812 poslabšanj), 1,07 pri uporabi glikopironija (900 poslabšanj) in 1,06 pri uporabi tiotropija (898 poslabšanj).
English: Step 3a:
Slovenian: Korak 3a:
English: A diastereomer of the hydroxylated derivative, a N-glucuronide of indacaterol, and C- and N-dealkylated products were further metabolites identified.
Slovenian: Določili so še naslednje presnovke: diastereomer hidroksiliranega derivata, N-glukuronid indakaterola ter C- in N-dealkilirana presnovka.
English: There was no evidence for tachyphylaxis to the effect of Ultibro Breezhaler over time when compared to placebo or its monotherapy components.
Slovenian: Po določenem času uporabe niso opažali nobenih znakov tahifilaksije pri učinkih zdravila Ultibro Breezhaler v primerjavi z uporabo placeba ali posameznih učinkovin zdravila v monoterapiji.
English: The steady-state mean peak and trough plasma concentrations of glycopyrronium at the recommended once-daily dosing regimen were 166 picograms/ml and 8 picograms/ml, respectively.
Slovenian: Pri uporabi priporočenega odmerka enkrat na dan sta bili povprečni vrednosti najvišje in najnižje koncentracije glikopironija v stanju dinamičnega ravnovesja 166 pikogramov/ml oziroma 8 pikogramov/ml.
English: Please read the full Instructions for Use before using the Ultibro Breezhaler.
Slovenian: Prosimo, da pred uporabo zdravila Ultibro Breezhaler v celoti preberete spodnja navodila za uporabo.
English: Ultibro Breezhaler is used as an ongoing treatment for your COPD.
Slovenian: Zdravilo Ultibro Breezhaler je namenjeno rednemu zdravljenju vaše KOPB.
English: At week 26, Ultibro Breezhaler produced statistically significant improvement in peak FEV1 compared to placebo in the first 4 hours post dose (LS mean treatment difference 330 ml) (p<0.001).
Slovenian: Po 26 tednih zdravljenja je zdravilo Ultibro Breezhaler doseglo statistično značilno izboljšanje najvišjih vrednosti FEV1 v primerjavi s placebom v prvih 4 urah po odmerjanju (razlika med obema načinoma zdravljenja po metodi najmanjših kvadratov: 330 ml) (p<0,001).
English: At 64 weeks, the reduction compared to tiotropium was statistically significant (LS mean treatment difference -2.69, p<0.001).
Slovenian: Tudi po 64 tednih zdravljenja je bilo znižanje ocene v primerjavi z uporabo tiotropija statistično značilno (razlika med obema načinoma zdravljenja po metodi najmanjših kvadratov: -2,69 točke, p<0,001).