FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Ultibro Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije manj kot 30 ml/min/1,73 m2), med katere sodijo tudi tisti s končno ledvično odpovedjo, ki potrebujejo dializno zdravljenje, se sme zdravilo Ultibro Breezhaler uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje (glejte poglavje 5.2).
English: • swelling mainly of the tongue, lips, face or throat (possible signs of angioedema).
Slovenian: • otekanje, zlasti jezika, ustnic, obraza ali grla oziroma žrela (kar so lahko znaki angioedema);
English: Ultibro Breezhaler prolonged time to first moderate or severe exacerbation with a 22% reduction in risk of an exacerbation (p<0.001) and prolonged time to first severe exacerbation with a 19% reduction in risk of an exacerbation (p=0.046).
Slovenian: Zdravilo Ultibro Breezhaler je podaljšalo čas do prvega zmernega oziroma hudega poslabšanja z 22-odstotnim zmanjšanjem tveganja za poslabšanje (p<0,001), čas do prvega hudega poslabšanja pa je podaljšalo z 19-odstotnim zmanjšanjem tveganja za poslabšanje (p=0,046).
English: Following inhalation of Ultibro Breezhaler, the median time to reach peak plasma concentrations of indacaterol and glycopyrronium was approximately 15 minutes and 5 minutes, respectively.
Slovenian: Po inhalaciji zdravila Ultibro Breezhaler znaša mediana vrednost časa, ko indakaterol in glikopironij dosežeta najvišjo koncentracijo v plazmi, približno 15 minut oziroma 5 minut.
English: Due to the differential density of beta2-adrenoceptors and M3-receptors in central versus peripheral airways, beta2-agonists should be more effective in relaxing peripheral airways, whilst an anticholinergic compound may be more effective in central airways.
Slovenian: Ker se gostota beta-2-adrenergičnih receptorjev in muskarinskih receptorjev M3 v centralnih dihalnih poteh razlikuje od gostote teh receptorjev v perifernih dihalnih poteh, bi morali biti agonisti beta-2 adrenergičnih receptorjev učinkovitejši pri relaksaciji perifernih dihalnih poti, antiholinergična učinkovina pa bi morala biti bolj učinkovita v centralnih dihalnih poteh.
English: A negative correlation between systemic exposure and lean body weight (or body weight) was observed; however, no dose adjustment is recommended due to the magnitude of the change or the predictive precision of lean body weight.
Slovenian: Med sistemsko izpostavljenostjo in pusto telesno maso (oziroma telesno maso) so namreč opažali negativno korelacijo, vendar na podlagi obsega spremembe oziroma napovedne natančnosti puste telesne mase ni priporočeno nikakršno prilagajanje odmerjanja.
English: I felt small pieces of the capsule on my tonguedoes this matter?
Slovenian: Na jeziku sem začutil manjši delec kapsule - ali je to pomembno?
English: Beta2-adrenergic agonists may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms.
Slovenian: Agonisti beta-2 adrenergičnih receptorjev lahko klinično pomembno vplivajo na kardiovaskularni sistem, kar se kaže kot povečan srčni utrip, zvišan krvni tlak in/ali pojav drugih simptomov.
English: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Slovenian: Dolgodelujoči agonisti beta-2 adrenergičnih receptorjev lahko pri uporabi za zdravljenje astme povečajo tveganje za resne neželene dogodke, ki so povezani z astmo, med drugim za smrt zaradi astme.
English: In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility to cardiac arrhythmias (see section 4.5).
Slovenian: Pri bolnikih s hudo KOPB lahko hipoksija in sočasna zdravila še poslabšajo hipokaliemijo, kar lahko poveča možnost za razvoj aritmij (glejte poglavje 4.5).
English: The safety profile is characterised by typical anticholinergic and beta-adrenergic symptoms related to the individual components of the combination.
Slovenian: Pri opisu varnostnih lastnosti so v ospredju značilni antiholinergični in beta adrenergični simptomi, ki jih povzročata posamezni učinkovini kombinacije.
English: Glucuronide and/or sulfate conjugates of glycopyrronium were found in urine of humans after repeated inhalation, accounting for about 3% of the delivered dose.
Slovenian: Po večkratnem inhaliranju so pri ljudeh v urinu našli glukuronidni in/ali sulfatni konjugat glikopironija, ki sta predstavljala približno 3 % prejetega odmerka.
English: Glycopyrronium at the recommended dose can be safely used in all age and body weight groups.
Slovenian: Glikopironij je v priporočenem odmerku mogoče varno uporabljati v vseh starostnih skupinah in kategorijah telesne mase bolnikov
English: This medicine contains two active substances called indacaterol and glycopyrronium.
Slovenian: To zdravilo vsebuje dve zdravilni učinkovini, ki ju imenujemo indakaterol in glikopironij.
English: Biliary clearance contributes to the non-renal clearance, but the majority of non-renal clearance is thought to be due to metabolism.
Slovenian: V neledvični očistek je vključeno izločanje z žolčem, večino neledvičnega očistka pa verjetno predstavlja presnova.
English: Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled, therefore caution and appropriate monitoring are advised in such patients.
Slovenian: Uporabe zdravila Ultibro Breezhaler niso proučevali pri bolnikih, ki niso imeli dobro urejene sladkorne bolezni, zato sta pri uporabi zdravila pri takšnih bolnikih priporočena previdnost in ustrezno spremljanje.
English: What Ultibro Breezhaler is and what it is used for What you need to know before you use Ultibro Breezhaler How to use Ultibro Breezhaler Possible side effects
Slovenian: Kaj je zdravilo Ultibro Breezhaler in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ultibro Breezhaler Kako uporabljati zdravilo Ultibro Breezhaler Možni neželeni učinki
English: During long-term clinical studies, more patients on Ultibro Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%).
Slovenian: V dolgoročnih kliničnih študijah so klinično opazne spremembe v koncentraciji glukoze v krvi pogosteje opažali pri bolnikih, ki so jemali zdravilo Ultibro Breezhaler v priporočenem odmerku, (4,9 %) v primerjavi s tistimi, ki so jemali placebo (2,7 %).
English: Glycopyrronium After intravenous administration of [
Slovenian: Glikopironij Po intravenskem odmerjanju s [
English: In a 64-week study comparing Ultibro Breezhaler (n=729), glycopyrronium (n=739) and tiotropium (n=737), Ultibro Breezhaler reduced the annualised rate of moderate or severe COPD exacerbations by 12% compared to glycopyrronium (p=0.038) and by 10% compared to tiotropium (p=0.096).
Slovenian: V 64-tedenski študiji, v kateri so primerjali zdravilo Ultibro Breezhaler (n=729), glikopironij (n=739) in tiotropij (n=737), je zdravilo Ultibro Breezhaler zmanjšalo letno pogostnost zmernih ali hudih akutnih poslabšanj KOPB za 12 % v primerjavi z glikopironijem (p=0,038) in za 10 % v primerjavi s tiotropijem (p=0,096).
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk (see sections 4.4 and 5.2).
Slovenian: Bolniki s hudo okvaro ledvic in bolniki, ki imajo končno ledvično odpoved in potrebujejo dializno zdravljenje, ga smejo uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje (glejte poglavji 4.4 in 5.2).
English: Not for acute use Ultibro Breezhaler is not indicated for the treatment of acute episodes of bronchospasm.
Slovenian: Zdravilo ni namenjeno akutni uporabi Zdravilo Ultibro Breezhaler ni indicirano za zdravljenje akutnih epizod bronhospazma.
English: • blocked nose, sneezing, cough, headache with or without fever - these may be signs of an upper respiratory tract infection.
Slovenian: • zamašen nos, kihanje, kašelj, glavobol z zvišano telesno temperaturo ali brez nje - to so lahko znaki okužbe zgornjih dihal.
English: There are no data available for the use of Ultibro Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2).
Slovenian: O uporabi zdravila Ultibro Breezhaler pri bolnikih s hudo okvaro jeter ni na voljo nobenih podatkov, zato je pri teh bolnikih potrebna previdnost (glejte poglavje 5.2).
English: It is not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk.
Slovenian: Ni znano, ali se indakaterol, glikopironij in njuni presnovki izločajo v materino mleko.
English: No evidence of carcinogenicity was seen in mice.
Slovenian: Pri miših ni bilo nobenih znakov kancerogenega delovanja.
English: Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle.
Slovenian: Indakaterol lahko zavira porod zaradi relaksantnega učinka na gladko mišičje maternice.
English: Step 1d:
Slovenian: Korak 1d:
English: What you need to know before you use Ultibro Breezhaler
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ultibro Breezhaler
English: • swollen hands, ankles and feet.
Slovenian: • otekanje rok, gležnjev in stopal
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Slovenian: Agonisti beta-2 adrenergičnih receptorjev lahko pri nekaterih bolnikih povzročijo pomembno hipokaliemijo, zaradi katere lahko pride do neželenih kardiovaskularnih učinkov.
English: Use of cardioselective beta blockers may be considered for treating beta2adrenergic effects, but only under the supervision of a physician and with extreme caution since the use of beta-adrenergic blockers may provoke bronchospasm.
Slovenian: Za zdravljenje učinkov beta-2-adrenergičnega sistema velja razmisliti o uporabi kardioselektivnih antagonistev beta adrenergičnih receptorjev, vendar le pod zdravniškim nadzorom in z izjemno previdnostjo, saj antagonisti beta adrenergičnih receptorjev lahko sprožijo bronhospazem.
English: • diarrhoea or stomach ache.
Slovenian: • driska ali bolečine v trebuhu
English: Smoking status and baseline FEV1 had no apparent effect on systemic exposure to indacaterol and glycopyrronium after inhalation of Ultibro Breezhaler.
Slovenian: Status kajenja in izhodiščna vrednost FEV1 nimata opaznega vpliva na sistemsko izpostavljenost indakaterolu in glikopironiju po inhlairanju zdravila Ultibro Breezhaler.
English: Ultibro Breezhaler should be used with caution in these patient groups.
Slovenian: Pri uporabi zdravila Ultibro Breezhaler pri teh skupinah bolnikov je potrebna previdnost.
English: In the 52-week activecontrolled study, patients were enrolled who had moderate to very severe COPD with a history of ≥1 moderate or severe COPD exacerbation in the previous year.
Slovenian: V 52-tedensko aktivno kontrolirano študijo so bili vključeni bolniki z zmerno do zelo hudo KOPB in anamnezo najmanj enega zmernega ali hudega poslabšanja KOPB v predhodnem letu.
English: • Do not use the Ultibro Breezhaler capsules with any other inhaler.
Slovenian: • Kapsul Ultibro Breezhaler ne uporabljajte z nobenim drugim inhalatorjem.
English: If this occurs, treatment should be discontinued immediately and alternative therapy instituted.
Slovenian: Če pride do paradoksnega bronhospazma, je treba zdravljenje takoj ukiniti in ga nadomestiti z drugim zdravljenjem.
English: • fast heart beat.
Slovenian: • hiter srčni utrip
English: In healthy volunteers, after the administration of 4 times the recommended therapeutic dose of Ultibro Breezhaler, the effect on serum potassium was very small (maximal difference -0.14 mmol/l when compared to placebo).
Slovenian: Pri zdravih prostovoljcih je bil po odmerjanju zdravila Ultibro Breezhaler v odmerku, ki je bil 4-krat višji od priporočenega terapevtskega odmerka, učinek na koncentracijo kalija v serumu zelo majhen (z največjo razliko -0,14 mmol/l v primerjavi z uporabo placeba).
English: In vitro enzyme induction studies did not indicate a clinically relevant induction by glycopyrronium bromide for any of the cytochrome P450 isoenzymes tested or for UGT1A1 and the transporters MDR1 and MRP2.
Slovenian: Rezultati in vitro študij indukcije encimov ne kažejo, da bi glikopironijev bromid lahko klinično pomembno induciral testirane izoencime citokroma P450, encim UGT1A1 ali prenašalca MDR1 in MRP2.
English: How to store Ultibro Breezhaler Contents of the pack and other information Instructions for use of Ultibro Breezhaler inhaler
Slovenian: Shranjevanje zdravila Ultibro Breezhaler Vsebina pakiranja in dodatne informacije Navodila za uporabo inhalatorja Ultibro Breezhaler
English: The mean bronchodilator effect derived from serial FEV1 measurements over 24 h was 320 ml after 26 weeks of treatment.
Slovenian: Po 26 tednih zdravljenja je povprečni bronhodilatatorni učinek, ki so ga izračunali iz rezultatov serije meritev FEV1 v času 24 ur, znašal 320 ml.
English: Insert capsule Never place a capsule directly into the mouthpiece.
Slovenian: Vstavite kapsulo Kapsule nikoli ne nameščajte neposredno v ustnik.
English: Concomitant administration of orally inhaled indacaterol and glycopyrronium, under steady-state conditions of both active substances, did not affect the pharmacokinetics of either active substance.
Slovenian: Sočasna uporaba peroralno inhaliranih indakaterola in glikopironija v stanju dinamičnega ravnovesja obeh učinkovin ni vplivala na farmakokinetične lastnosti niti prve niti druge od obeh učinkovin.
English: Multiple CYP isoenzymes contribute to the oxidative biotransformation of glycopyrronium.
Slovenian: Več izoencimov sistema CYP je vpletenih v oksidativno biotransformacijo glikopironija.
English: In a human ADME study, indacaterol given orally was excreted into human faeces primarily as unchanged parent substance (54% of the dose) and, to a lesser extent, hydroxylated indacaterol metabolites (23% of the dose).
Slovenian: V študiji absorpcije, porazdelitve, presnove in izločanja pri ljudeh se je indakaterol po peroralnem odmerjanju izločal z blatom predvsem v nespremenjeni osnovni obliki (54 % odmerka), v manjši meri pa še v obliki hidroksiliranih presnovkov indakaterola (23 % odmerka).
English: How long to continue your treatment with Ultibro Breezhaler Keep using Ultibro Breezhaler for as long as your doctor tells you.
Slovenian: Kako dolgo je treba nadaljevati z uporabo zdravila Ultibro Breezhaler - Zdravljenje z zdravilom Ultibro Breezhaler nadaljujte tako dolgo, kot vam naroči zdravnik.
English: Check capsule is empty Open the inhaler to see if any powder is left in the capsule.
Slovenian: Odprite inhalator in poglejte, ali je v kapsuli ostalo še kaj praška.
English: Increased incidences of benign ovarian leiomyoma and focal hyperplasia of ovarian smooth muscle in rats were consistent with similar findings reported for other beta2-adrenergic agonists.
Slovenian: Pri podganah so opažali povečani incidenci benignega ovarijskega leiomioma in fokalne hiperplazije gladkega mišičja jajčnika, kar se ujema s podobnimi izsledki, ki so jih opisovali pri drugih agonistih beta-2 adrenergičnih receptorjev.
English: The effect was significantly greater for Ultibro Breezhaler, when compared to indacaterol, glycopyrronium or tiotropium alone (difference 110 ml, for each comparison).
Slovenian: Pri uporabi zdravila Ultibro Breezhaler je bil ta učinek statistično značilno večji v primerjavi s samostojno uporabo indakaterola, glikopironija ali tiotropija (z razliko 110 ml za vsako od primerjav).
English: The use of Ultibro Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Slovenian: O uporabi zdravila Ultibro Breezhaler v času dojenja je smiselno razmišljati samo v primeru, da pričakovana korist za bolnico presega potencialno tveganje za otroka (glejte poglavje 5.3).
English: • difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention.
Slovenian: • ovirano in boleče uriniranje - to sta lahko znaka zapore sečnega mehurja ali zastoja urina
English: Glycopyrronium bromide is a high affinity muscarinic receptor antagonist.
Slovenian: Glikopironijev bromid je antagonist muskarinskih receptorjev z visoko afiniteto.
English: Systemic exposures (AUC) at the no-observed-adverse-effect level (NOAEL) for myocardial lesions were 64- and 59-fold higher than in humans, for each component respectively.
Slovenian: Ravni sistemske izpostavljenosti (AUC) pri koncentracijah posameznih učinkovin brez pomembnih neželenih učinkov (no-observed-adverse-effect level, NOAEL) za poškodbe miokarda sta bili 64-krat oziroma 59-krat večji od izpostavljenosti pri ljudeh.
English: Indacaterol:
Slovenian: Indakaterol:
English: The incidence of pneumonia was 3.2% in the Ultibro Breezhaler arm compared to 4.8% in the fluticasone/salmeterol arm (p=0.017).
Slovenian: Pogostnost pljučnice je v skupini z zdravilom Ultibro Breezhaler znašala 3,2 % v primerjavi s 4,8 % v skupini s kombinacijo flutikazon/salmeterol (p=0,017).
English: Ultibro Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Ultibro Breezhaler belong (see section 4.5).
Slovenian: Zdravila Ultibro Breezhaler se ne sme uporabljati sočasno z drugimi zdravili, ki vsebujejo dolgodelujoče agoniste beta adrenergičnih receptorjev ali dolgodelujoče antagoniste muskarinskih receptorjev, torej z zdravili iz obeh skupin, v kateri sodita učinkovini zdravila Ultibro Breezhaler (glejte poglavje 4.5).
English: The in vitro human plasma protein binding of glycopyrronium was 38% to 41% at concentrations of 1 to 10 nanograms/ml.
Slovenian: In vitro je pri koncentracijah od 1 do 10 nanogramov/ml vezava glikopironija na beljakovine v človeški plazmi znašala 38 % do 41 %.
English: Impairment of the hepatic metabolism of glycopyrronium is not thought to result in a clinically relevant increase of systemic exposure.
Slovenian: Motena presnova glikopironija v jetrih po vsej verjetnosti ne povzroči klinično pomembnega povečanja sistemske izpostavljenosti.
English: • Do not use the Ultibro Breezhaler inhaler to take any other capsule medicine.
Slovenian: • Inhalatorja Ultibro Breezhaler ne uporabljajte za inhaliranje drugih zdravil iz kapsul.
English: • difficulty breathing or swallowing, swelling of tongue, lips or face, urticaria, skin rash - these may be signs of an allergic reaction.
Slovenian: • oteženo dihanje ali požiranje, otekanje jezika, ustnic ali obraza, koprivnica, izpuščaj - to so lahko znaki alergijske reakcije;
English: Over 52 weeks, Ultibro Breezhaler reduced the use of rescue medication by 0.25 puffs per day compared to fluticasone/salmeterol (p<0.001).
Slovenian: V 52 tednih zdravljenja je zdravilo Ultibro Breezhaler zmanjšalo uporabo hitrega olajševalca za 0,25 vpiha na dan v primerjavi s kombinacijo flutikazon/salmeterol (p<0,001).
English: A greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor has been demonstrated using radioligand binding studies.
Slovenian: V študijah z vezavo radioliganda so dokazali, da je za humane M3 receptorje več kot 4-krat bolj selektiven kot za humane M2 receptorje.
English: Compared to fluticasone/salmeterol, Ultibro Breezhaler reduced the annualised rate of both moderate or severe exacerbations by 17% (p<0.001), and of severe exacerbations (requiring hospitalisation) by 13% (not statistically significant, p=0.231).
Slovenian: V primerjavi s kombinacijo flutikazon/salmeterol je zdravilo Ultibro Breezhaler zmanjšalo letno pogostnost zmernih oziroma hudih poslabšanj za 17 % (p<0,001), letno pogostnost hudih poslabšanj (zaradi katerih je potrebna hospitalizacija) pa za 13 % (razlika ni statistično značilna, p=0,231).
English: Ultibro Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Slovenian: Pri uporabi zdravila Ultibro Breezhaler pri bolnikih s kardiovaskularnimi boleznimi (s koronarno boleznijo, po akutnem miokardnem infarktu, z aritmijami, s hipertenzijo) je potrebna previdnost.
English: Mild irritancy or adaptive changes in the respiratory tract were seen in rats.
Slovenian: Pri podganah so opažali blago obliko draženja ali prilagoditvene spremembe v dihalih.
English: In vitro the UGT1A1 isoform is a major contributor to the metabolic clearance of indacaterol.
Slovenian: In vitro je izooblika UGT1A1 poglavitni dejavnik izločanja indakaterola s presnovo.
English: In the 64-week study patients were enrolled who had severe to very severe COPD with a history of ≥1 moderate or severe COPD exacerbation in the previous year.
Slovenian: V 64-tedensko študijo so bili vključeni bolniki s hudo do zelo hudo KOPB in anamnezo najmanj enega zmernega ali hudega poslabšanja KOPB v predhodnem letu.
English: Capsules with transparent yellow cap and natural transparent body containing a white to almost white powder, with 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: Kapsule vsebujejo bel do skoraj bel prašek in imajo na telesu kapsule pod dvema modrima črtama modro tiskano oznako “IGP110.50”, na pokrovčku pa črno tiskan zaščitni znak družbe ( ).
English: I coughed after inhaling - does this matter?
Slovenian: Po inhaliranju kašljamali je to pomembno?
English: Store the capsules in the original blister in order to protect from moisture and do not remove until immediately before use.
Slovenian: Kapsule shranjujte v originalnem pretisnem omotu, da jih zaščitite pred vlago, in jih vzemite iz ovojnine šele tik pred uporabo.
English: The effects of Ultibro Breezhaler on QTc interval were investigated in healthy volunteers after inhalation of Ultibro Breezhaler up to 4 times the recommended therapeutic dose in four dose steps each separated by one hour.
Slovenian: Učinek zdravila Ultibro Breezhaler na interval QTc so raziskovali pri zdravih prostovoljcih po inhaliranju zdravila Ultibro Breezhaler v odmerkih, ki so bili štirikrat višji od priporočenega terapevtskega odmerka, preiskovancem pa so jih odmerjali v štirih odmernih korakih s presledkom po eno uro.
English: Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder.
Slovenian: Ultibro Breezhaler 85 mikrogramov/43 mikrogramov prašek za inhaliranje, trde kapsule so prozorne in rumene ter vsebujejo bel do skoraj bel prašek.
English: diuretics (water tablets) used for high blood pressure (such as hydrochlorothiazide),
Slovenian: Med njimi so: steroidi (na primer prednizolon), diuretiki (tablete za odvajanje vode) za zdravljenje visokega krvnega tlaka (na primer hidroklorotiazid), zdravila za težave z dihanjem (na primer teofilin).
English: Systemic exposures (AUC) in rats and mice at the no-observed-adverse-effect levels in these studies were at least 7- and 49-fold higher, respectively, than in humans treated with indacaterol once a day at the maximum recommended therapeutic dose.
Slovenian: V teh študijah je bila raven sistemske izpostavljenosti (AUC) brez pomembnih neželenih učinkov pri podganah najmanj 7-krat višja, pri miših pa najmanj 49-krat višja od izpostavljenosti pri ljudeh, ki prejemajo indakaterol enkrat na dan v najvišjem priporočenem terapevtskem odmerku.