FrancophonIA/ELRC3.0 huggingface dataset:
English: INNER LID OF OUTER CARTON OF UNIT PACK AND OF INTERMEDIATE CARTON OF MULTIPACK
Croatian: UNUTARNJI POKLOPAC VANJSKE KARTONSKE KUTIJE JEDINIČNOG PAKIRANJA I SREDNJE KUTIJE U VIŠESTRUKOM PAKIRANJU
English: There were no major differences in total systemic exposure (AUC) for both compounds between Japanese and Caucasian subjects.
Croatian: Nije bilo većih razlika u ukupnoj sistemskoj izloženosti (AUC) za oba spoja između ispitanika japanskog podrijetla i bijelaca.
English: In vivo, M9 is formed from the swallowed dose fraction of inhaled glycopyrronium bromide.
Croatian: In vivo, M9 nastaje iz djelića doze inhaliranog glikopironijevog bromida koji se proguta.
English: 6 or 10 Ultibro Breezhaler capsules to be used in the inhaler
Croatian: 6 ili 10 Ultibro Breezhaler kapsula za korištenje u inhalatoru
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
Croatian: Što je Ultibro Breezhaler i za što se koristi Što morate znati prije nego počnete primjenjivati Ultibro Breezhaler Kako primjenjivati Ultibro Breezhaler Moguće nuspojave
English: Carcinogenicity studies in transgenic mice using oral administration and in rats using inhalation administration revealed no evidence of carcinogenicity at systemic exposures (AUC) of approximately 53-fold higher in mice and 75-fold higher in rats than the maximum recommended dose once daily for humans.
Croatian: Ispitivanja karcinogenosti u transgeničnih miševa korištenjem oralne primjene te u štakora korištenjem inhalacijske primjene nije otkrilo nikakve dokaze karcinogenosti pri sistemskim izloženostima (AUC) koje su bile otprilike 53 puta više u miševa i 75 puta više u štakora od maksimalne preporučene doze jedanput na dan za ljude.
English: In COPD patients both systemic exposure and total urinary excretion of glycopyrronium at pharmacokinetic steady state increased about dose-proportionally over the (delivered) dose range of 44 to 176 micrograms.
Croatian: U bolesnika s KOPB-om i sistemska izloženost i ukupno urinarno izlučivanje glikopironija u farmakokinetičkom stanju dinamičke ravnoteže povećali su se otprilike proporcionalno (isporučenoj) dozi u rasponu 44 do 176 mikrograma.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ultibro Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Ultibro Breezhalera u svim podskupinama pedijatrijske populacije s kroničnom opstruktivnom plućnom bolešću (KOPB) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: This will also help you to remember to use it. You can inhale Ultibro Breezhaler any time before or after food or drink.
Croatian: Možete inhalirati Ultibro Breezhaler u bilo kojem trenutku prije ili nakon uzimanja hrane ili pića.
English: Capsule chamber
Croatian: Komora za kapsulu
English: Cleaning the inhaler Wipe the mouthpiece inside and outside with a clean, dry, lint-free cloth to remove any powder residue.
Croatian: Čišćenje inhalatora Obrišite nastavak za usta iznutra i izvana suhom, čistom tkaninom koja ne ostavlja dlačice da biste uklonili ostatke praška ako ih ima.
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).
Croatian: Ultibro Breezhaler ne smije se primjenjivati istodobno s lijekovima koji sadrže druge dugodjelujuće beta-adrenergičke agoniste ili dugodjelujuće muskarinske antagoniste, farmakoterapijske skupine kojima pripadaju komponente Ultibro Breezhalera (vidjeti dio 4.5).
English: • Never wash your inhaler with water.
Croatian: • Nikad ne ispirite svoj inhalator vodom.
English: In patients with COPD, pharmacokinetic steady-state of glycopyrronium was reached within one week of the start of treatment.
Croatian: U bolesnika s KOPB-om, farmakokinetičko stanje dinamičke ravnoteže glikopironija bilo je postignuto unutar tjedan dana od početka liječenja.
English: CYP3A4 is concluded to be the predominant isoenzyme responsible for hydroxylation of indacaterol.
Croatian: Zaključeno je da je CYP3A4 predominantni izoenzim odgovoran za hidroksilaciju indakaterola.
English: In vitro inhibition studies demonstrated that glycopyrronium bromide has no relevant capacity to inhibit CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4/5, the efflux transporters MDR1, MRP2 or MXR, and the uptake transporters OCT1 or OCT2.
Croatian: In vitro ispitivanja inhibicije pokazala su da glikopironijev bromid nema relevantnu sposobnost inhibiranja CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ili CYP3A4/5, transportnih proteina MDR1, MRP2 ili MXR za izbacivanje, te transportnih proteina OCT1 ili OCT2 za unos.
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.
Croatian: Beta2-adrenergički agonisti mogu proizvesti klinički značajan kardiovaskularni učinak u nekih bolesnika kao što je ubrzanje pulsa, krvnog tlaka i/ili drugih simptoma.
English: Ultibro Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Croatian: Ultibro Breezhaler treba primjenjivati s oprezom u bolesnika s kardiovaskularnim poremećajima (bolest koronarnih arteria, akutni infarkt miokarda, srčane aritmije, hipertenzija).
English: The capsules must not be swallowed.
Croatian: Kapsule se ne smiju gutati.
English: Genotoxicity studies did not reveal any mutagenic or clastogenic potential.
Croatian: Ispitivanja genotoksičnosti nisu pokazala mutageni niti klastogeni potencijal.
English: The presentation of the safety profile is based on the experience with Ultibro Breezhaler and the individual active substances.
Croatian: Prikaz sigurnosnog profila temelji se na iskustvu s Ultibro Breezhalerom i pojedinačnim djelatnim tvarima.
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.
Croatian: Kapsule s prozirnom žutom kapicom i prozirnim tijelom koje sadrže bijeli do gotovo bijeli prašak, sa šifrom proizvoda „IGP110.50“ otisnutom plavom bojom ispod dvije plave linije na tijelu i logotipom tvrtke ( ) otisnutim crnom bojom na kapici.
English: Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at an exposure 14-fold higher than in humans treated with indacaterol.
Croatian: Iako indakaterol nije utjecao na opća reproduktivna svojstva u ispitivanju plodnosti u štakora, zapažen je pad broja trudnih F1 potomaka u ispitivanju peri- i postrazvojnim ispitivanjima u štakora pri izloženosti 14 puta većoj od one u ljudi liječenih indakaterolom.
English: Renal elimination of parent drug accounts for about 60 to 70% of total clearance of systemically available glycopyrronium whereas non-renal clearance accounts for about 30 to 40%.
Croatian: Bubrežna eliminacija ishodišnog lijeka predstavlja oko 60 do 70% ukupnog klirensa sistemski raspoloživog glikopironija dok procesi nebubrežnog klirensa predstavljaju oko 30 do 40%.
English: The combination of indacaterol and glycopyrronium in Ultibro Breezhaler showed a rapid onset of action within 5 minutes after dosing.
Croatian: Kombinacija indakaterola i glikopironija u Ultibro Breezhaleru pokazala je brzi nastup djelovanja u roku od 5 minuta od uzimanja doze.
English: Increased heart rates were apparent in dogs at all doses of Ultibro Breezhaler and each monotherapy component.
Croatian: Povišene srčane frekvencije bile su uočljive u pasa pri svim dozama Ultibro Breezhalera i uz monoterapiju svakom od komponenti.
English: Inhalation powder, hard capsule (inhalation powder).
Croatian: Prašak inhalata, tvrda kapsula (prašak inhalata).
English: Available pharmacokinetic/toxicological data have shown excretion of indacaterol, glycopyrronium and their metabolites in the milk of lactating rats.
Croatian: Dostupni farmakokinetički/toksikološki podaci dokazali su izlučivanje indakaterola, glikopironija i njihovih metabolita u mlijeko štakorica u laktaciji.
English: Please read the full Instructions for Use before using the Ultibro Breezhaler.
Croatian: Pročitajte u cijelosti Upute za primjenu prije korištenja Ultibro Breezhalera.
English: Not all pack sizes may be available in your country.
Croatian: Vaše zemlje se ne moraju nalaziti sve veličine pakiranja.
English: Ultibro Breezhaler is used as an ongoing treatment for your COPD.
Croatian: Ultibro Breezhaler se koristi kao kontinuirana terapija za Vaš KOPB.
English: The co-administration of Ultibro Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Croatian: Istodobna primjena Ultibro Breezhalera s drugim lijekovima koji sadrže antikolinergike nije bila ispitivana pa se stoga ne preporučuje (vidjeti dio 4.4).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Steady-state exposure to glycopyrronium (AUC over the 24-hour dosing interval) was about 1.4- to 1.7-fold higher than after the first dose.
Croatian: Izloženost glikopironiju u stanju dinamičke ravnoteže (AUC tijekom intervala doziranja od 24 sata) bila je oko 1,4 do 1,7 puta viša nego nakon prve doze.
English: The safety and efficacy of Ultibro Breezhaler in children have not been established.
Croatian: Sigurnost i djelotvornost Ultibro Breezhalera u djece nisu ustanovljeni.
English: Thus for bronchodilation in both peripheral and central airways of the human lung a combination of a beta2-adrenergic agonist and a muscarinic antagonist may be beneficial.
Croatian: Stoga bi za bronhodilataciju u perifernim i središnjim dišnim putevima ljudskih pluća mogla biti korisna kombinacija beta2-adrenergičkog agonista i muskarinskog antagonista.
English: Step 1a: Pull off cap
Croatian: Korak 1a: Skinite poklopac
English: • headache.
Croatian: • glavobolja.
English: OUTER CARTON OF UNIT PACK
Croatian: VANJSKA KARTONSKA KUTIJA JEDINIČNOG PAKIRANJA
English: In COPD the muscles around the airways tighten.
Croatian: Kod KOPB-a mišići oko dišnih puteva se stežu.
English: Do not push the capsule through the foil.
Croatian: Ne gurajte kapsulu kroz foliju.
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) glycopyrronium bromide can be used at the recommended dose.
Croatian: U bolesnika s KOPB-om i s blagim i umjerenim oštećenjem bubrega (procijenjena glomerularna filtracija, eGFR ≥30 ml/min/1,73 m2) glikopironijev bromid može se koristiti pri preporučenoj dozi.
English: In vitro the UGT1A1 isoform is a major contributor to the metabolic clearance of indacaterol.
Croatian: In vitro, UGT1A1 izoform uvelike doprinosi klirensu indakaterola putem metabolizma.
English: Treatment difference
Croatian: Razlika između terapija
English: Similarly, for glycopyrronium no QT prolongation was observed in a TQT study after an inhaled dose of 8 times the recommended therapeutic dose.
Croatian: Slično tome, za glikopironij nije bilo uočeno produljenje QT intervala u TQT ispitivanju nakon inhalirane doze koja je bila 8 puta veća od preporučene terapijske doze.
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.
Croatian: Učinci na srčanu frekvenciju za Ultibro Breezhaler povećali su se opsegom i trajanjem u usporedbi s promjenama uočenima za svaku komponentu zasebno koje su bile dosljedne aditivinom odgovoru.
English: Patients with mild and moderate hepatic impairment showed no relevant changes in Cmax or AUC of indacaterol, nor did protein binding differ between mild and moderate hepatic impaired subjects and their healthy controls.
Croatian: U bolesnika s blagim do umjerenim oštećenjem jetre nije bilo značajnih promjena u Cmax-u ili AUC-u indakaterola, niti je bilo razlika u vezanju za proteine između osoba s blagim do umjerenim oštećenjem jetre i zdravih kontrola.
English: What Ultibro Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Croatian: Što Ultibro Breezhaler sadrži - Djelatne tvari su indakaterol (u obliku indakaterolmaleata) i glikopironijev bromid.
English: Renal clearance of indacaterol was, on average, between 0.46 and 1.2 litres/hour.
Croatian: Bubrežni klirens indakaterola u prosjeku je bio između 0,46 i 1,20 litara/sat.
English: No specific interaction studies were conducted with Ultibro Breezhaler.
Croatian: Nisu provedena specifična ispitivanja interakcija s Ultibro Breezhalerom.
English: • feeling of pressure or pain in the cheeks and forehead - these may be signs of inflammation of the sinuses called sinusitis.
Croatian: • osjećaj pritiska ili boli u obrazima i čelu - to bi mogli biti znakovi upale sinusa koja se naziva sinusitis.
English: No effects on the embryo or foetus were seen at any dose level of Ultibro Breezhaler during an embryo-foetal development study in rats.
Croatian: Nisu uočeni nikakvi učinci na embrio i fetus pri bilo kojoj razini Ultibro Breezhalera tijekom ispitivanja embrio-fetalnog razvoja u štakora.
English: • Do not push the capsule through the foil to remove it from the blister.
Croatian: • Ne gurajte kapsulu kroz foliju da biste je izvadili iz blistera.
English: Effects attributable to the muscarinic receptor antagonist properties of glycopyrronium bromide included mild to moderate increases in heart rate in dogs, lens opacities in rats and, reversible changes associated with reduced glandular secretions in rats and dogs.
Croatian: Učinci koji se mogu pripisati svojstvima antagonista muskarinskih receptora koje ima glikopironijev bromid uključivali su blaga do umjerena povećanja srčane frekvencije u pasa, zamućenost leće u štakora, reverzibilne promjene povezane sa smanjenim žlijezdanim lučenjima u štakora i pasa.
English: • Do not press the side buttons while inhaling through the mouthpiece.
Croatian: • Ne pritišćite bočne tipke dok udišete kroz nastavak.
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.
Croatian: In vitro ispitivanja indukcije enzima nisu ukazala na klinički relevantnu indukciju glikopironijevim bromidom za testirane citokrom P450 izoenzime ili za UGT1A1 i transportere MDR1 i MRP2.
English: Concomitant use not recommended
Croatian: Kada se ne preporučuje istodobna primjena
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.
Croatian: Analiza podataka o farmakokinetici u populaciji bolesnika s KOPB-om nakon inhalacije Ultibro Breezhalera uputila je na nepostojanje značajnog učinka dobi, spola i (čiste tjelesne) težine na sistemsku izloženost indakaterolu i glikopironiju.
English: Method of administration For inhalation use only.
Croatian: Način primjene Samo za primjenu inhalacijom.
English: Ultibro Breezhaler showed clinically meaningful improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) in a number of clinical studies.
Croatian: Ultibro Breezhaler pokazao je klinički značajno poboljšanje plućne funkcije (mjereno forsiranim ekspiratornim volumenom u prvoj sekundi, FEV1) u brojnim kliničkim ispitivanjima.
English: Step 1b: Open inhaler
Croatian: Korak 1b: Otvorite inhalator
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).
Croatian: U bolesnika s teškim KOPB-om hipokalijemija može biti potencirana hipoksijom i istodobno primijenjenim lijekovima, što može povećati osjetljivost za srčane aritmije (vidjeti dio 4.5).
English: Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene.
Croatian: Tijelo i poklopac inhalatora napravljeni su od akrilonitril butadien stirena, tipke su napravljene od metil metakrilat akrilonitril butadien stirena.
English: Metabolism and nutrition disorders Hyperglycaemia and diabetes mellitus
Croatian: Poremećaji metabolizma i prehrane Hiperglikemija i šećerna bolest
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).
Croatian: U bolesnika s teškim oštećenjem bubrega (procijenjena glomerularna filtracija manja od 30 ml/min/1,73 m2), uključujući i one s bolešću bubrega u završnoj fazi koja zahtijeva dijalizu, Ultibro Breezhaler treba koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dio 5.2).
English: Indacaterol, one of the active substances in Ultibro Breezhaler, may prevent labour due to its effect on the uterus.
Croatian: Indakaterol, jedna od djelatnih tvari Ultibro Breezhalera, može spriječiti porod zbog njegovog utjecaja na maternicu.
English: Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Croatian: Ultibro Breezhaler je indiciran kao bronhodilatacijska terapija održavanja za ublažavanje simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB).
English: How to inhale Ultibro Breezhaler - Ultibro Breezhaler is for inhalation use.
Croatian: Kako inhalirati Ultibro Breezhaler - Ultibro Breezhaler je za primjenu inhalacijom.
English: In vitro investigations further indicated that indacaterol is a low affinity substrate for the efflux pump P-gp.
Croatian: Daljnja in vitro istraživanja su pokazala da je indakaterol supstrat niskog afiniteta za P-gp pumpu za izbacivanje.
English: Check capsule is empty Open the inhaler to see if any powder is left in the capsule.
Croatian: Otvorite inhalator kako biste provjerili je li ostalo praška u kapsuli.
English: Not for acute use Ultibro Breezhaler is not indicated for the treatment of acute episodes of bronchospasm.
Croatian: Nije za akutnu primjenu Ultibro Breezhaler nije indiciran za liječenje akutnih epizoda bronhospazma.
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).
Croatian: Najviše razine doze od 464 mikrograma/86 mikrograma Ultibro Breezhalera također su pokazale viši udio apsolutnih vrijednosti QTcF-a >450 ms (12,2% u usporedbi s 5,7% za placebo).
English: Psychiatric disorders Insomnia
Croatian: Psihijatrijski poremećaji Nesanica
English: There is no information on clinically relevant overdosing with Ultibro Breezhaler.
Croatian: Nema informacija o klinički relevantnom predoziranju Ultibro Breezhalerom.
English: - you have severe liver problems.
Croatian: - ako imate teške tegobe s jetrom.
English: Only pierce the capsule once.
Croatian: Probušite kapsulu samo jedanput.
English: No data are available for subjects with severe hepatic impairment.
Croatian: Nema dostupnih podataka za ispitanike s teškim oštećenjem jetre.
English: • combination of sore throat and runny nose - these may be signs of nasopharyngitis.
Croatian: • kombinacija grlobolje i curenja nosa - to bi mogli biti znakovi nazofaringitisa.
English: Mean renal clearance of glycopyrronium following inhalation was in the range of 17.4 and 24.4 litres/h.
Croatian: Srednji bubrežni klirens glikopironija nakon inhalacije bio je u rasponu od 17,4 do 24,4 litre/h.
English: Concomitant administration of other sympathomimetics (alone or as part of combination therapy) may potentiate the adverse events of indacaterol (see section 4.4).
Croatian: Istodobna primjena drugih simpatomimetika (samih ili u kombiniranom liječenju) može potencirati nuspojave indakaterola (vidjeti dio 4.4).
English: Genotoxicity studies did not reveal any mutagenic or clastogenic potential for glycopyrronium bromide.
Croatian: Ispitivanja genotoksičnosti nisu otkrila nikakav mutageni ili klastogeni potencijal glikopironijevog bromida.
English: Pre-clinical studies included in vitro and in vivo safety pharmacology assessments, repeated-dose inhalation toxicity studies in rats and dogs and an inhalation embryo-foetal development study in rats.
Croatian: Neklinička ispitivanja uključivala su in vitro i in vivo ocjene sigurnosne farmakologije, ispitivanja toksičnosti inhalacije ponovljenih doza u štakora i pasa te ispitivanje embrio-fetalnog razvoja uz inhalaciju u štakora.
English: Never wash your inhaler with water.
Croatian: Nikad ne perite inhalator vodom.
English: • difficulty breathing or swallowing, swelling of tongue, lips or face, urticaria, skin rash - these may be signs of an allergic reaction.
Croatian: • otežano disanje ili gutanje, oticanje jezika, usana ili lica, urtikarija, kožni osip - to bi mogli biti znakovi alergijske reakcije.
English: Effects on the cardiovascular system attributable to the beta2-agonistic properties of indacaterol included tachycardia, arrhythmias and myocardial lesions in dogs.
Croatian: U pasa, učinci na kardiovaskularni sustav vezani za beta2-agonistička svojstva indakaterola uključuju tahikardiju, aritmije i lezije miokarda.
English: Glycopyrronium plasma concentrations declined in a multi-phasic manner.
Croatian: Koncentracije glikopironija u plazmi smanjivale su se u nekoliko faza.
English: Ultibro Breezhaler further showed superiority in reducing the annualised rate of all exacerbations by 11% versus fluticasone/salmeterol (p=0.003).
Croatian: Ultibro Breezhaler nadalje je pokazao superiornost u smanjivanju godišnje stope svih egzacerbacija za 11% naspram flutikazona/salmeterola (p=0,003).
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).
Croatian: U bolesnika s teškim oštećenjem bubrega ili bolešću bubrega u završnoj fazi koja zahtijeva dijalizu smije se koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dijelove 4.4 i 5.2).
English: Indacaterol administered to dogs alone or in Ultibro Breezhaler was associated with a similar incidence and severity of myocardial lesions.
Croatian: Indakaterol primijenjen u pasa sam ili u Ultibro Breezhaleru bio je povezan sa sličnom incidencijom i težinom lezija miokarda.
English: Studies in subjects with severe hepatic impairment were not performed.
Croatian: Ispitivanja u osoba s teškim oštećenjem jetre nisu provedena.
English: Gender, smoking status and baseline FEV1 had no apparent effect on systemic exposure.
Croatian: Spol, pušački status i početni FEV1 izgleda da nemaju učinak na sistemsku izloženost.