FrancophonIA/ELRC3.0 huggingface dataset:
English: Aclidinium bromide is quickly broken down in plasma, the level of systemic anticholinergic side effects is therefore low.
Croatian: Aklidinijev bromid brzo se razgrađuje u plazmi, te je stoga razina sistemskih antikolinergičkih nuspojava niska.
English: The following side effects may occur whilst using Bretaris Genuair: Common: may affect up to 1 in 10 people - Headache - Inflammation of the sinuses (sinusitis) - Common cold (nasopharyngitis) - Cough - Diarrhoea - Nausea
Croatian: Tijekom uporabe Bretaris Genuair mogu se pojaviti sljedeće nuspojave: Česte: mogu se javiti u do 1 na 10 osoba - Glavobolja - Upala sinusa (sinusitis) - Obična prehlada (nazofaringitis) - Kašalj - Proljev - Mučnina
English: Experience in patients with cardiovascular comorbidities in clinical trials is limited (see section 5.1).
Croatian: Iskustvo s primjenom u bolesnika s istodobnim kardiovaskularnim bolestima u kliničkim ispitivanjima je ograničeno (vidjeti dio 5.1).
English: The pharmacokinetic properties of aclidinium bromide in patients with moderate to severe COPD appear to be similar in patients aged 40-59 years and in patients aged ≥70 years.
Croatian: Čini se da su farmakokinetička svojstva aklidinijeva bromida u bolesnika s umjerenim do teškim KOPB-om slična u bolesnika u dobi 40-59 godina i u bolesnika u dobi ≥70 godina.
English: Improvement over placebo p-value
Croatian: Poboljšanje u odnosu na placebo pvrijednost
English: RED
Croatian: CRVENO
English: If you forget a dose of Bretaris Genuair, inhale the dose as soon as you remember.
Croatian: Ako ste zaboravili primijeniti Bretaris Genuair Ako zaboravite dozu Bretaris Genuair, inhalirajte dozu čim se sjetite.
English: Consistent with its anticholinergic activity, aclidinium bromide should be used with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).
Croatian: U skladu sa svojim antikolinergičkim djelovanjem, aklidinijev bromid treba primjenjivati s oprezom kod bolesnika sa simptomatskom hiperplazijom prostate, opstrukcijom vrata mokraćnog mjehura ili glaukomom uskog kuta (iako je vrlo mala vjerojatnost izravnog kontakta lijeka s očima).
English: What you need to know before you use Bretaris Genuair
Croatian: Što morate znati prije nego počnete primjenjivati Bretaris Genuair
English: M3 receptors mediate contraction of airway smooth muscle.
Croatian: M3 receptori sudjeluju u kontrakciji glatkih mišića dišnih puteva.
English: Maximal bronchodilation was achieved within 1-3 hours after dosing with mean peak improvements in FEV1 relative to baseline of 227-268 mL at steady-state.
Croatian: Maksimalna bronhodilatacija postignuta je unutar 1-3 sata nakon doziranja uz srednju vrijednost vršnog poboljšanja FEV1 u odnosu na početnu vrijednost od 227-268 ml u stanju dinamičke ravnoteže.
English: The active ingredient of Bretaris Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators.
Croatian: Djelatna tvar lijeka Bretaris Genuair je aklidinijev bromid koji spada u skupinu lijekova pod nazivom bronhodilatatori.
English: White or almost white powder in a white inhaler with an integral dose indicator and a green dosage button.
Croatian: Bijeli ili gotovo bijeli prašak u bijelom inhalatoru s ugrađenim pokazivačem doze i zelenim gumbom za doziranje.
English: What Bretaris Genuair is and what it is used for
Croatian: Što je Bretaris Genuair i za što se koristi
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Croatian: Nositelj odobrenja će provoditi ispitivanja i dodatne aktivnosti predviđene Farmakovigilancijskim planom, kako je dogovoreno RMP-om prikazanim u Modulu 1.8.2. odobrenja za stavljanje gotovog lijeka u promet te sve daljnje dopune RMP-a dogovorene od strane Povjerenstva za humane lijekove (CHMP).
English: Clinical efficacy studies showed that Bretaris Genuair provided clinically meaningful improvements in lung function (as measured by the forced expiratory volume in 1 second [FEV1]) over 12 hours following morning and evening administration, which were evident within 30 minutes of the first dose (increases from baseline of 124-133 mL).
Croatian: U klinička ispitivanjima djelotvornosti Bretaris Genuair pokazao je klinički značajna poboljšanja plućne funkcije (mjereno forsiranim izdisajnim volumenom u prvoj sekundi [FEV1]) tijekom 12 sati nakon jutarnje i večernje primjene, koja su bila vidljiva u roku od 30 minuta nakon prve doze (povećanje od početne vrijednosti za 124-133 mL).
English: Similar observations were made with Bretaris Genuair in the 3 month study.
Croatian: Slična opažanja zabilježena su s lijekom Bretaris Genuair u 3-mjesečnom ispitivanju.
English: Uncommon: may affect up to 1 in 100 people - Dizziness - Dry mouth - Inflammation of the mouth (stomatitis) - Hoarseness (dysphonia) - Faster heart beat (tachycardia) - Sensation of heart beating (palpitations) - Difficulty passing urine (urinary retention) - Blurred vision - Rash - Itching of the skin
Croatian: Manje česte: mogu se javiti u do 1 na 100 osoba - Omaglica - Suha usta - Upala usta (stomatitis) - Promuklost (disfonija) - Ubrzani otkucaji srca (tahikardija) - Osjećaj lupanja srca (palpitacije) - Otežano mokrenje (zastoj mokraće) - Zamagljen vid - Osip - Svrbež kože
English: The low toxicity observed in nonclinical toxicity studies is in part due to rapid metabolism of aclidinium bromide in plasma and the lack of significant pharmacological activity of the major metabolites.
Croatian: Niska toksičnost zabilježena u nekliničkim ispitivanjima toksičnosti dijelom je posljedica brzog metabolizma aklidinijeva bromida u plazmi te nedostatka značajne farmakološke aktivnosti glavnih metabolita.
English: The Table below shows symptom relief obtained after 6 months treatment with Bretaris Genuair.
Croatian: Tablica u nastavku prikazuje ublažavanje simptoma postignuto nakon 6 mjeseci liječenja Bretaris Genuairom.
English: a) Before first use, tear open the sealed bag and remove the inhaler.
Croatian: a) Prije prve uporabe otvorite zatvorenu vrećicu i izvadite inhalator.
English: Bretaris Genuair may have minor influence on the ability to drive and use machines.
Croatian: Bretaris Genuair malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: No significant pharmacokinetic differences were observed between subjects with normal renal function and subjects with renal impairment.
Croatian: Nisu primijećene značajne farmakokinetičke razlike između ispitanika s normalnom funkcijom bubrega i ispitanika s oštećenjem bubrega.
English: Steady state peak plasma concentrations achieved after dry powder inhalation by COPD patients of 400 µg aclidinium bromide were approximately 224 pg/mL.
Croatian: Vršne koncentracije u plazmi u stanju dinamičke ravnoteže postignute nakon inhaliranja suhog praška kod KOPB bolesnika, u dozi od 400 µg aklidinijeva bromida bile su približno 224 pg/ml.
English: Patients discontinued treatment if they experienced a MACE event and entered into the post-treatment follow-up period during the study.
Croatian: Bolesnici su nakon nastupa MACE događaja prekinuli liječenje i ušli u razdoblje praćenja nakon liječenja, koje je bilo dio ispitivanja.
English: Although no formal in vivo drug interaction studies have been performed, inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Croatian: Iako nisu provedena formalna ispitivanja interakcije lijekova in vivo, aklidinijev bromid za inhalaciju koristio se istodobno s drugim lijekovima za KOPB uključujući simpatomimetičke bronhodilatatore, metilksantine, te oralne i inhalacijske steroide bez kliničkih dokaza o interakciji lijekova.
English: Lactose monohydrate.
Croatian: Laktoza hidrat.
English: Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Croatian: Bretaris Genuair je indiciran u terapiji održavanja bronhodilatacije za ublažavanje bronhoopstruktivnih simptoma, u odraslih bolesnika s kroničnom opstruktivnom bolesti pluća (KOPB) (vidjeti dio 5.1).
English: Posology The recommended dose is one inhalation of 322 micrograms aclidinium twice daily.
Croatian: Doziranje Preporučena doza je jedna inhalacija od 322 mikrograma aklidinija dvaput dnevno.
English: 1.3 Hold the inhaler horizontally with the mouthpiece facing you and the green button on top (Figure D).
Croatian: 1.3 Držite inhalator vodoravno, tako da nastavak za usta bude usmjeren prema Vama, a zeleni gumb okrenut prema gore (Slika D).
English: No effects on QT interval (corrected using either the Fridericia or Bazett method or individuallycorrected) were observed when aclidinium bromide (200 µg or 800 µg) was administered once daily for 3 days to healthy subjects in a thorough QT study.
Croatian: Nisu zabilježeni učinci na QT interval (korigiran bilo metodom Fridericia ili Bazett ili individualno) kod primjene aklidinijeva bromida (200 µg ili 800 µg) jednom dnevno tijekom 3 dana zdravim ispitanicima tijekom cijelog QT ispitivanja.
English: 2.1 Hold the inhaler away from your mouth, and breathe out completely.
Croatian: 2.1 Odmaknite inhalator od usta i izdahnite do kraja.
English: Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.
Croatian: Preosjetljivost na aklidinijev bromid ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: In vitro studies have shown that aclidinium bromide at the therapeutic dose or its metabolites do not inhibit or induce any of the cytochrome P450 (CYP450) enzymes and do not inhibit esterases (carboxylesterase, acetylcholinesterase and butyrylcholinesterase).
Croatian: Ispitivanja in vitro su pokazala da aklidinijev bromid u terapijskoj dozi ili njegovi metaboliti ne inhibiraju i ne induciraju bilo koji citokromni enzimi P450 (CYP450) i ne inhibiraju esteraze (karboksilesterazu, acetilkolinesterazu i butirilkolinesterazu).
English: Following intravenous administration of 400 µg radiolabelled aclidinium bromide to healthy subjects, approximately 1% of the dose was excreted as unchanged aclidinium bromide in the urine.
Croatian: Nakon intravenske primjene 400 µg radioobilježenog aklidinijeva bromida kod zdravih ispitanika, oko 1% doze se izlučilo u urin kao nepromijenjeni aklidinijev bromid.
English: Bretaris Genuair is indicated for maintenance treatment and should not be used to treat a sudden attack of breathlessness or wheezing.
Croatian: Bretaris Genuair se koristi u terapiji održavanja i ne smije se koristiti za liječenje iznenadnog napadaja nedostatka zraka ili piskanja.
English: Keep breathing in as long as possible after you hear the ‘click'.
Croatian: Nakon što čujete ‘klik' nastavite udisati što dulje možete.
English: Other medicines and Bretaris Genuair
Croatian: Drugi lijekovi i Bretaris Genuair
English: A placebo-controlled trial in 1791 patients with moderate to very severe COPD treated with Bretaris Genuair up to 36 months did not identify other adverse reactions.
Croatian: U placebom kontroliranom ispitivanju provedenom u 1791 bolesnika s umjerenim do vrlo teškim KOPB-om liječena lijekom Bretaris Genuair tijekom razdoblja do 36 mjeseci nisu utvrđene nikakve druge nuspojave.
English: EU/1/12/781/003 3 inhalers each containing 60 doses
Croatian: EU/1/12/781/003 3 inhalatora od kojih svaki sadrži 60 doza
English: Animal studies have shown excretion of small amounts of aclidinium bromide and/or metabolites into milk.
Croatian: Ispitivanja na životinjama pokazala su izlučivanje manjih količina aklidinijeva bromida/metabolita u mlijeko.
English: Aclidinium bromide is rapidly and extensively hydrolysed to its pharmacologically inactive alcoholand carboxylic acid-derivatives.
Croatian: Aklidinijev bromid se brzo i opsežno hidrolizira na svoje farmakološki neaktivne metabolite, derivate alkohola i karboksilne kiseline.
English: Regular use of Bretaris Genuair can help you when you have ongoing shortness of breath related to your disease to help you minimise the effects of the disease on your everyday life and reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Croatian: Redovito uzimanje lijeka Bretaris Genuair može Vam pomoći kad osjećate nedostatak zraka povezan s bolešću te tako pomoći smanjiti učinke bolesti na svakodnevni život i broj epizoda razbuktavanja bolesti (višednevnog pogoršanja simptoma KOPB-a).
English: In the long-term safety studies, Bretaris Genuair was associated with bronchodilatory efficacy when administered over a 1-year treatment period.
Croatian: U dugotrajnom ispitivanju sigurnosti primjene, Bretaris Genuair se pokazao djelotvornim u bronhodilataciji kod primjene u razdoblju duljem od 1 godine.
English: Keep breathing in for as long as possible.
Croatian: Udišite što dulje možete.
English: Make sure the green button is on top.
Croatian: Zeleni gumb mora biti okrenut prema gore.
English: - The other ingredient is lactose monohydrate (refer to Section 2 “Bretaris Genuair contains lactose”).
Croatian: - Pomoćna tvar je laktoza hidrat. (pogledajte dio 2. „Bretaris Genuair sadrži laktozu“)
English: Become familiar with the parts of your Genuair inhaler.
Croatian: Upoznajte se s dijelovima inhalatora Genuair.
English: Submission of the results of the agreed post-authorisation safety study (PASS) for aclidinium bromide to evaluate the overall mortality and the proposed cardiovascular safety endpoints (with an additional endpoint of cardiac arrhythmia) among patients with COPD using aclidinium, according to a protocol agreed by the PRAC.
Croatian: Post-Authorisation Safety Study, PASS) radi ocjene ukupne smrtnosti i predloženih mjera ishoda za kardiovaskularnu sigurnost (uz srčanu aritmiju kao dodatnu mjeru ishoda) među bolesnicima s KOPB-om liječenima aklidinijem, prema planu ispitivanja usuglašenom s PRAC-om.
English: Bretaris Genuair statistically significantly reduced lung hyperinflation at rest (functional residual capacity [FRC]=0.197 L [95% CI=0.321, 0.072; p=0.002]; residual volume [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) and also improved trough inspiratory capacity (by 0.078 L; 95% CI=0.01, 0.145; p=0.025) and reduced dyspnoea during exercise (Borg scale) (by 0.63 Borg units; 95% CI=1.11, 0.14; p=0.012).
Croatian: Bretaris Genuair statistički je značajno smanjio hiperinflaciju pluća u mirovanju (funkcionalni rezidualni kapacitet [FRC]=0,197 l [95% CI=0,321, 0,072; p=0,002]; rezidualni volumen [RV]=0,238 l [95% CI=0,396, 0,079; p=0,004]) te je također poboljšao najniži inspiracijski kapacitet (za 0,078 l; 95% CI=0,01, 0,145; p=0,025) i smanjio dispneju tijekom vježbanja (Borgova ljestvica) (za 0,63 jedinica na Borgovoj ljestvici; 95% CI=1,11, 0,14; p=0,012).
English: In the 6-month study, patients receiving Bretaris Genuair 322 µg twice daily experienced a clinically meaningful improvement in their lung function (as measured by FEV1).
Croatian: 6-mjesečnom ispitivanju, bolesnici koji su primali Bretaris Genuair od 322 µg dvaput dnevno imali su kliničko značajno poboljšanje funkcije pluća (mjereno s FEV1).
English: Talk to your doctor, pharmacist or nurse before using Bretaris Genuair: - if you have had heart problems recently.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Bretaris Genuair.
English: No dose adjustments are necessary.
Croatian: Nije potrebno prilagođavati dozu.
English: Check mouthpiece opening
Croatian: Provjerite otvor nastavka za usta
English: GREEN
Croatian: ZELENO
English: No studies have been performed on hepatically-impaired patients.
Croatian: Nisu provedena ispitivanja na bolesnicima s oštećenom jetrom.
English: 1.4 Press the green button all the way down to load your dose (Figure E).
Croatian: 1.4 Pritisnite zeleni gumb do kraja da biste pripremili dozu (Slika E).
English: Bretaris Genuair contains lactose
Croatian: Bretaris Genuair sadrži laktozu
English: In the event of a change in COPD intensity while the patient is being treated with aclidinium bromide so that the patient considers additional rescue medication is required, a re-evaluation of the patient and the patients' treatment regimen should be conducted.
Croatian: Ako za vrijeme liječenja aklidinijevim bromidom dođe do promjene intenziteta KOPB-a te bolesnik treba dodatni lijek za brzo ublažavanje simptoma, potrebno je ponovno procijeniti stanje bolesnika i način njegovog liječenja.
English: Do not use this medicine after the expiry date which is stated on the inhaler label and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici inhalatora i kutiji iza oznake „Rok valjanosti“.
English: Bronchodilators relax airways and help keep bronchioles open.
Croatian: Bronhodilatatori opuštaju dišne puteve i na taj način pomažu malim dišnim putevima da ostanu otvoreni.
English: Bretaris Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious, longterm lung disease characterised by breathing difficulties.
Croatian: Bretaris Genuair se koristi za pomoć pri otvaranju dišnih puteva i ublažavanje simptoma KOPB-a, ozbiljne, dugotrajne plućne bolesti koju karakterizira otežano disanje.
English: The Bretaris Genuair Phase III clinical development programme included 269 patients treated with Bretaris Genuair 322 µg twice daily in one 6-month randomised, placebo-controlled study and 190 patients treated with Bretaris Genuair 322 µg twice daily in one 3-month randomised, placebocontrolled study.
Croatian: Faza III kliničkog programa razvoja lijeka Bretaris Genuair uključivala je 269 bolesnika liječenih Bretaris Genuairom od 322 µg dvaput dnevno u jednom 6-mjesečnom randomiziranom, placebom kontroliranom ispitivanju i 190 bolesnika liječenih Bretaris Genuairom od 322 µg dvaput dnevno u jednom 3-mjesečnom randomiziranom, placebom kontroliranom ispitivanju.
English: Following inhalation of 200 µg and 400 µg of aclidinium bromide by healthy subjects or COPD patients, the urinary excretion of unchanged aclidinium was very low at about 0.1% of the administered dose, indicating that renal clearance plays a minor role in the total aclidinium clearance from plasma.
Croatian: Nakon što su zdravi ispitanici ili KOPB bolesnici udisali 200 µg i 400 µg aklidinijeva bromida, izlučivanje nepromijenjenog aklidinija mokraćom bilo je vrlo nisko, tj. oko 0,1% primijenjene doze, ukazujući da bubrežni klirens ima malu ulogu u ukupnom klirensu aklidinija iz plazme.
English: Dry mouth, which has been observed with medicines like Bretaris Genuair, may after using your medicine for a long time, be associated with tooth decay.
Croatian: Suha usta, zabilježena uz lijekove poput Bretaris Genuair mogu nakon dugotrajnog uzimanja lijeka biti povezani sa zubnim karijesom.
English: What Bretaris Genuair contains - The active substance is aclidinium bromide.
Croatian: Što Bretaris Genuair sadrži - Djelatna tvar je aklidinijev bromid.
English: Bronchodilation
Croatian: Bronhodilatacija
English: Pooled efficacy analysis of the 6-month and 3-month placebo controlled studies demonstrated a statistically significant reduction in the rate of moderate to severe exacerbations (requiring treatment with antibiotics or corticosteroids or resulting in hospitalisations) with aclidinium 322 µg twice daily compared to placebo (rate per patient per year: 0.31 vs 0.44 respectively; p=0.0149).
Croatian: Združena analiza djelotvornosti 6-mjesečnih i 3-mjesečnih placebom kontroliranih ispitivanja pokazala je statistički značajno smanjenje stope umjerenih do teških egzacerbacija (koje zahtijevaju liječenje antibioticima ili kortikosteroidima ili rezultiraju hospitalizacijama) uz aklidinij od 322 µg dvaput dnevno u usporedbi s placebom (stopa po bolesniku godišnje: 0,31 naspram 0,44; p=0,0149).
English: Read steps 2.1 to 2.7 fully before use.
Croatian: Prije primjene u cijelosti pročitajte korake od 2.1 do 2.7.
English: The Bretaris Genuair group showed a statistically significant delay in the time to first moderate or severe exacerbation while on-treatment compared to the placebo group.
Croatian: U skupini liječenoj lijekom Bretaris Genuair zabilježeno je statistički značajno dulje vrijeme do prve umjerene ili teške egzacerbacije tijekom liječenja u odnosu na skupinu koja je primala placebo.
English: This corresponds to a metered dose of 400 µg aclidinium bromide equivalent to 343 µg aclidinium.
Croatian: To odgovara odmjernoj dozi od 400 µg aklidinijeva bromida, odnosno 343 µg aklidinija.
English: It is unknown whether aclidinium bromide / metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se aklidinijev bromid/metaboliti u majčino mlijeko u ljudi.
English: Studies in animals have shown foetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su fetotoksičnost samo pri puno višim dozama od maksimalne izloženosti aklidinijevom bromidu kod ljudi (vidjeti dio 5.3).
English: These conditions may be affected by the anticholinergic mechanism of action.
Croatian: Antikolinergički mehanizam djelovanja mogao bi utjecati na ta stanja.
English: 1 inhaler containing 30 doses 1 inhaler containing 60 doses 3 inhalers each containing 60 doses
Croatian: 1 inhalator koji sadrži 30 doza 1 inhalalator koji sadrži 60 doza 3 inhalatora koji sadrže po 60 doza
English: Do not hold the green button down while inhaling.
Croatian: Nemojte pritiskati zeleni gumb dok inhalirate lijek.
English: Nonclinical in vitro and in vivo studies showed rapid, dose-dependent and long-lasting inhibition by aclidinium of acetylcholine-induced bronchoconstriction.
Croatian: Neklinička ispitivanja in vitro i in vivo s aklidinijem pokazala su brzu, o dozi ovisnu i dugotrajnu inhibiciju bronhokonstrikcije izazvane acetilkolinom.
English: 2.7 Make sure the control window is now red (Figure K).
Croatian: 2.7 Uvjerite se da je kontrolni prozorčić sada crvene boje (Slika K).
English: Whole lung deposition of inhaled aclidinium bromide via the Genuair inhaler averaged approximately 30% of the metered dose.
Croatian: Ukupno taloženje aklidinijeva bromida u pluća, inhaliranog putem Genuair inhalatora, bilo je prosječno oko 30% odmjerne doze.
English: Aclidinium bromide is a maintenance bronchodilator and should not be used for the relief of acute episodes of bronchospasm, i.e. as a rescue therapy.
Croatian: Aklidinijev bromid se primjenjuje za održavanje bronhodilatacije i ne smije se koristiti za ublažavanje akutnih epizoda bronhospazma, tj. kao lijek za brzo ublažavanje simptoma.
English: Patients treated with Bretaris Genuair required less rescue medication than patients treated with placebo (a reduction of 0.95 puffs per day at 6 months [p=0.005]).
Croatian: Bolesnici liječeni Bretaris Genuairom trebali su manje lijeka za brzo ublažavanje simptoma od bolesnika liječenih placebom (smanjenje od 0,95 potisaka dnevno nakon 6 mjeseci [p=0,005]).
English: Exercise tolerance
Croatian: Tolerancija fizičkog napora
English: The frequency of patients with at least one MACE was 3.85% vs. 4.23% patients in the aclidinium and placebo groups, respectively.
Croatian: Udio bolesnika s najmanje jednim MACE događajem iznosio je 3,85% u skupini liječenoj aklidinijevim bromidom naspram 4,23% u skupini koja je primala placebo.
English: As aclidinium bromide is metabolised mainly by chemical and enzymatic cleavage in the plasma, hepatic dysfunction is very unlikely to alter its systemic exposure.
Croatian: Kako se aklidinijev bromid metabolizira uglavnom kemijskim i enzimatskim cijepanjem u plazmi, vrlo je mala vjerojatnost promjene sistemske izloženosti aklidinijevom bromidu zbog oštećenja jetre.