FrancophonIA/ELRC3.0 huggingface dataset:
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/formoterol, according to a protocol agreed by the PRAC.
Croatian: Podnošenje rezultata dogovorenog ispitivanja sigurnosti primjene lijeka nakon stavljanja lijeka u promet (Post-Authorisation Safety Study, PASS) za aklidinijev bromid za procjenu ukupne smrtnosti i predloženih mjera ishoda kardiovaskularne sigurnosti (uz dodatnu mjeru ishoda, srčanu aritmiju) među bolesnicima s KOPB-om koji koriste aklidinij/formoterol, sukladno planu ispitivanja koji je usuglašen s PRACom.
English: Brimica Genuair is used for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD), in which the airways and air sacs in the lungs become damaged or blocked.
Croatian: Brimica Genuair se koristi kod odraslih bolesnika koji imaju poteškoće u disanju zbog bolesti pluća koja se naziva kronična opstruktivna plućna bolest (KOPB), pri kojoj su dišni putovi i zračne vrećice (alveole) u plućima oštećeni ili zatvoreni.
English: The Phase III clinical development programme included approximately 4,000 patients with a clinical diagnosis of COPD and comprised two 6-month randomised, placebo- and active-controlled studies (ACLIFORM-COPD and AUGMENT), a 6-month extension of the AUGMENT study and a further 12-month randomised controlled study.
Croatian: Program kliničkog razvoja faze III uključivao je približno 4000 bolesnika s kliničkom dijagnozom KOPB-a i sastojao se od dva 6-mjesečna randomizirana, placebom i aktivnim lijekom kontrolirana ispitivanja (ACLIFORM-COPD i AUGMENT), 6-mjesečni nastavak ispitivanja AUGMENT i daljnje 12-mjesečno randomizirano, kontrolirano ispitivanje.
English: Brimica Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Croatian: Brimica Genuair je indiciran u terapiji održavanja bronhodilatacije za ublažavanje simptoma u odraslih bolesnika s kroničnom opstruktivnom bolesti pluća (KOPB).
English: On the basis of the scientific conclusions for aclidinium bromide / formoterol fumarate dihydrate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aclidinium bromide / formoterol fumarate dihydrate is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za aklidinijev bromid/formoterolfumarat dihidrat, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) aklidinijev bromid/formoterolfumarat dihidrat nepromijenjen, uz predložene izmjene informacija o lijeku.
English: If you forget a dose of Brimica Genuair, just take it as soon as possible and take your next dose at the usual time.
Croatian: Ako ste zaboravili primijeniti Brimica Genuair Ako zaboravite dozu Brimica Genuaira, jednostavno je uzmite što je prije moguće i potom uzmite sljedeću dozu u uobičajeno vrijeme.
English: Make sure you have released the orange button, and you have breathed out completely.
Croatian: Obavezno otpustite narančasti gumb i potpuno izdahnite.
English: 2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips tightlyaround it (Figure J).
Croatian: 2.2 Držeći glavu uspravno, stavite nastavak u usta i čvrsto ga obujmite usnama (Slika J).
English: M3 receptors mediate contraction of airway smooth muscle.
Croatian: M3 receptori sudjeluju u kontrakciji glatkih mišića dišnih putova.
English: Do not use Brimica Genuair: - if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine (listed in Section 6).
Croatian: Nemojte primjenjivati Brimica Genuair: - ako ste alergični na aklidinij, formoterolfumarat dihidrat ili na drugi sastojak ovog lijeka
English: Following inhalation of Brimica Genuair 340/12 micrograms, with plasma sampling up to 24 hours post-dose, the terminal elimination half-life observed for aclidinium bromide ranged from 11-33 hours and for formoterol from 12-18 hours.
Croatian: Nakon inhalacije lijeka Brimica Genuair 340/12 mikrograma, s uzorkovanjem plazme do 24 sata nakon doziranja, opaženo terminalno poluvrijeme eliminacije za aklidinijev bromid je bilo u rasponu od 11-33 sata, a za formoterol od 12-18 sati.
English: The occurrence of blurred vision or dizziness may influence the ability to drive or to use machines.
Croatian: Pojava zamagljenog vida ili omaglice može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: - Instructions for use: Refer to the Instructions for Use at the end of this leaflet for instructions on how to use the Genuair inhaler.
Croatian: - Upute za uporabu: Za upute kako koristiti Genuair inhalator pogledajte Upute za uporabu.
English: Aclidinium has also been shown to provide benefits to patients with COPD in terms of symptoms reduction, improvement in disease-specific health status, reduction in exacerbation rates and improvements in exercise tolerance.
Croatian: Aklidinij ima dokazane koristi za bolesnike koji imaju KOPB u vidu smanjenja simptoma, poboljšanja u zdravstvenom statusu specifičnom za bolest, smanjenju stopa egzacerbacije i poboljšanju u toleranciji tjelesnog napora.
English: β2-adrenergic agonists may produce increases in pulse rate and blood pressure, electrocardiogram (ECG) changes such as T wave flattening, ST segment depression and prolongation of the QTcinterval in some patients.
Croatian: β2-adrenergički agonisti mogu u nekih bolesnika uzrokovati povišenje broja otkucaja i krvnog tlaka, promjene na elektrokardiogramu (EKG-u) kao što su ravnanje T vala, depresija ST segmenta i produljivanje QTc intervala.
English: A double dose should not be taken to make up for a forgotten dose.
Croatian: Ne smije se uzeti dvostruka doza kako bi se nadoknadila propuštena doza.
English: Lung volumes, exercise endurance and physical activity The effect of Brimica Genuair on lung volumes, exercise endurance and physical activity was investigated in an 8-week parallel, randomised, placebo-controlled clinical study in COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Croatian: Plućni volumeni, izdržani fizički napor i tjelesna aktivnost Učinak lijeka Brimica Genuair na plućne volumene, izdržani fizički napor i tjelesnu aktivnost, istražen je u paralelnom, randomiziranom, placebom kontroliranom kliničkom ispitivanju u trajanju od 8 tjedana u bolesnika koji imaju KOPB sa hiperinflacijom (funkcionalni rezidualni kapacitet [FRC]
English: Brimica Genuair is used as a maintenance (long-term) treatment for COPD.
Croatian: Brimica Genuair koristi se u terapiji održavanja (dugotrajnoj) kod KOPB-a.
English: Cytochrome P450 isoenzymes CYP2D6, CYP2C19, CYP2C9 and CYP2A6 are involved in the O-demethylation of formoterol.
Croatian: U O-demetilaciju formoterola uključeni su izoenzimi CYP2D6, CYP2C19,CYP2C9 i CYP2A6 citokroma P450.
English: These include: o corticosteroids that you take by mouth (such as prednisolone), o diuretics (such as furosemide or hydrochlorothiazide), o certain medicines used to treat breathing conditions (such as theophylline).
Croatian: Tu spadaju: o kortikosteroidi koji se uzimaju kroz usta (kao što je prednizolon), o diuretici (kao što su furosemid ili hidroklorotiazid), o određeni lijekovi kojima se liječe problemi s disanjem (kao što je teofilin).
English: The hydrolysis occurs both chemically (non-enzymatically) and enzymatically by esterases, butyrylcholinesterase being the main human esterase involved in the hydrolysis.
Croatian: Do hidrolize dolazi i kemijskim (neenzimskim) putem i enzimskim putem s esterazama, pri čemu je butirilkolinesteraza glavna humana esteraza uključena u hidrolizu.
English: 1.3 Hold the inhaler horizontally with the mouthpiece facing you and the orange button on top (Figure D).
Croatian: 1.3 Držite inhalator vodoravno, tako da nastavak za usta bude usmjeren prema Vama, a narančasti gumb okrenut prema gore (Slika D).
English: Brimica Genuair should be used with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma.
Croatian: Brimica Genuair treba oprezno koristiti u bolesnika s teškim kardiovaskularnim poremećajima, konvulzivnim poremećajima, tireotoksikozom i feokromocitomom.
English: A total of 1222 patients were treated with Brimica Genuair 340 micrograms /12 micrograms.
Croatian: Ukupno 1222 bolesnika bila su liječena Brimica Genuairom u dozi od 340 mikrograma/12 mikrograma.
English: Go to ‘STEP 2: Inhale your medicine'.
Croatian: Prijeđite na „2. KORAK: Inhalirajte lijek“.
English: Improvements in the PROactive total score were observed in patients treated with Brimica Genuair compared with placebo (p=0.0002).
Croatian: Poboljšanja u PROactive ukupnom rezultatu opažena su u bolesnika liječenih lijekom Brimica Genuair u usporedbi sa placebom (p=0,0002).
English: Brimica Genuair 340/12 micrograms twice daily consistently provided clinically meaningful improvements in lung function (as assessed by FEV1, forced vital capacity and inspiratory capacity) compared with placebo.
Croatian: Brimica Genuair u dozi od 340/12 mikrograma dvaput dnevno dosljedno je pokazao klinički značajna poboljšanja u funkciji pluća (po procjeni FEV1, forsiranog vitalnog kapaciteta i inspiratornog kapaciteta) u usporedbi s placebom.
English: The safety experience with Brimica Genuair comprised exposure in clinical trials at the recommended therapeutic dose for up to 12 months, and in post-marketing experience.
Croatian: Iskustvo sa sigurnošću Brimica Genuaira obuhvaća izloženost preporučenoj terapijskoj dozi u kliničkim ispitivanjima do 12 mjeseci, te iskustvo nakon stavljanja lijeka u promet.
English: The major part of a dose of formoterol is transformed by liver metabolism followed by renal elimination.
Croatian: Najveći dio doze formoterola metabolizira se u jetri, nakon čega slijedi bubrežna eliminacija.
English: Effects on lung function
Croatian: Učinci na funkciju pluća
English: The Genuair inhaler delivers the active ingredients directly into your lungs as you breathe in.
Croatian: Genuair inhalator prilikom udisaja dostavlja djelatne tvari izravno u Vaša pluća.
English: If you stop using Brimica Genuair
Croatian: Ako prestanete primjenjivati Brimica Genuair
English: Go back to ‘STEP 2 Inhale your medicine' and repeat steps 2.1 to 2.7.
Croatian: Vratite se na „2. KORAK: Inhalirajte lijek” i ponovite korake od 2.1 do 2.7.
English: - develop swelling of the face, throat, lips or tongue (with or without difficulty breathing or swallowing), severe itchy bumps on the skin (hives) as these may be symptoms of an allergic reaction.
Croatian: - Vam oteknu lice, grlo, usne ili jezik (sa ili bez otežanog disanja ili gutanja) te ako Vam se na koži pojave uzdignuća koje jako svrbe (koprivnjača) jer to mogu biti simptomi alergijske reakcije.
English: During the reporting period of the PSUR, study D6560C00002 was completed and showed that the proportion of patients with an adverse event of ‘peripheral oedema' was numerically lower in the aclidinium group than in the placebo group.
Croatian: Tijekom razdoblja obuhvaćenog PSUR-om, ispitivanje D6560C00002 je završeno te je pokazalo da je udio bolesnika sa štetnim događajem „periferni edem” brojčano manji u skupini koja je primala aklidinij u odnosu na skupinu koja je primala placebo.
English: In addition, Brimica Genuair statistically significantly delayed the time to first moderate or severe exacerbation compared to placebo (hazard ratio=0.70; p=0.027).
Croatian: Uz to, Brimica Genuair je statistički značajno odgodio vrijeme do prve umjerene ili teške egzacerbacije u usporedbi s placebom (omjer hazarda=0,70; p=0,027).
English: After removing the inhaler from the bag, the bag and desiccant sachet should be thrown away.
Croatian: Nakon što ste iz vrećice izvadili inhalator, potrebno je baciti vrećicu i vrećicu sa sredstvom za sušenje.
English: Electrocardiogram QTc prolonged Palpitations
Croatian: Produljeni QTc interval na elektrokardiogramu Palpitacije
English: White or almost white powder in a white inhaler with an integral dose indicator and an orange dosage button.
Croatian: Bijeli ili gotovo bijeli prašak u bijelom inhalatoru s ugrađenim pokazivačem doze i narančastim gumbom za doziranje.
English: Brimica Genuair has no or negligible influence on the ability to drive and use machines.
Croatian: Brimica Genuair ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In the long-term, dry mouth can be associated with tooth decay, so it is important to pay attention to oral hygiene.
Croatian: Nakon dugotrajnog uzimanja lijeka, suha usta mogu biti povezana sa zubnim karijesom stoga je važno voditi računa o higijeni usta.
English: Throw away the bag and the desiccant.
Croatian: Bacite vrećicu i sredstvo za sušenje.
English: No clinically relevant effects of Brimica Genuair on ECG parameters (including QT-interval) compared with aclidinium, formoterol and placebo were seen in Phase III studies of 6 to 12 months duration conducted in approximately 4,000 patients with COPD.
Croatian: Nisu zabilježeni klinički značajni učinci Brimica Genuaira na EKG parametre (uključujući QT interval) u usporedbi s aklidinijem, formoterolom i placebom u ispitivanjima faze III u trajanju od 6 do 12 mjeseci provedenim na približno 4000 bolesnika koji su imali KOPB.
English: Brimica Genuair is not indicated for the treatment of acute episodes of bronchospasm.
Croatian: Brimica Genuair ne smije se koristiti za liječenje akutnih epizoda bronhospazma.
English: Nonclinical studies investigating the effects of aclidinium/formoterol on cardiovascular parameters showed increased heart rates and arrhythmias at exposures sufficiently in excess of the maximum human exposure indication to be of little relevance to clinical use.
Croatian: Neklinička ispitivanja koja su istraživala učinke aklidinija/formoterola na kardiovaskularne parametre pokazala su povišenu srčanu frekvenciju i aritmije pri izloženostima koje su znatno veće od maksimalne izloženosti u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: Formoterol does not inhibit CYP450 enzymes at therapeutically relevant concentrations.
Croatian: Formoterol ne inhibira enzime CYP450 pri terapijski značajnim koncentracijama.
English: 1.4 Press the orange button all the way down to load your dose (Figure E).
Croatian: 1.4 Pritisnite narančasti gumb do kraja da biste pripremili dozu (Slika E).
English: Pooled efficacy analysis of the two 6-month Phase III studies demonstrated a statistically significant reduction of 29% in the rate of moderate or severe exacerbations (requiring treatment with antibiotics or corticosteroids or resulting in hospitalisations) with Brimica Genuair compared to placebo (rates per patient per year: 0.29 vs. 0.42, respectively; p=0.036).
Croatian: Združena analiza djelotvornosti dva 6-mjesečna ispitivanja faze III pokazala je statistički značajno smanjenje (od 29 %) stope umjerenih ili teških egzacerbacija (koje zahtijevaju liječenje antibioticima ili kortikosteroidima ili rezultiraju hospitalizacijama) s Brimica Genuairom u usporedbi s placebom (stopa po bolesniku po godini: 0,29 naspram 0,42; p=0,036).
English: Following intravenous administration of radiolabelled aclidinium 400 micrograms to healthy subjects, approximately 1% of the dose was excreted as unchanged aclidinium bromide in the urine.
Croatian: Nakon intravenske primjene 400 mikrograma radioobilježenog aklidinija kod zdravih ispitanika, oko 1% doze se izlučilo u urin kao nepromijenjeni aklidinijev bromid.
English: In vitro studies have shown that aclidinium or its metabolites are not substrates or inhibitors of P-glycoprotein.
Croatian: In vitro ispitivanja pokazala su da aklidinij i njegovi metaboliti nisu supstrati ni inhibitori P-glikoproteina.
English: Whole lung deposition of inhaled aclidinium via Genuair averaged approximately 30% of the metered dose.
Croatian: Ukupno nakupljanje aklidinija u plućima, inhaliranog putem Genuaira, bilo je prosječno oko 30% odmjerne doze.
English: Inhalation powder 1 inhaler containing 30 doses 1 inhaler containing 60 doses 3 inhalers each containing 60 doses
Croatian: 1 inhalator sadrži 30 doza 1 inhalator sadrži 60 doza 3 inhalatora od kojih svaki sadrži 60 doza
English: FEV1 at 1 hour post-dose and trough FEV1 (compared to aclidinium 400 micrograms and formoterol 12 micrograms, respectively) were defined as co-primary endpoints in both 6-month pivotal Phase III studies to demonstrate the bronchodilator contributions of formoterol and aclidinium in Brimica Genuair, respectively.
Croatian: FEV1 1 sat nakon doze i najniži FEV1 (u usporedbi s aklidinijem u dozi od 400 mikrograma odnosno formoterolom u dozi od 12 mikrograma) definirani su kao koprimarne mjere ishoda u oba 6-mjesečna pivotalna ispitivanja faze III kako bi se dokazali bronhodilatacijski doprinosi formoterola odnosno aklidinija u Brimica Genuairu.
English: It is supplied in a sealed protective aluminium bag containing a desiccant sachet.
Croatian: Isporučuje se u zatvorenoj zaštitnoj aluminijskoj vrećici koja sadrži vrećicu sa sredstvom za sušenje.
English: What Brimica Genuair contains - The active substances are aclidinium and formoterol fumarate dihydrate.
Croatian: Što Brimica Genuair sadrži - Djelatne tvari su aklidinij i formoterolfumarat dihidrat.
English: The Brimica Genuair clinical development programme was conducted in patients with moderate or severe COPD.
Croatian: Program kliničkog razvoja Brimica Genuaira proveo se na bolesnicima s umjerenim ili teškim KOPB-om.
English: - The effects of Brimica Genuair last for 12 hours; therefore, you should try to use Brimica Genuair at the same time each morning and evening as this will ensure that there is always enough medicine in your body to help you breathe more easily throughout the day and night.
Croatian: - Učinci Brimica Genuaira traju 12 sati; stoga nastojte koristiti Brimica Genuair uvijek u isto vrijeme ujutro, odnosno navečer.
English: Keep the Genuair inhaler protected inside the sealed bag until the administration period starts.
Croatian: Genuair inhalator čuvajte zaštićen u zatvorenoj vrećici do početka primjene lijeka.
English: The frequencies assigned to the adverse reactions are based on crude incidence rates observed with Brimica Genuair 340 micrograms /12 micrograms in the pooled analysis of randomised, placebo-controlled Phase III clinical studies of at least six months duration, or on experience with individual components.
Croatian: Učestalosti dodijeljene nuspojavama temelje se na grubim stopama incidencije zabilježenim s Brimica Genuairom u dozi od 340 mikrograma/12 mikrograma u združenoj analizi randomiziranih, placebom kontroliranih kliničkih ispitivanja faze III u trajanju od najmanje šest mjeseci, ili na iskustvu s pojedinim sastavnicama.
English: - If you get sudden tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Croatian: - Ako Vam se pojavi iznenadno stezanje u prsima, kašalj, piskanje ili nedostatak zraka neposredno nakon uzimanja lijeka.
English: Brimica Genuair provided a clinically meaningful improvement in disease-specific health status (as assessed by the St. George's Respiratory Questionnaire [SGRQ]) in study AUGMENT, with an improvement in the SGRQ total score compared to placebo of -4.35 units (p<0.0001).
Croatian: Brimica Genuair pokazao je klinički značajno poboljšanje zdravstvenog stanja povezanog s bolešću (procijenjenog pomoću upitnika St. George's Respiratory Questionnaire [SGRQ]) u ispitivanju AUGMENT, uz poboljšanje u SGRQ ukupnom rezultatu od -4,35 jedinica (p<0,0001) u usporedbi s placebom.
English: The inhaler is supplied sealed in a protective aluminium laminate bag containing a silica gel desiccant sachet, placed in a cardboard carton.
Croatian: Inhalator se isporučuje u zatvorenoj zaštitnoj vrećici od višeslojnog aluminija, koja sadržava vrećicu sa sredstvom za sušenje silikagel, u kartonskoj kutiji.
English: b. Do not press the orange button until you are ready to take a dose.
Croatian: b) Nemojte pritisnuti narančasti gumb dok ne budete spremni primijeniti dozu.
English: Brimica Genuair showed improvements compared to placebo in lung volumes at 2-3h post dose (FRC=-0.366 L [95% CI=0.515, -0.216; p<0.0001]; residual volume [RV]=-0.465 L [95% CI=-0.648, -0.281; p<0.0001] and inspiratory capacity [IC]=0.293 L [95% CI=0.208, 0.378; p<0.0001]).
Croatian: Brimica Genuair pokazao je poboljšanje, u usporedbi sa placebom, u plućnim volumenima 2-3 sata nakon primjene doze (FRC=-0,366 L [95% CI=-0,515, -0,216; p<0,0001]; rezidualni volumen [RV]=-0,465 L [95% CI=-0,648, -0,281; p<0,0001] i inspiracijski kapacitet [IC]= 0,293 L [95% CI=0,208, 0,378; p<0,0001]).
English: Clinical efficacy studies showed that Brimica Genuair provides clinically meaningful improvements in lung function (as measured by the forced expiratory volume in 1 second [FEV1]) over 12 hours following administration.
Croatian: Klinička ispitivanja djelotvornosti pokazala su da Brimica Genuair pruža klinički značajna poboljšanja plućne funkcije (mjereno forsiranim izdisajnim volumenom u prvoj sekundi [FEV1]) tijekom 12 sati nakon primjene.
English: This medicine contains two active ingredients called aclidinium and formoterol fumarate dihydrate.
Croatian: Lijek sadrži dvije djelatne tvari, aklidinij i formoterolfumarat dihidrat.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da bi mogli biti trudni ili planirate imati dijete obratite se svom liječniku, medicinskoj sestri ili ljekarniku za savjet prije nego uzmete ovaj lijek . Ne smijete koristiti Brimica Genuair ako ste trudni ili dojite osim ako Vam liječnik to ne kaže.
English: The mouthpiece is covered with a removable orange protective cap.
Croatian: Nastavak za usta pokriven je narančastom zaštitnom kapicom koja se može skidati.
English: In vitro studies have shown that aclidinium or its metabolites at the therapeutic dose are not expected to cause interactions with P-glycoprotein (P-gp) substrate drugs or drugs metabolised by cytochrome P450 (CYP450) enzymes and esterases.
Croatian: In vitro ispitivanja su pokazala da se ne očekuju interakcije aklidinija ili njegovih metabolita u terapijskoj dozi s lijekovima supstratima P-glikoproteina (P-gp) ili lijekovima koje metaboliziraju enzimi citokroma P450 (CYP450) i esteraze.
English: Studies in animals have shown foetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium and adverse effects in reproduction studies with formoterol at very high systemic exposure levels (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su fetalnu toksičnost samo pri dozama koje su značajno više od maksimalne izloženosti aklidiniju u ljudi te neželjene učinke u ispitivanjima reprodukcije s formoterolom pri vrlo visokim razinama sistemske izloženosti (vidjeti dio 5.3).
English: Following repeated inhalations of Brimica Genuair 340/12 micrograms, the systemic exposure of aclidinium and formoterol, as measured by AUC, is similar in Japanese and Caucasian patients.
Croatian: Nakon ponavljanih inhalacija lijeka Brimica Genuair 340/12 mikrograma, sistemska izloženost aklidiniju i formoterolu, mjereno prema AUC (površina ispod krivulje), je slična kod bolesnika Japanaca i bijelaca.
English: Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium and formoterol (see section 5.3).
Croatian: Ispitivanja na štakorima pokazala su blago smanjenje plodnosti samo pri dozama koje su značajno više od maksimalne izloženosti aklidiniju i formoterolu u ljudi (vidjeti dio 5.3).