FrancophonIA/ELRC3.0 huggingface dataset:
English: - Insomnia - Confusion
Croatian: - Nesanica - Smetenost
English: Caution should be exercised when administering mirabegron in these patients.
Croatian: Potreban je oprez kada se mirabegron primjenjuje kod ovih bolesnika.
English: What you need to know before you take Betmiga 3.
Croatian: Što morate znati prije nego počnete uzimati Betmigu
English: Mirabegron exposure (AUC) was increased 1.8-fold in the presence of the strong inhibitor of CYP3A/P-gp ketoconazole in healthy volunteers.
Croatian: Ekspozicija mirabegronu (AUC) porasla je 1,8 puta u prisustvu snažnog inhibitora CYP3A/P-gp ketokonazola u zdravih dobrovoljaca.
English: Do not crush.
Croatian: Ne drobiti.
English: If you are breast feeding, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako dojite, upitajte svoga liječnika ili ljekarnika za savjet prije nego li počnete uzimati ovaj lijek.
English: Effect on intraocular pressure (IOP)
Croatian: Učinak na intraokularni tlak (IOT)
English: The study population consisted of approximately 48% antimuscarinic treatment naïve patients as well as approximately 52% patients previously treated with antimuscarinic medicinal products.
Croatian: Ispitivana populacija sastojala se od oko 48% bolesnika koji prethodno nisu primali antimuskarinsku terapiju, te oko 52% bolesnika koji su ranije liječeni s antimuskarinskim lijekovima.
English: Mean Cmax and AUC increased more than dose proportionally over the dose range.
Croatian: Srednja vrijednost Cmax i AUC porasli su više nego proporcionalno s dozom u rasponu primijenjenih doza.
English: Mild: GFR 60 to 89 mL/min/1.73 m2; moderate: GFR 30 to 59 mL/min/1.73 m2; severe: GFR 15 to 29 mL/min/1.73 m2.
Croatian: Blago: GFR 60 do 89 ml/min/1,73 m2; umjereno: GFR 30 do 59 ml/min/1,73 m2; teško: GFR 15 do 29 ml/min/1,73 m2.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Betmiga in one or more subsets of the paediatric population in “Treatment of idiopathic overactive bladder” and “Treatment of neurogenic detrusor overactivity” (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Betmiga u jednoj ili više podskupina pedijatrijske populacije u “Liječenju idiopatskog prekomjerno aktivnog mokraćnog mjehura” i “Liječenje neurogene prekomjerne aktivnosti detruzora” (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The urinary excretion of unchanged mirabegron is dose-dependent and ranges from approximately 6.0% after a daily dose of 25 mg to 12.2% after a daily dose of 100 mg.
Croatian: Izlučivanje urinom nepromijenjenog mirabegrona ovisi o dozi i kreće se od oko 6,0 % nakon dnevne doze od 25 mg do 12,2% nakon dnevne doze od 100 mg.
English: MedDRA System organ class
Croatian: MedDRA klasifikacija organskog sustava
English: Following the administration of 160 mg 14C-mirabegron to healthy volunteers, approximately 55% of the radiolabel was recovered in the urine and 34% in the faeces.
Croatian: Nakon primjene 160 mg 14C-mirabegrona u zdravih dobrovoljaca, oko 55% radioaktivnog biljega ustanovljeno je u urinu i 34% u fecesu.
English: - Hypertensive crisis
Croatian: - Hipertenzivna kriza
English: Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients.
Croatian: Krvni tlak se treba izmjeriti na početku liječenja te se redovito pratiti tijekom liječenja mirabegronom, posebice u bolesnika s hipertenzijom.
English: In healthy volunteers, the inhibitory potency of mirabegron towards CYP2D6 is moderate and the CYP2D6 activity recovers within 15 days after discontinuation of mirabegron.
Croatian: U zdravih dobrovoljaca, inhibitorni potencijal mirabegrona prema CYP2D6 je umjeren i aktivnost CYP2D6 se oporavlja unutar 15 dana nakon prekida primjene mirabegrona.
English: On the basis of the scientific conclusions for mirabegron the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mirabegron is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za mirabegron, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) mirabegron nepromijenjen, uz predložene izmjene informacija o lijeku.
English: From these cases, in 9 patients the confusion symptoms started within one week of start of mirabegron and all of them had positive dechallenge.
Croatian: Među tim su se slučajevima kod 9 bolesnika simptomi konfuzije javili unutar tjedan dana od početka liječenja mirabegronom i kod svih je zabilježen pozitivan dechallenge.
English: Interaction studies of mirabegron with metoprolol and with metformin used mirabegron immediate-release (IR) 160 mg.
Croatian: Ispitivanja interakcije mirabegrona s metoprololom i metforminom koristila su mirabegron s neposrednim oslobađanjem (IR, engl. immediate release) od 160 mg.
English: Treatment satisfaction - visual analogue scale (FAS) (Secondary)
Croatian: Zadovoljstvo liječenjem - vizualna analogna skala (FAS) (Sekundarni)
English: Taking into account the PRAC Assessment Report on the PSUR(s) for mirabegron, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za mirabegron, znanstveni zaključci su sljedeći:
English: Renal clearance (CLR) is approximately 13 L/h, which corresponds to nearly 25% of CLtot.
Croatian: Bubrežni klirens (CLR) je oko 13 l/h, što odgovara gotovo 25% CLtot.
English: It is a bladder muscle relaxant (a so called beta 3-adrenoceptor agonist), which reduces the activity of an overactive bladder and treats the related symptoms.
Croatian: To je tvar koja opušta mišiće mokraćnog mjehura (takozvani agonist beta 3-adrenoreceptora), koji smanjuje aktivnost prekomjerno aktivnog mokraćnog mjehura i liječi s time povezane simptome.
English: During the urine voiding phase, the bladder is predominantly under parasympathetic nervous system control.
Croatian: Tijekom faze pražnjenja mjehura, mjehur je prvenstveno pod kontrolom parasimpatičkog živčanog sustava.
English: No effects on fertility were seen at sub-lethal doses (human equivalent dose was 19-fold higher than the maximum human recommended dose (MHRD)).
Croatian: U subletalnim dozama nije primijećen učinak na plodnost (doza kod ljudi bila je 19 puta veća od maksimalno preporučene doze za ljude (engl. maximum recommended human dose - MRHD).
English: Dyspepsia Gastritis
Croatian: Dispepsija Gastritis
English: These results indicate that mirabegron enhances urine storage function by stimulating beta 3-adrenoceptors in the bladder.
Croatian: Ovi rezultati ukazuju da mirabegron poboljšava funkciju zadržavanja urina stimuliranjem beta 3-adrenoreceptora u mjehuru.
English: It is recommended that your doctor check your blood pressure while you are taking Mirabegron
Croatian: Preporučuje se da Vam liječnik provjerava krvni tlak tijekom uzimanja mirabegrona.
English: Renal elimination of mirabegron is primarily through active tubular secretion along with glomerular filtration.
Croatian: Eliminacija mirabegrona bubregom odvija se prvenstveno aktivnom tubularnom sekrecijom zajedno s glomerularnom filtracijom.
English: Pharmacotherapeutic group: Urologicals, urinary antispasmodics ATC code: G04BD12.
Croatian: Farmakoterapijska skupina: Urologici, urinarni spazmolitici ATK oznaka: G04BD12.
English: The recommended dose is one 50 mg tablet by mouth once daily.
Croatian: Preporučena doza je jedna tableta od 50 mg na usta jedanput na dan.
English: Strong CYP3A inhibitors see section 4.5
Croatian: Za snažne inhibitore CYP3A vidjeti dio 4.5
English: The effect of co-administered medicinal products on the pharmacokinetics of mirabegron and the effect of mirabegron on the pharmacokinetics of other medicinal products was studied in single and multiple dose studies.
Croatian: Učinak istodobno primijenjenih lijekova na farmakokinetiku mirabegrona i učinak mirabegrona na farmakokinetiku drugih lijekova ispitivan je primjenom jednostruke i višestruke doze.
English: Multiple doses of mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy volunteers.
Croatian: Višekratne doze mirabegrona do 300 mg na dan kroz 10 dana izazvale su ubrzanje pulsa i porast sistoličkog krvnog tlaka, kada je lijek primjenjivan na zdravim dobrovoljcima.
English: Not known side effects (frequency cannot be estimated from the available data)
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka)
English: In vitro erythrocyte concentrations of 14C-mirabegron were about 2-fold higher than in plasma.
Croatian: In vitro koncentracija 14Cmirabegrona u eritrocitima bila je oko 2 puta viša nego u plazmi.
English: Betmiga 50 mg once daily was effective at the first measured time point of week 4, and efficacy was maintained throughout the 12-week treatment period.
Croatian: 50 mg lijeka Betmiga jedanput na dan bilo je djelotvorno u vrijeme prvog mjerenja rezultata nakon navršenih 4 tjedna liječenja, njegova djelotvornost je održana tijekom svih 12 tjedana liječenja.
English: Total body clearance (CLtot) from plasma is approximately 57 L/h.
Croatian: Ukupni klirens (CLtot) iz plazme je oko 57 l/h.
English: Mirabegron is metabolised via multiple pathways involving dealkylation, oxidation, (direct) glucuronidation, and amide hydrolysis.
Croatian: Mirabegron se metabolizira višestrukim putevima uključujući dealkilaciju, oksidaciju, (izravnu) glukuronidaciju i hidrolizu amida.
English: Vaginal infection Cystitis
Croatian: Vaginalna infekcija Cistitis
English: If you stop taking Betmiga
Croatian: Ako prestanete uzimati Betmigu
English: The cardiovascular malformations observed in the rabbit were shown to be mediated via activation of the beta 1-adrenoceptor.
Croatian: Pokazalo se da su se u kunića primjećene kardiovaskularne malformacije odvijale preko aktivacije beta 1-adrenoreceptora.
English: - The active substance is mirabegron.
Croatian: - Djelatna tvar je mirabegron.
English: Effect of enzyme inhibitors
Croatian: Učinak inhibitora enzima
English: Study 074
Croatian: Ispitivanje 074
English: During the urine storage phase, when urine accumulates in the bladder, sympathetic nerve stimulation predominates.
Croatian: Tijekom faze zadržavanja urina, kada se on akumulira u mjehuru, prevladava stimulacija simpatičkog živčanog sustava.
English: Hepatic impairment(2)
Croatian: Oštećenje jetre(2)
English: Κύπρος Ελλάδα
Croatian: Κύπρος
English: CYP2D6 genetic polymorphism has minimal impact on the mean plasma exposure to mirabegron (see section 5.2).
Croatian: Genetski polimorfizam CYP2D6 je imao minimalan učinak na srednju vrijednost ekspozicije plazme mirabegronu (vidjeti dio 5.2).
English: Table 2: Co-primary and selected secondary efficacy endpoints at end of treatment for pooled studies
Croatian: Tablica 2: Višestruki primarni i izabrani sekundarni ishodi djelotvornosti na kraju liječenja za objedinjene rezultate ispitivanja
English: Based on in vitro studies, mirabegron is unlikely to inhibit the metabolism of co-administered medicinal products metabolised by the following cytochrome P450 enzymes: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP2E1 because mirabegron did not inhibit the activity of these enzymes at clinically relevant concentrations.
Croatian: Temeljeno na ispitivanjima in vitro nije vjerojatno da mirabegron inhibira metabolizam istodobno primijenjenih lijekova koji se metaboliziraju putem sljedećih enzima citokroma P450: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP2E1, budući da mirabegron nije inhibirao aktivnost ovih enzima u klinički značajnim koncentracijama.
English: Although in vitro studies suggest a role for CYP2D6 and CYP3A4 in the oxidative metabolism of mirabegron, in vivo results indicate that these isozymes play a limited role in the overall elimination.
Croatian: Premda in vitro ispitivanja upućuju na ulogu CYP2D6 i CYP3A4 u oksidativnom metabolizmu mirabegrona, rezultati dobiveni in vivo indiciraju da ovi izoenzimi imaju ograničenu ulogu u procesu sveukupne eliminacije.
English: The supra-therapeutic doses represent approximately 2.6- and 6.5-fold the exposure of the therapeutic dose, respectively.
Croatian: Supraterapijske doze predstavljale su oko 2,6 puta odnosno 6,5 puta veću ekspoziciju od terapijske doze.
English: Blood levels of this medicine are measured by your doctor.
Croatian: Razinu ovog lijeka u krvi izmjerit će Vaš liječnik.
English: Each dose level of mirabegron and moxifloxacin was evaluated in separate treatment arms each including placebo-control (parallel cross-over design).
Croatian: Svaka razina doze mirabegrona i moksifloksacina ocjenjivana je odvojeno, svaka u svojoj terapijskoj skupini, s placebo-kontrolnom skupinom (paralelno križno ispitivanje).
English: Therefore, mirabegron can be taken with or without food at the recommended dose.
Croatian: Stoga se mirabegron može primjenjivati u preporučenim dozama s hranom ili bez nje.
English: Betmiga contains the active substance mirabegron.
Croatian: Betmiga sadrži djelatnu tvar mirabegron.
English: Study 046
Croatian: Ispitivanje 046
English: In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended.
Croatian: U slučaju predoziranja preporučuje se praćenje brzine pulsa, krvnog tlaka i EKG-a.
English: A thorough QT (TQT) study (n = 164 healthy male and n = 153 healthy female volunteers with a mean age of 33 years) evaluated the effect of repeat oral dosing of mirabegron at the indicated dose (50 mg once daily) and two supra-therapeutic doses (100 and 200 mg once daily) on the QTcI interval.
Croatian: U temeljitom ispitivanju QT (TQT) (n = 164 zdravih muških i n = 153 zdravih ženskih ispitanika dobrovoljaca srednje dobi 33 godine) procjenjivao se učinak ponovljenih oralnih doza mirabegrona u indiciranoj dozi (50 mg jedanput na dan) i 2 supraterapijske doze (100 i 200 mg jedanput na dan) na QTcI interval.
English: If the blood level is out of range, your doctor may adjust the dose of digoxin.
Croatian: Ako je ona izvan dozvoljenih granica liječnik će možda trebati prilagoditi dozu digoksina.
English: Noradrenaline is released from nerve terminals, leading predominantly to beta adrenoceptor activation in the bladder musculature, and hence bladder smooth muscle relaxation.
Croatian: Noradrenalin se oslobađa iz živčanih završetaka dovodeći do aktivacije pretežno beta adrenoreceptora u muskulaturi mjehura, i posljedične relaksacije glatke muskulature mjehura.
English: Mirabegron increased Cmax and AUC by 29% and 27%, respectively, of the P-gp substrate digoxin in healthy volunteers.
Croatian: Mirabegron je povećao Cmax i AUC za 29% odnosno 27%, za P-gp supstrat digoksina u zdravih dobrovoljaca.
English: Most of patients are elderly patients according to the information included in the EVDAs but there are also non-elderly patients.
Croatian: Prema podacima iz baze podataka Eudravigilance većina je bolesnika bila starije dobi, no bilo je i bolesnika koji nisu starije dobi.
English: These specific medicines may require dose adjustment by your doctor.
Croatian: Ovi specifični lijekovi mogu zahtijevati prilagodbu doze koju će izvršiti Vaš liječnik.
English: There are limited amount of data from the use of Betmiga in pregnant women.
Croatian: Podaci o primjeni lijeka Betmiga u trudnica su ograničeni.
English: Renal impairment(1)
Croatian: Oštećenje bubrega(1)
English: No clinically relevant interactions have been observed when mirabegron was co-administered with therapeutic doses of solifenacin, tamsulosin, warfarin, metformin or a combined oral contraceptive medicinal product containing ethinylestradiol and levonorgestrel.
Croatian: Nisu zabilježene klinički relevantne interakcije kada se mirabegron primjenjivao istodobno s terapijskim dozama solifenacina, tamsulozina, varfarina, metformina ili s kombiniranim oralnim kontracepcijskim lijekovima koji su sadržavali etinilestradiol i levonorgestrel.
English: Mirabegron is transported and metabolised through multiple pathways.
Croatian: Mirabegron se transportira i metabolizira u organizmu putem nekoliko načina.
English: Betmiga should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB.
Croatian: Betmiga se također treba primjenjivati s oprezom i u bolesnika koji uzimaju antimuskarinske lijekove za liječenje OAB-a.
English: No dose-adjustment is needed when Betmiga is combined with inhibitors of CYP3A and/or P-gp.
Croatian: Nije potrebno prilagođavanje doze kada se Betmiga kombinira s inhibitorima CYP3A i/ili P-gp.
English: The effect of mirabegron on human fertility has not been established.
Croatian: Učinak mirabegrona na plodnost ljudi još nije utvrđen.
English: No studies have been conducted to assess the impact of mirabegron on milk production in humans, its presence in human breast milk, or its effects on the breast-fed child. Betmiga should not be administered during breast-feeding.
Croatian: Nisu provedena ispitivanja radi procjene utjecaja mirabegrona na stvaranje majčinog mlijeka kod ljudi, njegove prisutnosti u majčinom mlijeku ili njegovu učinku na dojenu djecu.
English: Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Mirabegron nije ispitivan u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C).
English: If you forget to take Betmiga
Croatian: Ako ste zaboravili uzeti Betmigu
English: In this TQT study, mirabegron increased heart rate on ECG in a dose dependent manner across the 50 mg to 200 mg dose range examined.
Croatian: U ovom TQT ispitivanju mirabegron je ubrzao frekvenciju srca na EKG-u na način ovisno o dozi, u ispitivanom rasponu doza od 50 do 200 mg.
English: Betmiga is not recommended in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Betmiga kod žena reproduktivne dobi koje ne koriste kontracepciju.
English: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
Croatian: Simptomatsko liječenje urgencije, povećane učestalosti mokrenja i/ili urgentne inkontinencije koja se javlja u odraslih bolesnika sa sindromom prekomjerno aktivnog mokraćnog mjehura.
English: Stopping treatment may result in recurrence of symptoms of overactive bladder.
Croatian: Prekidom liječenja mogu se povratiti simptomi prekomjerno aktivnog mokraćnog mjehura.
English: If you have kidney or liver problems, your doctor may need to reduce your dose to one 25 mg tablet by mouth once daily.
Croatian: Vaš će liječnik možda trebati smanjiti dozu na jednu tabletu od 25 mg na usta jedanput na dan.
English: Substances that are inducers of CYP3A or P-gp decrease the plasma concentrations of mirabegron.
Croatian: Učinak induktora enzima Tvari koje induciraju CYP3A ili P-gp snižavaju koncentraciju mirabegrona u plazmi.
English: - Tell your doctor if you use dabigatran etexilate (a medicine which is used to reduce the risk of brain or body vessel obstruction by blood clot formation in adult patients with an abnormal heart beat (atrial fibrillation) and additional risk factors).
Croatian: - Obavijestite svog liječnika ako koristite dabigatran eteksilat (lijek koji se koristi za smanjenje rizika od začepljenja krvnih žila krvnim ugrušcima u mozgu ili tijelu, u odraslih bolesnika s abnormalnim otkucajima srca (fibrilacija atrija) te dodatnim čimbenicima rizika).
English: Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru ili boci iza oznake „Rok valjanosti“ ili kratice “EXP“.
English: After once daily administration, plasma exposure of mirabegron at steady state is approximately double that seen after a single dose.
Croatian: Nakon primjene mirabegrona jedanput dnevno ekspozicija u plazmi mirabegrona u stanju dinamičke ravnoteže je oko 2 puta veća od one nakon pojedinačne doze.
English: Tablet core: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate Film-coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) (25 mg tablet only).
Croatian: Jezgra tablete: Makrogoli, hidroksipropilceluloza, butilhidroksitoluen, magnezijev stearat Film ovojnica: Hipromeloza, makrogol, žuti željezov oksid (E172), crveni željezov oksid (E172) (samo tablete od 25 mg).
English: HDPE bottles with child-resistant closure of polypropylene (PP) and a silica gel desiccant containing 90 tablets.
Croatian: Boce od polietilena visoke gustoće (HDPE) sa zatvaračem sigurnim za djecu od polipropilena (PP) i silikagelom kao sredstvom za sušenje koje sadrže 90 tableta.
English: Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg).
Croatian: Podaci o primjeni su ograničeni kod bolesnika s hipertenzijom stadija 2 (sistolički tlak ≥ 160 mm Hg ili dijastolički tlak ≥ 100 mm Hg).
English: Acetylcholine, released from pelvic nerve terminals, stimulates cholinergic M2 and M3 receptors, inducing bladder contraction.
Croatian: Acetilkolin, otpušten iz zdjeličnih živčanih završetaka, stimulira M2 i M3 kolinergične receptore potičući time kontrakciju mjehura.
English: In a monkey model, mirabegron showed decreased voiding frequency.
Croatian: Na modelu mjehura majmuna mirabegron je smanjio učestalost uriniranja.
English: Your doctor may need to reduce your dose or may tell you not to take Betmiga, especially if you are taking other medicines such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections).
Croatian: Vam možda reći da ne uzimate Betmigu, naročito ako uzimate neke druge lijekove, poput itrakonazola, ketokonazola (za gljivične infekcije), ritonavira (za HIV/AIDS) ili klaritomicina
English: Studies of mirabegron using human liver microsomes and recombinant human CYP enzymes showed that mirabegron is a moderate and timedependent inhibitor of CYP2D6 and a weak inhibitor of CYP3A.
Croatian: Ispitivanja mirabegrona na mikrosomima ljudske jetre i ljudskih rekombinantnih enzima CYP pokazala su da je mirabegron umjereni i vremensko ovisni inhibitor CYP2D6 i slab inhibitor CYP3A.
English: The co-primary efficacy endpoints were (1) change from baseline to end of treatment in mean number of incontinence episodes per 24 hours and (2) change from baseline to end of treatment in mean number of micturitions per 24 hours based on a 3-day micturition diary.
Croatian: Višestruki primarni ishodi djelotvornosti bili su (1) promjena od početne vrijednosti do kraja liječenja u srednjoj vrijednosti broja epizoda inkontinencije tijekom 24 sata, te (2) promjena od početne vrijednosti do kraja liječenja u srednjoj vrijednosti broja mikcija tijekom 24 sata, na temelju vođenja dnevnika mikcije kroz 3 dana.
English: Study 047
Croatian: Ispitivanje 047
English: There were no treatment-related effects of mirabegron on fertility in animals (see section 5.3).
Croatian: Nije utvrđen učinak primjene mirabegrona na plodnost kod životinja (vidjeti dio 5.3).
English: The safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga for at least 1 year (365 days).
Croatian: 5648 primilo najmanje jednu dozu mirabegrona u fazi 2/3 kliničkog programa, a 622 bolesnika je primalo lijek Betmiga najmanje 1 godinu (365 dana).
English: † Least squares mean adjusted for baseline, gender, study, subgroup, and subgroup by treatment interaction for Pooled Studies and least squares mean adjusted for baseline, gender, geographical region, subgroup, and subgroup by treatment interaction for Study 046.
Croatian: podskupinu i podskupinu prema interakciji liječenja za objedinjena ispitivanja i najmanji kvadrat srednje vrijednosti prilagođene za polaznu vrijednost, spol, geografsku regiju, podskupinu i podskupinu prema interakciji liječenja za ispitivanje 046.