natgillin/translations-raw huggingface dataset:
Tablet core: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate Film-coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) (25 mg tablet only). 
Jezgra tablete: Makrogoli, hidroksipropilceluloza, butilhidroksitoluen, magnezijev stearat Film ovojnica: Hipromeloza, makrogol, žuti željezov oksid (E172), crveni željezov oksid (E172) (samo tablete od 25 mg).
HDPE bottles with child-resistant closure of polypropylene (PP) and a silica gel desiccant containing 90 tablets. 
Boce od polietilena visoke gustoće (HDPE) sa zatvaračem sigurnim za djecu od polipropilena (PP) i silikagelom kao sredstvom za sušenje koje sadrže 90 tableta.
Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg). 
Podaci o primjeni su ograničeni kod bolesnika s hipertenzijom stadija 2 (sistolički tlak ≥ 160 mm Hg ili dijastolički tlak ≥ 100 mm Hg).
Acetylcholine, released from pelvic nerve terminals, stimulates cholinergic M2 and M3 receptors, inducing bladder contraction. 
Acetilkolin, otpušten iz zdjeličnih živčanih završetaka, stimulira M2 i M3 kolinergične receptore potičući time kontrakciju mjehura.
In a monkey model, mirabegron showed decreased voiding frequency. 
Na modelu mjehura majmuna mirabegron je smanjio učestalost uriniranja.
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). 
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
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. 
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.
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. 
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.
Study 047 
Ispitivanje 047
There were no treatment-related effects of mirabegron on fertility in animals (see section 5.3). 
Nije utvrđen učinak primjene mirabegrona na plodnost kod životinja (vidjeti dio 5.3).
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). 
5648 primilo najmanje jednu dozu mirabegrona u fazi 2/3 kliničkog programa, a 622 bolesnika je primalo lijek Betmiga najmanje 1 godinu (365 dana).
† 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. 
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.
This was confirmed in rats with partial urethral obstruction, where mirabegron decreased the frequency of non-voiding contractions without affecting the voided volume per micturition, voiding pressure, or residual urine volume. 
Ovo je potvrđeno na štakorima s parcijalnom opstrukcijom uretre, kod kojih je mirabegron smanjio učestalost kontrakcija mjehura bez pražnjenja mjehura, ne utječući na volumen pražnjenja mjehura po mikciji, tlak uriniranja ili volumen rezidualnog urina.
Interaction of mirabegron with a known CYP2D6 inhibitor is not expected and was not studied. 
Ne očekuje se interakcija mirabegrona s poznatim inhibitorima CYP2D6, niti je ona ispitivana.
Macrogol 8,000 and 2,000,000 Hydroxypropylcellulose Butylhydroxytoluene Magnesium stearate 
Jezgra tablete makrogol 8000 i 2 000 000 hidroksipropilceluloza butilhidroksitoluen magnezijev stearat
Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies. 
Nuspojave primijećene tijekom jednogodišnjeg (dugoročnog) aktivno kontroliranog (muskarinskim antagonistima) ispitivanja bile su po tipu i težini slične onima u tri dvostruko slijepa, placebom kontrolirana ispitivanja faze 3 u trajanju od 12 tjedana.
Do not stop treatment with Betmiga early if you do not see an immediate effect. 
Ako ne vidite neposredni učinak Betmige, nemojte prerano prekinuti liječenje.
In addition, among the cases considered by the MAH as informative confounded cases there is also a case with confusion aggravated 2 days after initiating mirabegron and in the medical history a similar episode occurred 2 months prior the report after initiating mirabegron. 
Nadalje, među slučajevima koje je nositelj odobrenja ocijenio kao informativne slučajeve s ometajućim faktorom zabilježen je i slučaj pogoršanja konfuzije 2 dana nakon uvođenja mirabegrona, a u bolesnikovoj se anamnezi navodi slična epizoda nakon uvođenja mirabegrona 2 mjeseca prije prijavljivanja nuspojave.
Most drug-drug interactions were studied using a dose of 100 mg mirabegron given as oral controlled absorption system (OCAS) tablets. 
Najveći dio interakcija s drugim lijekovima ispitivan je primjenom doze od 100 mg mirabegrona danog kao tablete sa sistemom kontrolirane oralne apsorpcije (OCAS, engl. oral controlled absorption system).
In males, the difference was 2.89 msec (upper bound of the one-sided 95% CI 4.90 msec). 
Kod muškaraca razlika je iznosila 2,89 msek (gornja granica jednostranog 95% CI 4,90 msek).
How to take Betmiga 
Kako uzimati Betmigu
After oral administration of mirabegron in healthy volunteers mirabegron is absorbed to reach peak plasma concentrations (Cmax) between 3 and 4 hours. 
Nakon peroralne primjene mirabegrona u zdravih dobrovoljaca vršna koncentracija mirabegrona u plazmi (Cmax) dostignuta je za 3 do 4 sata.
Effect of mirabegron on CYP2D6 substrates 
Učinak mirabegrona na supstrate CYP2D6
Multiple once daily dosing of mirabegron IR resulted in a 90% increase in Cmax and a 229% increase in AUC of a single dose of metoprolol. 
Višekratno doziranje jednom dnevno mirabegrona IR rezultiralo je 90%-tnim povećanjem Cmax i 229%-tnim povećanjem AUC nakon jednokratne doze metoprolola.
The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors (see sections 4.4, 4.5 and 5.2). 
Sljedeća tablica navodi preporučene dnevne doze za osobe s oštećenom bubrežnom ili jetrenom funkcijom uz primjenu ili bez primjene snažnih inhibitora CYP3A (vidjeti dio 4.4, 4.5 i 5.2).
Mean difference from placebo† - 
Srednja razlika od placeba†
Betmiga has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, it is not recommended for use in this patient population. 
Betmiga nije ispitivana kod bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) te se stoga ne preporučuje njegova primjena u toj populaciji bolesnika.
- Tell your doctor if you use thioridazine (a medicine for mental illness), propafenone or flecainide (medicines for abnormal heart rhythm), imipramine or desipramine (medicines used for depression). 
- Obavijestite svog liječnika ako uzimate tioridazin (lijek za duševne bolesti), propafenon ili flekainid (lijekove za poremećaje srčanog ritma), imipramin ili dezipramin (lijekove koji se primjenjuju kod depresije).
- if you are allergic to mirabegron or any of the other ingredients of this medicine (listed in section 6) - if you have very high uncontrolled blood pressure. 
- ako ste alergični na mirabegron ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
They recovered in a short time after mirabegron discontinuation. 
Bolesnici su se oporavili ubrzo nakon prekida liječenja mirabegronom.
Pre-clinical studies have identified target organs of toxicity that are consistent with clinical observations. 
5.3 Neklinički podaci o sigurnosti primjene Pretklinička ispitivanja utvrdila su ciljne organe toksičnosti što se podudara s kliničkim zapažanjima.
In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. 
U 3 dvostruko slijepa, placebo kontrolirana ispitivanja faze 3, u trajanju od 12 tjedana, kod 88% bolesnika liječenje ovim lijekom provedeno je do kraja, a kod 4% bolesnika ono je prekinuto zbog nuspojava.
EU/1/12/809/001 10 prolonged-release tablets EU/1/12/809/002 20 prolonged-release tablets EU/1/12/809/003 30 prolonged-release tablets EU/1/12/809/004 60 prolonged-release tablets EU/1/12/809/005 90 prolonged-release tablets EU/1/12/809/006 200 prolonged-release tablets EU/1/12/809/015 50 prolonged-release tablets EU/1/12/809/016 100 prolonged-release tablets 
EU/1/12/809/001 10 tableta s produljenim oslobađanjem EU/1/12/809/002 20 tableta s produljenim oslobađanjem EU/1/12/809/003 30 tableta s produljenim oslobađanjem EU/1/12/809/004 60 tableta s produljenim oslobađanjem EU/1/12/809/005 90 tableta s produljenim oslobađanjem EU/1/12/809/006 200 tableta s produljenim oslobađanjem EU/1/12/809/015 50 tableta s produljenim oslobađanjem EU/1/12/809/016 100 tableta s produljenim oslobađanjem
- if you have kidney or liver problems. 
Imate li probleme s bubrezima i jetrom
In addition, malformations of the lung (absent accessory lobe of the lung) and increased post-implantation loss were observed in the rabbit at systemic exposures 14-fold higher than observed at the MHRD, while in the rat reversible effects on ossification were noted (wavy ribs, delayed ossification, decreased number of ossified sternebrae, metacarpi or metatarsi) at systemic exposures 22-fold higher than observed at the MHRD. 
Uz to utvrđene su malformacije pluća (nedostatak akcesornog lobusa pluća) te gubitak zametka nakon implantacije u kunića nakon sustavnog izlaganja 14 puta većeg od onog kod MHRD, dok su kod štakora, zabilježeni reverzibilni učinci osifikacija (neravna rebra i zakašnjela osifikacija sternebra, metakarpusa i metatarzusa) pri sustavnim izloženostima 22 puta većim od onih kod MHRD.
Transient increases in liver enzymes and hepatocyte changes (necrosis and decrease in glycogen particles) were seen in rats. 
U štakora je primijećen prolazni porast jetrenih enzima i promjene u hepatocitima (nekroza i sniženje glikogenskih čestica).
Mirabegron showed relaxation of bladder smooth muscle in rat and human isolated tissue, increased cyclic adenosine monophosphate (cAMP) concentrations in rat bladder tissue and showed a bladder relaxant effect in rat urinary bladder function models. 
Mirabegron je izazvao opuštanje glatke muskulature mjehura u štakora i u izoliranom humanom tkivu, porast koncentracije cikličkog adenozin-monofosfata (cAMP) u tkivu mjehura štakora i relaksirajući učinak na funkcionalnim modelima mjehura štakora.
Table 1: Daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors 
Tablica 1: Preporučene dnevne doze za osobe s oštećenom bubrežnom ili jetrenom funkcijom uz primjenu ili bez primjene snažnih inhibitora CYP3A
Clinically relevant drug interactions between mirabegron and medicinal products that inhibit, induce or are a substrate for one of the CYP isozymes or transporters are not expected except for the inhibitory effect of mirabegron on the metabolism of CYP2D6 substrates. 
Ne očekuje se klinički značajna interakcija između mirabegrona i lijekova koji inhibiraju, induciraju ili su supstrat u reakcijama za jedan od izoenzima CYP ili staničnim transporterima, osim inhibicijskog učinka mirabegrona na metabolizam supstrata CYP2D6.
However, in patients with mild to moderate renal impairment (GFR 30 to 89 mL/min/1.73 m2) or mild hepatic impairment (Child-Pugh Class A) concomitantly receiving strong CYP3A inhibitors, such as itraconazole, ketoconazole, ritonavir and clarithromycin, the recommended dose is 25 mg once daily with or without food (see section 4.2). 
30 do 89 ml/min/1,73 m2) ili blagim oštećenjem jetre (Child-Pugh stadij A) koji istodobno primaju snažne inhibitore CYP3A, poput itrakonazola, ketokonazola, ritonavira i klaritromicina, preporučena doza je 25 mg jedanput na dan s hranom ili bez nje (vidjeti dio 4.2).
The volume of distribution at steady state (Vss) is approximately 1670 L. Mirabegron is bound (approximately 71%) to human plasma proteins, and shows moderate affinity for albumin and alpha-1 acid glycoprotein. 
Mirabegron se veže (oko 71%) na humane proteine plazme i pokazuje umjereni afinitet za albumin i alfa-1 kiseli glikoprotein.
Betmiga at doses of 50 mg or 100 mg had no effect on the QT interval individually corrected for heart rate (QTcI interval) when evaluated either by sex or by the overall group. 
Učinak na QT-interval Betmiga u dozama od 50 mg ili 100 mg nije imao učinka na QT-interval, pojedinačno korigiran prema frekvenciji srčanih otkucaja (QTcI interval) kada je bio procjenjivan bilo po spolu ili sveukupno po skupinama.
Co-administration of a 50 mg tablet with a high-fat meal reduced mirabegron Cmax and AUC by 45% and 17%, respectively. 
Istodobna primjena tablete od 50 mg s obrokom s visokim sadržajem masnoće smanjuje Cmax i AUC mirabegrona za 45% odnosno 17%.
- Tell your doctor if you use digoxin (a medicine for heart failure or abnormal heart rhythm). 
- Obavijestite svog liječnika ako uzimate digoksin (lijek kod zatajivanja srca ili poremećenog srčanog ritma).
Data are limited in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2); based on a pharmacokinetic study (see section 5.2) a dose reduction to 25 mg is recommended in this population. 
Podaci o primjeni su ograničeni kod bolesnika s teškim oštećenjem bubrega (GFR 15 do 29 ml/min/1,73 m2); na temelju podataka dobivenih u ispitivanjima farmakokinetike (vidjeti dio 5.2) kod ovih se bolesnika preporučuje smanjenje doze na 25 mg.
Mirabegron has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis). 
Mirabegron nije ispitivan kod bolesnika u terminalnoj fazi bubrežne bolesti (GFR <15 ml/min/1,73 m2 ili bolesnicima na hemodijalizi).
No dose adjustment is needed for mirabegron when administered with therapeutic doses of rifampicin or other CYP3A or P-gp inducers. 
Nije potrebno prilagođavati dozu mirabegrona kada se primjenjuje s terapijskim dozama rifampicina ili drugih induktora CYP3A ili P-gp.
Mirabegron distributes to erythrocytes. 
Mirabegron se distribuira u eritrocite.
Urinary tract infection 
Infekcije urinarnog trakta
90 prolonged-release tablets 
90 tableta s produljenim oslobađanjem
CYP2D6 polymorphism 
Polimorfizam CYP2D6
In a phase 1 study assessing the effect of Betmiga on IOP using Goldmann applanation tonometry in 310 healthy subjects, a dose of mirabegron 100 mg was non-inferior to placebo for the primary endpoint of the treatment difference in mean change from baseline to day 56 in subject-average IOP; the upper bound of the two-sided 95% CI of the treatment difference between mirabegron 100 mg and placebo was 0.3 mm Hg. 
U ispitivanju faze 1 procjene učinka lijeka Betmiga na IOT korištenjem aplanacijskog tonometra po Goldmannu kod 310 zdravih ispitanika, doza mirabegrona od 100 mg nije bila inferiorna placebu za primarni ishod razlike liječenja u srednjoj vrijednosti promjene od početnih prosječnih vrijednosti IOT-a za ispitanike i vrijednosti nakon 56 dana liječenja; gornja granica dvostranog 95% CI razlike liječenja između 100 mg mirabegrona i placeba iznosila je 0,3 mm Hg.
Efficacy of Betmiga was evaluated in three phase 3 randomized, double blind, placebo controlled, 12week studies for the treatment of overactive bladder with symptoms of urgency and frequency with or without incontinence. 
Djelotvornost lijeka Betmiga ispitivana je u 3 randomizirana, dvostruko slijepa, placebo kontrolirana ispitivanja faze 3, u trajanju od 12 tjedana, za liječenje prekomjerno aktivnog mokraćnog mjehura sa simptomima nagona na mokrenje i učestalog mokrenja s inkontinencijom ili bez inkontinencije.
Therefore, after reviewing all data, confusional state should be included in section 4.8 of the SmPC with frequency unknown. 
Stoga je nakon ocjene svih podataka donesen zaključak da u dio 4.8 Sažetka opisa svojstava lijeka treba uvrstiti nuspojavu 'konfuzija' uz učestalost 'nepoznato'.
In volunteers with moderate hepatic impairment (Child-Pugh Class B), mean Cmax and AUC values were 175% and 65% higher. 
Kod dobrovoljaca s umjerenim oštećenjem jetre (Child-Pugh stadij B), srednje vrijednosti Cmax i AUC bile su više za 175% odnosno 65%.
FAS: Full analysis set, all randomized patients who took at least 1 dose of double blind study drug and who had a micturition measurement in the baseline diary and at least 1 post-baseline visit diary with a micturition measurement. 
Full Analysis Set), svi randomizirani bolesnici koji su primili najmanje 1 dozu dvostruko slijepo ispitivanog lijeka i kod kojih je provedeno mjerenje mikcije u dnevniku početnih vrijednosti, i najmanje 1 mjerenje mikcije u dnevniku kontrolnih pregleda s mjerenjem mikcije.
It is likely that this medicine passes into your breast milk. 
Betmiga vjerojatno prelazi u majčino mlijeko.
- Swelling of the eyelid (eyelid oedema) - Swelling of the lip (lip oedema) - Swelling of the deeper layers of the skin caused by a build-up of fluid, which can affect any part of the body including the face, tongue or throat and may cause difficulty in breathing 
- Oticanje usana (edem usana) - Oticanje dubljih slojeva kože uzrokovano nakupljanjem tekućine, koje može zahvatiti bilo koji dio tijela uključujući lice, jezik ili grlo i može uzrokovati otežano disanje (angioedem) - Male ljubičaste točke po koži (purpura) - Upala malih krvnih žila prvenstveno u koži (leukocitoklastični vaskulitis).
Mirabegron inhibited P-gp-mediated drug transport at high concentrations. 
Mirabegron je u visokim koncentracijama inhibirao transport lijeka posredovan P-gp-om.
The Cmax and AUC of mirabegron and its metabolites following multiple oral doses in elderly volunteers (≥ 65 years) were similar to those in younger volunteers (18-45 years). 
Nakon višekratnih oralnih doza u starijih dobrovoljaca (≥65 godina) Cmax i AUC mirabegrona i njegovih metabolita bili su slični onima u mlađih dobrovoljaca (18-45 godina).
If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital for advice immediately. 
Ako ste uzeli više tableta nego što Vam je rečeno, ili netko drugi slučajno uzme
10 prolonged-release tablets 20 prolonged-release tablets 30 prolonged-release tablets 50 prolonged-release tablets 60 prolonged-release tablets 90 prolonged-release tablets 100 prolonged-release tablets 200 prolonged-release tablets 
10 tableta s produljenim oslobađanjem 20 tableta s produljenim oslobađanjem 30 tableta s produljenim oslobađanjem 50 tableta s produljenim oslobađanjem 60 tableta s produljenim oslobađanjem 90 tableta s produljenim oslobađanjem 100 tableta s produljenim oslobađanjem 200 tableta s produljenim oslobađanjem
This medicinal product is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving strong CYP3A inhibitors (see section 4.5). 
Ovaj se lijek ne preporučuje za primjenu i u bolesnika s umjerenim oštećenjem jetre (Child-Pugh B) koji istodobno primaju snažne inhibitore CYP3A (vidjeti dio 4.5).
In volunteers with moderate renal impairment (eGFR-MDRD 30 to 59 mL/min/1.73 m2), Cmax and AUC were increased by 23% and 66%, respectively. 
U dobrovoljaca s umjerenim oštećenjem bubrega (eGFR-MDRD 30 do 59 ml/min/1,73 m2), Cmax i AUC bile su povećane za 23% odnosno 66%.
Vulvovaginal pruritus 
Vulvovaginal ni svrbež
Pooled studies consisted of 046 (Europe/Australia), 047 (North America [NA]) and 074 (Europe/NA). 
(Sjeverna Amerika) i 074 (Europa/Sjeverna Amerika).
Betmiga may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder. 
Vam može povećati vjerojatnost za nemogućnost pražnjenja mjehura ako imate opstrukciju izlaznog dijela mokraćnog mjehura ili ako uzimate lijekove za liječenje prekomjerno aktivnog mokraćnog mjehura.
Betmiga at doses of 50 mg and 100 mg once daily for 12 weeks in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO) showed no effect on cystometry parameters and was safe and well tolerated. 
Betmiga primijenjen u muškaraca sa simptomima donjeg urinarnog trakta i opstrukcijom na izlazu iz mjehura u dozama od 50 mg i 100 mg jedanput na dan kroz 12 tjedana, nije imao utjecaja na parametre cistometrije i njegova je primjena bila sigurna i dobro tolerirana.
Betmiga, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies (see section 5.1). 
Bolesnici s urođenim ili stečenim produljenjem QT intervala U kliničkim ispitivanjima Betmiga u terapijskim dozama nije pokazao klinički relevantno produljenje QT intervala (vidjeti dio 5.1).
Effect of CYP2D6 polymorphism 
Učinak polimorfizma CYP2D6
Angioedema* 
Purpura Angioedem*
Mirabegron is predicted not to cause clinically relevant inhibition of OCT-mediated drug transport. 
Ne očekuje se da će mirabegron izazvati klinički značajnu inhibiciju transporta lijeka pomoću sustava
Mirabegron is a weak inhibitor of P-gp. 
Učinak mirabegrona na transportere Mirabegron je slabi inhibitor P-gp.
EU/1/12/809/008 10 prolonged-release tablets EU/1/12/809/009 20 prolonged-release tablets EU/1/12/809/010 30 prolonged-release tablets EU/1/12/809/011 60 prolonged-release tablets EU/1/12/809/012 90 prolonged-release tablets EU/1/12/809/013 200 prolonged-release tablets EU/1/12/809/017 50 prolonged-release tablets EU/1/12/809/018 100 prolonged-release tablets 
EU/1/12/809/009 20 tableta s produljenim oslobađanjem EU/1/12/809/010 30 tableta s produljenim oslobađanjem EU/1/12/809/011 60 tableta s produljenim oslobađanjem EU/1/12/809/012 90 tableta s produljenim oslobađanjem
Mean level of urgency (FAS) (Secondary) 
Srednja razina urgencije (FAS) (Sekundarni)
Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. 
Oprez se također savjetuje pri istodobnoj primjeni mirabegrona sa supstratima CYP2D6 kojima se individualno titrira doza.
The MAH has cumulatively reviewed the cases of confusional state using the HLGT Deliria (including confusion). 
Nositelj odobrenja za stavljanje lijeka u promet proveo je kumulativnu ocjenu slučajeva konfuzije koristeći skupni pojam visoke razine (engl. high-level group term, HLGT) ‘delirij' (uključujući konfuziju).
There was also a case with confirmed positive rechallenge of symptoms after starting mirabegron three times. 
U jednom je slučaju potvrđen i pozitivan rechallenge, odnosno ponovna pojava simptoma nakon uvođenja mirabegrona u tri navrata.
In females administered mirabegron at the 50 mg dose, the mean difference from placebo on QTcI interval at 5 hours post dose was 3.67 msec (upper bound of the one-sided 95% CI 5.72 msec). 
Kod žena kojima je primjenjen mirabegron u dozi od 50 mg, razlika srednje vrijednosti naspram placebo skupine za QTcI interval 5 sati nakon primjene doze, iznosila je 3,67 msek (gornja granica jednostranog 95% CI 5,72 msek).