natgillin/translations-raw huggingface dataset:
- 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). 
- Zdravniku morate povedati, če jemljete dabigatran eteksilat (zdravilo, ki pri odraslih bolnikih z motnjo srčnega utripa (atrijsko fibrilacijo) in dodatnimi ogrožajočimi dejavniki zmanjša nevarnost, da bi krvni strdek zamašil krvno žilo v možganih ali telesu).
Interaction studies of mirabegron with metoprolol and with metformin used mirabegron immediate-release (IR) 160 mg. 
Za študije medsebojnega delovanja mirabegrona z metoprololom in metforminom so uporabili odmerek 160 mg mirabegrona v tabletah s takojšnjim sproščanjem.
100 mg, the upper bound of the one-sided 95% confidence interval did not exceed 10 msec at any time point for the largest time-matched mean difference from placebo in the QTcI interval. 
100 mg mirabegrona, zgornja meja enostranskega 95 % intervala zaupanja za interval QTcI ni ob nobenem času presegla 10 milisekund za največjo časovno usklajeno povprečno razliko v primerjavi s placebom.
From these informative cases, only 14 cases were described in detail as they are considered as informative positive cases. 
Od teh informativnih primerov je bilo le 14 primerov podrobno opisanih, kjer so poročali o pozitivni vzročni povezavi med začetkom jemanja zdravila in pojavom neželenega učinka.
It is recommended that your doctor check your blood pressure while you are taking Mirabegron 
Priporočljivo je, da vam zdravnik med jemanjem mirabegrona spremlja krvni tlak.
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. 
Večkratno odmerjanje mirabegrona v tabletah s takojšnjim sproščanjem enkrat na dan je povzročilo 90 % povečanje Cmax in 229 % povečanje AUC enega samega odmerka metoprolola.
Co-administration of a 50 mg tablet with a high-fat meal reduced mirabegron Cmax and AUC by 45% and 17%, respectively. 
Sočasna uporaba 50-mg tablete z zelo mastnim obrokom je zmanjšala Cmax mirabegrona za 45 % in njegovo AUC za 17 %.
A low-fat meal decreased mirabegron Cmax and AUC by 75% and 51%, respectively. 
Malo masten obrok je zmanjšal Cmax mirabegrona za 75 % in njegovo AUC za 51 %.
- Bladder infection (cystitis) - Feeling your heartbeat (palpitations) - Vaginal infection - Indigestion (dyspepsia) - Infection of the stomach (gastritis) - Swelling of the joints - Itching of the vulva or vagina (vulvovaginal pruritus) - Increased blood pressure - Increase in liver enzymes (GGT, AST and ALT) - Itching, rash or hives (urticaria, rash, rash macular, rash papular, pruritus) 
- okužba nožnice - težave z želodcem (dispepsija) - okužba želodca (gastritis) - oteklost sklepov - srbenje zunanjega ženskega spolovila ali nožnice (vulvovaginalni pruritus) - zvišan krvni tlak - zvišanje jetrnih encimov (GGT, AST in ALT)
Mean number of episodes with urgency grades 3 or 4 per 24 hours (FAS) (Secondary) 
Povprečno število epizod urgentne mikcije 3. ali 4. stopnje na 24 ur (FAS) (sekundarni)
Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg). 
Podatkov pri bolnikih s stopnjo hipertenzije 2 (sistolični krvni tlak ≥ 160 mmHg in/ali diastolični krvni tlak ≥ 100 mmHg) je malo.
This medicinal product is not recommended for use in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors (see section 4.5). 
Zdravila ni priporočljivo uporabljati pri bolnikih s hudo okvaro ledvic (GFR 15 do 29 ml/min/1,73 m2), ki sočasno prejemajo močan zaviralec CYP3A (glejte poglavje 4.5).
Mirabegron has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis). 
Mirabegron ni raziskan pri bolnikih s končno odpovedjo ledvic (GFR < 15 ml/min/1,73 m2 in bolnikih, ki potrebujejo hemodializo).
Effects on pulse rate and blood pressure in patients with OAB In OAB patients (mean age of 59 years) across three 12-week phase 3 double blind, placebo controlled studies receiving Betmiga 50 mg once daily, an increase in mean difference from placebo of approximately 1 bpm for pulse rate and approximately 1 mm Hg or less in systolic blood pressure/diastolic blood pressure (SBP/DBP) was observed. 
Pri bolnikih s PASM (povprečna starost 59 let) ki so v treh 12-tedenskih, dvojno slepih, s placebom kontroliranih študijah 3. faze prejemali 50 mg zdravila Betmiga enkrat na dan, so v primerjavi s placebom ugotovili povečanje povprečne razlike srčne frekvence za približno 1 utrip na minuto in sistoličnega/diastoličnega krvnega tlaka za približno 1 mmHg ali manj.
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). 
Zdravilo ni priporočljivo uporabljati pri bolnikih z zmerno okvaro jeter (Child-Pugh B), ki sočasno prejemajo močan zaviralec CYP3A (glejte poglavje
† 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. 
korigirano za izhodiščno vrednost, spol, geografsko regijo, podskupino in podskupino interakcij zdravljenja za študijo 046.
- 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 
- oteklost vek (edem vek) - oteklost ustnic (edem ustnic) - otekanje globljih plasti kože zaradi kopičenja tekočine , ki lahko prizadene kateri koli del telesa,
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. 
MHRD, pri kuncih opazili malformacije pljuč (odsotnost dodatnega režnja v pljučih) in povečanje izgub po presaditvi, medtem ko so pri podganah pri sistemski izpostavljenosti, ki je bila 22-krat višja kot pri MHRD, opazili reverzibilne učinke na okostenelost (valovita rebra, zapoznela osifikacija, zmanjšano število okostenelih reber, dlančnic ali stopalnic).
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 tablet s podaljšanim sproščanjem EU/1/12/809/010 30 tablet s podaljšanim sproščanjem EU/1/12/809/011 60 tablet s podaljšanim sproščanjem EU/1/12/809/012 90 tablet s podaljšanim sproščanjem
Do not crush or chew the tablet. 
Tablete ne zdrobite in ne zgrizite.
Mirabegron increased Cmax and AUC by 29% and 27%, respectively, of the P-gp substrate digoxin in healthy volunteers. 
Pri zdravih prostovoljcih je za 29 % povečal Cmax in za 27 % AUC digoksina, ki je substrat P-gp.
This medicine may require dose adjustment by your doctor. 
Zdravnik vam bo mogoče moral prilagoditi odmerek tega zdravila.
Musculoskeletal and connective tissue disorders 
Bolezni mišično skeletnega sistema in vezivnega tkiva oteklost sklepov
(angioedema) - Small purple spots on the skin (purpura) - Inflammation of small blood vessels mainly affecting the skin (leukocytoclastic vasculitis) - Inability to completely empty the bladder (urinary retention) 
- vnetje drobnih žil, ki prizadene predvsem kožo (levkocitoklastični vaskulitis) - nezmožnost popolnega praznjenja mehurja (zastoj urina)
An increase in heart rate was observed in rats, rabbits, dogs and monkeys. 
Pri podganah, kuncih, psih in opicah so ugotovili povečanje srčne frekvence.
Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy of Betmiga in this age group has not been established. 
Varnost in učinkovitost zdravila Betmiga pri otrocih in mladostnikih do 18. leta starosti še nista bili dokazani, zato jim tega zdravila ne dajajte.
Interval p-value † Least squares mean adjusted for baseline, gender and geographical region. 
† Povprečje po metodi najmanjših kvadratov, korigirano za izhodiščno vrednost, spol in geografsko regijo.
If you miss several doses, tell your doctor and follow the advice given to you. 
morate to povedati zdravniku in upoštevati, kar vam bo svetoval.
Mirabegron demonstrated statistically significant larger improvements compared to placebo for both co-primary endpoints as well as secondary endpoints (see Tables 2 and 3). 
Mirabegron je oba soprimarna opazovana dogodka in sekundarne opazovane dogodke izboljšal statistično značilno bolj kot placebo (glejte preglednici 2 in 3).
No effects on fertility were seen at sub-lethal doses (human equivalent dose was 19-fold higher than the maximum human recommended dose (MHRD)). 
Med uporabo subletalnih odmerkov (ekvivalent človeškega odmerka je bil več kot 19-krat večji od največjega priporočenega odmerka pri človeku (MHRD - maximum human recommended dose)) niso opazili nobenega vpliva na plodnost.
Mirabegron is transported and metabolised through multiple pathways. 
Transport in presnova mirabegrona potekata po več poteh.
Mirabegron is predicted not to cause clinically relevant inhibition of OCT-mediated drug transport. 
Transporta zdravil z OCT mirabegron predvidoma ne zavre klinično pomembno.
EXP Use within 6 months after opening of the bottle 
EXP: Po odprtju plastenke morate zdravilo porabiti v 6 mesecih.
- Tell your doctor if you use digoxin (a medicine for heart failure or abnormal heart rhythm). 
- Zdravniku morate povedati, če jemljete digoksin (zdravilo za zdravljenje srčnega popuščanja in motenj srčnega ritma).
Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) and, therefore, it is not recommended for use in this patient population. 
Zdravilo Betmiga ni raziskano pri bolnikih s končno odpovedjo ledvic (GFR < 15 ml/min/1,73 m2 in bolnikih, ki potrebujejo hemodializo), zato ga v tej populaciji bolnikov ni priporočljivo uporabljati.
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. 
Pri prostovoljcih z zmerno okvaro ledvic (eGFR-MDRD od 30 do 59 ml/min/1,73 m2) je bila Cmax za 23 % večja in AUC za 66 % večja.
† Least squares mean adjusted for baseline, gender, and study. 
† Povprečje po metodi najmanjših kvadratov, korigirano za izhodiščno vrednost, spol in študijo.
There were no treatment-related effects of mirabegron on fertility in animals (see section 5.3). 
Pri živalih niso ugotovili z zdravljenjem povezanih vplivov mirabegrona na plodnost (glejte poglavje
The maximum mean difference from placebo in heart rate ranged from 6.7 bpm with mirabegron 50 mg up to 17.3 bpm with mirabegron 200 mg in healthy subjects. 
Največja povprečna razlika srčne frekvence v primerjavi s placebom je pri zdravih preiskovancih segala od 6,7 utripov na minuto s 50 mg mirabegrona do 17,3 utripov na minuto z 200 mg mirabegrona.
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). 
622 bolnikov pa je zdravilo Betmiga prejemalo vsaj 1 leto (365 dni).
Mean level of urgency (FAS) (Secondary) 
Povprečna raven urgentnih mikcij (FAS) (sekundarni)
These specific medicines may require dose adjustment by your doctor. 
Vaš zdravnik bo morda moral prilagoditi odmerek teh zdravil.
Very rare side effects (may affect up to 1 in 10,000 people) 
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov)
Tablet core: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate Film-coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) (25 mg tablet only). 
Filmska obloga: hipromeloza, makrogol, rumeni železov oksid (E172), rdeči železov oksid
You should take this medicine with liquids and swallow the tablet whole. 
Zdravilo morate vzeti s tekočino.
Blood levels of this medicine are measured by your doctor. 
Zdravnik vam kontrolira koncentracijo tega zdravila v krvi.
The potential for inhibition of P-gp by mirabegron should be considered when Betmiga is combined with sensitive P-gp substrates e.g. dabigatran. 
Če je zdravilo Betmiga uporabljeno v kombinaciji z občutljivimi substrati P-gp, npr. z dabigatranom, je treba upoštevati možnost zavrtja P-gp z mirabegronom.
In addition, the use of mirabegron in elderly patients is high according to the data from postmarketing exposure presented in the PSUR. 
Poleg tega je (po podatkih o izpostavljenosti po prihodu zdravila na trg v PSUR) uporaba mirabegrona pri starejših bolnikih velika.
Pharmacotherapeutic group: Urologicals, urinary antispasmodics ATC code: G04BD12. 
Oznaka ATC: G04BD12.
No dose-adjustment is needed when Betmiga is combined with inhibitors of CYP3A and/or P-gp. 
V primeru uporabe zdravila Betmiga skupaj z zaviralci CYP3A in/ali P-gp odmerka ni treba prilagoditi.
- Increased heart rate (tachycardia) - Infection of the structures that carry urine (urinary tract infections) - Nausea - Constipation - Headache - Diarrhoea - Dizziness 
- okužbe delov sečil, po katerih potuje urin (okužbe urinarnega trakta) - navzea - zaprtje - glavobol - driska - vrtoglavica
Nausea* Constipation* Diarrhoea* 
Bolezni prebavil navzea* zaprtje* driska*
Posology 
PRILOGA
Mean number of micturitions per 24 hours (FAS) 
Povprečno število mikcij na 24 ur (FAS)
Mean volume voided (mL) per micturition (FAS) (Secondary) 
Povprečna količina urina na mikcijo (ml) (FAS) (sekundarni)
Caution is advised if mirabegron is co-administered with medicinal products with a narrow therapeutic index and significantly metabolised by CYP2D6, such as thioridazine, Type 1C antiarrhythmics (e.g., flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine). 
Previdnost je potrebna, če je mirabegron uporabljen sočasno z zdravili, ki imajo ozek terapevtski indeks in se v pomembni meri presnavljajo s CYP2D6, npr. s tioridazinom, antiaritmiki skupine 1C
Mean number of urgency incontinence episodes per 24 hours (FAS-I) (Secondary) 
Povprečno število epizod urgentne inkontinence na 24 ur (FAS-I) (sekundarni)
The frequency of tachycardia was 1.2% in patients receiving Betmiga 50 mg. Tachycardia led to discontinuation in 0.1% patients receiving Betmiga 50 mg. 
Tahikardija je povzročila prekinitev zdravljenja pri 0,1 % bolnikov, zdravljenih s 50 mg zdravila Betmiga.
In males, the difference was 2.89 msec (upper bound of the one-sided 95% CI 4.90 msec). 
Pri moških je bila razlika 2,89 ms (zgornja meja enostranskega 95 % IZ
No dose adjustment is needed for mirabegron when administered with therapeutic doses of rifampicin or other CYP3A or P-gp inducers. 
Med uporabo mirabegrona s terapevtskimi odmerki rifampicina ali drugih induktorjev CYP3A ali P-gp odmerka mirabegrona ni treba prilagoditi.
Mirabegron increased mean voided volume per micturition and decreased the frequency of non-voiding contractions, without affecting voiding pressure, or residual urine in rat models of bladder overactivity. 
Mirabegron v podganjih modelih prekomerne aktivnosti sečnega mehurja poveča povprečno izpraznjeno količino urina na mikcijo in zmanjša pogostnost nemikcijskih kontrakcij, ne da bi vplival na tlak med praznjenjem ali količino rezidualnega urina.
FAS-I: Subset of FAS who also had at least 1 incontinence episode in the baseline diary. 
FAS-I: podnabor celotnega nabora za analizo obsega bolnike, ki so imeli v izhodiščnem dnevniku vsaj 1 epizodo inkontinence.
Betmiga 50 mg prolonged-release tablets Hypromellose 2910, 6 mPa.s Macrogol 8,000 
Betmiga 50 mg tablete s podaljšanim sproščanjem hipromeloza 2910,6 mPa.s makrogol 8.000 rumeni železov oksid (E172)
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. 
Je relaksant mišic mehurja (tako imenovani agonist adrenergičnih receptorjev beta 3).
Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) or severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations (see sections 4.4 and 5.2). 
Pri bolnikih s končno odpovedjo ledvic (GFR < 15 ml/min/1,73 m2 ali bolnikih, ki potrebujejo hemodializo) ali s hudo okvaro jeter (Child-Pugh C) zdravilo Betmiga ni raziskano, zato ga v tej populaciji bolnikov ni priporočljivo uporabljati (glejte poglavji 4.4 in 5.2).
Contents of the pack and other information 
Shranjevanje zdravila Betmiga Vsebina pakiranja in dodatne informacije
Betmiga 25 mg prolonged-release tablets Hypromellose 2910, 6 mPa.s Macrogol 8,000 
Betmiga 25 mg tablete s podaljšanim sproščanjem hipromeloza 2910,6 mPa.s makrogol 8.000 rumeni železov oksid (E172)
Following single dose administration of 100 mg Betmiga in volunteers with mild hepatic impairment (Child-Pugh Class A), mean mirabegron Cmax and AUC were increased by 9% and 19% relative to volunteers with normal hepatic function. 
Pri prostovoljcih z blago okvaro jeter (Child-Pugh A) sta bili povprečna Cmax in AUC zdravila Betmiga po enkratnem odmerku 100 mg mirabegrona za 9 % (Cmax) oz. 19 % (AUC) večji kot pri prostovoljcih z normalnim delovanjem jeter.
Confidence Interval p-value 
Vrednost p
Betmiga 50 mg prolonged release film-coated tablets are oval, yellow film-coated tablets, debossed with the company logo and “355” on the same side. 
Betmiga 50 mg tablete s podaljšanim sproščanjem so ovalne, rumene filmsko obložene tablete z vtisnjenima oznakama logo podjetja in “355” na isti strani.
Very rare Not known (cannot be estimated from the available data) 
(ni mogoče oceniti iz razpoložljivih podatkov)
Noradrenaline is released from nerve terminals, leading predominantly to beta adrenoceptor activation in the bladder musculature, and hence bladder smooth muscle relaxation. 
To povzroči predvsem aktiviranje adrenergičnih receptorjev beta v mišičju mehurja in s tem sprostitev gladkih mišic mehurja.
Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medicinal products for the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron. 
V obdobju trženja so pri bolnikih z obstrukcijo iztoka iz sečnega mehurja (BOO - bladder outlet obstruction), ki so jemali mirabegron, in pri bolnikih, ki so sočasno z antimuskariniki za zdravljenje PASM jemali mirabegron, poročali o zastoju urina.
* Statistically significantly superior compared to placebo at the 0.05 level without multiplicity adjustment. 
* Statistično značilno superiorno v primerjavi s placebom pri stopnji 0,05 in brez korekcije za večkratne primerjave.
Betmiga 25 mg prolonged release film-coated tablets are oval, brown film-coated tablets, debossed with the company logo and “325” on the same side. 
Betmiga 25 mg tablete s podaljšanim sproščanjem so ovalne, rjave filmsko obložene tablete z vtisnjenima oznakama logo podjetja in “325” na isti strani.
Efficacy in patients with or without prior OAB antimuscarinic therapy Efficacy was demonstrated in patients with and without prior OAB antimuscarinic therapy. 
Učinkovitost pri bolnikih s predhodnim antimuskarinskim zdravljenjem PASM ali brez njega
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). 
QTcI v primerjavi s placebom po 5 urah 3,67 milisekund (zgornja meja enostranskega 95 % IZ 5,72 milisekunde).
In addition mirabegron showed efficacy in patients who previously discontinued OAB antimuscarinic therapy due to insufficient effect (see Table 4). 
ki so predhodno antimuskarinsko zdravljenje PASM končali zaradi nezadostne učinkovitosti (glejte preglednico 4).
# Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment. 
# Statistično značilno superiorno v primerjavi s placebom pri stopnji 0,05 in s korekcijo za večkratne primerjave.
If you are breast feeding, ask your doctor or pharmacist for advice before taking this medicine. 
Če dojite, pred uporabo zdravila vprašajte za nasvet zdravnika ali farmacevta.
See section 4. 
in OCT3.
Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate exceeding 100 beats per minute (bpm) (3 of 6 subjects). 
Pri tem odmerku so zabeleženi neželeni učinki obsegali palpitacije (1 od 6 preiskovancev) in povečanje srčne frekvence nad 100 utripov na minuto (3 od 6 preiskovancev).
Each tablet contains 25 mg of mirabegron. 
Ena tableta vsebuje 25 mg mirabegrona.
Woman of childbearing potential 
Ženske v rodni dobi
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. 
V zdravstveni anamnezi pa je bolnik že imel podobno epizodo po uvedbi mirabegrona, ki se je pojavila 2 meseca pred poročanjem.
Dyspepsia Gastritis 
dispepsija gastritis edem ustnic
No dose adjustment is needed for mirabegron when administered with CYP2D6 inhibitors or in patients who are CYP2D6 poor metabolisers. 
Med uporabo mirabegrona z zaviralci CYP2D6 ali pri bolnikih, ki so slabi metabolizatorji s CYP2D6, njegovega odmerka ni treba prilagoditi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLES 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE
Mirabegron inhibited P-gp-mediated drug transport at high concentrations. 
V velikih koncentracijah je zavrl transport zdravil s P-gp.
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. 
Neželeni učinki, opaženi med 1-letno (dolgoročno) študijo, kontrolirano z zdravilno učinkovino (antimuskarinik), so bili podobne vrste in podobno izraziti kot neželeni učinki, opaženi v treh 12
Each tablet contains 50 mg of mirabegron. 
Ena tableta vsebuje 50 mg mirabegrona.
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. 
ki jih presnavljajo encimi citokroma P450: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in
The pharmacokinetics of mirabegron are not influenced by race. 
Rasa ne vpliva na farmakokinetiko mirabegrona.
Betmiga 25 mg prolonged-release tablets Betmiga 50 mg prolonged-release tablets 
Betmiga 25 mg tablete s podaljšanim sproščanjem Betmiga 50 mg tablete s podaljšanim sproščanjem
‡ Not statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment. 
‡ Ni statistično značilno superiorno v primerjavi s placebom pri stopnji 0,05 in s korekcijo za večkratne primerjave.
Betmiga 25 mg prolonged-release tablets Each tablet contains 25 mg of mirabegron. 
Betmiga 25 mg tablete s podaljšanim sproščanjem Ena tableta vsebuje 25 mg mirabegrona.
Unchanged mirabegron accounted for the majority of the faecal radioactivity. 
Večina radioaktivnosti v blatu je šla na račun nespremenjenega mirabegrona.