FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Pri bolnikih s hudo okvaro ledvic (GFR 15 do 29 ml/min/1,73 m2) so na voljo omejeni podatki; na podlagi farmakokinetične študije (glejte poglavje 5.2) je pri tej populaciji bolnikov priporočeno znižanje odmerka na 25 mg.
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.
Slovenian: V tej študiji TQT je mirabegron v raziskanem razponu odmerkov od 50 mg do 200 mg povečal srčno frekvenco na EKG odvisno od odmerka.
English: Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu ali plastenki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Mirabegron is a substrate for cytochrome P450 (CYP) 3A4, CYP2D6, butyrylcholinesterase, uridine diphospho-glucuronosyltransferases (UGT), the efflux transporter P-glycoprotein (P-gp) and the influx organic cation transporters (OCT) OCT1, OCT2, and OCT3.
Slovenian: (CYP) 3A4, CYP2D6, butirilholinesteraze, uridin-difosfo-glukuronoziltransferaz (UGT), iztočnega transporterja P-glikoproteina (P-gp) in vtočnih transporterjev organskih kationov (OCT) OCT1, OCT2
English: Two major metabolites were observed in human plasma; both are phase 2 glucuronides representing 16% and 11% of total exposure.
Slovenian: V človeški plazmi so ugotovili dva presnovka; oba sta glukuronida 2. faze in predstavljata
English: Subjective improvement in health-related quality of life measurements In the three 12-week phase 3 double blind, placebo controlled studies, treatment of the symptoms of OAB with mirabegron once daily resulted in a statistically significant improvement over placebo on the following health-related quality of life measures: treatment satisfaction and symptom bother.
Slovenian: Subjektivno izboljšanje mer zdravstvene kakovosti življenja V treh 12-tedenskih, dvojno slepih, s placebom kontroliranih študijah 3. faze je zdravljenje simptomov PASM z mirabegronom enkrat na dan v primerjavi s placebom statistično značilno izboljšalo zadovoljstvo z zdravljenjem in moteči vpliv simptomov (meri zdravstvene kakovosti življenja).
English: Strong CYP3A inhibitors(3) Without inhibitor
Slovenian: Močni zaviralci CYP3A(3) brez zaviralca z zaviralcem okvara ledvic(1)
English: Administration of mirabegron at doses of 50 mg and 100 mg once daily for 12 weeks did not adversely affect the maximum flow rate or detrusor pressure at maximum flow rate.
Slovenian: Uporaba 50 mg oz. 100 mg mirabegrona na dan 12 tednov ni neugodno vplivala na največji pretok ali na tlak detruzorja med največjim pretokom.
English: Betmiga is used to treat the symptoms of an overactive bladder in adults such as: - suddenly needing to empty your bladder (called urgency) - having to empty your bladder more than usual (called increased urinary frequency) - not being able to control when to empty your bladder (called urgency incontinence)
Slovenian: Zdravilo Betmiga uporabljamo za zdravljenje prekomerno aktivnega sečnega mehurja pri odraslih, na primer: - nenadne potrebe po praznjenju mehurja (to imenujemo urgentna mikcija) - potrebe po pogostejšem praznjenju mehurja, kot po navadi (to imenujemo pogosto uriniranje) - nezmožnosti za obvladovanje praznjenja mehurja (to imenujemo urgentna inkontinenca)
English: The main findings in rabbit embryofetal development studies included malformations of the heart (dilated aorta, cardiomegaly) at systemic exposures 36-fold higher than observed at the MHRD.
Slovenian: Glavne ugotovitve fetalno embriorazvojnih študij na kuncih, pri 36-krat večji sistemski izpostavljenosti kot pri MHRD, so vključevale malformacije srca (razširjena aorta, kardiomegalija).
English: 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
Slovenian: EU/1/12/809/001 10 tablet s podaljšanim sproščanjem EU/1/12/809/002 20 tablet s podaljšanim sproščanjem EU/1/12/809/003 30 tablet s podaljšanim sproščanjem EU/1/12/809/004 60 tablet s podaljšanim sproščanjem EU/1/12/809/005 90 tablet s podaljšanim sproščanjem EU/1/12/809/006 200 tablet s podaljšanim sproščanjem EU/1/12/809/015 50 tablet s podaljšanim sproščanjem EU/1/12/809/016 100 tablet s podaljšanim sproščanjem
English: Macrogol 8,000 and 2,000,000 Hydroxypropylcellulose Butylhydroxytoluene Magnesium stearate
Slovenian: Jedro tablete makrogol 8.000 in 2.000.000 hidroksipropilceluloza butilhidroksitoluen magnezijev stearat
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.
Slovenian: Študije mirabegrona s človeškimi jetrnimi mikrosomi in rekombinantnimi človeškimi encimi CYP so pokazale, da mirabegron zmerno in od časa odvisno zavira CYP2D6 in da šibko zavira
English: At a mirabegron dose of 200 mg, the QTcI interval did not exceed 10 msec at any time point in males, while in females the upper bound of the one-sided 95% confidence interval did exceed 10 msec between 0.5-6 hours, with a maximum difference from placebo at 5 hours where the mean effect was 10.42 msec (upper bound of the one-sided 95% CI 13.44 msec).
Slovenian: Z odmerkom 200 mg mirabegrona interval QTcI pri moških ni ob nobenem času presegel 10 milisekund, pri ženskah pa je zgornja meja enostranskega 95 % intervala zaupanja presegla 10 milisekund v obdobju od 0,5 do 6 ur; največjo razliko v primerjavi s placebom so zabeležili po 5 urah, ko je bil povprečni učinek 10,42 milisekund (zgornja meja enostranskega 95 % IZ 13,44 milisekunde).
English: Mirabegron exposure (AUC) was increased 1.8-fold in the presence of the strong inhibitor of CYP3A/P-gp ketoconazole in healthy volunteers.
Slovenian: Vpliv zaviralcev encimovPri zdravih prostovoljcih se je izpostavljenost mirabegronu (AUC) v prisotnosti močnega zaviralca CYP3A/P-gp ketokonazola povečala za 1,8-krat.
English: Mirabegron is the major circulating component following a single dose of 14C-mirabegron.
Slovenian: Mirabegron je po enem odmerku 14C-mirabegrona glavna snov v obtoku.
English: How to take Betmiga
Slovenian: Kako jemati zdravilo Betmiga
English: Patients with bladder outlet obstruction and patients taking antimuscarinics medicinal products for OAB
Slovenian: Bolniki z obstrukcijo sečnega mehurja in bolniki, ki jemljejo antimuskarinike za zdravljenje PASM
English: Mirabegron 100 mg once daily did not increase IOP in healthy subjects after 56 days of treatment.
Slovenian: Mirabegron v odmerku 100 mg enkrat na dan pri zdravih osebah po 56 dneh uporabe ni zvišal očesnega tlaka.
English: 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.
Slovenian: Okvara jeter Zdravilo Betmiga ni raziskano pri bolnikih s hudo okvaro jeter (Child-Pugh C), zato ga v tej populaciji bolnikov ni priporočljivo uporabljati.
English: Mirabegron distributes to erythrocytes.
Slovenian: Mirabegron se porazdeli v eritrocite.
English: 90 prolonged-release tablets
Slovenian: 90 tablet s podaljšanim sproščanjem
English: Betmiga contains the active substance mirabegron.
Slovenian: Zdravilo Betmiga vsebuje zdravilno učinkovino mirabegron.
English: The table below reflects the adverse reactions observed with mirabegron in the three 12-week phase 3 double blind, placebo controlled studies.
Slovenian: Spodnja preglednica prikazuje neželene učinke, opažene z mirabegronom v treh 12-tedenskih dvojno slepih, s placebom kontroliranih študijah 3. faze.
English: The activation of the M2 pathway also inhibits beta 3-adrenoceptor induced increases in cAMP.
Slovenian: Aktivacija poti M2 zavre tudi zvišanje cAMP, izzvano preko adrenergičnih receptorjev beta 3.
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).
Slovenian: - 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).
English: Interaction studies of mirabegron with metoprolol and with metformin used mirabegron immediate-release (IR) 160 mg.
Slovenian: Za študije medsebojnega delovanja mirabegrona z metoprololom in metforminom so uporabili odmerek 160 mg mirabegrona v tabletah s takojšnjim sproščanjem.
English: 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.
Slovenian: 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.
English: From these informative cases, only 14 cases were described in detail as they are considered as informative positive cases.
Slovenian: 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.
English: It is recommended that your doctor check your blood pressure while you are taking Mirabegron
Slovenian: Priporočljivo je, da vam zdravnik med jemanjem mirabegrona spremlja krvni tlak.
English: 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.
Slovenian: Večkratno odmerjanje mirabegrona v tabletah s takojšnjim sproščanjem enkrat na dan je povzročilo 90 % povečanje Cmax in 229 % povečanje AUC enega samega odmerka metoprolola.
English: Co-administration of a 50 mg tablet with a high-fat meal reduced mirabegron Cmax and AUC by 45% and 17%, respectively.
Slovenian: Sočasna uporaba 50-mg tablete z zelo mastnim obrokom je zmanjšala Cmax mirabegrona za 45 % in njegovo AUC za 17 %.
English: A low-fat meal decreased mirabegron Cmax and AUC by 75% and 51%, respectively.
Slovenian: Malo masten obrok je zmanjšal Cmax mirabegrona za 75 % in njegovo AUC za 51 %.
English: - 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)
Slovenian: - 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)
English: Mean number of episodes with urgency grades 3 or 4 per 24 hours (FAS) (Secondary)
Slovenian: Povprečno število epizod urgentne mikcije 3. ali 4. stopnje na 24 ur (FAS) (sekundarni)
English: Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg).
Slovenian: Podatkov pri bolnikih s stopnjo hipertenzije 2 (sistolični krvni tlak ≥ 160 mmHg in/ali diastolični krvni tlak ≥ 100 mmHg) je malo.
English: 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).
Slovenian: 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).
English: Mirabegron has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis).
Slovenian: Mirabegron ni raziskan pri bolnikih s končno odpovedjo ledvic (GFR < 15 ml/min/1,73 m2 in bolnikih, ki potrebujejo hemodializo).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Zdravilo ni priporočljivo uporabljati pri bolnikih z zmerno okvaro jeter (Child-Pugh B), ki sočasno prejemajo močan zaviralec CYP3A (glejte poglavje
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.
Slovenian: korigirano za izhodiščno vrednost, spol, geografsko regijo, podskupino in podskupino interakcij zdravljenja za študijo 046.
English: - 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
Slovenian: - oteklost vek (edem vek) - oteklost ustnic (edem ustnic) - otekanje globljih plasti kože zaradi kopičenja tekočine , ki lahko prizadene kateri koli del telesa,
English: 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.
Slovenian: 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).
English: 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
Slovenian: 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
English: Do not crush or chew the tablet.
Slovenian: Tablete ne zdrobite in ne zgrizite.
English: Mirabegron increased Cmax and AUC by 29% and 27%, respectively, of the P-gp substrate digoxin in healthy volunteers.
Slovenian: Pri zdravih prostovoljcih je za 29 % povečal Cmax in za 27 % AUC digoksina, ki je substrat P-gp.
English: This medicine may require dose adjustment by your doctor.
Slovenian: Zdravnik vam bo mogoče moral prilagoditi odmerek tega zdravila.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva oteklost sklepov
English: (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)
Slovenian: - vnetje drobnih žil, ki prizadene predvsem kožo (levkocitoklastični vaskulitis) - nezmožnost popolnega praznjenja mehurja (zastoj urina)
English: An increase in heart rate was observed in rats, rabbits, dogs and monkeys.
Slovenian: Pri podganah, kuncih, psih in opicah so ugotovili povečanje srčne frekvence.
English: 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.
Slovenian: Varnost in učinkovitost zdravila Betmiga pri otrocih in mladostnikih do 18. leta starosti še nista bili dokazani, zato jim tega zdravila ne dajajte.
English: Interval p-value † Least squares mean adjusted for baseline, gender and geographical region.
Slovenian: † Povprečje po metodi najmanjših kvadratov, korigirano za izhodiščno vrednost, spol in geografsko regijo.
English: If you miss several doses, tell your doctor and follow the advice given to you.
Slovenian: morate to povedati zdravniku in upoštevati, kar vam bo svetoval.
English: Mirabegron demonstrated statistically significant larger improvements compared to placebo for both co-primary endpoints as well as secondary endpoints (see Tables 2 and 3).
Slovenian: Mirabegron je oba soprimarna opazovana dogodka in sekundarne opazovane dogodke izboljšal statistično značilno bolj kot placebo (glejte preglednici 2 in 3).
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)).
Slovenian: 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.
English: Mirabegron is transported and metabolised through multiple pathways.
Slovenian: Transport in presnova mirabegrona potekata po več poteh.
English: Mirabegron is predicted not to cause clinically relevant inhibition of OCT-mediated drug transport.
Slovenian: Transporta zdravil z OCT mirabegron predvidoma ne zavre klinično pomembno.
English: EXP Use within 6 months after opening of the bottle
Slovenian: EXP: Po odprtju plastenke morate zdravilo porabiti v 6 mesecih.
English: - Tell your doctor if you use digoxin (a medicine for heart failure or abnormal heart rhythm).
Slovenian: - Zdravniku morate povedati, če jemljete digoksin (zdravilo za zdravljenje srčnega popuščanja in motenj srčnega ritma).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: † Least squares mean adjusted for baseline, gender, and study.
Slovenian: † Povprečje po metodi najmanjših kvadratov, korigirano za izhodiščno vrednost, spol in študijo.
English: There were no treatment-related effects of mirabegron on fertility in animals (see section 5.3).
Slovenian: Pri živalih niso ugotovili z zdravljenjem povezanih vplivov mirabegrona na plodnost (glejte poglavje
English: 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.
Slovenian: 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.
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).
Slovenian: 622 bolnikov pa je zdravilo Betmiga prejemalo vsaj 1 leto (365 dni).
English: Mean level of urgency (FAS) (Secondary)
Slovenian: Povprečna raven urgentnih mikcij (FAS) (sekundarni)
English: These specific medicines may require dose adjustment by your doctor.
Slovenian: Vaš zdravnik bo morda moral prilagoditi odmerek teh zdravil.
English: Very rare side effects (may affect up to 1 in 10,000 people)
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov)
English: Tablet core: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate Film-coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) (25 mg tablet only).
Slovenian: Filmska obloga: hipromeloza, makrogol, rumeni železov oksid (E172), rdeči železov oksid
English: You should take this medicine with liquids and swallow the tablet whole.
Slovenian: Zdravilo morate vzeti s tekočino.
English: Astellas Pharmaceuticals AEBE Τηλ: +30 210 8189900
Slovenian: Ελλάδα Τηλ: +30 210 8189900
English: Blood levels of this medicine are measured by your doctor.
Slovenian: Zdravnik vam kontrolira koncentracijo tega zdravila v krvi.
English: The potential for inhibition of P-gp by mirabegron should be considered when Betmiga is combined with sensitive P-gp substrates e.g. dabigatran.
Slovenian: Če je zdravilo Betmiga uporabljeno v kombinaciji z občutljivimi substrati P-gp, npr. z dabigatranom, je treba upoštevati možnost zavrtja P-gp z mirabegronom.
English: In addition, the use of mirabegron in elderly patients is high according to the data from postmarketing exposure presented in the PSUR.
Slovenian: Poleg tega je (po podatkih o izpostavljenosti po prihodu zdravila na trg v PSUR) uporaba mirabegrona pri starejših bolnikih velika.
English: Pharmacotherapeutic group: Urologicals, urinary antispasmodics ATC code: G04BD12.
Slovenian: Oznaka ATC: G04BD12.
English: No dose-adjustment is needed when Betmiga is combined with inhibitors of CYP3A and/or P-gp.
Slovenian: V primeru uporabe zdravila Betmiga skupaj z zaviralci CYP3A in/ali P-gp odmerka ni treba prilagoditi.
English: - Increased heart rate (tachycardia) - Infection of the structures that carry urine (urinary tract infections) - Nausea - Constipation - Headache - Diarrhoea - Dizziness
Slovenian: - okužbe delov sečil, po katerih potuje urin (okužbe urinarnega trakta) - navzea - zaprtje - glavobol - driska - vrtoglavica
English: Nausea* Constipation* Diarrhoea*
Slovenian: Bolezni prebavil navzea* zaprtje* driska*
English: Posology
Slovenian: PRILOGA
English: Mean number of micturitions per 24 hours (FAS)
Slovenian: Povprečno število mikcij na 24 ur (FAS)
English: Mean volume voided (mL) per micturition (FAS) (Secondary)
Slovenian: Povprečna količina urina na mikcijo (ml) (FAS) (sekundarni)
English: 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).
Slovenian: 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