FrancophonIA/ELRC3.0 huggingface dataset:
English: In healthy subjects who are genotypically poor metabolisers of CYP2D6 substrates (used as a surrogate for CYP2D6 inhibition), mean Cmax and AUCinf of a single 160 mg dose of a mirabegron IR formulation were 14% and 19% higher than in extensive metabolisers, indicating that CYP2D6 genetic polymorphism has minimal impact on the mean plasma exposure to mirabegron.
Croatian: U zdravih osoba, koje po svom genotipu slabo metaboliziraju supstrate CYP2D6 (koji su korišteni kao surogati za inhibiciju CYP2D6), nakon primjene jednokratne doze mirabegrona od 160 mg u obliku pripravka s trenutnim oslobađanjem, srednja vrijednost Cmax i AUCinf bila je 14 % odnosno 19 % viša nego u osoba koje ekstenzivno metaboliziraju supstrat, indicirajući da genetski polimorfizam
English: 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).
Croatian: Betmiga nije ispitivan u bolesnika u terminalnom stadiju bubrežne bolesti (GFR <15 ml/min/1,73 m2 ili bolesnicima koji su zahtijevali hemodijalizu) ili s teškim oštećenjem jetre (Child-Pugh stadij C) te se stoga ne preporučuje njegova primjena u tim populacijama bolesnika (vidjeti dio 4.4 i 5.2).
English: Betmiga is not recommended in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) or patients with moderate hepatic impairment (Child-Pugh Class B) concomitantly receiving strong CYP3A inhibitors (see sections 4.2 and 4.4).
Croatian: Betmiga se ne preporučuje kod bolesnika s teškim oštećenjem bubrega (GFR 15 do 29 ml/min/1,73 m2) ili kod bolesnika s umjerenim oštećenjem jetre (Child-Pugh stadij B) koji istodobno primaju snažne inhibitore CYP3A (vidjeti dio 4.2 i 4.4).
English: In vitro and ex vivo studies have shown the involvement from butyrylcholinesterase, UGT and possibly alcohol dehydrogenase (ADH) in the metabolism of mirabegron, in addition to CYP3A4 and CYP2D6.
Croatian: Ispitivanja in vitro i ex vivo pokazala su da uz CYP3A4 i CYP2D6 u metabolizmu mirabegrona sudjeluju i butirilholinesteraza, UGT i vjerojatno alkoholna dehidrogenaza (ADH).
English: Table 4: Co-primary efficacy endpoints for patients with prior OAB antimuscarinic therapy
Croatian: Tablica 4: Višestruki primarni ishodi djelotvornosti kod bolesnika koji su ranije primali antimuskarinske lijekove za OAB-a
English: How to store Betmiga
Croatian: Kako čuvati Betmigu
English: Betmiga 25 mg tablets
Croatian: Betmiga 25 mg tablete
English: Leukocytoclastic vasculitis Purpura
Croatian: Leukocitoklast ični vaskulitis
English: Mean number of episodes with urgency grades 3 or 4 per 24 hours (FAS) (Secondary)
Croatian: Srednji broj epizoda urgencije stupnja 3 ili 4 tijekom 24 sata (FAS) (Sekundarni)
English: The activation of the M2 pathway also inhibits beta 3-adrenoceptor induced increases in cAMP.
Croatian: receptora također inhibira porast koncentracije cAMP induciranog stimulacijom beta 3
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).
Croatian: Savjetuje se oprez ako se mirabegron istodobno primjenjuje s lijekovima koji imaju uski terapijski indeks i kada se metaboliziraju pomoću CYP2D6, kao što su tioridazin, antiaritmici tipa 1C (npr.
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.
Croatian: Maksimalna srednja vrijednost razlike frekvencije srca u zdravih dobrovoljaca u odnosu na placebo kretala se između 6,7 otkucaja u minuti uz 50 mg mirabegrona, do 17,3 otkucaja u minuti uz 200 mg mirabegrona.
English: This medicine may require dose adjustment by your doctor.
Croatian: Liječnik će možda trebati prilagoditi dozu ovog lijeka.
English: No dose adjustment is needed for mirabegron when administered with CYP2D6 inhibitors or in patients who are CYP2D6 poor metabolisers.
Croatian: Nema potrebe prilagođavanja doze mirabegrona kada se primjenjuje s inhibitorima CYP2D6 ili kod bolesnika koji slabo metaboliziraju supstrat CYP2D6.
English: 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.
Croatian: Betmiga 50 mg tablete s produljenim oslobađanjem su ovalne, žute filmom obložene tablete, s utisnutim logom tvrtke i oznakom “355” s iste strane.
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).
Croatian: U dozi od 200 mg mirabregona QTcI interval nije prelazio 10 msek u niti jednom trenutku kod muškaraca, dok je kod žena gornja granica jednostranog 95 % CI prelazila 10 msek između 0,5-6 sati, s maksimalnom razlikom u placebo skupini nakon 5 sati, dok je srednja vrijednost učinka bila 10,42 msek (gornja granica jednostranog
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.
Croatian: Mirabegron je supstrat citokroma P450 (CYP) 3A4, CYP2D6, butirilholinesteraze, uridindifosfo-glukuronozil-transferaze
English: Rare side effects (may affect up to 1 in 1,000 people)
Croatian: Rijetke nuspojave (mogu se pojaviti kod do 1 na 1000 ljudi)
English: 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.
Croatian: Betmiga 25 mg tablete s produljenim oslobađanjem su ovalne, smeđe filmom obložene tablete, s utisnutim logom tvrtke i oznakom “325” s iste strane.
English: Oval, brown tablet, debossed with the company logo and “325” on the same side.
Croatian: Ovalna, smeđa tableta, s utisnutim logom tvrtke i oznakom “325” s iste strane.
English: Steady state concentrations are achieved within 7 days of once daily dosing with mirabegron.
Croatian: Koncentracije u stanju dinamičke ravnoteže postižu se unutar 7 dana primjenom
English: The table below reflects the adverse reactions observed with mirabegron in the three 12-week phase 3 double blind, placebo controlled studies.
Croatian: Tablica u nastavku prikazuje nuspojave zabilježene tijekom primjene mirabegrona u 3 dvostruko slijepa, placebo kontrolirana ispitivanja faze III u trajanju od 12 tjedana.
English: 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.
Croatian: Učestalost tahikardije bila je 1,2% kod bolesnika koji su primali 50 mg lijeka Betmiga.
English: The pharmacokinetics of mirabegron are not influenced by race.
Croatian: Rasa ne utječe na farmakokinetiku mirabegrona.
English: mesoridazine, haloperidol, and chlorpromazine; o anti-infectives such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.
Croatian: prokainamida, ibutilida, flekainida, dofetilida i amiodarona; o lijekovi koji se primjenjuju kod alergijskog rinitisa; o antipsihotici (lijekovi za duševne bolesti) poput tioridazina, mezoridazina, haloperidola i klorpromazina; o lijekovi protiv infekcija poput pentamidina, moksifloksacina, eritromicina i klaritromicina.
English: Most adverse reactions were mild to moderate in severity.
Croatian: Većina nuspojava bila je po težini blaga do umjerena.
English: Efficacy in patients with or without prior OAB antimuscarinic therapy Efficacy was demonstrated in patients with and without prior OAB antimuscarinic therapy.
Croatian: Djelotvornost kod bolesnika s ili bez ranije terapije OAB-a antimuskarinskim lijekovima
English: However, since patients with a known history of QT prolongation or patients who are taking medicinal products known to prolong the QT interval were not included in these studies, the effects of mirabegron in these patients is unknown.
Croatian: Međutim, budući da bolesnici, kod kojih je bilo poznato da imaju produljenje QT intervala ili bolesnici koji su uzimali lijekove za koje je poznato da produljuju QT
English: Interval p-value † Least squares mean adjusted for baseline, gender and geographical region.
Croatian: 95%-tni interval pouzdanosti p-vrijednost † najmanji kvadrati srednje vrijednosti prilagođene za polaznu vrijednost, spol i geografsku regiju.
English: Betmiga 50 mg prolonged-release tablets Hypromellose 2910, 6 mPa.s Macrogol 8,000
Croatian: Betmiga 50 mg tablete s produljenim oslobađanjem hipromeloza 2910, 6 mPa.s makrogol 8000 željezov oksid, žuti (E172)
English: 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).
Croatian: U toj dozi prijavljene nuspojave uključivale su palpitacije (1 od 6 ispitanika) i ubrzanje pulsa preko 100 otkucaja u minuti (3 od 6 ispitanika).
English: † Least squares mean adjusted for baseline, gender, and study.
Croatian: † najmanji kvadrati srednje vrijednosti prilagođeni za početnu vrijednost, spol i ispitivanje.
English: Multiple once daily dosing of mirabegron resulted in a 79% increase in Cmax and a 241% increase in AUC of a single dose of desipramine.
Croatian: 79%-tnim povećanjem Cmax i 241%-tnim povećanjem AUC nakon jednokratne doze dezipramina.
English: Talk to your doctor or pharmacist before taking Betmiga: - if you have trouble emptying your bladder or you have a weak urine stream or if you take other medicines for the treatment of overactive bladder such as anticholinergic medicines.
Croatian: ako imate problema s pražnjenjem svog mjehura ili imate slabiji mlaz urina ili ako uzimate ostale lijekove za liječenje sindroma prekomjerno aktivnog mjehura kao što su antikolinergički lijekovi - ako imate problema s bubrezima ili jetrom.
English: Mirabegron is extensively distributed.
Croatian: Distribucija mirabegrona je opsežna.
English: Betmiga is available in aluminium-aluminium blister in packs containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets and in high density polyethylene (HDPE) bottles with silica gel desiccant and child-resistant closures containing 90 tablets.
Croatian: 60, 90, 100 ili 200 tableta i u bocama od polietilena visoke gustoće (HDPE) sa sredstvom za sušenje sa silikagelom i zatvaračem sigurnim za djecu koje sadrže 90 tableta.
English: Eyelid oedema
Croatian: Edem kapaka
English: Mean volume voided (mL) per micturition (FAS) (Secondary)
Croatian: Srednji volumen mokrenja (ml) po mikciji (FAS) (Sekundarni)
English: In the overall population of males and females, a 2-fold increase in dose from 50 mg to 100 mg mirabegron increased Cmax and AUCtau by approximately 2.9- and 2.6-fold, respectively, whereas a 4-fold increase in dose from 50 mg to 200 mg mirabegron increased Cmax and AUCtau by approximately 8.4- and 6.5-fold.
Croatian: U sveukupnoj populaciji muškaraca i žena, udvostručavanjem doze s 50 mg na 100 mg mirabegrona njegova se Cmax i AUCtau povećavaju oko 2,9 odnosno 2,6 puta,
English: Mean number of micturitions per 24 hours (FAS)
Croatian: Srednji broj mikcija tijekom 24 sata (FAS)
English: Mean number of urgency incontinence episodes per 24 hours (FAS-I) (Secondary)
Croatian: Srednja vrijednost broja epizoda urgentne inkontinencije tijekom 24 sata (FAS-I) (Sekundarni)
English: Branch Belgique/Belgien Tél/Tel: +32 (0)2 5580710
Croatian: Astellas Pharma B.V.Branch Belgique/Belgien Tél/Tel: +32 (0)2 5580710
English: In volunteers with severe renal impairment (eGFR-MDRD 15 to 29 mL/min/1.73 m2), mean Cmax and AUC values were 92% and 118% higher.
Croatian: 15 do 29 ml/min1/.73 m2), srednje vrijednosti Cmax i AUC bile su 92% odnosno 118% više.
English: Patients with bladder outlet obstruction and patients taking antimuscarinics medicinal products for OAB
Croatian: Bolesnici koji su ranije primali antimuskarinske lijekove za OAB-a
English: Betmiga 25 mg prolonged-release tablets Each tablet contains 25 mg of mirabegron.
Croatian: Betmiga 25 mg tablete s produljenim oslobađanjem Svaka tableta sadrži 25 mg mirabegrona.
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.
Croatian: Betmiga kombinira s osjetljivim supstratima P-gp, npr. dabigatranom.
English: ALT increased *observed during post-marketing experience
Croatian: *primijećene nakon stavljanja lijeka u promet
English: Eye disorders
Croatian: Poremećaji očiju
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.
Croatian: (dilatirana aorta, kardiomegalija) nakon sustavnog izlaganja 36 puta većem od onog primjećenog kod
English: Mean number of micturitions per 24 hours (FAS) (Co-primary)
Croatian: Srednji broj mikcija tijekom 24 sata (FAS) (Višestruki primarni)
English: In addition mirabegron showed efficacy in patients who previously discontinued OAB antimuscarinic therapy due to insufficient effect (see Table 4).
Croatian: Nadalje, mirabegron je bio djelotvoran kod bolesnika koji su prethodno prekinuli terapiju
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.
Croatian: Kod bolesnika s OAB-om (srednje dobi od 59 godina) ispitivanih tijekom 12 tjedana dvostruko slijepog, placebo kontroliranog ispitivanja faze 3, koji su primali 50 mg lijeka Betmiga jedanput na dan, zabilježen je porast srednje vrijednosti razlike u odnosu na placebo u brzini pulsa od oko
English: 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.
Croatian: Mirabegron je na modelima hiperaktivnog mjehura štakora povećao srednju vrijednost volumena uriniranja po mikciji i smanjio učestalost kontrakcija bez uriniranja, bez djelovanja na tlak mokrenja ili rezidualni urin.
English: Headache* Dizziness*
Croatian: Glavobolja* Omaglica*
English: Pharmacokinetic studies performed with radio-labelled mirabegron have shown that the parent compound and/or its metabolites are excreted in the milk of rats at levels that were approximately 1.7-fold higher than plasma levels at 4 hours post administration (see section 4.6).
Croatian: Ispitivanja farmakokinetike provedena s radiološki obilježenim mirabegronom pokazala su da se ishodni spoj i/ili njegovi metaboliti izlučuju u mlijeko štakora dostižući razine koje su otprilike
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.
Croatian: U 3 dvostruko slijepa, placebo kontrolirana ispitivanja faze 3 u trajanju od 12 tjedana, liječenje simptoma OAB-a primjenom mirabegrona jedanput na dan, rezultiralo je, u usporedbi s placebom,
English: Urticaria Rash
Croatian: Urtikarija Osip
English: - Increased heart rate (tachycardia) - Infection of the structures that carry urine (urinary tract infections) - Nausea - Constipation - Headache - Diarrhoea - Dizziness
Croatian: - Vaginalna infekcija - Probavne tegobe (dispepsija) - Infekcija želuca (gastritis)
English: Mean change from baseline† Mean difference from placebo† (95% CI) p-value
Croatian: Srednja promjena od početne vrijednosti† Srednja razlika vrijednosti od placeba† (95% CI) p-vrijednost
English: The frequency of urinary tract infections was 2.9% in patients receiving Betmiga 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving Betmiga 50 mg. Serious adverse reactions included atrial fibrillation (0.2%).
Croatian: Učestalost infekcija urinarnog trakta bila je 2,9% kod bolesnika koji su primali 50 mg lijeka Betmiga.
English: Betmiga 25 mg prolonged-release tablets Betmiga 50 mg prolonged-release tablets
Croatian: Betmiga 25 mg tablete s produljenim oslobađanjem Betmiga 50 mg tablete s produljenim oslobađanjem
English: Woman of childbearing potential
Croatian: Žene reproduktivne dobi
English: In addition, the use of mirabegron in elderly patients is high according to the data from postmarketing exposure presented in the PSUR.
Croatian: Osim toga, prema podacima o izloženosti nakon stavljanja lijeka u promet prikazanima u PSUR-u, mirabegron se često koristi u starijih bolesnika.
English: Betmiga 25 mg prolonged-release tablets Hypromellose 2910, 6 mPa.s Macrogol 8,000
Croatian: Betmiga 25 mg tablete s produljenim oslobađanjem hipromeloza 2910, 6 mPa.s makrogol 8000 željezov oksid, žuti (E172) željezov oksid, crveni (E172)
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)
Croatian: - iznenadna potreba za pražnjenjem mokraćnog mjehura (nagon na mokrenje) - potreba za pražnjenjem mokraćnog mjehura češće nego li je to uobičajeno (povećana učestalost mokrenja)
English: o antipsychotic medicines (medicines for mental illness) such as thioridazine,
Croatian: o lijekovi koji se primjenjuju kod poremećaja srčanog ritma, poput kinidina, sotalola,
English: Patients with prior OAB antimuscarinic therapy Mean number of incontinence episodes per 24 hours (FAS-I)
Croatian: Placeb o Mirabegro n 50 mg Srednja vrijednost broja epizoda inkontinencije tijekom 24 sata (FAS-I) (Višestruki primarni)
English: 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.
Croatian: (Child-Pugh stadij A), srednja vrijednost Cmax i AUC mirabegrona povećana je za 9% odnosno 19%, u usporedbi s dobrovoljcima s normalnom funkcijom jetre.
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.
Croatian: I kod muškaraca i kod žena na kojima je primjenjen mirabegron u dozama od 50 i 100 mg najveća razlika u QTcI intervalu nije bila veća od 10 msek (gornja granica jednostranog 95% CI) u bilo kojem trenutku mjerenja u usporedbi s placebo skupinom.
English: The most common adverse reactions reported for patients treated with Betmiga 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections.
Croatian: dvostruko slijepa, placebo kontrolirana ispitivanja faze 3, u trajanju od 12 tjedana, bile su tahikardija i infekcije urinarnog trakta.
English: Adults (including elderly patients) The recommended dose is 50 mg once daily
Croatian: Preporučena doza iznosi 50 mg jedanput na dan.
English: * Statistically significantly superior compared to placebo at the 0.05 level without multiplicity adjustment.
Croatian: * Statistički značajno bolje u usporedbi s placebom na razini 0,05 bez prilagođavanja multipliciteta.
English: Teл.
Croatian: MHRD.
English: Each tablet contains 25 mg of mirabegron.
Croatian: Svaka tableta sadrži 25 mg mirabegrona.
English: Each tablet contains 50 mg of mirabegron.
Croatian: Svaka tableta sadrži 50 mg mirabegrona.
English: Mean change from baseline† -0.92 Mean difference from placebo† -95% Confidence Interval
Croatian: Srednja promjena od početne vrijednosti† Srednja razlika od placeba† 95%-tni interval pouzdanosti
English: 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.
Croatian: Zabilježena je retencija urina u bolesnika s opstukcijom izlaznog dijela mokraćnog mjehura (BOO, engl. bladder outlet opstruction) i u bolesnika koji uzimaju antimuskarinske lijekove za liječenje
English: Blood pressure increased
Croatian: Porast krvnog tlaka Porast GGT Porast AST Porast ALT
English: Tel: +421 2 4444 2157
Croatian: Astellas Pharma s.r.o. Tel: +421 2 4444 2157
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Ostale nuspojave uključuju: Česte nuspojave (mogu se pojaviti kod do 1 na 10 ljudi)
English: Fertility
Croatian: Pruritus
English: ‡ Not statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.
Croatian: ‡ Nije statistički značajno bolje u usporedbi s placebom na razini 0,05 s prilagođavanjem multipliciteta.
English: Drug-drug interactions
Croatian: Interakcije s drugim lijekovima
English: Astellas Pharma Ltd. Tel: +44 (0) 203 379 8700
Croatian: Tel: +44 (0) 203 379 8700
English: Astellas Pharma Europe B.V. Sylviusweg 62
Croatian: Sylviusweg 62
English: Betmiga 50 mg prolonged-release tablets
Croatian: Betmiga 50 mg tablete s produljenim oslobađanjem
English: Betmiga 50 mg prolonged-release tablets mirabegron
Croatian: Betmiga 50 mg tablete s produljenim oslobađanjem mirabegron
English: # Statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.
Croatian: # Statistički značajno bolje u usporedbi s placebom na razini 0,05 s prilagođavanjem multipliciteta.
English: Betmiga 25 mg prolonged-release tablets mirabegron
Croatian: Betmiga 25 mg tablete s produljenim oslobađanjem mirabegron
English: Each tablet contains 25 mg of mirabegron
Croatian: Svaka tableta sadrži 25 mg mirabegrona
English: Betmiga 25 mg prolonged-release tablets
Croatian: Betmiga 25 mg tablete s produljenim oslobađanjem
English: Each tablet contains 50 mg of mirabegron
Croatian: Svaka tableta sadrži 50 mg mirabegrona
English: Lip oedema
Croatian: Makularni osip
English: Astellas Pharma Kft. Tel.: +36 1 577 8200
Croatian: Tel.: +36 1 577 8200
English: Package leaflet: Information for the patient Betmiga 25 mg prolonged-release tablets Betmiga 50 mg prolonged-release tablets mirabegron
Croatian: Betmiga 25 mg tablete s produljenim oslobađanjem Betmiga 50 mg tablete s produljenim oslobađanjem mirabegron
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.
Croatian: <15 ml/min/1,73 m2 ili bolesnicima koji zahtijevaju hemodijalizu) te se stoga ne preporučuje njegova primjena u toj populaciji bolesnika.
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).
Croatian: 29 ml/min/1,73 m2) koji istodobno primaju snažne inhibitore CYP3A (vidjeti dio 4.5).
English: Mean number of incontinence episodes per 24 hours (FAS-I) (Co-primary)
Croatian: Srednji broj epizoda inkontinencije tijekom 24 sata (FAS-I)
English: Busuttil Ltd. Tel: +356 21447184
Croatian: Tel: +356 21447184
English: What you need to know before you take Betmiga Do not take Betmiga:
Croatian: Nemojte uzimati Betmigu:
English: Astellas Pharma Co. Ltd. Tel: +353 (0)1 4671555
Croatian: Astellas Pharma Ges.m.b.H. Tel.: +43 (0)1 8772668
English: Placebo
Croatian: Betmiga