FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: For patienter med mildt til moderat nedsat nyrefunktion (GFR 30 til 89 ml/min/1,73 m2) eller mildt nedsat leverfunktion (Child-Pughklasse A), som samtidig får stærke CYP3A-hæmmere, som f.eks. itraconazol, ketoconazol, ritonavir og clarithromycin, er den anbefalede dosering imidlertid 25 mg én gang dagligt med eller uden mad (se pkt.
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
Danish: EU/1/12/809/001 10 depottabletter EU/1/12/809/002 20 depottabletter EU/1/12/809/003 30 depottabletter EU/1/12/809/004 60 depottabletter EU/1/12/809/005 90 depottabletter EU/1/12/809/006 200 depottabletter EU/1/12/809/015 50 depottabletter EU/1/12/809/016 100 depottabletter
English: Renal impairment(1)
Danish: Nyrefunktionsnedsættelse(1)
English: Co-administration of a 50 mg tablet with a high-fat meal reduced mirabegron Cmax and AUC by 45% and 17%, respectively.
Danish: Administration af en 50 mg tablet samtidig med et måltid med højt fedtindhold reducerede mirabegrons Cmax og AUC med henholdsvis 45 % og 17 %.
English: Unchanged mirabegron accounted for the majority of the faecal radioactivity.
Danish: Uomdannet mirabegron udgjorde størstedelen af radioaktiviteten i fæces.
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.
Danish: Flere doseringer af mirabegron IR én gang dagligt resulterede i en 90 % stigning i Cmax og en 229 % stigning i AUC for en enkeltdosis af metoprolol.
English: Betmiga is not recommended in women of childbearing potential not using contraception.
Danish: Betmiga bør ikke anvendes til kvinder i den fertile alder, som ikke anvender kontraception.
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.
Danish: Virkning på hjertefrekvensen og blodtrykket hos patienter med OAB Hos OAB-patienter (gennemsnitsalder 59 år) i tre 12-ugers dobbeltblinde placebokontrollerede fase 3studier, som fik Betmiga 50 mg én gang dagligt, blev der på tværs af de tre studier observeret en øget gennemsnitlig forskel i forhold til placebo på ca. 1 slag pr. minut for hjertefrekvensen og ca. 1 mmHg eller derunder for det systoliske blodtryk/diastoliske blodtryk (SBP/DBP).
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.
Danish: De mest almindelige bivirkninger indberettet for patienter behandlet med Betmiga 50 mg under de tre 12-ugers dobbeltblinde placebokontrollerede fase 3-studier, er takykardi og urinvejsinfektioner.
English: PC: {number} SN: {number} NN:
Danish: PC: SN:
English: Table 1: Daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors
Danish: Tabel 1: Den anbefalede daglige dosering til personer med nedsat nyre- eller leverfunktion i fravær og tilstedeværelse af stærke CYP3A-hæmmere
English: 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.
Danish: Mirabegron resulterede i relaksation af den glatte blæremuskulatur i isoleret rottevæv og humant væv, øgede koncentrationerne af cyklisk adenosinmonophosphat (cAMP) i rotteblærevæv og udviste en blærerelakserende virkning i rotteurinblærefunktionsmodeller.
English: It may be taken with or without food.
Danish: Tabletten kan tages med eller uden mad.
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).
Danish: - Fortæl altid lægen, hvis du bruger dabigatran-etexilat (et lægemiddel som anvendes til at mindske risikoen for at få en blodprop i hjernen eller andre steder i kroppen hos voksne patienter, der har en unormal hjerterytme (atrieflimren) med andre risikofaktorer).
English: 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).
Danish: Cmax og AUC for mirabegron og metabolitter deraf efter flere orale doser hos ældre frivillige (≥ 65 år)
English: No clinically relevant interactions have been observed when mirabegron was co-administered with therapeutic doses of solifenacin, tamsulosin, warfarin, metformin or a combined oral contraceptive medicinal product containing ethinylestradiol and levonorgestrel.
Danish: Der er ikke observeret klinisk relevante interaktioner ved samtidig administration af mirabegron og terapeutiske doser af solifenacin, tamsulosin, warfarin, metformin eller kombineret ethinylestradiolog levonorgestrelholdig oral kontraception.
English: - Increased heart rate (tachycardia) - Infection of the structures that carry urine (urinary tract infections) - Nausea - Constipation - Headache - Diarrhoea - Dizziness
Danish: - Øget puls (takykardi) - Infektion i de urinledende strukturer (urinvejsinfektioner) - Kvalme - Obstipation - Hovedpine - Diarré - Svimmelhed
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.
Danish: Hos raske forsøgspersoner, som har genotypisk ringe metabolisme af CYP2D6-substrater (anvendt som surrogat for CYP2D6-hæmning), var de gennemsnitlige Cmax- og AUCinf-værdier ved en enkelt dosering af 160 mg af en mirabegronformulering IR 14 % og 19 % højere end hos personer med omfattende metabolisme, hvilket indikerer, at genetisk polymorfisme i CYP2D6 har minimal indflydelse på den gennemsnitlige plasmaeksponering for mirabegron.
English: Tachycardia Palpitation Atrial fibrillation
Danish: Palpitation Atrieflimren
English: Hepatic impairment(2)
Danish: Leverfunktionsnedsættelse(2)
English: This medicine may require dose adjustment by your doctor.
Danish: Lægen kan være nødt til at justere dosis af dette lægemiddel.
English: Insomnia* Confusional state*
Danish: Insomni* Konfusion*
English: Mean Cmax and AUC increased more than dose proportionally over the dose range.
Danish: De gennemsnitlige Cmax- og AUC-værdier steg mere end dosisproportionalt i dosisintervallet.
English: - 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).
Danish: - Fortæl altid lægen, hvis du bruger thioridazin (et lægemiddel mod psykisk sygdom), propafenon eller flecainid (lægemidler mod unormal hjerterytme), imipramin eller desipramin (lægemidler mod depression).
English: - Tell your doctor if you use digoxin (a medicine for heart failure or abnormal heart rhythm).
Danish: - Fortæl altid lægen, hvis du bruger digoxin (et lægemiddel mod hjertesvigt eller unormal hjerterytme).
English: 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.
Danish: I et fase 1-studie, som vurderede Betmigas virkning på IOP ved anvendelse af Goldmannapplanationstonometri hos 310 raske forsøgspersoner, var en dosis mirabegron 100 mg noninferiør i forhold til placebo for det primære endepunkt, som var behandlingsforskellen i gennemsnitlig ændring fra baseline frem til dag 56 i det gennemsnitlige IOP hos forsøgspersonerne; den øvre grænse for det tosidede 95 % KI for behandlingsforskellen mellem mirabegron 100 mg og placebo var 0,3 mmHg.
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).
Danish: Der tilrådes forsigtighed, hvis mirabegron administreres samtidig med lægemidler, som har et snævert terapeutisk indeks og metaboliseres i væsentlig grad af CYP2D6, som f.eks. thioridazin, klasse 1Cantiarytmika (f.eks. flecainid, propafenon) og tricykliske antidepressiva (f.eks. imipramin, desipramin).
English: Mean difference from placebo† -
Danish: Gennemsnitlig forskel i forhold til placebo†
English: The table below reflects the adverse reactions observed with mirabegron in the three 12-week phase 3 double blind, placebo controlled studies.
Danish: Nedenstående tabel omfatter bivirkningerne observeret med mirabegron i de tre 12-ugers dobbeltblinde placebokontrollerede fase 3-studier.
English: Betmiga 50 mg prolonged-release tablets Hypromellose 2910, 6 mPa.s Macrogol 8,000
Danish: Betmiga 50 mg depottabletter Hypromellose 2910, 6 mPa.s Macrogol 8.000
English: A low-fat meal decreased mirabegron Cmax and AUC by 75% and 51%, respectively.
Danish: Et måltid med lavt fedtindhold reducerede mirabegrons Cmax og AUC med henholdsvis 75 % og 51 %.
English: Patients with bladder outlet obstruction and patients taking antimuscarinics medicinal products for OAB
Danish: Patienter med blæreudgangsobstruktion og patienter i behandling med antimuskarine lægemidler af OAB
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.
Danish: Betmiga er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-klasse C) og bør derfor ikke anvendes til denne patientpopulation.
English: No dose-adjustment is needed when Betmiga is combined with inhibitors of CYP3A and/or P-gp.
Danish: Dosisjustering er ikke nødvendig, når Betmiga kombineres med CYP3A- og/eller P-gp-hæmmere.
English: 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.
Danish: Betmigas virkning blev evalueret i tre 12-ugers randomiserede dobbeltblinde placebokontrollerede fase 3-studier til behandling af overaktiv blære med symptomer på imperiøs vandladning og hyppighed med eller uden inkontinens.
English: Patients with prior OAB antimuscarinic therapy Mean number of incontinence episodes per 24 hours (FAS-I)
Danish: Patienter med tidligere antimuskarin OAB-behandling Gennemsnitligt antal inkontinensepisoder pr. 24 timer (FAS-I)
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.
Danish: Den maksimale gennemsnitlige forskel i forhold til placebo i hjertefrekvens lå fra 6,7 slag pr. minut med mirabegron 50 mg op til 17,3 slag pr. minut med mirabegron 200 mg hos raske forsøgspersoner.
English: Other medicines and Betmiga
Danish: Brug af anden medicin sammen med Betmiga
English: In a monkey model, mirabegron showed decreased voiding frequency.
Danish: I en abemodel reducerede mirabegron tømningshyppigheden.
English: 90 prolonged-release tablets
Danish: 90 depottabletter
English: In volunteers with moderate hepatic impairment (Child-Pugh Class B), mean Cmax and AUC values were 175% and 65% higher.
Danish: Hos frivillige med moderat nedsat leverfunktion (Child-Pugh-klasse B) var de gennemsnitlige Cmax- og AUC-værdier henholdsvis 175 % og 65 % højere.
English: Multiple doses of mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy volunteers.
Danish: Ved administration af flere doser af mirabegron på op til 300 mg dagligt i 10 dage til raske frivillige blev der påvist øget hjertefrekvens og systolisk blodtryk.
English: Blood levels of this medicine are measured by your doctor.
Danish: Lægen måler koncentrationen af dette lægemiddel i blodet.
English: Tablet core: Macrogols, hydroxypropylcellulose, butylhydroxytoluene, magnesium stearate Film-coating: Hypromellose, macrogol, iron oxide yellow (E172), iron oxide red (E172) (25 mg tablet only).
Danish: Tabletkerne: Macrogoler, hydroxypropylcellulose, butylhydroxytoluen, magnesiumstearat Filmovertræk: Hypromellose, macrogol, jernoxidgult (E 172), jernoxidrødt (E 172) (kun 25 mg tablet).
English: No dose adjustment is needed for mirabegron when administered with therapeutic doses of rifampicin or other CYP3A or P-gp inducers.
Danish: Dosisjustering er ikke nødvendig for mirabegron ved samtidig administration med terapeutiske doser af rifampicin eller andre CYP3A- eller P-gp-induktorer.
English: No dose adjustment is needed for mirabegron when administered with CYP2D6 inhibitors or in patients who are CYP2D6 poor metabolisers.
Danish: Dosisjustering er ikke nødvendig for mirabegron ved administration sammen med CYP2D6-hæmmere eller hos patienter med ringe CYP2D6-metabolisme.
English: Busuttil Ltd. Tel: +356 21447184
Danish: E.J. Busuttil Ltd. Tel: +356 21447184
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.
Danish: Frekvensen af takykardi var 1,2 % hos patienter, som fik Betmiga 50 mg. Takykardi førte til seponering for 0,1 % af de patienter, der fik Betmiga 50 mg. Frekvensen af urinvejsinfektioner var 2,9 % hos patienter, som fik Betmiga 50 mg. Urinvejsinfektioner førte ikke til seponering for nogen af de patienter, der fik Betmiga 50 mg.
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.
Danish: Hos frivillige med moderat nedsat nyrefunktion (eGFR-MDRD 30 til 59 ml/min/1,73 m2) steg Cmax og AUC med henholdsvis 23 % og 66 %.
English: Mean number of episodes with urgency grades 3 or 4 per 24 hours (FAS) (Secondary)
Danish: Gennemsnitligt antal episoder med imperiøs vandladning af grad 3 eller 4 pr. 24 timer (FAS) (sekundært)
English: The pharmacokinetics of mirabegron are not influenced by race.
Danish: Mirabegrons farmakokinetik er race-uafhængig.
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.
Danish: Mirabegron øgede den gennemsnitligt udtømte mængde pr. vandladning og reducerede hyppigheden af ikke-tømmende kontraktioner uden at påvirke tømningstrykket eller resturinmængden i rottemodeller af blæreoveraktivitet.
English: What you need to know before you take Betmiga Do not take Betmiga:
Danish: Det skal du vide, før du begynder at tage Betmiga Tag ikke Betmiga
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.
Danish: Efter administration af 100 mg Betmiga som enkeltdosis hos frivillige med mildt nedsat leverfunktion (Child-Pugh-klasse A) steg de gennemsnitlige Cmax- og AUC-værdier for mirabegron med 9 % og 19 % i forhold til værdierne for frivillige med normal leverfunktion.
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.
Danish: In vitro- og ex vivo-studier har påvist, at der foruden CYP3A4 og CYP2D6 er involvering af butyrylcholinesterase, UGT og muligvis alkoholdehydrogenase (ADH) i metabolismen af mirabegron.
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).
Danish: Dette lægemiddel bør ikke anvendes til patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B), som samtidig får stærke CYP3A-hæmmere (se pkt.
English: These specific medicines may require dose adjustment by your doctor.
Danish: Lægen kan være nødt til at justere dosis af disse specifikke lægemidler.
English: ALT increased *observed during post-marketing experience
Danish: * observeret efter markedsføring
English: Mirabegron has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis).
Danish: Mirabegron er ikke undersøgt hos patienter med nyresygdom i slutstadiet (GFR < 15 ml/min/1,73 m2 eller patienter med behov for hæmodialyse).
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)
Danish: - Du mærker dine hjerteslag (palpitationer) - Skedeinfektion - Fordøjelsesproblemer (dyspepsi) - Maveinfektion (gastritis) - Hævede led - Kløe i de ydre kvindelige kønsorganer eller skeden (vulvovaginal pruritis) - Øget blodtryk - Stigning i niveauerne af leverenzymer (GGT, ASAT og ALAT) - Kløe, udslæt eller nældefeber (urticaria, udslæt, makuløst udslæt, papuløst udslæt, pruritus)
English: Biocodex SIA Tel: +371 67 619365
Danish: Biocodex SIATel: +371 67 619365
English: 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
Danish: 10 depottabletter 20 depottabletter 30 depottabletter 50 depottabletter 60 depottabletter 90 depottabletter 100 depottabletter 200 depottabletter
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.
Danish: Hos frivillige med svært nedsat nyrefunktion (eGFR-MDRD 15 til 29 ml/min/1,73 m2) var de gennemsnitlige Cmax- og AUC-værdier henholdsvis 92 % og 118 % højere.
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.
Danish: Betmiga 50 mg filmovertrukne depottabletter er ovale, gule filmovertrukne tabletter præget med firmalogo og "355" på samme side.
English: There were no treatment-related effects of mirabegron on fertility in animals (see section 5.3).
Danish: Fertiliteten hos dyr blev ikke påvirket af behandling med mirabegron (se pkt.
English: Blood pressure increased
Danish: Øget blodtryk Øget GGT Øget ASAT Øget ALAT
English: Effect of enzyme inhibitors
Danish: Enzymhæmmeres virkning
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.
Danish: Betmiga 25 mg filmovertrukne depottabletter er ovale, brune filmovertrukne tabletter præget med firmalogo og "325" på samme side.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING TIL BLISTRE
English: Strong CYP3A inhibitors see section 4.5
Danish: Stærke CYP3A-hæmmere, se pkt.
English: Oval, yellow tablet, debossed with the company logo and “355” on the same side.
Danish: Oval, gul tablet præget med firmalogo og ”355” på samme side.
English: 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).
Danish: Nedenstående tabel angiver den anbefalede daglige dosering til personer med nedsat nyre- eller leverfunktion i fravær og tilstedeværelse af stærke CYP3A-hæmmere (se pkt.
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.
Danish: Hos patienter i behandling med mirabegron er der efter markedsføring blevet rapporteret urinretention hos patienter med blæreudgangsobstruktion (BOO) og hos patienter i behandling med antimuskarine lægemidler af OAB.
English: - 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.
Danish: - hvis du er allergisk over for mirabegron eller et af de øvrige indholdsstoffer i Betmiga (angivet i punkt 6).
English: Mean baseline
Danish: Gennemsnitlig baseline
English: Following single dose administration of 100 mg Betmiga in volunteers with mild renal impairment (eGFR-MDRD 60 to 89 mL/min/1.73 m2), mean mirabegron Cmax and AUC were increased by 6% and 31% relative to volunteers with normal renal function.
Danish: Efter administration af 100 mg Betmiga som enkeltdosis hos frivillige med mildt nedsat nyrefunktion (eGFR-MDRD 60 til 89 ml/min/1,73 m2) steg de gennemsnitlige Cmax- og AUC-værdier for mirabegron med 6 % og 31 % i forhold til værdierne for frivillige med normal nyrefunktion.
English: Mean number of incontinence episodes per 24 hours (FAS-I) (Co-primary)
Danish: Gennemsnitligt antal inkontinensepisoder pr. 24 timer (FAS-I) (co-primært)
English: Mean volume voided (mL) per micturition (FAS) (Secondary)
Danish: Gennemsnitlig udtømt mængde (ml) pr. vandladning (FAS) (sekundært)
English: Swallow the tablet whole.
Danish: Tabletten synkes hel.
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).
Danish: Dette lægemiddel bør ikke anvendes til patienter med svært nedsat nyrefunktion (GFR 15 til 29 ml/min/1,73 m2), som samtidig får stærke CYP3Ahæmmere (se pkt.
English: Posology
Danish: Læbeødem
English: AST increased
Danish: Hævede led
English: Betmiga 50 mg prolonged-release tablets Each tablet contains 50 mg of mirabegron.
Danish: Betmiga 50 mg depottabletter Hver tablet indeholder 50 mg mirabegron.
English: Mean number of urgency incontinence episodes per 24 hours (FAS-I) (Secondary)
Danish: Gennemsnitligt antal urge-inkontinensepisoder pr. 24 timer (FAS-I) (sekundært)
English: Oval, brown tablet, debossed with the company logo and “325” on the same side.
Danish: Oval, brun tablet præget med firmalogo og "325" på samme side.
English: Do not crush or chew the tablet.
Danish: Tabletten må ikke knuses eller tygges.
English: Betmiga 25 mg prolonged-release tablets Each tablet contains 25 mg of mirabegron.
Danish: Betmiga 25 mg depottabletter Hver tablet indeholder 25 mg mirabegron.