FrancophonIA/ELRC3.0 huggingface dataset:
English: They recovered in a short time after mirabegron discontinuation.
Danish: De forsvandt igen kort tid efter seponering af mirabegron.
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.
Danish: Administration af mirabegron i doser på 50 mg og 100 mg én gang dagligt i 12 uger havde ingen negativ virkning på den maksimale flowhastighed eller detrusortrykket ved den maksimale flowhastighed.
English: Total body clearance (CLtot) from plasma is approximately 57 L/h.
Danish: Kroppens totale plasmaclearance (CLtot) er ca. 57 l/t.
English: Effect of mirabegron on CYP2D6 substrates
Danish: Mirabegrons virkning på CYP2D6-substrater
English: Mirabegron is metabolised via multiple pathways involving dealkylation, oxidation, (direct) glucuronidation, and amide hydrolysis.
Danish: Mirabegron metaboliseres via flere pathways, som involverer dealkylering, oxidation, (direkte) glucuronidering og amidhydrolyse.
English: Gender No dose adjustment is necessary according to gender.
Danish: Køn Dosisjustering baseret på køn er ikke nødvendig.
English: After once daily administration, plasma exposure of mirabegron at steady state is approximately double that seen after a single dose.
Danish: Efter administration én gang dagligt er plasmaeksponeringen for mirabegron ved steady state ca. dobbelt så høj som efter en enkeltdosis.
English: During the urine voiding phase, the bladder is predominantly under parasympathetic nervous system control.
Danish: I urintømningsfasen styres blæren hovedsagelig af det parasympatiske nervesystem.
English: Alu-Alu blisters in cartons containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Danish: Aluminium/aluminium-blistre i pakninger med 10, 20, 30, 50, 60, 90, 100 eller 200 tabletter.
English: In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events.
Danish: I de tre 12-ugers dobbeltblinde placebokontrollerede fase 3-studier gennemførte 88 % af patienterne behandlingen med dette lægemiddel, og behandlingen blev seponeret hos 4 % af patienterne som følge af uønskede hændelser.
English: Mild: GFR 60 to 89 mL/min/1.73 m2; moderate: GFR 30 to 59 mL/min/1.73 m2; severe: GFR 15 to 29 mL/min/1.73 m2.
Danish: Mild: GFR 60 til 89 ml/min/1,73 m2; moderat: GFR 30 til 59 ml/min/1,73 m2; svær: GFR 15 til 29 ml/min/1,73 m2. 2.
English: Mirabegron increased Cmax and AUC by 29% and 27%, respectively, of the P-gp substrate digoxin in healthy volunteers.
Danish: Mirabegron øgede Cmax og AUC med henholdsvis 29 % og 27 % for P-gp-substratet digoxin hos raske frivillige.
English: In addition mirabegron showed efficacy in patients who previously discontinued OAB antimuscarinic therapy due to insufficient effect (see Table 4).
Danish: Mirabegron udviste desuden virkning hos patienter, der tidligere havde fået seponeret antimuskarin OAB-behandling som følge af utilstrækkelig virkning (se tabel 4).
English: Betmiga at doses of 50 mg or 100 mg had no effect on the QT interval individually corrected for heart rate (QTcI interval) when evaluated either by sex or by the overall group.
Danish: Betmiga i doser på 50 mg eller 100 mg havde ingen virkning på QT-intervallet individuelt korrigeret for hjertefrekvens (QTcI-intervallet) - hverken ved evaluering baseret på køn eller for den samlede gruppe.
English: In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended.
Danish: I tilfælde af overdosering anbefales monitorering af hjertefrekvens, blodtryk og EKG.
English: Betmiga may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction or if you are taking other medicines to treat overactive bladder.
Danish: Betmiga kan forøge din risiko for at ikke at kunne tømme blæren, hvis du har blæreudgangsobstruktion eller tager andre lægemidler til behandling af overaktiv blære.
English: A thorough QT (TQT) study (n = 164 healthy male and n = 153 healthy female volunteers with a mean age of 33 years) evaluated the effect of repeat oral dosing of mirabegron at the indicated dose (50 mg once daily) and two supra-therapeutic doses (100 and 200 mg once daily) on the QTcI interval.
Danish: Et grundigt QT (TQT)-studie (n = 164 raske mandlige og n = 153 raske kvindelige frivillige med en gennemsnitsalder på 33 år) evaluerede virkningen af gentaget oral dosering af mirabegron i den indicerede dosis (50 mg én gang dagligt) og to supraterapeutiske doser (100 og 200 mg én gang dagligt) på QTcI-intervallet.
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).
Danish: Farmakokinetiske studier udført med radioaktivt mærket mirabegron har påvist, at stamforbindelsen og/eller metabolitter deraf udskilles i rottemælk i niveauer, der var ca. 1,7 gange højere end plasmaniveauerne 4 timer efter administration (se pkt.
English: Study 046
Danish: Studie 046
English: Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen, blisteren eller glasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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.
Danish: De væsentligste fund i embryoføtale udviklingsstudier hos kaniner omfattede misdannelser i hjertet (dilateret aorta, kardiomegali) ved systemiske eksponeringer, der var 36 gange højere end dem, der blev observeret ved MRHD.
English: The urinary excretion of unchanged mirabegron is dose-dependent and ranges from approximately 6.0% after a daily dose of 25 mg to 12.2% after a daily dose of 100 mg.
Danish: Urinudskillelsen af uomdannet mirabegron er dosisafhængig og varierer fra ca. 6,0 % efter en daglig dosis på 25 mg til 12,2 % efter en daglig dosis på 100 mg.
English: Iron oxide yellow (E172)
Danish: Jernoxid, gult (E172)
English: The effect of co-administered medicinal products on the pharmacokinetics of mirabegron and the effect of mirabegron on the pharmacokinetics of other medicinal products was studied in single and multiple dose studies.
Danish: Interaktioner med andre lægemidler Samtidigt administrerede lægemidlers virkning på farmakokinetikken for mirabegron og mirabegrons virkning på farmakokinetikken for andre lægemidler blev undersøgt i enkelt- og flerdosisstudier.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorsgrad.
English: Mirabegron inhibited P-gp-mediated drug transport at high concentrations.
Danish: Det blev påvist, at mirabegron hæmmede P-gp-medieret lægemiddeltransport ved høje koncentrationer.
English: Nausea* Constipation* Diarrhoea*
Danish: Kvalme* Obstipation* Diarré*
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret {DD/MM/ÅÅÅÅ}
English: Although in vitro studies suggest a role for CYP2D6 and CYP3A4 in the oxidative metabolism of mirabegron, in vivo results indicate that these isozymes play a limited role in the overall elimination.
Danish: Selvom in vitro-studier indikerer, at CYP2D6 og CYP3A4 har en rolle i den oxidative metabolisme af mirabegron, indikerer in vivo-resultater, at disse isozymer har begrænset betydning i den samlede elimination.
English: The volume of distribution at steady state (Vss) is approximately 1670 L. Mirabegron is bound (approximately 71%) to human plasma proteins, and shows moderate affinity for albumin and alpha-1 acid glycoprotein.
Danish: Mirabegron distribueres i udstrakt grad. Distributionsvolumenet ved steady state (Vss) er ca. 1670 l. Mirabegron bindes (ca. 71 %) til humane plasmaproteiner og udviser moderat affinitet for albumin og surt alfa-1-glycoprotein.
English: Mirabegron 100 mg once daily did not increase IOP in healthy subjects after 56 days of treatment.
Danish: Mirabegron 100 mg én gang dagligt øgede ikke IOP hos raske forsøgspersoner i løbet af 56 dages behandling.
English: No studies have been conducted to assess the impact of mirabegron on milk production in humans, its presence in human breast milk, or its effects on the breast-fed child. Betmiga should not be administered during breast-feeding.
Danish: Der er ikke udført studier med henblik på vurdering af mirabegrons virkning på mælkeproduktionen hos mennesker, dets forekomst i human mælk eller dets påvirkning af det ammede barn.
English: During the urine storage phase, when urine accumulates in the bladder, sympathetic nerve stimulation predominates.
Danish: I fyldningsfasen, hvor der akkumuleres urin i blæren, dominerer den sympatiske nervestimulering.
English: Contents of the pack and other information What Betmiga contains
Danish: Pakningsstørrelser og yderligere oplysninger Betmiga indeholder:
English: Mirabegron exposure (AUC) was increased 1.8-fold in the presence of the strong inhibitor of CYP3A/P-gp ketoconazole in healthy volunteers.
Danish: Mirabegron-eksponeringen (AUC) blev øget 1,8 gange ved tilstedeværelse af den stærke CYP3A/P-gp-hæmmer ketoconazol hos raske frivillige.
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.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Betmiga - hvis du har problemer med at tømme din blære eller har en svag urinstråle eller hvis du er i behandling med andre lægemidler for overaktiv blære så som antikolinerge lægemidler.
English: Study 074
Danish: Studie 074
English: 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.
Danish: Bivirkninger observeret under det aktivt kontrollerede (muscarin antagonist) 1-årige (langtids-) studie svarede i type og sværhedsgrad til dem, der blev observeret i de tre 12-ugers dobbeltblinde placebokontrollerede fase 3-studier.
English: Betmiga, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies (see section 5.1).
Danish: Ved terapeutiske doser har Betmiga ikke udvist klinisk relevant QT-forlængelse i kliniske forsøg (se pkt.
English: In this study in male patients with LUTS/BOO, the adjusted mean (SE) change from baseline to end of treatment in post void residual volume (mL) was 0.55 (10.702), 17.89 (10.190), 30.77 (10.598) for the placebo, mirabegron 50 mg and mirabegron 100 mg treatment groups.
Danish: I dette studie med deltagelse af mandlige patienter med LUTS/BOO var den justerede gennemsnitlige ændring fra baseline til behandlingsafslutning (SE) i restmængden efter tømning (ml) 0,55 (10,702), 17,89 (10,190), 30,77 (10,598) for placebo-, mirabegron 50 mg- og mirabegron 100 mgbehandlingsgrupperne.
English: HDPE bottles with child-resistant closure of polypropylene (PP) and a silica gel desiccant containing 90 tablets.
Danish: HDPE-glas med børnesikrede polypropylenlåg (PP) og tørremiddel i form af silicagel, som indeholder 90 tabletter.
English: Acetylcholine, released from pelvic nerve terminals, stimulates cholinergic M2 and M3 receptors, inducing bladder contraction.
Danish: Acetylcholin, som frigives fra nerveender i pelvis, stimulerer cholinerge M2- og M3-receptorer, hvilket inducerer blærekontraktion.
English: 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.
Danish: Ud fra in vitro-studier er det usandsynligt, at mirabegron hæmmer metabolismen af samtidigt administrerede lægemidler, der metaboliseres af følgende cytochrom P450-enzymer: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP2E1, eftersom mirabegron ikke hæmmede aktiviteten af disse enzymer ved klinisk relevante koncentrationer.
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.
Danish: Subjektiv forbedring i målinger af helbredsrelateret livskvalitet I de tre 12-ugers dobbeltblinde placebokontrollerede fase 3-studier resulterede behandling af symptomerne på OAB med mirabegron én gang dagligt i en statistisk signifikant forbedring i forhold til placebo for følgende mål for helbredsrelateret livskvalitet: tilfredshed med behandlingen og symptomgener.
English: Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Mirabegron er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-klasse C).
English: If the blood level is out of range, your doctor may adjust the dose of digoxin.
Danish: Hvis koncentrationen i blodet er uden for det ønskede interval, kan lægen justere digoxindosis.
English: - Hypertensive crisis
Danish: Hypertensiv krise
English: In healthy volunteers, the inhibitory potency of mirabegron towards CYP2D6 is moderate and the CYP2D6 activity recovers within 15 days after discontinuation of mirabegron.
Danish: Hos raske frivillige hæmmer mirabegron CYP2D6 moderat, og CYP2D6-aktiviteten genvindes inden for 15 dage efter seponering af mirabegron.
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.
Danish: Der blev desuden observeret misdannelser i lungerne (fraværende accessorisk lungelap) og øget tab efter implantation hos kanin ved systemiske eksponeringer, som var 14 gange højere end dem, der blev observeret ved MRHD, mens der hos rotte blev bemærket reversibel virkning på ossifikation (bølgede ribben, forsinket ossifikation, reduceret antal ossificerede sternebrae, metacarpi eller metatarsi) ved systemiske eksponeringer, der var 22 gange højere end dem, der blev observeret ved MRHD.
English: Study 047
Danish: Studie 047
English: † Least squares mean adjusted for baseline, gender, and study.
Danish: † Mindste kvadraters gennemsnit justeret for baseline, køn og studie.
English: Betmiga at doses of 50 mg and 100 mg once daily for 12 weeks in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO) showed no effect on cystometry parameters and was safe and well tolerated.
Danish: Urodynamik Betmiga i doser på 50 mg og 100 mg én gang dagligt i 12 uger hos mænd med nedre urinvejssymptomer (LUTS) og blæreudgangsobstruktion (BOO) udviste ingen virkning på cystometriparametre og var sikkert og veltolereret.
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.
Danish: Studier af mirabegron ved anvendelse af humane levermikrosomer og rekombinante humane CYP-enzymer har vist, at mirabegron er en moderat og tidsafhængig CYP2D6-hæmmer og en svag CYP3A-hæmmer.
English: Betmiga should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB.
Danish: Betmiga bør også anvendes med forsigtighed til patienter i behandling med antimuskarine lægemidler af OAB.
English: The cardiovascular malformations observed in the rabbit were shown to be mediated via activation of the beta 1-adrenoceptor.
Danish: Det blev påvist, at de hos kanin observerede kardiovaskulære misdannelser medieres via aktivering af beta 1-adrenoceptoren.
English: Mirabegron is a weak inhibitor of P-gp.
Danish: Mirabegron er en svag P-gp-hæmmer.
English: Table 4: Co-primary efficacy endpoints for patients with prior OAB antimuscarinic therapy
Danish: Tabel 4: Co-primære effektendepunkter for patienter med tidligere antimuskarin OABbehandling
English: Efficacy in patients with or without prior OAB antimuscarinic therapy Efficacy was demonstrated in patients with and without prior OAB antimuscarinic therapy.
Danish: Virkning hos patienter med eller uden tidligere antimuskarin OAB-behandling Der blev påvist virkning hos patienter med og uden tidligere antimuskarin OAB-behandling.
English: Do not crush.
Danish: Må ikke knuses.
English: Clinically relevant drug interactions between mirabegron and medicinal products that inhibit, induce or are a substrate for one of the CYP isozymes or transporters are not expected except for the inhibitory effect of mirabegron on the metabolism of CYP2D6 substrates.
Danish: Der forventes ikke klinisk relevante lægemiddelinteraktioner mellem mirabegron og lægemidler, der hæmmer, inducerer eller er substrat for et af CYP-isozymerne eller en af CYP-transportørerne, bortset fra mirabegrons hæmmende virkning på metabolismen af CYP2D6-substrater.
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).
Danish: Mirabegron er blevet administreret til raske frivillige i enkeltdoser på op til 400 mg. Ved denne dosis omfattede de indberettede bivirkninger palpitationer (1 ud af 6 forsøgspersoner) og øget hjertefrekvens på mere end 100 slag pr. minut (3 ud af 6 forsøgspersoner).
English: If you stop taking Betmiga
Danish: Hvis du holder op med at tage Betmiga
English: CYP2D6 genetic polymorphism has minimal impact on the mean plasma exposure to mirabegron (see section 5.2).
Danish: Genetisk polymorfisme i CYP2D6 har minimal indflydelse på den gennemsnitlige plasmaeksponering for mirabegron (se pkt.
English: This was confirmed in rats with partial urethral obstruction, where mirabegron decreased the frequency of non-voiding contractions without affecting the voided volume per micturition, voiding pressure, or residual urine volume.
Danish: Dette blev bekræftet hos rotter med partiel ureterobstruktion, hvor mirabegron reducerede hyppigheden af ikke-tømmende kontraktioner uden at påvirke den udtømte mængde pr. vandladning, tømningstrykket eller resturinmængden.
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.
Danish: Mirabegron er substrat for cytochrom P450 (CYP) 3A4, CYP2D6, butyrylcholinesterase, uridin-diphospho-glucuronosyltransferaser (UGT), efflux-transportøren P-glycoprotein (P-gp) og organisk kation-transportørerne (OCT) OCT1, OCT2 og OCT3, som er influxtransportører.
English: Noradrenaline is released from nerve terminals, leading predominantly to beta adrenoceptor activation in the bladder musculature, and hence bladder smooth muscle relaxation.
Danish: Der frigives noradrenalin fra nerveenderne, hvilket hovedsagelig resulterer i beta-adrenoceptoraktivering i blæremuskulaturen og dermed relaksation af den glatte blæremuskulatur.
English: If you forget to take Betmiga
Danish: Hvis du har glemt at tage Betmiga
English: Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg).
Danish: Der er utilstrækkelige data for patienter med grad 2-hypertension (systolisk blodtryk ≥ 160 mm Hg eller diastolisk blodtryk ≥ 100 mm Hg).
English: Mean change from baseline†
Danish: Gennemsnitlig ændring fra baseline†
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.
Danish: I dette TQT-studie øgede mirabegron hjertefrekvensen ifølge EKG dosisafhængigt i hele det undersøgte 50 mg til 200 mg-dosisinterval.
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
Danish: EU/1/12/809/008 10 depottabletter EU/1/12/809/009 20 depottabletter EU/1/12/809/010 30 depottabletter EU/1/12/809/011 60 depottabletter EU/1/12/809/012 90 depottabletter EU/1/12/809/013 200 depottabletter EU/1/12/809/017 50 depottabletter EU/1/12/809/018 100 depottabletter
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.
Danish: Flere doseringer af mirabegron én gang dagligt resulterede i en 79 % stigning i Cmax og en 241 % stigning i AUC for en enkeltdosis af desipramin.
English: Dyspepsia Gastritis
Danish: Dyspepsi Gastritis
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)
Danish: Betmiga anvendes til behandling af symptomerne på en overaktiv blære hos voksne - med pludselig vandladningstrang (såkaldt imperiøs vandladning) - med vandladningstrang oftere end normalt (såkaldt øget vandladningshyppighed) - med manglende evne til at styre vandladningen (såkaldt urge-inkontinens)
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.
Danish: Betmiga fås i aluminium/aluminium-blistre i pakninger med 10, 20, 30, 50, 60, 90, 100 eller 200 tabletter og i højdensitetspolyethylen (HDPE)-glas med silica gel tørremiddel og børnesikrede låg, som indeholder 90 tabletter.
English: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
Danish: Symptomatisk behandling af imperiøs vandladning, øget vandladningshyppighed og/eller urgeinkontinens, som kan forekomme hos voksne patienter med overaktiv blære-syndrom (OABsyndrom).
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.
Danish: I den samlede population af mænd og kvinder øgede en fordobling af dosis fra 50 mg til 100 mg mirabegron Cmax og AUCtau med en faktor på henholdsvis ca. 2,9 og 2,6, mens en firedobling af dosis fra 50 mg til 200 mg mirabegron øgede Cmax og AUCtau med en faktor på ca. 8,4 og 6,5.
English: Tell your doctor or pharmacist if you are taking, have recently used or might use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated.
Danish: Forsigtighed tilrådes også, hvis mirabegron administreres samtidig med CYP2D6substrater, der dosistitreres individuelt.