FrancophonIA/ELRC3.0 huggingface dataset:
English: From these cases, in 9 patients the confusion symptoms started within one week of start of mirabegron and all of them had positive dechallenge.
Danish: Ud af disse tilfælde begyndte 9 patienter at få symptomer på konfusion i løbet af en uge efter initiering af mirabegron, og alle havde positiv dechallenge.
English: An increase in heart rate was observed in rats, rabbits, dogs and monkeys.
Danish: Der blev observeret øget hjertefrekvens hos rotter, kaniner, hunde og aber.
English: In summary, in spite that the majority of the patients had pre-existing medical conditions or concomitant medications that may cause confusional state, there are some cases with a narrow time to onset and a positive dechallenge and two cases with positive rechallenge (one confirmed and other suspected).
Danish: Til trods for at de fleste af patienterne havde præ-eksisterende sygdomme eller samtidig tog medicin, der kan forårsage konfusion, er der nogle tilfælde med kun kort tid til symptomudbrud og en positiv dechallenge samt to tilfælde med positiv rechallenge (et bekræftet og det andet mistænkt).
English: Very rare Not known (cannot be estimated from the available data)
Danish: Ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data)
English: If you miss several doses, tell your doctor and follow the advice given to you.
Danish: Hvis du har glemt flere doser, skal du fortælle det til din læge og følge de råd, du får.
English: Mirabegron is the major circulating component following a single dose of 14C-mirabegron.
Danish: Mirabegron er den væsentligste cirkulerende komponent efter en enkeltdosis af 14C-mirabegron.
English: Mirabegron can increase blood pressure.
Danish: Mirabegron kan øge blodtrykket.
English: Stopping treatment may result in recurrence of symptoms of overactive bladder.
Danish: Standsning af behandlingen kan resultere i tilbagevenden af symptomer på overaktiv blære.
English: Pooled studies consisted of studies 046 (Europe/Australia), 047 (North America [NA]) and 074 (Europe/NA).
Danish: De poolede studier bestod af studierne 046 (Europa/Australien), 047 (Nordamerika [NA]) og 074 (Europa/NA).
English: FAS-I: Subset of FAS who also had at least 1 incontinence episode in the baseline diary.
Danish: FAS-I: Undergruppe af FAS, som også havde mindst 1 inkontinensepisode i baseline-dagbogen.
English: Renal elimination of mirabegron is primarily through active tubular secretion along with glomerular filtration.
Danish: Den renale elimination af mirabegron sker primært via aktiv tubulær sekretion sammen med glomerulær filtrering.
English: Therefore beta 3-adrenoceptor stimulation should not interfere with the voiding process.
Danish: Beta 3-adrenoceptor-stimulering burde derfor ikke forstyrre tømningsprocessen.
English: Table 3: Co-primary and selected secondary efficacy endpoints at end of treatment for studies 046, 047 and 074
Danish: Tabel 3: Co-primære og udvalgte sekundære effektendepunkter ved behandlingsafslutning for studierne 046, 047 og 074
English: - The active substance is mirabegron.
Danish: - Det aktivte stof er mirabegron.
English: Changes in pulse rate and blood pressure are reversible upon discontinuation of treatment.
Danish: Ændringer i hjertefrekvens og blodtryk er reversible efter seponering af behandlingen.
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)).
Danish: Der blev ikke observeret virkning på fertilitet ved subletale doser (den ækvivalente humane dosis var 19 gange højere end den maksimale anbefalede humane dosis (MRHD)).
English: The effect of mirabegron on human fertility has not been established.
Danish: Mirabegrons virkning på human fertilitet er ikke klarlagt.
English: If you forget to take your medicine, take the missed dose as soon as you remember.
Danish: Hvis du har glemt at tage din medicin, skal du tage den glemte dosis, så snart du kommer i tanke om det.
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).
Danish: Mirabegron resulterede i statistisk signifikant større forbedringer end placebo for både co-primære endepunkter og sekundære endepunkter (se tabel 2 og 3).
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.
Danish: Dette lægemiddel må ikke gives til børn og unge under 18 år, da Betmigas sikkerhed og virkning ikke er klarlagt for denne aldersgruppe.
English: In addition, the use of mirabegron in elderly patients is high according to the data from postmarketing exposure presented in the PSUR.
Danish: Derudover er brugen af mirabegron hos ældre patienter høj i henhold til data fra eksponering efter markedsføring, som fremgår af PSUR.
English: Steady state concentrations are achieved within 7 days of once daily dosing with mirabegron.
Danish: Steady statekoncentrationer opnås inden for 7 dage med dosering af mirabegron én gang dagligt.
English: Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients.
Danish: Blodtrykket bør måles ved start af behandling og regelmæssigt under behandling med mirabegron, især i hypertensive patienter.
English: Unchanged mirabegron accounted for 45% of the urinary radioactivity, indicating the presence of metabolites.
Danish: Uomdannet mirabegron udgjorde 45 % af radioaktiviteten i urinen, hvilket indikerer tilstedeværelse af metabolitter.
English: The study population consisted of approximately 48% antimuscarinic treatment naïve patients as well as approximately 52% patients previously treated with antimuscarinic medicinal products.
Danish: Studiepopulationen bestod af ca. 48 % patienter, som var naive over for antimuskarin behandling, og ca. 52 % patienter, som tidligere var blevet behandlet med antimuskarine lægemidler.
English: Betmiga can be taken with or without food.
Danish: Betmiga kan tages med eller uden mad.
English: Urinary retention*
Danish: Urinretention*
English: - Insomnia - Confusion
Danish: - Søvnløshed - Forvirring
English: < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be established from the available data).
Danish: Bivirkningers frekvens er defineret som følger: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000) og ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data).
English: A single 400 mg dose of moxifloxacin was used as a positive control.
Danish: 400 mg moxifloxacin som enkeltdosis blev anvendt som positiv kontrol.
English: Do not stop taking Betmiga without talking to your doctor first, as your overactive bladder symptoms may come back.
Danish: Hold ikke op med at tage Betmiga uden først at tale med lægen, da dine symptomer på overaktiv blære kan vende tilbage.
English: Vaginal infection Cystitis
Danish: Vaginal infektion Cystitis
English: Each dose level of mirabegron and moxifloxacin was evaluated in separate treatment arms each including placebo-control (parallel cross-over design).
Danish: Hvert dosisniveau af mirabegron og moxifloxacin blev evalueret i separate behandlingsarme, som begge omfattede placebokontrol (parallelt overkrydsningsdesign).
English: Leukocytoclastic vasculitis Purpura
Danish: Leukocytoklastisk vasculitis Purpura Angioødem*
English: Renal clearance (CLR) is approximately 13 L/h, which corresponds to nearly 25% of CLtot.
Danish: Den renale clearance (CLR) er ca. 13 l/t., hvilket svarer til næsten 25 % af CLtot.
English: Effect on QT interval
Danish: Virkning på QT-intervallet
English: Female (72%) and male (28%) patients with a mean age of 59 years (range 1895 years) were included.
Danish: Studiet inkluderede kvindelige (72 %) og mandlige (28 %) patienter med en gennemsnitsalder på 59 år (interval 18 - 95 år).
English: The recommended dose is one 50 mg tablet by mouth once daily.
Danish: Den sædvanlige dosis er én 50 mg tablet gennem munden én gang dagligt.
English: It is likely that this medicine passes into your breast milk.
Danish: Det er sandsynligt, at dette lægemiddel udskilles i modermælk.
English: For patients who are initiating a combination of mirabegron and digoxin, the lowest dose for digoxin should be prescribed initially.
Danish: Patienter, der påbegynder en kombination af Betmiga og digoxin, bør indledningsvis få ordineret den laveste dosis af digoxin.
English: Mirabegron did not induce CYP1A2 or CYP3A.
Danish: Mirabegron inducerede hverken CYP1A2 eller CYP3A.
English: The observed embryofetal toxicity occurred at doses associated with maternal toxicity.
Danish: Den observerede embryoføtale toksicitet forekom ved doser associeret med maternel toksicitet.
English: The absolute bioavailability increased from 29% at a dose of 25 mg to 35% at a dose of 50 mg.
Danish: Den absolutte biotilgængelighed steg fra 29 % ved en dosis på 25 mg til 35 % ved en dosis på 50 mg.
English: Most adverse reactions were mild to moderate in severity.
Danish: De fleste bivirkninger var af mild til moderat sværhedsgrad.
English: After oral administration of mirabegron in healthy volunteers mirabegron is absorbed to reach peak plasma concentrations (Cmax) between 3 and 4 hours.
Danish: Efter oral administration af mirabegron hos raske frivillige absorberes mirabegron til opnåelse af maksimale plasmakoncentrationer (Cmax) i løbet af mellem 3 og 4 timer.
English: Effect of mirabegron on transporters
Danish: Mirabegrons virkning på transportører
English: These may be signs of severely elevated blood pressure.
Danish: Dette kan være symptomer på stærkt forhøjet blodtryk.
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).
Danish: Sikkerheden af Betmiga blev evalueret hos 8433 patienter med OAB, hvoraf 5648 fik mindst én dosis Betmiga i det kliniske fase 2/3-program, og 622 patienter fik Betmiga i mindst 1 år (365 dage).
English: Mirabegron is a potent and selective beta 3-adrenoceptor agonist.
Danish: Mirabegron er en potent og selektiv beta 3-adrenoceptoragonist.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for mirabegron, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for mirabegron er CHMP nået frem til følgende videnskabelige konklusioner:
English: Dose-adjustment is not recommended.
Danish: Dosisjustering er ikke nødvendig.
English: Symptoms of overdose may include a forceful beating of the heart, an increased pulse rate or an increased blood pressure.
Danish: Symptomer på overdosering kan omfatte kraftig hjertebanken, øget puls eller øget blodtryk.
English: The most serious side effects may include irregular heart beat (atrial fibrillation).
Danish: De mest alvorlige bivirkninger kan omfatte uregelmæssig puls (atrieflimren).
English: The bottle may not be available in your country.
Danish: Glasset er ikke nødvendigvis markedsført i dit land.
English: Betmiga 50 mg once daily was effective at the first measured time point of week 4, and efficacy was maintained throughout the 12-week treatment period.
Danish: Betmiga 50 mg én gang dagligt var effektivt på tidspunktet for første måling, uge 4, og virkningen blev opretholdt i hele 12-ugers behandlingsperioden.
English: Mirabegron distributes to erythrocytes.
Danish: Mirabegron distribueres til erytrocytterne.
English: Treatment satisfaction - visual analogue scale (FAS) (Secondary)
Danish: Tilfredshed med behandlingen - visuel analog skala (FAS) (sekundært)
English: Do not stop taking them when your bladder condition improves.
Danish: Hold ikke op med at tage dem ved bedring af din blæresygdom.
English: If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital for advice immediately.
Danish: Hvis du har taget flere tabletter, end du er blevet bedt om at tage, eller hvis en anden er kommet til at tage dine tabletter, skal du straks kontakte din læge, apoteket eller en skadestue.
English: CYP2D6 polymorphism
Danish: CYP2D6-polymorfisme
English: On the basis of the scientific conclusions for mirabegron the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mirabegron is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for mirabegron er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder mirabegron, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
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.
Danish: Da patienter med QT-forlængelse i anamnesen og patienter, der tager lægemidler, som vides at forlænge QT-intervallet, imidlertid ikke er omfattet af disse forsøg, er virkningen af mirabegron hos disse patienter ikke kendt.
English: Patients with congenital or acquired QT prolongation
Danish: Patienter med medfødt eller erhvervet QT-forlængelse
English: Betmiga contains the active substance mirabegron.
Danish: Betmiga indeholder det aktive stof mirabegron.
English: Macrogol 8,000 and 2,000,000 Hydroxypropylcellulose Butylhydroxytoluene Magnesium stearate
Danish: Macrogoler 8.000 and 2.000.000 Hydroxypropylcellulose Butylhydroxytoluen Magnesiumstearat
English: - Severe uncontrolled hypertension defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg.
Danish: - Svær ukontrolleret hypertension defineret som systolisk blodtryk ≥ 180 mm Hg og/eller diastolisk blodtryk ≥ 110 mm Hg.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Betmiga in one or more subsets of the paediatric population in “Treatment of idiopathic overactive bladder” and “Treatment of neurogenic detrusor overactivity” (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Betmiga i en eller flere undergrupper af den pædiatriske population vedrørende "Behandling af idiopatisk overaktiv blære" og "Behandling af neurogen detrusor-overaktivitet" (se pkt.
English: The effects of mirabegron on maximum flow rate and detrusor pressure at maximum flow rate were assessed in this urodynamic study consisting of 200 male patients with LUTS and BOO.
Danish: Mirabegrons virkning på den maksimale flowhastighed og detrusortrykket ved den maksimale flowhastighed blev vurderet i dette urodynamiske studie, som omfattede 200 mandlige patienter med LUTS og BOO.
English: Betmiga has no or negligible influence on the ability to drive and use machines.
Danish: Betmiga påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Tolterodine ER 4 mg
Danish: Tolterodin ER 4 mg
English: In addition, among the cases considered by the MAH as informative confounded cases there is also a case with confusion aggravated 2 days after initiating mirabegron and in the medical history a similar episode occurred 2 months prior the report after initiating mirabegron.
Danish: Derudover er der blandt de tilfælde, som indehaveren af markedsføringstilladelsen betragter som informative konfunderede tilfælde, også et tilfælde af forværret konfusion 2 dage efter initiering af mirabegron, og i en anamnese opstod en lignende episode 2 måneder før rapporten efter initiering af mirabegron.
English: Transient increases in liver enzymes and hepatocyte changes (necrosis and decrease in glycogen particles) were seen in rats.
Danish: Der blev set forbigående stigninger i leverenzymer og hepatocytforandringer (nekrose og reduktion i glycogenpartikler) hos rotter.
English: Pharmacotherapeutic group: Urologicals, urinary antispasmodics ATC code: G04BD12.
Danish: Farmakoterapeutisk klassifikation: Urologica, urologiske antispasmodica, ATC-kode: G04BD12.
English: In vitro erythrocyte concentrations of 14C-mirabegron were about 2-fold higher than in plasma.
Danish: In vitroerytrocytkoncentrationerne af 14C-mirabegron var ca. dobbelt så høje som i plasma.
English: Following the administration of 160 mg 14C-mirabegron to healthy volunteers, approximately 55% of the radiolabel was recovered in the urine and 34% in the faeces.
Danish: Efter administration af 160 mg 14C-mirabegron til raske frivillige blev ca. 55 % af det radioaktivt mærkede stof genfundet i urinen og 34 % i fæces.
English: Strong CYP3A inhibitors(3) Without inhibitor
Danish: Stærke CYP3A-hæmmere(3) Uden hæmmer
English: The supra-therapeutic doses represent approximately 2.6- and 6.5-fold the exposure of the therapeutic dose, respectively.
Danish: Eksponeringen for de supraterapeutiske doser udgør henholdsvis ca. 2,6 og 6,5 gange eksponeringen for den terapeutiske dosis.
English: If you are breast feeding, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du ammer, skal du spørge din læge eller apoteket til råds, før du tager dette lægemiddel.
English: A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with Betmiga; however, Betmiga should be administered with caution to patients with clinically significant BOO.
Danish: I et kontrolleret klinisk sikkerhedsstudie af patienter med BOO fandtes ikke en øget forekomst af urinretention hos patienter behandlet med Betmiga; dog bør Betmiga anvendes med forsigtighed til patienter med klinisk signifikant blæreudgangsobstruktion.
English: Mirabegron is excreted in the milk of rodents and therefore is predicted to be present in human milk (see section 5.3).
Danish: Mirabegron udskilles i mælk fra gnavere og forventes derfor at ville forekomme i human mælk (se pkt.
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.
Danish: Der bør tages højde for mirabegrons potentielle hæmning af P-gp, når Betmiga kombineres med følsomme P-gp-substrater som f.eks. dabigatran.
English: Interaction studies of mirabegron with metoprolol and with metformin used mirabegron immediate-release (IR) 160 mg.
Danish: Ved studier af interaktion mellem mirabegron og metoprolol hhv. metformin blev der anvendt mirabegron med øjeblikkelig frigivelse (IR) 160 mg.
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.
Danish: † Mindste kvadraters gennemsnit justeret for baseline, køn, studie, undergruppe og undergruppe baseret på behandlingsinteraktion for de poolede studier og mindste kvadraters gennemsnit justeret for baseline, køn, geografisk region, undergruppe og undergruppe baseret på behandlingsinteraktion for studie 046.
English: Interaction of mirabegron with a known CYP2D6 inhibitor is not expected and was not studied.
Danish: Interaktion af mirabegron med en kendt CYP2D6-hæmmer forventes ikke og blev ikke undersøgt.
English: The co-primary efficacy endpoints were (1) change from baseline to end of treatment in mean number of incontinence episodes per 24 hours and (2) change from baseline to end of treatment in mean number of micturitions per 24 hours based on a 3-day micturition diary.
Danish: De co-primære effektendepunkter var (1) ændring fra baseline til behandlingsafslutning i gennemsnitligt antal inkontinensepisoder pr. 24 timer og (2) ændring fra baseline til behandlingsafslutning i gennemsnitligt antal vandladninger pr. 24 timer baseret på en 3-dages vandladningsdagbog.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Mirabegron may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure.
Danish: Mirabegron kan få dit blodtryk til at stige eller forværre dit blodtryk, hvis du tidligere har haft højt blodtryk.
English: Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate.
Danish: Øget mirabegron-eksponering som følge af interaktioner med andre lægemidler kan være associeret med øget hjertefrekvens.
English: These results indicate that mirabegron enhances urine storage function by stimulating beta 3-adrenoceptors in the bladder.
Danish: Disse resultater indikerer, at mirabegron forbedrer urinakkumuleringsfunktionen ved at stimulere beta 3-adrenoceptorer i blæren.
English: FAS: Full analysis set, all randomized patients who took at least 1 dose of double blind study drug and who had a micturition measurement in the baseline diary and at least 1 post-baseline visit diary with a micturition measurement.
Danish: FAS: Fuldt analysesæt, alle randomiserede patienter, som tog mindst 1 dosis dobbeltblind forsøgsmedicin, og som havde en vandladningsmåling i baseline-dagbogen og mindst 1 dagbog med en vandladningsmåling fra efter baseline-besøget.
English: Your doctor may need to reduce your dose or may tell you not to take Betmiga, especially if you are taking other medicines such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections).
Danish: Din læge kan være nødt til at reducere din dosis eller kan fortælle dig, at du ikke må tage Betmiga, især hvis du tager anden medicin, som f.eks. itraconazol, ketoconazol (svampeinfektioner), ritonavir (HIV) og clarithromycin (bakterielle infektioner).
English: Your bladder might need some time to adapt.
Danish: Din blære kan have brug for tilvænningstid.
English: The activation of the M2 pathway also inhibits beta 3-adrenoceptor induced increases in cAMP.
Danish: Aktiveringen af M2's pathway hæmmer også beta 3-adrenoceptor-induceret stigning i cAMP.
English: CI: Confidence Interval
Danish: KI: Konfidensinterval
English: It is a bladder muscle relaxant (a so called beta 3-adrenoceptor agonist), which reduces the activity of an overactive bladder and treats the related symptoms.
Danish: Det virker afslappende på blæremuskulaturen (er en såkaldt beta 3-adrenoceptoragonist), som nedsætter aktiviteten i en overaktiv blære og behandler de dermed forbundne symptomer.
English: The MAH has cumulatively reviewed the cases of confusional state using the HLGT Deliria (including confusion).
Danish: Indehaveren af markedsføringstilladelsen har kumulativt gennemgået tilfældene af konfusion ved brug af HLGT Delirium (herunder konfusion).
English: Most drug-drug interactions were studied using a dose of 100 mg mirabegron given as oral controlled absorption system (OCAS) tablets.
Danish: De fleste interaktioner med andre lægemidler blev undersøgt ved anvendelse af en dosis på 100 mg mirabegron givet som orale tabletter med kontrolleret absorptionssystem (OCAS [oral controlled absorption system]-tabletter).
English: Table 2: Co-primary and selected secondary efficacy endpoints at end of treatment for pooled studies
Danish: Tabel 2: Co-primære og udvalgte sekundære effektendepunkter ved behandlingsafslutning for poolede studier
English: Mirabegron is predicted not to cause clinically relevant inhibition of OCT-mediated drug transport.
Danish: Mirabegron forventes ikke at forårsage klinisk relevant hæmning af OCTmedieret lægemiddeltransport.
English: Substances that are inducers of CYP3A or P-gp decrease the plasma concentrations of mirabegron.
Danish: Enzyminduktorers virkning Stoffer, der inducerer CYP3A eller P-gp, reducerer plasmakoncentrationerne af mirabegron.