FrancophonIA/ELRC3.0 huggingface dataset:
English: Betmiga, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies (see section 5.1).
Maltese: Betmiga, f'dożi terapewtiċi, ma weriex titwil ta' QT klinikament rilevanti fi studji kliniċi (ara ssezzjoni 5.1).
English: Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Mirabegron ma ġiex studjat f'pazjenti b'indeboliment tal-fwied sever (Child-Pugh Klassi C).
English: The pharmacokinetics of mirabegron are not influenced by race.
Maltese: Il-farmakokinetika ta' mirabegron mhijiex influwenzata mir-razza.
English: CYP2D6 polymorphism
Maltese: Polimorfiżmu CYP2D6
English: These metabolites are not pharmacologically active.
Maltese: Dawn il metaboliti mhumiex attivi farmakoloġikament.
English: CYP2D6 genetic polymorphism has minimal impact on the mean plasma exposure to mirabegron (see section 5.2).
Maltese: Il-polimorfiżmu ġenetiku ta' CYP2D6 għandu impatt minimu fuq l-esponiment medju fil-plażma għal mirabegron (ara s-sezzjoni 5.2).
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.
Maltese: Betmiga huwa disponibbli f'folja aluminju-aluminju f'pakketti ta' 10, 20, 30, 50, 60, 90, 100 jew 200 pillola u fi fliexken tal-polyethylene ta' densità għolja (HDPE - high density polyethylene),u b dessikant tas-silika ġel b'tapp li diffiċli jinfetaħ mit-tfal, li jkun fihom 90 pillola.
English: A single 400 mg dose of moxifloxacin was used as a positive control.
Maltese: Doża singola ta' 400 mg moxifloxacin intużat bħala kontroll pożittiv.
English: The absolute bioavailability increased from 29% at a dose of 25 mg to 35% at a dose of 50 mg.
Maltese: Il-bijodisponibbiltà assoluta żdiedet minn 29% b'doża ta' 25 mg għal 35% b'doża ta' 50 mg.
English: Mirabegron exposure (AUC) was increased 1.8-fold in the presence of the strong inhibitor of CYP3A/P-gp ketoconazole in healthy volunteers.
Maltese: L-esponiment għal mirabegron (AUC) żdied b'1.8 darbiet fil-preżenza tal-inibitur qawwi ta' CYP3A/P-gp ketoconazole f'voluntiera b'saħħithom.
English: Astellas Pharmaceuticals AEBE Τηλ: +30 210 8189900
Maltese: Ελλάδα Τηλ: +30 210 8189900
English: Nausea* Constipation* Diarrhoea*
Maltese: Dardir* Stitikezza* Dijarea*
English: Female (72%) and male (28%) patients with a mean age of 59 years (range 1895 years) were included.
Maltese: Ġew inklużi pazjenti nisa (72%) u rġiel (28%) b'età medja ta' 59 sena (firxa bejn it-18 u l-95 sena).
English: mesoridazine, haloperidol, and chlorpromazine; o anti-infectives such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.
Maltese: o antinfettivi bħal pentamidine, moxifloxacin, erythromycin u clarithromycin.
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.
Maltese: Studju komprensiv QT (TQT) (n = 164 voluntier raġel b'saħħtu u n = 153 voluntiera mara b'saħħitha b'età medja ta' 33 sena) evalwa l-effett ta' dożaġġ orali ripetut ta' mirabegron bid-doża indikata (50 mg darba kuljum) u żewġ dożi supraterapewtiċi (100 u 200 mg darba kuljum) fuq l-intervall QTcI.
English: Very rare side effects (may affect up to 1 in 10,000 people)
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000)
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.
Maltese: Ma ġewx osservati interazzjonijiet klinikament rilevanti meta mirabegron ġie koamministrat ma' dożi terapewtiċi ta' solifenacin, tamsulosin, warfarin, metformin jew ma' prodott mediċinali kontraċettiv orali kkombinat li fih ethinylestradiol u levonorgestrel.
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.
Maltese: F'voluntiera b'indeboliment renali moderat (eGFRMDRD 30 sa 59 mL/min/1.73 m2), Cmax u AUC żdiedu bi 23% u 66%, rispettivament.
English: Acetylcholine, released from pelvic nerve terminals, stimulates cholinergic M2 and M3 receptors, inducing bladder contraction.
Maltese: L-aċetilkolina, rilaxxata mit-terminali tan-nervituri pelviċi, tistimula r-riċetturi kolinerġiċi M2 u M3, u tinduċi lkontrazzjoni tal-bużżieqa tal-awrina.
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
Maltese: 10 pilloli b'rilaxx prolungat 20 pillola b'rilaxx prolungat 30 pillola b'rilaxx prolungat 50 pillola b'rilaxx prolungat 60 pillola b'rilaxx prolungat 90 pillola b'rilaxx prolungat 100 pillola b'rilaxx prolungat 200 pillola b'rilaxx prolungat
English: Betmiga 50 mg prolonged-release tablets Hypromellose 2910, 6 mPa.s Macrogol 8,000
Maltese: Betmiga 50 mg pilloli b'rilaxx prolungat Hypromellose 2910, 6 mPa.s Macrogol 8,000
English: Table 3: Co-primary and selected secondary efficacy endpoints at end of treatment for studies 046, 047 and 074
Maltese: Tabella 3: Punti ta' tmiem koprimarji u sekondarji magħżula ta' effikaċja fi tmiem il-kura għall-istudji 046, 047 u 074
English: In males, the difference was 2.89 msec (upper bound of the one-sided 95% CI 4.90 msec).
Maltese: Fl-irġiel, id-differenza kienet ta' 2.89 msec (il-limitu laktar għoli ta' CI ta' 95% b'naħa waħda 4.90 msec).
English: In one study, 495 patients received an active control (tolterodine prolonged release formulation).
Maltese: Fi studju wieħed, 495 pazjent ingħataw kontroll attiv (formulazzjoni b'rilaxx prolungat ta' tolterodine).
English: Strong CYP3A inhibitors(3) Without inhibitor
Maltese: Inibituri qawwija ta' CYP3A(3) Bla inibitur
English: Treatment satisfaction - visual analogue scale (FAS) (Secondary)
Maltese: Sodisfazzjon bil-kura - skala analoga viżwali (FAS) (Sekondarju)
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.
Maltese: F'dan l-istudju dwar il-pazjenti rġiel b'LUTS/BOO, il-bidla medja aġġustata (SE) millinja bażi sa tmiem il-kura fil-volum residwu wara t-tbattil (mL) kienet ta' 0.55 (10,702), 17.89 (10,190) u 30.77 (10,598) għall-gruppi ta' kura bi plaċebo, mirabegron 50 mg u mirabegron 100 mg.
English: Two major metabolites were observed in human plasma; both are phase 2 glucuronides representing 16% and 11% of total exposure.
Maltese: Żewġ metaboliti ewlenin ġew osservati fil-plażma umana; it tnejn huma glukuronidi tal-fażi 2 li jirrappreżentaw 16% u 11% tal-esponiment totali.
English: The terminal elimination half-life (t1/2) is approximately 50 hours.
Maltese: L-eliminazzjoni terminali tal half-life (t1/2) hija ta' madwar 50 siegħa.
English: Effect of mirabegron on transporters
Maltese: Effett ta' mirabegron fuq it-trasportaturi
English: Other medicines and Betmiga
Maltese: Mediċini oħra u Betmiga
English: The Cmax and AUC are approximately 40% to 50% higher in females than in males.
Maltese: Cmax u AUC huma madwar 40% sa 50% ogħla fin-nisa milli fl-irġiel.
English: Pre-clinical studies have identified target organs of toxicity that are consistent with clinical observations.
Maltese: Studji ta' qabel l-użu kliniku identifikaw organi fil-mira ta' tossiċità li huma konsistenti ma' osservazzjonijiet kliniċi.
English: Effect on QT interval
Maltese: Effett fuq l-intervall QT
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.
Maltese: Dożaġġ multiplu darba kuljum ta' mirabegron irriżulta f'żieda ta' 79% f'Cmax u żieda ta' 241% f'AUC ta' doża singola ta' desipramine.
English: The study population consisted of approximately 48% antimuscarinic treatment naïve patients as well as approximately 52% patients previously treated with antimuscarinic medicinal products.
Maltese: Madwar 48% tal-popolazzjoni tal-istudju kienet tikkonsisti f'pazjenti li ma ħadux kura antimuskarinika u madwar 52% tal-pazjenti li preċedentement kienu kkurati bi prodotti mediċinali antimuskariniċi.
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.
Maltese: Studji in vitro u ex vivo wrew l-involviment minn butyrylcholinesterase, UGT u possibilment alcohol dehydrogenase (ADH) fil-metaboliżmu ta' mirabegron, minbarra CYP3A4 u
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.
Maltese: Id-differenza medja massima minn plaċebo fit-taħbit tal-qalb kienet tvarja minn 6.7 bpm b'mirabegron 50 mg sa 17.3 bpm b'mirabegron 200 mg f'suġġetti b'saħħithom.
English: The supra-therapeutic doses represent approximately 2.6- and 6.5-fold the exposure of the therapeutic dose, respectively.
Maltese: Id-dożi supraterapewtiċi jirrappreżentaw madwar 2.6 u 6.5 darbiet aktar l-esponiment tad-doża terapewtika, rispettivament.
English: - Severe uncontrolled hypertension defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg.
Maltese: - Pressjoni severa u mhux kontrollata definita bħala pressjoni sistolika tad- demm ≥180 mm Hg u/jew pressjoni dijastolika tad-demm ≥110 mm Hg.
English: Table 4: Co-primary efficacy endpoints for patients with prior OAB antimuscarinic therapy
Maltese: Tabella 4: Punti ta' tmiem koprimarji tal-effikaċja għal pazjenti li preċedentement ħadu terapija antimuskarinika għall-OAB
English: Mirabegron is predicted not to cause clinically relevant inhibition of OCT-mediated drug transport.
Maltese: Huwa previst li mirabegron ma jikkawżax inibizzjoni klinikament rilevanti tat-trasport tal-mediċina blOCT.
English: Urticaria Rash
Maltese: Mhux rakkomandat
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.
Maltese: nisa u rġiel, l-irduppjar tad-doża minn 50 mg għal 100 mg mirabegron immultiplika Cmax u AUCtau b'madwar 2.9 u 2.6, rispettivament, filwaqt li l-multiplikazzjoni tad-doża b'erba' darbiet minn 50 mg għal 200 mg mirabegron immultiplikat Cmax u AUCtau b'madwar 8.4 u 6.5.
English: Cumulatively and according to the summary tabulations, confusional state was the most frequently serious Psychiatric disorder reported (37 serious reports, 18.5% of the serious psychiatric disorder reported.
Maltese: B'mod kumulattiv u skont is-sommarji f'listi tabulati, stat konfużjonali kien l-iktar wieħed frekwenti mid-Disturbi psikjatriċi serji rrappurtati (37 rapport serju, 18.5% tad-disturbi psikjatriċi serji rrappurtati).
English: Mirabegron is transported and metabolised through multiple pathways.
Maltese: Mirabegron jiġi trasportat u metabolizzat permezz ta' diversi mogħdijiet.
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).
Maltese: Wieħed għandu joqgħod attent jekk mirabegron jiġi koamministrat ma' prodotti mediċinali b'indiċi terapewtiku dejjaq u metabolizzat b'mod sinifikanti minn CYP2D6, bħal thioridazine, antiarritmiċi tatTip 1C (eż. flecainide, propafenone) u antidepressanti triċikliċi (eż. imipramine, desipramine).
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.
Maltese: P-gp minn mirabegron għandu jiġi kkunsidrat meta Betmiga jiġi kkombinat ma' substrati P-gp sensittivi eż. dabigatran.
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.
Maltese: Dożaġġ multiplu darba kuljum ta' mirabegron IR irriżulta f'żieda ta' 90% f'Cmax u żieda ta' 229% f'AUC ta' doża singola ta' metoprolol.
English: Mirabegron is metabolised via multiple pathways involving dealkylation, oxidation, (direct) glucuronidation, and amide hydrolysis.
Maltese: Mirabegron jiġi metabolizzat b'mogħdijiet varji li jinvolvu d-dealkilazzjoni, l-ossidazzjoni, il glukoronidazzjoni (diretta), u l-idrolosi amide.
English: Mean difference from placebo† -
Maltese: Differenza mill-plaċebo†
English: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
Maltese: Kura sintomatika ta' urġenza, żieda fil-frekwenza tal-mikturizzjoni u/jew inkontinenza urġenti kif jista' jseħħ f'pazjenti adulti bis-sindromu tal-bużżieqa tal-awrina iperattiva (OAB - overactive bladder).
English: Mean number of urgency incontinence episodes per 24 hours (FAS-I) (Secondary)
Maltese: Numru medju ta' episodji ta' inkontinenza urġenti kull 24 siegħa (FAS-I) (Sekondarju)
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.
Maltese: Wara amministrazzjoni ta' doża waħda ta' 100 mg ta' Betmiga f'voluntiera b'indeboliment tal-fwied ħafif (Child-Pugh Klassi A), Cmax u AUC medji ta' mirabegron żdiedu b'9% u 19% fir-rigward ta' voluntiera b'funzjoni epatika normali.
English: o antipsychotic medicines (medicines for mental illness) such as thioridazine,
Maltese: o mediċini użati għar-rinite allerġika; o mediċini antipsikotiċi (mediċini għall-mard mentali) bħal thioridazine, mesoridazine,
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.
Maltese: Effetti fuq ir-rata tal-polz u l-pressjoni tad-demm f'pazjenti b'OAB F'pazjenti b'OAB (età medja ta' 59 sena) matul it-tliet studji double blind ikkontrollati bi plaċebo tal fażi 3, mifruxin fuq 12-il ġimgħa li ngħataw Betmiga 50 mg darba kuljum, ġiet osservata żieda fid differenza medja minn plaċebo ta' madwar 1 bpm għar-rata tal-polz u madwar 1 mm Hg jew inqas filpressjoni tad-demm sistolika/pressjoni tad-demm dijastolika (SBP - systolic blood pressure/DBPdiastolic blood pressure).
English: Mean volume voided (mL) per micturition (FAS) (Secondary)
Maltese: Volum medju li tbattal (mL) kull mikturizzjoni (FAS) (Sekondarju)
English: Mean number of episodes with urgency grades 3 or 4 per 24 hours (FAS) (Secondary)
Maltese: Numru medju ta' episodji bi gradi ta' urġenza 3 jew 4 kull 24 siegħa (FAS) (Sekondarju)
English: Headache* Dizziness*
Maltese: Żamma ta ' l awrina*
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)).
Maltese: 19-il darba ogħla mid-doża massima rrakkomandata għall-bnedmin (MHRD - maximum human recommended dose)).
English: Co-administration of a 50 mg tablet with a high-fat meal reduced mirabegron Cmax and AUC by 45% and 17%, respectively.
Maltese: Il-koamministrazzjoni ta' pillola ta' 50 mg ma' ikla b'kontenut għoli ta' xaħam naqqset Cmax u AUC ta' mirabegron b'45% u 17% rispettivament.
English: Unchanged mirabegron accounted for 45% of the urinary radioactivity, indicating the presence of metabolites.
Maltese: Mirabegron mhux mibdul ikkontribwixxa għal 45% tar-radjuattività fl-awrina, fatt li jindika l-preżenza ta' metaboliti.
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).
Maltese: Is-sigurtà ta' Betmiga ġiet evalwata fi 8,433 pazjent b'OAB, li minnhom 5,648 ngħataw tal-inqas doża waħda ta' mirabegron fil-programm kliniku tal-fażi 2/3, u 622 pazjent ingħataw Betmiga għal tal-inqas sena (365 jum).
English: Vaginal infection Cystitis
Maltese: Infezzjoni vaġinali
English: Betmiga 25 mg prolonged-release tablets Hypromellose 2910, 6 mPa.s Macrogol 8,000
Maltese: Kisi b'rita Betmiga 25 mg pilloli b'rilaxx prolungat Hypromellose 2910, 6 mPa.s Macrogol 8,000
English: In volunteers with moderate hepatic impairment (Child-Pugh Class B), mean Cmax and AUC values were 175% and 65% higher.
Maltese: Klassi B), il-valuri medji Cmax u AUC kienu 175% u 65% ogħla.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
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).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita kif ġej: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) u mhux magħrufa (ma jistgħux jiġu stabbiliti mid-dejta disponibbli).
English: The activation of the M2 pathway also inhibits beta 3-adrenoceptor induced increases in cAMP.
Maltese: L-attivazzjoni tal-mogħdija M2 tinibixxi wkoll żidiet indotti ta' beta 3-adrenoceptors fis-cAMP.
English: Mirabegron has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis).
Maltese: Mirabegron ma ġiex studjat f'pazjenti li jinsabu fil-fażi finali ta' marda renali (GFR < 15 mL/min/1.73 m2 jew pazjenti li jeħtieġu l-emodijalisi).
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.
Maltese: Il-frekwenza tat-takikardija kienet 1.2% f'pazjenti li kienu qed jingħataw Betmiga 50 mg.
English: Pharmacotherapeutic group: Urologicals, urinary antispasmodics ATC code: G04BD12.
Maltese: Uroloġiċi, antispażmodiċi urinarji, Kodiċi ATC:
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.
Maltese: Wara l-amministrazzjoni ta' 160 mg 14C-mirabegron lil voluntiera b'saħħithom, madwar 55% tar-radjutikketta ġew irkuprati fl-awrina u 34% fil-purgar.
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.
Maltese: (eGFR-MDRD 60 sa 89 mL/min/1.73 m2), Cmax u AUC medji ta' mirabegron żdiedu b'6% u 31% firrigward ta' voluntiera b'funzjoni renali normali.
English: Effect of CYP2D6 polymorphism
Maltese: Effett tal-polimorfiżmu ta' CYP2D6
English: Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg).
Maltese: ≥ 160 mm Hg jew pressjoni tad-demm dijastolika ≥ 100 mm Hg).
English: Astellas Pharma S.p.A. Tel: +39 (0)2 921381
Maltese: Tel: +39 (0)2 921381
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.
Maltese: formulazzjoni mirabegron IR kienu 14% u 19% ogħla milli f'metabolizzaturi estensivi, u dan jindika li l-polimorfiżmu ġenetiku CYP2D6 għandu impatt minimu fuq l-esponiment medju tal-plażma għal mirabegron.
English: In females administered mirabegron at the 50 mg dose, the mean difference from placebo on QTcI interval at 5 hours post dose was 3.67 msec (upper bound of the one-sided 95% CI 5.72 msec).
Maltese: Fin-nisa li ngħataw mirabegron bid-doża ta' 50 mg, id-differenza medja minn plaċebo fl-intervall QTcI 5 sigħat wara li ttieħdet id-doża kienet ta' 3.67 msec (il-limitu l-aktar għoli ta' CI ta' 95% b'naħa waħda 5.72 msec).
English: Most drug-drug interactions were studied using a dose of 100 mg mirabegron given as oral controlled absorption system (OCAS) tablets.
Maltese: Il-parti l-kbira tal-interazzjonijiet bejn il-mediċini ġew studjati bl-użu ta' doża ta' 100 mg mirabegron mogħtija bħala pilloli b'sistema orali ta' assorbiment ikkontrollat (OCAS - oral controlled absorption system).
English: Urinary tract infection
Maltese: Infezzjoni tal-passaġġ urinarju
English: Results for QTcF and QTcIf were consistent with QTcI.
Maltese: Ir-riżultati għall-QTcF u l-QTcIf kienu konsistenti mal-QTcI.
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).
Maltese: F'doża ta' mirabegron 200 mg, l-intervall QTcI ma qabiżx 10 msec fl-ebda ħin fl-irġiel, filwaqt li fin-nisa, il-limitu l-aktar għoli tal-intervall ta' kunfidenza ta' 95% b'naħa waħda fil-fatt qabeż 10 msec bejn 0.5-6 sigħat, b'differenza massima minn plaċebo ta' 5 sigħat fejn l-effett medju kien ta' 10.
English: Therefore, after reviewing all data, confusional state should be included in section 4.8 of the SmPC with frequency unknown.
Maltese: Għalhekk, wara li ġiet riveduta d-data kollha, stat konfużjonali għandu jiġi inkluż fis-sezzjoni 4.8 tal-SmPC bi frekwenza mhux magħrufa.
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.
Maltese: Barra minn hekk, ġew osservati malformazzjonijiet tal-pulmun (assenza tal-lobu aċċessorju tal-pulmun) u żieda fit-telf ta' wara l-impjantazzjoni fil-fenek f'esponimenti sistemiċi 14-il darba ogħla minn dawk osservati fl-MHRD, filwaqt li fil-far ġew innutati effetti riversibbli fuq l-ossifikazzjoni (kustilji mxenglin, dewmien fl-ossifikazzjoni, tnaqqis fin-numru ta' sternebri, metakarpi jew metatarsi ossifikati) f'esponimenti sistemiċi 22 darba ogħla minn dawk osservati fl-MHRD.
English: Confidence Interval p-value
Maltese: Valur p
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.
Maltese: Interazzjonijiet mediċinali klinikament rilevanti bejn mirabegron u prodotti mediċinali li jinibixxu, jinduċu jew huma substrat għal wieħed mill-isożimi jew mit-trasportaturi ta' CYP mhumiex mistennija għajr għall-effett inibitorju ta' mirabegron fuq il-metaboliżmu ta' substrati ta' CYP2D6.
English: Each tablet contains 50 mg of mirabegron.
Maltese: Kull pillola fiha 50 mg mirabegron.