FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Betmiga
Maltese: Tiħux Betmiga:
English: Prolonged-release tablet.
Maltese: żieda tar-rata tal-polz.
English: Renal elimination of mirabegron is primarily through active tubular secretion along with glomerular filtration.
Maltese: L-eliminazzjoni renali ta' mirabegron primarjament isseħħ permezz ta' tnixxija tubulari attiva flimkien ma' filtrazzjoni glomerulari.
English: Betmiga 25 mg prolonged-release tablets Betmiga 50 mg prolonged-release tablets
Maltese: Betmiga 25 mg pilloli b'rilaxx prolungat Betmiga 50 mg pilloli b'rilaxx prolungat
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.
Maltese: mirabegron fuq il-farmakokinetika ta' prodotti mediċinali oħra ġew studjati fi studji ta' doża singola u multipla.
English: Film coating
Maltese: Żieda fil
English: Pooled studies consisted of studies 046 (Europe/Australia), 047 (North America [NA]) and 074 (Europe/NA).
Maltese: L-istudji miġbura kienu jikkonsistu fi studji 046 (l-Ewropa/l-Awstralja), 047 (l-Amerika ta' Fuq [NA]) u 074 (l-Ewropa/NA).
English: Data are limited in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2); based on a pharmacokinetic study (see section 5.2) a dose reduction to 25 mg is recommended in this population.
Maltese: It-tagħrif huwa limitat għal pazjenti b'indebolimenti renali sever (GFR 15 sa 29 mL/min/1.73 m2); abbażi ta' studju farmakokinetiku (ara s-sezzjoni 5.2) huwa rakkomandat tnaqqis tad-doża għal 25 mg għal din il-popolazzjoni.
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.
Maltese: Fi studju tal-ewwel fażi li jivvaluta l-effett ta' Betmiga fuq l-IOP bl-użu ta' tonometrija ta' applanazzjoni ta' Goldmann fi 310 suġġetti b'saħħithom, id-doża ta' mirabegron 100 mg ma kinitx inferjuri għal plaċebo għall-punt ta' tmiem primarju tad-differenza fit-trattament fil-bidla medja mil-linja bażi sas56 jum fl-IOP medja tas-suġġetti; il-limitu l-aktar għoli ta' CI ta' 95% b'żewġ naħat tad-differenza filkura bejn mirabegron 100 mg u plaċebo kien ta' 0.3 mm Hg.
English: Astellas Pharma Sp.z.o.o.
Maltese: Sp.z.o.o.
English: A low-fat meal decreased mirabegron Cmax and AUC by 75% and 51%, respectively.
Maltese: mirabegron b'75% u 51% rispettivament.
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).
Maltese: L-istudji farmakokinetiċi mwettqa b'mirabegron radjutikkettat urew li l-kompost prinċipali u/jew ilmetaboliti tiegħu jitneħħew fil-ħalib tal-firien f'livelli li kienu madwar 1.7 darbiet ogħla mil-livelli tal plażma 4 sigħat wara li ttieħed (ara s-sezzjoni 4.6).
English: Each tablet contains 25 mg of mirabegron
Maltese: Kull pillola fiha 25 mg mirabegron
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)
Maltese: - Infezzjoni tal-istonku (gastrite) - Nefħa tal-ġogi - Ħakk fil-vulva jew fil-vaġina (ħakk vulvovaġinali) - Żieda fil-pressjoni tad-demm - Żieda fl-enżimi tal-fwied (GGT, AST u ALT).
English: Mean level of urgency (FAS) (Secondary)
Maltese: Livell medju ta' urġenza (FAS) (Sekondarju)
English: - Increased heart rate (tachycardia) - Infection of the structures that carry urine (urinary tract infections) - Nausea - Constipation - Headache - Diarrhoea - Dizziness
Maltese: - Żieda fit-taħbit tal-qalb (takikardija) - Infezzjoni tal-istrutturi li jġorru l-awrina (infezzjonijiet tal-passaġġ urinarju) - Dardir - Stitikezza
English: Eyelid oedema
Maltese: Studji miġbura
English: * Statistically significantly superior compared with placebo at the 0.05 level without multiplicity adjustment.
Maltese: * Sinifikantement superjuri statistikament meta mqabbel mal-plaċebo fil-livell 0.05 mingħajr aġġustament tal-multipliċità.
English: Mean difference from placebo† (95% CI) p-value
Maltese: (CI ta' 95%) Valur p
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.
Maltese: Huwa rilassant tal-muskolu tal-bużżieqa tal-awrina (l-hekk imsejjaħ beta 3-adrenoceptor agonist), li jnaqqas l-attività ta' bużżieqa tal-awrina iperattiva u jikkura s-sintomi relatati.
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).
Maltese: It-tabella li ġejja tipprovdi d-dożaġġ kwotidjan rakkomandat għal suġġetti b'indeboliment renali jew tal-fwied fin-nuqqas u fil-preżenza ta' inibituri qawwija ta' CYP3A (ara s-sezzjonijiet 4.4, 4.5 u 5.2).
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.
Maltese: Mirabegron wera li jirrilassa lmuskolu lixx tal-bużżieqa tal-awrina fit-tessut iżolat tal-firien u l-bnedmin, iżid il-konċentrazzjonijiet ta' adenosine monophosphate ċikliku (cAMP) fit-tessut tal-bużżieqa tal-awrina tal-firien u wera li għandu effett rilassanti fuq il-bużżieqa tal-awrina fil-mudelli tal-funzjonijiet tal-bużżieqa tal-awrina tal-firien.
English: EXP
Maltese: GGT
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.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni rrappurtati għall-pazjenti kkurati bi Betmiga 50 mg matul it-tliet studji double blind ikkontrollati bi plaċebo tal-fażi 3, mifruxin fuq 12-il ġimgħa, huma t-takikardija u infezzjonijiet tal-passaġġ urinarju.
English: The observed embryofetal toxicity occurred at doses associated with maternal toxicity.
Maltese: It-tossiċità embrijofetali osservata seħħet f'dożi assoċjati mat-tossiċità fl-omm.
English: Betmiga is not recommended in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) or patients with moderate hepatic impairment (Child-Pugh Class B) concomitantly receiving strong CYP3A inhibitors (see sections 4.2 and 4.4).
Maltese: Betmiga mhuwiex rakkomandat għal pazjenti b'indeboliment renali sever (GFR 15 sa 29 mL/min/1.73 m2) jew pazjenti b'indeboliment tal-fwied moderat (Child-Pugh Klassi B) li fl-istess ħin ikunu qed jingħataw inibituri qawwija ta' CYP3A (ara s sezzjonijiet 4.2 u 4.4).
English: What you need to know before you take Betmiga 3.
Maltese: X'għandek tkun taf qabel ma tieħu Betmiga 3.
English: In vitro data
Maltese: Tagħrif in vitro
English: Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) or severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations (see sections 4.4 and 5.2).
Maltese: Betmiga ma ġiex studjat għal pazjenti b'mard renali fl-aħħar stadju (GFR < 15 mL/min/1.73 m2 jew pazjenti li jeħtieġu l-emodijalisi) jew indeboliment tal-fwied sever (Child-Pugh Klassi C) u għaldaqstant mhuwiex rakkomandat li jintuża minn dawn il-popolazzjonijiet ta' pazjenti (ara s sezzjonijiet 4.4 u 5.2).
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.
Maltese: Betmiga f'dożi ta' 50 mg jew 100 mg ma kellu l-ebda effett fuq l-intervall QT individwalment korrett skont it-taħbit tal-qalb (intervall QTcI) meta ġie evalwat skont is-sess jew skont il-grupp ġenerali.
English: ‡ Not statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.
Maltese: Sinifikantement superjuri statistikament meta mqabbel mal-plaċebo fil-livell 0.05 b'aġġustament tal multipliċità.
English: Interaction studies of mirabegron with metoprolol and with metformin used mirabegron immediate-release (IR) 160 mg.
Maltese: L-istudji ta' interazzjoni ta' mirabegron ma' metoprolol u ma' metformin użaw mirabegron b'rilaxx immedjat (IR) 160 mg.
English: Mirabegron is the major circulating component following a single dose of 14C-mirabegron.
Maltese: Mirabegron huwa l-komponent ewlieni li jiċċirkola wara doża waħda ta' 14C-mirabegron.
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).
Maltese: Mirabegron wera titjib sinifikantement ikbar statistikament meta mqabbel ma' plaċebo għaż-żewġ punti ta' tmiem koprimarji kif ukoll għall-punti ta' tmiem sekondarji (ara t-Tabelli 2 u 3).
English: 90 prolonged-release tablets
Maltese: 90 pillola b'rilaxx prolungat
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).
Maltese: Dan il-prodott mediċinali mhuwiex rakkomandat li jintuża minn pazjenti b'indeboliment renali sever (GFR 15 sa 29 mL/min/1.73 m2) li fl-istess ħin ikunu qed jingħataw inibituri qawwija ta' CYP3A (ara s-sezzjoni 4.5).
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.
Maltese: Fit-tliet studji double blind ikkontrollati bi plaċebo tal-fażi 3, mifruxin fuq 12-il ġimgħa, 88% tal-pazjenti lestew il-kura b'dan il-prodott mediċinali, u 4% tal-pazjenti waqqfuha minħabba effetti avversi.
English: Mirabegron is extensively distributed.
Maltese: Mirabegron jiġi distribwit b'mod estensiv.
English: Rash macular Rash papular Pruritus
Maltese: Urtikarja Raxx Raxx makulari
English: Total body clearance (CLtot) from plasma is approximately 57 L/h.
Maltese: It-tneħħija totali mill-ġisem (CLtot) tal-plażma hija ta' madwar 57 L/h.
English: Interaction of mirabegron with a known CYP2D6 inhibitor is not expected and was not studied.
Maltese: Interazzjoni ta' mirabegron b'inibitur magħruf CYP2D6 mhijiex mistennija u ma ġietx studjata.
English: Betmiga 50 mg prolonged-release tablets mirabegron
Maltese: Betmiga 50 mg pilloli b'rilaxx prolungat mirabegron
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.
Maltese: Abbażi ta' studji in vitro, huwa improbabbli li mirabegron jinibixxi l-metaboliżmu ta' prodotti mediċinali koamministrati metabolizzati bl-enżimi ta' cytochrome P450 li ġejjin: CYP1A2, CYP2B6,
English: Mean number of micturitions per 24 hours (FAS)
Maltese: Numru medju ta' mikturizzjonijiet kull 24 siegħa (FAS) (Koprimarju)
English: Pooled studies consisted of 046 (Europe/Australia), 047 (North America [NA]) and 074 (Europe/NA).
Maltese: L-istudji miġbura kienu jikkonsistu f'046 (l-Ewropa/l-Awstralja), f'047 (l-Amerika ta' Fuq [NA]) u f'074 (l-Ewropa/NA). †
English: Patients with bladder outlet obstruction and patients taking antimuscarinics medicinal products for OAB
Maltese: Pazjenti li preċedentement ħadu terapija antimuskarinika għall-OAB
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.
Maltese: Betmiga f'dożi ta' 50 mg u 100 mg darba kuljum għal 12-il ġimgħa fl-irġiel b'sintomi fil-parti ta' isfel tal-passaġġ urinarju (LUTS - lower urinary tract symptoms) u b'ostruzzjoni tal-iżbokk tal-bużżieqa tal-awrina (BOO - bladder outlet obstruction) ma wera l-ebda effett fuq il-parametri taċ-ċistometrija u huwa sigur u jiġi ttollerat sew.
English: Renal clearance (CLR) is approximately 13 L/h, which corresponds to nearly 25% of CLtot.
Maltese: It-tneħħija renali (CLR) hija ta' madwar 13 L/h, li tikkorrispondi għal kważi 25% ta' CLtot.
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.
Maltese: FAS (Full analysis set): Sett sħiħ ta' analiżi, il-pazjenti randomizzati kollha li ħadu mill-inqas doża waħda (1) ta' mediċina double blind u li kellhom kejl tal-mikturizzjoni fid-djarju tal-linja bażi u millinqas djarju wieħed (1) tal-visti ta' wara l-linja bażi b'kejl tal-mikturizzjoni.
English: This medicine may require dose adjustment by your doctor.
Maltese: X'aktarx li din il-mediċina tgħaddi fil-ħalib tiegħek.
English: Betmiga 25 mg prolonged-release tablets mirabegron
Maltese: Betmiga 25 mg pilloli b'rilaxx prolungat mirabegron
English: Each tablet contains 50 mg of mirabegron
Maltese: Kull pillola fiha 50 mg mirabegron
English: The table below reflects the adverse reactions observed with mirabegron in the three 12-week phase 3 double blind, placebo controlled studies.
Maltese: It-tabella ta' hawn taħt tirrifletti r-reazzjonijiet avversi osservati b'mirabegron fit-tliet studji double blind ikkontrollati bi plaċebo tal-fażi 3, mifruxin fuq 12-il ġimgħa.
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.
Maltese: Effett ta' mirabegron fuq is-substrati ta' CYP2D6 F'voluntiera b'saħħithom, il-potenza inibitorja ta' mirabegron lejn CYP2D6 hija moderata u l-attività ta' CYP2D6 tirkupra fi żmien 15-il jum wara li jitwaqqaf mirabegron.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati - rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
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.
Maltese: Il-punti ta' tmiem koprimarji tal-effikaċja kienu (1) bidla mil-linja bażi sa tmiem il-kura fin-numru medju ta' episodji ta' inkontinenza kull 24 siegħa u (2) bidla mil-linja bażi sa tmiem il-kura fin-numru medju ta' mikturizzjonijiet kull 24 siegħa abbażi ta' djarju ta' mikturizzjoni mifrux fuq tlett (3) ijiem.
English: Betmiga 50 mg prolonged-release tablets
Maltese: Pilloli Betmiga 50 mg b'rilaxx prolungat
English: Mirabegron inhibited P-gp-mediated drug transport at high concentrations.
Maltese: Mirabegron inibixxa ttrasport tal-mediċina b'P-gp f'konċentrazzjonijiet għolja.
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).
Maltese: It-tabib tiegħek jista' jkollu bżonn inaqqaslek id-doża jew jgħidlek biex ma tiħux Betmiga, speċjalment jekk tkun qed tieħu mediċini oħra bħal itraconazole, ketoconazole (infezzjonijiet fungali), ritonavir (HIV/AIDS) jew clarithromycin
English: Lip oedema
Maltese: TAGĦRIF
English: - if you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking any medicine known to cause this such as o medicines used for abnormal heart rhythm such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone; o medicines used for allergic rhinitis;
Maltese: - jekk għandek anormalità tal-ECG (traċċar tal-qalb) magħrufa bħala titwil ta' QT jew jekk qed tieħu xi mediċina magħrufa li tikkawżaha bħal o mediċini użati għar-ritmu anormali tal-qalb bħal quinidine, sotalol, procainamide,
English: Mean baseline
Maltese: B'inibitur
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.
Maltese: Għalkemm studji in vitro jissuġġerixxu li CYP2D6 u CYP3A4 għandhom rwol fil-metaboliżmu ossidattiv ta' mirabegron, riżultati in vivo jindikaw li dawn l-isożimi għandhom rwol limitat fl eliminazzjoni globali.
English: The frequency of urinary tract infections was 2.9% in patients receiving Betmiga 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving Betmiga 50 mg. Serious adverse reactions included atrial fibrillation (0.2%).
Maltese: Il-frekwenza tal-infezzjonijiet tal-passaġġ urinarju kienet 2.9% f'pazjenti li kienu qed jingħataw Betmiga 50 mg.
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).
Maltese: - Għid lit-tabib tiegħek jekk tuża thioridazine (mediċina għall-mard mentali), propafenone jew flecainide (mediċini għal ritmu anormali tal-qalb), imipramine jew desipramine (mediċini użati għad-depressjoni).
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).
Maltese: (≥ 65 sena) kienu simili għal dawk f'voluntiera iżgħar (18 - 45 sena).
English: Betmiga 25 mg prolonged-release tablets Each tablet contains 25 mg of mirabegron.
Maltese: Pilloli Betmiga 25 mg b'rilaxx prolungat Kull pillola fiha 25 mg 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).
Maltese: Dan il-prodott mediċinali mhuwiex rakkomandat li jintuża minn pazjenti b'indeboliment tal-fwied moderat (ChildPugh B) li fl-istess ħin ikunu qed jingħataw inibituri qawwija ta' CYP3A (ara s-sezzjoni 4.5).
English: Substances that are inducers of CYP3A or P-gp decrease the plasma concentrations of mirabegron.
Maltese: Is-sustanzi li jinduċu CYP3A jew P-gp inaqqsu l-konċentrazzjonijiet tal-plażma ta' mirabegron.
English: Betmiga 50 mg prolonged-release tablets Each tablet contains 50 mg of mirabegron.
Maltese: Betmiga 50 mg pilloli b'rilaxx prolungat Kull pillola fiha 50 mg mirabegron.
English: Busuttil Ltd. Tel: +356 21447184
Maltese: Tel: +356 21447184
English: Leukocytoclastic vasculitis Purpura
Maltese: Effett tal-ikel fuq l-assorbiment
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.
Maltese: F'voluntiera b'indeboliment renali sever (eGFR-MDRD 15 sa 29 mL/min/1.73 m2), il-valuri medji ta' Cmax u AUC
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.
Maltese: L-istudji dwar mirabegron li jużaw mikrosomi tal-fwied uman u enżimi CYP umani rikombinanti wrew li mirabegron huwa inibitur moderat u jiddependi fuq il-ħin ta' CYP2D6 u inibitur dgħajjef ta' CYP3A.
English: There are limited amount of data from the use of Betmiga in pregnant women.
Maltese: Hemm dejta limitata dwar l-użu ta' Betmiga f'nisa tqal.
English: Package leaflet: Information for the patient Betmiga 25 mg prolonged-release tablets Betmiga 50 mg prolonged-release tablets mirabegron
Maltese: Betmiga 25 mg pilloli b'rilaxx prolungat Betmiga 50 mg pilloli b'rilaxx prolungat mirabegron
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.
Maltese: Is-sejbiet ewlenin fl-istudji ta' żvilupp embrijofetali fil-fniek kienu jinkludu malformazzjonijiet tal-qalb (aorta dilatata, kardjomegalija) f'esponimenti sistemiċi 36 darba ogħla minn dawk osservati fl-MHRD.
English: From the 138 cases identified, none was considered as an index case by the MAH and only 55 cases were classified as informative.
Maltese: Mill-138 każ identifikat, l-ebda wieħed ma ġie kkunsidrat li hu każ indiċi millMAH u 55 każ biss ġew klassifikati bħala informattivi.
English: Pregnancy
Maltese: Urodinamika
English: Each dose level of mirabegron and moxifloxacin was evaluated in separate treatment arms each including placebo-control (parallel cross-over design).
Maltese: Kull livell ta' doża ta' mirabegron u moxifloxacin ġie evalwat fi gruppi ta' kura separati li kull wieħed minnhom jinkludi kontroll bi plaċebo (disinn inkroċjat parallel).
English: Mean baseline Mean change from baseline† Mean difference from placebo†
Maltese: Differenza medja mill plaċebo†
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.
Maltese: L-għoti ta' mirabegron f'dożi ta' 50 mg u 100 mg darba kuljum għal 12-il ġimgħa ma kellux effetti avversi fuq ir-rata tal-fluss massima jew il-pressjoni tad-detrusor b'rata talfluss massima.
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).
Maltese: M'hemmx bżonn aġġustament tad-doża meta Betmiga jiġi kkombinat ma' inibituri ta' CYP3A u/jew P-gp. Madankollu, għall-pazjenti b'indeboliment renali ħafif għal moderat (GFR 30 sa 89 mL/min/1.73 m2) jew b'indeboliment tal fwied ħafif (Child-Pugh Klassi A) li fl-istess ħin ikunu qed jingħataw inibituri qawwija ta' CYP3A,
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.
Maltese: is-sess, ir-reġjun ġeografiku, is-sottogrupp, u s-sottogrupp skont l-interazzjoni għall-Istudju 046.
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.
Maltese: 25 mg u 12.2% wara doża kuljum ta' 100 mg.
English: Oval, brown tablet, debossed with the company logo and “325” on the same side.
Maltese: Pillola ovali kannella, ibbuzzata bil-logo tal-kumpanija u bi “325” fuq l-istess naħa.