FrancophonIA/ELRC3.0 huggingface dataset:
English: You and your doctor should decide if you should take Betmiga or breastfeed.
Slovenian: Skupaj z zdravnikom se morate odločiti, ali boste jemali zdravilo Betmiga ali boste dojili.
English: Therefore, mirabegron can be taken with or without food at the recommended dose.
Slovenian: Zato se lahko mirabegron v priporočenem odmerku uporabi s hrano ali brez nje.
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.
Slovenian: Od teh primerov so se pri 9 bolnikih simptomi zmedenosti pojavili v enem tednu po začetku uporabe mirabegrona in pri vseh je neželen učinek po ukinitvi zdravila izzvenel.
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.
Slovenian: Učinke mirabegrona na največji pretok in na tlak detruzorja med največjim pretokom so ocenili v tej urodinamski študiji 200 moških s simptomi LUTS in BOO.
English: Hypertensive crisis*
Slovenian: Žilne bolezni hipertenzivna kriza*
English: Effect of enzyme inducers
Slovenian: Vpliv induktorjev encimov
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).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Betmiga za vse skupine pediatrične populacije pri "Zdravljenju idiopatskega prekomerno aktivnega sečnega mehurja" in "Zdravljenju nevrogene prekomerne aktivnosti detruzorja" (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Patients with congenital or acquired QT prolongation
Slovenian: Bolniki s prirojenim ali pridobljenim podaljšanjem intervala QT
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.
Slovenian: V kontrolirani klinični študiji pri bolnikih z BOO, zdravljenih z zdravilom Betmiga, ni bilo dokazanega povečanega zadrževanja urina; vendar pa je treba pri bolnikih s klinično pomembnim BOO zdravilo Betmiga uporabljati previdno.
English: There are limited amount of data from the use of Betmiga in pregnant women.
Slovenian: O uporabi zdravila Betmiga pri nosečnicah je malo podatkov.
English: Mirabegron may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure.
Slovenian: Mirabegron lahko povzroči povišanje krvnega tlaka ali poslabšanje stanja krvnega tlaka, če ste kdaj imeli visok krvni tlak.
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.
Slovenian: Študij za oceno vpliva mirabegrona na nastajanje mleka pri človeku, njegove prisotnosti v materinem mleku pri človeku in njegovih vplivov na dojenega otroka niso izvedli.
English: CYP2D6 genetic polymorphism has minimal impact on the mean plasma exposure to mirabegron (see section 5.2).
Slovenian: Genetski polimorfizem CYP2D6 ima minimalni vpliv na povprečno plazemsko izpostavljenost mirabegronu (glejte poglavje 5.2).
English: This leaflet was last revised in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL.
English: Effect of mirabegron on transporters
Slovenian: Vpliv mirabegrona na transporterje
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.
Slovenian: Pri zdravih prostovoljcih je zaviralna moč mirabegrona na CYP2D6 zmerna; aktivnost CYP2D6 se obnovi v 15 dneh po prenehanju uporabe mirabegrona.
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.
Slovenian: Pred začetkom jemanja zdravila Betmiga se posvetujte z zdravnikom ali farmacevtom: - če težko izpraznite mehur ali imate zmanjšan tok urina ali jemljete druga zdravila za zdravljenje prekomerno aktivnega sečnega mehurja kot so t.i. antiholinergična zdravila.
English: The recommended dose is one 50 mg tablet by mouth once daily.
Slovenian: Priporočeni odmerek je ena 50-mg tableta, ki jo zaužijete enkrat na dan.
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).
Slovenian: Če povzamemo: čeprav je imela večina bolnikov že predhodne zdravstvene motnje ali sočasna zdravila, ki lahko povzročijo stanje zmedenosti, je bilo nekaj primerov s kratkim časovnim intervalom do pojava neželenega učinka, ki je po ukinitvi zdravila izzvenel.
English: Betmiga is not recommended in women of childbearing potential not using contraception.
Slovenian: Zdravilo Betmiga ni priporočljivo za ženske v rodni dobi, ki ne uporabljajo kontracepcije.
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.
Slovenian: Zdravilo Betmiga v odmerkih 50 mg ali 100 mg ni vplivalo na interval QT, individualno korigiran za srčno frekvenco (interval QTcI), ovrednoten bodisi po spolu bodisi po celotni skupini.
English: The absolute bioavailability increased from 29% at a dose of 25 mg to 35% at a dose of 50 mg.
Slovenian: 29 % pri odmerku 25 mg na 35 % pri odmerku 50 mg.
English: Pooled studies consisted of studies 046 (Europe/Australia), 047 (North America [NA]) and 074 (Europe/NA).
Slovenian: Kumulativno prikazane študije obsegajo študijo 046 (Evropa/Avstralija), 047 (Severna Amerika) in 074 (Evropa/Severna Amerika).
English: After oral administration of mirabegron in healthy volunteers mirabegron is absorbed to reach peak plasma concentrations (Cmax) between 3 and 4 hours.
Slovenian: Po peroralni uporabi pri zdravih prostovoljcih se je mirabegron absorbiral tako, da je bila največja koncentracija v plazmi (Cmax) dosežena v 3 do 4 urah.
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.
Slovenian: Izločanje nespremenjenega mirabegrona v urinu je odvisno od odmerka in sega od približno 6,0 % po dnevnem odmerku 25 mg do 12,2 % po dnevnem odmerku 100 mg.
English: Most drug-drug interactions were studied using a dose of 100 mg mirabegron given as oral controlled absorption system (OCAS) tablets.
Slovenian: Večino medsebojnih delovanj med zdravili so raziskali z odmerkom 100 mg mirabegrona v peroralnih tabletah s sistemom nadzorovane absorpcije (OCAS - Oral Controlled Absorption System).
English: Interaction of mirabegron with a known CYP2D6 inhibitor is not expected and was not studied.
Slovenian: Medsebojnega delovanja mirabegrona z znanim zaviralcem CYP2D6 ni pričakovati in ni bilo raziskano.
English: Study 047
Slovenian: Študija 047
English: Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate.
Slovenian: Večja izpostavljenost mirabegronu, nastala zaradi medsebojnega delovanja zdravil, je lahko povezana z zvišano srčno frekvenco.
English: Κύπρος Ελλάδα
Slovenian: Κύπρος
English: There was also a case with confirmed positive rechallenge of symptoms after starting mirabegron three times.
Slovenian: Opisan je bil tudi primer potrjenih ponovnih pojavov simptomov po trikratni ponovni uvedbi mirabegrona.
English: Betmiga, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies (see section 5.1).
Slovenian: V kliničnih študijah s terapevtskimi odmerki zdravilo Betmiga ni pokazalo klinično značilnega ustreznega podaljšanja intervala QT (glejte poglavje 5.1).
English: Each dose level of mirabegron and moxifloxacin was evaluated in separate treatment arms each including placebo-control (parallel cross-over design).
Slovenian: Vsako raven odmerka mirabegrona in moksifloksacina so ocenili v ločenem terapevtskem kraku; vsak krak je vključeval kontrolo s placebom (vzporedni navzkrižni načrt študije).
English: Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Slovenian: Mirabegron ni raziskan pri bolnikih s hudo okvaro jeter (Child-Pugh C).
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.
Slovenian: Če ste vzeli večji odmerek zdravila Betmiga, kot bi smeli Če ste vzeli več tablet, kot vam je naročil zdravnik, ali če je kdo drug pomotoma vzel vaše tablete, se za nasvet takoj obrnite na zdravnika, farmacevta ali bolnišnico.
English: Table 2: Co-primary and selected secondary efficacy endpoints at end of treatment for pooled studies
Slovenian: Preglednica 2: Soprimarna opazovana dogodka in izbrani sekundarni končni dogodki učinkovitosti na koncu zdravljenja zbranih študij
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale škodljive učinke na sposobnost razmnoževanja (glejte poglavje 5.3).
English: In the event of overdose, pulse rate, blood pressure, and ECG monitoring is recommended.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo kontrolirati srčno frekvenco, krvni tlak in EKG.
English: Table 1: Daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors
Slovenian: Preglednica 1: Priporočeni dnevni odmerki za bolnike z okvaro ledvic ali jeter v primeru odsotnosti ali prisotnosti močnega zaviralca CYP3A
English: If you forget to take Betmiga
Slovenian: Če ste pozabili vzeti zdravilo Betmiga
English: Multiple doses of mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy volunteers.
Slovenian: Večkratni odmerki mirabegrona do 300 mg na dan 10 dni so pri zdravih prostovoljcih povzročili povečanje srčne frekvence in zvišanje sistoličnega krvnega tlaka.
English: CYP2D6 polymorphism
Slovenian: Polimorfizem CYP2D6
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.
Slovenian: V tej študiji pri moških bolnikih z LUTS/BOO, je bila prilagojena povprečna sprememba (SE) volumna (ml) po praznjenju urina od začetka do konca zdravljenja 0,55 (10,702) za placebo, 17,89 (10,190) za mirabegron 50 mg in 30,77 (10,598) za mirabegron 100 mg.
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.
Slovenian: Blaga: GFR 60 do 89 ml/min/1,73 m2; zmerna: GFR 30 do 59 ml/min/1,73 m2; huda: GFR
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).
Slovenian: Spodnja tabela prikazuje priporočene dnevne odmerke za bolnike z okvaro ledvic ali jeter v primeru odsotnosti ali prisotnosti močnega zaviralca CYP3A (glejte poglavja 4.4, 4.5 in 5.2).
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.
Slovenian: Večkratno odmerjanje mirabegrona enkrat na dan je povzročilo 79 % povečanje Cmax in 241 % povečanje AUC enega samega odmerka dezipramina.
English: mesoridazine, haloperidol, and chlorpromazine; o anti-infectives such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.
Slovenian: haloperidol in klorpromazin; o zdravila za zdravljenje okužb, kot so pentamidin, moksifloksacin, eritromicin in klaritromicin.
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.
Slovenian: To so potrdili pri podganah z delno zaporo sečnice, kjer je mirabegron zmanjšal pogostnost nemikcijskih kontrakcij, ne da bi vplival na količino izpraznjenega urina na mikcijo, na tlak med praznjenjem ali na rezidualno količino urina.
English: o antipsychotic medicines (medicines for mental illness) such as thioridazine,
Slovenian: o antipsihotična zdravila (zdravila za duševne bolezni), npr. tioridazin, mesoridazin,
English: Betmiga can be taken with or without food.
Slovenian: Zdravilo Betmiga lahko vzamete s hrano ali brez nje.
English: HDPE bottles with child-resistant closure of polypropylene (PP) and a silica gel desiccant containing 90 tablets.
Slovenian: HDPE plastenke s polipropilenskimi (PP) zaporkami s sistemom zapiranja, varnim pred otroci, in s sušilnim sredstvom iz silikagela, ki vsebujejo 90 tablet.
English: If you stop taking Betmiga
Slovenian: Če ste prenehali jemati zdravilo Betmiga
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.
Slovenian: Študije in vitro sicer kažejo vlogo CYP2D6 in CYP3A4 v oksidativni presnovi mirabegrona, toda rezultati in vivo kažejo, da imata ta izoencima v celotnem odstranjevanju majhno vlogo.
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.
Slovenian: Študije in vitro in ex vivo so pokazale, da so v presnovo mirabegrona poleg CYP3A4 in CYP2D6 vključene še butirilholinesteraza, UGT in morda alkoholna dehidrogenaza (ADH).
English: Betmiga should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB.
Slovenian: Zdravilo Betmiga je potrebno uporabljati previdno tudi pri bolnikih, ki jemljejo antimuskarinska zdravila za zdravljenje PASM.
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
Slovenian: 10 tablet s podaljšanim sproščanjem 20 tablet s podaljšanim sproščanjem 30 tablet s podaljšanim sproščanjem 50 tablet s podaljšanim sproščanjem 60 tablet s podaljšanim sproščanjem 90 tablet s podaljšanim sproščanjem 100 tablet s podaljšanim sproščanjem 200 tablet s podaljšanim sproščanjem
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.
Slovenian: Zdravilo Betmiga je na voljo v alu-alu pretisnih omotih, ki so v pakiranjih po 10, 20, 30, 50, 60, 90, 100 ali 200 tablet, in v plastenkah iz polietilena visoke gostote (HDPE) s silikagelom kot sušilnim sredstvom in sistemom zapiranja, varnim pred otroci, po 90 tablet.
English: Caution should be exercised when administering mirabegron in these patients.
Slovenian: Pri predpisovanju mirabegrona tem bolnikom je potrebna previdnost.
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.
Slovenian: Mirabegron sprosti gladke mišice sečnega mehurja v izoliranem podganjem in človeškem tkivu, poveča koncentracijo cikličnega adenozin monofosfata (cAMP) v tkivu podganjega sečnega mehurja in sprosti mehur v funkcijskih modelih podganjega sečnega mehurja.
English: After once daily administration, plasma exposure of mirabegron at steady state is approximately double that seen after a single dose.
Slovenian: Po uporabi enkrat na dan je plazemska izpostavljenost mirabegronu v stanju dinamičnega ravnovesja približno dvakrat tolikšna kot po enkratnem odmerku.
English: Effect of mirabegron on CYP2D6 substrates
Slovenian: Vpliv mirabegrona na substrate CYP2D6
English: Mirabegron is metabolised via multiple pathways involving dealkylation, oxidation, (direct) glucuronidation, and amide hydrolysis.
Slovenian: Mirabegron se presnovi po več poteh, ki vključujejo dealkilacijo, oksidacijo, (neposredno)
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.
Slovenian: Soprimarna opazovana dogodka učinkovitosti sta bila (1) sprememba povprečnega števila epizod inkontinence na 24 ur od izhodišča do konca zdravljenja in (2) spremembe povprečnega števila mikcij na 24 ur (na podlagi 3-dnevnega dnevnika mikcij) od izhodišča do konca zdravljenja.
English: Patients with prior OAB antimuscarinic therapy who discontinued due to insufficient effect Mean number of incontinence episodes per 24 hours (FAS-I)
Slovenian: Bolniki s predhodnim antimuskarinskim zdravljenjem PASM, ki so to zdravljenje končali zaradi nezadostne učinkovitosti Povprečno število pojavov inkontinence na 24 ur (FAS-I)
English: If you get headaches, especially sudden, migraine-like (throbbing) headaches, tell your doctor.
Slovenian: Povejte svojemu zdravniku, če se pojavijo glavoboli, zlasti nenadni, migreni podobni (utripajoči) glavoboli.
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.
Slovenian: V celotni populaciji moških in žensk je 2-kratno povečanje odmerka s 50 mg na 100 mg mirabegrona povečalo Cmax za približno 2,9-krat in AUCtau za približno 2,6-krat, 4-kratno povečanje odmerka s 50 mg na 200 mg mirabegrona pa je povečalo Cmax za približno 8,4-krat in AUCtau za približno 6,5-krat.
English: These results indicate that mirabegron enhances urine storage function by stimulating beta 3-adrenoceptors in the bladder.
Slovenian: Ti rezultati kažejo, da mirabegron s stimulacijo adrenergičnih receptorjev beta 3 v sečnem mehurju izboljša shranjevanje urina.
English: Acetylcholine, released from pelvic nerve terminals, stimulates cholinergic M2 and M3 receptors, inducing bladder contraction.
Slovenian: Acetilholin, ki se sprošča iz medeničnih živčnih končičev, spodbuja holinergične receptorje M2 in M3 in tako izzove krčenje mehurja.
English: Strong CYP3A inhibitors see section 4.5
Slovenian: Glede močnih zaviralcev CYP3A glejte poglavje 4.5.
English: What Betmiga looks like and contents of the pack
Slovenian: Izgled zdravila Betmiga in vsebina pakiranja
English: - if you are allergic to mirabegron or any of the other ingredients of this medicine (listed in section 6) - if you have very high uncontrolled blood pressure.
Slovenian: - če ste alergični na mirabegron ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
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).
Slovenian: A za bolnike z blago do zmerno okvaro ledvic (hitrost glomerularne filtracije od 30 do 89 ml/min/1,73 m2) ali blago okvaro jeter (Child-Pugh A), ki sočasno prejemajo močne zaviralce CYP3A, npr. itrakonazol, ketokonazol, ritonavir ali klaritromicin, je priporočeni odmerek 25 mg enkrat na dan s hrano ali brez nje (glejte poglavje 4.2).
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.
Slovenian: Med mirabegronom in zdravili, ki zavirajo, inducirajo ali so substrati enega od izoencimov CYP ali transporterjev, ni pričakovati drugih klinično pomembnih medsebojnih delovanj razen zaviralnega učinka mirabegrona na presnovo substratov CYP2D6.
English: - The active substance is mirabegron.
Slovenian: - Zdravilna učinkovina je mirabegron.
English: Efficacy of Betmiga was evaluated in three phase 3 randomized, double blind, placebo controlled, 12week studies for the treatment of overactive bladder with symptoms of urgency and frequency with or without incontinence.
Slovenian: Učinkovitost zdravila Betmiga so ocenili v treh 12-tedenskih, dvojno slepih, s placebom kontroliranih študijah 3. faze za zdravljenje prekomerno aktivnega sečnega mehurja s simptomi urgentne mikcije in pogostnosti, z inkontinenco ali brez nje.
English: If you are pregnant, think you may be pregnant or are planning to have a baby you should not take Betmiga.
Slovenian: Nosečnost in dojenje Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Betmiga.
English: Transient increases in liver enzymes and hepatocyte changes (necrosis and decrease in glycogen particles) were seen in rats.
Slovenian: Pri podganah so ugotovili prehodno zvišanje jetrnih encimov in spremembe hepatocitov (nekrozo in zmanjšanje glikogenskih delcev).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
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).
Slovenian: - Zdravniku morate povedati, če jemljete tioridazin (zdravilo za duševne bolezni), propafenon ali flekainid (zdravili za motnje srčnega ritma) ali imipramin ali dezipramin (zdravili za depresijo).
English: - Severe uncontrolled hypertension defined as systolic blood pressure ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg.
Slovenian: - Huda neobvladana hipertenzija (sistolični krvni tlak ≥ 180 mmHg in/ali diastolični krvni tlak
English: Pre-clinical studies have identified target organs of toxicity that are consistent with clinical observations.
Slovenian: 5.3 Predklinični podatki o varnosti Ugotovitve predkliničnih študij o ciljnih organih toksičnosti se skladajo s kliničnimi opažanji.
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.
Slovenian: FAS: celotni nabor za analizo (FAS - Full Analysis Set) obsega vse randomizirane bolnike, ki so vzeli vsaj 1 odmerek dvojno slepo dodeljenega raziskovanega zdravila ter so imeli meritev mikcije v izhodiščnem dnevniku ter vsaj 1 poizhodiščni dnevnik z meritvijo mikcije.
English: The supra-therapeutic doses represent approximately 2.6- and 6.5-fold the exposure of the therapeutic dose, respectively.
Slovenian: Izpostavljenost med uporabo supraterapevtskih odmerkov je bila približno 2,6-krat oz. 6,5-krat večja kot med uporabo terapevtskega odmerka.