FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not chew the tablet.
Slovenian: Tablete ne žvečite.
English: Caution should be exercised when prescribing or uptitrating fesoterodine to patients in whom an increased exposure to the active metabolite (see section 5.1) is expected:
Slovenian: Previdnost je potrebna pri predpisovanju ali povečevanju odmerka fesoterodina pri bolnikih, pri katerih je pričakovati povečano izpostavljenost aktivnemu presnovku (glejte poglavje 5.1):
English: TOVIAZ has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo TOVIAZ ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: The clinical relevance of these findings will depend on individual patient risk factors and susceptibilities present (see section 4.4).
Slovenian: Klinični pomen teh izsledkov je odvisen od dejavnikov tveganja pri vsakem posameznem bolniku ter njegove občutljivosti (glejte poglavje 4.4).
English: Reproduction studies have shown minor embryotoxicity at doses close to maternally toxic ones (increased number of resorptions, pre-implantation and post-implantation losses).
Slovenian: Študije sposobnosti razmnoževanja so pokazale manjšo embriotoksičnost pri odmerkih, ki so bili blizu odmerkom, toksičnim za mater (povečano število resorpcij, izgub ploda pred implantacijo in po njej).
English: Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.
Slovenian: Varnost in učinkovitost pri bolnikih z nevrogenim vzrokom za čezmerno aktivnost detruzorja še nista bili dokazani.
English: Fesoterodine treated patients had statistically significant mean reductions in the number of micturitions per 24 hours and in the number of urge incontinence episodes per 24 hours at the end of treatment compared to placebo.
Slovenian: Bolniki, ki so prejemali fesoterodin, so imeli statistično pomembno povprečno zmanjšanje števila uriniranj v 24 urah in števila epizod urgentne inkontinence v 24 urah ob koncu zdravljenja v primerjavi z osebami, ki so prejemale placebo.
English: What you need to know before you take TOVIAZ
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo TOVIAZ
English: What is in this leaflet What TOVIAZ is and what it is used for What you need to know before you take TOVIAZ How to take TOVIAZ Possible side effects How to store TOVIAZ Contents of the pack and other information
Slovenian: Kaj je zdravilo TOVIAZ in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo TOVIAZ Kako jemati zdravilo TOVIAZ Možni neželeni učinki
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake “Uporabno do” ali “EXP”.
English: Contraindicated
Slovenian: Kontraindicirano
English: If angioedema occurs, fesoterodine should be discontinued and appropriate therapy should be promptly provided.
Slovenian: Če se pojavi angioedem, je treba prenehati z uporabo fesoterodina in nemudoma uvesti ustrezno zdravljenje.
English: Fesoterodine may reduce the effect of medicinal products that stimulate the motility of the gastro-intestinal tract, such as metoclopramide.
Slovenian: Fesoterodin lahko zmanjša učinek zdravil, ki spodbujajo gibljivost gastrointestinalnega trakta, kot je npr. metoklopramid.
English: If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than one tablet in one day.
Slovenian: Če ste pozabili vzeti tableto, jo vzemite takoj, ko se spomnite, vendar ne vzemite več kot ene tablete na dan. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
English: The maximum daily dose is 8 mg.
Slovenian: Največji dnevni odmerek je 8 mg.
English: The safety of fesoterodine was evaluated in placebo-controlled clinical studies in a total of 2859 patients with overactive bladder, of which 780 received placebo.
Slovenian: Varnost fesoterodina so ocenili v s placebom nadzorovanih kliničnih študijah pri skupno 2.859 bolnikih s čezmerno aktivnim sečnim mehurjem, od katerih je 780 bolnikov prejelo placebo.
English: TOVIAZ can be taken with or without food.
Slovenian: Zdravilo TOVIAZ se lahko jemlje s hrano ali brez nje.
English: Other medicines and TOVIAZ
Slovenian: Druga zdravila in zdravilo TOVIAZ
English: TOVIAZ is indicated in adults for treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur with overactive bladder syndrome.
Slovenian: Zdravilo TOVIAZ je indicirano pri odraslih za zdravljenje simptomov (povečana pogostnost uriniranja in/ali urgentna mikcija in/ali urgentna inkontinenca), ki se lahko pojavijo pri sindromu čezmerno aktivnega sečnega mehurja.
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 or hospital for advice immediately.
Slovenian: Če ste vzeli večji odmerek zdravila TOVIAZ, kot bi smeli Če ste vzeli več tablet, kot so vam predpisali, ali če nekdo drug pomotoma vzame vaše tablete, se nemudoma posvetujte z zdravnikom ali pokličite v bolnišnico za nasvet.
English: The maternal No-Observed-Effect Level (NOEL) and the NOEL for effects on reproduction and early embryonic development were both 15 mg/kg/day.
Slovenian: Vrednost koncentracije brez opaznega učinka (No Observed Effect Level - NOEL) za samice-matere in vrednost NOEL za vpliv na sposobnost razmnoževanja in zgodnji embrionalni razvoj sta obe znašali 15 mg/kg/dan.
English: • having to empty your bladder more often than usual (called increased urinary frequency)
Slovenian: • potreba po praznjenju sečnega mehurja pogosteje kot običajno (imenovana povečana pogostnost uriniranja).
English: In populations where the dose may be increased to 8 mg once daily, the dose increase should be preceded by an evaluation of the individual response and tolerability.
Slovenian: Pri populacijah, pri katerih lahko odmerek povečamo na 8 mg enkrat na dan, je treba pred povečanjem odmerka oceniti posameznikov odziv in prenašanje.
English: Dry mouth, the only very common adverse reactions, occurred with a frequency of 28.8% in the fesoterodine group compared to 8.5% in the placebo group.
Slovenian: Pogostnost edinega zelo pogostega neželenega učinka, suhih ust, je bila 28,8 % v skupini, ki je prejemala fesoterodin, v primerjavi z 8,5 % v skupini, ki je prejemala placebo.
English: Findings in mice at exposures approximately 5 to 19 times those at the MRHD show an effect on female fertility, however, the clinical implications of these animal findings are not known (see section 5.3).
Slovenian: Ugotovitve pri miših pri izpostavljenostih, ki so bile približno 5- do 19-krat večje od izpostavljenosti pri MRHD, kažejo vpliv na plodnost pri samicah, vendar pa klinični pomen teh ugotovitev na živalih ni znan (glejte poglavje 5.3).
English: Caution should be exercised when driving or using machines due to possible occurrence of side effects such as blurred vision, dizziness, and somnolence (see section 4.8).
Slovenian: Pri vožnji ali uporabi strojev je potrebna previdnost zaradi možnosti pojava neželenih učinkov, kot so zamegljen vid, omotica in zaspanost (glejte poglavje 4.8).
English: They have mainly involved elderly (≥ 65 years) male patients with a history consistent with benign prostatic hyperplasia (see section 4.4).
Slovenian: To se je večinoma dogajalo pri starejših moških bolnikih (≥ 65 let) z benigno hiperplazijo prostate v anamnezi (glejte poglavje 4.4).
English: TOVIAZ is contraindicated in subjects with severe hepatic impairment (see section 4.3).
Slovenian: Zdravilo TOVIAZ je kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
Slovenian: • sočasna uporaba močnih zaviralcev CYP3A4 pri bolnikih z zmerno do hudo okvaro jeter ali ledvic;
English: Thus fesoterodine is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.
Slovenian: Zato ni verjetno, da bi fesoterodin spremenil očistek zdravil, ki jih ti encimi presnavljajo.
English: None of these metabolites contribute significantly to the antimuscarinic activity of fesoterodine.
Slovenian: Nobeden od teh presnovkov ne prispeva pomembno k antimuskarinskemu učinku fesoterodina.
English: Co-administration of a potent CYP2D6 inhibitor may result in increased exposure and adverse events.
Slovenian: Sočasna uporaba močnega zaviralca CYP2D6 lahko vodi do povečane izpostavljenosti in neželenih učinkov.
English: • difficulty sleeping (insomnia)
Slovenian: • težave pri spanju (nespečnost)
English: Induction of CYP3A4 may lead to subtherapeutic plasma levels.
Slovenian: Indukcija CYP3A4 lahko zmanjša koncentracijo v plazmi pod terapevtsko raven.
English: R-Pharm Germany GmbH Heinrich-Mack-Str. 35, 89257 Illertissen Germany
Slovenian: R-Pharm Germany GmbH Heinrich-Mack-Str. 35, 89257 Illertissen Nemčija
English: Table 1: Mean changes from Baseline to end of treatment for primary and selected secondary endpoints Study 1
Slovenian: Preglednica 1: Povprečna sprememba primarnega in izbranega sekundarnega opazovanega dogodka od začetka študije do konca zdravljenja
English: Paediatric population The pharmacokinetics of fesoterodine have not been evaluated in paediatric patients.
Slovenian: Pediatrična populacija Farmakokinetike fesoterodina pri pediatričnih bolnikih niso ocenili.
English: Tachycardia; Palpitations
Slovenian: Srčne bolezni tahikardija; palpitacije
English: In vitro data demonstrate that the active metabolite of fesoterodine does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, or induce CYP1A2, 2B6, 2C9, 2C19, or 3A4 at clinically relevant plasma concentrations.
Slovenian: Podatki in vitro kažejo, da aktivni presnovek fesoterodina pri klinično pomembnih koncentracijah v plazmi ne zavira encimov CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ali 3A4 ali inducira encimov CYP1A2, 2B6, 2C9, 2C19 ali 3A4.
English: The terminal half-life of the active metabolite following oral administration is approximately 7 hours and is absorption rate-limited.
Slovenian: Po peroralni uporabi je končni razpolovni čas aktivnega presnovka približno 7 ur in je omejen s hitrostjo absorpcije.
English: TOVIAZ is available in blister packs of 7, 14, 28, 30, 56, 84, 98 and 100 prolonged-release tablets.
Slovenian: Zdravilo TOVIAZ je na voljo v pretisnih omotih po 7, 14, 28, 30, 56, 84, 98 in 100 tablet s podaljšanim sproščanjem.
English: Reproductive toxicity studies with fesoterodine in animals show minor embryotoxicity.
Slovenian: Študije vpliva fesoterodina na sposobnost razmnoževanja na živalih so pokazale manjšo embriotoksičnost.
English: Organic causes must be excluded before any treatment with antimuscarinics is considered.
Slovenian: Pred kakršnimkoli zdravljenjem z antimuskariniki je treba izključiti organske vzroke.
English: The efficacy of fixed doses of fesoterodine 4 mg and 8 mg was evaluated in two Phase 3 randomised, double-blind, placebo-controlled, 12-week studies.
Slovenian: Učinkovitost fiksnih odmerkov fesoterodina 4 mg in 8 mg so ocenili v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih, 12-tedenskih študijah 3. faze.
English: The table below gives the frequency of treatment emergent adverse reactions from placebocontrolled clinical trials and from post-marketing experience.
Slovenian: V spodnji preglednici je navedena pogostnost neželenih učinkov, do katerih je prišlo zaradi zdravljenja, v kliničnih preskušanjih, nadzorovanih s placebom, in iz izkušenj v obdobju trženja.
English: (1) Mild GFR = 50-80 ml/min; Moderate GFR = 30-50 ml/min; Severe GFR = <30 ml/min (2) Cautious dose increase.
Slovenian: Se je treba izogniti Kontraindicirano (1) Blaga okvara: GFR = 50-80 ml/min; Zmerna: GFR = 30-50 ml/min; Huda: GFR = < 30 ml/min (2) Previdno povečanje odmerka.
English: In addition, TOVIAZ is also available in HDPE bottles containing 30 or 90 tablets.
Slovenian: Dodatno je zdravilo TOVIAZ na voljo tudi v plastenkah iz polietilena visoke gostote (HDPE), ki vsebujejo 30 ali 90 tablet.
English: Dose increases
Slovenian: Povečanje odmerka
English: It is rapidly and extensively hydrolysed by non-specific plasma esterases to the 5-hydroxymethyl derivative, its primary active metabolite, which is the main active pharmacological principle of fesoterodine.
Slovenian: Nespecifične esteraze v plazmi ga hitro in dobro hidrolizirajo v 5-hidroksimetilni derivat, njegov primarni aktivni presnovek, kar je osnovna aktivna farmakološka oblika fesoterodina.
English: TOVIAZ can cause blurred vision, dizziness, and sleepiness.
Slovenian: Zdravilo TOVIAZ lahko povzroči zamegljen vid, omotico in zaspanost.
English: Pharmacokinetics of fesoterodine in patients with severe hepatic impairment have not been studied.
Slovenian: Farmakokinetike fesoterodina pri bolnikih s hudo okvaro jeter niso preučevali.
English: Due to the pharmacological properties of fesoterodine, treatment may cause mild to moderate antimuscarinic effects like dry mouth, dry eye, dyspepsia and constipation.
Slovenian: Zaradi farmakoloških lastnosti fesoterodina lahko zdravljenje povzroči blage do zmerne antimuskarinske učinke, kot so suha usta, suhe oči, dispepsija in zaprtje.
English: The effect of fesoterodine 4 mg and 28 mg on the QT interval was thoroughly evaluated in a double-blind, randomised, placebo- and positive-controlled (moxifloxacin 400 mg) parallel group study with once-daily treatment over a period of 3 days in 261 male and female subjects aged 45 to 65 years.
Slovenian: Učinek 4 mg in 28 mg odmerkov fesoterodina na interval QT so temeljito ocenili v dvojno slepi, randomizirani, s placebom in pozitivno kontrolo (400 mg moksifloksacina) nadzorovani študiji vzporednih skupin z zdravljenjem 3 dni enkrat na dan, pri 261 moških in ženskih osebah, starih od 45 do 65 let.
English: Pharmacotherapeutic group: Urologicals, Urinary antispasmodics, ATC code: G04BD11.
Slovenian: Farmakoterapevtska skupina: zdravila za bolezni sečil, urospazmolitiki, oznaka ATC: G04BD11
English: Electrocardiograms were obtained from 782 patients treated with 4 mg, 785 treated with 8 mg, 222 treated with 12 mg fesoterodine and 780 with placebo.
Slovenian: Elektrokardiograme so naredili pri 782 bolnikih, ki so prejemali 4 mg fesoterodina, 785 bolnikih, ki so prejemali 8 mg fesoterodina, 222 bolnikih, ki so prejemali 12 mg fesoterodina in 780 bolnikih, ki so prejemali placebo.
English: After single or multiple-dose oral administration of fesoterodine in doses from 4 mg to 28 mg, plasma concentrations of the active metabolite are proportional to the dose.
Slovenian: Pri peroralni uporabi posameznih ali večkratnih odmerkov fesoterodina v velikosti od 4 do 28 mg so koncentracije aktivnega presnovka v plazmi sorazmerne z odmerkom.
English: This especially holds true when taking potent CYP3A4 inhibitors (see sections 4.2, 4.5 and 5.1).
Slovenian: To je še posebej pomembno pri sočasni uporabi močnih zaviralcev CYP3A4 (glejte poglavja 4.2, 4.5 in 5.1).
English: The coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, soya lecithin, indigo carmine aluminium lake (E132).
Slovenian: Obloga: polivinilalkohol, titanov dioksid (E171), makrogol (3350), smukec, sojin lecitin, indigotin (E132).
English: Do not store above 25oC.
Slovenian: Shranjujte pri temperaturi do 25 °C.
English: Dose dependent antimuscarinic adverse reactions are likely to occur.
Slovenian: Lahko se pojavijo od odmerka odvisni antimuskarinski neželeni učinki.
English: In the presence of fesoterodine there are no changes in the plasma concentrations of combined oral contraceptives containing ethinylestradiol and levonorgestrel.
Slovenian: V prisotnosti fesoterodina se plazemske koncentracije kombiniranih peroralnih kontraceptivov, ki vsebujejo etinilestradiol in levonorgestrel, ne spremenijo.
English: It is unknown whether fesoterodine/metabolites are excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.
Slovenian: Ni znano, ali se fesoterodin/presnovki izločajo v materino mleko; zato med zdravljenjem z zdravilom TOVIAZ dojenje ni priporočljivo.
English: TOVIAZ 4 mg and 8 mg tablets are packed in aluminium-aluminium blisters in cartons containing 7, 14, 28, 30, 56, 84, 98 or 100 tablets.
Slovenian: Tablete TOVIAZ 4 mg in 8 mg so pakirane v pretisne omote iz aluminija/aluminija in v škatle, ki vsebujejo 7, 14, 28, 30, 56, 84, 98 ali 100 tablet.
English: It is not known whether fesoterodine is excreted into human milk; therefore, do not breast-feed during treatment with TOVIAZ.
Slovenian: Ni znano, ali se fesoterodin izloča v materino mleko, zato med zdravljenjem z zdravilom TOVIAZ ne smete dojiti.
English: In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times the maximum recommended human dose (MRHD), respectively, based on AUC (see section 5.3).
Slovenian: V študijah vpliva na sposobnost razmnoževanja na živalih je peroralno dajanje fesoterodina brejim mišjim in kunčjim samicam v obdobju organogeneze povzročilo fetotoksičnost pri izpostavljenostih samic-mater, ki so bile 6-krat oziroma 3-krat večje od izpostavljenosti pri največjem priporočenem odmerku pri človeku (MRHD - Maximum Recommended Human Dose) na podlagi vrednosti AUC (glejte poglavje 5.3).
English: If you forget to take TOVIAZ
Slovenian: Če ste pozabili vzeti zdravilo TOVIAZ
English: If you stop taking TOVIAZ
Slovenian: Če ste prenehali jemati zdravilo TOVIAZ
English: • pain in the stomach
Slovenian: • bolečina v želodcu
English: Potent
Slovenian: Močni
English: Based on AUC, the systemic exposure was 0.6 to 1.5 times higher in mice than in humans at the MRHD, whereas based on peak plasma concentrations, the exposure in mice was 5 to 9 times higher.
Slovenian: Sistemska izpostavljenost na podlagi AUC je bila pri miših 0,6 do 1,5krat večja od sistemske izpostavljenosti pri ljudeh pri največjem priporočenem odmerku za človeka, medtem ko je bila sistemska izpostavljenost na podlagi največje koncentracije v plazmi pri miših 5 do 9-krat večja.
English: • Urinary retention
Slovenian: • retencija urina;
English: Taking them at the same time as fesoterodine may make side effects such as dry mouth, constipation, difficulty in completely emptying your bladder or drowsiness more serious or occur more often.
Slovenian: Sočasno jemanje s fesoterodinom lahko povzroči, da so neželeni učinki, kot so suha usta, zaprtje, težave pri popolnem praznjenju sečnega mehurja ali zaspanost, bolj izraziti ali bolj pogosti.
English: However in conscious dogs, the active metabolite had no effect on the QT interval and QTc interval at plasma exposures at least 33-fold higher than mean peak free plasma concentration in human subjects who are extensive metabolisers and 21-fold higher than measured in subjects who are poor CYP2D6 metabolisers after fesoterodine 8 mg once daily.
Slovenian: Vendar pri psih, ki so bili pri zavesti, aktivni presnovek ni imel učinka na interval QT in QTc pri koncentracijah v plazmi, ki so bile najmanj 33-krat večje od povprečne največje proste koncentracije v plazmi po jemanju 8 mg fesoterodina enkrat na dan pri osebah, ki so dobri presnavljalci, in 21-krat večje od povprečne vrednosti, izmerjene pri osebah, ki so slabi presnavljalci CYP2D6.
English: Other causes of frequent urination (treatment of heart failure or renal disease) should be assessed before treatment with fesoterodine.
Slovenian: Pred začetkom zdravljenja s fesoterodinom je treba oceniti druge vzroke za pogosto uriniranje (zdravljenje srčnega popuščanja ali ledvične bolezni).
English: The tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.
Slovenian: Jedro tablete: ksilitol, laktoza monohidrat, mikrokristalna celuloza, hipromeloza, glicerildibehenat, smukec.
English: 30 prolonged-release tablets 90 prolonged-release tablets
Slovenian: 30 tablet s podaljšanim sproščanjem 90 tablet s podaljšanim sproščanjem
English: Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception.
Slovenian: Fesoterodin ne vpliva na supresijo ovulacije, ki jo povzročijo peroralni hormonski kontraceptivi.
English: Voided volume per micturition (ml)
Slovenian: Izločen volumen na uriniranje (ml)
English: What TOVIAZ looks like and contents of the pack
Slovenian: Izgled zdravila TOVIAZ in vsebina pakiranja
English: TOVIAZ prolonged-release tablets contain lactose.
Slovenian: Zdravilo TOVIAZ tablete s podaljšanim sproščanjem vsebuje laktozo.
English: N=283 N=266
Slovenian: n = 279 n = 265 n = 276 n = 283 n = 266 n = 267 n = 267
English: In addition, TOVIAZ 4 mg and 8 mg tablets are also packed in HDPE bottles containing 30 or 90 tablets.
Slovenian: Dodatno so tablete TOVIAZ 4 mg in 8 mg pakirane tudi v plastenke iz polietilena visoke gostote (HDPE), ki vsebujejo 30 ali 90 tablet.
English: • Myasthenia gravis
Slovenian: • miastenija gravis;
English: Urinary retention (including feeling of residual urine; micturition disorder);
Slovenian: Bolezni sečil disurija retencija urina (vključno z občutkom rezidualnega urina; motnje pri uriniranju); urinarna hezitacija
English: The mean steady-state volume of distribution following intravenous infusion of the active metabolite is 169 l.
Slovenian: Po intravenskem infundiranju aktivnega presnovka je povprečna vrednost volumna porazdelitve v stanju dinamičnega ravnovesja 169 l.
English: TOVIAZ contains an active substance called fesoterodine fumarate, and is a so called antimuscarinic treatment which reduces the activity of an overactive bladder and it is used in adults to treat the symptoms.
Slovenian: Zdravilo TOVIAZ vsebuje učinkovino fesoterodinijev fumarat in je tako imenovano antimuskarinsko zdravilo, ki zmanjšuje aktivnost čezmerno aktivnega sečnega mehurja.
English: No clinical trials have been conducted to assess the effect of fesoterodine on human fertility.
Slovenian: Kliničnih preskušanj za oceno učinka fesoterodina na plodnost pri ljudeh niso izvedli.
English: TOVIAZ should be used with caution in patients with risk for QT prolongation (e.g. hypokalaemia, bradycardia and concomitant administration of medicines known to prolong QT interval) and relevant pre-existing cardiac diseases (e.g. myocardial ischaemia, arrhythmia, congestive heart failure), (see section 4.8).
Slovenian: Zdravilo TOVIAZ je treba pri bolnikih s tveganjem za podaljšanje intervala QT (npr. hipokaliemija, bradikardija in sočasna uporaba zdravil, ki podaljšajo interval QT) in že obstoječimi srčnimi boleznimi (npr. ishemija miokarda, aritmija, kongestivno srčno popuščanje) uporabljati previdno (glejte poglavje 4.8).
English: After oral administration, due to rapid and extensive hydrolysis by non-specific plasma esterases, fesoterodine was not detected in plasma.
Slovenian: Fesoterodin po peroralni uporabi hitro in obširno hidrolizirajo nespecifične esteraze v plazmi, zato ga v plazmi niso odkrili.
English: • difficulty in completely emptying the bladder (urinary retention)
Slovenian: • težave pri popolnem praznjenju sečnega mehurja (retencija urina)
English: 7 prolonged-release tablets 14 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 56 prolonged-release tablets 84 prolonged-release tablets 98 prolonged-release tablets 100 prolonged-release tablets
Slovenian: 7 tablet s podaljšanim sproščanjem 14 tablet s podaljšanim sproščanjem 28 tablet s podaljšanim sproščanjem 30 tablet s podaljšanim sproščanjem 56 tablet s podaljšanim sproščanjem 84 tablet s podaljšanim sproščanjem 98 tablet s podaljšanim sproščanjem 100 tablet s podaljšanim sproščanjem
English: TOVIAZ contains lactose and soya oil
Slovenian: Zdravilo TOVIAZ vsebuje laktozo in sojino olje
English: TOVIAZ treats the symptoms of an overactive bladder such as
Slovenian: Zdravilo TOVIAZ se uporablja za zdravljenje simptomov čezmerno aktivnega sečnega mehurja, kot so:
English: TOVIAZ 8 mg tablets
Slovenian: TOVIAZ 8 mg tablete
English: Urinary retention may occur uncommonly.
Slovenian: Občasno lahko pride do retencije urina.
English: • Severe ulcerative colitis
Slovenian: • hud ulcerozni kolitis;