FrancophonIA/ELRC3.0 huggingface dataset:
English: They have mainly involved elderly (≥ 65 years) male patients with a history consistent with benign prostatic hyperplasia (see section 4.4).
Croatian: Slučajevi su uglavnom uključivali starije bolesnike (u dobi od ≥ 65 godina) muškog spola koji su u anamnezi imali tegobe sukladne benignoj hiperplaziji prostate (vidjeti dio 4.4).
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.
Croatian: TOVIAZ 4 mg i 8 mg tablete pakirane su u aluminij-aluminij blisterima u kutijama koje sadrže 7, 14, 28, 30, 56, 84, 98 ili 100 tableta.
English: Co-administration of a potent CYP2D6 inhibitor may result in increased exposure and adverse events.
Croatian: Istovremena primjena jakog inhibitora CYP2D6 može rezultirati povećanom izloženošću i nuspojavama.
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.
Croatian: Djelotvornost fiksnih doza fesoterodina u dozi od 4 mg i 8 mg procijenila se u dva placebom kontrolirana, randomizirana, dvostruko slijepa ispitivanja u trajanju od 12 tjedana.
English: Angioedema has been reported with fesoterodine and has occurred after the first dose in some cases.
Croatian: Uz fesoterodin je zabilježena pojava angioedema koji je u nekim slučajevima nastao nakon prve doze.
English: In subjects with normal renal and hepatic function receiving concomitant administration of potent CYP3A4 inhibitors, the maximum daily dose of TOVIAZ should be 4 mg once daily (see section
Croatian: U osoba s normalnom funkcijom bubrega i jetre koji istovremeno primaju jake inhibitore enzima CYP3A4, maksimalna dnevna doza lijeka TOVIAZ treba biti 4 mg jedanput na dan (vidjeti dio
English: In addition, TOVIAZ 4 mg and 8 mg tablets are also packed in HDPE bottles containing 30 or 90 tablets.
Croatian: Uz to, TOVIAZ 4 mg i 8 mg tablete također su pakirane u HDPE boce koje sadrže 30 ili 90 tableta.
English: If urinary tract infection is present, an appropriate medical approach should be taken/antibacterial therapy should be started.
Croatian: Ako je prisutna infekcija mokraćnih puteva, potrebno je primijeniti odgovarajući medicinski pristup/započeti antibiotsku terapiju.
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.
Croatian: Podaci in vitro pokazuju da djelatni metabolit fesoterodina u klinički važnim koncentracijama u plazmi ne inhibira enzime CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ili 3A4 i ne inducira enzime CYP1A2, 2B6, 2C9, 2C19 ili 3A4.
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.
Croatian: Učinak fesoterodina u dozi od 4 mg i 28 mg na QT interval temeljito je provjeren u dvostruko slijepom, randomiziranom, placebom i aktivno kontroliranom (moksifloksacin u dozi od 400 mg) ispitivanju na usporednim skupinama u kojem se primjenjivao jedanput na dan tijekom razdoblja od 3 dana u 261 ispitanika oba spola u dobi od 45 do 65 godina.
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.
Croatian: Fesoterodinom liječeni bolesnici su, na kraju liječenja, imali statistički značajno smanjen prosječni broj mokrenja u 24 sata i broj epizoda urgentne inkontinencije u 24 sata u usporedbi s placebom.
English: Tachycardia; Palpitations
Croatian: Srčani poremećaji tahikardija; palpitacije
English: Thus fesoterodine is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.
Croatian: Stoga fesoterodin najvjerojatnije neće promijeniti klirens lijekova koje metaboliziraju ovi enzimi.
English: In addition, TOVIAZ is also available in HDPE bottles containing 30 or 90 tablets.
Croatian: Osim u takvom pakovanju, TOVIAZ je dostupan i u HDPE bocama koje sadrže 30 ili 90 tableta.
English: # primary end points
Croatian: # primarni ishodi
English: • Severe ulcerative colitis
Croatian: • teški ulcerozni kolitis
English: It is unknown whether fesoterodine/metabolites are excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.
Croatian: Nije poznato izlučuju li se fesoterodin/metaboliti u majčino mlijeko; stoga se ne preporučuje dojiti tijekom liječenja lijekom TOVIAZ.
English: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetke (mogu se javiti u najviše 1 na 1000 osoba) koprivnjača smetenost
English: If you forget to take TOVIAZ
Croatian: Ako ste zaboravili uzeti TOVIAZ
English: No accumulation occurs after multiple-dose administration.
Croatian: Ne dolazi do nakupljanja nakon primjene višestrukih doza.
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).
Croatian: Potreban je oprez kod upravljanja vozilima i rada na strojevima zbog mogućeg nastanka nuspojava kao što su zamagljen vid, omaglica i pospanost (vidjeti dio 4.8).
English: • Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1
Croatian: • preosjetljivost na djelatnu tvar, kikiriki, soju ili neku od pomoćnih tvari navedenih u dijelu
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.
Croatian: Međutim, u pasa koji su bili pri svijesti, djelatni metabolit nije imao nikakav učinak na QT interval i QTc interval kod koncentracija u plazmi koje su najmanje 33 puta više od prosječne vršne slobodne koncentracije u plazmi u ljudskih ispitanika s jakom sposobnošću metaboliziranja te 21 puta viša od one izmjerene u ispitanika sa slabom sposobnošću metaboliziranja putem CYP2D6 nakon primjene fesoterodina u dozi od 8 mg jedanput na dan.
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.
Croatian: Suha usta, jedina vrlo česta nuspojava, javila se učestalošću od 28,8% u skupini koja je primala fesoterodin i u 8,5% ispitanika u skupini koja je primala placebo.
English: The active metabolite is further metabolised in the liver to its carboxy, carboxy-N-desisopropyl, and N-desisopropyl metabolite with involvement of CYP2D6 and CYP3A4.
Croatian: Djelatni metabolit se dalje metabolizira u jetri do svog karboksi-, karboksi-N-dezizopropil i Ndezizopropilnog metabolita u čemu sudjeluju enzimi CYP2D6 i CYP3A4.
English: At 45 mg/kg/day, a lower number of corpora lutea, implantation sites and viable foetuses was observed in female mice administered fesoterodine for 2 weeks prior to mating and continuing through day 7 of gestation.
Croatian: Pri dozi od 45 mg/kg na dan zabilježen je manji broj žutih tijela, mjesta implantacije i fetusa s izgledima za preživljenje u ženki miševa kojima je davana doza fesoterodina tijekom 2 tjedna prije parenja pa sve do 7. dana gestacije.
English: The recommended starting dose is 4 mg once daily.
Croatian: Preporučuje se početna doza od 4 mg jedanput na dan.
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.
Croatian: U 782 bolesnika liječenih s 4 mg fesoterodina, 785 liječenih s 8 mg fesoterodina, 222 liječenih s 12 mg fesoterodina i 780 koji su primali placebo napravljen je elektrokardiogram.
English: TOVIAZ treats the symptoms of an overactive bladder such as
Croatian: TOVIAZ liječi simptome pretjerano aktivnog mokraćnog mjehura kao što su:
English: Due to the pharmacological properties of fesoterodine, treatment may cause mild to moderate antimuscarinic effects like dry mouth, dry eye, dyspepsia and constipation.
Croatian: Zbog farmakoloških svojstava fesoterodina, liječenje može prouzročiti blage do umjereno jake antimuskarinske učinke kao što su suha usta, suho oko, dispepsija i zatvor.
English: The heart rate corrected QT interval in fesoterodine treated patients did not differ from that seen in placebo treated patients.
Croatian: QT interval korigiran za srčanu frekvenciju u bolesnika liječenih fesoterodinom nije se razlikovao od onog u bolesnika koji su primali placebo.
English: • suddenly needing to empty your bladder (called urgency)
Croatian: • iznenadna potreba da se isprazni mokraćni mjehur (što se zove urgencija)
English: ALT increased; GGT increased
Croatian: Poremećaji jetre i žuči povišena ALT; povišena GGT
English: TOVIAZ contains lactose.
Croatian: TOVIAZ sadrži laktozu.
English: • having to empty your bladder more often than usual (called increased urinary frequency)
Croatian: • potreba da se mokraćni mjehur prazni češće nego obično (što se zove učestalo mokrenje).
English: • Uncontrolled narrow angle glaucoma
Croatian: • nekontrolirani glaukom uskog kuta
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.
Croatian: Ako ste uzeli više tableta nego što Vam je rečeno ili ako netko drugi slučajno uzme
English: Fesoterodine has been safely administered in clinical studies at doses up to 28 mg/day.
Croatian: U kliničkim je ispitivanjima primjena fesoterodina bila sigurna kad se davao u dozama do 28 mg/dan.
English: Caution should be exercised in coadministration of fesoterodine with other antimuscarinics and medicinal products with anticholinergic properties (e.g. amantadine, tri-cyclic antidepressants, certain neuroleptics) as this may lead to more pronounced therapeutic- and side-effects (e.g. constipation, dry mouth, drowsiness, urinary retention).
Croatian: Potreban je oprez kod istovremene primjene fesoterodina s drugim antimuskarinskim lijekovima i ostalim lijekovima s antikolinergičkim svojstvima (npr. amantadin, triciklički antidepresivi, određeni neuroleptici), jer to može dovesti do izraženijih terapijskih učinaka i nuspojava (npr. konstipacija, suha usta, omamljenost, retencija mokraće).
English: It is not known whether fesoterodine is excreted into human milk; therefore, do not breast-feed during treatment with TOVIAZ.
Croatian: Nije poznato izlučuje li se fesoterodin u majčino mlijeko; stoga, nemojte dojiti tijekom liječenja lijekom TOVIAZ.
English: - Severe central anticholinergic effects (e.g. hallucinations, severe excitation): treat with physostigmine - Convulsions or pronounced excitation: treat with benzodiazepines - Respiratory insufficiency: treat with artificial respiration - Tachycardia: treat with beta-blockers - Urinary retention: treat with catheterisation - Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room.
Croatian: - teški centralni antikolinergički učinci (npr. halucinacije, veliki nemir): liječiti fizostigminom - konvulzije ili izraziti nemir: liječiti benzodiazepinima - respiratorna insuficijencija: liječiti umjetnom respiracijom - tahikardija: liječiti beta blokatorima - retencija mokraće: liječiti kateterizacijom - midrijaza: liječiti pilokarpinskim kapima za oko i/ili staviti bolesnika u mračnu prostoriju.
English: TOVIAZ prolonged-release tablets contain lactose.
Croatian: TOVIAZ tablete s produljenim oslobađanjem sadrže laktozu.
English: TOVIAZ contains lactose and soya oil
Croatian: TOVIAZ sadrži laktozu i sojino ulje
English: • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
Croatian: • istovremena primjena jakih inhibitora CYP3A4 u osoba s umjereno teškim i teškim oštećenjem funkcije jetre ili bubrega
English: The table below gives the frequency of treatment emergent adverse reactions from placebocontrolled clinical trials and from post-marketing experience.
Croatian: Sljedeća tablica prikazuje učestalost nuspojava tijekom liječenja u placebom kontroliranim kliničkim ispitivanjima i razdoblju nakon stavljanja lijeka u promet.
English: Therefore, the maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors (e.g. atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir (and all ritonavir boosted PI-regimens), saquinavir and telithromycin (see sections 4.2 and 4.4)).
Croatian: Stoga maksimalnu dozu fesoterodina treba ograničiti na 4 mg kad se primjenjuje istovremeno s jakim inhibitorima enzima CYP3A4 (npr. atazanavirom, klaritromicinom, indinavirom, itrakonazolom, ketokonazolom, nefazodonom, nelfinavirom, ritonavirom (i svim režimima inhibitorima proteaze pojačanima ritonavirom), sakvinavirom i telitromicinom (vidjeti dijelove 4.2 i 4.4)).
English: The tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.
Croatian: Jezgra tablete: ksilitol, laktoza hidrat, mikrokristalična celuloza, hipromeloza, gliceroldibehenat, talk.
English: In the event of fesoterodine overdose, treat with gastric lavage and give activated charcoal.
Croatian: U slučaju predoziranja fesoterodinom, liječenje uključuje ispiranje želuca i davanje aktivnog ugljena.
English: TOVIAZ 8 mg tablets
Croatian: TOVIAZ 8 mg tablete
English: 30 prolonged-release tablets 90 prolonged-release tablets
Croatian: 30 tableta s produljenim oslobađanjem 90 tableta s produljenim oslobađanjem
English: How to take TOVIAZ
Croatian: Kako uzimati TOVIAZ
English: TOVIAZ contains soya oil.
Croatian: TOVIAZ sadrži sojino ulje.
English: The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of moderate and potent CYP3A4 inhibitors (see sections 4.3, 4.4, 4.5 and 5.2).
Croatian: Sljedeća tablica prikazuje preporučene dnevne doze za osobe s oštećenom funkcijom bubrega ili jetre koje uzimaju i one koje ne uzimaju umjerene i jake inhibitore CYP3A4 (vidjeti dijelove 4.3, 4.4, 4.5 i 5.2).
English: • not being able to control when you empty your bladder (called urgency incontinence)
Croatian: • nemogućnost kontrole mokrenja nakon pražnjenja mokraćnog mjehura (što se zove urgentna inkontinencija)
English: • The active substance is fesoterodine fumarate.
Croatian: • Djelatna tvar je fesoterodinfumarat.
English: Change from baseline in QTc based on the Fridericia correction method did not show any differences between the active treatment and placebo group.
Croatian: Promjena QTc-a temeljenog na Fridericijinoj metodi korekcije u odnosu na početnu vrijednost nije se razlikovala između skupine koja je primala aktivno liječenje i skupine koja je primala placebo.
English: TOVIAZ 4 mg tablets
Croatian: TOVIAZ 4 mg tablete
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
Croatian: 7 tableta s produljenim oslobađanjem 14 tableta s produljenim oslobađanjem 28 tableta s produljenim oslobađanjem 30 tableta s produljenim oslobađanjem 56 tableta s produljenim oslobađanjem 84 tableta s produljenim oslobađanjem 98 tableta s produljenim oslobađanjem 100 tableta s produljenim oslobađanjem
English: Pharmacological interactions
Croatian: Farmakološke interakcije
English: N=223 N=205
Croatian: N=223 N=205 N=228
English: No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice).
Croatian: Ne preporučuje se prilagodba doze u prisutnosti umjerenih inhibitora CYP3A4 (npr. eritromicina, flukonazola, diltiazema, verapamila i soka od grejpa).
English: Pharmacokinetics of fesoterodine in patients with severe hepatic impairment have not been studied.
Croatian: Farmakokinetika fesoterodina u bolesnika s teškim oštećenjem funkcije jetre nije ispitana.
English: Responder rate p-value
Croatian: Stopa ispitanika s odgovorom P-vrijednost
English: Following blockade of CYP3A4 by coadministration of the moderate CYP3A4 inhibitor fluconazole 200 mg twice a day for 2 days, Cmax and AUC of the active metabolite of fesoterodine increased approximately 19% and 27%, respectively.
Croatian: Nakon blokade CYP3A4 istovremenom primjenom umjereno jakog inhibitora CYP3A4 flukonazola u dozi od 200 mg dvaput na dan tijekom 2 dana, Cmax djelatnog metabolita fesoterodina povećala se približno 19%, a AUC 27%.
English: In patients with severe renal impairment (GFR < 30 ml/min), Cmax and AUC are increased 2.0 and 2.3-fold, respectively.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega (GFR <30 ml/min), Cmax povećala se 2,0 puta, a AUC se povećala 2,3 puta.
English: N=283 N=266
Croatian: N=283 N=266 N=267
English: The incidence rates of QTc 500 ms post baseline or QTc increase of 60 ms is 1.9%, 1.3%, 1.4% and 1.5%, for fesoterodine 4 mg, 8 mg, 12 mg and placebo, respectively.
Croatian: Incidencija QTc ≥ 500 ms nakon početka liječenja ili povišenje QTc za ≥ 60 ms iznosila je 1,9% u skupini koja je primala 4 mg, 1,3% u skupini koja je primala 8 mg, 1,4% u skupini koja je primala 12 mg fesoterodina te 1,5% u skupini koja je primala placebo.
English: Immediate Packaging HDPE Bottle - 8 mg
Croatian: Unutarnje pakiranje HDPE boca - 8 mg
English: Česká Republika Pfizer PFE, spol.
Croatian: Česká Republika Pfizer PFE, spol. s r.o.
English: - Hepatic impairment (see sections 4.2, 4.3 and 5.2) - Renal impairment (see sections 4.2, 4.3 and 5.2) - Concomitant administration of potent or moderate CYP3A4 inhibitors (see sections 4.2 and
Croatian: - oštećenje funkcije jetre (vidjeti dijelove 4.2, 4.3 i 5.2) - oštećenje funkcije bubrega (vidjeti dijelove 4.2, 4.3 i 5.2) - istovremena primjena jakih ili umjereno jakih inhibitora CYP3A4 (vidjeti dijelove 4.2 i 4.5) - istovremena primjena jakog inhibitora CYP2D6 (vidjeti dijelove 4.5 i 5.2).
English: In clinical trials of fesoterodine, cases of markedly elevated liver enzymes were reported with the occurrence frequency no different from the placebo group.
Croatian: U kliničkim ispitivanjima fesoterodina, zabilježena učestalost slučajeva s izrazito povišenim enzimima jetre nije bila veća od one u skupini koja je primala placebo.
English: Parameter Placebo Fesoterodine 4 mg
Croatian: Parametar Placebo Fesoterodin 4 mg
English: In patients with mild or moderate renal impairment (GFR 30 - 80 ml/min), Cmax and AUC of the active metabolite increased up to 1.5 and 1.8-fold, respectively, as compared to healthy subjects.
Croatian: U bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega (GFR 30 - 80 ml/min), Cmax djelatnog metabolita povećala se do 1,5 puta, a AUC do 1,8 puta u usporedbi s onima u zdravih ispitanika.
English: Microcrystalline cellulose Hypromellose Glycerol dibehenate Talc
Croatian: Jezgra tablete ksilitol laktoza hidrat mikrokristalična celuloza hipromeloza gliceroldibehenat talk
English: In patients with moderate hepatic impairment (Child Pugh B), Cmax and AUC of the active metabolite increased 1.4 and 2.1-fold, respectively, as compared to healthy subjects.
Croatian: U bolesnika s umjerenim oštećenjem funkcije jetre (Child Pugh B), Cmax djelatnog metabolita povećala se 1,4 puta, a AUC 2,1 puta u usporedbi sa zdravim ispitanicima.
English: How to store TOVIAZ
Croatian: Kako čuvati TOVIAZ
English: See sections 4.4, 4.5 and 5.2 (3) Moderate CYP3A4 inhibitors.
Croatian: Vidjeti dijelove 4.4, 4.5 i 5.2. (3) Umjereno jaki inhibitori CYP3A4.
English: Talk to your doctor before taking TOVIAZ, if any of the following apply to you: - if you have difficulties in completely emptying your bladder (for example due to prostate enlargement) - if you ever experience decreased bowel movements or suffer from severe constipation - if you are being treated for an eye disease called narrow angle glaucoma - if you have serious kidney or liver problems, your doctor may need to adjust your dose - if you have a disease called autonomic neuropathy which you notice from symptoms such as changes in your blood pressure or disorders in the bowel or sexual function - if you have a gastrointestinal disease that affects the passage and/or digestion of food - if you have heartburn or belching.
Croatian: Razgovarajte sa svojim liječnikom prije nego uzmete TOVIAZ, ako nešto od sljedećeg vrijedi za Vas: - ako imate poteškoće s potpunim pražnjenjem mokraćnog mjehura (na primjer, zbog povećanja prostate) - ako ikad imate smanjeno pražnjenje crijeva ili bolujete od teškog zatvora - ako se liječite zbog očne bolesti koja se zove glaukom uskog kuta - ako imate ozbiljne tegobe s bubrezima ili jetrom, liječnik će Vam morati prilagoditi dozu - ako imate bolest koja se zove autonomna neuropatija, koju možete primijetiti po simptomima kao što su promjene krvnog tlaka ili poremećaji crijeva ili seksualne funkcije - ako imate bolest probavnog sustava koja utječe na prolazak i/ili probavu hrane - ako imate žgaravicu ili često podrigivanje - ako imate infekciju mokraćnih puteva, liječnik će Vam morati propisati neke antibiotike.
English: Following induction of CYP3A4 by coadministration of rifampicin 600 mg once a day, Cmax and AUC of the active metabolite of fesoterodine decreased by approximately 70% and 75%, respectively, after oral administration of fesoterodine 8 mg.
Croatian: Nakon indukcije CYP3A4 istovremenom primjenom rifampicina u dozi od 600 mg jedanput na dan, Cmax djelatnog metabolita fesoterodina smanjila se za približno 70%, a AUC za približno 75% nakon peroralne primjene fesoterodina u dozi od 8 mg.
English: Immediate packaging HDPE Bottle - 4 mg
Croatian: Unutarnje pakiranje HDPE boca - 4 mg
English: Pfizer Ελλάς A.E. Τλ: +30 210 6785800
Croatian: Τλ: +30 210 6785800
English: TOVIAZ 4 mg tablets Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 91.125 mg of lactose.
Croatian: Jedna tableta s produljenim oslobađanjem od 4 mg sadrži 0,525 mg sojinog lecitina i 91,125 mg laktoze.
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).
Croatian: U ispitivanjima reproduktivne toksičnosti na životinjama, peroralna primjena fesoterodina u nosećih ženki miševa i kunića tijekom organogeneze rezultirala je fetotoksičnošću pri maternalnim izloženostima koje su bile 6 odnosno 3 puta veće od maksimalne preporučene doze za ljude (engl.
English: Baseline Change from baseline p-value
Croatian: Promjena od početne vrijednosti P-vrijednost
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
Croatian: Što je TOVIAZ i za što se koristi Što morate znati prije nego počnete uzimati TOVIAZ
English: Infections and infestations
Croatian: Infekcije i infestacije infekcija mokraćnih puteva
English: Organic causes must be excluded before any treatment with antimuscarinics is considered.
Croatian: Prije razmatranja bilo kakvog liječenja antimuskarinskim lijekovima potrebno je isključiti organske uzroke.
English: TOVIAZ 8 mg tablets EU/1/07/386/006-010 EU/1/07/386/012
Croatian: TOVIAZ 8 mg tablete EU/1/07/386/006-010 EU/1/07/386/012
English: • Gastric retention
Croatian: • želučana retencija
English: R-Pharm Germany GmbH Heinrich-Mack-Str. 35, 89257 Illertissen Germany
Croatian: 35 , 89257 Illertissen Njemačka
English: Tel: 1800 633 363 (toll free) Tel: +44 (0)1304 616161
Croatian: Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) Tel: +44 (0)1304 616161