FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/07/386/006 7 prolonged-release tablets EU/1/07/386/007 14 prolonged-release tablets EU/1/07/386/008 28 prolonged-release tablets EU/1/07/386/020 30 prolonged-release tablets EU/1/07/386/009 56 prolonged-release tablets EU/1/07/386/010 98 prolonged-release tablets EU/1/07/386/012 84 prolonged-release tablets EU/1/07/386/018 100 prolonged-release tablets
Maltese: EU/1/07/386/006 7 pilloli li jerħu l-mediċina bil-mod EU/1/07/386/007 14-il pillola li jerħu l-mediċina bil-mod EU/1/07/386/008 28 pillola li jerħu l-mediċina bil-mod EU/1/07/386/020 30 pillola li jerħu l-mediċina bil-mod EU/1/07/386/009 56 pillola li jerħu l-mediċina bil-mod EU/1/07/386/010 98 pillola li jerħu l-mediċina bil-mod EU/1/07/386/012 84 pillola li jerħu l-mediċina bil-mod EU/1/07/386/018 100 pillola li jerħu l-mediċina bil-mod
English: EU/1/07/386/001 7 prolonged-release tablets EU/1/07/386/002 14 prolonged-release tablets EU/1/07/386/003 28 prolonged-release tablets EU/1/07/386/019 30 prolonged-release tablets EU/1/07/386/004 56 prolonged-release tablets EU/1/07/386/005 98 prolonged-release tablets EU/1/07/386/011 84 prolonged-release tablets EU/1/07/386/017 100 prolonged-release tablets
Maltese: EU/1/07/386/001 7 pilloli li jerħu l-mediċina bil-mod EU/1/07/386/002 14-il pillola li jerħu l-mediċina bil-mod EU/1/07/386/003 28 pillola li jerħu l-mediċina bil-mod EU/1/07/386/019 30 pillola li jerħu l-mediċina bil-mod EU/1/07/386/004 56 pillola li jerħu l-mediċina bil-mod EU/1/07/386/005 98 pillola li jerħu l-mediċina bil-mod EU/1/07/386/011 84 pillola li jerħu l-mediċina bil-mod EU/1/07/386/017 100 pillola li jerħu l-mediċina bil-mod
English: This especially holds true when taking potent CYP3A4 inhibitors (see sections 4.2, 4.5 and 5.1).
Maltese: Dan japplika speċjalment meta jittieħdu inibituri qawwija ta' CYP3A4 (ara sezzjonijiet 4.2, 4.5 u 5.1).
English: - medicines containing any of the following active substances may increase the blood levels of fesoterodine: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicine for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections), nefazodone (used to treat depression), fluoxetine or paroxetine (used to treat depression or anxiety), bupropion (used for smoking cessation or to treat depression), quinidine (used to treat arrhythmias) and cinacalcet (used to treat hyperparathyroidism).
Maltese: Itraconazole jew ketoconazole (użati biex jittrattaw infezzjonijiet tal-fungu), ritonavir, atazanavir, indinavir, saquinavir jew nelfinavir (mediċini anti-virali użati għat-trattament ta' HIV), clarithromycin jew telithromycin (użati għat-trattament ta' infezzjonijiet batteriċi), nefazodone (użat għat-trattament tad-depressjoni), fluoxetine jew paroxetine (użati biex jittrattaw depressjoni u ansjetà), bupropion (użat għal waqfien mit-tipjip u biex jitratta ddepressjoni), quinidine (użat biex jitratta arritmiji) ucinacalcet (użat biex jitratta iperparatirojdiżmu).
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.
Maltese: Pazjenti trattati b'fesoterodine kellhom tnaqqis statistikament sinifikanti medju fl-għadd ta' mikturizzjonijiet kull 24 siegħa u fl-għadd ta' episodji mqanqla ta' inkontinenza kull 24 siegħa fittmiem tat-trattament meta mqabblin ma dawk li hadu l-plaċebo.
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.
Maltese: Wara l-imblukkar ta' CYP3A4 bl-għoti flimkien tal-impeditur moderat ta' CYP3A4 fluconazole 200mg darbtejn kuljum għal jumejn, is-Cmax u l-AUC tal-metabolit attiv ta' fesoterodine żdiedu b' 19% u 27%, rispettivament.
English: TOVIAZ contains soya oil.
Maltese: TOVIAZ fih iż-żejt tas-soja.
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.
Maltese: Wara stimulazzjoni ta' CYP3A4 bl-għoti flimkien ta' rifampicin 600 mg darba kuljum, is-Cmax u lAUC tal-metabolit attiv ta' fesoterodine naqas b'madwar 70% u 75% rispettivament wara l-għoti orali ta' 8 mg fesoterodine
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.
Maltese: Huwa idroliżżat malajr u estensivament minn esterase mhux speċifiku fil-plażma u jifforma id-derivat 5-hydroxymethyl, ilprodott attiv primarju tal-metaboliżmu, li huwa wkoll il-prinċipju farmakoloġiku attiv ewlieni ta' fesoterodine.
English: Concomitant use with CYP3A4 inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) is not recommended (see section 4.4).
Maltese: (i.e. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's wort) m'hux rakkomandat (ara sezzjoni 4.5).
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).
Maltese: Ipokalimja, bradikardja u użu fl-istess żmien ta' mediċini magħrufa li jtawwlu l-intervall QT) u mard tal-qalb ġa eżistenti (eż. Iskemja mijokardijaka, arritmija, insuffiċjenza tal-qalb konġestiva), (ara sezzjoni 4.8).
English: After oral administration of fesoterodine, approximately 70% of the administered dose was recovered in urine as the active metabolite (16%), carboxy metabolite (34%),
Maltese: Wara li fesoterodine jittieħed mill-ħalq, madwar 70% tad-doża mogħtija ġiet rkuprata mill-awrina bħala l-metabolit attiv (16%), metabolit carboxy (34%), metabolit carboxy-Ndesisopropyl (18%), jew metabolit N-desisopropyl (1%), u ammont iżgħar (7%) ġie rkuprat flippurgar.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilmediċini http://www.ema.europa.eu/
English: Abdominal discomfort;
Maltese: Uġigħ addominali;
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.
Maltese: F'pazjenti li għandhom indeboliment ħafif jew moderat tal-kliewi (GFR 30 - 80 ml/min), is-Cmax u lAUC tal-metabolit attiv ogħlew sa 1.5 u 1.8 darba, rispettivament, meta mqabblin ma' suġġetti b'saħħithom.
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.
Maltese: TOVIAZ fih is-sustanza attiva msejjħa fesoterodine fumarate, u huwa trattament antimuskariniku, li jnaqqas l-attivita eċċessiva tal-bużżieqa ta' l-awrina u jintuża fl-adulti biex jittratta s-sintomi.
English: • not being able to control when you empty your bladder (called urgency incontinence)
Maltese: • nuqqas ta' kontroll meta tbattal il-bużżieqa ta' l-awrina (magħruf bħala inkontinenza ta'
English: Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of fesoterodine.
Maltese: Ġo kull pillola li terħi l-mediċina bil-mod hemm 8 mg fesoterodine fumarate, dan jikkorrespondi għal 6.2 mg ta' fesoterodine.
English: This may lead to a greater risk of dental caries.
Maltese: Dan jista jwassal għal riskju akbar ta' problemi tas-snien.
English: Fesoterodine may reduce the effect of medicinal products that stimulate the motility of the gastro-intestinal tract, such as metoclopramide.
Maltese: Fesoterodine jista jnaqqas l-effectt ta' prodotti mediċinali li jistimulaw il-moviment tal-passaġġ gastrointestinali bħal metoclopramide.
English: Fesoterodine has been safely administered in clinical studies at doses up to 28 mg/day.
Maltese: Fesoterodine ingħata mingħajr periklu fi studji kliniċi f'dożi sa 28 mg/jum.
English: • difficulty in completely emptying the bladder (urinary retention)
Maltese: • diffikultà biex tbattal kompletament il-bużżieqa ta' l-awrina (żamma urinarja)
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)).
Maltese: (eż. atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir (u l-korsijiet PI kollha li huma awmentati b'ritonavir), saquinovir u telithromycin (ara sezzjonijiet 4.2 u 4.4)).
English: A dose reduction to 4 mg may be needed (see section 4.4).
Maltese: Tnaqqis fid-doża għal 4 mg jista' jkun meħtieġ (ara sezzjoni 4.4).
English: In a study of fertility and early embryonic development in mice, fesoterodine had no effect on male reproductive function or fertility at doses up to 45 mg/kg/day.
Maltese: Fi studju tal-fertilità u żvilupp embrijoniku fil-bidu fil-ġrieden, fesoterodine ma kellux effett fuq ilfunzjoni riproduttiva jew fuq il-fertilità maskili f'dożi sa 45 mg/kg/jum.
English: Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of fesoterodine.
Maltese: Ġo kull pillola li terħi l-mediċina bil-mod hemm 4 mg fesoterodine fumarate, dan jikkorrespondi għal 3.1 mg ta' fesoterodine.
English: TOVIAZ is available in blister packs of 7, 14, 28, 30, 56, 84, 98 and 100 prolonged-release tablets.
Maltese: TOVIAZ jinsab fi folji ta' 7, 14, 28, 30, 56, 84, 98 u 100 pillola li jerħu l-mediċina bil-mod. Barra minn hekk, TOVIAZ jinsab ukoll fi fliexken ta' HDPE li fihom 30 jew 90 pillola.
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.
Maltese: TOVIAZ hu indikat fl-adulti għat-trattament tas-sintomi (żieda fil-frekwenza urinarja u/jew urġenza u/jew urġenza ta' nkontinenza) li jistgħu jinstabu f'sindrome ta' bużżieqa ta' l-awrina li hi attiva wisq.
English: TOVIAZ 4 mg tablets EU/1/07/386/001-005 EU/1/07/386/011 EU/1/07/386/013-014
Maltese: TOVIAZ 4 mg pilloli EU/1/07/386/001-005
English: Tablet core Xylitol
Maltese: Ħalq xott
English: TOVIAZ is contraindicated in subjects with severe hepatic impairment (see section 4.3).
Maltese: TOVIAZ huwa kontraindikat f'individwi li għandhom indeboliment serju tal-fwied (ara sezzjoni 4.3).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza ta' galactose, defiċjenza ta' Lapp lactase jew li ma jistgħux jassorbu glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: EU/1/07/386/013 30 prolonged-release tablets EU/1/07/386/014 90 prolonged-release tablets
Maltese: EU/1/07/386/013 30 pilloli li jerħu l-mediċina bil-mod EU/1/07/386/014 90 pilloli li jerħu l-mediċina bil-mod
English: • Uncontrolled narrow angle glaucoma
Maltese: • Glawkoma ta' angolu dejjaq mhix ikkontrollata
English: EU/1/07/386/015-016 EU/1/07/386/018
Maltese: EU/1/07/386/015-016
English: EU/1/07/386/015 30 prolonged-release tablets EU/1/07/386/016 90 prolonged-release tablets
Maltese: EU/1/07/386/015 30 pilloli li jerħu l-mediċina bil-mod EU/1/07/386/016 90 pilloli li jerħu l-mediċina bil-mod
English: Table 1: Mean changes from Baseline to end of treatment for primary and selected secondary endpoints Study 1
Maltese: Tabella 1: Tibdiliet medji mil-linji bażi ta' Referenza sa tmiem it-trattament għal endpoints primarji u sekondarji magħżula
English: Mean Cmax and AUC of the active metabolite are 1.7 and 2-fold higher, respectively, in CYP2D6 poor metabolisers as compared to extensive metabolisers.
Maltese: Is-Cmax medju u l-AUC tal-metabolit attiv huma ogħla b'fatturi ta' 1.7 u 2, rispettivament, f'dawk il-metaboliżżaturi dgħajfin ta' CYP2D6 meta mqabblin ma'metaboliżżaturi estensivi.
English: Prolonged-release tablet.
Maltese: Urihom il-pakkett tal-pilloli tiegħek.
English: Pharmacological interactions
Maltese: Interazzjonijiet farmakoloġiċi
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.
Maltese: L-effikaċja ta' dożi fissi ta' fesoterodine 4 mg u 8 mg kienet valutata f'żewg studji randomised, double blind, u bi plaċebo bħala kontroll ta' Fażi 3 mifruxa fuq 12-il ġimgħa.
English: Pharyngolaryng eal pain; Cough; Nasal dryness
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI
English: 30 prolonged-release tablets 90 prolonged-release tablets
Maltese: 30 pilloli li jerħu l-mediċina bil-mod 90 pilloli li jerħu l-mediċina bil-mod
English: The mean steady-state volume of distribution following intravenous infusion of the active metabolite is 169 l.
Maltese: Il-medja tal-volum ta' distribuzzjoni fiss wara infużjoni ġol-vina tal-metabolit attiv hu 1691.
English: • cough
Maltese: Qawwi
English: - Clinically significant bladder outflow obstruction at risk of urinary retention (e.g. clinically significant prostate enlargement due to benign prostatic hyperplasia, see section 4.3) - Gastrointestinal obstructive disorders (e.g. pyloric stenosis) - Gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis - Decreased gastrointestinal motility - Autonomic neuropathy - Controlled narrow-angle glaucoma
Maltese: - Rifluss gastro-esofagali u/jew li qed jieħdu prodotti mediċinali fl-istess waqt (bħal bisphosphonates li jittieħdu mill-ħalq) li jistgħu jikkaġunaw jew iħarrxu l-esofaġite - Moviment gastro-intestinali mnaqqas - Newropatija awtonomika - Glawkoma ta' angolu dejjaq ikkontrollata
English: Reproductive toxicity studies with fesoterodine in animals show minor embryotoxicity.
Maltese: Studji dwar tossiċità fis-sistema riproduttiva b'fesoterodine fuq bhejjem urew tossiċità minuri fl-embriju.
English: Immediate Packaging HDPE Bottle - 8 mg
Maltese: Pakkett li jmiss mal-prodott- Flixkun ta' HDPE - 8 mg
English: Rash; Dry skin; Pruritus
Maltese: Raxx; Ġilda xotta;
English: It is unknown whether fesoterodine/metabolites are excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.
Maltese: Mhux magħruf jekk fesoterodine/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem; għalhekk, treddigħ mhux rakkomandat waqt trattament b'TOVIAZ.
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.
Maltese: Madankollu fi klieb konxji, il-metabolit attiv m'għandu l-ebda effett fuq l-intervall tal-QT u l-intervall tal-QTc f'espożizzjonijiet fil-plażma ta' lanqas 33 darba ogħla mill-medja ta' l-ogħla konċentrazzjoni filplażma tal-metabolit ħieles f'suġġetti umani li huma metabolizzaturi estensivi u 21 darba ogħla minn suġġetti li huma metabolizzaturi ta' CYP2D6 dgħajfin wara li jkunu ħadu fesoterodine 8 mg darba kuljum.
English: EU/1/07/386/017 EU/1/07/386/019
Maltese: EU/1/07/386/017
English: • increased heart beat (tachycardia)
Maltese: • żieda fir-rata tat-taħbit tal-qalb (takikardja)
English: N=199
Maltese: N=211 N=199
English: Immediate packaging HDPE Bottle - 4 mg
Maltese: Pakkett li jmiss mal-prodott- Flixkun ta' HDPE - 4 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA (I) ATTIVA
English: Ear and labyrinth disorders
Maltese: Disturbi filwidnejn u ssistema labirintika
English: Serious allergic reactions including angioedema occurred rarely.
Maltese: Reazzjonijiet allerġiċi serji li jinkludu anġjoedema seħħew rarament.
English: • wind (flatulence)
Maltese: • gass (gass fl-istonku)
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
Maltese: Għal suġġetti li għandhom funzjoni normali renali u tal-fwied, li qed jieħdu waqt l-istess żmien inibituri potenti ta' CYP3A4, id-doża massima ta' kuljum ta' TOVIAZ li tista' tingħata hi ta' 4 mg kuljum (ara sezzjoni 4.5).
English: TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets
Maltese: TOVIAZ 4 mg, pilloli li jerħu l-mediċina bil-mod TOVIAZ 8 mg, pilloli li jerħu l-mediċina bil-mod
English: Overdose with antimuscarinics, including fesoterodine can result in severe anticholinergic effects.
Maltese: Doża eċċessiva b'mediċini anti-muskariniċi, li jinkludu fesoterodine tista' tirriżulta f'effetti antikolinergiċi qawwijin ħafna.
English: Potent CYP3A4 inducers
Maltese: Inibituri potenti ta' CYP3A4.
English: Each tablet contains 8 mg fesoterodine fumarate
Maltese: Kull pillola fiha 8 mg fesoterodine fumarate
English: CYP3A4 inhibitors
Maltese: Impedituri CYP3A4
English: They have mainly involved elderly (≥ 65 years) male patients with a history consistent with benign prostatic hyperplasia (see section 4.4).
Maltese: Pazjenti anzjani irġiel (≥ 65 sena) bi storja konsistenti ta' tkabbir beninn tal-prostata kienu nvoluti prinċipalment (ara sezzjoni 4.4).
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 web-portal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza talUnjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
Maltese: • Użu fl-istess waqt ta' inibituri ta' CYP3A4 potenti f'suġġetti li għandhom indeboliment epatiku jew renali minn moderat sa serju.
English: - Concomitant administration of a potent CYP2D6 inhibitor (see sections 4.5 and 5.2).
Maltese: (ara sezzjonijiet 4.2 u 4.5) - L-għoti fl-istess waqt ta' inibitur potenti ta CYP2D6 (ara sezzjonijiet 4.5 u 5.2)
English: • Urinary retention
Maltese: Eżitazzjoni urinarja
English: TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
Maltese: TOVIAZ 4 mg Pilloli li jerħu l-mediċina bil-mod TOVIAZ 8 mg Pilloli li jerħu l-mediċina bil-mod fesoterodine fumarate
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffetwaw sa persuna 1 minn kull 100)
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.
Maltese: Is-sigurtà ta' fesoterodine ġiet valutata fi studji kontrollati bi plaċebo f'total ta' 2859 pazjent li kellhom il-bużżieqa ta' l-awrina attiva wisq, li minn dawn 780 irċevew plaċebo
English: TOVIAZ (listed in section 6) (see section 2, “TOVIAZ contains lactose and soya oil”) - if you are not able to completely empty your bladder (urinary retention) - if your stomach empties slowly (gastric retention) - if you have an eye disease called narrow angle glaucoma (high pressure in the eye), which is not under control - if you have excessive weakness of the muscles (myasthenia gravis) - if you have ulceration and inflammation of the colon (severe ulcerative colitis) - if you have an abnormally large or distended colon (toxic megacolon) - if you have severe liver problems.
Maltese: Tieħux TOVIAZ: - jekk inti allerġiku/a għal fesoterodine jew għal karawett jew għal soja jew għal xi wieħed missustanzi l-oħra ta' TOVIAZ (mniżżla f'sezzjoni 6.1) (ara sezzjoni 2, “TOVIAZ fih lactose u żejt tas-soja”) - jekk ma tistax tbattal kompletament l-bużżieqa ta' l-awrina (żamma ta' l-awrina) - jekk l-istonku tiegħek jitbattal bil-mod (żamma gastrika) - jekk għandek il-marda ta' l-għajnejn imsejħa glawkoma ta' l-angolu dejjaq (pressjoni għolja ġewwa l-għajn) li m'hix ikkontrollata - jekk għandek dgħjufija eċċessiva tal-muskoli (majestenja gravis) - jekk għandek ulċerazjoni u infjammazzjoni tal-kolon (kolite ulċerattiva qawwija) - jekk għandek kolon ikbar minn normal jew minfuħ (megakolon tossiku) - jekk għandek problemi serji tal-fwied - jekk għandek problemi fil-kliewi jew problemi moderati jew serji fil-fwied u qed tieħu mediċini li fihom wieħed mis-sustanzi attivi li ġejjin: itraconazole jew ketoconazole (użati biex jittrattaw infezzjonijiet tal-fungu), ritonavir, atazanavir, indinavir, saquinavir jew nelfinavir (mediċina anti-virali użati għat-trattament ta' HIV), clarithromycin jew telithromycin (użati għattrattament ta' infezzjonijiet batteriċi) u nefazodone (użat għat-trattament tad-depressjoni)
English: Blister label 4 mg
Maltese: Tikketta tal-folja 4mg
English: TOVIAZ 4 mg prolonged-release tablets fesoterodine fumarate
Maltese: Kull pillola fiha 4 mg fesoterodine fumarate
English: The clinical relevance of these findings will depend on individual patient risk factors and susceptibilities present (see section 4.4).
Maltese: Ir-rilevanza klinika ta' dawn ir-riżultati tiddependi fuq il-fatturi tar-riskju u suxxettibilita' ta' kull pazjent individwali (ara sezzjoni 4.4).
English: Nausea
Maltese: Disurja
English: Contains lactose and soya lecithin: see the package leaflet for further information.
Maltese: Fih lactose u soya lecithin: ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: TOVIAZ 8 mg prolonged-release tablets are blue, oval, curved outwards on both sides, film-coated tablets, and engraved on one side with the letters ‘FT'.
Maltese: TOVIAZ 8 mg, pilloli li jerħu l-mediċina bil-mod, huma ta' kulur kaħlani, ovali, imbuzzati fuq iżżewg naħat, miksijin b'rita trasparenti u mnaqqxin fuq naħa waħda bl-ittri ‘FT'.
English: Co-administration of a potent CYP2D6 inhibitor may result in increased exposure and adverse events.
Maltese: L-għoti flimkien ta' impeditur potenti ta' CYP2D6 jista' jirriżulta f'espożizzjoni ogħla u reazzjonijiet avversi.
English: Constipation;
Maltese: Dijarrea;
English: In addition, TOVIAZ 4 mg and 8 mg tablets are also packed in HDPE bottles containing 30 or 90 tablets.
Maltese: Barra minn hekk, il-pilloli TOVIAZ 4mg u 8 mg huma wkoll ippakkjati ġewwa fliexken ta' HDPE li fihom 30 jew 90 pillola.
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.
Maltese: Fuq il-bażi tal-AUC, lesponiment sistemiku kien ta' 0.6 sa 1.5 darbiet ogħla fil-ġrieden milli fil-bnedmin fil-MRHD, filwaqt li fuq il-bażi tal-ogħla konċentrazzjonijiet fil-plażma, l-espożizzjoni fil-ġrieden kienet 5 sa 9 darbiet ogħla.