FrancophonIA/ELRC3.0 huggingface dataset:
English: After oral administration, due to rapid and extensive hydrolysis by non-specific plasma esterases, fesoterodine was not detected in plasma.
Danish: På grund af hurtig og omfattende hydrolyse af ikke-specifikke plasmaesteraser, blev fesoterodin ikke påvist i plasma efter oral administration.
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.
Danish: Kardiologisk elektrofysiologi: Virkningen af fesoterodin 4 mg og 28 mg på QT-intervallet blev grundigt evalueret i et dobbeltblindt, randomiseret, placebo- og positivkontrolleret (moxifloxacin 400 mg) parallelgruppeforsøg med behandling 1 gang dagligt i en periode på 3 dage hos 261 mandlige og kvindelige forsøgspersoner i alderen 45 til 65 år.
English: In clinical trials of fesoterodine, cases of markedly elevated liver enzymes were reported with the occurrence frequency no different from the placebo group.
Danish: I kliniske forsøg med fesoterodin blev der rapporteret om tilfælde af markant forhøjede leverenzymer med samme hyppighedsfrekvens som i placebogruppen.
English: • Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1
Danish: • Overfølsomhed over for det aktive stof, over for et eller flere af hjælpestofferne anført i punkt 6.1 eller over for jordnødder eller soja.
English: Paediatric population The pharmacokinetics of fesoterodine have not been evaluated in paediatric patients.
Danish: Pædiatrisk population Fesoterodins farmakokinetik er ikke undersøgt hos pædiatriske patienter.
English: N=223 N=205
Danish: N=211 N=199 N=223 N=223 N=205 N=228 N=218
English: The recommended starting dose of TOVIAZ is one 4 mg tablet a day.
Danish: Den anbefalede startdosis er 1 TOVIAZ 4 mg tablet dagligt.
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.
Danish: Hvis disse lægemidler tages samtidigt med fesoterodin, kan det føre til, at bivirkninger som tør mund, forstoppelse, besvær med at tømme blæren eller søvnighed bliver kraftigere eller de kan få dem til at forekomme oftere.
English: They have mainly involved elderly (≥ 65 years) male patients with a history consistent with benign prostatic hyperplasia (see section 4.4).
Danish: Det har hovedsageligt været tale om ældre mandlige patienter (> 65 år), som tidligere har haft prostatahyperplasi (se pkt.
English: Please also inform your doctor if you are taking any of the following medicines: - medicines containing any of the following active substances may increase the break-down of fesoterodine and thus decrease its effect: St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy).
Danish: Fortæl det også til lægen, hvis du tager noget af følgende medicin: - Medicin, der indeholder de følgende aktive stoffer, kan øge nedbrydningen af fesoterodin og dermed nedsætte virkningen: prikbladet perikon (naturmedicin), rifampicin (der bruges til behandling af bakterieinfektioner), carbamazepin, phenytoin og phenobarbital (bruges bl.a. til behandling af epilepsi).
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjældne (forekommer hos op til 1 ud af 1.000 personer)
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).
Danish: Der bør udvises forsigtighed ved samtidig administration af fesoterodin og andre lægemidler, som har antimuskarine eller antikolinerge egenskaber (f.eks. amantadin, tricykliske antidepressiva, visse neuroleptika), da dette kan medføre mere udtalte terapeutiske virkninger og bivirkninger (f.eks. forstoppelse, mundtørhed, døsighed, urinretention).
English: TOVIAZ contains soya oil.
Danish: TOVIAZ indeholder sojaolie.
English: TOVIAZ treats the symptoms of an overactive bladder such as
Danish: TOVIAZ behandler de symptomer, som du kan få, hvis du har en overaktiv blære, som f.eks.:
English: See sections 4.4, 4.5 and 5.2 (3) Moderate CYP3A4 inhibitors.
Danish: 4.4, 4.5 og 5.2 (3) Moderate CYP3A4-hæmmere.
English: • Urinary retention
Danish: • Urinretention
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).
Danish: TOVIAZ bør anvendes med forsigtighed til patienter med risiko for QT-forlængelse (f.eks. hypokaliæmi, bradykardi og samtidig behandling med lægemidler, der forlænger QT-intervallet) og relevante forud bestående hjertekarsygdomme (f.eks. myokardie iskæmi, arytmi, venstresidig hjerteinsufficiens; se pkt.
English: Rash; Dry skin; Pruritus
Danish: Udslæt; tør hud; pruritus
English: TOVIAZ is contraindicated in subjects with severe hepatic impairment (see section 4.3).
Danish: TOVIAZ er kontraindiceret til patienter med svært nedsat leverfunktion (se pkt.
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).
Danish: Man bør udvise forsigtighed, når man fører motorkøretøj eller anvender maskiner på grund af mulige bivirkninger som tågesyn, svimmelhed eller søvnighed (se pkt.
English: • difficulty in completely emptying the bladder (urinary retention)
Danish: • svært ved at tømme blæren helt (urinretention)
English: Indigo carmine aluminium lake (E132)
Danish: Sojalecithin Indigotin I (E132)
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.
Danish: Efter blokering af CYP3A4 på grund af samtidig administration af den moderate CYP3A4-hæmmer fluconazol 200 mg 2 gange dagligt i 2 dage, blev Cmax og AUC af den aktive metabolit af fesoterodin øget med henholdsvis ca. 19% og 27%.
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)).
Danish: Derfor bør maksimaldosis af fesoterodin begrænses til 4 mg ved samtidig brug af potente CYP3A4-hæmmere (f.eks. atazanavir, clarithromycin, indinavir, itraconazol, ketoconazol, nefazodon, nelfinavir, ritonavir (og alle ritonavir-boostede protease-hæmmer-regimer), saquinovir og telithromycin (se pkt.
English: 30 prolonged-release tablets 90 prolonged-release tablets
Danish: 30 depottabletter 90 depottabletter
English: Titanium dioxide (E171) Macrogol (3350)
Danish: Filmovertræk Poly(vinylalkohol) Titandioxid (E 171) Macrogol (3350) Talkum
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
Danish: 7 depottabletter 14 depottabletter 28 depottabletter 30 depottabletter 56 depottabletter 84 depottabletter 98 depottabletter 100 depottabletter
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.
Danish: Hos patienter med let eller moderat nedsat nyrefunktion (GFR 30-80 ml/min) steg Cmax og AUC for den aktive metabolit op til henholdsvis 1,5 og 1,8 gange sammenlignet med raske forsøgspersoner.
English: N=283 N=266
Danish: N=279 N=265 N=276 N=283 N=266 N=267 N=267
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.
Danish: Efter induktion af CYP3A4 ved samtidig administration af rifampicin 600 mg 1 gang dagligt faldt Cmax og AUC for fesoterodins aktive metabolit med henholdsvis cirka 70% og 75% efter oral administration af 8 mg fesoterodin.
English: TOVIAZ 4 mg tablets Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 91.125 mg of lactose.
Danish: TOVIAZ 4 mg tabletter Hver 4 mg depottablet indeholder 0,525 mg sojalecithin og 91,125 mg lactose.
English: Pharmacological interactions
Danish: Farmakologiske interaktioner
English: • straining or pain when emptying the bladder (dysuria)
Danish: • anstrengelse eller smerter, når blæren tømmes
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).
Danish: - Medicin, der indeholder de følgende aktive stoffer, kan øge mængden af fesoterodin i blodet: itraconazol eller ketoconazol (bruges til behandling af svampeinfektioner), ritonavir, atazanavir, indinavir, saquinavir eller nelfinavir (antiviral medicin, der bruges til behandling af HIV), clarithromycin eller telithromycin (der bruges til behandling af bakterieinfektioner), nefazodon (bruges til at behandle depression), fluoxetin eller paroxetin (bruges til behandling af depression eller angst), bupropion (bruges ved rygeafvænning eller til behandling af depression), quinidin (bruges til at behandle uregelmæssig hjerterytme) og cinacalcet (bruges til at behandle problemer med skjoldbruskkirtlen).
English: Parameter Placebo Fesoterodine 4 mg
Danish: Parameter Placebo Fesoterodin 4 mg
English: TOVIAZ contains lactose.
Danish: TOVIAZ indeholder lactose.
English: TOVIAZ 8 mg tablets Each 8 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 58.125 mg of lactose.
Danish: TOVIAZ 8 mg tabletter Hver 8 mg depottablet indeholder 0,525 mg sojalecithin og 58,125 mg lactose.
English: In the event of fesoterodine overdose, treat with gastric lavage and give activated charcoal.
Danish: I tilfælde af overdosering af fesoterodin bør patienter behandles med udskylning af mavesækken og aktivt kul.
English: Supratherapeutic concentrations of the active metabolite of fesoterodine, have been shown to inhibit K+ current in cloned human ether-à-go-go-related gene (hERG) channels and prolong action potential duration (70% and 90% repolarisation) in canine isolated Purkinje fibres.
Danish: +-strømmen i klonede humane ether-à-go-go-related (hERG)-kanaler og forlænger aktionspotentialets varighed (70% og 90% repolarisering) i isolerede Purkinjefibre fra hunde.
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.
Danish: - Svære antikolinerge virkninger (f.eks. hallucinationer, svær ekscitation) med fysostigmin - kramper og udtalt ekscitation med benzodiazepiner - nedsat åndedrætsfunktion med kunstig respiration - takykardi med betablokkere - urinretention med anlæggelse af kateter - mydriasis med pilocarpin-øjendråber og/eller patienten placeres i et mørkt rum.
English: The effect of weak CYP3A4 inhibitors (e.g. cimetidine), was not examined; it is not expected to be in excess of the effect of moderate inhibitor.
Danish: Virkningen af svage CYP3A4-hæmmere (f.eks. cimetidin) er ikke undersøgt.
English: The heart rate corrected QT interval in fesoterodine treated patients did not differ from that seen in placebo treated patients.
Danish: Hos de patienter, som blev behandlet med fesoterodin, adskilte QT-intervallet korrigeret for hjertefrekvens sig ikke fra det, der blev målt hos patienterne, som fik placebo.
English: After oral administration of fesoterodine, approximately 70% of the administered dose was recovered in urine as the active metabolite (16%), carboxy metabolite (34%),
Danish: Efter oral administration af fesoterodin blev cirka 70% af den administrerede dosis genfundet i urinen som den aktive metabolit (16%), carboxylmetabolitten (34%), carboxyl-N-desisopropyl-metabolitten (18%), eller N-desisopropyl-metabolitten (1%), og en mindre mængde (7%) blev genfundet i fæces.
English: TOVIAZ 4 mg tablets
Danish: TOVIAZ 4 mg tabletter
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
Danish: Den maksimale daglige dosis af TOVIAZ hos patienter med normal nyre- og leverfunktion, der samtidig behandles med potente CYP3A4-hæmmere, bør være 4 mg 1 gang dagligt (se pkt.
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.
Danish: Hos patienter med let eller moderat leverinsufficiens (Child Pugh B) steg Cmax og AUC for den aktive metabolit henholdsvis 1,4 og 2,1 gange sammenlignet med raske forsøgspersoner.
English: Following inhibition of CYP3A4 by co-administration of ketoconazole 200 mg twice daily, Cmax and AUC of the active metabolite of fesoterodine increased 2.0 and 2.3-fold in CYP2D6 extensive metabolisers and 2.1 and 2.5-fold in CYP2D6 poor metabolisers, respectively.
Danish: Efter hæmning af CYP3A4 ved samtidig administration af ketoconazol 200 mg 2 gange dagligt blev Cmax og AUC for fesoterodins aktive metabolit øget med henholdsvis 2,0 og 2,3 gange hos hurtige CYP2D6-omsættere og 2,1 og 2,5 gange hos langsomme CYP2D6-omsættere.
English: Other medicines and TOVIAZ
Danish: Brug af anden medicin samme med TOVIAZ
English: TOVIAZ 8 mg tablets EU/1/07/386/006-010 EU/1/07/386/012
Danish: TOVIAZ 8 mg tabletter EU/1/07/386/006-010 EU/1/07/386/012
English: Pharmacokinetics of fesoterodine in patients with severe hepatic impairment have not been studied.
Danish: Fesoterodins farmakokinetik er ikke undersøgt hos patienter med svært nedsat leverfunktion.
English: Immediate packaging HDPE Bottle - 4 mg
Danish: Indre emballage HDPE-beholder - 4 mg
English: A.
Danish: oC.
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.
Danish: Den aktive metabolits gennemsnitlige Cmax og AUC er op til henholdsvis 1,7 og 2 gange højere hos langsomme CYP2D6-omsættere sammenlignet med hurtige omsættere.
English: Tel: 1800 633 363 (toll free) Tel: +44 (0)1304 616161
Danish: Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) Tel: +44 (0)1304 616161
English: Immediate Packaging HDPE Bottle - 8 mg
Danish: Indre emballage HDPE-beholder - 8 mg
English: If you are allergic to peanut or soya, do not use this medicinal product.
Danish: Tag ikke dette lægemiddel, hvis du er allergisk over for jordnødder eller soja.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: TOVIAZ depottabletter indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: Please inform your doctor if you are taking medicines according to the following list.
Danish: Fortæl det til lægen, hvis du tager noget af den medicin, som er nævnt her.
English: Placebo Fesoterodine 4 mg
Danish: Placebo Fesoterodin 4 mg
English: Do not stop taking TOVIAZ without talking to your doctor, as your symptoms of overactive bladder may come back again or become worse once you stop taking TOVIAZ.
Danish: Symptomerne på overaktiv blære kan komme igen eller blive forværret, når du holder op med at tage TOVIAZ.
English: - if you have kidney problems or moderate to severe liver problems and are taking medicines containing any of the following active substances: 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) and nefazodone (used to treat depression)
Danish: • hvis du har nyreproblemer, eller moderate til alvorlige leverproblemer, og tager medicin, som indeholder nogen af følgende aktive stoffer: itraconazol eller ketoconazol (anvendes til behandling af svampeinfektioner), ritonavir, atazanavir, indinavir, saquinavir eller nelfinavir
English: Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception.
Danish: Fesoterodin hæmmer ikke P-pillers undertrykkelse af ovulation.
English: This especially holds true when taking potent CYP3A4 inhibitors (see sections 4.2, 4.5 and 5.1).
Danish: Dette gør sig især gældende ved brug af potente CYP3A4-hæmmere (se pkt.
English: How to take TOVIAZ
Danish: Sådan skal du tage TOVIAZ
English: Dry mouth Abdominal pain; Diarrhoea;
Danish: Mave-tarm-kanalen Mundtørhed Abdominalsmerter; diaré; dyspepsi; forstoppelse; kvalme
English: Very common (may affect more than 1 in 10 people) You may get a dry mouth.
Danish: Meget almindelige (forekommer hos flere end 1 ud af 10 personer) Mundtørhed.
English: Each tablet contains 4 mg fesoterodine fumarate
Danish: Hver tablet indeholder 4 mg fesoterodinfumarat
English: • dry throat
Danish: • tørhed i halsen
English: Blister label 4 mg
Danish: Blisteretiket 4 mg
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
Danish: 4.3) - gastrointestinale obstruktive lidelser (f.eks. pylorusstenose) - gastro-øsofageal refluks og/eller samtidig indtagelse lægemidler (som orale bisfosfonater), som kan forårsage eller forværre oesophagitis - reduceret gastrointestinal motilitet
English: Concomitant use with CYP3A4 inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) is not recommended (see section 4.4).
Danish: Samtidig brug af CYP3A4-induktorer (f.eks. carbamazepin, rifampicin, phenobarbital, phenytoin, perikon) frarådes (se pkt.
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
Danish: 4.2, 4.3 og 5.2) - samtidig behandling med potent eller moderat CYP3A4-hæmmer (se pkt.
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
Danish: EU/1/07/386/001 7 depottabletter EU/1/07/386/002 14 depottabletter EU/1/07/386/003 28 depottabletter EU/1/07/386/019 30 depottabletter EU/1/07/386/004 56 depottabletter EU/1/07/386/005 98 depottabletter EU/1/07/386/011 84 depottabletter EU/1/07/386/017 100 depottabletter
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
Danish: EU/1/07/386/006 7 depottabletter EU/1/07/386/007 14 depottabletter EU/1/07/386/008 28 depottabletter EU/1/07/386/020 30 depottabletter EU/1/07/386/009 56 depottabletter EU/1/07/386/010 98 depottabletter EU/1/07/386/012 84 depottabletter EU/1/07/386/018 100 depottabletter
English: It is unknown whether fesoterodine/metabolites are excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.
Danish: Det er ukendt, om fesoterodin/metabolitter udskilles i modermælk.
English: Each tablet contains 8 mg fesoterodine fumarate
Danish: Hver tablet indeholder 8 mg fesoterodinfumarat
English: • increased heart beat (tachycardia)
Danish: • du har langsomt hjerteslag (bradykardi)
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).
Danish: Fund fra mus ved eksponeringer, der var ca. 5 til 19 gange højere end MRHD, viser en påvirkning af hunnens fertilitet.
English: See section 4.5 (4) Potent CYP3A4 inhibitors.
Danish: 4.5 (4) Potente CYP3A4-hæmmere.
English: Blister label 8 mg
Danish: Blisteretiket 8 mg
English: • trouble digesting food (dyspepsia)
Danish: • besvær med at fordøje maden
English: TOVIAZ 4 mg tablets EU/1/07/386/001-005 EU/1/07/386/011 EU/1/07/386/013-014
Danish: TOVIAZ 4 mg tabletter EU/1/07/386/001-005 EU/1/07/386/011
English: • urticaria
Danish: • udslæt
English: The concomitant use of fesoterodine with a potent CYP3A4 inducer (i.e. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) is not recommended (see section 4.5).
Danish: Samtidig brug af fesoterodin og en stærk CYP3A4-induktor (dvs. carbamazepin, rifampicin, phenobarbital, phenytoin, prikbladet perikon) frarådes (se pkt.
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.
Danish: Dette blev målt ved en plasmaeksponering, som var mindst 33 gange højere end plasmakoncentration hos hurtige CYP2D6-omsættere, og 21 gange højere end målt hos personer, som er langsomme CYP2D6-omsættere efter administration af fesoterodin 8 mg 1 gang dagligt.
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).
Danish: Følgende tabel angiver dosisrekommandationer for patienter med nedsat nyre- og leverfunktion, både med og uden samtidig behandling med potente CYP3A4-hæmmere (se pkt.
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
Danish: Det skal du vide, før du begynder at tage TOVIAZ Sådan skal du tage TOVIAZ Bivirkninger