natgillin/translations-raw huggingface dataset:
Når de 1, 2 ml koncentrat blandes med de 1, 8 ml af solvensen, fås et totalt volumen på 3, 0 ml og koncentrationen af temsirolimus vil blive 10 mg/ ml.
One vial of 1.2 ml of TORISEL 25 mg/ ml concentrate contains 30 mg of temsirolimus: when the 1.2 ml concentrate is combined with 1.8 ml of withdrawn diluent, a total volume of 3.0 ml is obtained and the concentration of temsirolimus will be 10 mg/ ml.
TILSÆTNING AF BLANDINGEN AF KONCENTRAT OG SOLVENS TIL NATRIUMKLORID INFUSIONSVÆSKE • Træk den ønskede mængde blanding af koncentrat og solvens (indeholdende 10 mg/ ml temsirolimus) op af hætteglasset, d. v. s.
ADMINISTRATION OF CONCENTRATE-DILUENT MIXTURE IN SODIUM CHLORIDE INFUSION
2, 5 ml til en temsirolimus- dosis på 25 mg. • Injicer den optrukne mængde hurtigt i 250 ml natriumklorid 9 mg/ ml (0, 9%) injektionsvæske, opløsning, for at sikre tilstrækkelig blanding.
• Withdraw the required amount of concentrate-diluent mixture (which contains temsirolimus 10 mg/ ml) from the vial; i. e., 2.5 ml for a temsirolimus dose of 25 mg. • Inject the withdrawn volume rapidly into 250 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to ensure adequate mixing.
Brug af infusionspumpe er den foretrukne indgivelsesmetode for at sikre nøjagtig indgivelse af lægemidlet. • Hensigtsmæssige materialer til indgivelse skal være fremstillet af glas, polyolefin eller polyethylen for at undgå for kraftigt tab af lægemiddel og for at nedsætte ekstraktionsgraden af DEHP.
• Appropriate administration materials must be composed of glass, polyolefin, or polyethylene to avoid excessive loss of medicinal product and to decrease the rate of DEHP extraction.
Materialerne til indgivelse skal bestå af slanger med et passende filter af non- DEHP, non- PVC.
The administration materials must consist of non-DEHP, non-PVC tubing with appropriate filter.
Hvis infusionssættet, som er til rådighed,
An in-line polyethersulfone filter with a pore size of not greater than 5 microns is recommended for administration to avoid the possibility of particles bigger than 5 microns being infused.
33 ikke har et integreret filter i slangen, skal der sættes et filter for enden af sættet (d. v. s. et endefilter), før tilblandingen når patientens vene.
If the administration set available does not have an in-line filter incorporated, a filter should be added at the end of the set (i. e., an end-filter) before the admixture reaches the vein of the patient.
Der kan bruges forskellige endefiltre varierende i porestørrelse fra 0, 2 µ til 5 µ.
Different end-filters can be recommended used ranging in filter pore size from 0.2 microns up to 5 microns.
• TORISEL indeholder, når det er fortyndet, polysorbat 80, der øger ekstraktionsgraden af DEHP fra PVC.
• TORISEL, when diluted, contains polysorbate 80, which is known to increase the rate of DEHP extraction from PVC.
Denne uforligelighed skal tages i betragtning ved tilberedning og indgivelse af TORISEL, herunder den opbevaringstid, der er forløbet i en polivinylbeholder efter fortynding.
This incompatibility has to be considered during the preparation and administration of TORISEL.
4. 2. og 6. 6 i produktresuméet følges nøje.
It is important that the recommendations in sections 4.2 and 6.6 in the SPC be followed closely.
Destruktion Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
Any unused product or waste material should be disposed of in accordance with local requirements.
TOVIAZ 4 mg depottabletter
TOVIAZ 4 mg prolonged-release tablets
En depottablet indeholder fesoterodinfumarat 4 mg svarende til 3, 1 mg fesoterodin.
Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of fesoterodine.
Hver 4 mg depottablet indeholder 0, 525 mg sojalecithin og 91, 125 mg lactosemonohydrat.
Excipients Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 91.125 mg lactose monohydrate.
Depottablet 4 mg- tabletterne er lyseblå, ovale, bikonvekse, filmovertrukne og er på den ene side præget med bogstaverne ‘ FS ’.
Prolonged-release tablets The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘ FS’.
Behandling af de symptomer (hyppig vandladning og/ eller imperiøs vandladningstrang og/ eller urgeinkontinens), som kan forekomme hos patienter med overaktiv blære.
Treatment of the symptoms (increased urinary frequency and/ or urgency and/ or urgency incontinence) that may occur in patients with overactive bladder syndrome.
Voksne (herunder ældre) Den anbefalede startdosis er 4 mg 1 gang dagligt.
Adults (including elderly) The recommended starting dose is 4 mg once daily.
4. 5).
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 4.5).
4. 4 og 4. 5).
During concomitant administration of a moderate CYP3A4 inhibitor, a dose increase to 8 mg should be preceded by an evaluation of the individual response and tolerability (see sections 4.4 and 4.5).
4. 3, 4. 4, 4. 5 og 5. 2).
Renal and hepatic impairment 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).
2 CYP3A4- inhibitor
2 Moderate(3) or potent(4) CYP3A4 inhibitors
Nedsat nyrefunktion
Renal impairment(1)
2
Should be avoided
Bør undgås
Moderate
Moderat
4→ 8 mg(2)
Bør undgås
avoided
4→8 mg2
4 mg
Bør undgås
Should be
GFR = 30- 50 ml/ min; svær GFR = < 30 ml/ min (2) Dosis øges forsigtigt.
(1) Mild GFR = 50-80 ml/ min; Moderate GFR = 30-50 ml/ min; Severe GFR = < 30 ml/ min (2) Cautious dose increase.
4. 4, 4. 5 og 5. 2 (3) Studier med moderate CYP3A4- inhibitorer er ikke udført.
See sections 4.4, 4.5 and 5.2 (3) Studies with moderate CYP3A4 inhibitors have not been conducted.
4. 5 (4) Potente CYP3A4- inhibitorer.
See section 4.5 (4) Potent CYP3A4 inhibitors.
4. 3, 4. 4 og 4. 5
See sections 4.3, 4.4 and 4.5
4. 3).
TOVIAZ is contraindicated in subjects with severe hepatic impairment (see section 4.3).
5. 2).
Paediatric population TOVIAZ is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy (see section 5.2).
• Overfølsomhed over for det aktive stof, over for et eller flere af hjælpestofferne eller over for jordnødder eller soja. • Urinretention • Ventrikelretention • Ukontrolleret snævervinklet glaukom • Myasthenia gravis • Svært nedsat leverfunktion (Child Pugh C) • Samtidig brug af potente CYP3A4- inhibitorer hos patienter med svært nedsat lever - eller nyrefunktion • Svær colitis ulcerosa • Toksisk megacolon
• Hypersensitivity to the active substance or to peanut or soya or any of the excipients • Urinary retention • Gastric retention • Uncontrolled narrow angle glaucoma • Myasthenia gravis • Severe hepatic impairment (Child Pugh C) • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment • Severe ulcerative colitis • Toxic megacolon.
TOVIAZ bør anvendes med forsigtighed hos patienter med: • klinisk signifikant blæreobstruktion og deraf følgende risiko for urinretention (se pkt.
TOVIAZ should be used with caution in patients with:
4. 3) • gastrointestinale obstruktive lidelser (f. eks. pylorusstenose) • gastro- oesofagal refluks og/ eller samtidig indtagelse lægemidler (som orale bisfosfonater), som kan forårsage eller forværre oesophagitis • reduceret gastrointestinal motilitet • autonom neuropati • velbehandlet snævervinklet glaukom
- Clinically significant bladder outflow obstruction at risk of urinary retention (see section 4.3)
5. 1): • nedsat leverfunktion (se pkt.
- Hepatic impairment (see sections 4.2, 4.3 and 5.2)
4. 2, 4. 3 og 5. 2) • nedsat nyrefunktion (se pkt.
- Renal impairment (see section 4.2, 4.3 and 5.2)
4. 2, 4. 3 og 5. 2) • samtidig behandling med potent eller moderat CYP3A4- inhibitor (se pkt.
- Concomitant administration of potent or moderate CYP3A4 inhibitors (see sections 4.2 and
4. 5 og 5. 2).
- Concomitant administration of a potent CYP2D6 inhibitor (see sections 4.5 and 5.2).
Patienter med en kombination af disse faktorer må forventes at være yderligere eksponerede for den aktive metabolit.
3 In patients with a combination of these factors, additional exposure increases are expected.
Dosisafhængige antimuskarine bivirkninger må forventes at forekomme.
Dose dependent antimuscarinic side effects are likely to occur.
3 Som med alle lægemidler, der er indiceret til behandling af overaktiv blære, skal organiske årsager udelukkes, før en behandling med antimuskarine lægemidler overvejes.
As with all medicinal products indicated for the treatment of overactive bladder, organic causes must be excluded before any treatment with antimuscarinics is considered.
Hvis der er urinvejsinfektion, bør relevant medicinsk/ antibakteriel behandling indledes.
If urinary tract infection is present, an appropriate medical approach should be taken/ antibacterial therapy should be started.
4. 5).
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).
Som med andre antimuskariner, bør fesoterodin 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. myokardieiskæmi, arytmi, venstresidig hjerteinsufficiens; se pkt.
As with other antimuscarinics, fesoterodine 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).
4. 2, 4. 5 og 5. 1).
This especially holds true when taking potent CYP3A4 inhibitors (see sections 4.2, 4.5 and 5.1).
Lactose TOVIAZ depottabletter indeholder lactose.
Lactose TOVIAZ prolonged-release tablets contain lactose.
Bør ikke anvendes til patienter med sjældne arvelige former for galactoseintolerans, Lapp lactase- mangel eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Farmakologiske interaktioner 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).
Pharmacological interactions Caution should be exercised in coadministration of fesoterodine with other antimuscarinic agents 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).
Fesoterodin kan nedsætte virkningen af lægemidler, der stimulerer motiliteten af mavetarmkanalen, f. eks. metoclopramid.
Fesoterodine may reduce the effect of medicinal products that stimulate the motility of the gastro- intestinal tract, such as metoclopromide.
Farmakokinetiske interaktioner In vitro- data viser, at fesoterodins aktive metabolit ikke hæmmer CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 eller 3A4 eller inducerer CYP1A2, 2B6, 2C9, 2C19 eller 3A4 ved klinisk relevante plasmakoncentrationer.
Pharmacokinetic interactions 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.
CYP3A4- inhibitorer
CYP3A4 Inhibitors
Potente CYP3A4- inhibitorer 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.
Potent CYP3A4 Inhibitors 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.
4. 2 og 4. 4).
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), saquinivir and telithromycin (see sections 4.2 and 4.4)).
Moderate CYP3A4- inhibitorer Der er ikke foretaget kliniske forsøg med henblik på at klarlægge en moderat CYP3A4- inhibitors (f. eks. amprenavir, aprepitant, diltiazem, erythromycin, fluconazol, fosamprenavir, grapefrugtjuice, verapamil) virkning på fesoterodins farmakokinetik.
4 Moderate CYP3A4 Inhibitors No study has been performed evaluating the effect of a moderate CYP3A4 inhibitor (e. g. amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil) on the pharmacokinetics of fesoterodine.
4. 2 og 4. 4).
However, an increase in the exposure of the active metabolite of fesoterodine is expected, although a smaller increase than observed with a potent CYP3A4 inhibitor (see sections 4.2 and 4.4).
4 CYP3A4- induktorer 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.
CYP3A4 Inducers 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.
4. 4).
Concomitant use with CYP3A4 inducers (e. g. carbamazepine, rifampicin, phenobarbital, phenytoin, St John’ s Wort) is not recommended (see section 4.4).
CYP2D6- inhibitorer Interaktion med CYP2D6- inhibitorer er ikke klinisk undersøgt.
CYP2D6 Inhibitors The interaction with CYP2D6 inhibitors was not tested clinically.
Gennemsnitlig Cmax og AUC for den aktive metabolit er henholdsvis 1, 7 og 2 gange højere hos langsomme CYP2D6- omsættere og hurtige omsættere.
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.
Samtidig anvendelse af en potent CYP2D6- inhibitor kan resultere i øget eksponering og bivirkninger.
Co-administration of a potent CYP2D6 inhibitor may result in increased exposure and adverse events.
4. 4).
A dose reduction to 4 mg may be needed (see section 4.4).
P- piller Fesoterodin hæmmer ikke P- pillers undertrykkelse af ovulation.
Oral contraceptives Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception.
Ved brug af fesoterodin er der ingen ændringer i plasmakoncentrationerne for kombinations- P- piller, som indeholder ethinylestradiol og levonorgestrel.
In the presence of fesoterodine there are no changes in the plasma concentrations of combined oral contraceptives containing ethinylestradiol and levonorgestrel.
Graviditet Der foreligger ikke tilstrækkelige data om brugen af fesoterodin hos gravide kvinder.
Pregnancy There are no adequate data from the use of fesoterodine in pregnant women.
5. 3).
Reproductive toxicity studies with fesoterodine in animals show minor embryotoxicity (see section 5.3).
Derfor bør TOVIAZ ikke bruges til kvinder der ammer.
Lactation It is not known whether fesoterodine is excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.
4. 8).
As with other antimuscarinic agents, 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).
Sikkerheden af fesoterodin blev vurderet i placebokontrollerede kliniske forsøg med i alt 2. 859 patienter med overaktiv blære, hvoraf 780 fik placebo.
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.
På grund af fesoterodins farmakologiske egenskaber kan behandlingen give milde til moderate antimuskarine virkninger som mundtørhed, tørre øjne, dyspepsi og forstoppelse.
Due to the pharmacological properties of fesoterodine, treatment may cause mild to moderate antimuscarinic effects like dry mouth, dry eye, dyspepsia and constipation.
Mundtørhed, som er den eneste meget almindelige bivirkning, forekom med en frekvens på 28, 8% i fesoterodin- gruppen sammenlignet med 8, 5% i placebogruppen.
Dry mouth, the only very common event, occurred with a frequency of 28.8% in the fesoterodine group compared to 8.5% in the placebo group.
Hovedparten af bivirkningerne forekom i løbet af den første måned af behandlingen, med undtagelse af urinretention med mere end 200 ml residualurin, der kunne forekomme efter længere tids behandling og forekom hyppigere hos mænd end hos kvinder.
The majority of ADRs occurred during the first month of treatment with the exception of cases classified as urinary retention or post void residual urine
Nedenstående tabel viser hyppigheden af bivirkninger, som forekom under behandlingen i placebokontrollerede kliniske undersøgelser.
5 greater than 200 ml, which could occur after long term treatment and was more common in male than female subjects.
De bivirkninger, som er anført i denne tabel, er de
The table below gives the frequency of treatment emergent adverse reactions from placebo-controlled clinical trials.
5 bivirkninger, som var meget almindelige (≥ 1/ 10), almindelige (≥ 1/ 100 til < 1/ 10) eller ikke almindelige (≥ 1/ 1. 000 til < 1/ 100).
The adverse reactions reported in this table are those events that were very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) or uncommon (≥ 1/ 1,000 to < 1/ 100).
Ikke almindelig *
Uncommon*
Sygdomme i nervesystemet Øjensygdomme Sygdomme i det ydre og det indre øre
Nervous system disorders
Svimmelhed; Hovedpine Øjentørhed
Eye disorders Ear and labyrinth disorders
Dysgeusi; Søvnighed Vertigo
Vertigo
Tørhed i svælget
Dry throat
Smerter i hals og svælg; Hoste; Tørhed i næsen
Pharyngolaryngeal pain; Cough; Nasal dryness
Mundtørhed
Dry mouth
Abdominalsmerter; Diaré; Dyspepsi; Forstoppelse; Kvalme
Abdominal pain; Diarrhoea; Dyspepsia; Constipation; Nausea
Ubehag i maven; Oppustethed
Abdominal discomfort; Flatulence
Urinretention (herunder følelse af resturin, miktionslidelser); Igangsætningsbesvær ved vandladning
Urinary retention (including feeling of residual urine; micturition disorder); Urinary hesitation
Sygdomme i hud og subkutane væv Infektiøse og parasitære sygdomme
Skin and subcutaneous tissue disorders
Udslæt; Tør hud Urinvejsinfektion
Rash; Dry skin
Almene lidelser og reaktioner på indgivelsesstedet
Infections and infestations General disorders and administration site conditions
Træthed
Hepatobiliary disorders
Sygdomme i lever og galdeveje Psykiske lidelser * 5 tilfælde eller mere
ALT increased; GGT increased
Søvnløshed
Psychiatric disorders *5 or more cases
Øget ALAT; Øget GGT
Insomnia
Sammenhængen med fesoterodin - behandlingen er uklar.
The relation to fesoterodine treatment is unclear.
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.
The heart rate corrected QT interval in fesoterodine treated patients did not differ from that seen in placebo treated patients.
Incidensen af QTc ≥ 500 ms post baseline eller af QTc- stigning på ≥ 60 ms er henholdsvis 1, 9%, 1, 3%, 1, 4% og 1, 5%, for fesoterodin 4 mg, 8 mg, 12 mg og placebo.
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.
4. 4).
The clinical relevance of these findings will depend on individual patient risk factors and susceptibilities present (see section 4.4).
Overdosering med antimuskarine stoffer, herunder fesoterodin, kan resultere i svære antikolinerge virkninger.
Overdose with antimuscarinic agents, including fesoterodine can result in severe anticholinergic effects.
I tilfælde af overdosering
In the event of overdose, ECG monitoring
6 anbefales EKG- monitorering, og der bør træffes standardmæssige understøttende foranstaltninger til håndtering af QT- forlængelse.
6 is recommended; standard supportive measures for managing QT prolongation should be adopted.
Fesoterodin er i kliniske undersøgelser administreret sikkert ved doser på op til 28 mg/ dag.
Fesoterodine has been safely administered in clinical studies at doses up to 28 mg/ day.
• Svære antikolinerge virkninger (f. eks. hallucinationer, svær excitation) med fysostigmin • kramper og udtalt excitation 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.
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.
Urologiske antispasmodika, ATC- kode:
Urinary antispasmodics, ATC code:
Fesoterodin er en kompetitiv, specifik muskarin- receptorantagonist.
Fesoterodine is a competitive, specific muscarinic receptor antagonist.
Den hydrolyseres hurtigt og omfattende via ikke- specifikke plasmaesteraser til et 5- hydroxymethylderivat, den primære aktive metabolit, som er fesoterodins primære, aktive farmakologiske princip.
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.
Virkningen af fast doseret fesoterodin 4 mg og 8 mg blev evalueret i to randomiserede, dobbeltblinde, placebokontrollerede fase 3- undersøgelser af 12- ugers varighed.
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.
Undersøgelserne omfattede kvindelige (79%) og mandlige (21%) patienter med en gennemsnitsalder på 58 år (mellem 19- 91 år).
Female (79%) and male (21%) patients with a mean age of 58 years (range 19-91 years) were included.
I alt 33% af patienterne var ≥ 65 år og 11% var ≥ 75 år.
A total of 33% of patients were ≥ 65 years of age and 11% were ≥ 75 years of age.
24 timer ved behandlingens afslutning sammenlignet med patienterne, der fik placebo.
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.
Ligeså var responsraten (procentvis andel af patienter, som rapporterede, at deres tilstand var "meget forbedret" eller "forbedret" ved hjælp af en 4- punkts skala til vurdering af behandlingen) signifikant større med fesoterodin sammenlignet med placebo.
Likewise, the response rate (% of patients reporting that their condition has been “ greatly improved” or “ improved” using a 4-point Treatment Benefit Scale) was significantly greater with fesoterodine compared to placebo.
Gennemsnitlig ændring fra baseline til behandlingsafslutning for primære og udvalgte sekundære endepunkter.
Mean changes from Baseline to end of treatment for primary and selected secondary endpoints
Fesoterodin Fesoterodin Aktiv Placebo Fesoterodin
Placebo Fesoterodine4 mg Fesoterodine Active Placebo
4 mg
Number of micturitions per 24 hours#
4 mg 8 mg komparator 4 mg
4 mg
Baseline Ændring fra baseline
Baseline Change from baseline