FrancophonIA/ELRC3.0 huggingface dataset:
English: Also in conditions such as ulcerative colitis, and intestinal atony.
Danish: Det samme gælder for patienter med colitis ulcerosa og intestinal atoni.
English: Cough, increased upper airway secretion
Danish: Ikke almindelig Hoste, øget sekret i de øvre luftveje
English: Clinical efficacy:
Danish: Klinisk virkning:
English: The effect of sunscreen on the absorption of oxybutynin when applied 30 minutes before or 30 minutes after Kentera application was evaluated in a single-dose randomised crossover study (N=16).
Danish: Virkningen af solbeskyttelsesmidler på absorptionen af oxybutynin, der er appliceret 30 minutter før eller 30 minutter efter applicering af Kentera, blev undersøgt i et enkeltdosis-, randomiseret overkrydsningsforsøg (N = 16).
English: Try not to touch the sticky surface of the patch.
Danish: Undgå berøring af plasterets klæbende overflade.
English: Mean and median change from baseline in daily incontinence episodes (primary endpoint), urinary frequency, and urinary void volume between placebo and active treatment groups are summarised in the table below.
Danish: De gennemsnitlige og mediane ændringer fra baseline i daglige inkontinensepisoder (primært endepunkt), urinfrekvens og urinmængde ved vandladning mellem placebogruppen og gruppen med aktiv behandling er opstillet i nedenstående tabel.
English: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.
Danish: Symptomatisk behandling af urge-inkontinens og/eller øget vandladningshyppighed og -trang, som kan forekomme hos voksne patienter med ustabil blære.
English: This should be borne in mind when administering azole antifungals (e.g. ketoconazole) or macrolide antibiotics (e.g. erythromycin) concurrently with oxybutynin.
Danish: Der skal tages hensyn til dette ved administration af antimykotika fra azolgruppen (f.eks. ketoconazol) eller makrolidantibiotika (f.eks. erythromycin) samtidigt med oxybutynin.
English: The oxybutynin, triacetin and acrylic adhesive are coated on clear PET/EVA backing film and covered with a siliconised polyester release liner.
Danish: Oxybutynin, triacetin og akrylklæbestof sidder på en klar PET/EVA-foringsfilm og er dækket af en beskyttende folie af silikoniseret polyester.
English: Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
Danish: Brugte plastre må ikke skylles ud i toilet eller afløb.
English: The approved application sites for Kentera are the shaded areas shown in Figure A. These are the abdomen (stomach area), upper arms/shoulder, and thigh.
Danish: De områder, der er godkendt til påføring af Kentera, er markeret med gråt på figur A. Områderne er maven, overarmene/skuldrene og lårene.
English: Oxybutynin may antagonise prokinetic therapies, such as cisapride and metocloparamide, and should be avoided in the presence of reduced gastrointestinal motility conditions.
Danish: Oxybutynin kan modvirke prokinetiske behandlinger såsom cisaprid og metoclopramid og bør undgås i tilfælde af lidelser med nedsat mave-tarm-motilitet.
English: Kentera contains the active substance oxybutynin and is used in adults to control the symptoms of urge incontinence and/or increased urinary frequency and urgency.
Danish: Kentera indeholder det aktive stof oxybutynin og anvendes hos voksne til at kontrollere symptomer på ufrivillig vandladning (urge-inkontinens) og/eller øget vandladningshyppighed og -trang.
English: The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in vitro studies, but has a greater binding affinity for parotid tissue than oxybutynin.
Danish: Den aktive metabolit, N-desethyloxybutynin, har farmakologisk aktivitet på den humane detrusormuskel, som svarer til den fra in vitro-undersøgelser af oxybutynin, men har en større bindingsaffinitet for ørespytkirtelvæv end oxybutynin.
English: Apply immediately upon removal from the protective sachet.
Danish: Påføres straks efter fjernelse fra det beskyttende brev.
English: Oxybutynin may cause drowsiness or blurred vision.
Danish: Oxybutynin kan forårsage døsighed og sløret syn.
English: Plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s).
Danish: Plasmakoncentrationen for oxybutynin aftager inden for 1 til 2 timer efter, at depotplasteret er fjernet.
English: Apply a new Kentera patch twice weekly (every 3 to 4 days).
Danish: Påfør et nyt Kentera-plaster to gange ugentligt (hver 3. til 4. dag).
English: - Apply immediately to your skin; do not keep or store the patch outside the sealed sachet.
Danish: - Sæt straks plasteret på huden; opbevar det aldrig uden for det forseglede brev.
English: No matter what day this happens, continue with the twice-a-week schedule that you have marked on your patch box.
Danish: Uanset hvilken dag dette sker, skal du fortsætte med den samme påføring to gange ugentligt efter skemaet, som du har afmærket på plasteræsken.
English: Release Liner Siliconised polyester
Danish: Beskyttende folie Silikoniseret polyester
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET LABELLING
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Activities that may lead to excessive sweating, or exposure to water or extreme temperature may contribute to adhesion problems.
Danish: Efter aktiviteter, der har medført voldsom svedtendens, eller hvis plasteret er blevet udsat for vand eller ekstreme temperaturer, kan det forekomme, at plasteret ikke klæber.
English: The R-isomer of oxybutynin shows greater selectivity for the M1 and M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the M2 subtype (predominant in cardiac tissue).
Danish: R-isomeren af oxybutynin viser en større selektivitet for de M1 og M3 muskarine undertyper (fortrinsvis i detrusor og ørespytkirtlen) sammenlignet med M2 undertypen (fortrinsvis i hjertevæv).
English: The transdermal patches are individually contained in LDPE/paper laminate sachets and supplied in Patient Calendar Boxes of 2, 8 or 24 patches.
Danish: Kentera depotplastre er indpakket enkeltvis i breve af LDPE- og papirlaminat og leveres i patientkalender-æsker med 2, 8 eller 24 plastre.
English: Apply a single dose as soon as you realise you have missed an application.
Danish: Påfør en enkelt dosis, så snart du opdager, at du har glemt at smøre Kentera på.
English: Only apply Kentera to intact skin.
Danish: Kentera må kun smøres på intakt hud.
English: Rapid drying, clear, smooth, odourless, and colourless hydroalcoholic gel.
Danish: Hurtigttørrende, klar, blød, lugtfri og farveløs hydroalkoholisk gel.
English: Following the application of Kentera, oxybutynin plasma concentration increases for approximately 24 to 48 hours, reaching average maximum concentrations of 3 to 4 ng/ml.
Danish: Efter applicering af Kentera øges oxybutynin-plasmakoncentrationen i ca. 24 til 48 timer og når en gennemsnitlig maksimumkoncentration på 3 til 4 ng/ml.
English: Backing film Clear polyester/ethylene-vinyl acetate (PET/EVA)
Danish: Foringsfilm Klar polyester/ethylenvinylacetat (PET/EVA)
English: Keep application sites covered with clothing when coming into contact with breast-feeding women or nursing babies.
Danish: Hold påføringsstederne dækket af tøj, når du er i kontakt med ammende kvinder eller børn, der bliver ammet.
English: Somnolence, dysgeusia, poor quality to sleep, tremor
Danish: Ikke almindelig Somnolens, dysgeusi, dårlig søvnkvalitet, tremor Sjælden
English: Gently washing the application site with warm water and a mild soap should remove any adhesive that remains on your skin after removal of the patch.
Danish: Forsigtig afvaskning af påføringsområdet med varmt vand og mild sæbe skulle fjerne eventuelle rester af klæbestof på huden efter fjernelse af plasteret.
English: The frequency of possible side effects listed below is defined using the following convention: - Very common (affects more than 1 user in 10) - Common (affects 1 to 10 users in 100) - Uncommon (affects 1 to 10 users in 1,000) - Rare (affects 1 to 10 users in 10,000) - Very rare (affects less than 1 user in 10,000) - Not known (frequency cannot be estimated from the available data)
Danish: Hyppigheden af de mulige bivirkninger, der er anført nedenfor, defineres på følgende måde: - Meget almindelig (forekommer hos flere end 1 ud af 10 brugere) - Almindelig (forekommer hos 1 til 10 ud af 100 brugere) - Ikke almindelig (forekommer hos 1 til 10 ud af 1.000 brugere) - Sjælden (forekommer hos 1 til 10 ud af 10.000 brugere) - Meget sjælden (forekommer hos færre end 1 ud af 10.000 brugere) - Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Do not continue rubbing after Kentera has dried.
Danish: Hold op med at gnide på huden, når Kentera er tørret ind.
English: Kentera is not recommended for use in children or adolescents.
Danish: Kentera anbefales ikke til behandling af børn eller unge.
English: Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin (see section 4.7).
Danish: Patienterne skal oplyses om, at alkohol kan forstærke den døsighed, der forårsages af antikolinergika såsom oxybutynin (se pkt.
English: Apply as directed above.
Danish: Påfør gelen som beskrevet ovenfor.
English: Figure A:
Danish: Figur A:
English: - Are above 65 years old - Chronic dry mouth that has resulted in periodontal disease or oral fungal infections - Nerve disorder that affects involuntary body functions including heart rate, blood pressure,
Danish: - er over 65 år - kronisk mundtørhed, der har medført paradental sygdom eller svampeinfektion i munden - nervesygdom, der påvirker de ufrivillige kropsfunktioner såsom hjertefrekvens, blodtryk,
English: Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics.
Danish: Kentera bør anvendes med forsigtighed hos ældre patienter, som kan være mere følsomme for virkningerne af centralt virkende antikolinergika og kan udvise forskelle i farmakokinetikken.
English: Memory impairment#, amnesia#, lethargy#, disturbance in attention#
Danish: Hukommelsesbesvær#, amnesi#, letargi#, opmærksomhedsforstyrrelse#
English: Urinary retention, dysuria
Danish: Ikke almindelig Urinretention, dysuri
English: The multidose container is comprised of an outer bottle with a pouch liner, a metering pump and a cap.
Danish: Flerdosisbeholderen består af en ydre flaske med en indre foring, en doseringspumpe og en hætte.
English: Squeeze from the bottom of the sachet toward the open end.
Danish: Tryk på brevet fra bunden og hen imod den åbne ende.
English: Pharmacotherapeutic group: Urologicals, urinary antispasmodics, ATC code: G04B D04.
Danish: Farmakoterapeutisk klassifikation: Urologica, urologiske antispasmodica, ATC-kode: G04BD04.
English: Patients on Kentera therapy should keep application sites covered with clothing when coming into contact with breast-feeding or pregnant women or breast-fed infants.
Danish: Patienter i behandling med Kentera bør tildække applikationsstedet med tøj, når de er i kontakt med ammende eller gravide kvinder eller børn, der bliver ammet.
English: - If you are unable to have complete bowel movements.
Danish: - hvis du ikke er i stand til at tømme tarmen helt.
English: If the patch starts to lift off your skin, apply a little bit of pressure using your fingertips.
Danish: Hvis plasteret løfter sig fra huden, så tryk det let fast med fingerspidserne.
English: Backing: polyester/ethylene-vinyl acetate film; siliconised polyester film.
Danish: Foring: film af polyester/etylenvinylacetat; film af silikoniseret polyester.
English: Your urge incontinence may return and you may have increased urinary frequency if you decide to stop using the gel.
Danish: Din urge-inkontinens kan komme igen, og du kan opleve en øget vandladningshyppighed, hvis du beslutter dig for at holde op med at bruge gelen.
English: The patch should be applied to dry, intact skin on the abdomen, hip, or buttock immediately after removal from the protective sachet.
Danish: Plasteret skal påføres på tør, intakt hud på mave, hofte eller balde straks efter, at det er blevet fjernet fra det beskyttende brev.
English: Following the application of Kentera, oxybutynin plasma concentration increases for approximately 7 days, reaching average maximum concentrations of 4 to 5 ng/ml.
Danish: Efter applicering af Kentera øges oxybutyninplasmakoncentrationen i ca. 7 dage og når en gennemsnitlig maksimumkoncentration på 4 til 5 ng/ml.
English: After applying the gel, hands should immediately be washed thoroughly with soap and water.
Danish: Efter applicering af gelen skal hænderne med det samme vaskes grundigt med vand og sæbe.
English: Sleep and energy Severity (coping) measures
Danish: Søvn og energi
English: It is recommended to cover the application site with clothing once the gel has dried.
Danish: Det anbefales at tildække applikationsstedet med tøj, når gelen er tørret ind.
English: The use of Kentera in patients with hepatic impairment should be carefully monitored since oxybutynin is extensively hepatic metabolised.
Danish: Patienter med nedsat leverfunktion, som anvender Kentera, skal overvåges omhyggeligt, da oxybutynin metaboliseres i vid udstrækning via leveren.
English: Travel subscale
Danish: Underskala for rejser
English: See Figure C.
Danish: Se figur C.
English: The effect of showering on the absorption of oxybutynin was evaluated in a randomised, steady-state crossover study under conditions of no shower, or showering 1, 2 or 6 hours after Kentera application (N=20).
Danish: Virkningen af et brusebad på absorptionen af oxybutynin blev undersøgt i et randomiseret, steady state-overkrydsningsforsøg med eller uden brusebadning 1, 2 eller 6 timer efter applicering af Kentera (N = 20).
English: Kentera is used in adults to control the symptoms of urge incontinence and/or increased urinary frequency and urgency.
Danish: Kentera anvendes hos voksne til at kontrollere symptomer på ufrivillig vandladning (urge-inkontinens) og/eller øget vandladningshyppighed og -trang.
English: Nonetheless Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics (see section
Danish: Ikke desto mindre bør Kentera anvendes med forsigtighed hos ældre patienter, som kan være mere følsomme for virkningerne af centralt virkende antikolinergika og kan udvise forskelle i farmakokinetikken (se pkt.
English: Anticholinergic medicinal products should be used with caution in patients who have autonomic neuropathy, cognitive impairment or Parkinson's disease.
Danish: Antikolinergika skal anvendes med forsigtighed hos patienter med autonom neuropati, kognitiv svækkelse eller Parkinsons sygdom.
English: Person-to-person transference
Danish: Overførsel fra person til person
English: Your urge incontinence may return and you may have increased urinary frequency if you decide to stop using the patch.
Danish: Din urge-inkontinens kan komme igen, og du kan opleve en øget vandladningshyppighed, hvis du beslutter dig for at holde op med at bruge plasteret.
English: Mean (SD) change from baseline for IIQ total score and subscales at Week 12 (LOCF)
Danish: Gennemsnitlig (SD) ændring fra baseline for samlet IIQ-score og underskalaer i uge 12 (LOCF)
English: Always place the small protective cap back firmly on the tip of the pump nozzle and the large pump cover over the top of the pump after each use.
Danish: Sæt altid den lille beskyttelseshætte godt fast på spidsen af pumpedysen efter hver brug, og sæt den store hætte fast på pumpens top.
English: If prime is lost during the use (no gel is dispensed after depressing the pump), repeat as instructed above to re-prime the pump.
Danish: Hvis pumpen mister evnen til at pumpe (der kommer ikke gel ud, når pumpen trykkes ned), forberedes pumpen igen ved at gentage den ovenfor beskrevne proces.
English: Kentera is a transdermal patch and it is packaged in cartons containing 2, 8, and 24 patches.
Danish: Kentera er et depotplaster, som er pakket i æsker med 2, 8 eller 24 plastre.
English: 2 transdermal patches 8 transdermal patches 24 transdermal patches
Danish: 2 depotplastre 8 depotplastre 24 depotplastre
English: How to use the sachets:
Danish: Sådan skal du bruge brevene:
English: Do not use Kentera after the date shown on the sachet and the carton.
Danish: Brug ikke Kentera efter den udløbsdato, der står på brevet og æsken.
English: The multidose container is comprised of an outer polypropylene bottle with a Low Density Polyethylene (LDPE) pouch liner, a polypropylene metering pump, with ethylene propylene diene monomer (EPDM) gaskets, and a polypropylene cap.
Danish: Flerdosisbeholderen består af en ydre flaske af polypropylen beklædt indvendigt med et lavdensitetspolyethylen (LDPE)-lag, en doseringspumpe af polypropylen, med ethylen-propylen-dienmonomer (EPDM)-pakninger og en hætte af polypropylen.
English: - The other ingredients are: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide (for pH adjustment), and purified water.
Danish: - Øvrige indholdsstoffer: ethanol (96 %), glycerol, hydroxypropylcellulose, natriumhydroxid (til justering af pH-værdi) og renset vand.
English: Do not expose the patch to the sun.
Danish: Plasteret må ikke udsættes for sollys.
English: Mean (SD) change from baseline in KHQ Domain Scores at Week 12 (LOCF)
Danish: Gennemsnitlig (SD) ændring fra baseline i score for KHQ-områder i uge 12 (LOCF)
English: Pre-clinical data reveal no special hazard for humans based on studies for acute toxicology, repeat dose toxicity, genotoxicity, carcinogenic potential and local toxicity.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra undersøgelser af akut toksicitet, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og lokal toksicitet.
English: Very common Application site pruritis Common
Danish: Meget almindelig Kløe ved applikationssted Almindelig
English: Kentera pump should be discarded in household trash in a manner that prevents accidental application or ingestion by household members or pets.
Danish: Smid Kenterapumpen ud sammen med almindeligt husholdningsaffald på en måde, der forhindrer, at medlemmer af husholdningen eller kæledyr får Kentera på sig eller kommer til at indtage det.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Når lægemidlet er godkendt, erindberetning af formodede bivirkninger vigtig.
English: Fully depress the pump once onto your hand (palm or fingers), or directly onto the application site.
Danish: Tryk pumpen helt ned, så der kommer gel ud i din hånd (håndflade eller fingre) eller direkte på påføringsstedet.
English: General health perception Incontinence impact Symptom severity Role limitations Physical limitations Social limitations Personal relationships Emotions
Danish: Sværhedsgrad af symptomer Begrænsninger i adfærd Fysiske begrænsninger
English: After applying Kentera, immediately wash your hands thoroughly with soap and water.
Danish: Når du har påført Kentera, skal du straks vaske hænderne grundigt med vand og sæbe.
English: Apply immediately after gel is dispensed from the pump.
Danish: Påføres med det samme, efter at gelen er pumpet ud af pumpen.
English: Kentera has a concentration of oxybutynin sufficient to maintain continuous transport over the 3 to 4 day dosing interval.
Danish: Oxybutynin-koncentrationen i Kentera er tilstrækkelig til at opretholde en kontinuerlig administration over et doseringsinterval på 3 til 4 dage.
English: The usual dose is one sachet applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs, which delivers 4 mg of oxybutynin in 24 hours.
Danish: Den sædvanlige dosis er ét brev, som én gang dagligt påføres tør, intakt hud på maven, overarmene/skuldrene eller lårene, og som afgiver 4 mg oxybutynin i løbet af 24 timer.
English: FURTHER INFORMATION What Kentera contains
Danish: YDERLIGERE OPLYSNINGER Kentera indeholder:
English: Empty multidose container must be discarded in accordance with local requirements.
Danish: Tomme flerdosisbeholdere skal bortskaffes i henhold til lokale retningslinjer.
English: As oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4, interactions with medicinal products that inhibit this isoenzyme cannot be ruled out.
Danish: Da oxybutynin metaboliseres af cytokrom P 450-isoenzymet CYP3A4, kan interaktioner med lægemidler, der hæmmer dette isoenzym, ikke udelukkes.
English: Transdermal administration of oxybutynin bypasses the first-pass gastrointestinal and hepatic metabolism, reducing the formation of the N-desethyl metabolite.
Danish: Ved transdermal administration af oxybutynin undgås førstepassagemetabolismen i mave-tarm-kanal og lever, hvilket reducerer dannelsen af N-desethyl-metabolitten.
English: Dry mouth, constipation, diarrhoea, nausea, abdominal pain
Danish: Mundtørhed, forstoppelse, diarré, kvalme, abdominale smerter
English: There are no adequate data on the use of oxybutynin transdermal patch in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af oxybutynin depotplastre til gravide kvinder.
English: Pharmacotherapeutic group: urinary antispasmodic, ATC code: G04B D04.
Danish: Farmakoterapeutisk klassifikation: krampestillende (urinvej), ATC-kode: G04B D04.
English: Anticholinergic medicinal products should be used with caution in patients who have hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.
Danish: Antikolinergika skal anvendes med forsigtighed hos patienter med hiatushernie/gastroøsofageal refluks og/eller patienter, der samtidig indtager lægemidler (såsom bisfosfonater), som kan forårsage eller forværre øsofagitis.
English: How to use the multidose container with metering pump:
Danish: Sådan skal du bruge flerdosisbeholderen med doseringspumpen:
English: Each patch of 39 cm2 contains 36 mg of oxybutynin.
Danish: Hvert depotplaster på 39 cm2 indeholder 36 mg oxybutynin.
English: Contains 1 transdermal patch.
Danish: Indeholder 1 depotplaster.
English: Cartons of 30 sachets.
Danish: Æsker med 30 breve.
English: Take special care with Kentera:
Danish: Vær ekstra forsigtig med at bruge Kentera:
English: Carefully throw away the open sachet so that children and pets are not exposed to it.
Danish: Når du smider det åbnede brev ud, skal du omhyggeligt sørge for, at børn og dyr ikke kan komme i nærheden af det.
English: Psychiatric and central nervous system (CNS) anticholinergic events like sleep disorders (e.g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients.
Danish: Psykiske og antikolinerge CNS-bivirkninger såsom søvnforstyrrelser (f.eks. søvnløshed) og kognitive forstyrrelser er sat i forbindelse med oxybutynin, navnlig hos ældre.
English: As oxybutynin is metabolised by the cytochrome P 450 isoenzyme CYP 3A4, interactions with medicinal products that inhibit this isoenzyme, or known inducers of CYP 3A4, cannot be ruled out.
Danish: Da oxybutynin metaboliseres af cytokrom P 450-isoenzymet CYP3A4, kan interaktioner med lægemidler, der hæmmer dette isoenzym, eller med kendte induktorer af CYP3A4 ikke udelukkes.
English: Application site pruritis, application site dermatitis
Danish: Kløe på applikationsstedet, dermatitis på applikationsstedet
English: Anxiety, confusion, nervousness, agitation, insomnia
Danish: Ikke almindelig Angst, konfusion, nervøsitet, agitation, søvnløshed Sjælden
English: BEFORE YOU USE KENTERA Do not use Kentera:
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE KENTERA Brug ikke Kentera:
English: EU/1/03/270/005 <1 multidose container with metering pump>
Danish: EU/1/03/270/005 <1 flerdosisbeholder med doseringspumpe >
English: Effects of showering
Danish: Virkningen af at tage et brusebad
English: Abdominal discomfort, dyspepsia
Danish: Ikke almindelig Abdominal ubehag, dyspepsi
English: The active substance is oxybutynin.
Danish: Aktivt stof: oxybutynin.