FrancophonIA/ELRC3.0 huggingface dataset:
English: Use with sunscreen
Danish: Brug med solbeskyttelsesmidler
English: If applying Kentera to the stomach, care should be taken to avoid the area around the navel (belly button).
Danish: Hvis du smører Kentera på huden på maven, skal du være påpasselig med at undgå området omkring navlen.
English: When oxybutynin is used during breast-feeding, a small amount is excreted in the mother's milk.
Danish: Hvis oxybutynin anvendes under amning, udskilles en lille mængde i modermælken.
English: Kentera should be used with caution in patients with hepatic or renal impairment.
Danish: Kentera skal anvendes med forsigtighed til patienter med nedsat lever- eller nyrefunktion.
English: The sachet is constructed from a multi-layer foil based laminate pouch material (polymethacrylate/acrylonitrile copolymer/adhesive/aluminum/low density polyethylene/paper).
Danish: Brevet består af et flerlaget lamineret foliemateriale (polymethacrylat/akrylonitril copolymer/klæbestof/aluminium/lavdensitetspolyethylen/papir).
English: - The active substance is oxybutynin.
Danish: - Aktivt stof: oxybutynin.
English: The application site may be covered with clothing once Kentera has dried.
Danish: Påføringsstedet kan dækkes af tøj, når Kentera er tørret ind.
English: Kentera is a rapid drying, clear, smooth, odorless, and colorless hydroalcoholic gel that is packaged in a multidose container with metering pump.
Danish: Kentera er en hurtigttørrende, klar, blød, lugtfri og farveløs hydroalkoholisk gel, der leveres i en flerdosisbeholder med doseringspumpe.
English: perspiration and digestion - Problems with memory, language, or thinking abilities - A progressive neurological disease characterised by tremor of resting muscles, rigidity,
Danish: svedproduktion og fordøjelse - problemer med at huske, tale eller tænke - en fremskridende neurologisk sygdom, der er karakteriseret af muskler, der ryster i hvile,
English: The recommended dose is one sachet applied once daily which corresponds to a delivery dose of approximately 4 mg.
Danish: Den anbefalede dosis er ét brev påført én gang dagligt, hvilket svarer til en administreret dosis på cirka 4 mg.
English: It is recommended to cover the application site with clothing once Kentera has dried.
Danish: Det anbefales at tildække applikationsstedet med tøj, når Kentera er tørret ind.
English: There are no adequate data on the use of oxybutynin topical gel in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af topisk gel med oxybutynin til gravide kvinder.
English: EU/1/03/270/005 1 multidose container with metering pump
Danish: EU/1/03/270/005 1 flerdosisbeholder med doseringspumpe
English: Adverse reactions considered associated with anticholinergic therapy,in general or observed with oral administration of oxybutynin, but as of yet not with Kentera in clinical trials or post-marketing, are: anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, paranoia, photosensitivity, erectile dysfunction.
Danish: Bivirkninger, der anses for at være forbundet med antikolinerge lægemidler generelt, eller observeret med oral administration af oxybutynin, men ikke på nuværende tidspunkt med Kentera i kliniske studier eller efter markedsføring, er anoreksi, opkastning, refluksøsofagit, nedsat svedproduktion, hedeslag, nedsat tåredannelse, mydriasis, takykardi, arytmi, mareridt, rastløshed, kramper, intraokulær hypertension og induktion af glaukom, paranoia, fotosensibilitet, erektil dysfunktion.
English: Excipients: ethanol (96%), glycerol, hydroxypropylcellulose, sodium hydroxide (for pH adjustment), and purified water.
Danish: Hjælpestoffer: ethanol (96 %), glycerol, hydroxypropylcellulose, natriumhydroxid (til justering af pHværdi) og renset vand.
English: Apply immediately after dose delivered from the multidose container with metering pump.
Danish: Påføres, straks efter at dosen er pumpet ud af flerdosisbeholderen med doseringspumpen.
English: The usual dose is the contents of one dispensed dose from the multidose container with metering pump 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 svarer til den mængde, der kommer ud af flerdosisbeholderen med doseringspumpen, som én gang dagligt påføres på tør, intakt hud på maven, overarmene/skuldrene eller lårene, og som afgiver 4 mg oxybutynin i løbet af 24 timer.
English: Do not use Kentera after the expiry date which is stated on the multidose container with metering pump and the carton after EXP.
Danish: Brug ikke Kentera efter den udløbsdato, der står på flerdosisbeholderen med doseringspumpen og æsken.
English: EU/1/03/270/004 <30 sachets>
Danish: EU/1/03/270/004 <30 breve>
English: The recommended dose is one metered dose from the multidose container with metering pump applied once daily which corresponds to a delivery dose of approximately 4 mg.
Danish: Den anbefalede dosis er én afmålt dosis fra flerdosisbeholderen med doseringspumpen påført én gang dagligt, hvilket svarer til en administreret dosis på cirka 4 mg.
English: Oxybutynin may slow the digestive tract and thereby influence the adsorption of other oral medicines, or the use of this medicine together with other medicines may increase the effect of oxybutynin.
Danish: Oxybutynin kan få fordøjelseskanalen til at arbejde langsommere og derved påvirke optagelsen af andre lægemidler, der tages gennem munden, og brugen af dette lægemiddel sammen med anden medicin kan øge virkningen af oxybutynin.
English: There is no experience with the use of Kentera in patients with renal impairment.
Danish: Der er ingen erfaring med brug af Kentera hos patienter med nedsat nyrefunktion.
English: Always use Kentera exactly as your doctor has told you.
Danish: Brug altid Kentera nøjagtigt efter lægens anvisning.
English: Fatigue, oedema peripheral, application site papules, application site anaesthesia, application site erythema, application site irritation, application site pain, application site pustules
Danish: Ikke almindelig Træthed, perifert ødem, papler på applikationsstedet, anæstesi på applikationsstedet, erytem på applikationsstedet, irritation på applikationsstedet, smerte på applikationsstedet, pustler på applikationsstedet
English: Rare side effects - panic reaction - mental confusion - hallucinations - disorientation - memory impairment - loss of memory - abnormal tiredness - poor concentration
Danish: Sjældne bivirkninger - panikreaktion - delirium - hallucinationer - desorientering - hukommelsesbesvær - hukommelsestab - abnorm træthed - nedsat koncentrationsevne
English: Mean and median change from baseline for incontinence episodes, urinary frequency, and urinary void volume at Week 12 (LOCF)
Danish: Gennemsnitlig og median ændring fra baseline for inkontinensepisoder, urinfrekvens og urinmængde ved vandladning i uge 12 (LOCF)
English: The difference in AUC and Cmax of oxybutynin and the active metabolite N-desethyloxybutynin following transdermal administration of Kentera on either the abdomen, upper arms/shoulders and thighs is not clinically relevant.
Danish: Forskellen på AUC og Cmax for oxybutynin og den aktive metabolit, N-desethyloxybutynin, efter transdermal administration af Kentera på enten mave, overarmene/skuldrene eller lårene er ikke klinisk relevant.
English: Gastrointestinal disorders: Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
Danish: Gastrointestinale lidelser: Antikolinergika kan reducere gastrointestinal motilitet og skal ordineres med forsigtighed til patienter med gastrointestinale obstruktive sygdomme på grund af risikoen for gastrisk retention.
English: The area of the patch is 39 cm2, releasing a nominal 3.9 mg of oxybutynin per 24 hours.
Danish: Plasterets størrelse er 39 cm2, hvilket frigiver nominelt 3,9 mg oxybutynin pr. 24 timer.
English: The sachet is constructed from a multi-layer foil based laminated pouch material.
Danish: Brevet er en lomme, der er fremstillet i et flerlaget lamineret foliemateriale.
English: Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention, and in conditions such as ulcerative colitis, and intestinal atony.
Danish: Antikolinergika kan reducere den gastrointestinale motilitet og skal ordineres med forsigtighed til patienter med gastrointestinale obstruktive sygdomme på grund af risikoen for gastrisk retention og til patienter med lidelser såsom ulcerøs tyktarmsbetændelse og intestinal atoni.
English: Mechanism of action: oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.
Danish: Virkningsmekanisme: Oxybutynin virker som en kompetitiv antagonist for acetylkolin på postganglionære, muskarine receptorer, hvilket medfører en afslapning af glat muskulatur i blæren.
English: Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy
Danish: Oxybutynin kan forværre symptomer på hyperthyroidisme, koronar hjertesygdom, kongestivt hjertesvigt, hjertearytmier, takykardi, hypertension og prostatahypertrofi.
English: Daily incontinence episodes Baseline
Danish: Daglige inkontinensepisoder Baseline
English: EU/1/03/270/004 30 sachets
Danish: EU/1/03/270/004 30 breve
English: The difference in AUC and Cmax of oxybutynin and the active metabolite N-desethyloxybutynin following transdermal administration of Kentera on either the abdomen, buttocks or hip is not clinically relevant.
Danish: Forskellen på AUC og C-maks for oxybutynin og den aktive metabolit, N-desethyloxybutynin, efter transdermal administration af Kentera på enten mave, balder eller hofte er ikke klinisk relevant.
English: Daily urinary frequency Baseline
Danish: Daglig urinfrekvens Baseline
English: Emotional health subscale
Danish: Underskala for følelsesmæssigt velvære
English: Kentera transdermal patch:
Danish: Kentera depotplaster:
English: Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.
Danish: Oxybutynin virker som en kompetitiv antagonist for acetylkolin på post-ganglionære, muskarine receptorer, hvilket medfører en afslapning af glat muskulatur i blæren.
English: - Free of cuts, rashes or any other skin irritation.
Danish: - Fri for sår, udslæt eller anden form for hudirritation.
English: Application should not be made to the same site on consecutive days.
Danish: Gelen bør ikke appliceres på samme sted to eller flere dage i træk.
English: See Figure B.
Danish: Se figur B.
English: There is no experience with the use of Kentera in patients with hepatic impairment.
Danish: Der er ingen erfaring med brug af Kentera hos patienter med nedsat leverfunktion.
English: Tear the sachet open at the indentation just before use.
Danish: Åbn brevet ved at rive det op ved markeringen umiddelbart før brug.
English: Daily nocturia episodes Baseline
Danish: Daglige nykturi-episoder Baseline
English: P-value (Kentera vs.
Danish: p-værdi (Kentera over for placebo)
English: Oxybutynin may slow the digestive tract and thereby influence the adsorption of other oral medicines, interfere with bowel movement therapies, and the use of this medicine together with other medicines may increase the effect of oxybutynin.
Danish: Oxybutynin kan få fordøjelseskanalen til at arbejde langsommere og derved påvirke optagelsen af andre lægemidler, der tages gennem munden, samt påvirke behandlinger af tarmbevægelserne, og brugen af dette lægemiddel sammen med anden medicin kan øge virkningen af oxybutynin.
English: EU/1/03/270/001 <8 transdermal patches> EU/1/03/270/002 <24 transdermal patches> EU/1/03/270/003 <2 transdermal patches>
Danish: EU/1/03/270/001 <8 depotplastre> EU/1/03/270/002 <24 depotplastre> EU/1/03/270/003 <2 depotplastre>
English: The concomitant use of oxybutynin with other anticholinergic medicinal products or with other active substances that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of dry mouth, constipation, and drowsiness.
Danish: Samtidig anvendelse af oxybutynin og andre antikolinergika eller andre aktive stoffer, der konkurrerer om CYP3A4-enzymmetabolismen, kan forøge hyppigheden eller graden af mundtørhed, forstoppelse og døsighed.
English: Acrylic copolymer adhesive solution containing 2-ethylhexyl acrylate N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains
Danish: Akryl-copolymer-klæbestof, der indeholder domænerne 2-etylhexyl-akrylat, N-vinylpyrrolidon og hexametylenglycol-dimetakrylatpolymer
English: Please read all the information below before you begin to apply Kentera.
Danish: Læs nedenstående oplysninger omhyggeligt, før du begynder at påsætte Kentera.
English: You should not apply Kentera to the same site on consecutive days.
Danish: Kentera bør ikke smøres på samme sted to eller flere dage i træk.
English: Excipients: triacetin; acrylic adhesive (containing 2-ethylhexyl acrylate; N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains).
Danish: Hjælpestoffer: triacetin, akrylklæbestof (indeholder domænerne 2-etylhexyl-akrylat, N-vinylpyrrolidon og hexametylenglycol-dimetakrylatpolymer).
English: Kentera is a rapid drying, clear, smooth, odourless, and colourless hydroalcoholic gel that is packaged in single dose sachets.
Danish: Kentera er en hurtigttørrende, klar, blød, lugtfri og farveløs hydroalkoholisk gel, der leveres i breve med én dosis.
English: - If you have further questions, please ask your doctor or your pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Anticholinergic medicinal products may potentially alter the absorption of some concomitantly administered medicinal products due to anticholinergic effects on gastrointestinal motility.
Danish: Antikolinergika kan potentielt ændre optagelsen af nogle samtidigt indgivne lægemidler som følge af antikolinerge påvirkninger af den gastrointestinale motilitet.
English: Ingestion of 100 mg oral oxybutynin chloride in association with alcohol has been reported in a 13 year old boy who experienced memory loss, and in a 34 year old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine.
Danish: Indtagelse af 100 mg oral oxybutyninchlorid sammen med alkohol er blevet rapporteret for en 13-årig dreng, som oplevede hukommelsestab, og hos en 34-årig kvinde, som udviklede stupor efterfulgt af desorientering og uro ved opvågning, forstørrede pupiller, tør hud, hjertearytmier og urinretention.
English: The use of Kentera in patients with hepatic impairment should be carefully monitored.
Danish: Patienter med nedsat leverfunktion, som anvender Kentera, skal overvåges omhyggeligt.
English: Application site erythema, application site reaction, application site rash
Danish: Erytem ved applikationssted, reaktion ved applikationssted, udslæt ved applikationssted
English: BEFORE YOU USE KENTERA Do not use Kentera
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE KENTERA Brug ikke Kentera
English: You should not apply more than one sachet during a 24 hour period.
Danish: Du må ikke påføre mere end et enkelt brev inden for 24 timer.
English: Ingestion of 100 mg oral oxybutynin in association with alcohol has been reported in a 13 year old boy who experienced memory loss, and in a 34 year old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine.
Danish: Indtagelse af 100 mg oral oxybutynin sammen med alkohol er blevet rapporteret for en 13-årig dreng, som oplevede hukommelsestab, og hos en 34-årig kvinde, som udviklede stupor efterfulgt af desorientering og uro ved opvågning, forstørrede pupiller, tør hud, hjertearytmier og urinretention.
English: Each multidose container contains at least 30 grams of Kentera and dispenses 30 metered 1 gram doses.
Danish: Hver flerdosisbeholder indeholder mindst 30 gram Kentera og leverer 30 afmålte doser a 1 gram. Hver æske indeholder 1 flerdosisbeholder med doseringspumpe.
English: The concomitant use of oxybutynin with other anticholinergic medicinal products or with other agents that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of dry mouth, constipation, and drowsiness.
Danish: Samtidig anvendelse af oxybutynin og andre antikolinergika eller andre stoffer, der konkurrerer om CYP3A4-enzymmetabolismen, kan forøge hyppigheden eller graden af mundtørhed, forstoppelse og døsighed.
English: Anticholinergic agents may potentially alter the absorption of some concomitantly administered medicinal products due to anticholinergic effects on gastrointestinal motility.
Danish: Antikolinergika kan potentielt ændre absorptionen af nogle samtidigt indgivne lægemidler som følge af antikolinerg påvirkning af den gastrointestinale motilitet.
English: Applying Kentera while taking other medicines that have similar side effects, such as dry mouth, constipation, and drowsiness, may increase how often and how severe these side effects are experienced.
Danish: Hvis du bruger Kentera, samtidig med at du bruger andre lægemidler, der har lignende bivirkninger såsom mundtørhed, forstoppelse og døsighed, kan hyppigheden og sværhedsgraden af disse bivirkninger opleves som øget.
English: Discard the protective liners.
Danish: - Smid den beskyttende folie ud.
English: - Grab the loose edge at either corner and peel off the second piece of the liner.
Danish: - Tag fat i et af hjørnerne på den løse kant og træk det sidste stykke folie af.
English: Each transdermal patch contains 36 mg of oxybutynin.
Danish: Hvert depotplaster indeholder 36 mg oxybutynin.
English: Before using the pump for the first time the multidose container should be primed.
Danish: Før ibrugtagning skal flerdosisbeholderen forberedes.
English: Figure B:
Danish: Figur B:
English: Figure C:
Danish: Figur C:
English: Figure D:
Danish: Figur D:
English: EU/1/03/270/001 8 transdermal patches EU/1/03/270/002 24 transdermal patches EU/1/03/270/003 2 transdermal patches
Danish: EU/1/03/270/001 8 depotplastre EU/1/03/270/002 24 depotplastre EU/1/03/270/003 2 depotplastre
English: Gel in sachet.
Danish: Gel i brev.
English: Applying the Kentera patch at the same time as taking other medicines that have similar side effects such as dry mouth, constipation and drowsiness, may increase how often and how severe these side effects are experienced.
Danish: Hvis du bruger Kentera-plasteret samtidig med at du bruger andre lægemidler, der har lignende bivirkninger såsom mundtørhed, forstoppelse og døsighed, kan hyppigheden og sværhedsgraden af disse bivirkninger opleves som øget.
English: Read leaflet before use.
Danish: Læs indlægssedlen inden brug.
English: Anticholinergic medicinal products should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
Danish: Antikolinergika skal ordineres med forsigtighed til patienter med klinisk signifikant blæreobstruktion på grund af risikoen for urinretention.
English: slowness of movement, impaired balance, and a shuffling gait; - Overactive thyroid gland which can cause increased appetite, weight loss, or sweating; - Narrowing of the blood vessels that supply blood and oxygen to the heart; - Heart problems which can cause shortness of breath or ankle swelling; - Irregular heart beat; - Faster heart beat; - High blood pressure; - Enlarged prostate.
Danish: stivhed, langsomme bevægelser, nedsat balance og slæbende gang - overaktiv skjoldbruskkirtel, der kan forårsage øget appetit, vægttab eller sveden - forsnævring af de blodkar, der forsyner hjertet med blod og ilt - hjerteproblemer, der kan forårsage kortåndethed eller hævelse af ankler - uregelmæssig hjerterytme - hurtigere hjerterytme - højt blodtryk - forstørret prostata
English: Important: Kentera is for application to the skin only.
Danish: Kentera må kun bruges til at smøre på huden.
English: Kentera 3.9 mg / 24 hours transdermal patch
Danish: Kentera, 3,9 mg/24 timers depotplaster
English: Discard empty multidose containers in accordance with local requirements.
Danish: Kassér tomme flerdosisbeholdere i henhold til lokale retningslinjer.
English: Oxybutynin may lead to suppressed salivary secretions which could result in dental caries, parodontosis or oral candidiasis.
Danish: Oxybutynin kan medføre undertrykkelse af spytsekretionen, hvilket kan forårsage caries, paradentose eller svamp i munden.
English: Thus based on current clinical evidence no need for dose adjustment in elderly patients is considered necessary.
Danish: Det anses derfor ikke for at være nødvendigt med en josisjustering hos ældre patienter, baseret på aktuel klinisk evidens.
English: In the subcutaneous fertility study in rats, while no effects were reported in males, in females, fertility was impaired and a NOAEL (no observed adverse effect level) of 5 mg/kg was identified.
Danish: Et NOAEL (no observed adverse effect level - niveau uden konstatering af bivirkninger) på 5 mg/kg blev i den forbindelse påvist.
English: Urinary retention: Anticholinergic products should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
Danish: Urinretention: Antikolinergika skal ordineres med forsigtighed til patienter med klinisk signifikant blæreobstruktion på grund af risikoen for urinretention.
English: HOW TO STORE KENTERA
Danish: Hvordan påsættes Kentera?
English: MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Read package leaflet before use.
Danish: Læs pakningens indlægsseddel før brug.
English: Overdosage with oxybutynin has been associated with anticholinergic effects including CNS excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.
Danish: Overdosering med oxybutynin er blevet sat i forbindelse med antikolinerge effekter, herunder CNS-excitation i, rødmen, feber, dehydrering, hjertearytmier, opkastning og urinretention.
English: - Without touching the sticky surface, firmly press the patch, adhesive face down, onto the part of the abdomen, hips or buttocks you have selected for application.
Danish: - Tryk plasteret godt fast uden at berøre den klæbende overflade, som skal vende nedad på det valgte hudområde på mave, hofter eller balder.
English: Kentera 3.9 mg / 24 hours transdermal patch oxybutynin
Danish: Kentera 3,9 mg/24 timers depotplaster oxybutynin
English: Each transdermal patch releases 3.9 mg of oxybutynin per 24 hours.
Danish: Hvert depotplaster frigør 3,9 mg oxybutynin pr. 24 timer.
English: Common side effects - headache - dizziness - dry mouth - constipation - itchiness - itchiness, inflammation, or pain at the application site
Danish: Almindelige bivirkninger - hovedpine - svimmelhed - mundtørhed - forstoppelse - kløe - kløe, betændelse eller smerte på påføringsstedet
English: Apply immediately after opening the sachet.
Danish: Påføres straks efter åbning af brevet.
English: Baths, showers, swimming and exercise should not affect the patch as long as you don't rub the patch as you wash. Avoid soaking in a hot bath for a long period of time, which can make the patch come off.
Danish: Karbad, brusebad, svømning og motion påvirker ikke Kentera-plasteret, så længe du ikke gnider på det under afvaskning.
English: Store pump in the upright position.
Danish: Opbevares i lodret position.