FrancophonIA/ELRC3.0 huggingface dataset:
English: Clear PVC/CTFE/aluminium or PVC/PVDC/aluminium blisters in cartons containing 7, 14, 28, 49, 56 or 98 tablets as unit pack or in multipacks containing 140 (10x14) tablets.
Danish: Klar PVC/CTFE/aluminium eller PVC/PVDC/aluminium blister i kartoner indeholdende 7, 14, 28, 49, 56 eller 98 tabletter som enkeltpakning eller i multipakninger indeholdende 140 (10x14) tabletter.
English: However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.
Danish: Der var imidlertid ingen sammenhæng mellem forekomst af bivirkninger relateret til galdevejen hos darifenacinbehandlede patienter og stigende alder.
English: Emselex has been administered in clinical trials at doses up to 75 mg (five times maximum therapeutic dose).
Danish: Emselex er i kliniske studier blevet administreret i doser op til 75 mg (5 gange den maksimale terapeutiske dosering).
English: Always take Emselex exactly as your doctor has told you.
Danish: Tag altid Emselex nøjagtigt efter lægens anvisning.
English: The potentiation of anticholinergic effects with antiparkinson agents and tricyclic antidepressants may also occur if antimuscarinic agents are used concurrently with such medicinal products.
Danish: Potentiering af antikolinerg effekt med anti-parkinson midler og tricykliske antidepressiva kan også forekomme, hvis antimuskarine stoffer bruges samtidig med sådanne lægemidler.
English: Visual disturbance, including vision blurred
Danish: Synsforstyrrelser, inklusive sløret syn
English: Treatment with Emselex administered at dosages of 7.5 mg and 15 mg daily has been investigated in four double-blind, Phase III, randomised, controlled clinical studies in male and female patients with symptoms of overactive bladder.
Danish: Behandling med Emselex administreret i doser á 7,5 mg og 15 mg daglig er blevet undersøgt i fire dobbelt-blindede, randomiserede, kontrollerede fase III kliniske studier på mandlige og kvindlige patienter med symptomer på overaktiv blære.
English: The interaction with midazolam lacks clinical relevance, and therefore no dose adjustment is needed for CYP3A4 substrates.
Danish: Interaktionen med midazolam mangler klinisk relevans, og derfor er det ikke nødvendigt med dosisjustering for CYP3A4 substrater.
English: Caution should be used when prescribing antimuscarinics to patients with pre-existing cardiac diseases.
Danish: Der bør udvises forsigtighed, når antimuskarinika udskrives til patienter med præeksisterende hjertelidelser.
English: Studies in animals have shown toxicity to parturition (for details, see section 5.3).
Danish: Dyreforsøg har påvist toksicitet ved fødsel (for detaljer, se pkt.
English: A few percent of the population have increased CYP2D6 enzyme levels (ultrafast metabolisers).
Danish: Nogle få procent af populationen har øget CYP2D6 enzym niveau (ultra hurtig metabolisme).
English: This medicine has been prescribed for you.
Danish: Lægen har ordineret dette lægemiddel til dig personligt.
English: Severe ulcerative colitis.
Danish: • Svær colitis ulcerosa.
English: Standard therapeutic prothrombin time monitoring for warfarin should be continued.
Danish: Standard tidsmonitorering af terapeutisk protrombin skal fortsættes uændret.
English: It can therefore be concluded that darifenacin administration does not alter the pharmacokinetics of CYP3A4 substrates in vivo.
Danish: Det kan derfor konkluderes, at administration af darifenacin ikke ændrer farmakokinetikken af CYP3A4 substrater in vivo.
English: • if you have severe ulcerative colitis or toxic megacolon (acute dilation of the colon due to complication of infection or inflammation).
Danish: • hvis du har svær tyktarmsbetændelse (colitis ulcerosa) eller toksisk megacolon (akut udvidelse af tyktarmen pga. komplikationer med infektion eller betændelse).
English: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Danish: Symptomatisk behandling af urgeinkontinens og/eller øget vandladningsfrekvens og imperiøs vandladning, som kan forekomme hos voksne patienter med overaktiv blæresyndrom.
English: Due to a greater contribution of CYP3A4 after higher darifenacin doses, the magnitude of the effect is expected to be even more pronounced when combining ketoconazole with darifenacin 15 mg.
Danish: Grundet en større indsats af CYP3A4 efter højere darifenacin doser, forventes størrelsen af effekten at være mere udtalt, når ketoconazol kombineres med darifenacin 15 mg.
English: If you have not noticed any effect by then, discuss it with your doctor.
Danish: Hvis du ikke har mærket nogen effekt ved behandlingens afslutning, skal du tale med din læge om det.
English: 26-28, rue Edward Steichen L-2540 Luxembourg Tel: +352 26 37 58 78
Danish: 26-28, rue Edward Steichen L-2540 Luxembourg Tlf: +352 26 37 58 78
English: 1 Hodges Lehmann estimate: median difference from placebo in change from baseline 2 Stratified Wilcoxon test for difference from placebo.
Danish: 1 Hodges Lehmann estimat: median forskel fra placebo ved ændringer fra basisniveau 2 Opdelt Wilcoxon test for forskellen fra placebo.
English: Fatigue, accidental injury, facial swelling, high blood pressure, diarrhoea, flatulence, inflammation of the mucous membrane of the mouth, increased liver enzymes, swelling, dizziness, sleeplessness, drowsiness, abnormal thinking, runny nose (rhinitis), cough, shortness of breath, dry skin, itching, rash, sweating, visual disturbance including blurred vision, taste disturbance, urinary tract disorder or infection, impotence, discharge and itching in the vagina, bladder pain, inability to empty your bladder.
Danish: Ikke almindelige (forekommer hos op til 1 ud af 100 patienter) Træthed, utilsigtede skader, hævelse i ansigtet, forhøjet blodtryk, diarré, flatulens, betændelsestilstand i mundslimhinden, forhøjede levertal, hævelser, svimmelhed, søvnløshed, døsighed, unormal tankegang, rindende næse, hoste, åndenød, tør hud, kløe, hududslæt, svedtendens, synsforstyrrelser inklusive sløret syn, smagsforstyrrelser, urinvejsforstyrrelser eller -infektion, impotens, udflåd og kløe i skeden, blæresmerter, besvær med at tømme blæren.
English: • if you have difficulties in passing urine and a weak stream of urine.
Danish: • hvis du har besvær med at komme af med urinen og en svag urinstråle.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge Deres din læge til råds, før De du tager bruger dette lægemiddel.
English: Caution should be exercised when darifenacin is used concomitantly with medicinal products that are predominantly metabolised by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine, or tricyclic antidepressants such as imipramine.
Danish: Der tilrådes forsigtighed, når darifenacin anvendes samtidig med lægemidler, som fortrinsvis metaboliseres af CYP2D6, og som har et snævert terapeutisk vindue, såsom flecainide, thioridazine eller tricycliske antidepressiva som imipramin.
English: The effect of warfarin on prothrombin time was not altered when co-administered with darifenacin.
Danish: Effekten af warfarin på protrombin blev ikke ændret ved samtidig administration af darifenacin.
English: In subjects who are poor metabolisers, darifenacin exposure increased approximately 10-fold.
Danish: Hos patienter, som har beskeden metabolisme, øges eksponeringen af darifenacin cirka 10 gange.
English: However, the patient discontinuation rates due to these adverse reactions were low (dry mouth: 0%0.9% and constipation: 0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).
Danish: Antallet af patienter som stoppede behandlingen på grund af disse bivirkninger var dog lav (mundtørhed: 0% - 0,9% og forstoppelse: 0,6% - 2,2% for darifenacin, afhængig af dosis; og 0% og 0,3% for placebo, for henholdsvis mundtørhed og forstoppelse).
English: Concomitant treatment with potent CYP2D6 inhibitors results in an increase in exposure (e.g. of 33% with 20 mg paroxetine at the 30 mg dose of darifenacin).
Danish: Samtidig behandling med potente CYP2D6 hæmmere resulterer i en øget eksponering (f.eks. 33% for 20 mg paroxetin ved en dosering på 30 mg darifenacin).
English: A population pharmacokinetic analysis of patient data indicated a trend for clearance to decrease with age (19% per decade based on Phase III population pharmacokinetic analysis of patients aged 6089 years), see section 4.2.
Danish: En populationsfarmakokinetisk analyse af patientdata indikerede en tendens til, at clearence falder med alderen (19% pr. 10-år baseret på fase III populationsfarmakokinetikanalyse af patienter i alderen 60-89 år), se pkt.
English: • if you are taking medicinal products that can cause or worsen inflammation of the oesophagus such as oral bisphosphonates (a class of medicinal products that prevent the loss of bone mass and are used to treat osteoporosis).
Danish: • hvis du tager medicin, der kan forårsage eller forværre betændelse i spiserøret såsom orale bisfosfonater (en klasse af lægemidler, der forebygger tab af knoglemasse og bruges til behandling af knogleskørhed).
English: If you forget to take Emselex at the usual time, take it as soon as you remember, unless it is the time for your next dose.
Danish: Hvis du har glemt at tage Emselex til sædvanlig tid, skal du tage medicinen så snart, du husker det. Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Table 2: Pooled analysis of data from three Phase III clinical studies assessing fixed doses of 7.5 mg and 15 mg Emselex
Danish: Tabel 2: Samlet analyse af data fra tre fase III kliniske studier bestemt på faste doser à 7,5 mg og 15 mg Emselex
English: Grapefruit juice may interact with Emselex.
Danish: Grapefrugtjuice kan påvirke virkningen af Emselex.
English: Darifenacin 30 mg once daily (two times greater than the recommended daily dose) co-administered with digoxin at steady state resulted in a small increase in digoxin exposure (AUC: 16% and Cmax: 20%).
Danish: Samtidig indgift af 30 mg darifenacin 1 gang daglig, (det dobbelte af den anbefalede daglige dosis) og digoxin ved steady state resulterede i en lille øgning af digoxin eksponering (AUC: 16% og Cmax: 20%).
English: • if you have an obstructive gastrointestinal disorder (any obstruction of the passage of intestinal or gastric contents, such as narrowing of the pylorus, the lower part of the stomach) - your doctor will have told you if you have this.
Danish: • hvis du har en obstruktiv mave-tarmlidelse (enhver tilstopning af passagen i mave-tarm kanalen, såsom forsnævring af pylorus, den nederste del af maven) - din læge vil have fortalt dig, hvis du lider af dette.
English: The following events have been reported in association with darifenacin use in worldwide postmarketing experience: generalised hypersensitivity reactions including angioedema, depressed mood/mood alterations, hallucination.
Danish: Erfaringer fra brug af darifenacin efter markedsføring på verdensplan har vist tilfælde af generaliserede overfølsomhedsreaktioner, inklusive angioødem, nedtrykthed/humørsvingninger, hallucinationer.
English: Doubling the darifenacin dose from 7.5 mg to 15 mg result in a 150% increase in steady-state exposure.
Danish: Fordobling af darifenacindosis fra 7,5 mg til 15 mg resulterer i 150% øgning ved steady state eksponering.
English: • certain anticonvulsants (carbamazepine, barbiturates),
Danish: • visse krampestillende midler (carbamacepin, barbiturater),
English: CYP3A4 substrates
Danish: CYP3A4 substrater
English: • if you have heartburn and belching.
Danish: • hvis du har halsbrand og opstød.
English: P value2
Danish: P værdi2
English: Emselex belongs to a class of medicines which relax the muscles of the bladder.
Danish: Emselex hører til gruppen af stoffer som virker afslappende på blæremusklen.
English: However, caution should be exercised when treating this population (see section 5.2).
Danish: Der bør dog tilrådes forsigtighed ved behandling af denne patientgruppe (se pkt.
English: The three main metabolic routes are as follows: monohydroxylation in the dihydrobenzofuran ring; dihydrobenzofuran ring opening and
Danish: De tre vigtigste metaboliseringsveje er følgende: monohydroxylering i dihydrobenzfuranringen; åbning af dihydrobenzfuranringen og;
English: However, there is a risk of increased exposure in this population (see section 5.2).
Danish: Der er dog risiko for øget eksponering hos denne patientgruppe (se pkt.
English: However, protein binding of darifenacin was affected by moderate hepatic impairment.
Danish: Proteinbinding af darifenacin blev dog påvirket af moderat leverinsufficiens.
English: As with any other antimuscarinic agents, concomitant use of medicinal products that possess antimuscarinic properties, such as oxybutynin, tolterodine and flavoxate, may result in more pronounced therapeutic and side effects.
Danish: Som for andre antimuskarine stoffer kan samtidig brug af lægemidler, der har antimuskarine egenskaber, som oxybutynin, tolterodin og flavoxat, føre til øget terapeutisk effekt og mere udtalte bivirkninger.
English: Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively, 18.7% after flexible dose titration, and 8% - 9% for placebo) and constipation (14.8% and 21% for the 7.5 mg and 15 mg dose, respectively, 20.9% after flexible dose titration, and 5.4% - 7.9% for placebo).
Danish: I overensstemmelse med den farmakologiske profil er de hyppigst rapporterede bivirkninger mundtørhed (som forekom hos 20,2% og 35% af patienterne behandlet med henholdsvis 7,5 mg og 15 mg darifenacin, 18,7% efter fleksibel dosistitrering og 8% - 9% for placebo) og forstoppelse (14,8% og 21% for henholdsvis 7,5 mg og 15 mg dosis darifenacin, 20,9% efter fleksibel dosistitrering og 5,4% - 7,9% for placebo).
English: A similar trend is also seen for the discontinuation rates.
Danish: En lignende udvikling sås også i frekvensen af ophør med behandlingen.
English: Flatulence, diarrhoea, mouth ulceration
Danish: Flatulens, diarré, ulcerative stomatit
English: Maximum plasma levels are reached approximately 7 hours after administration of the prolonged-release tablets and steady-state plasma levels are achieved by the sixth day of administration.
Danish: Maximal plasmakoncentration nås efter ca. 7 timer og steady-state plasmakoncentrationen opnås på 6.dagen for påbegyndt behandling.
English: • if you are allergic to darifenacin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for aliskiren eller et af de øvrige indholdsstoffer i Emselex (angivet i punkt 6)..
English: Merus Labs Netherlands B.V., Alexander Battalaan 37
Danish: Merus Labs Netherlands B.V., Alexander Battalaan 37 6221 CB Maastricht Holland
English: At steady state, peak-to-trough fluctuations in darifenacin concentrations are small (PTF: 0.87 for 7.5 mg and 0.76 for 15 mg), thereby maintaining therapeutic plasma levels over the dosing interval.
Danish: Ved steady-state er fluktationerne mellem laveste og højeste plasmakoncentrationer af darifenacin små (PTF: 0,87 for 7,5 mg og 0,76 for 15 mg), hvilket betyder, at terapeutisk plasmakoncentration bibeholdes over doseringsintervallet.
English: After 2 weeks of starting therapy, patients should be reassessed.
Danish: Patienterne bør revurderes 2 uger efter behandlingsstart.
English: Depending on your response to Emselex, your doctor may increase your dose to 15 mg daily, two weeks after starting therapy.
Danish: Afhængigt af virkningen af Emselex kan din læge øge doseringen til 15 mg daglig efter 2 ugers behandling.
English: Do not chew, split or crush it.
Danish: Tabletterne må ikke tygges, deles eller knuses.
English: PHARMACEUTICAL FORM AND CONTENTS 140 tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 140 tabletter
English: For Emselex, these side effects have been reported to be uncommon.
Danish: Disse bivirkninger er for Emselex rapporteret som værende usædvanlige.
English: For those patients who have an acceptable tolerability profile but require greater symptom relief, the dose may be increased to 15 mg daily, based on individual response (see section 5.2).
Danish: For patienter, som har en acceptabel tolerenceprofil, men kræver større symptomlindring, kan dosis øges til 15 mg daglig baseret på individuelt respons (se pkt.
English: A population pharmacokinetic analysis of patient data indicated that darifenacin exposure was 23% lower in males than females (see section 5.1).
Danish: En populationsfarmakokinetisk analyse af patientdata indikerede at ekspositionen var 23% lavere hos mænd end hos kvinder (se pkt.
English: Severe hepatic impairment (Child Pugh C).
Danish: • Svær leverfunktionsnedsættelse (Child Pugh C).
English: Emselex 7.5 mg and 15 mg were associated with statistically significant improvements over placebo in some aspects of quality of life as measured by the Kings Health Questionnaire including incontinence impact, role limitations, social limitations and severity measures.
Danish: Behandling med 7,5 mg og 15 mg Emselex viste statistisk signifikant forbedring af nogle livskvalitetsmål i forhold til placebo målt med Kings Health Questionnaire, inkluderende betydning af at være inkontinent, begrænsninger i adfærd, sociale begrænsninger og mål for sværhedsgrad.
English: Special patient population
Danish: Specielle patientgrupper
English: Treatment with Emselex may possibly mask symptoms associated with gallbladder disease.
Danish: Behandling med Emselex kan muligvis maskere symptomer associeret til lidelser i galdeblæren.
English: Emselex should be used with caution in patients with risk of decreased gastrointestinal motility, gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis.
Danish: Emselex bør anvendes med forsigtighed til patienter med risiko for nedsat gastrointestinal motilitet, gastroøsofagal reflux og/eller samtidig tager lægemidler, der kan være årsag til eller forværre esophagitis (så som orale bisphosphonater).
English: These doses are suitable for people with mild liver problems or people with kidney problems.
Danish: Denne dosering er egnet til patienter med milde leversygdomme eller patienter med nyrelidelser.
English: A small study of subjects (n=24) with varying degrees of renal impairment (creatinine clearance between 10 ml/min and 136 ml/min) given darifenacin 15 mg once daily to steady state demonstrated no relationship between renal function and darifenacin clearance (see section 4.2).
Danish: I et lille forsøg med patienter (n=24) med varierende grader af nyreinsufficiens (creatinin clearence mellem 10 ml/min og 136 ml/min) som fik 15 mg darifenacin en gang daglig indtil steady state sås ikke sammenhæng mellem nyrefunktion og darifenacin clearence (se pkt.4.2).
English: As seen in Table 2 below, a pooled analysis of 3 of the studies for the treatment with both Emselex 7.5 mg and 15 mg provided a statistically significant improvement in the primary endpoint, reduction in incontinence episodes, versus placebo.
Danish: Som det ses i tabel 2 herunder, viste en samlet analyse af behandlingerne på 3 af studierne for både Emselex 7,5 mg og 15 mg en signifikant forbedring i det primære endepunkt, reduktion af inkontinensepisoder, i forhold til placebo.
English: • if you have autonomic neuropathy (damage to the nerves that communicate between the brain and internal organs, muscles, skin, and blood vessels to regulate vital functions, including the heart rate, blood pressure and bowel function) - your doctor will have told you if you have this.
Danish: • hvis du har autonom neuropati (skade på nerverne, der kommunikerer mellem hjernen og indre organer, muskler, hud og blodårer for at regulere livsvigtige funktioner, inkl.
English: Emselex should be administered with caution to patients with autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or gastrointestinal obstructive disorders, such as pyloric stenosis.
Danish: Emselex skal anvendes med forsigtighed til patienter med autonom neuropati, hiatushernie, klinisk signifikant blæreobstruktion, risiko for urinretension, svær forstoppelse eller gastroentestinal obstruktion såsom pylorusstenose.
English: Myasthenia gravis.
Danish: • Myastenia gravis.
English: However, a population pharmacokinetic analyses of Phase III data indicated that on average steady-state exposure is 66% higher in poor metabolisers than in extensive metabolisers.
Danish: Det er dog indikeret i en fase III populationsfarmakokinetikanalyse, at ved gennemsnitlig steady state er eksponering 66% højere hos patienter med beskeden metabolisme i forhold til patienter med stor metabolisme.
English: Calcium hydrogen phosphate, anhydrous
Danish: Calciumhydrogenphosphat, vandfri
English: Darifenacin treatment resulted in a modest increase in the exposure of the CYP3A4 substrate midazolam.
Danish: Behandling med darifenacin resulterede i en lettere øget eksponering af CYP3A4 substratet midazolam.
English: Co-administration of darifenacin 7.5 mg with the potent CYP3A4 inhibitor ketoconazole 400 mg resulted in a 5-fold increase in steady-state darifenacin AUC.
Danish: Co-administration af darifenacin 7,5 mg og den potente CYP3A4 hæmmer ketoconazol 400 mg, resulterede i 5 gange så høj AUC for darifenacin ved steadystate.
English: In one pharmacokinetic study the steady-state exposure in poor metabolisers was 164% and 99% higher during treatment with 7.5 mg and 15 mg once daily, respectively.
Danish: I et farmakokinetisk studie af patienter med beskeden metabolisme var eksponeringen 164% og 99% højere ved steady state ved behandling med henholdsvis 7,5 mg og 15 mg en gang daglig.
English: Emselex 7.5 mg once daily Placebo
Danish: Emselex 7,5 mg 1 gang daglig Placebo
English: The effects of darifenacin on the metabolism of CYP2D6 substrates are mainly clinically relevant for CYP2D6 substrates which are individually dose titrated.
Danish: Effekten af darifenacin på metabolismen af CYP2D6 substrater er hovedsagelig klinisk relevant for CYP2D6 substrater, som dosistitreres individuelt.
English: Due to extensive first-pass metabolism darifenacin has a bioavailability of approximately 15% and 19% after 7.5 mg and 15 mg daily doses at steady state.
Danish: På grund af stor first-pass metabolisme har darifenacin en biotilgængelighed ved steady state omkring 15% og 19% efter doser på 7,5 mg og 15 mg daglig.
English: No dose adjustment is required in patients with impaired renal function.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: No dose adjustment is required in patients with mild hepatic impairment (Child Pugh A).
Danish: Der kræves ikke dosisjustering hos patienter med mildt nedsat leverfunktion (Child Pugh A).
English: Talk to your doctor before taking Emselex
Danish: Kontakt lægen, før du tager Emselex
English: SPECIAL STORAGE CONDITIONS Keep the blister packs in the outer carton in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar blisterpakningen i den ydre karton for at beskytte mod lys.
English: • certain antibiotics (e.g. erythromycin, clarithromycin and rifampicin),
Danish: • visse antibiotika (fx erythromycin, clarithromycin og rifampicin),
English: In peri and post-natal studies in rats, dystocia, increased foetal deaths in utero and toxicity to post-natal development (pup body weight and development land marks) were observed at systemic exposure levels up to 11 times the AUC0-24h of free plasma concentration at MRHD.
Danish: I peri- og postnatale studier i rotter, blev der observeret dystoci, øget fosterdød in utero og toksicitet for postnatal udvikling (ungernes kropsvægt og udvikling af karaktertræk) ved systemiske eksponeringsniveauer på op til 11 gange AUC0-24t af den frie plasmakoncentration ved MRHD.