FrancophonIA/ELRC3.0 huggingface dataset:
English: The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%).
Danish: Den absolutte orale biotilgængelighed for duloxetin lå på 32% til 80% (gns.
English: YENTREVE may cause a sensation of restlessness or an inability to sit or stand still.
Danish: YENTREVE kan give en følelse af uro eller manglende evne til at sidde eller stå stille.
English: If while on YENTREVE therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Danish: Hvis patienten under behandling med YENTREVE udvikler agitation eller depressive symptomer bør en specialist konsulteres, eftersom depression er en alvorlig medicinsk tilstand.
English: The recommended dose of YENTREVE is 40 mg twice daily without regard to meals.
Danish: Den anbefalede dosering af YENTREVE er 40 mg to gange dagligt uden hensyntagen til måltider.
English: Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.
Danish: Sammenlignet med raske patienter var den tilsyneladende plasma-clearance for duloxetin 79% lavere, den tilsyneladende terminale halveringstid var 2,3 gange længere, og AUC var 3,7 gange højere hos patienter med moderat leversygdom.
English: Taking a MAOI together with many prescription medicines, including YENTREVE, can cause serious or even life-threatening side effects.
Danish: Hvis De tager en MAO-hæmmer sammen med en række forskellige receptpligtige lægemidler, heriblandt YENTREVE, kan det medføre alvorlige og endda livstruende bivirkninger.
English: However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e.g. nausea).
Danish: Imidlertid var størstedelen af de oftest forekommende bivirkninger milde til moderate og ophørte inden for 30 dage (f.eks. kvalme).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis Deres læge har fortalt Dem, at De ikke kan tåle visse sukkerarter, skal De kontakte Deres læge, inden De tager denne medicin.
English: YENTREVE may make you feel sleepy or dizzy.
Danish: YENTREVE kan gøre Dem søvnig og svimmel.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen), og enhver efterfølgende godkendt opdatering af RMP.
English: 4 Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation.
Danish: 4 Sager med aggression og vrede er blevet rapporteret, især i tidligt i behandlingen eller efter behandlingsophør.
English: • If you take YENTREVE near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders.
Danish: • Hvis De tager YENTREVE i slutningen af graviditeten, er der en øget risiko for kraftig vaginal blødning kort efter fødslen, især hvis De tidligere har haft blødningsforstyrrelser.
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Danish: Der blev ikke observeret klinisk signifikante forskelle på QT-, PR-, QRS- eller QTcB-målinger mellem duloxetinbehandlede og placebobehandlede patienter.
English: You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
Danish: Det kan muligvis være til hjælp for Dem, hvis De fortæller en ven eller slægtning, at De har en depression eller en angstsygdom, og beder dem læse denne indlægsseddel.
English: Medicines like Yentreve (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Danish: Lægemidler som YENTREVE (såkaldte SSRI/SNRI'er) kan give symptomer på seksuel dysfunktion (se pkt.
English: YENTREVE is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities.
Danish: YENTREVE menes at virke ved at øge styrken i lukkemusklen i blæren, som holder urinen tilbage, når De ler, nyser eller udøver fysisk aktivitet.
English: YENTREVE should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: YENTREVE bør kun bruges under graviditeten, hvis de potentielle behandlingsfordele opvejer de potentielle risici for fosteret.
English: The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies.
Danish: Virkningen af YENTREVE er ikke blevet undersøgt længere end 3 måneder i placebokontrollerede studier.
English: Suicidal ideation5,7
Danish: Selvmordstanker5,7
English: The primary efficacy measures were Incontinence Episode Frequency (IEF) from diaries and an incontinence specific quality of life questionnaire score (I-QOL).
Danish: De primære mål for effekten var hyppigheden af inkontinensepisoder (IEF) ud fra dagbøger og et spørgeskema vedrørende livskvalitet i forbindelse med inkontinens (I-QOL).
English: If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Danish: Hvis De har en depression eller lider af en angstsygdom, kan De af og til få tanker om at skade Dem selv eller begå selvmord.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Patienter med sjældne arvelige lidelser som fructoseintolerans, glucose/galactosemalabsorption eller invertase/isomaltasemangel bør ikke tage denne medicin.
English: • dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
Danish: • svimmelhed, uklarhed eller besvimelse efter at have rejst sig op, kolde fingre og/eller tæer
English: In an additional study limited to patients with severe SUI, all responses with duloxetine were achieved within 2 weeks.
Danish: I et yderligere studie, som var begrænset til patienter med svær stressinkontinens, blev alle responser på duloxetin opnået inden for 2 uger.
English: The amount of duloxetine in breast milk is approximately 7 µg/day while on 40 mg twice daily dosing.
Danish: Mængden af duloxetin i modermælk er ca. 7 µg/dag under en dosering på 40 mg to gange dagligt.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Graviditet og amning Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Inducers of CYP1A2: Population pharmacokinetic studies analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Danish: CYP1A2-induktorer: Befolkningsfarmakokinetiske analyser har vist, at rygere har næsten 50% lavere plasmakoncentration af duloxetin sammenlignet med ikke-rygere.
English: Weight decrease Weight increase Blood cholesterol increased Blood creatine
Danish: Vægttab Vægtstigning Forhøjet blodkolesterol Forhøjet kreatinkinase i blodet
English: You should use YENTREVE only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Danish: De bør kun bruge YENTREVE efter, at De har talt med Deres læge om de mulige fordele og mulige risici for Deres ufødte barn.
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with YENTREVE (see section 4.4).
Danish: Det antibiotiske lægemiddel linezolid er en reversibel, ikke-selektiv MAOI og bør ikke gives til patienter, der er i behandling med YENTREVE (se pkt.
English: Although YENTREVE is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medicinal product.
Danish: Selvom YENTREVE ikke er godkendt til behandling af depression, findes dets aktive lægemiddelstof (duloxetin) også i et antidepressivt lægemiddel.
English: Treating your disorder properly is important to help you get better.
Danish: For at De kan få det bedre, er det vigtigt, at Deres sygdom behandles korrekt.
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at a greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
Danish: Patienter, der tidligere har udført selvmordsrelaterede handlinger, eller patienter, der før behandlingsstart har udvist en signifikant grad af selvmordsforestillinger, har en større risiko for selvmordstanker eller selvmordsadfærd og bør følges nøje under behandlingen.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: YENTREVE and Prior Continence Surgery: There are limited data that suggest that the benefits of YENTREVE are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
Danish: YENTREVE og tidligere operativ behandling af inkontinens: Der er begrænset data som tyder på, at fordelene ved YENTREVE ikke mindskes hos kvinder med stressinkontinens, som tidligere er blevet opereret for inkontinens.
English: The main ingredient of YENTREVE, duloxetine, is used in other medicines for other conditions:
Danish: Det aktive stof (duloxetin) i YENTREVE bruges i andre lægemidler mod andre tilstande:
English: If concomitant treatment with duloxetine and other serotonergic agents that may affect the serotonergic and/or dopaminergic neurotransmitter systems in clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Danish: Hvis samtidig behandling med duloxetin og andre serotonerge lægemidler, som kan påvirke det serotonerge og/eller dopaminerge neurotransmittersystem, er klinisk påkrævet, anbefales det at følge patienten nøje, særligt i starten af behandlingen og ved øgning af dosis.
English: Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/kg/day), but these were considered to be secondary to hepatic microsomal enzyme induction.
Danish: Hunmus, som modtog duloxetin i 2 år, havde kun forøget incidens af hepatocellulære adenomer og karcinomer ved den høje dosis (144 mg/kg/dag), men disse blev betragtet som værende sekundære til den mikrosomale enzyminduktion i leveren.
English: Quality of Life: Incontinence Quality of Life (I-QOL) questionnaire scores were significantly improved in the duloxetine-treated patient group compared with the placebo-treated group (9.2 versus 5.9 score improvement, p<0.001).
Danish: Livskvalitet: Resultater fra livskvalitets-/Incontinence Quality of Life (I-QOL) undersøgelser viste sig signifikant forbedret i gruppen med duloxetin-behandlede patienter sammenlignet med placebogruppen (9,2 mod 5,9 i score forbedring, p<0,001).
English: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Danish: Hvis De på noget tidspunkt får tanker om at skade Dem selv eller begå selvmord, skal De straks kontakte Deres læge eller skadestuen.
English: In animal studies, increased levels of 5-HT and NE in the sacral spinal cord, lead to increased urethral tone via enhanced pudendal nerve stimulation to the urethral striated sphincter muscle only during the storage phase of the micturition cycle.
Danish: I dyrestudier fører forhøjet niveau af 5-HT og NA i den sakrale ende af rygsøjlen til øget uretral tonus via en forstærket nervus pudendusstimulering af urinrørets tværstribede lukkemuskel kun i opbevaringsfasen af vandladningscyklussen.
English: YENTREVE contains the active substance duloxetine.
Danish: YENTREVE indeholder det aktive stof duloxetin.
English: YENTREVE should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Danish: YENTREVE skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/eller krampeanfald.
English: Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.
Danish: Duloxetin bør bruges med forsigtighed til patienter i behandling med andre lægemiddelstoffer, som er forbundet med leverskade.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Yentreve in all subsets of the paediatric population in the treatment of stress urinary incontinence.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med YENTREVE i alle undergrupper af den pædiatriske population med stressinkontinens (se pkt.
English: The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose (see section 5.2).
Danish: Den anslåede dosis i mg/kg, som et spædbarn ville modtage, er omkring 0,14% af moderens dosis (se pkt.
English: Using a global improvement scale (PGI), significantly more women using duloxetine considered their symptoms of stress incontinence to be improved with treatment compared with women using placebo (64.6% versus 50.1%, p<0.001).
Danish: Ved brug af en Patient Global Improvement (PGI) skala viste kvinder behandlet med duloxetin at vurdere deres symptomer på stressinkontinens som signifikant forbedret i forhold til kvinder på placebo (64,6% mod 50,1%, p<0,001).
English: • serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips
Danish: • alvorlige allergiske reaktioner, som forårsager åndedrætsbesvær eller svimmelhed og hævelse af tunge eller læber
English: Thoughts of suicide and worsening of depression or anxiety disorder Although YENTREVE is not indicated for the treatment of depression, its active ingredient (duloxetine) is used as an antidepressant medicine.
Danish: Selvmordstanker og forværring af depression eller angstsygdom Selvom YENTREVE ikke er godkendt til behandling af depression, bruges det aktive stof (duloxetin) også som en antidepressiv medicin.
English: Call your doctor or pharmacist immediately if you take more than the amount of YENTREVE prescribed by your doctor.
Danish: Kontakt omgående lægen eller apoteket, hvis De har taget mere YENTREVE, end lægen har ordineret.
English: • feeling of dizziness or “spinning” (vertigo)
Danish: • følelse af at være ”rundtosset” (vertigo)
English: If you forget to take YENTREVE
Danish: Hvis De har glemt at tage YENTREVE
English: Your doctor may decide to start your treatment with 20 mg twice a day for two weeks before increasing the dose to 40 mg twice a day.
Danish: Deres læge kan beslutte, at De skal starte Deres behandling med 20 mg to gange dagligt i to uger før stigning til dosis på 40 mg to gange dagligt.
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take YENTREVE.
Danish: De skal vente mindst 14 dage, efter at De er holdt op med at tage en MAO-hæmmer, før De må begynde at tage YENTREVE.
English: Dysgeusia Poor quality sleep
Danish: Dysgeusi Dårlig søvnkvalitet
English: 1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.
Danish: 1 Der er også rapporteret tilfælde af kramper og tilfælde af tinnitus efter behandlingsophør.
English: Metabolism and nutrition disorders Appetite decreased
Danish: Metabolisme og ernæring Nedsat appetit
English: Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two weeks before increasing to the recommended dose of 40 mg twice daily.
Danish: Nogle patienter kan have nytte af at starte behandlingen med 20 mg to gange dagligt i to uger før stigning til den anbefalede dosering på 40 mg to gange dagligt.
English: Hyperglycaemia (reported especially in diabetic patients) Hyponatraemia
Danish: Dehydrering Hyperglykæmi (især rapporteret hos diabetikere)
English: • Yentreve may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
Danish: • Yentreve kan medføre bivirkninger, som du måske ikke er opmærksom på, f.eks. forhøjede leverenzymer eller forhøjede værdier af kalium, kreatinkinase, sukker eller kolesterol i blodet
English: The pattern of liver damage was predominantly hepatocellular.
Danish: Det mønster der tegner sig for leverskade er overvejende hepatocellulært.
English: Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold.
Danish: Fluvoxamin (100 mg én gang dagligt), en potent CYP1A2-hæmmer, mindskede den tilsyneladende plasmaclearance af duloxetin med omtrent 77 % og øgede AUC0-t 6 gange.
English: Stevens-Johnson Syndrome6
Danish: Stevens-Johnsons syndrom6
English: Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
Danish: Start eller afbryd ikke behandlingen med medicin, det gælder også for medicin, som ikke er på recept samt naturlægemidler, før De har talt med Deres læge.
English: • abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, abnormal production of breast milk
Danish: • unormal menstruation herunder voldsom, smertefuld, uregelmæssig eller forlænget blødning, usædvanlig sparsom eller manglende menstruation, unormal mælkeproduktion
English: Extra-pyramidal symptoms6
Danish: Ekstra-pyramidale symptomer6
English: Gynaecological haemorrhage Menopausal symptoms
Danish: Gynækologisk blødning Menopausale symptomer
English: Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from clotting.
Danish: Orale antikoagulantia eller medicin, der påvirker blodpladerne: Medicin der fortynder blodet og modvirker dannelse af blodpropper.
English: A meta-analysis of placebocontrolled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Danish: En metaanalyse af placebokontrollerede kliniske studier af antidepressive lægemidler til behandling af psykiske lidelser viste en forøget risiko for selvmordsadfærd med antidepressiva sammenlignet med placebo hos patienter under 25 år.
English: • difficulty or inability to pass urine, needing to pass more urine than normal, having a decreased urine flow
Danish: • besværet eller manglende evne til at lade vandet, behov for hyppigere vandladning end normalt, nedsat urinmængde
English: The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
Danish: Samtidig behandling med duloxetin (40 mg to gange dagligt) forøger steady state-AUC for tolterodin (2 mg to gange dagligt) med 71%, men påvirker ikke farmakokinetikken for tolterodins aktive 5-hydroxy-metabolit, og der anbefales ingen dosisjustering.
English: Monoamine oxidase inhibitors (MAOIs): Due to the risk of serotonin syndrome, duloxetine should not be used in combination with non-selective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Danish: Monoaminoxidasehæmmere (MAO-hæmmere): På grund af risikoen for serotoninsyndrom må duloxetin ikke anvendes sammen med ikke-selektive, irreversible monoaminoxidasehæmmere (MAOhæmmere) samt i mindst 14 dage efter afbrudt behandling med en MAO-hæmmer.
English: The safety and efficacy of duloxetine for the treatment of stress urinary incontinence has not been studied.
Danish: Duloxetins sikkerhed og virkning ved behandling af stressinkontinens er ikke klarlagt.
English: Talk to your doctor if you have high blood pressure or heart disease.
Danish: Fortæl Deres læge, hvis De har forhøjet blodtryk.
English: Also, you need to wait at least 5 days after you stop taking YENTREVE before you take a MAOI.
Danish: De skal ligeledes vente mindst 5 dage, efter at De er holdt op med at tage YENTREVE, før De må begynde at tage en MAO-hæmmer.
English: Stress urinary incontinence is a medical condition in which patients have accidental loss or leakage of urine during physical exertion or activities such as laughing, coughing, sneezing, lifting, or exercise.
Danish: Stressinkontinens er en medicinsk tilstand, hvor patienten oplever ufrivillig urinlækager under fysisk anstrengelse eller aktiviteter såsom latter, hoste, nysen, løft eller motion.
English: Photo-sensitivity reactions
Danish: Lysfølsomhedsreaktioner
English: See section 4.2 for information on patients with mild or moderate renal dysfunction.
Danish: 4.2 for information om patienter med let til moderat nyreinsufficiens.
English: If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of YENTREVE is recommended (see section 4.2).
Danish: Hvis det vurderes, at der skal iværksættes en farmakologisk antidepressiv behandling, anbefales det at seponere behandlingen med YENTREVE gradvist (se pkt.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opført opstillet efter, hvor alvorlige de er.
English: Antacids and H2 antagonists: Co-administration of YENTREVE with aluminium- and magnesiumcontaining antacids or with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Danish: Antacida og H2-antagonister: Samtidig administration af YENTREVE med aluminium- og magnesiumholdige antacida eller med famotidin har ingen signifikant virkning på absorptionshastigheden eller absorptionsfraktionen af duloxetin efter en oral dosis på 40 mg.
English: Supra-ventricular arrhythmia, mainly atrial fibrillation6
Danish: Supra-ventrikulær arytmi, hovedsagelig atrieflimren6
English: The most commonly reported adverse events in patients treated with YENTREVE in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation.
Danish: De hyppigst rapporterede bivirkninger hos patienter i behandling med YENTREVE i kliniske studier med SUI og andre lidelser i de nedre urinveje var kvalme, mundtørhed, træthed og forstoppelse.
English: Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Danish: Tilfælde af leverskade herunder alvorlig forhøjede leverenzymer (>10 gange den normale øvre grænse), hepatitis og gulsot er rapporteret for duloxetin (se pkt.
English: YENTREVE is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).
Danish: YENTREVE er indiceret til behandling af kvinder med moderat til svær stressinkontinens (SUI).
English: You should ask your doctor or pharmacist for advice.
Danish: Spørg Deres læge eller apoteket til råds.
English: The following are reasons why YENTREVE may not be suitable for you.
Danish: I følgende situationer kan De muligvis ikke bruge YENTREVE.