FrancophonIA/ELRC3.0 huggingface dataset:
English: Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor.
Danish: Duloxetin er en kombineret serotonin- (5-HT) og noradrenalin (NA)-genoptagelseshæmmer.
English: • trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm, unusual dreams
Danish: • søvnbesvær, ophidselse, mindre lyst til sex, angst, problemer med at opnå orgasme, mærkelige drømme
English: Duloxetine normalised pain thresholds in several preclinical models of neuropathic and inflammatory pain and attenuated pain behaviour in a model of persistent pain.
Danish: Duloxetin normaliserede smertetærsklen i flere prækliniske modeller af neuropatisk og inflammatorisk smerte og svækkede smerteoplevelsen i en model af vedvarende smerte.
English: Duloxetine Lilly is indicated in adults.
Danish: Duloxetin Lilly er indiceret til voksne.
English: Despite this, your doctor may prescribe Duloxetine Lilly for patients under 18 because he/she decides that this is in their best interests.
Danish: På trods af dette kan din læge ordinere Duloxetin Lilly til patienter under 18 år, hvis lægen skønner, at det er til patientens bedste.
English: • painful urination, frequent urination
Danish: • smertefuld vandladning, hyppig vandladning
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Duloxetine Lilly.
Danish: Du skal vente mindst 14 dage efter, at du er holdt op med at tage en MAO-hæmmer, før du må begynde at tage Duloxetin Lilly.
English: A meta-analysis of placebo-controlled 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 lille forøget risiko for selvmordsadfærd med antidepressiva sammenlignet med placebo hos patienter under 25 år.
English: Treatment of generalised anxiety disorder.
Danish: Behandling af generaliseret angst.
English: c. Description of selected adverse reactions
Danish: c. Beskrivelse af udvalgte bivirkninger
English: Discontinuation due to adverse events was higher in patients taking duloxetine compared with those treated with fluoxetine, mostly due to nausea.
Danish: Afbrydelse af behandlingen pga. bivirkninger skete oftere hos duloxetinbehandlede patienter sammenlignet med fluoxetinbehandlede, som regel pga. kvalme.
English: The most commonly reported adverse reactions in patients treated with Duloxetine Lilly were nausea, headache, dry mouth, somnolence, and dizziness.
Danish: De hyppigst rapporterede bivirkninger hos patienter i behandling med Duloxetin Lilly var kvalme, hovedpine, mundtørhed, søvnighed og svimmelhed.
English: Table 1: Adverse reactions
Danish: Tabel 1: Bivirkninger
English: However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
Danish: Imidlertid var størstedelen af de hyppigst forekommende bivirkninger milde til moderate, de indtrådte typisk i starten af behandlingen, og de fleste bivirkninger aftog ved fortsat behandling.
English: Oral contraceptives and other steroidal agents: Results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Danish: P-piller og andre steroider: In vitro-studier viser, at duloxetin ikke inducerer CYP3A's nedbrydende aktivitet.
English: Duloxetine Lilly increases the levels of serotonin and noradrenaline in the nervous system.
Danish: Duloxetin Lilly øger indholdet af serotonin og noradrenalin i nervesystemet.
English: The majority of cases of hyponatraemia were reported in the elderly, especially when coupled with a recent history of, or condition pre-disposing to, altered fluid balance.
Danish: Hovedparten af hyponatriæmi-tilfældene blev observeret hos ældre, især med nylige tilfælde af forstyrrelser i væskebalancen eller med tilstande, som disponerer for dette.
English: The disposition of duloxetine was studied in 6 lactating women who were at least 12-weeks postpartum.
Danish: Duloxetins fordeling i kroppen blev undersøgt hos 6 ammende kvinder, som havde født mindst 12 uger forinden.
English: Duloxetine is extensively metabolised by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation.
Danish: Duloxetin metaboliseres i udstrakt grad af oxiderende enzymer (CYP1A2 og det polymorfe CYP2D6) efterfulgt af konjugering.
English: Extra-pyramidal symptoms6
Danish: Ekstra pyramidale symptomer6
English: • increased pressure in the eye (glaucoma)
Danish: • øget tryk i øjet (grøn stær, glaukom)
English: Suicidal ideation5,7
Danish: Selvmordstanke r 5,7
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials.
Danish: Tabel 1 viser observerede bivirkninger fra spontane rapporter samt fra placebo-kontrollerede kliniske studier.
English: Consequently, caution is advised when Duloxetine Lilly is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Danish: Som konsekvens heraf anbefales det at udvise forsigtighed, når Duloxetin Lilly tages sammen med andre centralt virkende lægemidler eller stoffer, herunder alkohol og sederende lægemidler (f.eks. benzodiazepiner, morphinlignende præparater, antipsykotika, phenobarbital, sederende antihistaminer).
English: The incidence of relapse during the 6-months double-blind follow-up period was 14% for Duloxetine Lilly and 42% for placebo.
Danish: Incidensen af tilbagefald under den 6-måneders dobbeltblinde followup periode var 14 % for Duloxetin Lilly og 42 % for placebo.
English: The recommended starting dose in patients with generalised anxiety disorder is 30 mg once daily with or without food.
Danish: Den anbefalede startdosis til patienter med generaliseret angst er 30 mg en gang dagligt uden hensyn til måltider.
English: 6 Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Danish: 6 Estimeret hyppighed baseret på rapporterede bivirkninger under overvågning efter markedsføring; ikke observeret i placebokontrollerede kliniske studier.
English: However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or S-warfarin.
Danish: Hos raske forsøgspersoner i et klinisk farmakologisk studie resulterede co-administration af duloxetin med warfarin ved steady state dog ikke i en klinisk signifikant ændring i INR fra baseline eller i farmakokinetikken af R- eller S-warfarin.
English: A total of 509 paediatric patients aged 7 to 17 years with major depressive disorder and 241 paediatric patients aged 7 to 17 years with generalised anxiety disorder were treated with duloxetine in clinical trials.
Danish: I alt blev 509 pædiatriske patienter i alderen 7 til 17 år med moderat til svær depression og 241 pædiatriske patienter i alderen 7 til 17 år med generaliseret angst behandlet med duloxetin i kliniske studier.
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) eller i mindst 14 dage efter afbrudt behandling med en MAO-hæmmer.
English: At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
Danish: Mindst 30% smertereduktion blev observeret hos ca. 65% duloxetinbehandlede patienter mod 40% placebobehandlede.
English: In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetinetreated patients.
Danish: I de kliniske 12-ugers akut fase duloxetin studier med patienter med diabetisk neuropatisk smerte blev der observeret en lille men statistisk signifikant stigning i faste blodglucose hos duloxetinbehandlede patienter.
English: For depression and diabetic neuropathic pain:
Danish: Mod depression og diabetiske neuropatiske smerter:
English: Two patients who transitioned from placebo to duloxetine after the acute phase experienced suicidal behaviours while taking duloxetine during the extension phase.
Danish: To patienter, som skiftede fra placebo til duloxetin efter akutfasen, udviste selvmordsrelateret adfærd under behandlingen med duloxetin i forlængelsesfasen.
English: Each capsule of Duloxetine Lilly contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Danish: Hver Duloxetin Lilly kapsel indeholder pellets af det aktive stof med en belægning, som beskytter dem mod mavesyre.
English: A total of 467 paediatric patients initially randomized to duloxetine in clinical trials experienced a 0.1 kg mean decrease in weight at 10-weeks compared with a 0.9 kg mean increase in 353 placebo-treated patients.
Danish: 467 pædiatriske patienter, som blev randomiseret til behandling med duloxetin i kliniske studier, havde efter 10 uger et gennemsnitligt vægttab på 0,1 kg sammenlignet med en gennemsnitlig vægtstigning på 0,9 kg hos 353 placebobehandlede patienter.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant
Danish: Erfaringer fra undersøgelser har vist, at der er en øget risiko for selvmordsadfærd hos unge under 25 år med en psykisk forstyrrelse, som bliver behandlet med antidepressiv medicin.
English: Duloxetine Lilly should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Danish: Duloxetin Lilly skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/eller krampeanfald.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Duloxetine Lilly in all subsets of the paediatric population in the treatment of major depressive disorder, diabetic neuropathic pain and generalised anxiety disorder.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Duloxetin Lilly i alle undergrupper af den pædiatriske population med moderat til svær depression, diabetisk neuropatisk smerte og generaliseret angst (se pkt.
English: Ejaculation delayed
Danish: Forsinket ejakulation
English: Medicinal products metabolised by CYP2D6: Duloxetine is a moderate inhibitor of CYP2D6.
Danish: Lægemidler, der metaboliseres via CYP2D6: Duloxetin er en moderat CYP2D6-hæmmer.
English: Duloxetine should not be used in children and adolescents under the age of 18 years for the treatment of major depressive disorder because of safety and efficacy concerns (see sections 4.4, 4.8 and 5.1).
Danish: Duloxetin bør ikke anvendes til børn og unge under 18 år til behandling af major depression (moderat til svær depression) på grund af problemstillinger vedrørende sikkerhed og virkning (se pkt.
English: Stevens-Johnson Syndrome6
Danish: StevensJohnsons syndrom 6
English: Also, you need to wait at least 5 days after you stop taking Duloxetine Lilly before you take a MAOI.
Danish: Du skal ligeledes vente mindst 5 dage, efter at du er holdt op med at tage Duloxetin Lilly, før du må begynde at tage en MAO-hæmmer.
English: Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Danish: Medicin der kan virke sløvende: Dette omfatter receptpligtig medicin inklusive benzodiazepiner, stærk smertestillende medicin, antipsykotika, phenobarbital og antihistaminer.
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Duloxetine Lilly to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Danish: Der er rapporteret om tilfælde af mydriasis i forbindelse med duloxetin, og der skal derfor udvises forsigtighed ved udskrivning af Duloxetin Lilly til patienter med forhøjet intraokulært tryk eller til patienter med risiko for akut snævervinklet glaukom.
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Duloxetine Lilly 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Danish: Der bør dog som for al anden medicin udvises forsigtighed ved behandling af ældre, især ved behandling med Duloxetin Lilly 120 mg daglig for moderate til svære depressioner eller generaliseret angst, da der er begrænsede data tilgængelige (se pkt.
English: Duloxetine Lilly is used in adults to treat:
Danish: Duloxetin Lilly anvendes hos voksne til behandling af
English: In a relapse prevention study, patients responding to 6 months of acute treatment with open-label Duloxetine Lilly were randomised to either Duloxetine Lilly or placebo for a further 6-months.
Danish: I et studie med forebyggelse af tilbagefald blev de patienter, som responderede på 6 måneders akut behandling med open-label Duloxetin Lilly, randomiseret til enten Duloxetin Lilly eller placebo i yderligere 6 måneder.
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 svært forhøjede leverenzymer (>10 gange den normale øvre grænse), hepatitis og gulsot er sjældent rapporteret for duloxetin (se pkt.
English: Serotonin syndrome6
Danish: Serotoninsyndrom6
English: In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered.
Danish: Hos patienter, som responderer på duloxetin, og som tidligere gentagne gange har haft moderate til svære depressioner, bør yderligere langtidsbehandling med en dosis på 60 til 120 mg/dag overvejes.
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Danish: Gynækologisk blødning Menstruationsfo rstyrrelser Seksuel dysfunktion Smerter i testiklerne
English: Duloxetine dose-dependently increases extracellular levels of serotonin and noradrenaline in various brain areas of animals.
Danish: Afhængig af dosis forøger duloxetin ekstracellulær serotonin og noradrenalin i forskellige dele af hjernen hos dyr.
English: It is therefore advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no less than 2 weeks, according to the patient's needs (see section 4.2).
Danish: Ved afbrydelse af behandling anbefales det derfor, at duloxetin gradvis nedtrappes over en periode på ikke mindre end 2 uger i henhold til patientens behov (se pkt.
English: • liver failure, yellowing of the skin or whites of the eyes (jaundice)
Danish: • leversvigt, gulfarvning af huden eller det hvide i øjnene (gulsot)
English: The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
Danish: De hjertefrekvenskorrigerede QT-intervaller hos duloxetinbehandlede patienter adskilte sig ikke fra dem, der blev observeret i placebogruppen.
English: • abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, pain in the testicles or scrotum
Danish: • unormal vaginalblødning, unormal menstruation herunder voldsom, smertefuld, uregelmæssig eller forlænget blødning, usædvanlig sparsom eller manglende menstruation, smerter i testiklerne eller pungen
English: In addition, one patient who transitioned from placebo to duloxetine experienced a suicidal behaviour while taking duloxetine.
Danish: Derudover udviste en patient, som skiftede fra placebo til duloxetin, selvmordsrelateret adfærd under behandlingen med duloxetin.
English: As with other serotonergic medicinal products, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Danish: Som for andre serotonerge lægemidler kan seponeringssymptomer forekomme hos det nyfødte barn, hvis moderen har indtaget duloxetin i den sidste del af graviditeten.
English: However, data on elderly patients exposed to the maximum dose (120 mg per day) are limited and, thus, caution is recommended when using this dose with the elderly population.
Danish: Der er dog begrænsede data vedrørende den maksimale dosis (120 mg dagligt) hos ældre patienter, hvorfor det anbefales at udvise forsigtighed, når denne dosis bruges hos den ældre population.
English: Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function (e.g. NSAIDs or acetylsalicylic acid (ASA)), and in patients with known bleeding tendencies.
Danish: Det anbefales at udvise forsigtighed hos patienter i behandling med antikoagulantia og/eller lægemidler (f.eks. NSAID eller acetylsalisylsyre), som påvirker trombocytfunktionen, og hos patienter med kendt blødningstendens.
English: • feeling of dizziness or “spinning” (vertigo), ear pain
Danish: • følelse af at være ”rundtosset” (vertigo), ørepine
English: Response and remission rates were also statistically significantly higher with Duloxetine Lilly compared with placebo.
Danish: Data for virkning og bedring viste sig også statistisk signifikant bedre for Duloxetin Lilly sammenlignet med placebo.
English: Therefore Duloxetine Lilly should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section
Danish: Duloxetin Lilly bør derfor ikke gives i kombination med potente CYP1A2-hæmmere som fluvoxamin (se pkt.
English: There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Danish: Der var også en lille stigning i faste blodglucose og i total kolesterol hos de duloxetinbehandlede patienter i modsætning til gruppen, der modtog standardbehandling.
English: Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Danish: Dyrestudier har vist reproduktionstoksicitet ved systemisk indgift af duloxetin i doser (AUC) mindre end den maksimale kliniske dosis (se pkt.
English: Treatment with duloxetine showed a statistically significantly greater improvement in GAD symptoms, as measured by PARS severity score for GAD (mean difference between duloxetine and placebo of 2.7 points [95% CI 1.3-4.0]), after 10 weeks of treatment.
Danish: Behandling med duloxetin gav en statistisk signifikant større forbedring af symptomerne på generaliseret angst målt med PARS (Paediatric Anxiety Rating Scale) sværhedsscore for generaliseret angst (gennemsnitlig forskel på 2,7 point [95 % CI 1,3-4,0] mellem duloxetin og placebo) efter 10 ugers behandling.
English: • dehydration, low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)
Danish: • dehydrering (væskemangel), lavt indhold af natrium i blodet (oftest hos ældre mennesker; symptomerne omfatter bl.a. svimmelhed, svaghed, forvirring, søvnighed eller udpræget træthed eller kvalme og opkastning; mere alvorlige symptomer er besvimelse, krampeanfald eller fald), syndrom med uhensigtsmæssig sekretion af anti-diuretisk hormon (SIADH)
English: Duloxetine Lilly showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
Danish: Duloxetin Lilly viste sammenlignelige resultater med venlafaxin udtrykt i HAM-A totalscore.
English: Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
Danish: Der har dog også været tilfælde med duloxetin alene i doser på omkring 1000 mg. Tegn og symptomer på overdosering (duloxetin alene eller sammen med andre lægemidler) omfatter: Søvnighed, koma, serotoninsyndrom, kramper, opkastning og takykardi.
English: Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min).
Danish: Forhøjede plasmakoncentrationer af duloxetin forekommer hos patienter med svært nedsat nyrefunktion i hæmodialyse (kreatininclearance < 30 ml/min.).
English: Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Danish: Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
English: Duloxetine Lilly contains the active substance duloxetine.
Danish: Duloxetin Lilly indeholder det aktive stof duloxetin.
English: • diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock.
Danish: • diabetiske neuropatiske smerter (beskrives ofte som brændende, stikkende, sviende, jagende,
English: Inhibitors of CYP1A2: Because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Danish: CYP1A2-hæmmere: Da CYP1A2 er involveret i metaboliseringen af duloxetin, vil samtidig behandling med Duloxetin Lilly og potente CYP1A2-hæmmere sandsynligvis medføre højere koncentrationer af duloxetin.
English: Diabetic Peripheral Neuropathic Pain: The efficacy of Duloxetine Lilly as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Danish: Effekten af Duloxetin Lilly som en behandling af diabetiske neuropatiske smerter blev etableret i 2 randomiserede 12-ugers, dobbeltblinde, placebokontrollerede studier med fast dosis hos voksne (22 til 88 år), som havde haft diabetiske neuropatiske smerter i mindst 6 måneder.
English: Peripheral coldness
Danish: Perifer kuldefornemmelse
English: data on elderly patients exposed to the maximum dose (120mg per day) are limited and thus, caution is recommended when treating this population.
Danish: Idet data for ældre patienter udsat for den maksimale dosis (120 mg daglig) er begrænset anbefales det derfor at der udvises forsigtighed, når denne befolkningsgruppe behandles.
English: For patients not experiencing somnolence, clinical response was observed in 47% of patients receiving duloxetine and 27% of patients on placebo.
Danish: Hos patienter, som ikke havde oplevet somnolens, blev der observeret klinisk respons hos 47% af de duloxetinbehandlede patienter og 27% af de placebobehandlede patienter.
English: Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 5400 mg were reported.
Danish: Der er rapporteret tilfælde af overdosering af duloxetin, alene eller i kombination med andre lægemidler, i doser på 5400 mg. Der er sket dødsfald, hovedsageligt med samtidig overdosering af andre lægemidler.
English: Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland.