FrancophonIA/ELRC3.0 huggingface dataset:
English: Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures.
Danish: Det anbefales at monitorere hjertefunktionen og andre vitale funktioner samt at etablere passende symptomatiske og understøttende behandling.
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking Duloxetine Lilly.
Danish: • Fortæl din læge, hvis du bliver gravid, eller hvis du prøver at blive gravid, mens du tager Duloxetin Lilly.
English: However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations.
Danish: Der er dog ingen kliniske beviser for, at patienter, som ikke reagerer på den først anbefalede dosis, har gavn af dosisoptitreringer.
English: Abrupt discontinuation should be avoided.
Danish: Pludselig afbrydelse af behandlingen bør undgås.
English: Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Danish: Generelt er disse symptomer selvbegrænsende og forsvinder sædvanligvis inden for 2 uger, selvom de i nogle tilfælde kan vare ved i længere tid (2-3 måneder eller flere).
English: • falls (mostly in elderly people), fatigue
Danish: • fald (oftest hos ældre), træthed
English: In patients with insufficient response the dose should be increased to 60 mg, which is the usual maintenance dose in most patients.
Danish: Til patienter med utilstrækkeligt respons bør dosis øges til 60 mg, som er den normale vedligeholdelsesdosis til de fleste patienter.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Danish: Disse tanker kan forstærkes især i starten af behandlingen med antidepressiva, da det tager nogen tid før denne slags medicin virker, sædvanligvis omkring to uger, men af og til længere.
English: The primary outcome measure was the weekly mean of 24-hour average pain, which was collected in a daily diary by patients on an 11-point Likert scale.
Danish: Det primære endepunkt var den ugentlige middelværdi af 24-timers gennemsnitlig smerte, som blev noteret hver dag af patienterne i dagbog målt på en 11-punkts Likert skala.
English: Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminium foil.
Danish: Polyvinylchlorid (PVC), polyethylen (PE) og polychlorotrifluoroethylen (PCTFE)-blister forseglet med aluminiumfolie.
English: Effect of duloxetine on other medicinal products
Danish: Duloxetins virkning på andre lægemidler
English: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Danish: Der er fundet farmakokinetiske forskelle mellem yngre og ældre kvinder (≥ 65 år) (AUC-værdien forøges med ca. 25%, og halveringstiden er ca. 25% længere hos ældre) men omfanget af disse forandringer er ikke tilstrækkelige til at retfærdiggøre dosisjusteringer.
English: The most commonly reported reactions are listed in section 4.8.
Danish: De mest almindelige bivirkninger er anført under punkt 4.8.
English: SN:
Danish: SN: {nummer}
English: Limited data suggest that the plasma levels of duloxetine are higher in these patients.
Danish: Begrænsede data tyder på, at duloxetin plasmaniveauet hos disse patienter er højere.
English: • fast and/or irregular heart beat
Danish: • hurtig og/eller uregelmæssig puls
English: Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).
Danish: Epidemiologiske data tyder på, at brug af SSRI-præparater under graviditet, især sent i graviditeten, kan øge risikoen for persisterende pulmonal hypertension hos nyfødte (PPHN).
English: If you take Duloxetine Lilly near the end of your pregnancy, your baby might have some symptoms when it is born.
Danish: Hvis du tager Duloxetin Lilly i slutningen af graviditeten, kan dit barn udvise visse symptomer, når det bliver født.
English: The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Danish: De samme forholdsregler, som iagttages ved behandling af patienter med moderate til svære depressioner, bør derfor tages ved behandling af patienter med andre psykiske sygdomme.
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 nogen klinisk signifikante forskelle på QT, PR, QRS eller QTcB målinger mellem duloxetinbehandlede og placebobehandlede patienter.
English: 9 Estimated frequency based on all clinical trial data.
Danish: 9 Estimeret hyppighed baseret på data fra alle kliniske studier.
English: • problems getting an erection, changes in ejaculation
Danish: • problemer med at få erektion, ændret ejakulation
English: Hence, some patients that respond insufficiently to 60 mg may benefit from a higher dose.
Danish: Derfor kan nogle patienter, som ikke responderer tilstrækkeligt på 60 mg, drage nytte af en højere dosis.
English: Children and adolescents under 18 years of age with depression treated with this medicine had some weight loss when they first start taking this medicine.
Danish: Børn og unge under 18 år, som blev behandlet med dette lægemiddel, oplevede et vægttab i begyndelsen af behandlingen.
English: Other psychiatric conditions for which Duloxetine Lilly is prescribed can also be associated with an increased risk of suicide-related events.
Danish: Andre psykiske tilstande, som Duloxetin Lilly anvendes til, kan ligeledes være forbundet med en øget risiko for selvmordsrelaterede handlinger.
English: You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself - are a young adult.
Danish: Du vil mere sandsynligt tænke på dette, hvis du: - tidligere har haft tanker om at begå selvmord eller at gøre skade på dig selv.
English: Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic).
Danish: Eksempler på MAO-hæmmere er bl.a. moclobemid (mod depression) og linezolid (antibiotika).
English: The therapeutic benefit should be reassessed regularly (at least every three months) (see section 5.1).
Danish: Den terapeutiske effekt bør vurderes med jævne mellemrum (mindst hver tredje måned) (se pkt.
English: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Danish: Der er fundet farmakokinetiske forskelle mellem mænd og kvinder (den tilsyneladende plasmaclearance er omkring 50% lavere hos kvinder).
English: If your doctor thinks that you no longer need Duloxetine Lilly he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Danish: Hvis lægen mener, at du ikke længere behøver at tage Duloxetin Lilly, vil lægen bede dig reducere dosis over mindst 2 uger, før du stopper behandlingen helt.
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 din læge har fortalt dig, at du ikke kan tåle visse sukkerarter, skal du kontakte din læge, inden du tager denne medicin.
English: This may be due to the noradrenergic effect of duloxetine.
Danish: Dette kan skyldes duloxetins noradrenerge effekt.
English: Some patients who stop taking Duloxetine Lilly suddenly have had symptoms such as:
Danish: Nogle patienter, som pludselig holdt op med at tage Duloxetin Lilly, oplevede symptomer som:
English: Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Danish: Duloxetin metaboliseres i udstrakt grad, og metabolitterne udskilles hovedsageligt med urinen.
English: Hypertension3,7 Orthostatic hypotension2
Danish: Hypertension3,7 Ortostatisk hypotension2
English: Hypertensive crisis3,6
Danish: Hypertensiv krise3,6
English: Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats.
Danish: Duloxetin var ikke genotoksisk i en række standardtest og var ikke karcinogent hos rotter.
English: If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Danish: Ved forekomst af utålelige symptomer efter en nedsættelse af dosis eller ved seponering kan det overvejes at vende tilbage til den tidligere ordinerede dosis.
English: Most of them occurred during the first months of treatment.
Danish: De fleste skete inden for de første 4 måneder af behandlingen.
English: Syncope2
Danish: Synkope2
English: To help you remember to take Duloxetine Lilly, you may find it easier to take it at the same times every day.
Danish: Det kan være lettere at huske at tage Duloxetin Lilly, hvis du tager det på samme tidspunkt hver dag.
English: The risk of withdrawal symptoms seen with SSRI's and SNRI's may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Danish: Risikoen for seponeringssymptomer set for SSRI og SNRI kan afhænge af flere faktorer blandt andet behandlingsvarigheden, dosis og hvor hurtigt dosis reduceres.
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 tidligt i behandlingen eller efter behandlingsophør.
English: Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients.
Danish: Duloxetin har været forbundet med en øgning af blodtrykket og klinisk signifikant hypertension hos nogle patienter.
English: Only a small proportion of patients included in pivotal clinical trials had severe depression (baseline HAM-D>25).
Danish: Kun en lille del af de inkluderede patienter i de vigtigste kliniske studier led af svære depressioner (basislinie HAM-D>25).
English: Orgasm abnormal Abnormal dreams
Danish: Angst Abnorm orgasme Abnorme drømme relser
English: The dose may be adjusted up to 120 mg a day based on your response to Duloxetine Lilly.
Danish: Dosis kan justeres op til 120 mg daglig afhængigt af dit respons på Duloxetin Lilly.
English: Taking a MAOI together with many prescription medicines, including Duloxetine Lilly, can cause serious or even life-threatening side effects.
Danish: Hvis du tager en MAO-hæmmer sammen med en række forskellige receptpligtige lægemidler, heriblandt Duloxetin Lilly, kan det medføre alvorlige og endda livstruende bivirkninger.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking (see section 4.8).
Danish: Derudover mangler der data for langtidssikkerheden hos børn og unge hvad angår vækst, modning, kognitiv udvikling og adfærdsudvikling (se pkt.
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 dig, hvis du fortæller en ven eller slægtning, at du har en depression eller en angstsygdom, og beder dem læse denne indlægsseddel.
English: A flexible dose regimen was used in this study, to allow for slow dose escalation from 30 mg once daily to higher doses (maximum 120 mg once daily).
Danish: I studiet blev der anvendt et fleksibelt dosisregime for at muliggøre en langsom dosiseskalering fra 30 mg en gang daglig til højere doser (maksimalt 120 mg en gang daglig).
English: Patients meeting diagnostic criteria for major depressive disorder were excluded from these trials.
Danish: Patienter, som levede op til diagnose kriterierne for moderat til svær depression, blev ekskluderet fra disse studier.
English: Caution is required in patients at increased risk for hyponatraemia, such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Danish: Der skal udvises forsigtighed ved behandling af patienter med øget risiko for hyponatriæmi, såsom ældre, cirrotiske eller dehydrerede patienter samt patienter i behandling med diuretika.
English: Based upon in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive.
Danish: På baggrund af in vitrostudier betragtes duloxetins cirkulerende metabolitter som farmakologisk inaktive.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Danish: Det kan muligvis være skadeligt for patienter, der udvikler disse symptomer, at øge dosis.
English: No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered.
Danish: Der kendes ingen antidot mod duloxetin men i tilfælde af serotoninsyndrom, kan specifik behandling (såsom for cyproheptadin og/eller temperatur kontrol) overvejes.
English: Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Danish: Det overlap, der er i de kønsbaserede farmakokinetiske forskelle i clearanceområdet, retfærdiggør ikke en anbefaling om lavere dosis til kvindelige patienter.
English: Blood pressure and heart rate
Danish: Blodtryk og hjertefrekvens
English: The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Danish: Duloxetins farmakokinetik viser stor variation mellem patienter (generelt 50-60%), delvist på grund af køn, alder, ryger-/ikkerygerstatus og CYP2D6-metaboliseringsstatus.
English: The study included a 10 week placebo-controlled acute phase, followed by an 18 week extension treatment period.
Danish: I studiet indgik en 10 ugers placebokontrolleret akutfase efterfulgt af en forlænget behandlingsperiode på 18 uger.
English: Paediatric population Duloxetine has not been studied in patients under the age of 7.
Danish: Pædiatrisk population Duloxetin er ikke blevet undersøgt hos patienter under 7 år.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC: {nummer}
English: • suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger
Danish: • selvmordsrelateret adfærd, mani (overaktivitet, tanker, der løber løbsk og nedsat behov for søvn), hallucinationer, aggressivitet og vrede
English: A conclusion on the overall benefit/risk in this age group has not been established (see also sections 4.2 and 4.8).
Danish: Der foreligger ikke en overordnet benefit/risk-konklusion for denne aldersgruppe (se også pkt.
English: Pharmacotherapeutic group: psychoanaleptics, antidepressants, other antidepressants.
Danish: Farmakoterapeutisk gruppe: psychoanaleptica, antidepressiva, andre antidepressiva.
English: Inducers of CYP1A2: Population pharmacokinetic 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: Subsequently, over the four- to six-month extension period, patients on average trended toward recovery to their expected baseline weight percentile based on population data from age- and gender-matched peers.
Danish: I løbet af en efterfølgende 4-6 måneders forlængelsesperiode tenderede disse patienter i gennemsnit til at genvinde deres forventede baselinevægtpercentil baseret på populationsdata fra kønsmatchede jævnaldrende.
English: Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity.
Danish: Disse symptomer er generelt lette til moderate, for nogle patienter kan de dog være svære i intensitet.
English: Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Danish: Selvmordstanker og forværring af din depression eller angstsygdom Hvis du har en depression eller lider af en angstsygdom, kan du af og til få tanker om at skade dig selv eller begå selvmord.
English: Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Danish: Derefter kan lægen fortsætte nedsættelse af dosis - denne gang i flere trin.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule content:
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Kapselindhold:
English: Myoclonus Akathisia7
Danish: Myoclonus Akatisi7
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 plasmaclearance 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: 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 du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.
Danish: Duloxetin har stor fordelingsvolumen, og forceret diurese, hæmoperfusion og udskiftningstransfusion har sandsynligvis ingen gavnlig virkning.
English: This is most likely to occur within the first few weeks of treatment.
Danish: Der er størst sandsynlighed for, at det forekommer inden for de første par uger af behandlingsforløbet.
English: In patients with insufficient response to 60 mg, escalation up to 90 mg or 120 mg may therefore be considered.
Danish: Hos patienter med utilstrækkeligt respons på 60 mg kan mulig regulering op til 90 mg eller 120 mg derfor overvejes.
English: Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Danish: I kliniske studier blev selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (overvejende aggression, modsættende adfærd og vrede) hyppigere observeret hos børn og unge behandlet med antidepressiva sammenlignet med placebobehandlede.
English: • throat inflammation that causes a hoarse voice
Danish: • halsbetændelse, som forårsager hæs stemme
English: If concomitant treatment with duloxetine and other serotonergic agents that may affect the serotonergic and/or dopaminergic neurotransmitter systems is 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 nøje at følge patienten, særligt i starten af behandlingen og ved øgning af dosis.
English: Duloxetine is administered as a single enantiomer.
Danish: Duloxetin indgives som en enkelt enantiomer.
English: After consolidation of the antidepressive response, it is recommended to continue treatment for several months, in order to avoid relapse.
Danish: Efter konsolidering af det antidepressive respons anbefales det at fortsætte behandlingen i adskillelige måneder for at undgå tilbagefald.
English: Close supervision of patients and in particular those at high risk should accompany medicinal product therapy especially in early treatment and following dose changes.
Danish: Patienter, og specielt højrisikopatienter, i medicinsk behandling bør følges nøje, især tidligt i behandlingen og efter dosisændringer.
English: − are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
Danish: - tager fluvoxamin, som normalt anvendes til behandling af depression, ciprofloxacin eller enoxacin,
English: Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Danish: Moderat leversygdom (Child-Pugh-gruppe B) påvirkede duloxetins farmakokinetik.
English: Concerning risk factors for suicidality in depression, see above.
Danish: Se ovenstående angående risikofaktorer for selvmord under depression.
English: • Tell your doctor if you are breast-feeding.
Danish: • Fortæl din læge, hvis du ammer.
English: Treating your disorder properly is important to help you get better.
Danish: For at du kan få det bedre, er det vigtigt, at din sygdom behandles korrekt.
English: Talk with your doctor about how long you should keep taking Duloxetine Lilly.
Danish: Tal med din læge om, hvor længe du skal blive ved med at tage Duloxetin Lilly.
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 du på noget tidspunkt får tanker om at skade dig selv eller begå selvmord, skal du straks kontakte din læge eller skadestuen.
English: Suicidal behaviour5,7
Danish: Selvmordsrelate ret adfærd5,7
English: Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulfate conjugate of 5-hydroxy 6-methoxy duloxetine.
Danish: Både cytochrom P450-2D6 og -1A2 katalyserer dannelsen af de to hovedmetabolitter: glukuronidkonjugat af 4-hydroxy-duloxetin og sulfatkonjugat af 5-hydroxy-6-methoxy-duloxetin.
English: There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain)
Danish: eller påvirkninger såsom berøring, varme, kulde eller tryk kan fremkalde smerte).
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Duloxetine Lilly.
Danish: Du skal fortælle din læge, hvis et af ovenstående symptomer opstår eller forværres hos en patient under 18 år, som er i behandling med Duloxetin Lilly.
English: • menopausal symptoms, abnormal production of breast milk in men or women
Danish: • symptomer på overgangsalder, unormal mælkeproduktion hos mænd og kvinder
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 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: All patients had previously responded to duloxetine during open-label duloxetine treatment (28 to 34 weeks) at a dose of 60 to 120 mg/day.
Danish: Alle patienter havde tidligere responderet på duloxetin i en ublindet duloxetin-behandlingsperiode (28 til 34 uger) med en dosis på 60 til 120 mg/dag.
English: These medicines might increase the risk of bleeding.
Danish: Disse typer medicin øger risikoen for bivirkninger.