FrancophonIA/ELRC3.0 huggingface dataset:
English: You should tell your doctor if this happens to you.
Danish: Hvis det sker for dig, bør du fortælle din læge dette.
English: CNS medicinal products: The risk of using duloxetine in combination with other CNS-active medicinal products has not been systematically evaluated, except in the cases described in this section.
Danish: CNS-lægemidler: Bortset fra de her i afsnittet nævnte interaktioner er risikoen ved brug af duloxetin i kombination med andre CNS-aktive lægemidler ikke blevet systematisk undersøgt.
English: Major Depressive Disorder: Duloxetine Lilly was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Danish: Moderate til svære depressioner:I et klinisk forsøgsprogram med 3.158 patienter (svarende til 1.285 patientår) blev Duloxetin Lilly undersøgt mod DSM-IV kriterierne for moderate til svære depressioner.
English: Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity study.
Danish: I karcinogenitetsstudiet med rotter blev der set celler med flere cellekerner i leveren i fravær af andre histopatologiske ændringer.
English: Hypromellose acetate succinate Sucrose
Danish: Hypromelloseacetatsuccinat Saccharose
English: Two randomized, double-blind, parallel clinical trials were performed in 800 paediatric patients aged 7 to 17 years with major depressive disorder (see section 4.2).
Danish: Der er gennemført to randomiserede, dobbeltblindede parallel-studier med 800 pædiatriske patienter i alderen 7-17 år med moderat til svær depression (se pkt.
English: In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum clinical exposure (AUC).
Danish: I et embryotoxicitetstudie foretaget på kaniner blev der observeret en højere incidens af kardiovaskulære- og knogle-deformationer, hvor hunkaninerne blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
English: Medicinal products metabolised by CYP1A2: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
Danish: Lægemidler, der metaboliseres via CYP1A2: Theophyllins (et CYP1A2-substrat) farmakokinetik blev ikke påvirket signifikant ved samtidig behandling med duloxetin (60 mg to gange daglig).
English: Duloxetine Lilly demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Danish: Duloxetin Lilly viste sig signifikant bedre end placebo målt som forbedring i total score på Hamilton 17-punkts skalaen (HAM-D) (inklusiv både følelses og somatiske symptomer ved depression).
English: 28 hard gastro-resistant capsules 56 hard gastro-resistant capsules 84 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Danish: 28 hårde enterokapsler 56 hårde enterokapsler 84 hårde enterokapsler 98 hårde enterokapsler
English: Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive disorder, generalised anxiety disorder and stress urinary incontinence).
Danish: Duloxetin benyttes under forskellige varemærker til flere indikationer (behandling af diabetiske neuropatiske smerter, moderate til svære depressioner, generaliseret angst og stress-inkontinens).
English: Component of a multipack, can't be sold separately.
Danish: Må ikke sælges separat.
English: Duloxetine Lilly is available in 2 strengths: 30 mg and 60 mg.
Danish: Duloxetin Lilly findes i to styrker: 30 mg og 60 mg:
English: Titanium dioxide (E171) Triethyl citrate
Danish: Titandioxid (E171) Triethylcitrat
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: Metabolism and nutrition disorders Decreased
Danish: Metabolisme og ernæring Nedsat appetit
English: As a general recommendation, caution should be exercised when treating the elderly (see sections 4.2 and 4.4).
Danish: Det er en generel anbefaling, at der bør udvises forsigtighed ved behandling af ældre (se pkt.
English: Nervous system disorders Headache
Danish: Nervesystemet Hovedpine Søvnighed
English: NN:
Danish: NN: {nummer}
English: Duloxetine Lilly 60 mg is available in packs of 28, 56, 84 and 98 hard gastro-resistant capsules and in multipacks containing 100 (5 packs of 20) and 500 (25 packs of 20) hard gastro-resistant capsules.
Danish: Duloxetin Lilly 60 mg findes i pakninger med 28, 56, 84 og 98 hårde enterokapsler og i flerstykspakninger med 100 (5 pakninger a 20) og 500 (25 pakninger a 20) hårde enterokapsler.
English: Stomatitis Haematochezia Breath odour Microscopic colitis9
Danish: Stomatitis Hæmatokeksi Dårlig ånde Mikroskopisk kolitis9
English: • chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
Danish: • brystsmerter, kuldefølelse, tørst, skælven, varmefølelse, unormal gangart
English: The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively.
Danish: Hyppigheden af tilbagefald i den 6-måneders dobbeltblinde followup-periode var henholdsvis 17% for duloxetin og 29% for placebo.
English: The 60 mg capsules are blue and green and are printed with ‘60 mg' and the code ‘9542'.
Danish: 60 mg kapslerne er blå og grønne med påskriften "60 mg" og koden "9542".
English: • suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack of motivation
Danish: • selvmordstanker, søvnbesvær, tænderskæren eller sammenbidte tænder, desorientering, manglende motivation
English: Current available data are described in sections 4.8, 5.1 and 5.2.
Danish: 4.8, 5.1 og 5.2.
English: The efficacy of Duloxetine Lilly 30-120 mg (flexible dosing) once a day in elderly patients (>65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Danish: Effekten af Duloxetin Lilly 30-120 mg (fleksibel dosering) en gang dagligt hos ældre patienter (> 65 år) med generaliseret angst blev evalueret i et studie, som viste statistisk signifikant forbedring i HAM-A-totalscoren hos duloxetinbehandlede patienter sammenlignet med placebobehandlede patienter.
English: The concomitant use of Duloxetine Lilly with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Danish: Samtidig brug af Duloxetin Lilly og selektive, reversible MAO-hæmmere, som f.eks. moclobemid, anbefales ikke (se pkt.
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Danish: Doseringer over 60 mg en gang dagligt op til maksimaldosis på 120 mg dagligt i ligeligt fordelte doser er evalueret ud fra et sikkerhedsmæssigt perspektiv i kliniske studier.
English: Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
Danish: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: Eli Lilly Benelux S.A./N.V.
Danish: Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V.
English: The general toxicity profile of duloxetine in juvenile rats was similar to that in adult rats.
Danish: Duloxetins overordnede toksicitetsprofil hos rotteunger svarede til den beskrevet hos voksne rotter.
English: Duloxetine Lilly 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p<0.001) on the prevention of relapse, as measured by time to relapse.
Danish: Duloxetin Lilly 60 mg til 120 mg en gang daglig viste statistisk signifikant fordel sammenlignet med placebo (p<0.0001) ved forebyggelse af tilbagefald målt som tid til tilbagefald.
English: Effects of other medicinal products on duloxetine Antacids and H2 antagonists: Co-administration of duloxetine with aluminium- and magnesiumcontaining antacids or duloxetine 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 duloxetin 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: Duloxetine Lilly may have a mild to moderate influence on the ability to drive and use machines.
Danish: Duloxetin Lilly påvirker i mild til moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Diabetic Peripheral Neuropathic Pain: As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.
Danish: Som for andre lægemidler med lignende farmakologisk virkning (antidepressiva) er der blevet rapporteret isolerede tilfælde af selvmordsforestillinger og -adfærd under duloxetinbehandling eller kort efter behandlingsophør.
English: The 30 mg capsules are blue and white and are printed with ‘30 mg' and the code ‘9543'.
Danish: 30 mg kapslerne er blå og hvide med påskriften "30 mg" og koden "9543".
English: Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose.
Danish: Duloxetin absorberes godt efter oral indgift med Cmaks.
English: Tel: +372 6 817 280
Danish: Eesti Tel: +372 6 817 280
English: Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
Danish: Farmakokinetiske data på duloxetin er begrænset hos patienter med let til moderat nedsat nyrefunktion.
English: During 52 weeks of placebo-controlled double blind treatment, duloxetine-treated patients with recurrent MDD had a significantly longer symptom free period (p<0.001) compared with patients randomised to placebo.
Danish: I løbet af 52 ugers placebo-kontrolleret dobbeltblind behandling, havde duloxetin-behandlede patienter med tilbagevendende moderat til svær depression, en signifikant længere symptomfri periode (p < 0,001) sammenlignet med placebo-randomiserede patienter.
English: Aggression and anger4
Danish: Hallucinationer Aggression og vrede4
English: In general, the adverse reaction profile of duloxetine in children and adolescents was similar to that seen for adults.
Danish: Generelt lignede bivirkningsprofilen for duloxetin hos børn og unge bivirkningsprofilen hos voksne.
English: There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Danish: Blødningsabnormaliteter såsom ekkymoser, purpura og gastrointestinal blødning er set ved brug af selektive serotoningenoptags-hæmmere - (SSRI-præparater) og serotonin/noradrenalingenoptagshæmmere (SNRI-præparater), herunder duloxetin.
English: The main ingredient of Duloxetine Lilly, duloxetine, is used in other medicines for other conditions: • diabetic neuropathic pain, depression, anxiety and urinary incontinence
Danish: Det aktive stof (duloxetin) i Duloxetin Lilly bruges i andre lægemidler mod andre tilstande: • diabetisk neuropatisk smerte, depression, angst og stressinkontinens.
English: Weight decrease Weight increase Blood creatine phosphokinase increased
Danish: Vægtstigning Forhøjet kreatinkinase i blodet
English: Duloxetine Lilly demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
Danish: Duloxetin Lilly viste statistisk signifikant fordel i forhold til placebo målt som bedring på Hamilton Anxiety Scale (HAM-A) totalscore og på Sheehan Disability Scale (SDS) som score for total funktionel hæmning.
English: When stopping treatment with Duloxetine Lilly the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Danish: Ved ophør af behandling med Duloxetin Lilly skal dosis gradvis reduceres over en periode på mindst en til to uger for at mindske risikoen for seponeringssymptomer (se pkt.
English: Each capsule may contain up to 111 mg sucrose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel kan indeholde op til 111 mg saccharose.
English: Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid).
Danish: Medicin, som øger niveauet af serotonin: Triptaner, tramadol, tryptophan, SSRI-præparater (såsom paroxetin og fluoxetin), SNRI-præparater (såsom venlafaxin), tricykliske antidepressiva (såsom clomipramin, amitriptylin), pethidin, perikon og MAO-hæmmere (såsom moclobemid og linezolid).
English: Major Depressive Disorder and Generalised Anxiety Disorder: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Danish: Depression er forbundet med en øget risiko for selvmordstanker, at forvolde skade på sig selv og selvmord (selvmordsrelaterede handlinger).
English: Liver disease resulting in hepatic impairment (see section 5.2).
Danish: Leversygdomme resulterende i nedsat leverfunktion (se pkt.
English: Pharmacokinetics of duloxetine in paediatric patients aged 7 to 17 years with major depressive disorder following oral administration of 20 to 120 mg once daily dosing regimen was characterized using population modelling analyses based on data from 3 studies.
Danish: Duloxetins farmakokinetik ved oral behandling med 20 til 120 mg en gang daglig hos pædiatriske patienter i alderen 7 til 17 år med moderat til svær depression, er karakteriseret ved brug af populationsmodelleringsanalyser baseret på data fra tre studier.
English: • inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of the eyes
Danish: • betændelse i leveren, som kan give mavesmerter og gulfarvning af huden eller det hvide i øjnene
English: Data on the use of Duloxetine Lilly 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Danish: Der er begrænsede data om brug af Duloxetin Lilly 120 mg til ældre patienter med moderat til svær depression eller generaliseret angst.
English: In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine and routine care groups, but the mean increase was 0.3% greater in the duloxetinetreated group.
Danish: I denne periode var der stigninger i HbA1C både i duloxetin- og standardbehandling-grupperne, den gennemsnitlige stigning var 0,3% større i gruppen behandlet med duloxetin.
English: Caution is advised if Duloxetine Lilly is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Danish: Det anbefales at udvise forsigtighed ved administration af Duloxetin Lilly sammen med præparater, som hovedsageligt metaboliseres via CYP2D6 (risperidon, tricycliske antidepressiva [TCA'er] såsom nortriptylin, amitriptylin og imipramin), specielt hvis disse præparater har et snævert terapeutisk indeks (som f.eks. flecainid, propafenon og metoprolol).
English: Respiratory, thoracic and mediastinal disorders Yawning
Danish: Luftveje, thorax og mediastinum Gaben
English: Elimination The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
Danish: Halveringstiden for duloxetin ligger på 8-17 timer (gns.
English: 2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
Danish: 2 Sager med ortostatisk hypotension og synkope er blevet rapporteret - særligt i behandlingsopstarten 3 Se pkt 4.4.
English: As the safety of duloxetine in infants is not known, the use of Duloxetine Lilly while breast-feeding is not recommended.
Danish: Eftersom sikkerheden af duloxetin hos spædbørn ikke er kendt, frarådes behandling med Duloxetin Lilly i ammeperioden.
English: Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients.
Danish: Ventrikelskylning kan være indiceret, hvis den foretages kort efter indtagelse eller hos patienter med symptomer.
English: Icepharma hf. Sími + 354 540 8000
Danish: Sími + 354 540 8000
English: The efficacy and safety of Duloxetine Lilly 30-120 mg once daily in elderly patients with generalised anxiety disorder was similar to that seen in studies of younger adult patients.
Danish: Virkningen og sikkerheden af Duloxetin Lilly 30-120 mg en gang dagligt hos ældre patienter med generaliseret angst svarede til virkningen og sikkerheden observeret i studier med yngre voksne patienter.
English: Talk to your doctor before you take Duloxetine Lilly if you: - are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Lilly') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Lilly')
Danish: - har en nyresygdom - tidligere har haft krampeanfald - tidligere har haft mani - lider af en bipolar sygdom - har øjenproblemer, såsom visse typer af grøn stær (glaukom - forøget tryk i øjet) - tidligere har lidt af blødningsforstyrrelser (tendens til blå mærker) - har risiko for at få lavt natrium i blodet (for eksempel hvis du tager vanddrivende medicin, især hvis du er ældre) - er i samtidig behandling med medicin, som kan skade leveren - samtidig tager anden medicin med duloxetin (se ”Brug af anden medicin sammen med Duloxetin
English: As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with duloxetine treatment, particularly with concomitant use of other serotonergic agents (including SSRIs, SNRIs tricyclic antidepressants or triptans), with agents that impair metabolism of serotonin such as MAOIs, or with antipsychotics or other dopamine antagonists that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Danish: Som ved andre serotonerge lægemidler kan den potentielt livstruende tilstand serotoninsyndrom forekomme ved behandling med duloxetin, især i kombination med andre serotonerge lægemidler (inklusive SSRI'er, SNRI'er, tricykliske antidepressiva og triptaner), med lægemidler, som hæmmer metabolismen af serotonin som f.eks. MAOI'er, eller med antipsykotika eller andre dopaminantagonister, som kan påvirke de serotonerge transmittersystemer (se pkt.
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Duloxetine Lilly, you should see your doctor.
Danish: Oplever du uventede virkninger, mens du tager en af disse typer medicin sammen med Duloxetin Lilly, skal du kontakte din læge.
English: Ejaculation disorder
Danish: Ejakulationsforstyrrelser
English: Duloxetine is detected in breast milk, and steady-state concentrations in breast milk are about one-fourth those in plasma.
Danish: Steady state koncentrationerne i human mælk er ca. en fjerdedel af plasmakoncentrationerne.
English: Convulsion1
Danish: Tinnitus1
English: The initiation of treatment with Duloxetine Lilly is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and
Danish: For patienter med ukontrolleret hypertension er der kontraindikation for opstart af behandling med Duloxetin Lilly, da det kan udsætte patienterne for en potentiel risiko for hypertensive kriser (se pkt.
English: Duloxetine Lilly should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Danish: Duloxetin Lilly må ikke anvendes sammen med potente CYP1A2 hæmmere, som fluvoxamin, ciprofloxacin og enoxacin, idet kombinationen resulterer i forhøjet plasmakoncentration af duloxetin (se pkt.
English: • decreased thyroid gland activity which can cause tiredness or weight gain
Danish: • nedsat aktivitet af skjoldbruskkirtlen, som kan forårsage træthed eller vægtøgning
English: Akathisia/psychomotor restlessness
Danish: Akatisi/psykomotorisk uro
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Duloxetine Lilly before starting an MAOI (see section
Danish: På baggrund af duloxetins halveringstid skal der gå mindst 5 dage efter endt behandling med Duloxetin Lilly, før en behandling med en MAO-hæmmer påbegyndes (se afsnit 4.3).
English: In patients with uncontrolled hypertension duloxetine should not be initiated (see section 4.3).
Danish: Hos patienter med ukontrolleret hypertension bør behandling med duloxetin ikke sættes i gang (se pkt.
English: Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
Danish: Symptomer på serotoninsyndrom omfatter bl.a. ændringer i mentaltilstanden (f.eks. agitation, hallucinationer, koma), autonom ustabilitet (f.eks. takykardi, ustabilt blodktryk, hypertermi), neuromuskulære afvigelser (f.eks. hyperreflexia, manglende koordination) og/eller gastrointestinale symptomer (f.eks. kvalme, opkastning, diarré).
English: 5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).
Danish: 5 Sager med selvmordsforestillinger og -adfærd er blevet rapporteret under duloxetinbehandling eller tidligt efter behandlingsophør (se pkt.
English: Multipack: 100 (5 packs of 20) hard gastro-resistant capsules Multipack: 500 (25 packs of 20) hard gastro-resistant capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 100 (5 pakninger a 20) hårde enterokapsler Multipakning: 500 (25 pakninger a 20) hårde enterokapsler
English: Eosinophilic pneumonia6
Danish: Interstitiel lungesygdom10 Eosinofil pneumoni6
English: Generalised Anxiety Disorder: Duloxetine Lilly demonstrated statistically significant superiority over placebo in five out of five studies including four randomised, double-blind, placebo-controlled acute studies and a relapse prevention study in adult patients with generalised anxiety disorder.
Danish: Duloxetin Lilly viste statistisk signifikant fordel i forhold til placebo i fem ud af fem studier inklusive fire randomiserede, dobbeltblinde, placebokontrollerede akutstudier og et studie af forebyggelse af tilbagefald hos voksne patienter med generaliseret angst.
English: Skin and subcutaneous tissue disorders Sweating increased
Danish: Hud og subkutane væv Øget perspiration Hududslæt
English: If you stop taking Duloxetine Lilly
Danish: Hvis du holder op med at tage Duloxetin Lilly
English: For generalised anxiety disorder:
Danish: Mod generaliseret angst: