FrancophonIA/ELRC3.0 huggingface dataset:
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 at følge patienten nøje, særligt i starten af behandlingen og ved øgning af dosis.
English: Xeristar increases the levels of serotonin and noradrenaline in the nervous system.
Danish: Xeristar øger indholdet af serotonin og noradrenalin i nervesystemet.
English: You should use Xeristar only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Danish: Du må kun bruge Xeristar efter, at du har talt med din læge om de mulige fordele for dig og de mulige risici for dit ufødte barn.
English: Xeristar may make you feel sleepy or dizzy.
Danish: Xeristar kan gøre dig søvnig og svimmel.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) 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: Neither duloxetine (30-120 mg) nor the active control arm (fluoxetine 20-40 mg) statistically separated from placebo on change from baseline to endpoint in the Children´s Depression Rating Scale-Revised (CDRS-R) total score.
Danish: Hverken duloxetin (30-120 mg) eller den aktive kontrolarm (fluoxetin 20-40 mg) adskilte sig statistisk set fra placebo hvad angår ændring fra baseline til endepunkt i den samlede score på Children's Depression Rating Scale-Revised (CDRS-R).
English: Tolerability of Xeristar 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Danish: Tolerancen af Xeristar 60 mg en gang dagligt hos ældre patienter var sammenlignelig med den, der blev set hos yngre voksne.
English: There was no statistically significant difference in discontinuation due to adverse events between duloxetine and placebo groups during the 10 week acute treatment phase.
Danish: Der var ikke statistisk signifikant forskel i seponeringsfrekvens på grund af bivirkninger mellem duloxetingruppen og placebogruppen i løbet af akutfasen på 10 uger.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Danish: Det skal gøres klart for patienter og pårørende, at det er nødvendigt at være opmærksom på enhver forværring af tilstanden, selvmordsrelateret adfærd eller selvmordstanker, samt usædvanlige ændringer i opførsel og straks at søge lægehjælp, hvis disse symptomer viser sig.
English: Contains sucrose See leaflet for further information
Danish: LISTE OVER HJÆLPESTOFFER Indeholder saccharose Se indlægssedlen for yderligere information
English: Each capsule of Xeristar contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Danish: Hver Xeristar-kapsel indeholder pellets af duloxetinhydrochlorid med en belægning, som beskytter dem mod mavesyre.
English: Xeristar 60 mg is available in packs of 28, 56, 84, 98, 100 and 500 capsules.
Danish: Xeristar 60 mg findes i blisterpakning med 28, 56, 84, 98, 100 og 500 kapsler.
English: The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%).
Danish: Den absolutte orale biotilgængelighed for duloxetin ligger på 32-80 % (gns.
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: Perifere diabetiske neuropatiske smerter: Som for andre lægemidler med lignende farmakologisk virkning (antidepressiva) er der blevet rapporteret isolerede tilfælde af selvmordsforestillinger ogadfærd under duloxetinbehandling eller kort efter behandlingsophør.
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Xeristar.
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 Xeristar.
English: Xeristar contains the active substance duloxetine.
Danish: Xeristar indeholder det aktive stof duloxetin.
English: Xeristar should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Danish: Xeristar skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/eller krampeanfald.
English: Diabetic Peripheral Neuropathic Pain: The efficacy of Xeristar 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: Perifere diabetiske neuropatiske smerter: Effekten af Xeristar 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: Clinical response rates (50% or greater improvement in pain) were analysed according to whether or not the patient experienced somnolence during treatment.
Danish: Klinisk respons (mindst 50 % smertereduktion) blev analyseret i forhold til om, patienten havde oplevet somnolens under behandlingen.
English: During the 52-week placebocontrolled double blind treatment phase 14.4% of the duloxetine-treated patients and 33.1% of the placebo-treated patients experience a return of their depressive symptoms (p<0.001).
Danish: I løbet af den 52 uger lange placebokontrollerede dobbeltblinde behandlingsperiode oplevede 14,4 % af de duloxetinbehandlede patienter og 33,1 % af de placebobehandlede patienter en tilbagevenden af deres depressive symptomer (p<0,001).
English: The main ingredient of Xeristar, duloxetine, is used in other medicines for other conditions:
Danish: Det aktive stof (duloxetin) i Xeristar bruges i andre lægemidler mod andre tilstande:
English: The dose may be adjusted up to 120 mg a day based on your response to Xeristar.
Danish: Dosis kan justeres op til 120 mg dagligt afhængigt af dit respons på Xeristar.
English: Despite this, your doctor may prescribe Xeristar for patients under 18 because he/she decides that this is in their best interests.
Danish: På trods af dette kan din læge ordinere Xeristar til patienter under 18 år, hvis lægen skønner, at det er til patientens bedste.
English: Over the entire 36-week course of the study, 6 out of 333 patients initially randomized to duloxetine and 3 out of 225 patients initially randomized to fluoxetine experienced suicidal behaviour (exposure adjusted incidence 0.039 events per patient year for duloxetine and 0.026 for fluoxetine).
Danish: I løbet af studiets 36 ugers varighed udviste 6 ud af 333 patienter, som initialt var randomiseret til duloxetin og 3 ud af 225 patienter initialt randomiseret til fluoxetin selvmordsrelateret adfærd (eksponeringsjusteret forekomst var 0,039 hændelser pr. patientår for duloxetin og 0,026 for fluoxetin).
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: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Danish: Takykardi Supra-ventrikulær arytmi, hovedsagelig atrieflimren
English: Duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity.
Danish: Duloxetin påvirker ikke hanners fertilitet, og påvirkning af hunners fertilitet er kun set ved doser, som forårsagede maternel toksicitet.
English: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of Xeristar in this age group have not yet been demonstrated.
Danish: Ydermere foreligger der endnu ikke data på langtidssikkerhed hos denne aldersgruppe hvad angår vækst, modning, kognitiv- og adfærdsudvikling ved brug af Xeristar.
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.
English: The incidence of relapse during the 6months double-blind follow-up period was 14% for Xeristar and 42% for placebo.
Danish: Incidensen af tilbagefald under den 6-måneders dobbeltblinde follow-up periode var 14 % for Xeristar og 42 % for placebo.
English: Xeristar is available in 2 strengths: 30 mg and 60 mg.
Danish: Xeristar findes i 2 styrker: 30 mg og 60 mg.
English: If you stop taking Xeristar
Danish: Hvis du holder op med at tage Xeristar
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Xeristar before starting an MAOI (see section 4.3).
Danish: På baggrund af duloxetins halveringstid skal der gå mindst 5 dage efter endt behandling med Xeristar, før en behandling med en MAO-hæmmer påbegyndes (se afsnit 4.3).
English: Also, you need to wait at least 5 days after you stop taking Xeristar before you take a MAOI.
Danish: Du skal ligeledes vente mindst 5 dage, efter at du er holdt op med at tage Xeristar, før du må begynde at tage en MAOhæmmer.
English: Menopausal symptoms Galactorrhoea Hyperprolactinae mia
Danish: Menopausale symptomer Galaktorré Hyperprolaktinæmi
English: • Xeristar 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: • Xeristar 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 model predicted duloxetine steady state plasma concentrations in paediatric patients were mostly within theconcentration range observed in adult patients.
Danish: De modelforventede steady state-plasmaskoncentrationer af duloxetin hos pædiatriske patienter var generelt inden for koncentrationsintervallet observeret hos voksne patienter.
English: The most commonly reported adverse reactions in patients treated with Xeristar were nausea, headache, dry mouth, somnolence, and dizziness.
Danish: De hyppigst rapporterede bivirkninger hos patienter i behandling med Xeristar var kvalme, hovedpine, mundtørhed, søvnighed og svimmelhed.
English: In a relapse prevention study, patients responding to 6 months of acute treatment with open-label Xeristar were randomised to either Xeristar 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 Xeristar, randomiseret til enten Xeristar eller placebo i yderligere 6 måneder.
English: Duloxetine did not show efficacy in reducing pain as measured by primary outcome measure of Brief Pain Inventory (BPI) average pain score endpoint: least squares (LS) mean change from baseline in BPI average pain score at 13 weeks was -0.97 in the placebo group, compared with -1.62 in the duloxetine 30/60 mg group (p = 0.052).
Danish: Duloxetin viste ingen effekt på reduktion af smerte for det primære endepunkt, målt ved gennemsnitligt smerteindeks i henhold til Brief Pain Inventory (BPI): gennemsnitlig ændring fra baseline ved mindste kvadraters metode (LS) i BPI gennemsnitlig smertescore ved 13 uger var -0,97 i placebogruppen sammenlignet med -1,62 i gruppen duloxetin 30/60 mg (p = 0,052).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xeristar 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 Xeristar i alle undergrupper af den pædiatriske population med moderat til svær depression, diabetisk neuropatisk smerte og generaliseret angst (se pkt.
English: Other medicines and Xeristar
Danish: Brug af anden medicin sammen med Xeristar
English: Stevens-Johnson Syndrome6
Danish: StevensJohnsons syndrom6
English: Response and remission rates were also higher with Xeristar compared to placebo.
Danish: Graden af respons og bedring var også højere med Xeristar sammenlignet med placebo.
English: Major Depressive Disorder: Xeristar 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 Xeristar undersøgt mod DSM-IV kriterierne for moderate til svære depressioner.
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Xeristar 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 Xeristar 120 mg daglig for moderate til svære depressioner eller generaliseret angst, da der er begrænsede data tilgængelige (se pkt.
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: Hypertension3,7 Orthostatic hypotension2 Peripheral coldness
Danish: Hypertension3,7 Ortostatisk hypotension2
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: Consequently, caution is advised when Xeristar 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 Xeristar tages sammen med andre centralt virkende lægemidler eller stoffer, herunder alkohol og sederende lægemidler (f.eks. benzodiazepiner, morphinlignende præparater, antipsykotika, phenobarbital, sederende antihistaminer).
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 (kreatinin-clearance < 30 ml/min.).
English: Xeristar 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: Xeristar viste sig signifikant bedre end placebo målt som forbedring i total score på Hamilton 17punkts skalaen (HAM-D) (inklusiv både følelses og somatiske symptomer ved depression).
English: Xeristar showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
Danish: Xeristar viste sammenlignelige resultater med venlafaxin udtrykt i HAM-A totalscore.
English: 28 hard gastro-resistant capsules 84 hard gastro-resistant capsules 98 hard gastro-resistant capsules 56 hard gastro-resistant capsules
Danish: 28 hårde enterokapsler 84 hårde enterokapsler 98 hårde enterokapsler 56 hårde enterokapsler
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Danish: Gynækologisk blødning Menstruationsforstyrrelser Seksuel dysfunktion Smerter i testiklerne
English: Xeristar 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: Xeristar 60 mg findes i pakninger med 28, 56, 84 og 98 hårde enterokapsler og i multipakninger med 100 (5 pakninger a 20) og 500 (25 pakninger a 20) 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 stressinkontinens).
English: Therefore Xeristar should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Danish: Xeristar bør derfor ikke gives i kombination med potente CYP1A2-hæmmere som fluvoxamin (se pkt.
English: If you forget to take Xeristar
Danish: Hvis du har glemt at tage Xeristar
English: Monoamine oxidase inhibitors (MAOIs): You should not take Xeristar if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Danish: Monoaminoxidasehæmmere (MAO-hæmmere): Du må ikke tage Xeristar, hvis du tager, eller inden for de sidste 14 dage har taget et antidepressivt lægemiddel kaldet en MAO-hæmmer.
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 og potente CYP1A2-hæmmere sandsynligvis medføre højere koncentrationer af duloxetin.
English: Generalised Anxiety Disorder: Xeristar 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: Generaliseret angst: Xeristar 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: When stopping treatment with Xeristar 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 Xeristarskal dosis gradvis reduceres over en periode på mindst en til to uger for at mindske risikoen for seponeringssymptomer (se pkt.
English: The concomitant use of Xeristar with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Danish: Samtidig brug af Xeristar og selektive, reversible MAO-hæmmere, som f.eks. moclobemid, anbefales ikke (se pkt.
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: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Xeristar to patients with increased intraocular pressure, or those at risk of acute narrowangle glaucoma.
Danish: Der er rapporteret om tilfælde af mydriasis i forbindelse med duloxetin, og der skal derfor udvises forsigtighed ved udskrivning af Xeristar til patienter med forhøjet intraokulært tryk eller til patienter med risiko for akut snævervinklet glaukom.
English: Agitation Libido decreased Anxiety
Danish: Nedsat libido Angst
English: The efficacy of Xeristar 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 Xeristar 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: As the safety of duloxetine in infants is not known, the use of Xeristar while breast-feeding is not recommended.
Danish: Eftersom sikkerheden af duloxetin hos spædbørn ikke er kendt, frarådes behandling med Xeristar i ammeperioden.
English: Xeristar 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: Xeristar 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: 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: Xeristar 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: Xeristar 60 mg til 120 mg en gang dagligt viste statistisk signifikant fordel sammenlignet med placebo (p<0.0001) ved forebyggelse af tilbagefald målt som tid til tilbagefald.
English: Data on the use of Xeristar 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Danish: Der er begrænsede data om brug af Xeristar 120 mg til ældre patienter med moderate til svære depressioner eller generaliseret angst.
English: Duloxetine
Danish: Duloxetin
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, parallelstudier med 800 pædiatriske patienter i alderen 7-17 år med moderat til svær depression (se pkt.
English: Response and remission rates were also statistically significantly higher with Xeristar compared with placebo.
Danish: Data for virkning og bedring viste sig også statistisk signifikant bedre for Xeristar sammenlignet med placebo.
English: Hypromellose acetate succinate Sucrose
Danish: Kapselindhold Hypromellose Hypromelloseacetatsuccinat Saccharose
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.