FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of duloxetine 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 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-Atotalscoren hos duloxetinbehandlede patienter sammenlignet med placebobehandlede patienter.
English: There may be loss of feeling in the affected area, or sensations such as touch,
Danish: Der kan forekomme følelsesløshed i det angrebne område,
English: Bottle packs only: Use within 6 months of opening.
Danish: Kun for beholdere: Skal bruges inden for 6 måneder efter åbningen.
English: Duloxetine Mylan 30 mg is available in blister packs of 7, 14, 28, 49, 98 and in a multipack of 98 comprising 2 cartons, each containing 49 capsules, in perforated blister packs containing 7 x1, 28 x 1, 30 x 1 capsules and in bottles containing 30, 100, 250, 500 capsules and a desiccant.
Danish: Duloxetin Mylan 30 mg findes i blisterpakninger med 7, 14, 28, 49, 98 og en multipakning med 98, der består af 2 æsker hver med 49 kapsler, i perforerede blisterpakninger med 7 × 1, 28 × 1, 30 × 1 kapsler og i beholdere med 30, 100, 250, 500 kapsler og et tørremiddel.
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: Duloxetine Mylan may make you feel sleepy or dizzy.
Danish: Duloxetine Mylan kan gøre dig søvnig og svimmel.
English: Treatment of major depressive disorder.
Danish: Behandling af major depression (moderat til svær depression).
English: Doses up to 120 mg per day have been shown to be efficacious and have been evaluated from a safety perspective in clinical trials.
Danish: Doser op til 120 mg daglig har vist effekt og er blevet evalueret fra et sikkerhedsmæssigt perspektiv i kliniske studier.
English: Duloxetine Mylan contains the active substance duloxetine.
Danish: Duloxetine Mylan indeholder det aktive stof duloxetin.
English: Therefore Duloxetine Mylan should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Danish: Duloxetine Mylan bør derfor ikke gives i kombination med potente CYP1A2-hæmmere som fluvoxamin (se pkt.
English: Duloxetine Mylan 60 mg is available in blister packs of 14, 28, 49, 84, 98 and in a multipack of 98 comprising 2 cartons, each containing 49 capsules, in perforated blister packs containing 28 x 1, 30 x 1, and 100 x 1capsules and bottles containing 30, 100, 250 and 500 capsules and a desiccant.
Danish: Duloxetin Mylan 60 mg findes i blisterpakninger med 14, 28, 49, 84, 98 og en multipakning med 98, der består af 2 æsker hver med 49 kapsler, i perforerede blisterpakninger med 28 × 1, 30 × 1 og 100 x 1 kapsler og i beholdere med 30, 100, 250, 500 kapsler og et tørremiddel.
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 knogledeformationer, hvor hunkaninerne blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
English: However, data on elderly patients exposed to the maximum dose (120 mg 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 dagligt) er begrænset anbefales det derfor at der udvises forsigtighed, når denne befolkningsgruppe behandles.
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 dagligt).
English: When stopping treatment with Duloxetine Mylan 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 Duloxetine Mylan skal dosis gradvis reduceres over en periode på mindst en til to uger for at mindske risikoen for seponeringssymptomer (se pkt.
English: • sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor sleep quality
Danish: • pludselig, ufrivillig spjætten eller sitren i musklerne, følelse af rastløshed eller manglende evne til at sidde eller stå stille, nervøsitet, koncentrationsbesvær, ændret smagsoplevelse, problemer med at styre sine bevægelser f.eks. koordinationsbesvær eller ufrivillige muskelbevægelser, restless legs syndrom (stærk uro og krybende fornemmelse i underbenene), dårlig søvnkvalitet
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: The concomitant use of Duloxetine Mylan with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Danish: Samtidig brug af Duloxetine Mylan og selektive, reversible MAO-hæmmere, som f.eks. moclobemid, anbefales ikke (se pkt.
English: Duloxetine 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 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: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Danish: Palpitationer Takykardi Supraventrikulær arytmi, hovedsagelig atrieflimren
English: Paediatric population: 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: Pædiatrisk population: Duloxetins farmakokinetik ved oral behandling med 20 til 120 mg en gang dagligt 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: Duloxetine Mylan is used in adults to treat:
Danish: Duloxetine Mylan anvendes hos voksne til behandling af
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 placebokontrolleret dobbeltblind behandling, havde duloxetinbehandlede patienter med tilbagevendende moderat til svær depression, en signifikant længere symptomfri periode (p < 0,001) sammenlignet med placeborandomiserede patienter.
English: Hypromellose phthalate Diethyl phthalate
Danish: Hypromellosephthalat Diethylphthalat
English: Duloxetine 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 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: Response and remission rates were also statistically significantly higher with duloxetine compared with placebo.
Danish: Data for virkning og bedring viste sig også statistisk signifikant bedre for duloxetin sammenlignet med placebo.
English: As the safety of duloxetine in infants is not known, the use of Duloxetine Mylan while breast-feeding is not recommended.
Danish: Eftersom sikkerheden af duloxetin hos spædbørn ikke er kendt, frarådes behandling med Duloxetine Mylan i ammeperioden.
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 duloxetine-treated group.
Danish: I denne periode var der stigninger i HbA1C både i duloxetin- og standardbehandlingsgrupperne, men den gennemsnitlige stigning var 0,3% større i gruppen behandlet med duloxetin.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/galactosemalabsorption eller invertase/isomaltasemangel.
English: Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8).
Danish: Selektive serotoningenoptagelseshæmmere (SSRI)/serotonin- og noradrenalingenoptagelseshæmmere (SNRI) kan give symptomer på seksuel dysfunktion (se pkt.
English: 7 hard gastro-resistant capsules 14 hard gastro-resistant capsules 28 hard gastro-resistant capsules 49 hard gastro-resistant capsules 98 hard gastro-resistant capsules 7 x 1 hard gastro-resistant capsules 28 x 1 hard gastro-resistant capsules 30 x 1 hard gastro-resistant capsules
Danish: 7 hårde enterokapsler 14 hårde enterokapsler 28 hårde enterokapsler 49 hårde enterokapsler 98 hårde enterokapsler 7 x 1 hårde enterokapsler 28 x 1 hårde enterokapsler 30 x 1 hårde enterokapsler
English: White ink
Danish: Hvidt blæk
English: Caution is advised if Duloxetine Mylan 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 Duloxetine Mylan 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: 30 hard gastro-resistant capsules 100 hard gastro-resistant capsules 250 hard gastro-resistant capsules 500 hard gastro-resistant capsules
Danish: 30 hårde enterokapsler 100 hårde enterokapsler 250 hårde enterokapsler 500 hårde enterokapsler
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: • inflammation of the mouth, passing bright red blood in your stools, bad breath, inflammation of the large intestine (leading to diarrhoea)
Danish: • betændelseslignende tilstand (inflammation) i mundhulen, frisk rødt blod i afføringen, dårlig ånde, inflammation i tyktarmen (kan medføre diarré)
English: The efficacy and safety of duloxetine 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 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: Generalised Anxiety Disorder: Duloxetine 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 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: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Duloxetine Mylan, you should see your doctor.
Danish: Hvis du får usædvanlige symptomer, når du tager et af disse lægemidler sammen med Duloxetine Mylan, skal du kontakte din læge.
English: Duloxetine Mylan 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: Duloxetine Mylan må ikke anvendes sammen med potente CYP1A2 hæmmere, som fluvoxamin, ciprofloxacin og enoxacin, idet kombinationen resulterer i forhøjet plasmakoncentration af duloxetin (se pkt.
English: • trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm,
Danish: • søvnbesvær, ophidselse, mindre lyst til sex, angst, problemer med at opnå orgasme, mærkelige drømme
English: Stevens-Johnson Syndrome Angio-neurotic oedema
Danish: StevensJohnsons syndrom Angioødem
English: Data on the use of duloxetine 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Danish: Der er begrænsede data om brug af Duloxetine Mylan 120 mg til ældre patienter med moderat til svær depression eller generaliseret angst.
English: Weight decrease Weight increase Blood creatine phosphokinase increased
Danish: Vægtstigning Forhøjet kreatinkinase i blodet Forhøjet kalium i blodet
English: Propylene glycol Sodium hydroxide Povidone
Danish: Propylenglycol Natriumhydroxid Povidon
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: If you take more Duloxetine Mylan than you should Call your doctor or pharmacist immediately if you take more than the amount of Duloxetine Mylan prescribed by your doctor.
Danish: Kontakt omgående lægen eller apoteket, hvis du har taget mere Duloxetine Mylan, end lægen har ordineret.
English: Hyponatraemia has been reported when administering Duloxetine Mylan, including cases with serum sodium lower than 110 mmol/l.
Danish: Hyponatriæmi, herunder tilfælde med serum-natriumværdier under 110 mmol/l, er blevet rapporteret efter indgivelse af Duloxetine Mylan.
English: Propylene glycol Strong ammonia solution Yellow iron oxide (E172)
Danish: Propylenglycol Stærk ammoniumopløsning Gul jernoxid (E172)
English: Use in children and adolescents under 18 years of age Duloxetine Mylan should not be used in the treatment of children and adolescents under the age of 18 years.
Danish: Duloxetine Mylan bør ikke bruges til behandling af børn og unge under 18 år.
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 daglig op til maksimaldosis på 120 mg daglig i ligeligt fordelte doser er evalueret ud fra et sikkerhedsmæssigt perspektiv i kliniske studier.
English: Excipient(s) with known effect Each capsule contains 124.2 mg sucrose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver kapsel indeholder 124,2 mg saccharose.
English: Caution is advisable if Duloxetine Mylan is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Danish: Det anbefales at udvise forsigtighed, hvis Duloxetine Mylan anvendes sammen med serotonerge lægemidler som SSRIpræparater, SNRI-præparater, tricykliske antidepressiva (f.eks. clomipramin eller amitriptylin), MAOI'er som moclobemid eller linezolid, perikon (Hypericum perforatum) eller triptaner, tramadol, pethidin og tryptophan (se afsnit 4.4).
English: Duloxetine Mylan must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Danish: Duloxetine Mylan må ikke bruges til patienter med svært nedsat nyrefunktion (kreatininclearance <30 ml/min, se pkt.
English: Overall, duloxetine's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Danish: Som helhed er der vist effekt af duloxetin ved en daglig fast dosering mellem 60 og 120 mg i fem ud af syv randomiserede dobbeltblinde, placebokontrollerede studier på voksne akutte ambulante patienter med moderate til svære depressioner.
English: Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Danish: Estimeret hyppighed af bivirkninger rapporteret efter markedsføring; ikke set i placebo-kontrollerede kliniske studier.
English: If you forget to take Duloxetine Mylan
Danish: Hvis du har glemt at tage Duloxetine Mylan
English: The initiation of treatment with Duloxetine Mylan is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Danish: For patienter med ukontrolleret hypertension er der kontraindikation for opstart af behandling med Duloxetine Mylan, da det kan udsætte patienterne for en potentiel risiko for hypertensive kriser (se pkt.
English: 30 mg capsules Capsule shell Brilliant blue (E133) Titanium dioxide (E171) Gelatin
Danish: 60 mg kapsler Kapselskal Brilliant blue (E133) Gul jernoxid (E172) Titandioxid (E171) Gelatine
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter)
English: Duloxetine Mylan hard gastro-resistant capsules contain sucrose and sodium.
Danish: Duloxetine Mylan hårde enterokapsler indeholder saccharose og natrium.
English: Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).
Danish: Der er blevet rapporteret tilfælde af selvmordstanker og -adfærd under duloxetinbehandling eller tidligt efter behandlingens ophør (se pkt.
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials.
Danish: Doseringer over 60 mg en gang daglig op til maksimaldosis på 120 mg om dagen er evalueret ud fra et sikkerhedsmæssigt perspektiv i kliniske studier.
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with duloxetine and 23% of patients taking placebo.
Danish: I kliniske studier er der observeret utilsigtede hændelser ved pludselig afbrydelse af behandlingen hos ca. 45% og 23% af patienterne behandlet med hhv. duloxetin og placebo.
English: Adverse reactions may be more common during concomitant use of Duloxetine Mylan and herbal preparations containing St John's wort (Hypericum perforatum).
Danish: Bivirkninger kan forekomme hyppigere ved samtidig brug af Duloxetine Mylan og naturlægemidler samt kosttilskud indeholdende perikon (hypericum perforatum).
English: Excipient(s) with known effect Each capsule contains 62.1 mg sucrose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver kapsel indeholder 62,1 mg saccharose.
English: What you need to know before you take Duloxetine Mylan
Danish: Det skal du vide, før du begynder at tage Duloxetine Mylan
English: • Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals),
Danish: • Stevens-Johnsons syndrom (en alvorlig lidelse med blærer i huden, munden, øjnene og på kønsorganerne), alvorlige allergiske reaktioner, som kan forårsage hævelse i ansigtet eller halsen (angioødem)
English: Feeling hot Gait disturbance
Danish: Føler sig syg Varmefølelse Gangforstyrrelse
English: The efficacy of duloxetine at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Danish: Effekten af duloxetin er vist med den anbefalede faste dosis på 60 mg én gang dagligt i tre ud af tre randomiserede dobbeltblinde, placebokontrollerede studier på voksne akutte ambulante patienter med moderate til svære depressioner.
English: The following are reasons why Duloxetine Mylan may not be suitable for you.
Danish: I følgende situationer kan du muligvis ikke anvende Duloxetine Mylan.
English: • dizziness, tingling feelings like pins and needles or electric shock like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Danish: • svimmelhed, prikkende følelse som når noget sover eller følelse af elektriske stød (især i hovedet), søvnforstyrrelser (livagtige drømme, mareridt, søvnløshed), træthed, søvnighed, rastløshed eller uro, angst, kvalme eller opkastning, rystelser (tremor), hovedpine, muskelsmerter, irritation, diarré, forøget tendens til at svede eller svimmelhed.
English: Майлан ЕООД Тел: +359 2 44 55 400
Danish: Тел: +359 2 44 55 400
English: Rare side effects (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter)
English: Syncope Hypertension Orthostatic hypotension Peripheral coldness
Danish: Ortostatisk hypotension Perifer kuldefornemmelse
English: If your doctor has prescribed Duloxetine Mylan for a patient under 18 and you want to discuss this, please go back to your doctor.
Danish: Du bedes henvende dig til din læge, hvis din læge har udskrevet Duloxetine Mylan til en patient under 18 år, og du gerne vil diskutere dette.
English: Do not eat the desiccant.
Danish: Tørremidlet må ikke spises.