FrancophonIA/ELRC3.0 huggingface dataset:
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with Duloxetine Mylan (see section 4.4).
Danish: Det antibiotiske lægemiddel linezolid er en reversibel ikke-selektiv MAOI og bør ikke gives til patienter, der er i behandling med Duloxetine Mylan (se afsnit 4.4).
English: • If you take Duloxetine Mylan near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders.
Danish: • Hvis du tager Duloxetine Mylan i slutningen af graviditeten, er der en øget risiko for kraftig vaginal blødning kort efter fødslen, især hvis du tidligere har haft blødningsforstyrrelser.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Duloxetine Mylan.
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 Duloxetine Mylan.
English: The usual starting dose of Duloxetine Mylan is 30 mg once a day after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Danish: Den sædvanlige startdosis af Duloxetine Mylan er 30 mg en gang dagligt, hvorefter de fleste patienter vil få 60 mg en gang dagligt, men din læge vil fastlægge den dosis, som passer til dig.
English: Talk with your doctor about how long you should keep taking Duloxetine Mylan.
Danish: Tal med din læge om, hvor længe du skal blive ved med at tage Duloxetine Mylan.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. kapsel, dvs. den er i det væsentlige natrium-fri.
English: • Make sure your midwife and/or doctor knows you are on Duloxetine Mylan.
Danish: • Du skal sikre dig, at din jordemoder og/eller læge ved, at du tager Duloxetine Mylan.
English: Libido decreased Anxiety
Danish: Nedsat libido Angst
English: Your doctor should decide whether you can take Duloxetine Mylan with other medicines.
Danish: Din læge bør afgøre, om Duloxetine Mylan kan tages sammen med anden medicin.
English: Observational data have provided evidence of an increased risk (less than 2-fold) of postpartum haemorrhage following duloxetine exposure within the month prior to birth.
Danish: Observationsdata har vist en øget risiko (under det dobbelte) for postpartum blødning efter eksponering for duloxetin inden for 1 måned før fødslen.
English: Medicines like Duloxetine Mylan (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Danish: Lægemidler som Duloxetine Mylan (såkaldte SSRI/SNRI'er) kan give symptomer på seksuel dysfunktion (se pkt.
English: Duloxetine Mylan should normally not be used for children and adolescents under 18 years.
Danish: Duloxetine Mylan bør normalt ikke bruges til behandling af børn og unge under 18 år.
English: In animal studies, duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity.
Danish: I dyreforsøg, påvirker duloxetin ikke hanners fertilitet, og påvirkning af hunners fertilitet er kun set ved doser, som forårsagede maternel toksicitet.
English: The randomised, double-blind, placebo-controlled, parallel study of duloxetine was conducted in 184 adolescents aged 13 to 18 years (mean age 15.53 years) with JPFS.
Danish: Det randomiserede, dobbeltblindede, placebokontrollerede, parallelgruppe studie med duloxetin blev gennemført med 184 unge i alderen 13 til 18 år (gennemsnitsalder 15,53 år) med JPFS.
English: Duloxetine Mylan may cause a sensation of restlessness or an inability to sit or stand still.
Danish: Duloxetine Mylan kan give en følelse af uro eller manglende evne til at sidde eller stå stille.
English: Duloxetine Mylan should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Duloxetine Mylan bør kun bruges under graviditeten, hvis de potentielle behandlingsfordele opvejer de potentielle risici for fosteret.
English: Hepatic impairment: Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Danish: Nedsat leverfunktion: Moderat leversygdom (Child-Pugh-gruppe B) påvirkede duloxetins farmakokinetik.
English: Care should be taken if you drink alcohol while you are being treated with Duloxetine Mylan.
Danish: Du bør udvise forsigtighed, hvis du drikker alkohol, samtidig med, at du er i behandling med Duloxetine Mylan.
English: Multipack: 98 (2 packs of 49) hard gastro-resistant capsules
Danish: Multipakning: 98 (2 pakninger med 49) hårde enterokapsler
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 duloxetinbehandlingsperiode (28 til 34 uger) med en dosis på 60 til 120 mg/dag.
English: During the 52-week placebo-controlled 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 placebo-behandlede patienter en tilbagevenden af deres depressive symptomer (p<0,001).
English: Your doctor may continue to give you Duloxetine Mylan when you are feeling better to prevent your depression or anxiety from returning.
Danish: Din læge kan vælge at fortsætte din behandling med Duloxetine Mylan efter, at du har fået det bedre for at forebygge, at din depression eller angst skal vende tilbage.
English: The model-predicted duloxetine steady state plasma concentrations in paediatric patients were mostly within the concentration 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: Contains sucrose See leaflet for further information
Danish: Indeholder saccharose Læs indlægssedlen for yderligere information.
English: General disorders and administration site conditions Falls
Danish: Almene symptomer og reaktioner på administrationsstedet Fald
English: The study included a 13-week double-blind period where patients were randomised to duloxetine 30 mg/60 mg, or placebo daily.
Danish: Studiet inkluderede en 13 ugers dobbeltblindet periode hvor patienter blev randomiseret til duloxetin 30 mg/60 mg eller placebo dagligt.
English: Each capsule of Duloxetine Mylan contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Danish: Hver Duloxetine Mylan kapsel indeholder pellets af duloxetinhydrochlorid med en belægning, som beskytter dem mod mavesyre.
English: You should use Duloxetine Mylan only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Danish: Du må kun bruge Duloxetine Mylan efter, at du har talt med din læge om de mulige fordele for dig og de mulige risici for dit ufødte barn.
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 daglig) med 71%, men påvirker ikke farmakokinetikken for tolterodins aktive 5-hydroxy-metabolit, og der anbefales ingen dosisjustering.
English: Duloxetine Mylan starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better.
Danish: Hos de fleste mennesker med depression eller angst begynder Duloxetine Mylan at virke indenfor de første to uger, men det kan vare 2-4 uger, før du får det bedre.
English: • Duloxetine Mylan 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: • Duloxetine Mylan 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: Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
Danish: Sager med ortostatisk hypotension og synkope er blevet rapporteret - særligt i behandlingsopstarten Se pkt.
English: Dehydration Hyponatraemia SIADH
Danish: Dehydrering Hyponatriæmi SIADH
English: Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUCo-t 6-fold.
Danish: Fluvoxamin (100 mg én gang dagligt), en potent CYP1A2-hæmmer, mindskede den tilsyneladende plasmaclearance af duloxetin med omtrent 77 % og øgede AUC0-t 6 gange.
English: Elimination: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
Danish: Elimination: Halveringstiden for duloxetin ligger på 8-17 timer (gns.
English: Tolerability of duloxetine 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Danish: Tolerancen af Duloxetin 60 mg en gang dagligt hos ældre patienter var sammenlignelig med den, der blev set hos yngre voksne.
English: The amount of duloxetine in breast milk is approximately 7 μg/day while on 40 mg twice daily dosing.
Danish: Mængden af duloxetin i human mælk er ca. 7 µg/dag under en dosering på 40 mg to gange dagligt.
English: Sugar spheres (sucrose, maize starch) Hypromellose
Danish: Sukkerkugler (saccharose, majsstivelse) Hypromellose
English: Duloxetine Mylan is for oral use.
Danish: Duloxetine Mylan er til oral brug.
English: 30 mg capsules
Danish: 30 mg kapsler
English: Breast-feeding mothers: The disposition of duloxetine was studied in 6 lactating women who were at least 12-weeks postpartum.
Danish: Ammende mødre: Duloxetins fordeling i kroppen blev undersøgt hos 6 ammende kvinder, som havde født mindst 12 uger forinden.
English: • headache, feeling sleepy
Danish: • hovedpine, søvnighed
English: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of Duloxetine Mylan 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 Duloxetine Mylan.
English: Duloxetine Mylan increases the levels of serotonin and noradrenaline in the nervous system.
Danish: Duloxetine Mylan øger indholdet af serotonin og noradrenalin i nervesystemet.
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 was0.97 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: Despite this, your doctor may prescribe Duloxetine Mylan for patients under 18 because he/she decides that this is in their best interests.
Danish: På trods af dette kan din læge ordinere Duloxetine Mylan til patienter under 18 år, hvis lægen skønner, at det er til patientens bedste.
English: Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Danish: Tilfælde af leverskade herunder svært forhøjede leverenzymer (>10 gange den normale øvre grænse), hepatitis og gulsot er rapporteret for duloxetin (se pkt.
English: Duloxetine Mylan should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Danish: Duloxetine Mylan skal anvendes med forsigtighed til patienter med en anamnese med mani eller en diagnose med bipolar forstyrrelse og/eller krampeanfald.
English: 60 mg capsules
Danish: 60 mg kapsler
English: In patients with co-morbid major depressive disorder, the starting and maintenance dose is 60 mg once daily (please see also dosing recommendation above).
Danish: Til patienter med samtidig moderat til svær depression er begyndelses- og vedligeholdelsesdosis 60 mg en gang daglig (se også ovenstående dosisanbefaling).
English: Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.
Danish: Der er også rapporteret tilfælde af kramper og tinnitus efter behandlingsophør.
English: Duloxetine Mylan may be associated with sedation and dizziness.
Danish: Duloxetine Mylan kan være forbundet med sedation og svimmelhed.
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Duloxetine Mylan.
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 Duloxetine Mylan.
English: Duloxetine Mylan is indicated in adults.
Danish: Duloxetine Mylan er indiceret til voksne.
English: Consequently, caution is advised when Duloxetine Mylan 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 Duloxetine Mylan tages sammen med andre centralt virkende lægemidler eller stoffer, herunder alkohol og sederende lægemidler (f.eks. benzodiazepiner, morphinlignende præparater, antipsykotika, phenobarbital, sederende antihistaminer).
English: The incidence of relapse during the 6-months double-blind follow-up period was 14% for duloxetine and 42% for placebo.
Danish: Incidensen af tilbagefald under den 6-måneders dobbeltblinde followup periode var 14 % for duloxetin og 42 % for placebo.
English: In a relapse prevention study, patients responding to 6 months of acute treatment with open-label duloxetine were randomised to either duloxetine or placebo for a further 6-months.
Danish: I et studie med forebyggelse af tilbagefald blev de patienter, som responderede på 6 måneders akut behandling med open-label duloxetin, randomiseret til enten duloxetin eller placebo i yderligere 6 måneder.
English: In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine-treated patients.
Danish: I de kliniske 12-ugers akut fase duloxetin studier med patienter med diabetisk neuropatisk smerte blev der observeret en lille men statistisk signifikant stigning i faste blodglucose hos duloxetinbehandlede patienter.
English: Duloxetine Mylan is available in 2 strengths: 30 mg and 60 mg.
Danish: Duloxetine Mylan findes i to styrker: 30 mg og 60 mg:
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Duloxetine Mylan 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 Duloxetine Mylan 120 mg daglig for moderate til svære depressioner eller generaliseret angst, da der er begrænsede data tilgængelige (se pkt.
English: Major Depressive Disorder: Duloxetine 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 undersøgt mod DSM-IV kriterierne for moderate til svære depressioner.
English: The most commonly reported adverse reactions in patients treated with duloxetine were nausea, headache, dry mouth, somnolence, and dizziness.
Danish: De hyppigst rapporterede bivirkninger hos patienter i behandling med duloxetin var kvalme, hovedpine, mundtørhed, søvnighed og svimmelhed.
English: Capsule shell: Brilliant blue (E133), yellow iron oxide (E172) (60 mg only), titanium dioxide (E171), gelatin and edible gold ink (30 mg only) or edible white ink (60 mg only).
Danish: Kapselskal: Brilliant blue (E133), gul jernoxid (E172) (kun 60 mg), titandioxid (E171), gelatine og spiseligt guldblæk (kun 30 mg) eller spiseligt hvidt blæk (kun 60 mg).
English: A total of 467 paediatric patients initially randomized to duloxetine in clinical trials, experienced a 0.1 kg mean decrease in weight at 10-weeks compared with a 0.9 kg mean increase in 353 placebo-treated patients.
Danish: 467 pædiatriske patienter, som blev randomiseret til behandling med duloxetin i kliniske studier, havde efter 10 uger et gennemsnitligt vægttab på 0,1 kg sammenlignet med en gennemsnitlig vægtstigning på 0,9 kg hos 353 placebobehandlede patienter.
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Duloxetine Mylan before starting an MAOI (see section 4.3).
Danish: På baggrund af duloxetins halveringstid skal der gå mindst 5 dage efter endt behandling med Duloxetine Mylan, før en behandling med en MAO-hæmmer påbegyndes (se afsnit 4.3).
English: Gold ink contains Shellac
Danish: Guldblæk indeholder Shellac
English: Capsule content: Sugar spheres (sucrose, maize starch), hypromellose, Macrogol, Crospovidone, talc, sucrose, hypromellose phthalate, diethyl phthalate
Danish: Kapselindhold: Sukkerkugler (saccharose, majsstivelse), hypromellose, Macrogol, Crospovidon, talkum, saccharose, hypromellosephthalat, diethylphthalat
English: It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors.
Danish: Det hæmmer svagt dopamingenoptagelsen uden nogen signifikant affinitet til histaminerge, dopaminerge,
English: DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Danish: Hvis du holder op med at tage Duloxetine Mylan Du må ikke holde op med at tage kapslerne uden at have konsulteret din læge, heller ikke selv om du har fået det bedre.
English: The European Medicines Agency has waived the obligation to submit the results of studies with duloxetine in all subsets of the paediatric population in the treatment of major depressive disorder, diabetic neuropathic pain and generalised anxiety disorder.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med duloxetin i alle undergrupper af den pædiatriske population med moderat til svær depression, diabetisk neuropatisk smerte og generaliseret angst (se pkt.
English: Absorption: Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose.
Danish: Absorption: Duloxetin absorberes godt efter oral indgift med Cmaks.
English: Hepatitis Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Danish: Hepatitis Forhøjede leverenzymer (ALAT, ASAT, basisk fosfatase) Akut leverskade
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Danish: Gynækologisk blødning Menstruations forstyrrelser Seksuel dysfunktion Smerter i testiklerne
English: Duloxetine may increase the risk of postpartum haemorrhage (see section 4.6).
Danish: Duloxetin kan øge risikoen for postpartum blødning (se pkt.
English: Diabetic Peripheral Neuropathic Pain: The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Danish: Effekten af duloxetin 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: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Duloxetine Mylan to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Danish: Der er rapporteret om tilfælde af mydriasis i forbindelse med duloxetin, og der skal derfor udvises forsigtighed ved udskrivning af Duloxetine Mylan til patienter med forhøjet intraokulært tryk eller til patienter med risiko for akut snævervinklet glaukom.
English: White ink contains Shellac
Danish: Hvidt blæk indeholder Shellac
English: Monoamine oxidase inhibitors (MAOIs): You should not take Duloxetine Mylan 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 Duloxetine Mylan, 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 Duloxetine Mylan og potente CYP1A2-hæmmere sandsynligvis medføre højere koncentrationer af duloxetin.
English: Bottle packs only: Once opened, use within 180 days.
Danish: Kun for beholdere: Skal anvendes inden for 180 dage efter åbning.
English: Also, you need to wait at least 5 days after you stop taking Duloxetine Mylan before you take a MAOI.
Danish: Du skal ligeledes vente mindst 5 dage, efter at du er holdt op med at tage Duloxetine Mylan, før du må begynde at tage en MAO-hæmmer.
English: The recommended starting dose in patients with generalised anxiety disorder is 30 mg once daily with or without food.
Danish: Den anbefalede startdosis til patienter med generaliseret angst er 30 mg en gang daglig uden hensyn til måltider.
English: HDPE bottle pack, with desiccant, containing 30, 100, 250 and 500 hard gastro-resistant capsules
Danish: HDPE-beholder med tørremiddel med 30, 100, 250 og 500 hårde enterokapsler
English: Duloxetine 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 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: Duloxetine showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
Danish: Duloxetin viste sammenlignelige resultater med venlafaxin udtrykt i HAM-A totalscore.
English: 60 mg capsules Capsule shell Brilliant blue (E133)
Danish: 30 mg kapsler Kapselskal Brilliant blue (E133) Gelatine
English: Response and remission rates were also higher with duloxetine compared to placebo.
Danish: Graden af respons og bedring var også højere med duloxetin sammenlignet med placebo.
English: • abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, sexual dysfunction, pain in the testicles or scrotum
Danish: • unormal vaginalblødning, unormal menstruation herunder voldsom, smertefuld, uregelmæssig eller forlænget blødning, usædvanlig sparsom eller manglende menstruation, seksuel dysfunktion, smerter i testiklerne eller pungen