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 Lilly (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 Duloxetin Lilly (se afsnit 4.4).
English: Care should be taken if you drink alcohol while you are being treated with Duloxetine Lilly.
Danish: Du bør udvise forsigtighed, hvis du drikker alkohol, samtidig med, at du er i behandling med Duloxetin Lilly.
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: • serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips, allergic reactions
Danish: • alvorlige allergiske reaktioner, som forårsager åndedrætsbesvær eller svimmelhed og hævelse af tunge eller læber, allergiske reaktioner
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: • Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), serious allergic reaction which causes swelling of the face or throat (angioedema)
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: • difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow
Danish: • besværet eller manglende evne til at lade vandet, besvær med at påbegynde vandladning, behov for vandladning i løbet af natten, behov for hyppigere vandladning end normalt, nedsat urinmængde
English: Reproductive system and breast disorders Erectile dysfunction
Danish: Det reproduktive system og mammae Erektil dysfunktion
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 seponeringfrekvens på grund af bivirkninger mellem duloxetingruppen og placebogruppen i løbet af akutfasen på 10 uger.
English: After consolidation of the response, it is recommended to continue treatment for several months, in order to avoid relapse.
Danish: Efter respons er konsolideret, tilrådes det at fortsætte i flere måneder for at undgå tilbagefald.
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: Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/kg/day), but these were considered to be secondary to hepatic microsomal enzyme induction.
Danish: Hunmus, som modtog duloxetin i 2 år, havde forøget incidens af hepatocellulære adenomer og karcinomer ved den høje dosis (144 mg/kg/dag), men disse blev betragtet som værende sekundære til den mikrosomale enzyminduktion i leveren.
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, kolinerge og adrenerge receptorer.
English: • increased blood pressure, flushing
Danish: • forhøjet blodtryk, rødmen
English: Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Danish: Seponering af duloxetin (særlig ved pludseligt ophør) medfører normalt seponeringssymptomer.
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: Hepatitis/increased liver enzymes
Danish: Hepatitis/forhøjede leverenzymer
English: These two studies included a 10 week placebo and active (fluoxetine) controlled acute phase followed by six months period of active controlled extension treatment.
Danish: I disse to studier indgik en 10 ugers akutfase med placebo og aktiv (fluoxetin) kontrol efterfulgt af en 6 måneders behandlingsfase med aktiv kontrol.
English: Duloxetine Lilly should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Duloxetin Lilly bør kun bruges under graviditeten, hvis de potentielle behandlingsfordele opvejer de potentielle risici for fosteret.
English: Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure.
Danish: Duloxetin bør bruges med forsigtighed til patienter, hvis tilstand kan bringes i fare ved øget hjertefrekvens eller øget blodtryk.
English: Your doctor should decide whether you can take Duloxetine Lilly with other medicines.
Danish: Din læge bør afgøre, om Duloxetin Lilly kan tages sammen med anden medicin.
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: Method of administration For oral use.
Danish: Administration Til oral brug
English: When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold.
Danish: Når duloxetin blev givet i doser af 60 mg to gange dagligt sammen med en enkelt dosis af desipramin, et CYP2D6-substrat, blev AUC for desipramin forøget 3 gange.
English: There are no adequate data on the use of duloxetine in pregnant women.
Danish: Data for anvendelse af duloxetin til gravide er utilstrækkelige.
English: The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose (see section 5.2).
Danish: Den anslåede dosis i mg/kg, som et spædbarn ville modtage, er omkring 0,14 % af moderens dosis (se pkt.
English: Your doctor may continue to give you Duloxetine Lilly when you are feeling better to prevent your depression or anxiety from returning
Danish: Din læge kan vælge at fortsætte din behandling med Duloxetin Lilly efter, at du har fået det bedre for at forebygge, at din depression eller angst skal vende tilbage.
English: • generalised anxiety disorder (chronic feeling of anxiety or nervousness)
Danish: • angst (kronisk fornemmelse af angst og nervøsitet)
English: Medicinal products containing duloxetine
Danish: Lægemidler indeholdende duloxetin
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Danish: Takykardi Supraventrikulær arytmi, hovedsagelig atrieflimren
English: Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some patients they may be severe and/or prolonged.
Danish: Generelt for SSRI- og SNRI-hæmmere er disse symptomer lette til moderate og selvbegrænsende, selvom de hos nogle patienter kan være svære og/eller vedvare i længere tid.
English: • night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
Danish: • natlig sveden, nældefeber, koldsved, øget følsomhed over for sollys, øget tendens til blå mærker
English: Duloxetine Lilly should normally not be used for children and adolescents under 18 years.
Danish: Duloxetin Lilly bør normalt ikke bruges til behandling af børn og unge under 18 år.
English: During the 10-week acute treatment period, suicidal behaviours were reported (duloxetine 0/333 [0%], fluoxetine 2/225 [0.9%], placebo 1/220 [0.5%]).
Danish: Selvmordsrelateret adfærd blev indberettet i løbet af den 10 uger lange akutfase med aktiv behandling (duloxetin 0/333 [0 %], fluoxetin 2/225 [0,9 %], placebo 1/220 [0,5 %]).
English: Check with your doctor if you are already taking other medicines containing duloxetine.
Danish: Spørg din læge om du allerede tager andre lægemidler indeholdende duloxetin.
English: The safety and efficacy of duloxetine for the treatment of generalised anxiety disorder in paediatric patients aged 7-17 years have not been established.
Danish: Duloxetins sikkerhed og virkning ved behandling af generaliseret angst hos pædiatriske patienter i alderen 7-17 år er ikke klarlagt.
English: Duloxetine Lilly 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 Duloxetin Lilly at virke inden for de første to uger, men det kan vare 2-4 uger, før du får det bedre.
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 placebo-kontrollerede dobbeltblinde behandlingsperiode oplevede 14,4 % af de duloxetin-behandlede patienter og 33,1 % af de placebobehandlede patienter en tilbagevenden af deres depressive symptomer (p<0,001).
English: Protein binding is not affected by renal or hepatic impairment.
Danish: Proteinbindingen påvirkes ikke af nedsat nyre- eller leverfunktion.
English: Make sure your midwife and/or doctor knows you are on Duloxetine Lilly.
Danish: Du skal sikre dig, at din jordemoder og/eller læge ved, at du tager Duloxetin Lilly.
English: Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
Danish: Start eller afbryd ikke behandlingen med medicin, det gælder også for medicin, som ikke er på recept samt naturlægemidler og kosttilskud, før du har talt med din læge.
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 daglig.
English: Duloxetine binds to both albumin and alpha-l acid glycoprotein.
Danish: Duloxetin bindes til både albumin og alfa-1-syre-glykoprotein.
English: Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from clotting.
Danish: Orale antikoagulantia eller medicin, der påvirker blodpladerne: Medicin, der fortynder blodet og modvirker dannelse af blodpropper.
English: Studies in juvenile rats reveal transient effects on neurobehaviour, as well as significantly decreased body weight and food consumption; hepatic enzyme induction; and hepatocellular vacuolation at 45 mg/kg/day.
Danish: Studier med rotteunger viser en forbigående påvirkning af neuroadfærd samt signifikant nedsat kropsvægt og fødeindtagelse, induktion af leverenzymer og hepatoceullær vakuolisering ved 45 mg/kg/dag.
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: General disorders and administration site conditions Falls8
Danish: Almene symptomer og reaktioner på administrationsstedet Fald8
English: In studies of up to 9 months an overall mean decrease of 1% in height percentile (decrease of 2% in children (7-11 years) and increase of 0.3% in adolescents (12-17 years)) was observed in duloxetinetreated paediatric patients (see section 4.4).
Danish: I studier af op til 9 måneders varighed sås et overordnet gennemsnitligt fald på 1 % i højdepercentilen (et fald på 2 % hos børn (7-11 år) og en stigning på 0,3 % hos unge (12-17 år)) hos pædiatriske patienter behandlet med duloxetin (se pkt.
English: You should use Duloxetine Lilly only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Danish: Du må kun bruge Duloxetin Lilly efter, at du har talt med din læge om de mulige fordele for dig og de mulige risici for dit ufødte barn.
English: The pain inhibitory action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system.
Danish: Den smertehæmmende virkning af duloxetin menes at være et resultat af en potensering af descenderende smertehæmmende baner i centralnervesystemet.
English: Anticoagulants and antiplatelet agents: Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction.
Danish: Antikoagulantia og antitrombotiske midler: Der bør udvises forsigtighed, når duloxetin gives sammen med orale antikoagulantia eller antitrombotiske midler på grund af en potentiel øget risiko for blødning, der kan tilskrives en farmakodynamisk interaktion.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: Det er generel klinisk erfaring med alle antidepressive behandlinger, at risikoen for selvmord kan stige i de tidlige stadier af behandlingen.
English: Call your doctor or pharmacist immediately if you take more than the amount of Duloxetine Lilly prescribed by your doctor.
Danish: Kontakt omgående lægen eller apoteket, hvis du har taget mere Duloxetin Lilly, end lægen har ordineret.
English: Dehydration Hyponatraemia SIADH6
Danish: Dehydrering Hyponatriæmi SIADH6
English: Duloxetine Lilly may be associated with sedation and dizziness.
Danish: Duloxetin Lilly kan være forbundet med sedation og svimmelhed.
English: The usually recommended starting dose of Duloxetine Lilly 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 anbefalede startdosis af Duloxetin Lilly er 30 mg en gang daglig, hvorefter de fleste patienter vil få 60 mg en gang daglig, men din læge vil fastlægge den dosis, som passer til dig.
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 daglig) 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: When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish.
Danish: Lignende præparater (SSRI'er) kan, når de tages under graviditeten, øge risikoen for en alvorlig lidelse kaldet persisterende pulmonal hypertension hos spædbørn (PPHN), hvilket gør barnet blåligt i huden og får det til at trække vejret hurtigere.
English: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min).
Danish: Dosisjustering er ikke nødvendig til patienter med let eller moderat nedsat nyrefunktion (kreatininclearance 30-80 ml/min).
English: Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.
Danish: Duloxetin bør bruges med forsigtighed til patienter i behandling med andre lægemidler, som er forbundet med leverskade.
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 daglig), en potent CYP1A2-hæmmer, mindskede den tilsyneladende plasmaclearance af duloxetin med omtrent 77 % og øgede AUC0-t 6 gange.
English: You should ask your doctor or pharmacist for advice.
Danish: Spørg din læge eller apoteket til råds.
English: 10Estimated frequency based on placebo-controlled clinical trials.
Danish: 10 Estimeret hyppighed baseret på placebokontrollerede kliniske studier.
English: Blood cholesterol increased
Danish: Forhøjet kolesterol i blodet
English: Menopausal symptoms Galactorrhoea Hyperprolactinae mia
Danish: Menopausale symptomer Galaktorré Hyperprolaktin æmi
English: Female rats receiving duloxetine (45 mg/kg/day) before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Danish: Hunrotter, som fik duloxetin (45 mg/kg/dag) før og under parring samt i den tidlige drægtighedsperiode, havde nedsat fødeindtagelse og kropsvægt, afbrydelse af brunstcyklussen, et nedsat indeks for levende fødsler og overlevelse af afkom samt forsinket vækst hos afkommet ved udsættelse for systemisk påvirkning estimeret til at være højst ved den maksimale kliniske eksponering (AUC).
English: These usually begin at birth or within a few days of your baby being born.
Danish: Som regel opstår de ved fødslen eller inden for få dage efter fødslen.
English: • Duloxetine Lilly 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: • Duloxetin Lilly 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: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of Duloxetine Lilly 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 Duloxetin Lilly.
English: 1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.
Danish: 1 Der er også rapporteret tilfælde af kramper og tinnitus efter behandlingsophør.
English: • fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
Danish: • besvimelse, svimmelhed, uklarhed eller besvimelse efter at have rejst sig op, kolde fingre og/eller tæer
English: The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain has not been studied.
Danish: Duloxetins sikkerhed og virkning ved behandling af perifere diabetiske neuropatiske smerter er ikke klarlagt.
English: The pattern of liver damage was predominantly hepatocellular.
Danish: Det mønster, der tegner sig for leverskade, er overvejende hepatocellulært.
English: In addition, these conditions may be co-morbid with major depressive disorder.
Danish: Disse tilstande kan yderligere være samtidige med moderate til svære depressioner.
English: Lactation did not influence duloxetine pharmacokinetics.
Danish: Laktation påvirkede ikke duloxetins farmakokinetik.
English: Although no studies have investigated the association of PPHN to SNRI treatment, this potential risk cannot be ruled out with duloxetine taking into account the related mechanism of action (inhibition of the re-uptake of serotonin).
Danish: Skønt der ikke foreligger studier, som har undersøgt sammenhængen mellem PPHN og behandling med SNRI, kan risikoen herfor ikke udelukkes, når man tager duloxetins lignende virkningsmekanisme i betragtning (hæmning af serotonin-genoptag).
English: Caution should also be exercised when duloxetine is used with medicinal products that may impair its metabolism (see section 4.5).
Danish: Der bør ligeledes udvises forsigtighed, når duloxetin bruges sammen med lægemidler, der kan forringe dets metabolisme (se pkt.
English: Furthermore, increases in INR values have been reported when duloxetine was co-administered to patients treated with warfarin.
Danish: Endvidere er der rapporteret stigning i INR-værdier, når duloxetin blev givet til patienter, der samtidigt blev behandlet med warfarin.
English: A randomised, double-blind, placebo-controlled study was performed in 272 patients aged 7-17 years with generalised anxiety disorder.
Danish: Der er gennemført et dobbeltblindet, randomiseret, placebokontrolleret studie med 272 patienter i alderen 7-17 år med generaliseret angst.
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 dagligt har vist effekt og er blevet evalueret fra et sikkerhedsmæssigt perspektiv i kliniske studier.
English: For patients who experience a sustained increase in blood pressure while receiving duloxetine either dose reduction or gradual discontinuation should be considered (see section 4.8).
Danish: Hos patienter som oplever et vedvarende forhøjet blodtryk under behandling med duloxetin, bør enten reduktion af eller gradvis ophør med behandlingen overvejes (se pkt.
English: Cases of hypertensive crisis have been reported with duloxetine, especially in patients with pre-existing hypertension.
Danish: For duloxetin er der rapporteret tilfælde af hypertensive kriser, specielt hos patienter, der tidligere har haft hypertension.
English: Duloxetine Lilly is for oral use.
Danish: Duloxetin Lilly er til oral brug.
English: Do not store above 30°C.
Danish: Må ikke opbevares over 30°C.
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 stateplasmaskoncentrationer af duloxetin hos pædiatriske patienter var generelt inden for koncentrationsintervallet observeret hos voksne patienter.
English: Duloxetine Lilly may cause a sensation of restlessness or an inability to sit or stand still.
Danish: Duloxetin Lilly kan give en følelse af uro eller manglende evne til at sidde eller stå stille.
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 dagligt (se også ovenstående dosisanbefaling).
English: Serotonergic agents: In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents.
Danish: Serotonerge lægemidler: Der er i sjældne tilfælde rapporteret om serotoninsyndrom hos patienter i behandling med SSRI/SNRI-præparater sammen med serotonerge lægemidler.
English: Lilly Hungária Kft. Tel: + 36 1 328 5100
Danish: Magyarország Lilly Hungária Kft. Tel: + 36 1 328 5100