FrancophonIA/ELRC3.0 huggingface dataset:
English: The same precautions should therefore be observed when treating patients with other psychiatric disorders.
Danish: Derfor bør der udvises samme forholdsregler ved behandling af patienter med andre psykiske lidelser.
English: However, the CHMP considered that the impact of the marked toxicity observed in the juvenile study, as well as the relevance of these data for children and adolescents were difficult to assess.
Danish: CHMP fandt det dog vanskeligt at vurdere virkningen af den udtalte toksiske virkning, der er iagttaget i forsøget med unge dyr, ligesom det er vanskeligt at vurdere relevansen af disse oplysninger for børn og unge.
English: The available pre-clinical data on growth suggested an impairment of bone development/growth in young rodents exposed to fluoxetine.
Danish: De foreliggende prækliniske oplysninger om vækst tyder på, at knogleudvikling/vækst hæmmes hos unge gnavere, der eksponeres for fluoxetin.
English: Ecchymosis has been reported as an infrequent event during treatment with fluoxetine.
Danish: Ekkymose er rapporteret som en usædvanlig hændelse ved behandling med fluoxetin.
English: Treatment should be discontinued in any patient who develops seizures or where there is an increase in seizure frequency.
Danish: Behandlingen skal seponeres, hvis patienten udvikler krampeanfald eller hvor disse stiger i frekvens.
English: • are using medicinal products that effect the coagulation of blood (see ‘Taking other medicines').
Danish: • Hvis du tager medicin, der påvirker blodets størkningsevne (se Anvendelse af anden medicin).
English: If you have not improved, your treatment should be reassessed.
Danish: Hvis der ikke er sket nogen forbedring, bør behandling genovervejes.
English: In these two studies the mean absolute changes in CDRS-R from baseline to endpoint were 20 for fluoxetine versus 11 for placebo, P=0.002 and 22 for fluoxetine versus 15 for placebo, P<0.001.
Danish: I disse to forsøg var de gennemsnitlige absolutte ændring i CDRS-R fra basis til endepunktet 20 for fluoxetin mod 11 for placebo, P=0,002 og 22 for fluoxetin mod 15 for placebo, P<0,001.
English: Therefore, as with other antidepressants, fluoxetine should be introduced cautiously in patients who have a history of seizures.
Danish: Derfor, som ved andre antidepressiva, bør fluoxetin introduceres med forsigtighed hos patienter, der tidligere har haft krampeanfald.
English: Mint flavour (containing 0.23% alcohol) Purified Water
Danish: Pebermynte-essens (indeholdende 0,23% alkohol) Renset vand.
English: In conclusion, some concerns in relation to growth, pubertal development, hostility and suicide related behaviour in children and adolescents treated with fluoxetine remain.
Danish: Det må konkluderes, at der tilbagestår visse betænkeligheder vedrørende vækst, pubertal udvikling, samt fjendtlig og selvmordsrelateret adfærd hos børn og unge behandlet med fluoxetin.
English: In addition, these conditions may be co-morbid with major depressive disorder.
Danish: Desuden kan disse tilstande have komorbiditet med MDD (major depressive disorder).
English: Most people find that any symptoms on stopping (Invented name)® are mild and go away on their own within a few weeks.
Danish: De fleste personer oplever at symptomer, som opstår ved afslutning af SÆRNAVN® behandling er milde og forsvinder af sig selv efter få uger.
English: In paediatric clinical trials, manic reactions, including mania and hypomania, were reported (2.6% of fluoxetine-treated patients vs. 0% in placebo-controls), leading to discontinuation in the majority of cases.
Danish: I kliniske pædiatriske forsøg blev der hyppigt rapporteret maniske reaktioner, herunder mani og hypomani (2,6% af de fluoxetin-behandlede patienter vs. 0% i kontrolgruppen, som fik placebo), hvilket i de fleste tilfælde medførte seponering af behandlingen.
English: Pharmaceutical grade edible printing ink components: Formulation 1:
Danish: Blæk anvendt til mærkning af kapslen: Formulering 1:
English: Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Danish: Du bør også vide, at patienter under 18 år har øget risiko for bivirkninger såsom selvmordsforsøg, selvmordstanker og fjendtlighed (overvejende aggression, opsætsig (oppositionel) adfærd og vrede, når de tager medicin fra denne gruppe af lægemidler.
English: Patients receiving warfarin therapy should receive careful coagulation monitoring when fluoxetine is initiated or stopped.
Danish: Patienter, der behandles med warfarin, bør overvåges nøje ved initiering eller seponering af fluoxetin.
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Danish: Hvis det under hensyntagen til kliniske behov alligevel besluttes at behandle patienter i denne gruppe, bør disse overvåges omhyggeligt for selvmordssymptomer.
English: Efficacy of fluoxetine in children and adolescents in the treatment of moderate to severe major depressive episodes has been demonstrated in three short-term (8-12 weeks duration) placebocontrolled studies.
Danish: Virkningen af fluoxetin hos børn og unge til behandling af svære depressive episoder er påvist i tre placebokontrollerede korttidsundersøgelser af 8-12 ugers varighed.
English: If you forget to take (Invented name)®
Danish: Hvis du glemmer at tage SÆRNAVN®
English: DATE OF REVISION OF THE TEXT <[To be completed nationally]>
Danish: DATO FOR ÆNDRING AF TEKSTEN <[Udfyldes nationalt]>
English: Seizures: Seizures are a potential risk with antidepressant drugs.
Danish: Krampeanfald: Krampeanfald er en potentiel risiko ved brug af antidepressiva.
English: Fluoxetine has a non-linear pharmacokinetic profile with first pass liver effect.
Danish: Metabolisme: Fluoxetin har en non-lineær farmakokinetisk profil med first-pass metabolisme i leveren.
English: An extended time for close medical observation may be needed in patients who have taken excessive quantities of a tricyclic antidepressant if they are also taking, or have recently taken, fluoxetine.
Danish: En tidsmæssig forlængelse af den medicinske monitorering kan være nødvendig for patienter, der har taget en overdosis af tricykliske antidepressiva, hvis de samtidig eller kort forinden har været i behandling med fluoxetin.
English: Some cases presented with features resembling serotonin syndrome (which may resemble and be diagnosed as neuroleptic malignant syndrome).
Danish: Nogle reaktioner mindede om serotoninsyndrom (som kan ligne/diagnosticeres som neuroleptisk malignt syndrom).
English: Response rates (the primary endpoint, defined as a 30% decrease in the CDRS-R score) demonstrated a statistically significant difference in one of the two pivotal studies (58% for fluoxetine versus 32% for placebo, P=0.013 and 65% for fluoxetine versus 54% for placebo, P=0.093).
Danish: Responsraterne (defineret ud fra en 30%-mindskning i CDRS-R-scoren) viste en statistisk signifikant forskel i det ene af de to centrale forsøg (58% for fluoxetin mod 32% for placebo, P=0,013 og 65% for fluoxetin mod 54% for placebo, P=0,093).
English: Results from this study would demonstrate whether fluoxetine is associated with an effect on the HPG axis in juvenile rats.
Danish: Resultaterne af dette forsøg vil vise, om fluoxetin er forbundet med en påvirkning af hypothalamushypofyse-gonade-aksen hos unge rotter.
English: Phenytoin: Changes in blood levels have been observed when combined with fluoxetine.
Danish: Phenytoin: Ændringer i plasmakoncentration er observeret i kombination med fluoxetin.
English: Obsessive-compulsive disorder: In short-term trials (under 24 weeks), fluoxetine was shown to be significantly more effective than placebo.
Danish: Obsessiv-kompulsiv sygdom (OCD): I forsøg af kort varighed (< 24 uger) er det vist, at fluoxetin er signifikant mere effektivt end placebo.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: De generelle kliniske erfaringer for al form for behandling af depression er, at risikoen for selvmordsforsøg kan øges i de tidlige stadier af bedringen.
English: • warfarin or other medicines used to thin the blood; (Invented name)® may alter the effect of these medicines on the blood.
Danish: • Warfarin eller andre lægemidler brugt til at fortynde blodet, da SÆRNAVN® kan påvirke disse lægemidlers virkningen på blodet.
English: Fluoxetine is excreted in breast milk and can cause side effects in babies.
Danish: SÆRNAVN® udskilles i modermælken og kan give bivirkninger hos spædbørn.
English: If fluoxetine has been prescribed chronically and/or at a high dose, a longer interval should be considered.
Danish: Ifald fluoxetin har været anvendt i længere tid og/eller i en høj dosis, bør et længere interval overvejes.
English: Respiratory System - sore throat, shortness of breath.
Danish: Respirationsystemet - hals onde, åndenød.
English: The elimination half-life of fluoxetine is 4 to 6 days and for norfluoxetine 4 to16 days.
Danish: Udskillelse: Halveringstiden for fluoxetin er 4-6 dage og for norfluoxetin 4-16 dage.
English: Steady state plasma concentrations are dependent on body weight and are higher in lower weight children (see 4.2 Posology and method of administration).
Danish: Steady state-plasmakoncentrationerne afhænger af kropsvægt og er højere hos børn med lav vægt (se pkt.
English: (Invented name)®, at a dose of 20mg, has been shown to be significantly more effective than placebo in two short-term pivotal studies, as measured by the reduction of Childhood Depression Rating Scale-Revised (CDRS-R) total scores and Clinical Global Impression of Improvement (CGI-I) scores.
Danish: Ved en dosis på 20 mg har SÆRNAVN® vist sig signifikant mere effektivt end placebo i to centrale korttidsforsøg - målt ud fra reduktionen i samlet score på CDRS-Rskalaen (Childhood Depression Rating Scale-Revised) og CGI-I-scoren (Clinical Global Impression of Improvement).
English: Examples of MAOIs include nialamide, iproniazide, selegeline, moclobemide, phenelzine, tranylcypromine, isocarboxazid and toloxatone.
Danish: Eksempler på MOA-hæmmere er: nialamid, iproniazid, selegelin, moclobemid, phenelzin, tranylxypromin, isocarboxazid og toloxaton.
English: • You should not start to take the herbal remedy St John's wort while you are being treated with (Invented name)® since this may result in an increase of undesirable effects.
Danish: • Du bør ikke begynde at tage naturmedicinen Hyperikum medens du tager SÆRNAVN®, da dette kan resultere i en uønsket forøgelse af virkningen.
English: If no improvement is observed within 10 weeks, treatment with fluoxetine should be reconsidered.
Danish: Hvis der ikke observeres bedring inden for 10 uger, bør behandlingen med fluoxetin tages op til fornyet overvejelse.
English: In this study, fluoxetine would be administered to CD rats from postnatal day 33 to postnatal day 62 with evaluations in the elevated zero maze, forced swimming test and prepulse inhibition test, once during treatment and 2 months post-treatment.
Danish: I undersøgelsen skal fluoxetin gives til CD-rotter fra dag 33 postnatalt til dag 62, og rotterne skal vurderes i elevated zero-labyrinttest, forceret svømmetest og prepulse-hæmningstest én gang under og to måneder efter behandlingen.
English: • Renal insufficiency: After single-dose administration of fluoxetine in patients with mild, moderate or complete (anuria) renal insufficiency, kinetic parameters have not been altered when compared to healthy volunteers.
Danish: • Nyreinsufficiens: Efter enkeltdosering af fluoxetin til patienter med let, moderat eller fuldstændig (anuri) nyreinsufficiens er ikke observeret ændrede farmakokinetiske parametre i forhold til raske frivillige forsøgspersoner.
English: The dose should be increased carefully to ensure that you receive the lowest effective dose.
Danish: Dosis bør øges forsigtigt for at sikre, at du får den laveste effektive dosis.
English: Capsule components:
Danish: Kapsel:
English: Pharmacokinetic data indicate that given a similar dosage, children have twice the serum levels as adolescents.
Danish: De farmakokinetiske data viser, at serumniveauet hos børn vil være dobbelt så højt som hos unge, når der indgives samme dosis.
English: The maximum dose is 60 mg per day.
Danish: Den maksimale dosis er 60 mg daglig.
English: In study X065, the starting dose was 20 mg/d, which, in case of intolerance, could be decreased to every second day of administration.
Danish: I undersøgelse X065 var doseringen initialt 20 mg dagligt, men kunne ved intolerans reduceres til indgivelse hver anden dag (20 mg hver anden dag).
English: However, after repeated administration, an increase in steady-state plateau of plasma concentrations may be observed.
Danish: Ved gentagen indgift vil en forhøjet steady-state koncentration eventuelt kunne observeres.
English: Doses above 80 mg/day have not been systematically evaluated.
Danish: Der foreligger ingen systematiske evalueringer af doser over 80 mg dagligt.
English: Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy.
Danish: Nogle læger er fortalere for samtidig adfærdsterapi til patienter, der har responderet på medicinsk behandling.
English: Fluoxetine should be discontinued in any patient entering a manic phase.
Danish: Fluoxetin bør seponeres, hvis en patient går ind i en manisk fase.
English: Two placebo-controlled studies were conducted in patients meeting Pre-Menstrual Dysphoric Disorder (PMDD) diagnostic criteria according to DSM-IV.
Danish: To placebo-kontrollerede forsøg er udført med patienter, der opfylder DSM-IV-kriteriet for præmenstruel dysforisk lidelse (PMDD).
English: The majority of reports were associated with older patients, and patients taking diuretics or otherwise volume depleted.
Danish: Størstedelen af tilfældene var relateret til ældre patienter, patienter i samtidig behandling med diuretika, eller som på anden måde havde væsketab.
English: Withdrawal symptoms seen on discontinuation of SSRI treatment: Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8 Undesirable effects).
Danish: Seponeringssymptomer set i forbindelse med afbrydelse af behandling med SSRI: Seponeringssymptomer ved afbrydelse af behandlingen er almindelige, særligt hvis afbrydelsen er brat (se afsnit 4.8 Bivirkninger).
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: A study in juvenile mice has indicated that inhibition of the serotonin transporter prevents the accrual of bone formation.
Danish: Et forsøg med unge mus har indikeret, at hæmning af serotonintransporteren forhindrer tilvækst i dannelsen af knoglevæv.
English: Fluoxetine has practically no affinity to other receptors such as α1-, α2-, and β-adrenergic, serotonergic; dopaminergic; histaminergic1; muscarinic; and GABA receptors.
Danish: Fluoxetin har næsten ingen affinitet til andre receptorer, såsom α1-, α2- og βadrenerge, serotonerge, dopaminerge, H1-, muskarine og GABA-receptorer.
English: Rash and allergic reactions: Rash, anaphylactoid events and progressive systemic events, sometimes serious (involving skin, kidney, liver or lung) have been reported.
Danish: Udslæt og allergiske reaktioner: Udslæt, anafylaktiske og progredierende systemiske reaktioner, som undertiden er alvorlige (involverende hud, nyrer, lever eller lunger) er observeret.
English: • Moderate to severe major depressive disorder, if the depression does not respond to psychological therapy after 4-6 sessions.
Danish: • Moderat til svær depressiv episode, hvis depressionen ikke responderer på psykologisk behandling efter 4-6 sessioner.
English: Lithium and tryptophan: There have been reports of serotonin syndrome when SSRIs have been given with lithium or tryptophan and, therefore, the concomitant use of fluoxetine with these drugs should be undertaken with caution.
Danish: Lithium og tryptophan: Da der har været rapporter om serotoninsyndrom, når et SSRI-præparat har været givet sammen med lithium eller tryptophan, bør der ved samtidig brug af fluoxetin og disse præparater udvises forsigtighed.
English: Fluoxetine is primarily metabolised by the liver to the active metabolite norfluoxetine (desmethylfluoxetine), by desmethylation.
Danish: Fluoxetin mataboliseres primært i leveren til den aktive metabolit norfluoxetin (demethylfluoxetin) via demethylering.
English: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions.
Danish: Moderat til svær depressiv episode, hvis depressionen ikke responderer på psykologisk behandling efter 4-6 sessioner.
English: If you have any of the following symptoms and they bother you, or last for some time, tell your doctor or a pharmacist.
Danish: Hvis du har nogen af de følgende symptomer og de bekymrer dig, fortæl det da til din læge eller apotek.
English: In a juvenile toxicology study in CD rats, administration of 30 mg/kg/day of fluoxetine hydrochloride on postnatal days 21 to 90 resulted in irreversible testicular degeneration and necrosis, epididymal epithelial vacuolation, immaturity and inactivity of the female reproductive tract and decreased fertility.
Danish: I et toksikologiforsøg med unge CD-rotter resulterede indgift af fluoxetinhydrochlorid 30 mg/kg/dag i den postnatale periode fra dag 21 til 90 i en irreversibel degeneration og nekrose af testiklerne, epitelcelle-vakuolisering af bitestiklerne, umodenhed og inaktivitet i forplantningsorganerne hos hunmus samt mindsket yngleevne.
English: Reproductive disorders: Sexual dysfunction (delayed or absent ejaculation, anorgasmia), priapism, galactorrhoea.
Danish: Forplantningssystem: Seksuel dysfunktion (forsinket eller udeblevet ejakulation og orgasme), priapisme, hypergalaktia.
English: In terms of non-clinical data, the studies in rats and mice identified several areas of concern, including effects on sexual development, growth, testicular toxicity and potential long-term neurobehavioural effects.
Danish: I den ikke-kliniske dokumentation fandtes der flere punkter i rotte- og museforsøgene, som var betænkelige, herunder påvirkningen af kønsmodningen, den toksiske virkning på testiklerne og de potentielle adfærdsneurologiske langtidsvirkninger.
English: After 19 weeks of treatment, paediatric subjects treated with fluoxetine in a clinical trial gained an average of 1.1 cm less in height (p=0.004) and 1.1 kg less in weight (p=0.008) than subjects treated with placebo.
Danish: Efter 19 ugers behandling havde de pædiatriske patienter, som fik behandling med fluoxetin i et klinisk forsøg, en gennemsnitlig mindre højdeøgning på 1,1 cm (p=0,004) og en gennemsnitlig mindre vægtøgning på 1,1 kg (p=0,008) end de patienter, som fik placebobehandling.
English: The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Danish: De samme forholdsregler, der træffes ved behandling af patienter med MDD (major depressive disorder), skal derfor også træffes ved behandling af patienter med andre psykiatriske lidelser.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Danish: Selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
English: Isolated cases of growth retardation have also been reported from clinical use.
Danish: I klinisk praksis er der desuden rapporteret isolerede tilfælde af forsinket vækst.
English: Bulimia nervosa: In short term trials (under 16 weeks), in out-patients fulfilling DSM-III-R-criteria for bulimia nervosa, fluoxetine 60 mg/day was shown to be significantly more effective than placebo for the reduction of bingeing and purging activities.
Danish: Bulimia nervosa: I forsøg af kort varighed (< 16 uger) hos ambulante patienter, der opfylder DSM-IIIR-kriteriet for bulimia nervosa, er det vist, at 60 mg fluoxetin dagligt er signifikant mere effektivt end placebo til reduktion af spiseanfald og tvangsopkastninger.
English: • have a history of bleeding disorders or you develop bruises or unusual bleeding.
Danish: • Hvis du tidligere har haft blødningsforstyrrelser eller du får blå mærker eller usædvanlig blødning.
English: In a 19-week clinical trial decreased height and weight gain was observed in children and adolescents treated with fluoxetine (see section 4.8).
Danish: I et 19-ugers klinisk forsøg blev der observeret mindsket højde- og vægtøgning hos børn og unge, der fik behandling med fluoxetin (se pkt.
English: • Major depressive episodes
Danish: • Episoder med svær depression
English: Despite this, your doctor may prescribe (Invented name)® for patients under 18 for moderate to severe major depressive episode in combination with psychological therapy because he/she decides that this is in their best interests.
Danish: Til trods for dette, vil din læge muligvis ordinere SÆRNAVN® til patienter under 18 år, fordi han/hun vurderer, at det er i deres egen bedste interesse.
English: Monoamine Oxidase Inhibitors: Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued an SSRI and have been started on a MAOI.
Danish: Monoaminooxidasehæmmere (MAO-hæmmere): Alvorlige og i nogle tilfælde fatale reaktioner er rapporteret for patienter, der indtager et SSRI-præparat i kombination med en MAO-hæmmer, samt for patienter, der for nylig har stoppet SSRI-behandling og påbegyndt behandling med en MAO-hæmmer.
English: • a combination of symptoms (know as serotonin syndrome) including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (only rarely);
Danish: • En kombination af symptomer (kaldet serotoninsyndrom) inklusiv uforklarlig feber with hurtig vejrtrækning eller hjertefrekvens, hævelse, muskelstivhed eller rysten, forvirring, ekstrem opstemthed eller søvnighed (kun sjældent).
English: (Invented name)® should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes and it should not be used in other indications.
Danish: SÆRNAVN® bør kun anvendes til behandling af børn og unge i alderen 8 til 18 år til behandling af moderate til svære depressive episoder og det skal ikke bruges til andre indikationer.
English: • the CHMP agreed that fluoxetine is effective in children and adolescents aged 8 years and above in the indication of moderate to severe major depressive episodes, if depression is unresponsive to psychological therapy after 4-6 sessions.
Danish: • Der var i CHMP enighed om, at fluoxetin er effektivt til børn og unge over 8 år til indikationen moderate til svære depressive episoder med manglende respons på psykoterapi efter 4-6 seancer.
English: Do not stop taking (Invented name)® until your doctor tells you to.
Danish: Lad ikke være med at tage SÆRNAVN® medmindre din læge siger det.
English: If you stop taking (Invented name)®
Danish: Hvis du holder op med at tage SÆRNAVN®