FrancophonIA/ELRC3.0 huggingface dataset:
English: • phenytoin (for epilepsy); because (Invented name)® may influence the blood levels of this drug, your doctor may need to introduce phenytoin more carefully and carry out check-ups when given with (Invented name)®.
Danish: • Phenytoin (til epilepsi), fordi SÆRNAVN® kan påvirke koncentrationen af dette lægemiddel i blodet, kan det være nødvendigt for din læge at introducere phenytoin med større forsigtighed og udføre hyppigere opfølgninger ved samtidig brug af SÆRNAVN®.
English: What (Invented name)® is and what it is used for Before you take (Invented name)® How to take (Invented name)® Possible side effects
Danish: Hvad SÆRNAVN® er, og hvad det anvendes til Hvad du skal gøre, før du begynder at tage SÆRNAVN® Hvordan du tager SÆRNAVN® Hvilke mulige bivirkninger SÆRNAVN® har Hvordan du opbevarer SÆRNAVN® Yderligere oplysninger
English: • have heart problems
Danish: • Hvis du har en hjertesygdom.
English: Belgium: Prozac, Fontex, Fluoxetine ‘Lilly'
Danish: Belgien: Prozac, Fontex, Fluoxetine 'Lilly' Frankrig: Prozac, Fluoxétine Lilly
English: The active substance is fluoxetine hydrochloride.
Danish: Det aktive stof er fluoxetin
English: The MAH also undertook to participate in a prospective placebo-controlled study, which will explore possible effects of fluoxetine treatment on sexual maturation.
Danish: Indehaveren af markedsføringstilladelsen forpligtede sig desuden til at medvirke til en prospektiv placebokontrolleret undersøgelse af de mulige virkninger af fluoxetinbehandling på kønsmodningen.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 20 mg hard capsules
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS 20 MG HÅRDE KAPSLER
English: • Taking your medicine at the same time each day may help you to remember to take it regularly.
Danish: • Hvis du tager SÆRNAVN® på samme tidspunkt hver dag, er det lettere at huske.
English: Fluoxetine is a selective inhibitor of serotonin reuptake, and this probably accounts for the mechanism of action.
Danish: Fluoxetin hæmmer specifikt genoptagelsen af serotonin, hvilket regnes for at være virkningsmekanismen.
English: Two of these trials were sponsored by the MAH (HCJE and X065) and were reviewed during the MR variation procedure.
Danish: To af disse undersøgelser (HCJE og X065) er sponsoreret af indehaveren af markedsføringstilladelsen og er blevet gennemgået som led i behandlingen af ansøgningen om ændringen i henhold til den gensidige anerkendelsesprocedure.
English: • clozapine, (used to treat certain mental disorders), tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension.
Danish: • Clozapin (brugt til behandling af mentale lidelser), tramadol (smertestillende) eller triptaner (migrænemidler), for disse er der en forøget risiko for forøget blodtryk.
English: Adults - All indications: The recommended dose may be increased or decreased.
Danish: De anbefalede doser kan øges eller mindskes.
English: If (Invented name)® has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor.
Danish: Hvis SÆRNAVN® har været ordineret i længere tid og/eller i en høj dosis, bør din læge overveje et mellemrum af længere varighed.
English: In addition, only limited evidence is available concerning long-term effect on safety in children and adolescents, including effects on growth, sexual maturation and cognitive, emotional and behavioural developments (see section 5.3).
Danish: Derudover mangler der langtidsdata om sikkerhed hos børn og unge med hensyn til vækst, modning og kognitiv og adfærdsmæssig udvikling (se pkt.
English: Long-term efficacy (more than 24 weeks) has not been demonstrated in OCD.
Danish: Effekten ved behandling udover 24 uger er ikke på vist for OCD.
English: Fluoxetine is well absorbed from the gastrointestinal tract after oral administration.
Danish: Absorption: Fluoxetin absorberes godt efter oral administration.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDLER
English: • If you are allergic (hypersensitive) to fluoxetine or any of the other ingredients of (Invented name)®.
Danish: • hvis du er allergisk (overfølsom) over for det aktive stof eller et af de øvrige indholdsstoffer i
English: The black edible printing ink consists of shellac, propylene glycol, ammonium hydroxide, black iron oxide (E172) (formulation 1) or shellac, soya lecithin, antifoam DC 1510, black iron oxide (E172) (formulation 2).
Danish: Den spiselige sorte skrift består af: shellac, propylenglycol, ammoniumhydroxid, sort jernoxid (E 172) (formulering 1) eller shellac, soya lecithin, antifoam DC 1510, sort jernoxid (E172) (formulering 2).
English: Eli Lilly Sweden AB Gustav III:s boulevard 42, P.O.
Danish: Eli Lilly Sweden AB Gustav III:s boulevard 42, P.O. Box 721
English: At 10 mg/kg/day, plasma levels achieved in animals were approximately 0.8 to 8.8 fold (fluoxetine) and 3.6 to 23.2 fold (norfluoxetine) those usually observed in paediatric patients.
Danish: Ved 10 mg/kg/dag var de opnåede plasmaniveauer i forsøgsdyr ca. 0,8 til 8,8 gange større (fluoxetin) og 3,6 til 23,2 gange større (norfluoxetin) end dem, der normalt observeres hos pædiatriske patienter.
English: However, the CHMP requested the MAH to undertake an additional study in young rats, to assess the neurohormonal status of hypothalamic-pituitary-gonadal (HPG) axis during sexual maturation of juvenile male and female rats.
Danish: CHMP anmodede imidlertid indehaveren af markedsføringstilladelsen om at udføre et supplerende forsøg hos unge rotter til vurdering af den neurohormonale status af hypothalamus-hypofyse-gonade-aksen under kønsmodning af unge hun- og hanrotter.
English: • flecainide or encainide (for heart problems), carbamazepine (for epilepsy), tricyclic antidepressants (for example imipramine, desipramine and amitriptyline); because (Invented name)® may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with (Invented name)®.
Danish: • Flecain eller encainid (for hjerteproblemer), carbamazepin (til epilepsi), tricykliske antidepressiva (for eksempel imipramin, desipramin og amitriptylin), da SÆRNAVN® kan påvirke koncentrationen af dissee lægemidler i blodet, kan det være nødvendigt for din læge at nedsætte doseringen af disse ved samtidig brug af SÆRNAVN®.
English: Additionally, only limited information concerning the long-term safety of (Invented name)® on growth, puberty, mental, emotional and behavioural development in this age group is available.
Danish: Desuden er langtidsvirkningerne af SÆRNAVN® på vækst, pubertet, mental udvikling og adfærdsmæssig udvikling hos denne aldersgruppe endnu ikke blevet undersøgt.
English: • Bulimia nervosa: The recommended dose is 60 mg daily.
Danish: • Bulimi: den anbefalede daglige dosis er 60 mg.
English: 13 rue Pagès 92158 Suresnes Cedex FRANCE
Danish: 13 rue Pagès 92158 Suresnes Cedex FRANKRIG
English: Major depressive episodes.
Danish: Svære depressive episoder.
English: Hepatic/Renal Function: Fluoxetine is extensively metabolised by the liver and excreted by the kidneys.
Danish: Lever- og nyrefunktion: Fluoxetin metaboliseres i stor udstrækning i leveren og udskilles via nyrerne.
English: Do not drive or use machinery without advice from your physician or pharmacist.
Danish: Kør ikke bil eller betjen ikke værktøj eller maskiner uden vejledning af din læge eller apotek, fordi brugen af denne medicin kan påvirke din dømmekraft eller koordination.
English: The MAH committed therefore to study further the characterisation of effects on specified emotional behaviours in juvenile rats.
Danish: Indehaveren af markedsføringstilladelsen forpligtede sig derfor til udføre en undersøgelse til nærmere karakterisering af virkningen på specifikke emotionelle adfærdsmønstre hos unge rotter.
English: • the CHMP agreed that the benefits/risk balance for fluoxetine in the treatment of moderate to severe major depressive episode in children and adolescents aged 8 to 18 is favourable,
Danish: • CHMP fandt, at benefit/risk-forholdet var gunstigt for fluoxetin til behandling af moderate til svære depressive episoder hos børn og voksne i alderen 8 til 18 år.
English: • If you get a rash or allergic reaction such as itching, swollen lips/tongue or wheezing/shortness of breath, stop taking the capsules straight away and tell your doctor immediately.
Danish: • Hvis du får udslæt eller allergiske reaktion som kløe, hævede læber/tunge eller hvæsen/åndenød, skal du straks stoppe med at tage kapslerne og fortælle din læge om det.
English: The starting dose was agreed to be 10mg/day given as 2.5ml of the Prozac liquid formulation.
Danish: Som initialdosis er fastsat 10 mg/dag, givet som 2,5 ml af væskeformuleringen af Prozac.
English: Whole body - chills, sensitivity to sunlight, weight loss.
Danish: Generelt - kuldegysninger, lysfølsomhed, vægttab.
English: As with all antidepressants, fluoxetine should be discontinued in any patient entering a manic phase.
Danish: Som ved alle antidepressiva skal behandling med fluoxetin seponeres hvis patienten indtræder i en manisk fase.
English: Lilly France S.A.S 13 rue Pagès 92158 Suresnes Cedex, FRANCE
Danish: Lilly France S.A.S 13 rue Pagès 92158 Suresnes Cedex, FRANKRIG
English: Haemorrhage: There have been reports of cutaneous bleeding abnormalities such as ecchymosis and purpura with SSRI's.
Danish: Blødning: Der har i forbindelse med SSRI-præparater været rapporter om kutane blødningsabnormaliteter såsom ekkymose og purpura.
English: Hallucinations, manic reaction, confusion, agitation, anxiety and associated symptoms (e.g. nervousness), impaired concentration and thought process (e.g. depersonalisation), panic attacks, suicidal thoughts and behaviour (these symptoms may be due to the underlying disease), very rarely serotonin syndrome.
Danish: Hallucinationer, manisk reaktion, konfusion, agitation, angst og relaterede symptomer (f.eks. nervøsitet), koncentrationsbesvær og tankeforstyrelser (f.eks. depersonalisering), panikanfald (disse symptomer kan skyldes den bagvedliggende sygdom), meget sjældent serotoninsyndrom.
English: However caution should be exercised when used during pregnancy, especially during late pregnancy or just before giving birth since the following effects have been reported in new born children: irritability, tremor, muscle weakness, persistent crying, difficulty in sucking or in sleeping.
Danish: Der skal dog udvises forsigtighed ved brug under graviditet specielt sent i graviditeten eller lige op til fødslen eftersom følgende påvirkninger af det nyfødte barn er observeret: irritabilitet, rysten, muskelsvaghed, vedvarende gråd, besværlighed ved amning eller ved at sove.
English: SPECIAL STORAGE CONDITIONS Do not store above 25˚C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25°C
English: The MAH should perform the following studies and report the results to the RMS:
Danish: Indehaveren af markedsføringstilladelsen udfører nedenstående undersøgelser og indberetter resultaterne heraf til referencemedlemsstaten:
English: Hypersensitivity to fluoxetine or to any of its excipients.
Danish: Overfølsomhed overfor fluoxetin eller øvrige indholdsstoffer.
English: Hypoglycaemia has occurred during therapy with fluoxetine and hyperglycaemia has developed following discontinuation.
Danish: Hypoglykæmi er set under behandling med fluoxetin, mens hyperglykæmi har vist sig efter seponering af fluoxetin.
English: Nervous system - headache, sleep problems or unusual dreams, dizziness, poor appetite, tiredness, abnormally high mood, uncontrollable movements, fits, extreme restlessness, hallucinations, untypical wild behaviour, confusion, agitation, anxiety, nervousness, not being able to concentrate or think properly, panic attacks; or thoughts of suicide or harming yourself.
Danish: Nervesystemet - hovedpine, søvnproblemer eller usædvanlige drømme, svimmelhed, nedsat appetit, unormalt højt humør, ukontrollerbare bevægelser, kramper, ekstrem uro, hallucinationer, atypisk vild opførsel, forvirring, opstemthed, angst, koncentrations- eller tankebesvær, panik anfald eller tanker om at gøre skade på sig selv.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig eller du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du fortælle det til din læge.
English: Fluoxetine is extensively metabolised by the polymorphic enzyme CYP2D6.
Danish: Fluoxetin metaboliseres i udpræget grad via cytochrom P450IID6-systemet.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Østrig: Fluctine
English: - Juvenile rat study to characterize the development and potential reversibility of testicular toxicity (ie, neurohormonal and histopathologic evaluations) in male juvenile CD rats administered fluoxetine.
Danish: - Et undersøgelse med henblik på karakterisering af udviklingen af de testikulære forandringer og disses eventuelle reversibilitet (dvs. neurohormonal og histopatologisk bedømmelse) hos unge CD-rotter af hankøn, der gives fluoxetin.
English: However, the combination of SSRI treatment and alcohol is not advisable.
Danish: Dog frarådes samtidig brug af et SSRI-præparat og alkohol.
English: However treatment with fluoxetine can be started the following day after discontinuation of certain MAOIs called reversible MAOI-A (for instance moclobemide)
Danish: Dog kan behandling med fluoxetin påbegyndes dagen efter afbrydelse af behandling med særlige MAO-hæmmere kaldet MAO-A-hæmmere (for eksempel moclobemid).
English: Withdrawal symptoms seen on discontinuation of fluoxetine treatments: Discontinuation of fluoxetine commonly leads to withdrawal symptoms.
Danish: Seponeringssymptomer set i forbindelse med afbrydelse af behandling med fluoxetin: Seponering af fluoxetin medfører ofte abstinenssymptomer.
English: Bulimia nervosa: (Invented name)® is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity.
Danish: Bulimia nervosa: SÆRNAVN® er indiceret som supplement til psykoterapi til reduktion af spiseanfald og tvangsopkastninger.
English: Symptoms of overdose have included nausea, vomiting, seizures, cardiovascular dysfunction ranging from asymptomatic arrhythmias to cardiac arrest, pulmonary dysfunction, and signs of altered CNS status ranging from excitation to coma.
Danish: Symptomerne ved overdosering har inkluderet kvalme, opkastning, kramper, kredsløbsforstyrrelser rangerende fra asymptomatiske arytmier til hjertestop, pulmonal dysfunktion samt ændret CNS-status rangerende fra irritation til koma.
English: Urogenital system and reproductive disorders - difficulty passing urine or passing urine too frequently, poor sexual performance, prolonged erections, and producing breastmilk.
Danish: Lidelser i urinveje og det reproduktive system - vandladningsbesvær eller hyppig vandladning, dårlig seksuel formåen, forlængede erektioner, mælkeproduktion.
English: Caution is advised in patients taking SSRI's, particularly in concomitant use with oral anticoagulants, drugs known to affect platelet function (e.g. atypical antipsychotics such as clozapine, phenothiazines, most TCA's, aspirin, NSAID's) or other drugs that may increase risk of bleeding as well as in patients with a history of bleeding disorders.
Danish: Forsigtighed tilrådes specielt hos patienter, der samtidig med et SSRI-præparat behandles med orale antikoagulantia, præparater med kendt effekt på trombocyt-funktionen (f.eks. atypiske antipsykotika som clozapin, phenothiazin, de fleste tricykliske antidepressiva, acetylsalicylsyre, NSAID'er) eller andre præparater, der kan øge blødningsrisikoen.
English: • lithium, tryptophan; there is an increased risk of serotonin syndrome when these drugs are coadministered with (Invented name)®.
Danish: • Litium, tryptophan, der kan være en forøget risiko for serotoninsyndrom ved brugen af disse lægemidler samtidig med SÆRNAVN®.
English: POSSIBLE SIDE EFFECTS
Danish: HVILKE MULIGE BIVIRKNINGER SÆRNAVN® HAR
English: Concomitant therapy with drugs predominantly metabolised by this isoenzyme, and which have a narrow therapeutic index (such as flecainide, encainide, carbamazepine and tricyclic antidepressants), should be initiated at or adjusted to the low end of their dose range.
Danish: Samtidig behandling med andre lægemidler, der hovedsageligt metaboliseres via cytochrom P450IID6systemet, og som har et relativt lille terapeutisk indeks (såsom flecainid, encainid, carbamazepin og tricykliske antidepressiva), bør derfor indledes i eller justeres til den lave ende af dosisintervallet.
English: If you are already taking St John's wort when you start on (Invented name)®, stop taking the St John's wort and tell your doctor at your next visit.
Danish: Hvis du allerede tager Hyperikum, når du starter på SÆRNAVN® behandling, skal du stoppe med at tage Hyperikum og fortælle din læge dette ved næste konsultation.
English: Do not chew the capsules.
Danish: Kapslerne må ikke tygges.
English: Treatment with fluoxetine can be initiated the following day after discontinuation of a reversible MAOI.
Danish: Behandling med fluoxetin kan påbegyndes dagen efter seponering af en reversibel MAO-hæmmer.
English: It is therefore advised that (Invented name)® should be gradually tapered when discontinuing treatment over a period of at least one to two weeks, according to the patient's needs (see "Withdrawal Symptoms Seen on Discontinuation of (Invented name)®", section 4.2 Posology and Method of Administration).
Danish: Det tilrådes derfor, at SÆRNAVN® ved afbrydelse af behandlingen nedtrappes gradvist over en periode på mindst én til to uger, alt efter patientens behov (se Seponeringssymptomer set i forbindelse med afbrydelse af behandling med SÆRNAVN®", afsnit 4.2 Dosering og indgivelsesmåde).
English: At 3 mg/kg/day, plasma levels achieved in animals were approximately 0.04 to 0.5 fold (fluoxetine) and 0.3 to 2.1 fold (norfluoxetine) those usually achieved in paediatric patients.
Danish: Ved 3 mg/kg/dag var de opnåede plasmaniveauer i forsøgsdyr ca. 0,04 til 0,5 gange større (fluoxetin) og 0,3 til 2,1 gange større (norfluoxetin) end dem, der normalt observeres hos pædiatriske patienter.
English: At-risk populations
Danish: Risikopatienter:
English: In general, efficacy of fluoxetine was modest.
Danish: Generelt var der kun beskedne beviser på fluoxetins effekt.
English: Consideration should be given to using conservative titration schedules of the concomitant drug and to monitoring clinical status.
Danish: Forsigtig titrering bør overvejes under samtidig monitorering af den kliniske tilstand.
English: Due to higher plasma levels in lower weight children, the therapeutic effect may be achieved with lower doses (see Section 5.2 Pharmacokinetic properties).
Danish: På grund af højere plasmaniveauer hos børn med lav vægt kan den terapeutiske effekt muligvis opnås med lavere doser (se pkt.
English: Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Symptoms of a drug interaction with a MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma.
Danish: Symptomer på interaktion med en MAO-hæmmer inkluderer hypertermi, rigiditet, myoklonus, autonom ustabilitet med mulige hurtige udsving i vitale tegn, ændring af mental tilstand i form af konfusion, irritabilitet og ekstrem agitation ledende til delirium og koma.
English: Other - hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flushes, feeling dizzy when you stand up, or joint or muscle pain, low levels of sodium in the blood.
Danish: Andre - hårtab, gaben, sløret syn, uforklarlige blå mærker eller blødninger, svedeture, hedeture, føle sig svimmel, når man rejser sig op eller led- eller muskelsmerter, lav natrium niveau i blodet.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Du bør konsultere din læge eller apoteket, hvis du er usikker.Den normale dosis er:
English: Glycerin
Danish: Glycerol
English: After one to two weeks, the dose may be increased to 20mg/day.
Danish: Efter én til to uger kan dosis øges til 20 mg/dag.
English: (see ‘Precautions', Haemorrhage).
Danish: (Se Blødning under pkt.
English: The MAH also committed to use registries in some Member States that could be used to provide data on the effects of fluoxetine on sexual maturation.
Danish: Endvidere forpligtede indehaveren af markedsføringstilladelsen sig til anvende visse medlemsstaters registre til at skaffe oplysninger om fluoxetins indvirkning på kønsmodningen.
English: Lactation: Fluoxetine and its metabolite norfluoxetine, are known to be excreted in human breast milk.
Danish: Amning: Fluoxetin og norfluoxetin udskilles i modermælken.
English: Pulmonary events (including inflammatory processes of varying histopathology and/or fibrosis) have been reported rarely.
Danish: Lungesymptomer (inklusiv forskellige histopatologiske inflammatoriske processer og/eller fibrosis) er rapporteret som sjældne.
English: If you experience symptoms when you stop treatment, contact your doctor.
Danish: Kontakt din læge, hvis du oplever symptomer, når du stopper behandlingen.
English: MARKETING AUTHORIZATION NUMBER
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: When given fluoxetine 20 mg/day for 2 months, patients with severe renal failure (GFR <10 ml/min) requiring dialysis showed no difference in plasma levels of fluoxetine or norfluoxetine compared to controls with normal renal function.
Danish: Ved indgift af fluoxetin 20 mg dagligt i 2 måneder observeredes ingen forskel i plasmakoncentrationerne af fluoxetin og norfluoxetin hos patienter med alvorlig dialysekrævende nyresvigt (GFR < 10 ml/min) i forhold til kontrolgruppen med normal nyrefunktion.
English: When appropriate the dosage can be gradually increases up to a maximum of 60 mg.
Danish: I dette tilfælde kan dosis gradvis sættes op til maksimalt 60 mg om dagen.
English: Cardiac Disease: No conduction abnormalities that resulted in heart block were observed in the ECG of 312 patients who received fluoxetine in double blind clinical trials.
Danish: Hjertesygdomme: I et dobbeltblindt klinisk forsøg, hvor 312 patienter fik fluoxetin, observeredes ved EKG ingen ledningsforstyrrelser resulterende i grenblok.
English: Isolated cases of adverse events potentially indicating delayed sexual maturation or sexual dysfunction have been reported from paediatric clinical use.
Danish: I klinisk pædiatrisk praksis er der rapporteret isolerede tilfælde af utilsigtede hændelser, der potentielt kunne indikere forsinket seksuel udvikling eller seksuel dysfunktion.
English: - Juvenile rat study to evaluate neurohormonal status of hypothalamic-pituitary-gonadal (HPG) axis during sexual maturation of juvenile CD male and female rats administered fluoxetine.
Danish: - En undersøgelse af unge rotter for at vurdere den neurohormonale status af hypothalamushypofyse-gonade-aksen under kønsmodning hos unge CD-rotter af begge køn, der behandles med fluoxetin.
English: If you feel like this, contact your doctor.
Danish: Kontakt din læge, hvis du har denne følelse.
English: INFORMATION IN BRAILLE (Invented name)® 20 mg
Danish: INFORMATION I BRAILLE-SKRIFT SÆRNAVN® 20 mg
English: Fluoxetine is secreted into breast milk.
Danish: Fluoxetin udskilles via modermælken.
English: Serotonergic drugs: Co-administration with serotonergic drugs (e.g. tramadol, triptans) may increase the risk of serotonin syndrome.
Danish: Præparater med serotonerg virkning: Samtidig brug af præparater med serotonerg virkning (f.eks. tramadol, triptaner) kan øge risikoen for serotoninsyndrom.