FrancophonIA/ELRC3.0 huggingface dataset:
English: In long term studies (three short term studies extension phase and a relapse prevention study) efficacy has not been shown.
Danish: I længerevarende forsøg (tre forsøg af kort varighed inklusiv forlængelsesfase samt en undersøgelse af tilbagefald) er effekten ikke blevet vist.
English: Patients with a history of suicide-related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Danish: Patienter med en anamnese med selvmordsrelaterede hændelser, de patienter, der udviser en markant grad af selvmordsforestillinger inden påbegyndelse af behandling, er kendt for at have større risiko for selvmordstanker eller selvmordsforsøg og bør monitoreres nøje under behandlingen.
English: In relation to emotional behaviour, the difficulties in conducing a clinical study include problems related to defining and measuring the outcome variable (emotional behaviour), and problems related to identifying an adequate control group.
Danish: Hvad angår den emotionelle adfærd, vil en klinisk undersøgelse blive vanskeliggjort af problemer med at fastlægge og måle resultatvariablen (den emotionelle adfærd) og problemer med udpegelse af en egnet kontrolgruppe.
English: Rats administered 30 mg/kg also had decreased femur lengths compared with controls and skeletal muscle degeneration, necrosis and regeneration.
Danish: Rotter, som fik indgivet 30 mg/kg, havde også mindskede femurlængder sammenlignet med kontrollerne og degeneration af skeletmuskel, nekrose og regeneration.
English: The clinical studies in children and adolescents moderate to severe major depressive episodes showed a modest but positive effect, comparable to what has been seen in adults.
Danish: I de kliniske undersøgelser hos børn og unge med moderate til svære depressive episoder er iagttaget en beskeden, men positiv virkning, som er sammenlignelig med den, der ses hos voksne.
English: These long half-lives are responsible for persistence of the drug for 5-6 weeks after discontinuation.
Danish: Disse lange halveringstider er skyld i tilstedeværelsen af lægemidlet op til 5-6 uger efter endt behandling.
English: In addition, the evaluation of the study HCLS designed to examine the growth of fluoxetine-treated children/adolescents as compared to untreated patients with the same diagnosis provided some reassurance regarding the effect of fluoxetine on growth, as fluoxetine did not have a clinically significant impact on this parameter.
Danish: Endvidere giver vurderingen af HCLSundersøgelsen, der var tilrettelagt med henblik på at sammenligne væksten hos fluoxetin-behandlede børn/unge med ubehandlede patienter med samme diagnose, en vis grad af sikkerhed med hensyn til fluoxetins indvirkning på væksten, da fluoxetin ikke havde nogen indvirkning af klinisk betydning på dette parameter.
English: • If you feel restless and feel like you cannot sit or stand still, you may have something called akathisia; increasing your dose of (Invented name)® may make you feel worse.
Danish: • Hvis du føler rastløs og føler at du ikke kan sidde eller stå stille kan du have noget der kaldes akathisi, øgning af din dosis af SÆRNAVN® kan forværre dette.
English: Results from this study will characterize the development of testicular lesions, and the reversibility of these findings at multiple time points; and potentially identify specific cellular targets and/or neurohormonal mechanisms involved in the development of these lesions.
Danish: Resultaterne af denne undersøgelse vil karakterisere udviklingen af de testikulære forandringer og deres reversibilitet på forskellige tidspunkter, og vil potentielt kunne fastlægge de specifikke cellulære mål og/eller neurohormonale mekanismer, der spiller ind ved udvikling af sådanne forandringer.
English: Patients using oral contraceptives were excluded.
Danish: Patienter der benyttede orale kontraceptiva, blev ekskluderet fra forsøgene.
English: • MAO-inhibitors (used to treat depression).
Danish: • MAO-hæmmere (brugt til behandling af depression).
English: The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Danish: Risikoen for abstinenssymptomer kan afhænge af flere faktorer, herunder behandlingsvarighed ogdosering og hyppigheden af dosisreduktion.
English: Your doctor should review the need for continuing treatment beyond 6 months.
Danish: Din læge bør vurdere behovet for at fortsætte behandlingen efter 6 måneder.
English: • have liver problems (your doctor may need to adjust your dosage)
Danish: • Hvis du har leverproblemer (kan din læge justere din dosis).
English: In order to warrant a restriction of treatment to patients who are similar to those that were included in the study, the indication was restricted to patients non-responsive to several sessions of psychological therapy and to be treated in combination with psychological therapy.
Danish: For at sikre, at behandlingen kun omfatter patienter svarende til dem, der indgik i undersøgelsen, er indikationen begrænset til patienter, der ikke har responderet på flere seancer med psykoterapi, og for hvilke behandlingen skal kombineres med psykoterapi.
English: The CHMP concluded that the data evaluated on fluoxetine has shown this medicinal product to be effective in children and adolescents with moderate to severe major depressive episodes.
Danish: CHMP konkluderede, at de evaluerede oplysninger om fluoxetin viste, at dette lægemiddel er effektivt hos børn og unge med moderate til svære depressive episoder.
English: Take your next dose the next day at the usual time.
Danish: • Hvis du glemmer en dosis, skal du bare tage din næste dosis ved sædvanlig tid næste dag.
English: Pharmacotherapeutic group: Selective serotonin reuptake inhibitors, ATC code: N06A B03.
Danish: Farmakoterapeutisk klassifikation: Selektive serotoningenoptagshæmmere, ATC-kode: N06A B 03
English: This will also apply if fluoxetine has been taken in the previous 5 weeks.
Danish: Dette gælder også for patienter, der har taget fluoxetin inden for de sidste 5 uger.
English: In one of the short-term studies, responders (in total 40 patients) were included in a 32-week placebocontrolled relapse prevention study.
Danish: I en af korttidsundersøgelserne indgik de patienter, der havde udvist respons (i alt 40 patienter), i en 32 ugers placebokontrolleret undersøgelse af redicivforebyggelse.
English: Another study in juvenile mice (treated on postnatal days 4 to 21) has demonstrated that inhibition of the serotonin transporter had long lasting effects on the behaviour of the mice.
Danish: Et andet forsøg med unge mus (behandlet på de postnatale dage 4 til 21) viste, at hæmning af serotonintransporteren havde langvarige virkninger på musenes adfærd.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Oral brug
English: If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis.
Danish: Hvis der er opnået god effekt, kan behandlingen fortsættes med dosis justeret efter individuelt behov.
English: Ireland, Italy, Netherlands, Portugal, Spain, UK: Prozac Luxembourg: Prozac, Fontex <[See Annex I - To be completed nationally]>
Danish: Irland, Italien, Holland, Portugal, Spanien og Storbritannien: Prozac Luxemborg: Prozac, Fontex <[Se bilag I - Udfyldes nationalt]>
English: Other psychiatric conditions for which (Invented name)® is prescribed can also be associated with an increased risk of suicide-related events.
Danish: Andre psykiatriske tilstande, hvor SÆRNAVN® ordineres, kan også være forbundet med en øget risiko for selvmordsrelaterede hændelser.
English: There was a therapeutic effect at 20 mg/day, but higher doses (40 or 60 mg/day) showed a higher response rate.
Danish: Der sås behandlingsmæssig effekt ved 20 mg dagligt, men højere doser (40 eller 60 mg dagligt) medførte en højere responsrate.
English: If breastfeeding is continued, your doctor may prescribe a lower dose of fluoxetine.
Danish: Hvis amningen fortsættes, kan din læge ordinere en lavere dosis fluoxetin til dig.
English: Dista S.A., Avenida Industria 30 28108 Alcobendas - Madrid SPAIN
Danish: Dista S.A., Avenida Industria 30 28108 Alcobendas - Madrid SPANIEN
English: While there are no systematic studies to answer the question of how long to continue fluoxetine treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients.
Danish: Der er ingen systematiske undersøgelser, der viser hvor lang tid man bør fortsætte fluoxetin-behandlingen; men idet OCD er en kronisk tilstand, vil det være rimeligt at overveje behandling udover 10 uger hos responderende patienter.
English: The balance of benefits and risks for fluoxetine in the treatment of depression in children and adolescents in this condition is judged to be favourable.
Danish: Benefit/risk-forholdet for fluoxetin til behandling af depression hos børn og unge i denne tilstand er vurderet som gunstigt.
English: Steady-state concentrations after prolonged dosing are similar to concentrations seen at 4 to 5 weeks.
Danish: Steady-state koncentrationer efter langvarig behandling svarer til de koncentrationer, som observeres efter 4-5 ugers behandling.
English: (Invented name)® has been shown to be significantly more effective than placebo as measured by the Hamilton Depression Rating Scale (HAM-D).
Danish: SÆRNAVN® er vist at være signifikant mere effektiv end placebo målt ved Hamilton Depression Rating Scale (HAM-D).
English: - Juvenile rat study to characterize the effects on specified emotional behaviours.
Danish: - En undersøgelse af unge rotter med henblik på karakterisering af virkningen på specificerede emotionelle adfærdsmønstre.
English: Germany: Fluctin
Danish: Tyskland: Fluctin
English: Taking (Invented name)® with food or drink
Danish: Hvordan man tager SÆRNAVN® sammen med mad og drikkevarer
English: • have diabetes your doctor may need to adjust your dose of insulin or other antidiabetic treatment);
Danish: • Hvis du har diabetes, kan det blive nødvendigt at justere doseringen af din insulin eller anden medicin for diabetes.
English: As in adults, fluoxetine and norfluoxetine accumulated extensively following multiple oral dosing; steady-state concentrations were achieved within 3 to 4 weeks of daily dosing.
Danish: Hos voksne akkumuleres fluoxetin og norfluoxetin i høj grad efter gentagne orale indgivelser - steady state-koncentrationerne blev opnået inden for 3 til 4 ugers daglig indgivelse.
English: Delays in sexual maturation occurred in males (10 and 30 mg/kg/day) and females (30 mg/kg/day).
Danish: Forsinkelser i kønsmodenhed forekom hos hanmus (10 og 30 mg/kg/dag) og hunmus (30 mg/kg/dag).
English: Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage.
Danish: Aktivt kul, der kan benyttes med sorbitol, kan være ligeså effektivt eller bedre end provokeret opkastning og ventrikelskylning.
English: The MAHs committed to provide this protocol to the RMS as soon as it is made available to them.
Danish: Indehaverne af markedsføringstilladelserne forpligter sig til at fremlægge denne protokol for referencemedlemsstaten, så snart den er til rådighed.
English: The relevance of these data for a depressed child cannot be established, however the MAH has committed to perform additional studies to further explore the mechanism of these effects.
Danish: Hvor relevante sådanne resultater er for et barn med depression, lader sig ikke afgøre, men indehaveren af markedsføringstilladelsen har forpligtet sig til at udføre supplerende undersøgelser til nærmere belysning af mekanismen i disse virkninger.
English: LIST OF EXCIPIENTS Also contains sucrose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder saccharose.
English: If (Invented name)® treatment is started or stopped when you are taking warfarin, your doctor will need to perform certain tests.
Danish: Hvis SÆRNAVN® behandling påbegyndes eller afsluttes mens du tages warfarin, skal læge udføre visse prøver.
English: Cases of overdose of fluoxetine alone usually have a mild course.
Danish: Tilfælde af overdosering med fluoxetin alene har sædvanligvis et mildt forløb.
English: • are taking diuretics (water tablets), especially when you are elderly;
Danish: • Hvis du tager vanddrivende medicin, særligt hvis du er ældre.
English: Use with triptans carries the additional risk of coronary vasoconstriction and hypertension.
Danish: Samtidig brug af triptaner medfører desuden risiko for koronar vasokontraktion og hypertension.
English: Abnormal liver function has been reported rarely, with very rare cases of hepatitis.
Danish: Unormal leverfunktion er rapporteret sjældent med meget sjældne tilfælde af hepatitis.
English: In relation to suicidality, the CHMP concluded that the current warning of the product information already informs doctors and parents to monitor patients carefully for the appearance of suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment.
Danish: Vedrørende selvmordsfare konkluderede CHMP, at den nuværende advarsel i produktoplysningerne allerede oplyser læger og forældre om, at patienterne nøje skal overvåges for tegn på selvmordsrelateret, selvbeskadigende eller fjendtlig adfærd, navnlig ved behandlingens indledning.
English: Fluoxetine may be administered as a single or divided dose, during or between meals.
Danish: Fluoxetin kan administreres som en enkelt eller delt dosis med eller uden samtidig fødeindtagelse.
English: • the CHMP agreed that appropriate warnings to inform doctors and parents about the need to monitor patients for the appearance of events in relation to growth, pubertal development, hostility and suicide related behaviour should be strengthen in the product information,
Danish: • CHMP fandt, at de pågældende advarsler til læger og forældre om nødvendigheden af at overvåge patienterne for tegn vedrørende vækst, pubertal udvikling, fjendtlig og selvmordsrelateret adfærd bør skærpes i produktoplysningerne.
English: Pregnancy and lactation
Danish: Graviditet og Amning
English: However, clinical experience in acute cardiac disease is limited, therefore caution is advisable.
Danish: Da kliniske erfaringer i forbindelse med akutte hjertesygdomme er begrænsede tilrådes det at udvise forsigtighed.
English: In common with other SSRIs the following undesirable effects have been seen:
Danish: Fælles for alle SSRI-præparater er observeret følgende bivirkninger:
English: Significantly more patients (twice as many) relapsed on placebo compared to fluoxetine.
Danish: Der var signifikant flere patienter (dobbelt så mange), der fik recidiv på placebo end på fluoxetin.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking (Invented name)®.
Danish: Du bør oplyse din læge, hvis der er tegn på eller forværring af nogen af ovenstående symptomer i forbindelse med patienter under 18 år, som tager SÆRNAVN®.
English: Use in children and adolescents under 18 years of age
Danish: Anvendelse til børn og unge under 18 år
English: (Invented name)® oral liquid contains sucrose: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: SÆRNAVN® oral opløsning indeholder saccharose: Patienter med sjældne, arvelige problemer med fruktose intolerance, glucosegalactose malabsorption eller sucrase-isomaltase insufficiens bør ikke tage dette lægemiddel.
English: MAOinhibitors type B (selegeline) can be used with (Invented name)® provided that your doctor monitors you closely.
Danish: MAO-hæmmere type B (selegelin) kan bruges sammen SÆRNAVN® givet at din læge overvåger dette nøje.
English: In clinical trials adverse events seen on treatment discontinuation occurred in approximately 60% of patients in both the fluoxetine and placebo groups.
Danish: I kliniske forsøg opstod der utilsigtede hændelser efter afbrydelse af behandlingen hos ca. 60% af patienterne i både fluoxetin- og placebogrupperne.
English: If you have a liver problem or are using other medication that might have an influence on fluoxetine, your doctor may decide to prescribe a lower dose or instruct you to use (Invented name)® every other day.
Danish: Hvis du har et leverproblem eller tager medicin, der kan påvirke fluoxetin, kan din læge vælge at ordinere en lavere dosis eller bede dig om at tage SÆRNAVN® hver anden dag.
English: The time to occur and the duration of these symptoms may be related to the long half-life of fluoxetine (4-6 days) and its active metabolite, norfluoxetine (4-16 days).
Danish: Tidspunktet og varigheden af disse symptomer kan være relateret til den lange halveringstid for fluoxetin (4-6 dage) og den aktive metabolit norfluoxetin (4-16 dage).
English: • Hepatic insufficiency: In case of hepatic insufficiency (alcoholic cirrhosis), fluoxetine and norfluoxetine half-lives are increased to 7 and 12 days, respectively.
Danish: • Leverinsufficiens: I tilfælde af leverinsufficiens (alkoholinduceret cirrhose) vil halveringstiden for fluoxetin og norfluoxetin forøges til henholdsvis 7 og 12 dage.
English: In paediatric clinical trials, fluoxetine treatment was associated with a decrease in alkaline phosphatase levels.
Danish: I kliniske pædiatriske forsøg var fluoxetin forbundet med en formindskelse af niveauer af alkalisk fosfatase.
English: In relation to sexual maturation, in animal studies there were indications of dose-related delay in both male and female sexual development.
Danish: I forbindelse med kønsmodning viste dyreforsøgene tegn på dosisafhængig forsinkelse i kønsmodningen hos begge køn.
English: However, definitive conclusions on efficacy and duration of treatment cannot be drawn from these studies.
Danish: Der kan på baggrund af disse forsøg dog ikke drages endelige konklusioner om effekt og behandlingslængde.
English: Not all pack sizes may be marketed 6.6.
Danish: <Ikke alle pakningsstørrelser er nødvendigvis markedsført.>
English: Forced diuresis, dialysis, haemoperfusion, and exchange transfusion are unlikely to be of benefit.
Danish: Tvungen diurese, dialyse, hæmoperfusion og udskiftningstransfusion vil formodentlig ikke have effekt.
English: Effects on ability to drive and use machines
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
English: • the MAH committed to perform additional pre-clinical studies to explore further the mechanism of the effects on sexual development, testicular toxicity and emotional behaviour seen in rats, and to discuss any necessary follow up measures needed as a result of these studies,
Danish: • Indehaveren af markedsføringstilladelsen forpligter sig til at udføre supplerende prækliniske forsøg til nærmere belysning af mekanismerne i påvirkningen af kønsmodningen, den testikulære toksicitet og den emotionelle adfærd, der er iagttaget i rotter, og på at drøfte eventuelle opfølgende foranstaltninger, som forsøgene måtte vise, der er behov for.
English: In two studies (HCJE and TADS), the starting dose 10 mg/d was increased to 20mg/d after one week with an optional further increase to 40 mg/d in one study.
Danish: I to af undersøgelserne (HCJE og TADS) blev den initiale dosering på 10 mg dagligt efter en uge sat op til 20 mg dagligt med mulighed for yderligere forhøjelse til 40 mg dagligt i den ene undersøgelse.
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events).
Danish: Depression er forbundet med en forøget risiko for selvmordstanker, skade på sig selv og selvmordsforsøg (selvmordsrelaterede hændelser).
English: Fatality attributed to overdose of fluoxetine alone has been extremely rare.
Danish: Dødsfald som følge af overdosering med fluoxetin alene har været yderst sjældne.
English: Non-selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) should not be used with (Invented name)® as serious or even fatal reactions (serotonin syndrome) can occur (see section “Do not take (Invented name)®”).
Danish: Ikke-selektive MAO-hæmmere og MAOhæmmere type A (moclobemid) bør ikke bruges samtidig med SÆRNAVN®, da der kan ske alvorlige eller dødlige reaktioner (serotoninsyndrom) (se Du bør ikke tage SÆRNAVN®).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <[To be completed nationally]>
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN <[Udfyldes nationalt]>
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA
English: Upon the appearance of rash or of other allergic phenomena for which an alternative aetiology cannot be identified, fluoxetine should be discontinued.
Danish: Hvis der forekommer udslæt eller andre mulige allergiske reaktioner, for hvilke en alternativ ætiologi ikke kan bestemmes, bør fluoxetin seponeres.
English: Major depressive episodes: Clinical trials in patients with major depressive episodes have been conducted versus placebo and active controls.
Danish: Svære depressive episoder: Der er foretaget kliniske forsøg hos patienter med major depression versus placebo og aktiv kontrolgruppe.
English: Pregnancy: Data on a large number of exposed pregnancies do not indicate a teratogenic effect of fluoxetine.
Danish: Graviditet: Data om fluoxetin fra et stort antal graviditeter indikerer ingen teratogen effekt.
English: There is no evidence of carcinogenicity or mutagenicity from in vitro or animal studies.
Danish: Der er ikke påvist karcinogen eller mutagen effekt eller forringelse af fertiliteten med fluoxetin i in vitro undersøgelser eller i dyreforsøg.
English: Alcohol: In formal testing, fluoxetine did not raise blood alcohol levels or enhance the effects of alcohol.
Danish: Alkohol: Forsøg har vist, at fluoxetin ikke øger alkoholmængden i blodet eller forstærker effekten af alkohol.
English: If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered.
Danish: Hvis der ikke opnås nogen klinisk gavnlig effekt inden for 9 uger, skal behandlingen genovervejes.
English: Mania: Antidepressants should be used with caution in patients with a history of mania/hypomania.
Danish: Mani: Antidepressiva bør anvendes med forsigtighed til patienter med tidligere manifestationer af mani/hypomani.
English: These symptoms may indicate either serotonergic effects or a withdrawal syndrome.
Danish: Disse symptomer kan indikere enten serotonerg effekt eller abstinenssymptomer.
English: Some cases were possibly due to the syndrome of inappropriate antidiuretic hormone secretion.
Danish: Visse tilfælde havde formodentlig baggrund i utilstrækkelig sekretion af ADH.
English: Cardiac and vital signs monitoring are recommended, along with general symptomatic and supportive measures.
Danish: Det anbefales at monitorere hjertefunktion og andre vitale funktioner samt at yde generel symptomatisk behandling.
English: The combination of fluoxetine with a reversible MAOI (e.g. moclobemide) is not recommended.
Danish: Kombinationen af fluoxetin og en reversibel MAO-hæmmer (f.eks. moclobemid) kan ikke anbefales.
English: Akathisia/psychomotor restlessness: The use of fluoxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Danish: Akathisi/psykomotorisk uro: Brug af fluoxetin har være forbundet med udvikling af akatisi karakteriseret ved en subjektivt ubehagelig eller foruroligende rastløshed og behov for bevæge sig hyppigt, ledsaget af en manglende evne til at sidde eller stå stille.
English: In these studies, (Invented name)® produced a significantly higher rate of response (defined by a 50% decrease in the HAM-D score) and remission, compared to placebo.
Danish: I disse forsøg gav SÆRNAVN® en signifikant højere responsrate (defineret ud fra en 50% nedsættelse i HAM-D score) samt remissionsrate i forhold til placebo.