natgillin/translations-raw huggingface dataset:
Den tredje undersøgelse er sponsoreret af National Institute of Mental Health (NIMH) – TADS- undersøgelsen (Treatment of Adolescents with Depression).
The third was a trial sponsored by the National Institute of Mental Health (NIMH) – the Treatment of Adolescents with Depression trial (TADS).
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.
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.
I undersøgelse X065 var doseringen initialt 20 mg dagligt, men kunne ved intolerans reduceres til indgivelse hver anden dag (20 mg hver anden dag).
In study X065, the starting dose was 20 mg/ d, which, in case of intolerance, could be decreased to every second day of administration.
I en af korttidsundersøgelserne indgik de patienter, der havde udvist respons (i alt 40 patienter), i en 32 ugers placebokontrolleret undersøgelse af redicivforebyggelse.
In one of the short-term studies, responders (in total 40 patients) were included in a 32-week placebo- controlled relapse prevention study.
Som initialdosis er fastsat 10 mg/ dag, givet som 2, 5 ml af væskeformuleringen af Prozac.
The starting dose was agreed to be 10mg/ day given as 2.5ml of the Prozac liquid formulation.
Dosis bør omhyggeligt justeres til den enkelte patient for at holde patienten på den laveste effektive dosis.
Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose.
Først efter en til to uger kan doseringen øges til 20 mg dagligt.
Only after one to two weeks, the dose may be increased to 20mg/ day.
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.
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.
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.
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.
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De foreliggende prækliniske oplysninger om vækst tyder på, at knogleudvikling/ vækst hæmmes hos unge gnavere, der eksponeres for fluoxetin.
The available pre-clinical data on growth suggested an impairment of bone development/ growth in young rodents exposed to fluoxetine.
Endvidere giver vurderingen af HCLS - undersøgelsen, 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.
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.
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.
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.
Indehaveren af markedsføringstilladelsen pegede på muligheden af fluoxetin- induceret hæmning af GnRH som en årsag til forstyrrelse af det endokrine system.
The MAH suggested the involvement of fluoxetine-induced inhibition of GnRH, so that fluoxetine would act as an endocrine disrupter.
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.
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.
Resultaterne af dette forsøg vil vise, om fluoxetin er forbundet med en påvirkning af hypothalamus - hypofyse- gonade- aksen hos unge rotter.
Results from this study would demonstrate whether fluoxetine is associated with an effect on the HPG axis in juvenile rats.
Benefit/ risk- forholdet for fluoxetin til behandling af depression hos børn og unge i denne tilstand er vurderet som gunstigt.
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.
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12, i Kommissionens forordning (EF) nr.
SUMMARIES OF
1084/ 2003 for Prozac og tilknyttede navne (jf. bilag I).
CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS Whereas, • the CHMP considered the referral made under Article 6(12) of Commission Regulation EC No 1084/ 2003, for Prozac and associated names (see Annex I),
• 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.
• 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.
Antidepressiv medikamentel behandling bør kun tilbydes børn eller unge med moderat til svær depression, når den kombineres med sideløbende psykoterapi.
Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy,
• 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.
• 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,
De særlige betingelser fremgår af bilag IV.
The CHMP recommended the granting of the variation of the Marketing Authorisations for which the Summaries of Product Characteristics, Labelling and Package Leaflets are set out in Annex III and under the conditions set out in Annex IV.
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PRODUKTRESUME, ETTIKETTERING OG INDLÆGSSEDDEL
SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS
Disse produktoplysninger er de samme som dem, der var vedlagt Kommissionens afgørelse af denne artikel 6- indbringelse vedrørende lægemidler indeholdende fluoxetin.
This Product Information is the one that was Annexed to the Commission Decision on this Article 6(12) referral for fluoxetine containing medicinal products.
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1.
SÆRNAVN® 20 mg hårde kapsler
NAME OF THE MEDICAL PRODUCT
< [Se bilag I - Udfyldes nationalt] >
(Invented name)® 20 mg hard capsules< [See Annex I - To be completed nationally] >
Hver kapsel indeholder 20 mg fluoxetin som fluoxetinhydrochlorid.
Each capsule contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine.
Kapsler, hårde.
Hard capsules.
Obsessiv- kompulsiv sygdom (OCD).
Obsessive-compulsive disorder.
Bulimia nervosa:
Bulimia nervosa:
SÆRNAVN® er indiceret som supplement til psykoterapi til reduktion af spiseanfald og tvangsopkastninger.
(Invented name)® is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity.
Børn og unge fra 8 år.
Children and adolescents aged 8 years and above:
Moderat til svær depressiv episode, hvis depressionen ikke responderer på psykologisk behandling efter 4- 6 sessioner.
Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4– 6 sessions.
Antidepressiva bør kun tilbydes til et barn eller en ung person med moderat til svær depression i kombination med en samtidig psykologisk behandling (såsom kognitiv adfærdsterapi eller familieterapi).
Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
20- 60 mg dagligt.
Adults and the elderly:
Det anbefales initialt at give 20 mg dagligt.
The recommended dose is 20mg daily.
På trods af den mulige forøgede risiko for bivirkninger ved højere doser kan en øgning af dosis overvejes efter 3 uger, hvis patienten ikke har responderet på initialdosis.
Dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate.
Det anbefales initialt at give 20 mg dagligt.
Although there may be an increased potential for undesirable effects at higher doses, in some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 60 mg (see section 5.1).
På trods af den mulige forøgede risiko for bivirkninger ved højere doser kan en øgning af dosis overvejes efter 2 uger, hvis patienten ikke har responderet på initialdosis.
Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose.
Hvis der er opnået god effekt, kan behandlingen fortsættes med dosis justeret efter individuelt behov.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Der er ingen systematiske EMEA/ CHMP/ 46089/ 2006/ DA
EMEA/ CHMP/ 46089/ 2006/ EN Obsessive-compulsive disorder -
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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.
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.
Justering af dosis bør foretages på en individuel basis, således at patienten kan holdes på den laveste effektive dosis.
Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose.
Bulimia nervosa:
Bulimia nervosa - Adults and the elderly:
60 mg dagligt.
A dose of 60 mg/ day is recommended.
Effekten ved behandling udover 3 mdr. af bulimia nervosa er ikke påvist.
Long-term efficacy (more than 3 months) has not been demonstrated in bulimia nervosa.
Voksne – Alle indikationer:
Adults - All indications:
De anbefalede doser kan øges eller mindskes.
The recommended dose may be increased or decreased.
Der foreligger ingen systematiske evalueringer af doser over 80 mg dagligt.
Doses above 80 mg/ day have not been systematically evaluated.
Startdoseringen er 10 mg/ dag indgivet som 2, 5 ml SÆRNAVN® oral opløsning.
The starting dose is 10mg/ day given as 2.5ml of the (Invented name)® liquid formulation.
Efter én til to uger kan dosis øges til 20 mg/ dag.
After one to two weeks, the dose may be increased to 20mg/ day.
Der er meget begrænset klinisk erfaring med daglige doser over 20 mg.
Clinical trial experience with daily doses greater than 20mg is minimal.
Der foreligger kun begrænsede data for behandling i mere end 9 uger.
There is only limited data on treatment beyond 9 weeks.
5. 2 Farmakokinetiske egenskaber).
Due to higher plasma levels in lower weight children, the therapeutic effect may be achieved with lower doses (see Section 5.2 Pharmacokinetic properties).
Daglig dosis bør generelt ikke overstige 40 mg.
Caution is recommended when increasing the dose and the daily dose should generally not exceed 40 mg.
Maksimal anbefalet dosis er 60 mg dagligt.
Maximum recommended dose is 60 mg/ day.
20 mg hver 2. dag) overvejes (se pkt 5. 2 Farmakokinetiske egenskaber).
A lower or less frequent dose (e. g.
4. 5 Interaktion med andre lægemidler og andre former for interaktion).
20 mg every second day) should be considered in patients with hepatic impairment (see 5.2 Pharmacokinetic properties), or in patients where concomitant medication has the potential for interaction with (Invented name)® (see 4.5 Interactions).
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seponering kan det overvejes at vende tilbage til den tidligere ordinerede dosis.
Abrupt discontinuation should be avoided.
Overfølsomhed overfor fluoxetin eller øvrige indholdsstoffer.
Hypersensitivity to fluoxetine or to any of the excipients.
Monoaminooxidasehæmmere (MAO- hæmmere):
Monoamine Oxidase Inhibitors:
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.
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.
Behandling med fluoxetin bør først startes 2 uger efter seponering af en irreversibel MAO- hæmmer.
Treatment of fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI and the following day after discontinuation of a reversible MAOI-A.
Nogle reaktioner mindede om serotoninsyndrom (som kan ligne/ diagnosticeres som neuroleptisk malignt syndrom).
Some cases presented with features resembling serotonin syndrome (which may resemble and be diagnosed as neuroleptic malignant syndrome).
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.
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.
Fluoxetin er derfor kontraindiceret i kombination med en non- selektiv MAO- hæmmer.
Therefore, fluoxetine is contra-indicated in combination with a non-selective MAOI.
Behandling med en MAO- hæmmer bør ikke påbegyndes førend 5 uger efter seponering af fluoxetin.
Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI.
Ifald fluoxetin har været anvendt i længere tid og/ eller i en høj dosis, bør et længere interval overvejes.
If fluoxetine has been prescribed chronically and/ or at a high dose, a longer interval should be considered.
Kombinationen af fluoxetin og en reversibel MAO- hæmmer (f. eks. moclobemid) kan ikke anbefales.
The combination of fluoxetine with a reversible MAOI (e. g. moclobemide) is not recommended.
Behandling med fluoxetin kan påbegyndes dagen efter seponering af en reversibel MAO- hæmmer.
Treatment with fluoxetine can be initiated the following day after discontinuation of a reversible MAOI.
Anvendelse til børn og unge under 18 år:
Use in children and adolescents under 18 years of age
5. 3).
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).
4. 8).
In a 19-week clinical trial decreased height and weight gain was observed in children and adolescents treated with fluoxetine (see section 4.8).
5. 3 og 4. 8).
The possibility of a delay in puberty cannot be ruled out (see sections 5.3 and 4.8).
Vækst og pubertetsudvikling (højde, vægt og TANNER- stadie) bør derfor monitoreres under og efter behandling med fluoxetin.
Growth and pubertal development (height, weight and TANNER staging) should therefore be monitored during and after treatment with fluoxetine.
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Krampeanfald er en potentiel risiko ved brug af antidepressiva.
Seizures are a potential risk with antidepressant drugs.
Fluoxetin bør undgås til patienter med dårligt kontrollerede anfaldslidelser/ epilepsi og patienter med kontrolleret epilepsi bør nøje monitoreres.
Fluoxetine should be avoided in patients with unstable seizure disorders/ epilepsy and patients with controlled epilepsy should be carefully monitored.
Mani:
Mania:
Antidepressiva bør anvendes med forsigtighed til patienter med tidligere manifestationer af mani/ hypomani.
Antidepressants should be used with caution in patients with a history of mania/ hypomania.
Lever - og nyrefunktion:
Hepatic/ Renal Function:
Fluoxetin metaboliseres i stor udstrækning i leveren og udskilles via nyrerne.
Fluoxetine is extensively metabolised by the liver and excreted by the kidneys.
Behandling med nedsat dosis, evt. dosering hver anden dag, anbefales hos patienter med betydelig leverfunktionsnedsættelse.
A lower dose, e. g., alternate day dosing, is recommended in patients with significant hepatic dysfunction.
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.
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.
Hjertesygdomme:
Cardiac Disease:
I et dobbeltblindt klinisk forsøg, hvor 312 patienter fik fluoxetin, observeredes ved EKG ingen ledningsforstyrrelser resulterende i grenblok.
No conduction abnormalities that resulted in heart block were observed in the ECG of 312 patients who received fluoxetine in double blind clinical trials.
Vægttab:
Weight Loss:
Dette er sædvanligvis proportionalt med personens startvægt.
Weight loss may occur in patients taking fluoxetine but it is usually proportional to baseline body weight.
Den glykæmiske regulering kan ændres hos diabetikere i behandling med et SSRI- præparat.
In patients with diabetes, treatment with an SSRI may alter glycaemic control.
Det kan være nødvendigt at justere doseringen af insulin eller orale antidiabetika, når behandling med fluoxetin påbegyndes eller seponeres.
Insulin and/ or oral hypoglycaemic dosage may need to be adjusted.
Depression er forbundet med en øget risiko for selvmordstanker For antidepressiva gælder generelt, at der kan gå nogle uger før patienten opnår en bedring.
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Patienten bør derfor nøje monitoreres i denne periode.
This risk persists until significant remission occurs.
Risikoen for selvmordsforsøg er forbundet med depression og denne risiko kan vedblive, indtil betydelig bedring indtræder.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
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Seponeringssymptomer set i forbindelse med afbrydelse af behandling med SSRI:
Akathisia/ psychomotor restlessness:
Seponeringssymptomer ved afbrydelse af behandlingen er almindelige, særligt hvis afbrydelsen er brat (se afsnit 4. 8 Bivirkninger).
This is most likely to occur within the first few weeks of treatment.
I kliniske forsøg opstod der utilsigtede hændelser efter afbrydelse af behandlingen hos ca.
In patients who develop these symptoms, increasing the dose may be detrimental.
60% af patienterne i både fluoxetin - og placebogrupperne.
In clinical trials adverse events seen on treatment discontinuation occurred in approximately 60% of patients in both the fluoxetine and placebo groups.
Af disse utilsigtede hændelser var 17% i fluoxetin- gruppen og 12% i placebogruppen af alvorlig karakter.
Of these adverse events, 17% in the fluoxetine group and 12% in the placebo group were severe in nature.
Risikoen for abstinenssymptomer kan afhænge af flere faktorer, herunder behandlingsvarighed og - dosering og hyppigheden af dosisreduktion.
The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
De mest hyppigt rapporterede reaktioner er svimmelhed, sensibilitetsforstyrrelser (herunder paræstesi), søvnforstyrrelser (herunder søvnløshed og intense drømme), asteni, agitation eller angst, kvalme og/ eller opkastning, rysten og hovedpine er de mest hyppigt rapporterede reaktioner.
Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), asthenia, agitation or anxiety, nausea and/ or vomiting, tremor and headache are the most commonly reported reactions.
Generelt er disse symptomer selvbegrænsende og forsvinder som regel inden for 2 uger, selvom de hos nogle personer kan være langvarige (2- 3 måneder eller mere).
Generally these symptoms are self- limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
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).
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).
Der har i forbindelse med SSRI- præparater været rapporter om kutane blødningsabnormaliteter såsom ekkymose og purpura.
There have been reports of cutaneous bleeding abnormalities such as ecchymosis and purpura with SSRI’ s.
Andre blødningsmanifestationer (f. eks. gynækologiske, gastrointestinale og andre kutane eller mukøse blødninger) er rapporteret som værende sjældne.
Other hemorrhagic manifestations (e. g., gynaecological haemorrhages, gastrointestinal bleedings and other cutaneous or mucous bleedings) have been reported rarely.
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.
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.
Elektrokonvulsiv terapi (ECT):
Electroconvulsive Therapy (ECT):
Der opfordres til forsigtighed, da der i sjældne tilfælde er observeret forlængede krampeanfald hos patienter i samtidig behandling med fluoxetin og ECT.
There have been rare reports of prolonged seizures in patients on fluoxetine receiving ECT treatment, therefore caution is advisable.
Perikum:
St John’ s Wort: