natgillin/translations-raw huggingface dataset:
En forøget serotonerg effekt såsom serotoninsyndrom kan forekomme ved samtidig brug af et SSRI- præparat og præparater indeholdende perikum (Hypericum perforatum).
An increase in serotonergic effects, such as serotonin syndrome, may occur when selective serotonin reuptake inhibitors and herbal preparations containing St John’ s Wort (Hypericum perforatum) are used together.
L- tryptophan) og/ eller neuroleptika.
On rare occasions development of a serotonin syndrome or neuroleptic malignant syndrome-like events have been reported in association with treatment of fluoxetine, particularly when given in combination with other serotonergic (among others L-tryptophan) and/ or neuroleptic drugs.
(se pkt.
4.5.
4. 3 Kontraindikationer).
Interaction with other medicinal products and other forms of interaction
På grund af risikoen for serotoninsyndrom anbefales klinisk monitorering.
Interaction studies have only been performed in adults.
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Ændringer i plasmakoncentration er observeret i kombination med fluoxetin.
Changes in blood levels have been observed when combined with fluoxetine.
Præparater med serotonerg virkning:
Serotonergic drugs:
Samtidig brug af præparater med serotonerg virkning (f. eks. tramadol, triptaner) kan øge risikoen for serotoninsyndrom.
Co-administration with serotonergic drugs (e. g. tramadol, triptans) may increase the risk of serotonin syndrome.
Lithium og tryptophan:
Lithium and 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.
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.
Cytochrom P450IID6:
CYP2D6 isoenzyme:
Samtidig behandling med præparater, der også metaboliseres via dette enzym- system vil kunne medføre interaktioner.
Because fluoxetine’ s metabolism (like tricyclic antidepressants and other selective serotonin antidepressants) involves the hepatic cytochrome CYP2D6 isoenzyme system, concomitant therapy with drugs also metabolised by this enzyme system may lead to drug interactions.
Samtidig behandling med andre lægemidler, der hovedsageligt metaboliseres via cytochrom P450IID6 - systemet, 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.
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.
Der er ved samtidig administration af fluoxetin og orale antikoagulantia i sjældne tilfælde observeret en ændret antikoagulerende effekt (laboratorieværdier og/ eller kliniske tegn og symptomer) med øget blødning, dog uden et ensartet mønster.
Altered anti-coagulant effects (laboratory values and/ or clinical signs and symptoms), with no consistent pattern, but including increased bleeding, have been reported uncommonly when fluoxetine is co-administered with oral anticoagulants.
(Se Blødning under pkt.
(see ‘ Precautions’, Haemorrhage).
Forsøg har vist, at fluoxetin ikke øger alkoholmængden i blodet eller forstærker effekten af alkohol.
In formal testing, fluoxetine did not raise blood alcohol levels or enhance the effects of alcohol.
Dog frarådes samtidig brug af et SSRI- præparat og alkohol.
However, the combination of SSRI treatment and alcohol is not advisable.
Perikum:
John’ s Wort:
Som ved andre SSRI- præparater kan der forekomme farmakodynamiske interaktioner mellem fluoxetin og perikum (Hypericum perforatum), der kan medføre en øgning af bivirkningerne.
John’ s Wort (Hypericum perforatum) may occur, which may result in an increase of undesirable effects.
Data om fluoxetin fra et stort antal graviditeter indikerer ingen teratogen effekt.
Data on a large number of exposed pregnancies do not indicate a teratogenic effect of fluoxetine.
Disse symptomer kan indikere enten serotonerg effekt eller abstinenssymptomer.
These symptoms may indicate either serotonergic effects
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Bivirkninger vil kunne formindskes i intensitet og hyppighed ved fortsat behandling og bør generelt ikke lede til et ophør med behandlingen.
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).
Fælles for alle SSRI- præparater er observeret følgende bivirkninger:
Adverse events have been reported in breastfeeding infants.
Generelt:
4.7.
Overfølsomhed (f. eks. puritis, udslæt, urticaria, anafylaktiske reaktioner, vasculitis, serumsygdom- lignende reaktioner, angioødem) (se pkt.
Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive drug may impair judgment or skills.
4. 3 Kontraindikationer samt pkt.
Undesirable effects
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen), kulderystelser, serotoninsyndrom, fotosensitivitet samt meget sjældent toksisk epidermal nekrolyse (Lyell syndrom).
Hypersensitivity (e. g. pruritis, rash, urticaria, anaphylactoid reaction, vasculitis, serum sickness-like reaction, angioedema) (see ‘ Contraindications’ and ‘ Warnings’), chills, serotonin syndrome, photosensitivity, very rarely Toxic Epidermal Necrolysis (Lyell syndrome).
Fordøjelsessystem:
Digestive system:
Gastrointestinale symptomer (f. eks. diarré, kvalme, opkastning, dyspepsi, dysfagi, smagsforvrængning), mundtørhed.
Gastrointestinal disorders (e. g. diarrhoea, nausea, vomiting, dyspepsia, dysphagia, taste perversion), dry mouth.
Nervesystem:
Nervous system:
Hovedpine, søvnforstyrrelser (f. eks. abnorme drømme, søvnløshed), svimmelhed, appetitløshed, træthed (f. eks. søvnighed, døsighed), eufori, forbigående bevægelsesforstyrrelser (f. eks. muskeltrækninger, ataksi, tremor, myoklonus), krampeanfald samt psykomotorisk rastløshed.
Headache, sleep abnormalities (e. g. abnormal dreams, insomnia), dizziness, anorexia, fatigue (e. g. somnolence, drowsiness), euphoria, transient abnormal movement (e. g., twitching, ataxia, tremor, myoclonus), seizures and rarely psychomotor restlessness/ akathisia (see section 4.4 Special warning and precautions for use).
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.
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.
Urogenitalsystem:
Urogenital system:
Vandladningsbesvær, vandladningsfrekvens.
Urinary retention, urinary frequency
Forplantningssystem:
Reproductive disorders:
Seksuel dysfunktion (forsinket eller udeblevet ejakulation og orgasme), priapisme, hypergalaktia.
Sexual dysfunction (delayed or absent ejaculation, anorgasmia), priapism, galactorrhoea.
Hårtab, gaben, synsforstyrrelser (f. eks. sløret syn, mydriasis), svedtendens, vasodilatation, ledsmerter, muskelsmerter, postural hypotension, ekkymose.
Alopecia, yawn, abnormal vision (e. g., blurred vision, mydriasis), sweating, vasodilatation, arthralgia, myalgia, postural hypotension, ecchymosis.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
Other haemorrhagic manifestations (e. g., gynaecological haemorrhages, gastrointestinal bleedings and other cutaneous or mucous bleedings) have been reported rarely (see ‘ Precautions’, Haemorrhage).
Hyponatriæmi:
Hyponatraemia:
Disse var reversible ved seponering af fluoxetin.
Hyponatraemia (including serum sodium below 110 mmol/ l) has been rarely reported and appeared to be reversible when fluoxetine was discontinued.
Respirationssystemet:
Respiratory system:
Pharyngitis, dyspnø.
Pharyngitis, dyspnoea.
Lungesymptomer (inklusiv forskellige histopatologiske inflammatoriske processer og/ eller fibrosis) er rapporteret som sjældne.
Pulmonary events (including inflammatory processes of varying histopathology and/ or fibrosis) have been reported rarely.
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Seponeringssymptomer set i forbindelse med afbrydelse af behandling med fluoxetin:
Withdrawal symptoms seen on discontinuation of fluoxetine treatments:
Seponering af fluoxetin medfører ofte abstinenssymptomer.
Discontinuation of fluoxetine commonly leads to withdrawal symptoms.
Generelt er disse hændelser milde til moderate og er selvbegrænsende, men hos nogle patienter kan de være alvorlige og/ eller langvarige (se pkt.
Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/ or prolonged (see section 4.4 Special warnings and precautions for use).
4. 2 Dosering og indgivelsesmåde og pkt.
It is therefore advised that when (Invented name)® treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 Posology and Method of Administration and section 4.4 Special warnings and precautions for use).
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen):
Children and adolescents (see section 4.4 Special warnings and precautions for use):
I kliniske pædiatriske forsøg blev der hyppigt rapporteret maniske reaktioner, herunder mani og hypomani (2, 6% af de fluoxetin- behandlede patienter vs.
In paediatric clinical trials, manic reactions, including mania and hypomania, were reported (2.6% of fluoxetine-treated patients vs.
0% i kontrolgruppen, som fik placebo), hvilket i de fleste tilfælde medførte seponering af behandlingen.
0% in placebo-controls), leading to discontinuation in the majority of cases.
Disse patienter havde ikke tidligere haft episoder med hypomani/ mani.
These patients had no prior episodes of hypomania/ mania.
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.
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.
(se også afsnit 5. 3)
(see also section 5.3)
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.
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.
EMEA/ CHMP/ 46089/ 2006/ DA 5.
EMEA/ CHMP/ 46089/ 2006/ EN
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Fluoxetin har næsten ingen affinitet til andre receptorer, såsom α1 -, α2 - og β - adrenerge, serotonerge, dopaminerge, H1 -, muskarine og GABA- receptorer.
Fluoxetine has practically no affinity to other receptors such as α 1-, α 2-, and β -adrenergic, serotonergic; dopaminergic; histaminergic1; muscarinic; and GABA receptors.
Svære depressive episoder:
Major depressive episodes:
Der er foretaget kliniske forsøg hos patienter med major depression versus placebo og aktiv kontrolgruppe.
Clinical trials in patients with major depressive episodes have been conducted versus placebo and active controls.
SÆRNAVN® er vist at være signifikant mere effektiv end placebo målt ved Hamilton Depression Rating Scale (HAM- D).
(Invented name)® has been shown to be significantly more effective than placebo as measured by the Hamilton Depression Rating Scale (HAM-D).
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.
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.
Obsessiv- kompulsiv sygdom (OCD):
Obsessive-compulsive disorder:
I forsøg af kort varighed (< 24 uger) er det vist, at fluoxetin er signifikant mere effektivt end placebo.
In short-term trials (under 24 weeks), fluoxetine was shown to be significantly more effective than placebo.
Der sås behandlingsmæssig effekt ved 20 mg dagligt, men højere doser (40 eller 60 mg dagligt) medførte en højere responsrate.
There was a therapeutic effect at 20 mg/ day, but higher doses (40 or 60 mg/ day) showed a higher response rate.
I forsøg af kort varighed (< 16 uger) hos ambulante patienter, der opfylder DSM- III - R- kriteriet for bulimia nervosa, er det vist, at 60 mg fluoxetin dagligt er signifikant mere effektivt end placebo til reduktion af spiseanfald og tvangsopkastninger.
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.
For langtids- effekten kunne der ikke drages konklusioner.
However, for long-term efficacy no conclusion can be drawn.
To placebo- kontrollerede forsøg er udført med patienter, der opfylder DSM- IV- kriteriet for præmenstruel dysforisk lidelse (PMDD).
Two placebo-controlled studies were conducted in patients meeting Pre-Menstrual Dysphoric Disorder (PMDD) diagnostic criteria according to DSM-IV.
Her observeredes en forbedring i det primære effektmål (” Daily Record of Severity of Problems score ”).
In the second study, with intermittent luteal phase dosing (20 mg daily for 14 days) for 3 cycles, improvement was observed in the primary efficacy parameter (Daily Record of Severity of Problems score).
Episoder med svær depression (børn og unge):
Major depressive episodes (children and adolescents):
Der er foretaget kliniske placebosammenlignings - forsøg med børn og unge fra 8 år.
Clinical trials in children and adolescents aged 8 years and above have been conducted versus placebo.
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- R - skalaen (Childhood Depression Rating Scale- Revised) og CGI- I- scoren (Clinical Global Impression of Improvement).
(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.
I begge forsøg opfyldte patienterne kriterierne for vedvarende moderat til svær MDD (DSM- III eller DSM- IV) ved tre forskellige evalueringer af praktiserende børnepsykiatere.
In both studies, patients met criteria for moderate to severe MDD (DSM-III or DSM-IV) at three different evaluations by practising child psychiatrists.
Fluoxetins effekt i kliniske forsøg kan muligvis afhænge af inklusion af en selektiv patientpopulation (en der ikke har haft spontan helbredelse inden for en periode på 3- 5 uger, og hvis depression varede ved trods væsentlig opmærksomhed).
Efficacy in the fluoxetine trials may depend on the inclusion of a selective patient population (one that has not spontaneously recovered within a period of 3-5 weeks and whose depression persisted in the face of considerable attention).
Generelt var der kun beskedne beviser på fluoxetins effekt.
There is only limited data on safety and efficacy beyond 9 weeks.
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).
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).
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.
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.
EMEA/ CHMP/ 46089/ 2006/ DA 5. 2 Farmakokinetiske egenskaber
EMEA/ CHMP/ 46089/ 2006/ EN
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Fluoxetin absorberes godt efter oral administration.
Fluoxetine is well absorbed from the gastrointestinal tract after oral administration.
95%.
Distribution Fluoxetine is extensively bound to plasma proteins (about 95%) and it is widely distributed (Volume of Distribution:
Fordelingsvolumenet er 20- 40 l/ kg.
20 - 40 l/ kg).
Steady- state plasmakoncentrationer opnås først efter flere ugers behandling.
Steady-state plasma concentrations are achieved after dosing for several weeks.
Steady- state koncentrationer efter langvarig behandling svarer til de koncentrationer, som observeres efter 4- 5 ugers behandling.
Steady-state concentrations after prolonged dosing are similar to concentrations seen at 4 to 5 weeks.
Fluoxetin har en non- lineær farmakokinetisk profil med first- pass metabolisme i leveren.
Metabolism Fluoxetine has a non-linear pharmacokinetic profile with first pass liver effect.
6- 8 timer efter oral administration.
Maximum plasma concentration is generally achieved 6 to 8 hours after administration.
Fluoxetin metaboliseres i udpræget grad via cytochrom P450IID6- systemet.
Fluoxetine is extensively metabolised by the polymorphic enzyme CYP2D6.
Halveringstiden for fluoxetin er 4- 6 dage og for norfluoxetin 4- 16 dage.
Elimination The elimination half-life of fluoxetine is 4 to 6 days and for norfluoxetine 4 to16 days.
Disse lange halveringstider er skyld i tilstedeværelsen af lægemidlet op til 5- 6 uger efter endt behandling.
These long half-lives are responsible for persistence of the drug for 5-6 weeks after discontinuation.
60%) gennem nyrerne.
Excretion is mainly (about 60%) via the kidney.
Risikopatienter: • Ældre:
At-risk populations • Elderly:
Farmakokinetiske parametre er ikke ændret hos raske ældre i forhold til yngre personer. • Børn og unge:
Kinetic parameters are not altered in healthy elderly when compared to younger subjects • Children and adolescents:
2 gange større end den, der ses hos voksne, og den gennemsnitlige koncentration af norfluoxetin er 1, 5 gange højere.
The mean fluoxetine concentration in children is approximately 2- fold higher than that observed in adolescents and the mean norfluoxetine concentration 1.5-fold higher.
4. 2 Dosering og indgivelsesmåde).
Steady state plasma concentrations are dependent on body weight and are higher in lower weight children (see 4.2 Posology and method of administration).
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. • Leverinsufficiens:
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. • Hepatic insufficiency:
I tilfælde af leverinsufficiens (alkoholinduceret cirrhose) vil halveringstiden for fluoxetin og norfluoxetin forøges til henholdsvis 7 og 12 dage.
In case of hepatic insufficiency (alcoholic cirrhosis), fluoxetine and norfluoxetine half-lives are increased to 7 and 12 days, respectively.
Her bør en lavere eller mindre hyppig dosering overvejes. • Nyreinsufficiens:
A lower or less frequent dose should be considered. • Renal insufficiency:
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.
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.
Ved gentagen indgift vil en forhøjet steady- state koncentration eventuelt kunne observeres.
However, after repeated administration, an increase in steady-state plateau of plasma concentrations may be observed.
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.
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.
Forsinkelser i kønsmodenhed forekom hos hanmus (10 og 30 mg/ kg/ dag) og hunmus (30 mg/ kg/ dag).
Delays in sexual maturation occurred in males (10 and 30 mg/ kg/ day) and females (30 mg/ kg/ day).
Rotter, som fik indgivet 30 mg/ kg, havde også mindskede femurlængder sammenlignet med kontrollerne og degeneration af skeletmuskel, nekrose og regeneration.
Rats administered 30 mg/ kg also had decreased femur lengths compared with controls and skeletal muscle degeneration, necrosis and regeneration.
Ved 10 mg/ kg/ dag var de opnåede plasmaniveauer i forsøgsdyr ca.
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.
Ved 3 mg/ kg/ dag var de opnåede plasmaniveauer i forsøgsdyr ca.
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.
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Stivelse Dimeticon
Starch flowable Dimeticone
Patent Blue V (E131) Jernoxid, gul (E172) Titandioxid (E171) Gelatine
Patent blue V (E 131) Yellow iron oxide (E172) Titanium dioxide (E 171) Gelatin
Blæk anvendt til mærkning af kapslen:
Pharmaceutical grade edible printing ink components:
Formulering 1:
Formulation 1:
Shellac Propylenglycol Ammoniumhydroxid Jernoxid, sort (E172)
Shellac Propylene Glycol Ammonium Hydroxide Black Iron Oxide E172
Shellac Soya lecithin Antifoam DC 1510 Jernoxid, sort (E172)
Shellac Soya Lecithin Antifoam DC 1510 Black Iron Oxide E172
Må ikke opbevares over 25°C
Do not store above 25˚ C.
6. 5 Emballage (art og indhold)
Nature and contents of container
< [Udfyldes nationalt] >
< [To be completed nationally] > Not all pack sizes may be marketed
< Ikke alle pakningsstørrelser er nødvendigvis markedsført. >
6.6.
6. 6 Særlige forholdsregler ved bortskaffelse og anden håndtering af produktet
Special precautions for disposal
EMEA/ CHMP/ 46089/ 2006/ DA < [Se bilag I – Udfyldes nationalt] >
MARKETING AUTHORISATION HOLDER
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LÆGEMIDLETS NAVN
EMEA/ CHMP/ 46089/ 2006/ EN SUMMARY OF PRODUCT CHARACTERISTICS
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SÆRNAVN® 20 mg pr.
NAME OF THE MEDICINAL PRODUCT
5 ml oral opløsning < [Se bilag I - Udfyldes nationalt] >
(Invented name)® 20mg per 5ml oral liquid .< [To be completed nationally] >
Hver 5 ml oral opløsning indeholder 20 mg fluoxetin som fluoxetinhydrochlorid.
Each 5ml of oral liquid contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine.
Oral opløsning
Oral liquid.
20- 60 mg dagligt.
The recommended dose is 20mg daily.