natgillin/translations-raw huggingface dataset:
Disse symptomer er sædvanligvis lette til moderate og forsvinder spontant inden for nogle få dage. 
These effects are usually mild to moderate and disappear spontaneously within a few days.
• Information om risikoen for leverreaktioner og kliniske tegn på leverproblemer 
• Information about the risk of hepatic reactions and clinical signs of liver problems
Det kan være en hjælp at fortælle en pårørende eller en ven, at De er deprimeret, og bede dem læse denne indlægsseddel. 
You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet.
Der bør derfor udvises forsigtighed ved ordinering af agomelatin til disse patienter. 
Therefore, caution should be exercised when prescribing agomelatine to these patients.
Der blev også observeret effekt hos mere alvorligt depressive patienter (baseline HAM-D ≥ 25) i alle positive placebokontrollerede studier. 
Efficacy was also observed in more severely depressed patients (baseline HAM-D ≥ 25) in all positive placebo-controlled trials.
Under Deres behandling med Valdoxan: 
During your treatment with Valdoxan :
Generelt viser den kliniske erfaring, at risikoen for selvmord kan øges i de tidlige faser af bedringen. 
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Tabletten skal synkes hel med et glas vand. 
You should swallow your tablet with a drink of water.
Tolerabiliteten af agomelatin hos ældre patienter var sammenlignelig med den, der ses hos yngre voksne. 
Tolerability of agomelatine in elderly patients was comparable to that seen in the younger adults.
Der blev ikke observeret nogen forbedring hos meget ældre patienter (≥ 75 år, N=69, hvoraf 48 fik agomelatin). 
No improvement was observed in very elderly patients (≥75 years, N= 69, of which 48 on agomelatine).
Derefter vil leverfunktionen blive kontrolleret, hvis lægen finder det nødvendigt. 
Thereafter tests will be taken if the doctor finds it necessary.
Det vides ikke, om agomelatin/metabolitter udskilles i human mælk. 
It is not known whether agomelatine/metabolites are excreted in human milk.
Mani/hypomani * 
Mania/hypomania*
Behandlingen af en overdosis bør bestå i behandling af de kliniske symptomer og standardovervågning. 
Management of overdose should consist of treatment of clinical symptoms and routine monitoring.
Responsraterne var statistisk set signifikant højere med agomelatin sammenlignet med placebo. 
Response rates were statistically significantly higher with agomelatine compared with placebo.
De må ikke tage Valdoxan, hvis Deres lever ikke fungerer ordentligt. 
You must not use Valdoxan if your liver does not work properly.
Der er ikke dokumenteret nogen virkning hos patienter ≥ 75 år. 
No effect is documented in patients ≥75 years.
En depression er en vedholdende forstyrrelse af sindsstemningen, der påvirker dagligdagen. 
Depression is a continuing disturbance of mood that interferes with everyday life.
Kalenderen, der er trykt på blisterkortet med tabletterne, kan hjælpe Dem til at huske, hvornår De sidst har taget en Valdoxan tablet. 
The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Valdoxan.
- fedme/overvægt/ikke-alkoholisk fedtleverlidelse, diabetes, 
- obesity/overweight/non-alcoholic fatty liver disease, diabetes
En person, der havde indtaget 2.450 mg agomelatin, kom sig spontant uden kardiovaskulære og biologiske forstyrrelser. 
One person having ingested 2,450 mg agomelatine, recovered spontaneously without cardiovascular and biological abnormalities.
Nogle patienter kan få forhøjede leverenzymer i blodet under behandling med Valdoxan. 
Some patients may get increased levels of liver enzymes in their blood during treatment with Valdoxan.
Bivirkningerne var sædvanligvis milde eller moderate og indtrådte i løbet af de første to ugers behandling. 
Adverse reactions were usually mild or moderate and occurred within the first two weeks of treatment.
De største metabolitter, hydroxyleret og demethyleret agomelatin, er ikke aktive, og de konjugeres hurtigt og udskilles i urinen. 
The major metabolites, hydroxylated and demethylated agomelatine, are not active and are rapidly conjugated and eliminated in the urine.
Indtagelse af føde (standardmåltid eller måltid med højt fedtindhold) påvirker ikke biotilgængelighed eller absorptionshastighed. 
Food intake (standard meal or high fat meal) does not modify the bioavailability or the absorption rate.
Enhver patient, der udvikler forhøjede serumaminotransferaser, bør have undersøgelserne af leverfunktionen gentaget inden for 48 timer. 
Any patient who develops increased serum transaminases should have his/her liver function tests repeated within 48 hours.
Der blev ikke observeret nogen virkninger af agomelatin på unge dyrs adfærd eller, visuelle og reproduktive funktion. 
No effect of agomelatine on juvenile animals behavioural performances, visual and reproductive function were observed.
Børn og unge Valdoxan bør ikke anvendes til børn og unge (under 18 år). 
Valdoxan should not be used in children and adolescents (under 18 years old).
Depression sættes i forbindelse med en øget risiko for selvmordstanker, selvpåført skade og selvmord (selvmordsrelaterede hændelser). 
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events).
Hallucinationer* 
Hallucinations*
De kan være mere tilbøjelig til at få disse tanker: - hvis De tidligere har haft selvmordstanker eller tænkt på at skade Dem selv. 
You may be more likely to think like this: - if you have previously had thoughts about killing or harming yourself.
Beslutningen om at øge dosis skal afvejes mod en højere risiko for stigning i aminotransferaser. 
Decision of dose increase has to be balanced with a higher risk of transaminases elevation.
Hos mus, rotter og aber observeredes sedative virkninger efter en enkelt og gentagen administration af høje doser. 
In mice, rats and monkeys sedative effects were observed after single and repeated administration at high doses.
Restless leg syndrom* 
Paraesthesia Restless leg syndrome*
Aluminium/PVC blisterkort pakket i karton. 
Aluminium/PVC blister packed in cardboard boxes.
I disse studier var det dog ikke tilladt at øge startdosis af enten agomelatin, paroxetin eller fluoxetin, selv om responset ikke var tilstrækkelig. 
However, in these studies it was not allowed to increase the start dose of either agomelatine, paroxetine or fluoxetine even if the response was not adequate.
De vil normalt indtræffe i løbet af de første to ugers behandling og er sædvanligvis forbigående. 
They usually occur within the first two weeks of the treatment and are usually temporary.
Vægtstigning* 
Weight increased *
Agomelatin er en melatonerg agonist (MT1- og MT2-receptorer) og en 5-HT2C-antagonist. 
Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist.
Elimination sker hurtigt, den gennemsnitlige halveringstid i plasma er 1-2 timer, og clearance er høj (ca. 1.100 ml/min) og sker hovedsagligt via stofskiftet. 
Elimination is rapid, the mean plasma half-life is between 1 and 2 hours and the clearance is high (about 1,100 ml/min) and essentially metabolic.
Bipolar sygdom/mani/hypomani 
Bipolar disorder/ mania / hypomania
Disse bivirkninger var sædvanligvis forbigående og medførte ikke generelt behandlingsophør. 
These adverse reactions were usually transient and did not generally lead to cessation of therapy.
4.4) Agitation og beslægtede symptomer* (såsom irritabilitet og rastløshed) 
Agitation and related symptoms* (such as irritability and restlessness) Aggression*
Der er begrænset erfaring med overdosering af agomelatin. 
There is limited experience with agomelatine overdose.
Da der muligvis ikke opstår bedring i løbet af de første ugers behandling, bør patienterne overvåges nøje, indtil bedringen indtræffer. 
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
I visse tilfælde kan lægen ordinere en højere dosis (50 mg), dvs. to tabletter, som skal tages samtidig ved sengetid. 
In some cases, your doctor may prescribe a higher dose (50 mg), i.e. two tablets to be taken together at bedtime.
Agomelatin øger frigivelsen af noradrenalin og dopamin, specifikt i cortex frontalis, og har ingen indflydelse på niveauet af ekstracellulær serotonin. 
Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin.
Leverfunktionen bør kontrolleres hos alle patienter før initiering af behandling. 
Liver function tests should be performed in all patients before starting treatment.
Der skal tages beslutning om at ophøre med amning eller at seponere/afstå fra behandling med Valdoxan under hensyntagen til fordelen for barnet ved amning og fordelen ved behandling for kvinden. 
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Valdoxan therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
De kan opleve abstinenssymptomer i nogle uger i forbindelse med, at De stopper med det tidligere lægemiddel, selv hvis dosis af det tidligere lægemiddel mod depression gradvist reduceres. 
You may experience discontinuation symptoms related to stopping of your previous medicine for a few weeks, even if the dose of your previous antidepressant medicine is decreased gradually.
Valdoxan anvendes til voksne. 
Valdoxan is used in adults.
Det er ikke relevant at anvende agomelatin hos børn fra fødslen frem til 2 år til behandling af svære depressive episoder. 
There is no relevant use of agomelatine in children from birth to 2 years for treatment of major depressive episodes.
Patienter med depression bør behandles i en tilstrækkelig lang periode på mindst seks måneder for at sikre, at de er symptomfri. 
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Som en forsigtighedsforanstaltning bør Valdoxan undgås under graviditet. 
As a precautionary measure, it is preferable to avoid the use of Valdoxan during pregnancy.
Dosistilpasning er ikke nødvendig hos ældre patienter. 
No dose adaptation is required in elderly patients.
De vil muligvis opleve svimmelhed eller søvnighed, hvilket kan påvirke evnen til at føre motorkøretøj og betjene maskiner. 
You might experience dizziness or sleepiness which could affect your ability to drive or operate machines.
Agomelatins virkning og sikkerhed ved moderat til svær depression er undersøgt i et klinisk program med 7.900 patienter behandlet med agomelatin. 
The efficacy and safety of agomelatine in major depressive episodes have been studied in a clinical programme including 7,900 patients treated with agomelatine.
14 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 98 filmovertrukne tabletter 100 filmovertrukne tabletter 
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Interaktioner, der muligvis påvirker agomelatin 
Potential interactions affecting agomelatine
Ud fra en evaluering af disse undersøgelser vil lægen afgøre, om De bør fortsætte med at bruge Valdoxan eller ej (se også punkt 3, 'Sådan skal De tage Valdoxan'). 
Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Valdoxan (see also under “How to take Valdoxan” in section 3).
Dato for første markedsføringstilladelse: 19. februar 2009 Dato for seneste fornyelse af tilladelsen: 12. december 2018 
Date of latest renewal : 12 December 2018
Deres depression bør behandles i en tilstrækkelig lang periode på mindst 6 måneder for at sikre, at De er symptomfri. 
Your depression should be treated for a sufficient period of at least 6 months to ensure that you are free of symptoms.
Agomelatin havde en neutral virkning på hjertefrekvens og blodtryk i kliniske studier. 
Agomelatine had neutral effect on heart rate and blood pressure in clinical trials.
de los Madroños, 33 -28043 Madrid, Spanien 
de los Madroños, 33 -28043 Madrid, Spain
Incidensen af recidiv i den seksmåneders, dobbeltblinde opfølgningsperiode var 22% og 47% for hhv. agomelatin og placebo. 
The incidence of relapse during the 6-months double-blind follow up period was 22% and 47% for agomelatine and placebo, respectively.
Orange til gul, aflang, 9,5 mm lang, 5,1 mm bred filmovertrukket tablet med blåt firmalogo påtrykt den ene side. 
Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet with blue imprint of company logo on one side.
- alkoholrelateret sygdom og/eller væsentligt alkoholforbrug og hos patienter, der samtidig får lægemidler, der er forbundet med risiko for leverskade. 
- alcohol use disorder and /or substantial alcohol intake and in patients receiving concomitant medicinal products associated with risk of hepatic injury.
Anvendelse til pædiatrisk population 
Use in paediatric population
[EU/1/08/499/002] 14 filmovertrukne tabletter [EU/1/08/499/003] 28 filmovertrukne tabletter [EU/1/08/499/005] 56 filmovertrukne tabletter [EU/1/08/499/006] 84 filmovertrukne tabletter [EU/1/08/499/007] 98 filmovertrukne tabletter [EU/1/08/499/008] 100 filmovertrukne tabletter 
[EU/1/08/499/002] 14 film-coated tablets [EU/1/08/499/003] 28 film-coated tablets [EU/1/08/499/005] 56 film-coated tablets [EU/1/08/499/006] 84 film-coated tablets [EU/1/08/499/007] 98 film-coated tablets [EU/1/08/499/008] 100 film-coated tablets
Variabiliteten øges ved indtagelse af fedtholdig kost. 
The variability is increased with high fat food.
Agomelatin viste ikke krampefremkaldende egenskaber ved intraperitoneale doser på op til 128 mg/kg i mus og rotter. 
Agomelatine did not show proconvulsive properties at ip doses up to 128 mg/kg in mice and rats.
Inden for det terapeutiske dosisinterval stiger systemisk eksponering for agomelatin proportionalt med dosis. 
In the therapeutic dose-range, agomelatine systemic exposure increases proportionally with dose.
(≥1/10), almindelig (≥1/100 til < 1/10), ikke almindelig (≥1/1.000 til < 1/100), sjælden (≥1/10.000 til 
Adverse reactions are listed below using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Farmakoterapeutisk klassifikation: Psykoanaleptika, Andre antidepressiva, ATC-kode: N06AX22 
Pharmacotherapeutic group: Psychoanaleptics, other antidepressants, ATC-code: N06AX22 Mechanism of action
I karcinogenicitetsstudier inducerede agomelatin en stigning i incidensen af levertumorer hos rotter og mus ved en dosis, der var mindst 110 gange højere end den terapeutiske dosis. 
In carcinogenicity studies agomelatine induced an increase in the incidence of liver tumours in the rat and the mouse, at a dose at least 110-fold higher than the therapeutic dose.
I et farmakokinetisk studie med ældre patienter (≥ 65 år) blev det vist, at ved en dosis på 25 mg var middel AUC og middel Cmax omkring 4 gange og 13 gange højere hos patienter ≥ 75 år sammenlignet med patienter < 75 år. 
In a pharmacokinetic study in elderly patients (≥ 65 years), it was showed that at a dose of 25 mg the mean AUC and mean Cmax were about 4-fold and 13-fold higher for patients ≥ 75 years old compared to patients < 75 years old.
Lægen kan fortsætte med at give Dem Valdoxan, efter De har fået det bedre, for at forebygge, at depressionen vender tilbage. 
Your doctor may continue to give you Valdoxan when you are feeling better to prevent your depression from returning.
Analysen af de samlede resultater fra undersøgelser baseret på Arizona Sexual Experience Scale (ASEX) viste, at agomelatin ikke var forbundet med seksuel dysfunktion. 
The pooled analysis of trials using the Arizona Sexual Experience Scale (ASEX) showed that agomelatine was not associated with sexual dysfunction.
Lægemidler, der reagerer med disse isoenzymer, kan nedsætte eller øge agomelatins biotilgængelighed. 
Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine.
Agomelatin passerer placenta og går over i fostre hos gravide rotter. 
Agomelatine passes into the placenta and foetuses of pregnant rats.
Fordelingsvolumen ved steady-state er ca. 35 l. Plasmaproteinbindingen er 95% uafhængigt af koncentrationen og ændres ikke med alder eller hos patienter med nedsat nyrefunktion, men den frie fraktion fordobles hos patienter med nedsat leverfunktion. 
Steady state volume of distribution is about 35 l and plasma protein binding is 95% irrespective of the concentration and is not modified with age and in patients with renal impairment but the free fraction is doubled in patients with hepatic impairment.
Hvis Valdoxan-behandlingen startes, mens dosis af det tidligere lægemiddel nedtrappes, må mulige abstinenssymptomer ikke forveksles med manglende tidlig virkning af Valdoxan. 
If Valdoxan is initiated while tapering the dosage of the previous medicine, possible discontinuation symptoms should not be confounded with a lack of early effect of Valdoxan.
Procentdelen af patienter med mindst ét seponeringssymptom én uge efter behandlingsstop med SSRI/SNRI var lavere i gruppen med langsom nedtrapning (gradvis seponering af tidligere SSRI/SNRI i løbet af 2 uger) end i gruppen med hurtig nedtrapning (gradvis seponering af tidligere SSRI/SNRI i løbet af 1 uge) og i gruppen med brat behandlingsskift (brat behandlingsophør): henholdsvis 56,1 %, 62,6 % og 79,8 %. 
The percentage of patients with at least one discontinuation symptom one week after the SSRI/SNRI treatment stop, was lower in the long tapering group (gradual cessation of the previous SSRI/SNRI within 2 weeks) than in the short tapering group (gradual cessation of the previous SSRI/SNRI within 1 week) and in the abrupt substitution group (abrupt cessation): 56.1%, 62.6 % and 79.8% respectively.
Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Frankrig Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co. Wicklow, Irland Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul. 
Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co. Wicklow, Ireland Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Udskillelse sker hovedsagligt gennem urinen (80%) og i form af metabolitter, og kun ringe mængder uomdannet stof kan genfindes i urinen. 
Excretion is mainly (80%) urinary and in the form of metabolites, whereas unchanged compound recovery in urine is negligible.
Agomelatins mulige påvirkning af andre lægemidler 
Potential for agomelatine to affect other medicinal products
Agomelatin kan initieres umiddelbart, mens dosis af et SSRI/SNRI nedtrappes (se pkt. 
Agomelatine can be started immediately while tapering the dosage of a SSRI//SNRI (see section
Disse tanker kan forekomme oftere i starten af behandlingen med antidepressiv medicin, da det varer nogen tid, inden det virker, normalt omkring to uger, men nogle gange længere. 
These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Agomelatin blev ikke sammenlignet direkte med paroxetin og fluoxetin, da disse komparatorer blev tilføjet for at sikre assay-følsomhed af studierne. 
Agomelatine was not compared directly with paroxetine and fluoxetine as these comparators where added in order to ensure assay sensitivity of the trials.
Der foreligger dog kun begrænsede kliniske data om brug af agomelatin til patienter med alvorligt eller moderat nedsat nyrefunktion og svære depressive episoder. 
However, only limited clinical data on the use of agomelatine in depressed patients with severe or moderate renal impairment with major depressive episodes is available.
Dosisjustering er ikke nødvendig i relation til alder (se pkt. 
No dose adjustment is required in relation to age (see section 5.2).
Bivirkningerne i tabellen nedenfor er bivirkninger, der er observeret i placebo-kontrollerede og aktivtkontrollerede kliniske studier. 
The below table gives the adverse reactions observed from placebo-controlled and active-controlled clinical trials.
Der bør kun ordineres behandling med Valdoxan efter omhyggelig afvejning af fordele og risici hos patienter med risikofaktorer for leverskade f.eks.: 
Treatment with Valdoxan should only be prescribed after careful consideration of benefit and risk in patients with hepatic injury risk factors e.g.:
- efter omkring 3 uger, - efter omkring 6 uger (afslutning af den akutte fase), - efter omkring 12 og 24 uger (afslutning af vedligeholdelsesfasen) - derefter, når det er klinisk indiceret. 
- after around 3 weeks, - after around 6 weeks (end of acute phase), - after around 12 and 24 weeks (end of maintenance phase), - and thereafter when clinically indicated.
Patienten (og patientens omsorgspersoner) skal orienteres om at holde øje med tegn på klinisk forværring, selvmordsadfærd eller selvmordstanker samt usædvanlige ændringer i patientens adfærd og om straks at søge lægehjælp, hvis disse symptomer opstår. 
Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Deres læge vil udføre laboratorieundersøgelser for at kontrollere, at Deres lever fungerer ordentligt, før De starter behandlingen og derefter jævnligt under behandlingen, sædvanligvis efter 3, 6, 12 og 24 uger. 
Your doctor will run laboratory tests to check that your liver is working properly before starting treatment and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks.
Der bør udvises forsigtighed før initiering af behandling og tæt overvågning bør udføres under hele behandlingsperioden hos alle patienter, især ved tilstedeværelse af risikofaktorer for leverskade eller ved samtidig behandling med lægemidler, der er forbundet med risiko for leverskade. 
Caution should be exercised before starting treatment and close surveillance should be performed throughout the treatment period in all patients, especially if hepatic injury risk factors or concomitant medicinal products associated with risk of hepatic injury are present.
I to andre studier var det ikke muligt at udlede en konklusion, da de aktive kontrolstoffer, paroxetin eller fluoxetin, ikke adskilte sig fra placebo. 
In two other trials, it was not possible to draw any conclusions because the active controls, paroxetine or fluoxetine, failed to differentiate from placebo.
Der er ikke set relevante ændringer i farmakokinetiske parametre hos patienter med alvorligt nedsat nyrefunktion (n=8, enkeltdosis 25 mg), men der skal udvises forsigtighed hos patienter med alvorligt eller moderat nedsat nyrefunktion, da der kun foreligger begrænsede kliniske data om disse patienter (se pkt. 
No relevant modification of pharmacokinetic parameters in patients with severe renal impairment has been observed (n=8, single dose of 25 mg), but caution should be exercised in patients with severe or moderate renal impairment as only limited clinical data are available in these patients (see section 4.2).
Hos gnavere sås en markant induktion af CYP2B og en moderat induktion af CYP1A og CYP3A fra 125 mg/kg/døgn, mens induktionen hos aber var beskeden for CYP2B og CYP3A med 375 mg/kg/døgn. 
In rodents, a marked induction of CYP2B and a moderate induction of CYP1A and CYP3A were seen from 125 mg/kg/day whereas in monkeys the induction was slight for CYP2B and CYP3A at 375 mg/kg/day.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med agomelatin i en eller flere undergrupper af den pædiatriske population ved behandling af svære depressive episoder (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with agomelatine in one or more subsets of the paediatric population in the treatment of major depressive episodes (see section 4.2 for information on paediatric use).