FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased ALT and/or AST (in clinical trials, increases >3 times the upper limit of the normal range for ALT and/or AST were seen in 1.2% of patients on agomelatine 25 mg daily and 2.6 % on agomelatine 50 mg daily vs. 0.5% on placebo).
Danish: Forhøjede ALAT- og/eller ASAT-værdier (i kliniske afprøvninger er der set stigninger > 3 x øvre grænse for normalområdet i ALAT og ASAT hos 1,2 % af patienterne i agomelatin-gruppen med 25 mg daglig og hos 2,6 % på 50 mg daglig vs. 0,5 % for placebogruppen)
English: At the end of treatment (over 6 or 8 weeks), significant efficacy of agomelatine 25-50 mg was demonstrated in 6 out of the ten short-term double-blind placebo-controlled trials.
Danish: Ved behandlingens afslutning (efter 6 eller 8 uger) sås en signifikant effekt af agomelatin 25-50 mg i 6 af de ti kortvarige dobbeltblinde, placebokontrollerede studier.
English: No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
Danish: Der er ikke påvist farmakokinetisk eller farmakodynamisk interaktion med følgende lægemidler, som kan ordineres sammen med Valdoxan, hos målpopulationen i kliniske fase I-studier: Benzodiazepiner, lithium, paroxetin, fluconazol og theophyllin.
English: Agomelatine has shown an antidepressant-like effect in animal models of depression (learned helplessness test, despair test, chronic mild stress) as well as in models with circadian rhythm desynchronisation and in models related to stress and anxiety.
Danish: Agomelantin udviste en antidepressiv-lignende virkning i dyremodeller for depression (tillært hjælpeløshedstest, fortvivlelsestest, kronisk lettere stress) samt i modeller med desynkroniseret døgnrytme og modeller forbundet med stress og angst.
English: - If you are obese or overweight, ask your doctor for advice.
Danish: - Hvis De lider af fedme eller er overvægtig, så spørg lægen til råds.
English: You have been given Valdoxan to treat your depression.
Danish: De har fået Valdoxan til behandling af en depression.
English: Effect of Valdoxan is not documented in patients aged 75 years and older.
Danish: Det er ikke dokumenteret, at Valdoxan virker hos patienter i alderen 75 år og ældre.
English: Valdoxan should not be used for the treatment of major depressive episodes in elderly patients with dementia since the safety and efficacy of Valdoxan have not been established in these patients.
Danish: Valdoxan bør ikke anvendes til behandling af major depression hos ældre patienter med demens, da Valdoxans sikkerhed og virkning ikke er påvist hos disse patienter.
English: INFORMATION IN BRAILLE Valdoxan 25 mg
Danish: INFORMATION I BRAILLESKRIFT Valdoxan 25 mg
English: Valdoxan film-coated tablets may be taken with or without food.
Danish: Valdoxan filmovertrukne tabletter kan tages uden for eller i forbindelse med et måltid.
English: In depressed patients, treatment with agomelatine 25 mg increased slow wave sleep without modification of REM (Rapid Eye Movement) sleep amount or REM latency.
Danish: Hos depressive patienter forlængede agomelatin 25 mg den dybe søvn (Slow Wave Sleep) uden at ændre mængden af REM-søvn (Rapid Eye Movement) eller REM-latenstiden.
English: A battery of in vitro and in vivo standard genotoxicity assays concludes to no mutagenic or clastogenic potential of agomelatine.
Danish: I et standardbatteri af in vitro- og in vivo-genotoksiske studier påvistes hverken mutagent eller klastogent potentiale for agomelatin.
English: Valdoxan can be taken with or without food.
Danish: Valdoxan kan tages alene eller sammen med et måltid.
English: In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
Danish: Hos mennesker har agomelatin positive faseændrende egenskaber, idet det fremskynder indsovningstid, fald i legemstemperatur og frigivelse af melatonin.
English: Agomelatine does not alter daytime vigilance and memory in healthy volunteers.
Danish: Agomelatin ændrede ikke årvågenhed og hukommelse i dagtimerne hos raske forsøgspersoner.
English: The safety and efficacy of agomelatine in children from 2 years onwards for treatment of major depressive episodes have not yet been established.
Danish: Agomelatins sikkerhed og virkning hos børn i alderen fra 2 år og opefter til behandling af svære depressive episoder er endnu ikke klarlagt.
English: Binding studies indicate that agomelatine has no effect on monoamine uptake and no affinity for α, β adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors.
Danish: Undersøgelser af binding viser, at agomelatin ikke påvirker optagelsen af monoamin og ikke har affinitet til α-, β-adrenerge, histaminerge, kolinerge, dopaminerge og benzodiazepinreceptorer.
English: Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes.
Danish: Behandlingen skal derfor ledsages af nøje overvågning af patienterne og særligt patienter i højrisikogruppen, især i starten af behandlingen og ved dosisændringer.
English: Calendar packs containing 14, 28, 56, 84 and 98 film-coated tablets.
Danish: Kalenderpakninger a 14, 28, 56, 84 og 98 filmovertrukne tabletter.
English: While there was no specific safety signal in the 800 patients treated in combination with oestrogens, caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) until more experience has been gained (see section 4.4).
Danish: Selv om der ikke opstod specifikke tegn på kompromitteret sikkerhed hos de 800 patienter, der fik agomelatin i kombination med et østrogen, bør der udvises forsigtighed ved ordination af agomelatin sammen med andre moderate CYP1A2-hæmmere (fx propranolol, enoxacin), indtil der er opnået mere erfaring (se pkt.
English: A meta-analysis of placebocontrolled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old.
Danish: En metaanalyse af placebokontrollerede kliniske studier med antidepressiva hos voksne patienter med psykiske forstyrrelser viste en øget risiko for selvmordsadfærd hos patienter under 25 år, der fik antidepressiva, sammenlignet med patienter, der fik placebo.
English: If you forget to take Valdoxan
Danish: Hvis De har glemt at tage Valdoxan
English: Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure.
Danish: Fluvoxamin, som er en potent CYP1A2- og en moderat CYP2C9-hæmmer, hæmmer omsætningen af agomelatin markant, hvilket fører til en stigning med faktor 60 (interval 12-412) i eksponeringen for agomelatin.
English: If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Valdoxan.
Danish: Hvis De har dårlige nyrer, vil Deres læge foretage en individuel vurdering af, om det er sikkert for Dem at tage Valdoxan.
English: Agomelatine has no abuse potential as measured in healthy volunteer studies on a specific visual analogue scale or the Addiction Research Center Inventory (ARCI) 49 check-list.
Danish: I undersøgelser hos raske forsøgspersoner har agomelatin intet potentiale for misbrug målt på en specifik visuel analog skala eller ud fra Addiction Research Center Inventory (ARCI) 49-tjeklisten.
English: Valdoxan is not recommended in the treatment of depression in patients under 18 years of age since safety and efficacy of Valdoxan have not been established in this age group.
Danish: Valdoxan bør ikke anvendes til behandling af depression hos patienter under 18 år, da Valdoxans sikkerhed og virkning ikke er påvist hos denne aldersgruppe.
English: Following discontinuation of Valdoxan therapy liver function tests should be repeated until serum transaminases return to normal.
Danish: Efter seponering af Valdoxanbehandling bør undersøgelser af leverfunktionen gentages indtil serumaminotransferaser vender tilbage det normale niveau.
English: The recommended dose of Valdoxan is one tablet (25 mg) at bedtime.
Danish: Den anbefalede dosis Valdoxan er 1 tablet (25 mg) ved sengetid.
English: In a trial designed to assess discontinuation symptoms by the Discontinuation Emergent Signs and Symptoms (DESS) check-list in patients with remitted depression, agomelatine did not induce discontinuation syndrome after abrupt treatment cessation.
Danish: I en undersøgelse designet til at vurdere seponeringssymptomer ved hjælp af Discontinuation Emergent Signs and Symptoms (DESS-) tjeklisten hos patienter med remitteret depression inducerede agomelatin ikke seponeringssyndrom efter brat behandlingsstop.
English: Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility (see section
Danish: Reproduktionsstudier med rotter og kaniner indikerede ingen virkninger af agomelatin på fertilitet (se pkt.
English: Responder rate analysis favoured agomelatine.
Danish: Analyse af respondentrate favoriserede agomelatin.
English: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%).
Danish: Agomelatin omdannes hovedsageligt via CYP1A2 (90%) og via CYP2C9/19 (10%).
English: The recommended dose is 25 mg once daily taken orally at bedtime.
Danish: Den anbefalede dosis er 25 mg per os en gang dagligt ved sengetid.
English: From the first week of treatment, onset of sleep and the quality of sleep were significantly improved without daytime clumsiness as assessed by patients.
Danish: Fra første behandlingsuge opnåede patienterne ifølge egen vurdering signifikant forbedring af indsovningstid og søvnkvalitet uden klodsethed i dagtimerne.
English: Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.
Danish: Hos de fleste mennesker begynder Valdoxan at virke mod symptomer på depression i løbet af 2 ugers behandling.
English: The Marketing Authorisation Holder shall ensure that at launch and after launch all physicians who are expected to prescribe or use Valdoxan are provided with the updated educational material containing the following:
Danish: Ved og efter lancering skal indehaveren af markedsføringstilladelsen sikre, at alle læger, som forventes at ordinere eller anvende Valdoxan, forsynes med opdateret informationsmateriale med følgende indhold:
English: Patients responding to 8/10-weeks of acute treatment with open-label agomelatine 25-50 mg once daily were randomised to either agomelatine 25-50 mg once daily or placebo for further 6-months.
Danish: Patienter, der responderede på 8/10 ugers akut behandling med agomelatin 25-50 mg en gang dagligt i et ublindet studie blev randomiseret til enten agomelatin 25-50 mg en gang dagligt eller placebo i yderligere 6 måneder.
English: Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro.
Danish: Agomelatin hæmmer ikke CYP1A2 in vivo eller de øvrige CYP-isoenzymer in vitro.
English: - If you are diabetic, ask your doctor for advice.
Danish: - Hvis De har sukkersyge (diabetes), så spørg lægen til råds.
English: Switching therapy from SSRI/SNRI antidepressant to agomelatine Patients may experience discontinuation symptoms after cessation from an SSRI/ SNRI antidepressant.
Danish: Behandlingsskift fra SSRI/SNRI-antidepressiva til agomelatin Patienter kan opleve seponeringssymptomer efter behandlingsstop med et SSRI/SNRI-antidepressivum.
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/
Danish: Yderligere oplysningerom Valdoxan findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The Marketing Authorisation Holder shall agree the format and content of the patient booklet with the National Competent Authority in the Member State.
Danish: Indehaveren af markedsføringstilladelsen skal aftale formatet og indholdet af en patienthåndbog med de nationale myndigheder.
English: Calendar packs of 100 film-coated tablets for hospital use.
Danish: Kalenderpakninger a 100 filmovertrukne tabletter til hospitalsbrug.
English: Valdoxan is indicated for the treatment of major depressive episodes in adults.
Danish: Valdoxan er indiceret til behandling af major depression (moderat til svær depression)hos voksne.
English: In a specific sexual dysfunction comparative trial with remitted depressed patients, there was a numerical trend (not statistically significant) towards less sexual emergent dysfunction than venlafaxine for Sex Effects Scale (SEXFX) drive arousal or orgasm scores on agomelatine.
Danish: Hos patienter med depression i remission har en specifik komparativ undersøgelse af seksuel dysfunktion vist en numerisk tendens (ikke statistisk signifikant) til mindre seksuel dysfunktion under behandlingen med agomelatin end med venlafaxin ved måling af seksualdrift, ophidselse og orgasme ud fra scoringen på Sex Effects Scale (SEXFX).
English: Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (aged less than 25 years) with psychiatric conditions who were being treated with an antidepressant.
Danish: Oplysninger fra kliniske studier har vist en øget risiko for selvmordsadfærd hos yngre personer under 25 år med psykiske lidelser og i behandling med et middel mod depression.
English: Valdoxan should be used with caution in patients with a history of bipolar disorder, mania or hypomania and should be discontinued if a patient develops manic symptoms (see section 4.8).
Danish: Valdoxan bør anvendes med forsigtighed til patienter med bipolar sygdom, mani eller hypomani i anamnesen, og lægemidlet skal seponeres hos patienter, der udvikler maniske symptomer (se pkt.
English: The Physician's guide to prescribing, including a liver monitoring scheme.
Danish: • Vejledning for læger i ordination af Valdoxan, inklusive et skema for monitorering af leverfunktionen.
English: During treatment transaminases should be monitored periodically after around three weeks, six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated (see also section 4.4).
Danish: Under behandling bør aminotransferaser monitoreres jævnligt efter ca. 3 uger, 6 uger (afslutningen af den akutte fase), 12 uger og 24 uger (afslutningen af vedligeholdelsesfasen) og derefter ved klinisk indikation (se også pkt.
English: - When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.
Danish: - Når dosis øges, skal undersøgelse af leverfunktionen igen foretages med samme hyppighed som ved initiering af behandlingen.
English: Therefore, agomelatine should not be used by patients in this age group (see sections 4.4 and 5.1).
Danish: Agomelatin bør derfor ikke anvendes af patienter i denne aldersgruppe (se pkt.
English: The most common adverse reactions were headache, nausea and dizziness.
Danish: De mest almindelige bivirkninger var hovedpine, kvalme og svimmelhed.
English: In a specific study involving cirrhotic patients with chronic mild (Child-Pugh type A) or moderate (Child-Pugh type B) liver impairment, exposure to agomelatine 25 mg was substantially increased (70times and 140-times, respectively), compared to matched volunteers (age, weight and smoking habit) with no liver failure (see section 4.2, 4.3 and 4.4).
Danish: I et specifikt studie hos cirrosepatienter med kronisk mildt (Child-Pugh type A) eller moderat (Child-Pugh type B) nedsat leverfunktion, steg eksponeringen for agomelatin 25 mg betydeligt (hhv. 70 og 140 gange) sammenlignet med matchede kontrolpersoner (alder, vægt og rygevaner) uden leverproblemer (se pkt.
English: Rifampicin an inducer of all three cytochromes involved in the metabolism of agomelatine may decrease the bioavailability of agomelatine.
Danish: Rifampicin, der inducerer alle tre CYP-isoenzymer, der er involveret i metaboliseringen af agomelatin, kan nedsætte biotilgængeligheden af agomelatin.
English: • A guidance on the scheme of hepatic monitoring
Danish: • Vejledning i planen for overvågning af leverfunktion
English: Valdoxan contains the active ingredient agomelatine.
Danish: Valdoxan indeholder det aktive stof agomelatin.
English: The efficacy and safety of agomelatine (25 to 50mg/day) have been established in elderly depressed patients (< 75years).
Danish: Ældre Virkningen og sikkerheden for agomelatin (25-50 mg/dag) er klarlagt hos ældre, depressive patienter
English: Valdoxan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natriumfrit.
English: Diarrhoea Constipation Abdominal pain Vomiting*
Danish: Obstipation Abdominalsmerter Opkastninger *
English: Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine.
Danish: Kombination af agomelatin med østrogener (moderate CYP1A2-hæmmere) fører til en flere gange større eksponering for agomelatin.
English: Superiority (2 trials) or non-inferiority (4 trials) has been shown in six out of seven efficacy trials in heterogeneous populations of depressed adult patients versus SSRI/SNRI (sertraline, escitalopram, fluoxetine, venlafaxine or duloxetine) The anti-depressive effect was assessed with the HAMD-17 score either as primary or secondary endpoint.
Danish: Superioritet (2 studier) eller non-inferioritet (4 studier) er vist i seks ud af syv effektstudier i den heterogene population af depressive voksne patienter versus SSRI/SNRI (sertralin, escitalopram, fluoxetin, venlaflaxin eller duloxetin).
English: - If you have increased levels of liver enzymes before treatment, your doctor will decide if Valdoxan is right for you.
Danish: - Hvis De har forhøjede leverenzymer før behandlingen, vil Deres læge beslutte, om Valdoxan er den rette medicin for Dem.
English: At higher doses, a saturation of the first-pass effect occurs.
Danish: Ved højere doser indtræder mætning efter første passage.
English: Caution should be exercised when Valdoxan is administered to patients with pretreatment elevated transaminases (> the upper limit of the normal ranges and ≤3 times the upper limit of the normal range).
Danish: Der bør udvises forsigtighed, når Valdoxan administreres til patienter, der før behandling har forhøjede aminotransferaser (> den øvre grænse inden for normalområdet og ≤3 X den øvre grænse for normalområdet).
English: Safety pharmacology studies showed no effect of agomelatine on hERG (human Ether à-go-go Related Gene) current or on dog Purkinje cells action potential.
Danish: Undersøgelser af sikkerhedsfarmakologi viste ingen virkning af agomelatin på strømmen gennem den hurtige kaliumkanal (HERG) eller på Purkinje-cellers aktionspotentiale hos hunde.
English: Agomelatine failed to differentiate from placebo in two trials where the active control, paroxetine or fluoxetine showed assay sensitivity.
Danish: Agomelatin adskilte sig ikke fra placebo i to studier, hvor der var assay-følsomhed for det aktive kontrolstof, paroxetin eller fluoxetin.
English: Agomelatine resynchronises circadian rhythms in animal models of circadian rhythm disruption.
Danish: Agomelatin resynkroniserer døgnrytmen i dyremodeller vedrørende døgnrytmeforstyrrelser.
English: Breastfeeding should be discontinued if you take Valdoxan.
Danish: De bør holde op med at amme, hvis De tager Valdoxan.
English: Agomelatine 25 mg also induced an advance of the time of sleep onset and of minimum heart rate.
Danish: Agomelatin 25 mg forkortede også indsovningstid og tid til laveste hjertefrekvens.
English: The symptoms of depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight.
Danish: Symptomerne på en depression er forskellige hos forskellige personer, men vil ofte omfatte en uhyre tristhed, en følelse af ikke at slå til, manglende lyst til at gøre selv det, man bedst kan lide, søvnforstyrrelser, en fornemmelse af at køre på nedsat kraft, angst og vægtforandringer.
English: Anxiety Abnormal dreams*
Danish: Unormale drømme*
English: In clinical trials among children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed compared to those treated with placebo (see section 4.2).
Danish: I kliniske studier sås selvmordsadfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (overvejende aggressivitet, oppositionel adfærd og vrede) hyppigere hos børn og unge, der fik andre antidepressiva, end hos dem, der fik placebo (se pkt.
English: Animal studies have not shown proconvulsant properties (see section 5.3).
Danish: Dyrestudier har ikke påvist krampefremkaldende egenskaber (se pkt.
English: In healthy volunteers agomelatine preserved sexual function in comparison with paroxetine.
Danish: Raske forsøgspersoner bevarede seksualfunktionen med agomelatin sammenlignet med paroxetin.
English: - Rare side effects (may affect up to 1 in 1,000 people): serious skin eruption (erythematous rash), face oedema (swelling) and angioedema (swelling of the face, lips, tongue and/or throat that may cause difficulty in breathing or swallowing), hepatitis, yellow coloration of the skin or the whites of the eyes (jaundice), hepatic failure*, hallucinations, inability to remain still (due to physical and mental unrest), inability to completely empty the bladder.
Danish: - Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer): Alvorligt hududslæt (erytematøst udslæt), ansigtsødem (hævelse) og angioødem (hævelse af ansigt, læber, tunge og/eller svælg, som kan medføre vejrtræknings- og synkebesvær), hepatitis, gulfarvning af huden eller det hvide i øjnene (gulsot), leversvigt*, hallucinationer, manglende evne til at holde sig i ro (pga. fysisk og psykisk uro), manglende evne til at tømme blæren helt.
English: Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) (see section 4.5).
Danish: Samtidig brug af potente CYP1A2-hæmmere (fx fluvoxamin, ciprofloxacin) (se pkt.
English: It is not advisable to drink alcohol while you are being treated with Valdoxan.
Danish: Brug af Valdoxan sammen med alkohol De frarådes at indtage alkohol, mens De er i behandling med Valdoxan.
English: When treatment was switched from these antidepressants to agomelatine, discontinuation symptoms arose after cessation of the SSRI or SNRI treatment, either after abrupt cessation or gradual cessation of the previous treatment.
Danish: Ved behandlingsskift fra disse antidepressiva til agomelatin opstod der seponeringssymptomer efter behandlingsophør med et SSRI/SNRI-antidepressivum, både efter brat seponering og efter trinvis seponering af den tidligere behandling.
English: Caution should be exercised when prescribing Valdoxan with moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) which may result in increased exposure of agomelatine.
Danish: Der bør udvises forsigtighed ved ordination af Valdoxan sammen med moderate CYP1A2-hæmmere (fx propranolol, enoxacin), da det kan føre til øget eksponering for agomelatin.
English: Do not use this medicine after the expiry date which is stated on the carton and blister.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In vivo, agomelatine does not induce CYP450 isoenzymes.
Danish: Agomelatin inducerer ikke CYP-isoenzymer in vivo.