FrancophonIA/ELRC3.0 huggingface dataset:
English: Your depression should be treated for a sufficient period of at least 6 months to ensure that you are free of symptoms.
Danish: Deres depression bør behandles i en tilstrækkelig lang periode på mindst 6 måneder for at sikre, at De er symptomfri.
English: Agomelatine had neutral effect on heart rate and blood pressure in clinical trials.
Danish: Agomelatin havde en neutral virkning på hjertefrekvens og blodtryk i kliniske studier.
English: de los Madroños, 33 -28043 Madrid, Spain
Danish: de los Madroños, 33 -28043 Madrid, Spanien
English: The incidence of relapse during the 6-months double-blind follow up period was 22% and 47% for agomelatine and placebo, respectively.
Danish: Incidensen af recidiv i den seksmåneders, dobbeltblinde opfølgningsperiode var 22% og 47% for hhv. agomelatin og placebo.
English: Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet with blue imprint of company logo on one side.
Danish: Orange til gul, aflang, 9,5 mm lang, 5,1 mm bred filmovertrukket tablet med blåt firmalogo påtrykt den ene side.
English: - alcohol use disorder and /or substantial alcohol intake and in patients receiving concomitant medicinal products associated with risk of hepatic injury.
Danish: - alkoholrelateret sygdom og/eller væsentligt alkoholforbrug og hos patienter, der samtidig får lægemidler, der er forbundet med risiko for leverskade.
English: Use in paediatric population
Danish: Anvendelse til pædiatrisk population
English: [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
Danish: [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
English: The variability is increased with high fat food.
Danish: Variabiliteten øges ved indtagelse af fedtholdig kost.
English: Agomelatine did not show proconvulsive properties at ip doses up to 128 mg/kg in mice and rats.
Danish: Agomelatin viste ikke krampefremkaldende egenskaber ved intraperitoneale doser på op til 128 mg/kg i mus og rotter.
English: In the therapeutic dose-range, agomelatine systemic exposure increases proportionally with dose.
Danish: Inden for det terapeutiske dosisinterval stiger systemisk eksponering for agomelatin proportionalt med dosis.
English: 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
Danish: (≥1/10), almindelig (≥1/100 til < 1/10), ikke almindelig (≥1/1.000 til < 1/100), sjælden (≥1/10.000 til
English: Pharmacotherapeutic group: Psychoanaleptics, other antidepressants, ATC-code: N06AX22 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Psykoanaleptika, Andre antidepressiva, ATC-kode: N06AX22
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Your doctor may continue to give you Valdoxan when you are feeling better to prevent your depression from returning.
Danish: Lægen kan fortsætte med at give Dem Valdoxan, efter De har fået det bedre, for at forebygge, at depressionen vender tilbage.
English: The pooled analysis of trials using the Arizona Sexual Experience Scale (ASEX) showed that agomelatine was not associated with sexual dysfunction.
Danish: Analysen af de samlede resultater fra undersøgelser baseret på Arizona Sexual Experience Scale (ASEX) viste, at agomelatin ikke var forbundet med seksuel dysfunktion.
English: Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine.
Danish: Lægemidler, der reagerer med disse isoenzymer, kan nedsætte eller øge agomelatins biotilgængelighed.
English: Agomelatine passes into the placenta and foetuses of pregnant rats.
Danish: Agomelatin passerer placenta og går over i fostre hos gravide rotter.
English: 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.
Danish: 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.
English: 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.
Danish: Hvis Valdoxan-behandlingen startes, mens dosis af det tidligere lægemiddel nedtrappes, må mulige abstinenssymptomer ikke forveksles med manglende tidlig virkning af Valdoxan.
English: 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.
Danish: 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 %.
English: 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.
Danish: 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.
English: Excretion is mainly (80%) urinary and in the form of metabolites, whereas unchanged compound recovery in urine is negligible.
Danish: Udskillelse sker hovedsagligt gennem urinen (80%) og i form af metabolitter, og kun ringe mængder uomdannet stof kan genfindes i urinen.
English: Potential for agomelatine to affect other medicinal products
Danish: Agomelatins mulige påvirkning af andre lægemidler
English: Agomelatine can be started immediately while tapering the dosage of a SSRI//SNRI (see section
Danish: Agomelatin kan initieres umiddelbart, mens dosis af et SSRI/SNRI nedtrappes (se pkt.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Danish: 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.
English: Agomelatine was not compared directly with paroxetine and fluoxetine as these comparators where added in order to ensure assay sensitivity of the trials.
Danish: Agomelatin blev ikke sammenlignet direkte med paroxetin og fluoxetin, da disse komparatorer blev tilføjet for at sikre assay-følsomhed af studierne.
English: 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.
Danish: Der foreligger dog kun begrænsede kliniske data om brug af agomelatin til patienter med alvorligt eller moderat nedsat nyrefunktion og svære depressive episoder.
English: No dose adjustment is required in relation to age (see section 5.2).
Danish: Dosisjustering er ikke nødvendig i relation til alder (se pkt.
English: The below table gives the adverse reactions observed from placebo-controlled and active-controlled clinical trials.
Danish: Bivirkningerne i tabellen nedenfor er bivirkninger, der er observeret i placebo-kontrollerede og aktivtkontrollerede kliniske studier.
English: Treatment with Valdoxan should only be prescribed after careful consideration of benefit and risk in patients with hepatic injury risk factors e.g.:
Danish: Der bør kun ordineres behandling med Valdoxan efter omhyggelig afvejning af fordele og risici hos patienter med risikofaktorer for leverskade f.eks.:
English: - 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.
Danish: - 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: In two other trials, it was not possible to draw any conclusions because the active controls, paroxetine or fluoxetine, failed to differentiate from placebo.
Danish: I to andre studier var det ikke muligt at udlede en konklusion, da de aktive kontrolstoffer, paroxetin eller fluoxetin, ikke adskilte sig fra placebo.
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: If your doctor increase the dose to 50mg, laboratory tests should be performed at this initiation and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks.
Danish: Hvis Deres læge øger dosis til 50 mg, bør der foretages laboratorieundersøgelser ved start af øgningen og derefter periodevis i løbet af behandlingen, sædvanligvis efter 3 uger, 6 uger, 12 uger og 24 uger.
English: Packs contain 14, 28, 56, 84 or 98 tablets.
Danish: Pakninger a 14, 28, 56, 84 og 98 tabletter.
English: There were mild non dose dependent decreases in body weight related to the pharmacological properties and some minor effects on male reproductive tract without any impairment on reproductive performances.
Danish: Der var lette ikke-dosisafhængige fald i legemsvægt relateret til de farmakologiske egenskaber og nogle mindre virkninger på reproduktionskanalen hos hanner uden nogen forringelse af reproduktionsevnen.
English: You should not take Valdoxan together with certain medicines (see also under “Do not take Valdoxan” in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic) can modify the expected dose of agomelatine in your blood.
Danish: De må ikke tage Valdoxan sammen med visse andre lægemidler (se også under 'Tag ikke Valdoxan' i punkt 2): fluvoxamin (et andet middel mod depression) og ciprofloxacin (et antibiotikum) kan ændre den forventede koncentration af agomelatin i Deres blod.
English: The frequency of benign mammary fibroadenomas observed in the rat was increased with high exposures (60-fold the exposure at the therapeutic dose) but remains in the range of that of controls.
Danish: Hyppigheden af godartede fibroadenomer i mammae hos rotter steg ved høj eksponering (60 gange højere end den terapeutiske dosis), men lå inden for kontrolgruppens interval.
English: Agomelatine 25-50 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.0001) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Danish: Agomelatin 25-50 mg en gang dagligt viste et statistisk signifikant bedre resultat sammenlignet med placebo (p=0,0001) for det primære effektmål, dvs. forebyggelse af recidiverende depression målt som tid til recidiv.
English: These discontinuation symptoms may be confounded with a lack of early benefit of agomelatine.
Danish: Disse seponeringssymptomer kan forveksles med manglende tidlig agomelatin-virkning.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in milk (see section 5.3).
Danish: Tilgængelige farmakodynamiske/toksikologiske data hos dyr har vist, at agomelatin/metabolitter udskilles i mælk (se pkt.
English: Liver tumours are most likely related to enzyme induction specific to rodents.
Danish: Levertumorer er højst sandsynligt forbundet med gnavernes specifikke enzyminduktion.
English: Confusional state*
Danish: Konfusionstilstand*
English: Therefore, clinical consequences of ECT performed concomitantly with agomelatine treatment, are considered to be unlikely.
Danish: Det anses derfor for usandsynligt, at ECT udført samtidig med behandling med agomelatin skulle få kliniske konsekvenser.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Valdoxan, are provided with patient booklets to be distributed to their patients being prescribed this medicine.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der forventes at ordinere eller anvende Valdoxan, har patienthåndbøger tilrådighed til udlevering til de patienter, der får ordineret dette lægemiddel.
English: Smoking induces CYP1A2 and has been shown to decrease the bioavailability of agomelatine, especially in heavy smokers (> 15 cigarettes/day) (see section 5.2).
Danish: Rygning inducerer CYP1A2 og er vist at nedsætte biotilgængeligeheden af agomelatin, især hos storrygere (≥ 15 cigaretter/dag) (se pkt.
English: • lactose monohydrate, maize starch, povidone (K30), sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica,hypromellose, glycerol, macrogol (6000), yellow iron oxide (E172) and titanium dioxide (E171).
Danish: • Lactosemonohydrat, majsstivelse, polyvidon (K30), natriumstivelsesglycolat type A, stearinsyre, magnesiumstearat, kolloid vandfri silica, hypromellose, glycerol, macrogol (6000), gul jernoxid (E172) og titandioxid (E171).
English: There is no data on the influence of race on agomelatine pharmacokinetics.
Danish: Der foreligger ingen data om racemæssig påvirkning af agomelatins farmakokinetik.
English: Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450.
Danish: Agomelatin påvirker derfor ikke eksponeringen for lægemidler, der metaboliseres af CYP.
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Danish: Patienter med selvmordsrelaterede hændelser i anamnesen samt patienter, som udviser en signifikant grad af selvmordstanker inden påbegyndelse af behandlingen, vides at have større risiko for selvmordstanker eller selvmordsforsøg, og de skal overvåges nøje under behandlingen.
English: The pattern of liver damage is predominantly hepatocellular with increased serum transaminases, which usually return to normal levels on cessation of agomelatine.
Danish: Mønstret for leverbeskadigelse er hovedsagelig hepatocellulært med forhøjede serum-aminotransferaser, der sædvanligvis vender tilbage til normale niveauer ved seponering af agomelatin.
English: Do not take Valdoxan - if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Valdoxan - hvis De er allergisk over for agomelatin eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: The maintenance of antidepressant efficacy was demonstrated in a relapse prevention trial.
Danish: Vedvarende antidepressiv effekt blev påvist i et studie vedrørende forebyggelse af recidiv.
English: A specific controlled, 3-week trial has been conducted in patients suffering from major depressive disorder and insufficiently improved with paroxetine (a SSRI) or venlafaxine (a SNRI).
Danish: Et specifikt, kontrolleret, 3.ugers studie er udført hos patienter med major depression og utilstrækkelig bedring med paroxetin (et SSRI) eller venlaflaxin (et SNRI).
English: Treatment discontinuation No dosage tapering is needed on treatment discontinuation.
Danish: Seponering af behandlingen Det er ikke nødvendigt at nedtrappe dosis ved seponering af behandlingen.
English: Weight decreased* * Frequency estimated from clinical trials for adverse reactions detected from spontaneous report (1) Few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors.
Danish: Ikke almindelig Vægttab* * Hyppighed estimeret ud fra kliniske studier for spontant indberettede bivirkninger (1) Få tilfælde blev undtagelsesvist rapporteret med fatalt udfald eller levertransplantation hos patienter med hepatiske risikofaktorer.
English: The SmPC of the actual SSRI/SNRI should be consulted on how to withdraw the treatment to avoid this.
Danish: Produktresuméet for det pågældende SSRI/SNRI skal kontrolleres for at undersøge, hvordan behandlingen kan seponeres, og dette undgås.
English: After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime.
Danish: Såfremt der ikke er opnået bedring af symptomerne efter to ugers behandling, kan dosis øges til 50 mg en gang dagligt, dvs. to tabletter a 25 mg indtaget samtidig ved sengetid.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår drægtighed, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: You should discuss with your doctor on the best way of stopping your previous antidepressant medicine when starting Valdoxan.
Danish: Tal med lægen om, hvordan De bedst kan stoppe med det tidligere lægemiddel mod depression, når De starter med Valdoxan.
English: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Danish: Hvis De på noget tidspunkt tænker på at skade Dem selv eller begå selvmord, skal De straks kontakte lægen eller skadestuen.
English: Increased gamma-glutamyltransferase* (GGT)(>3 times the upper limit of the normal range
Danish: Ikke almindelig Forhøjet gamma-glutamyltransferase* (GGT) (> 3 x øvre grænse for normalområdet)
English: No effect of agomelatine is documented in patients ≥75 years, therefore agomelatine should not be used by patients in this age group (see also sections 4.2 and 5.1).
Danish: Der er ikke dokumenteret nogen virkning af agomelatin hos patienter ≥ 75 år, hvorfor agomelatin ikke bør anvendes til patienter i denne aldersgruppe (se også pkt.
English: - if you are taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).
Danish: - hvis De tager fluvoxamin (et andet middel mod depression) eller ciprofloxacin (et antibiotikum).
English: No specific antidotes for agomelatine are known.
Danish: Der kendes ingen specifik antidot mod agomelatin.
English: Ten placebo controlled trials have been performed to investigate the short term efficacy of agomelatine in major depressive disorder in adults, with fixed dose and/or dose up-titration.
Danish: Der er foretaget ti placebokontrollerede studier til undersøgelse af agomelatins virkning på kort sigt på major depression hos voksne med fast dosis og/eller dosis-optitrering.
English: Baseline liver function tests should be undertaken in all patients and treatment should not be initiated in patients with baseline values of ALT and/or AST >3 X upper limit of normal (see section 4.3).
Danish: Der bør foretages undersøgelse af leverfunktionen ved baseline hos alle patienter og behandling bør ikke initieres hos patienter med baselineværdier for ALAT og/eller ASAT, der er > 3 X den øvre grænse for normalområdet (se pkt.
English: The combination of agomelatine and alcohol is not advisable.
Danish: Det frarådes at kombinere agomelatin og alkohol.
English: Any dose increase to 50 mg should be made on an individual patient benefit/risk basis and with strict respect of Liver Function Test monitoring.
Danish: Enhver dosisøgning til 50 mg skal altid foretages ud fra den enkelte patients fordele og risici og med nøje overholdelse af monitorering af leverfunktionen.
English: Level of sodium
Danish: Natriumniveau