FrancophonIA/ELRC3.0 huggingface dataset:
English: The request followed reports to the Spanish agency of serious adverse effects affecting the heart including fatal heart attacks, angina and arrhythmias (irregular heartbeat) as well as cases of serious bleeding including bleeding in the brain.
Danish: Anmodningen fulgte efter indberetninger til det spanske agentur om alvorlige bivirkninger, der påvirkede hjertet, herunder dødelige hjerteslag, angina pectoris og arytmier (uregelmæssig puls), samt tilfælde af alvorlig blødning, herunder hjerneblødning.
English: The Spanish Agency for Medicines and Health Products (AEMPS) asked the CHMP to carry out a review of these medicines following a number of reports of serious suspected side effects, in particular affecting the heart, as well as cases of serious bleeding.
Danish: Det spanske agentur for lægemidler og sundhedsprodukter (AEMPS) anmodede CHMP om at udføre en gennemgang af disse lægemidler efter et antal indberetninger om alvorlige, formodede bivirkninger, der især påvirkede hjertet, samt tilfælde af alvorlig blødning.
English: The Agency's recommendations are based on a review by the Committee for Medicinal Products for Human Use (CHMP), which looked at available data on the benefits and risks of cilostazol.
Danish: Yderligere oplysninger om vurderingen: Agenturets anbefalinger er baseret på en gennemgang foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som så på tilgængelige data om fordele og risici ved cilostazol.
English: Cilostazol works by blocking an enzyme called phosphodiesterase type 3, which is found in the walls of arteries and is involved in various processes affecting circulation, including aggregation (clumping together) of blood platelets and narrowing of the arteries.
Danish: Cilostazol virker ved at blokere et enzym, der hedder phosphodiesterase type 3, som findes i arterievæggene og er involveret i forskellige processer, der påvirker kredsløbet, herunder aggregation (sammenklumpning) af blodplader og forsnævring af arterierne.
English: • Cilostazol should also not be given to patients also receiving both aspirin and clopidogrel, or any other combination of two or more additional antiplatelet or anticoagulant medicines.
Danish: • Cilostazol bør heller ikke gives til patienter, der også modtager både aspirin og clopidogrel eller nogen anden kombination af to eller flere yderligere antithrombocyt- eller antikoagulationslægemidler.
English: • Cilostazol should not be given to patients who have unstable angina or who have had myocardial infarction or a coronary intervention (PCI) within the last six months, nor to those with a history of severe tachyarrhythmia.
Danish: • Cilostazol bør ikke gives til patienter, der har ustabil angina, eller som har haft myokardie-infarkt eller en koronarintervention (PCI) inden for de seneste seks måneder, og ej heller til patienter med svær tachyarrytmi i anamnesen.
English: The CHMP examined available clinical trial data on the benefits and risks of the medicines provided by the companies that market these medicines, as well as data from scientific literature, reports of suspected side effects, post-marketing studies and experimental studies before making its recommendations.
Danish: fordele og risici ved lægemidlerne, der blev leveret af virksomhederne, som markedsfører disse lægemidler, samt data fra videnskabelig litteratur, indberetninger om formodede bivirkninger, undersøgelser efter markedsføringen og eksperimentelle undersøgelser, før det forelagde sine anbefalinger.
English: In addition, cilostazol-containing medicines should not be used in patients who have suffered severe tachyarrhythmia (fast, abnormal heart rhythm), or recent unstable angina, heart attack or bypass surgery, or who take two or more antiplatelet or anticoagulant medicines such as aspirin and clopidogrel.
Danish: Derudover bør lægemidler, der indeholder cilostazol, ikke anvendes til patienter, der har lidt af svær tachyarrytmi (hurtig, abnorm hjerterytme) eller nylig, ustabil angina, hjerteslag eller bypass-operation, eller som tager to eller flere antitrombocyt- eller antikoagulationslægemidler, såsom aspirin og clopidogrel.
English: Cilostazol is a medicine that is used to improve walking distance in patients who have intermittent claudication due to peripheral arterial obstructive disease (obstruction and narrowing of the arteries of the limbs, leading to reduced blood flow).
Danish: Cilostazol er et lægemiddel, der anvendes til at forøge gangdistancen hos patienter, der har claudicatio intermittens på grund af perifer, arterieobstruerende sygdom (obstruktion og forsnævring af arterierne i ekstremiteterne, hvilket medfører reduceret blodgennemstrømning).
English: • Cilostazol is used to treat intermittent claudication, a condition where walking becomes painful and difficult because of problems with blood circulation in the arteries of the legs.
Danish: • Cilostazol anvendes til behandling af claudicatio intermittens, en tilstand, hvor gang bliver pinefuld og vanskelig på grund af problemer med blodcirkulationen i benenes arterier.
English: • Cilostazol has been shown to produce modest increases in walking distance compared with placebo; meta-analysis of pooled individual patient data from nine efficacy trials involving 3,122 patients indicated a mean percentage increase from baseline of 59.4% for cilostazol, compared with 24.3% for placebo.
Danish: Metaanalyse af indsamlede, individuelle patientdata fra ni effektivitetsforsøg, der involverede 3122 patienter, viste en gennemsnitlig procentvis forøgelse fra baseline på 59,4 % for cilostazol, sammenlignet med 24,3 % for placebo.
English: • Prescribers should be aware of the risk of interactions with cilostazol; its dose should be reduced in patients also taking strong inhibitors of CYP3A4 or CYP2C19.
Danish: Dosis bør reduceres til patienter, der også tager stærke inhibitorer af CYP3A4 eller CYP2C19.
English: • If you have any questions, you should contact your doctor or pharmacist.
Danish: • Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/16/1137/001 Granpidam 20 mg Film-coated tablet
Danish: Styrke Lægemiddelform Administration Emballage
English: - if you are a young adult.
Danish: - hvis De er en yngre person.
English: This risk persists until significant remission occurs.
Danish: Risikoen foreligger, indtil der er opnået signifikant remission.
English: The total number of patients receiving 50 mg was too low to draw any conclusions.
Danish: Det totale antal patienter, der fik 50 mg, var for lavt til at drage nogen konklusioner.
English: PC: SN: NN:
Danish: PC: SN:
English: Therefore follow-up tests should take place at the following time points:
Danish: Derfor bør opfølgende undersøgelser foretages på følgende tidspunkter:
English: It belongs to a group of medicines called antidepressants.
Danish: Det tilhører en gruppe medicin, der kaldes antidepressiva.
English: Just carry on with the next dose at the usual time.
Danish: Fortsæt blot med næste dosis på det sædvanlige tidspunkt.
English: * Few cases resulting in liver transplantation or death have been reported.
Danish: *Få tilfælde resulterende i levertransplantation eller død er blevet rapporteret.
English: Most of them occurred during the first months of treatment.
Danish: De fleste tilfælde forekom i løbet af de første måneder af behandlingen.
English: Surveillance of the liver function (see also section 2):
Danish: Kontrol af leverfunktionen (se også punkt 2):
English: Use in elderly with dementia
Danish: Anvendelse til ældre med demens
English: Agomelatine is rapidly and well (≥ 80%) absorbed after oral administration.
Danish: Agomelatin absorberes hurtigt og godt (≥ 80%) efter oral administration.
English: Most side effects are mild or moderate.
Danish: De fleste bivirkninger er lette eller moderate.
English: The peak plasma concentration is reached within 1 to 2 hours.
Danish: Maksimal plasmakoncentration nås i løbet af 1-2 timer.
English: The frequencies have not been corrected for placebo.
Danish: Frekvensen er ikke justeret for placebo.
English: Medical follow-up in a specialised environment is recommended.
Danish: Medicinsk opfølgning på specialafdeling anbefales.
English: Ask your doctor for advice on which medicine that is.
Danish: Spørg lægen til råds om, hvilken medicin det drejer sig om.
English: You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Danish: De kan f.eks. bede dem sige til, hvis de mener, at Deres depression er blevet værre, eller hvis de er bekymrede over ændringer i Deres opførsel.
English: Primary endpoint was change in HAMD-17 score from baseline.
Danish: Det primære endepunkt var ændring i HAMD-17 score fra baseline.
English: Ethnic groups
Danish: Etniske grupper
English: • Frequency of liver function tests - before starting treatment - and then:
Danish: • Hyppighed for undersøgelser af leverfunktion - før initiering af behandling - og:
English: The bioavailability is increased by intake of oral contraceptives and reduced by smoking.
Danish: Biotilgængeligheden forhøjes ved indtagelse af orale kontraceptiva og nedsættes af rygning.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of agomelatine in pregnant women.
Danish: Der er ingen eller utilstækkelige data (mindre end 300 graviditeter) fra anvendelse af agomelatin til gravide kvinder.
English: What to do to avoid potential serious liver problems - Your doctor should have checked that your liver is working properly before starting the treatment.
Danish: For at forebygge mulige alvorlige leverproblemer: - Deres læge bør have kontrolleret, at Deres lever fungerer korrekt inden De starter behandlingen.
English: These symptoms may also be due to the underlying disease (see section 4.4).
Danish: Disse symptomer kan også skyldes den underliggende sygdom (se pkt.
English: Before starting treatment
Danish: Før initiering af behandling
English: Electroconvulsive therapy (ECT)
Danish: Elektrokonvulsiv terapi (ECT)
English: Absolute bioavailability is low (< 5% at the therapeutic oral dose) and the interindividual variability is substantial.
Danish: Absolut biotilgængelighed er lav (< 5% efter terapeutiske orale doser) og med betydelig interindividuel variation.
English: • A blood tests appointments reminder.
Danish: • Påmindelse om blodprøvetagning.
English: Annopol 6B - 03-236 Warszawa, Poland Laboratorios Servier, S.L, Avda.
Danish: Annopol 6B - 03-236 Warszawa, Polen Laboratorios Servier, S.L, Avda.
English: The Patient's Booklet should contain the following key messages:
Danish: Patienthåndbogen skal indeholde følgende hovedbudskaber:
English: Valdoxan should therefore not be used in these patients.
Danish: Valdoxan bør derfor ikke anvendes til disse patienter.
English: The expected benefits of Valdoxan are to reduce and gradually remove the symptoms related to your depression.
Danish: De forventede fordele af Valdoxan er at reducere og gradvist fjerne symptomer relateret til Deres depression.
English: (<1/10,000), not known (cannot be estimated from the available data).
Danish: <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The bioavailability is increased in women compared to men.
Danish: Biotilgængeligheden er højere hos kvinder end hos mænd.
English: These effects are usually mild to moderate and disappear spontaneously within a few days.
Danish: Disse symptomer er sædvanligvis lette til moderate og forsvinder spontant inden for nogle få dage.
English: • Information about the risk of hepatic reactions and clinical signs of liver problems
Danish: • Information om risikoen for leverreaktioner og kliniske tegn på leverproblemer
English: You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet.
Danish: Det kan være en hjælp at fortælle en pårørende eller en ven, at De er deprimeret, og bede dem læse denne indlægsseddel.
English: Therefore, caution should be exercised when prescribing agomelatine to these patients.
Danish: Der bør derfor udvises forsigtighed ved ordinering af agomelatin til disse patienter.
English: Efficacy was also observed in more severely depressed patients (baseline HAM-D ≥ 25) in all positive placebo-controlled trials.
Danish: Der blev også observeret effekt hos mere alvorligt depressive patienter (baseline HAM-D ≥ 25) i alle positive placebokontrollerede studier.
English: During your treatment with Valdoxan :
Danish: Under Deres behandling med Valdoxan:
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: Generelt viser den kliniske erfaring, at risikoen for selvmord kan øges i de tidlige faser af bedringen.
English: You should swallow your tablet with a drink of water.
Danish: Tabletten skal synkes hel med et glas vand.
English: Tolerability of agomelatine in elderly patients was comparable to that seen in the younger adults.
Danish: Tolerabiliteten af agomelatin hos ældre patienter var sammenlignelig med den, der ses hos yngre voksne.
English: No improvement was observed in very elderly patients (≥75 years, N= 69, of which 48 on agomelatine).
Danish: Der blev ikke observeret nogen forbedring hos meget ældre patienter (≥ 75 år, N=69, hvoraf 48 fik agomelatin).
English: Thereafter tests will be taken if the doctor finds it necessary.
Danish: Derefter vil leverfunktionen blive kontrolleret, hvis lægen finder det nødvendigt.
English: It is not known whether agomelatine/metabolites are excreted in human milk.
Danish: Det vides ikke, om agomelatin/metabolitter udskilles i human mælk.
English: Mania/hypomania*
Danish: Mani/hypomani *
English: Management of overdose should consist of treatment of clinical symptoms and routine monitoring.
Danish: Behandlingen af en overdosis bør bestå i behandling af de kliniske symptomer og standardovervågning.
English: Response rates were statistically significantly higher with agomelatine compared with placebo.
Danish: Responsraterne var statistisk set signifikant højere med agomelatin sammenlignet med placebo.
English: You must not use Valdoxan if your liver does not work properly.
Danish: De må ikke tage Valdoxan, hvis Deres lever ikke fungerer ordentligt.
English: No effect is documented in patients ≥75 years.
Danish: Der er ikke dokumenteret nogen virkning hos patienter ≥ 75 år.
English: Depression is a continuing disturbance of mood that interferes with everyday life.
Danish: En depression er en vedholdende forstyrrelse af sindsstemningen, der påvirker dagligdagen.
English: The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Valdoxan.
Danish: Kalenderen, der er trykt på blisterkortet med tabletterne, kan hjælpe Dem til at huske, hvornår De sidst har taget en Valdoxan tablet.
English: - obesity/overweight/non-alcoholic fatty liver disease, diabetes
Danish: - fedme/overvægt/ikke-alkoholisk fedtleverlidelse, diabetes,
English: One person having ingested 2,450 mg agomelatine, recovered spontaneously without cardiovascular and biological abnormalities.
Danish: En person, der havde indtaget 2.450 mg agomelatin, kom sig spontant uden kardiovaskulære og biologiske forstyrrelser.
English: Some patients may get increased levels of liver enzymes in their blood during treatment with Valdoxan.
Danish: Nogle patienter kan få forhøjede leverenzymer i blodet under behandling med Valdoxan.
English: Adverse reactions were usually mild or moderate and occurred within the first two weeks of treatment.
Danish: Bivirkningerne var sædvanligvis milde eller moderate og indtrådte i løbet af de første to ugers behandling.
English: The major metabolites, hydroxylated and demethylated agomelatine, are not active and are rapidly conjugated and eliminated in the urine.
Danish: De største metabolitter, hydroxyleret og demethyleret agomelatin, er ikke aktive, og de konjugeres hurtigt og udskilles i urinen.
English: Food intake (standard meal or high fat meal) does not modify the bioavailability or the absorption rate.
Danish: Indtagelse af føde (standardmåltid eller måltid med højt fedtindhold) påvirker ikke biotilgængelighed eller absorptionshastighed.
English: Any patient who develops increased serum transaminases should have his/her liver function tests repeated within 48 hours.
Danish: Enhver patient, der udvikler forhøjede serumaminotransferaser, bør have undersøgelserne af leverfunktionen gentaget inden for 48 timer.
English: No effect of agomelatine on juvenile animals behavioural performances, visual and reproductive function were observed.
Danish: Der blev ikke observeret nogen virkninger af agomelatin på unge dyrs adfærd eller, visuelle og reproduktive funktion.
English: Valdoxan should not be used in children and adolescents (under 18 years old).
Danish: Børn og unge Valdoxan bør ikke anvendes til børn og unge (under 18 år).
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events).
Danish: Depression sættes i forbindelse med en øget risiko for selvmordstanker, selvpåført skade og selvmord (selvmordsrelaterede hændelser).
English: Hallucinations*
Danish: Hallucinationer*
English: You may be more likely to think like this: - if you have previously had thoughts about killing or harming yourself.
Danish: De kan være mere tilbøjelig til at få disse tanker: - hvis De tidligere har haft selvmordstanker eller tænkt på at skade Dem selv.
English: Decision of dose increase has to be balanced with a higher risk of transaminases elevation.
Danish: Beslutningen om at øge dosis skal afvejes mod en højere risiko for stigning i aminotransferaser.
English: In mice, rats and monkeys sedative effects were observed after single and repeated administration at high doses.
Danish: Hos mus, rotter og aber observeredes sedative virkninger efter en enkelt og gentagen administration af høje doser.
English: Paraesthesia Restless leg syndrome*
Danish: Restless leg syndrom*
English: Aluminium/PVC blister packed in cardboard boxes.
Danish: Aluminium/PVC blisterkort pakket i karton.
English: 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.
Danish: I disse studier var det dog ikke tilladt at øge startdosis af enten agomelatin, paroxetin eller fluoxetin, selv om responset ikke var tilstrækkelig.
English: They usually occur within the first two weeks of the treatment and are usually temporary.
Danish: De vil normalt indtræffe i løbet af de første to ugers behandling og er sædvanligvis forbigående.
English: Weight increased *
Danish: Vægtstigning*
English: Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist.
Danish: Agomelatin er en melatonerg agonist (MT1- og MT2-receptorer) og en 5-HT2C-antagonist.
English: 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.
Danish: 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.
English: Bipolar disorder/ mania / hypomania
Danish: Bipolar sygdom/mani/hypomani
English: These adverse reactions were usually transient and did not generally lead to cessation of therapy.
Danish: Disse bivirkninger var sædvanligvis forbigående og medførte ikke generelt behandlingsophør.
English: Agitation and related symptoms* (such as irritability and restlessness) Aggression*
Danish: 4.4) Agitation og beslægtede symptomer* (såsom irritabilitet og rastløshed)
English: There is limited experience with agomelatine overdose.
Danish: Der er begrænset erfaring med overdosering af agomelatin.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Danish: Da der muligvis ikke opstår bedring i løbet af de første ugers behandling, bør patienterne overvåges nøje, indtil bedringen indtræffer.
English: In some cases, your doctor may prescribe a higher dose (50 mg), i.e. two tablets to be taken together at bedtime.
Danish: I visse tilfælde kan lægen ordinere en højere dosis (50 mg), dvs. to tabletter, som skal tages samtidig ved sengetid.
English: Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin.
Danish: Agomelatin øger frigivelsen af noradrenalin og dopamin, specifikt i cortex frontalis, og har ingen indflydelse på niveauet af ekstracellulær serotonin.
English: Liver function tests should be performed in all patients before starting treatment.
Danish: Leverfunktionen bør kontrolleres hos alle patienter før initiering af behandling.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Valdoxan is used in adults.
Danish: Valdoxan anvendes til voksne.
English: There is no relevant use of agomelatine in children from birth to 2 years for treatment of major depressive episodes.
Danish: Det er ikke relevant at anvende agomelatin hos børn fra fødslen frem til 2 år til behandling af svære depressive episoder.
English: Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Danish: Patienter med depression bør behandles i en tilstrækkelig lang periode på mindst seks måneder for at sikre, at de er symptomfri.
English: As a precautionary measure, it is preferable to avoid the use of Valdoxan during pregnancy.
Danish: Som en forsigtighedsforanstaltning bør Valdoxan undgås under graviditet.
English: No dose adaptation is required in elderly patients.
Danish: Dosistilpasning er ikke nødvendig hos ældre patienter.
English: You might experience dizziness or sleepiness which could affect your ability to drive or operate machines.
Danish: De vil muligvis opleve svimmelhed eller søvnighed, hvilket kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: The efficacy and safety of agomelatine in major depressive episodes have been studied in a clinical programme including 7,900 patients treated with agomelatine.
Danish: Agomelatins virkning og sikkerhed ved moderat til svær depression er undersøgt i et klinisk program med 7.900 patienter behandlet med agomelatin.
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 98 filmovertrukne tabletter 100 filmovertrukne tabletter
English: Potential interactions affecting agomelatine
Danish: Interaktioner, der muligvis påvirker agomelatin
English: 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).
Danish: 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').
English: Date of latest renewal : 12 December 2018
Danish: Dato for første markedsføringstilladelse: 19. februar 2009 Dato for seneste fornyelse af tilladelsen: 12. december 2018