FrancophonIA/ELRC3.0 huggingface dataset:
English: - Uncommon side effects (may affect up to 1 in 100 people): migraine, pins and needles in the fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder that is characterized by an uncontrollable urge to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also under “Warnings and precautions” in section 2), suicidal thoughts or behaviour,confusion, weight decreased.
Danish: - Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer): Migræne, snurrende fornemmelse i fingre og tæer (paræstesier), uskarpt syn, restless legs syndrom (en lidelse, der er karakteriseret ved uimodståelig trang til at bevæge benene), ringen for ørerne, svedudbrud (hyperhidrose), eksem, kløe, urticaria (nældefeber), ophidselse, irritabilitet, rastløshed, aggressiv adfærd, mareridt, mani/hypomani (se også under ”Advarsler og forsigtighedsregler” i punkt 2), selvmordstanker eller selvmordsrelateret adfærd, forvirring, vægttab.
English: Valdoxan contains lactose
Danish: Valdoxan indeholder lactose
English: What Valdoxan contains - The active substance is agomelatine.
Danish: Valdoxan indeholder: - Aktivt stof: Agomelatin.
English: There is no experience of concurrent use of agomelatine with ECT.
Danish: Der er ikke erfaring med samtidig brug af agomelatin og ECT.
English: If your doctor changes your previous antidepressant medicine from an SSRI or SNRI to Valdoxan, he/she will advise you on how you should discontinue your previous medicine when starting Valdoxan.
Danish: Sådan skiftes fra et lægemiddel mod depression (SSRI/SNRI) til Valdoxan Hvis Deres læge ændrer Deres tidligere lægemiddel mod depression fra et SSRI eller SNRI til Valdoxan, vil lægen vejlede Dem i, hvordan De skal stoppe med det tidligere lægemiddel, når De starter med Valdoxan.
English: Each film-coated tablet contains 25 mg of agomelatine.
Danish: Hver filmovertrukket tablet indeholder 25 mg agomelatin.
English: Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility, embryofoetal development and pre- and post natal development.
Danish: I reproduktionsstudier hos rotter og kaniner havde agomelatin ingen virkning på fertilitet, embryoets/fostrets udvikling, fødslen og den postnatale udvikling.
English: Suicidal thoughts or behaviour (see section
Danish: Ikke almindelig Selvmordstanker eller selvmordsadfærd (se pkt.
English: Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Danish: Samtidig administration af Valdoxan og potente CYP1A2-hæmmere (fx fluvoxamin og ciprofloxacin) er derfor kontraindiceret.
English: If you have taken more Valdoxan than you should, or if for example a child has taken medicine by accident, contact your doctor immediately.
Danish: Hvis De har taget for mange Valdoxan-tabletter Kontakt straks Deres læge, hvis De har taget flere Valdoxan-tabletter, end De burde, eller hvis f.eks. et barn har taget medicinen ved en fejl.
English: Be vigilant about signs and symptoms that your liver may not be working properly - If you observe any of these signs and symptoms of liver problems: unusual darkening of the urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue (especially associated with other symptoms listed above), seek urgent advice from a doctor who may advise you to stop taking Valdoxan.
Danish: - Hvis De observerer nogen af følgende tegn og symptomer på problemer med leveren: Usædvanlig mørkfarvning af urinen, lys afføring, gulfarvning af hud/øjne, smerter øverst til højre i maven, usædvanlig træthed (især i forbindelse med andre af ovennævnte symptomer), så rådfør Dem hurtigst muligt med lægen, der måske vil råde Dem til at holde op med at tage Valdoxan.
English: What you need to know before you take Valdoxan
Danish: Det skal De vide, før De begynder at tage Valdoxan
English: Cases of liver injury, including hepatic failure (few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors), elevations of liver enzymes exceeding 10 times upper limit of normal, hepatitis and jaundice have been reported in patients treated with agomelatine in the post-marketing setting (see section 4.8).
Danish: Efter markedsføringen er der rapporteret tilfælde af leverskade, inklusive leverinsufficiens (få tilfælde blev undtagelsesvist rapporteret med fatalt udfald eller levertransplantation hos patienter med hepatiske risikofaktorer), forhøjelse af leverenzymer ud over 10 gange den øvre grænse for normalområdet, hepatitis og gulsot hos patienter behandlet med agomelatin (se pkt.
English: • printing ink : shellac, propylene glycol and indigo carmine aluminium lake (E132)
Danish: • Blækket: Shellac, propylenglycol og indigotin (E132).
English: Magnesium stearate Silica, colloidal anhydrous
Danish: Magnesiumstearat Kolloid vandfri silica
English: Printing ink containing shellac, propylene glycol and indigo carmine aluminium lake (E132).
Danish: Blækket indeholder shellac, propylenglycol og indigotin (E132).
English: Each film-coated tablet contains 61.8 mg lactose (as monohydrate) For the full list of excipients, see section 6.1.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 61,8 mg lactose (som monohydrat).
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg of agomelatine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En filmovertrukket tablet indeholder 25 mg agomelatin.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Valdoxan indeholder lactose og bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Nightmares*
Danish: Mareridt *
English: Erythematous rash Face oedema and angioedema*
Danish: Erytematøst udslæt Ansigtsødem og angioødem*
English: During treatment period Valdoxan treatment should be discontinued immediately if: ‐ patient develops symptoms or signs of potential liver injury (such as dark urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, sustained new-onset and unexplained fatigue).
Danish: Under behandlingsperioden Valdoxanbehandling bør øjeblikkeligt seponeres hvis: - patienten udvikler symptomer eller tegn på en potentiel leverskade (såsom mørkfarvet urin, lysfarvet afføring, gulfarvning af hud/øjne, smerter i højre side af øvre abdomen, nyopstået vedvarende og uforklarlig træthed) - stigning i serumaminotransferaser overstiger 3 X den øvre grænse for normalområdet.
English: Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 X upper limit of normal (see sections 4.2 and 4.4).
Danish: Nedsat leverfunktion (dvs. levercirrose eller aktiv leversygdom) eller aminotransferaser, der overskrider 3 X den øvre grænse af normalen (se pkt.
English: Packs of 100 film-coated tablets are also available for hospital use.
Danish: Pakninger a 100 filmovertrukne tabletter fås til hospitalsbrug.
English: Discontinuation symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking.
Danish: Abstinenssymptomerne omfatter: svimmelhed, følelsesløshed, søvnforstyrrelser, uro eller angst, hovedpine, kvalme, opkastning og rysten.
English: Anpharm Przedsiebiorstwo Farmaceutyczne S.A. 03-236 Warszawa ul.
Danish: Anpharm Przedsiebiorstwo Farmaceutyczne S.A. ul.
English: A placebo-controlled 8-week trial of agomelatine 25-50mg/day in elderly depressed patients (≥ 65 years, N=222, of which 151 on agomelatine) demonstrated a statistically significant difference of 2.67 points on HAM-D total score, the primary outcome.
Danish: (≥ 65 år, N=222, hvoraf 151 fik agomelatin) påviste en statistisk signifikant forskel på 2,67 point i
English: Valdoxan 25 mg film-coated tablets are available in calendar blisters.
Danish: Valdoxan 25 mg filmovertrukne tabletter fås som blisterkort med kalender.
English: 9 DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation : 19 February 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Macrogol (6000) Magnesium stearate Titanium dioxide (E171)
Danish: Titandioxid (E171)
English: If you stop taking Valdoxan Do not stop taking your medicine without the advice of your doctor even if you feel better.
Danish: Selv om De får det bedre, må De ikke holde op med at tage medicinen medmindre lægen anbefaler det.
English: Make sure to tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used in the treatment of hypertension), enoxacin (antibiotic) Make sure to tell your doctor if you are smoking more than15 cigarettes/day.
Danish: Vær opmærksom på at fortælle det til lægen, hvis De tager et eller flere af følgende slags medicin: propranolol (en betablokker, der anvendes til behandling af forhøjet blodtryk) og enoxacin (antibiotikum).
English: The experience of overdoses with Valdoxan is limited but reported symptoms include pain in the upper part of the stomach, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise.
Danish: Der er begrænset erfaring med overdosering af Valdoxan, men der er indberettet symptomer som smerter øverst i maven, døsighed, træthed, rastløs uro, angst, spænding, svimmelhed, blåfarvning af hud og slimhinder (cyanose) og utilpashed.
English: Experience with agomelatine in overdose has indicated that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise have been reported.
Danish: Ved overdosering af agomelatin er der indberettet smerter i epigastriet, døsighed, træthed, agitation, angst, spænding, svimmelhed, cyanose og utilpashed.
English: When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.
Danish: Ved dosisøgning bør leverfunktionen kontrolleres med samme hyppighed som ved behandlingsstart.
English: Povidone (K30) Sodium starch glycolate type A Stearic acid
Danish: Natriumstivelsesglycolat type A Stearinsyre
English: Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
Danish: Under en depression kan man af og til tænke på at skade sig selv eller begå selvmord.
English: How to take Valdoxan
Danish: Sådan skal De tage Valdoxan
English: - If you have bipolar disorder, have experienced or if you develop manic symptoms (a period of abnormally high excitability and emotions) talk to your doctor before you start taking this medicine or before you continue with this medicine (see also under “Possible side effects” in section 4).
Danish: Tal med lægen, inden De begynder at tage denne medicin, eller inden De fortsætter med at tage den (se også punkt 4, ”Bivirkninger”).
English: Kinetics are not modified after repeated administration.
Danish: Farmakokinetikken påvirkes ikke af gentagne doser.
English: Treatment should not be initiated if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4).
Danish: Behandling bør ikke initieres, hvis aminotransferaser overstiger 3 X den øvre grænse for normalområdet (se pkt.
English: Papaellinas Ltd. Τηλ: +357 22741741
Danish: Τηλ: +357 22741741
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 25 mg of agomelatine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 25 mg agomelatin.
English: Jaundice*
Danish: Urticaria*
English: - If you are suffering from dementia, your doctor will make an individual evaluation of whether it is right for you to take Valdoxan.
Danish: - Hvis De lider af demens, vil Deres læge undersøge Dem for at vurdere, om Valdoxan er det rigtige lægemiddel for Dem.
English: No hepatotoxicity was observed in rodents and monkeys in the repeat dose toxicity studies.
Danish: Der sås ingen levertoksicitet i undersøgelser af gentagen dosistoksicitet hos gnavere og aber.
English: Česká republika Servier s.r.o.
Danish: Servier s.r.o.
English: Valdoxan contains sodium
Danish: Valdoxan indeholder natrium
English: Hypromellose Yellow iron oxide (E172) Glycerol
Danish: Jernoxid, gul (E172)
English: ‐ the increase in serum transaminases exceeds 3 X upper limit of normal.
Danish: • Kontraindiceret hos patienter med aminotransferaser, der overstiger 3 X den øvre grænse for normalområdet;
English: Migraine
Danish: Hepatitis
English: What Valdoxan looks like and contents of the pack Valdoxan 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of ‘company logo'
Danish: Valdoxan 25 mg filmovertrukne tabletter (tablet) er aflange orange til gule tabletter med firmalogoet trykt i blåt på den ene side.
English: Tinnitus*
Danish: Pruritus*
English: Hepatic impairment Agomelatine is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Danish: Nedsat leverfunktion Agomelatin er kontraindiceret til patienter med nedsat leverfunktion (se pkt.
English: Combination with CYP1A2 inhibitors (see sections 4.3 and 4.5)
Danish: Kombination med CYP1A2-hæmmere (se pkt.
English: No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed.
Danish: Hos patienter med alvorligt nedsat nyrefunktion er der ikke set relevante ændringer i agomelatins farmakokinetiske parametre.
English: 4.7 Effects on ability to drive and use machines Agomelatine has minor influence on the ability to drive and use machines.Considering that dizziness and somnolence are common adverse reactions, patients should be cautioned about their ability to drive or operate machines.
Danish: Da svimmelhed og søvnighed er almindelige bivirkninger, skal patienten advares om at udvise forsigtighed i forhold til evnen til at føre motorkøretøj eller betjene maskiner.
English: - if your liver does not work properly (hepatic impairment).
Danish: - hvis De har leverproblemer (nedsat leverfunktion).
English: Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4).
Danish: Behandling bør seponeres, hvis aminotransferaser overstiger 3 X den øvre grænse for normalområdet (se pkt.
English: Valdoxan 25 mg film-coated tablets agomelatine
Danish: Valdoxan 25 mg filmovertrukne tabletter agomelatin
English: Tel: +371 67502039
Danish: SIA Servier Latvia Tel: +371 67502039
English: Following oral administration, agomelatine is rapidly metabolised mainly via hepatic CYP1A2; CYP2C9 and CYP2C19 isoenzymes are also involved but with a low contribution.
Danish: Efter oral administration metaboliseres agomelatin hurtigt, primært af leverenzymet CYP1A2.
English: NAME OF THE MEDICINAL PRODUCT Valdoxan 25 mg tablets agomelatine
Danish: LÆGEMIDLETS NAVN Valdoxan 25 mg tabletter agomelatin
English: Make sure that your reactions are normal before driving or operating machines.
Danish: De må derfor kun føre motorkøretøj og betjene maskiner, hvis Deres reaktionsevne er normal.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Valdoxan Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: 1 NAME OF THE MEDICINAL PRODUCT Valdoxan 25 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Valdoxan 25 mg filmovertrukne tabletter
English: The Marketing Authorisation Holder shall agree the format and content of the physician's guide to prescribing with the National Competent Authority prior to launch in the Member State.
Danish: • Yderligere risikominimeringsforanstaltninger Før lancering i medlemslandet skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om form og indhold af vejledningen for læger i ordination af Valdoxan.
English: What Valdoxan is and what it is used for What you need to know before you take Valdoxan How to take Valdoxan
Danish: Det skal De vide, før De begynder at tage Valdoxan Sådan skal De tage Valdoxan Bivirkninger
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Ikke almindelig Hyperhidrose Eksem
English: 6 PHARMACEUTICAL PARTICULARS
Danish: FARMAKOLOGISKE EGENSKABER
English: NAME OF THE MEDICINAL PRODUCT Valdoxan 25 mg film-coated tablets agomelatine
Danish: LÆGEMIDLETS NAVN Valdoxan 25 mg filmovertrukne tabletter agomelatin
English: Valdoxan is for oral use.
Danish: Valdoxan er beregnet til indtagelse gennem munden.
English: BATCH NUMBER Batch
Danish: FREMSTILLERENS BATCHNUMMER Lot:
English: Headache
Danish: Øjne
English: 10 DATE OF REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN MM/ÅÅÅÅ
English: Edistride received a marketing authorisation valid throughout the EU on 9 November 2015.
Danish: Edistride fik en markedsføringstilladelse med gyldighed i hele EU den 9. november 2015.
English: This authorisation was based on the authorisation granted for Forxiga in 2012.
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Forxiga i 2012.
English: Further information on Edistride can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Edistride.
Danish: Yderligere information om Edistride findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Edistride.
English: As for all medicines, data on the use of Edistride are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Edistride løbende overvåget.
English: Other information about Edistride
Danish: Andre oplysninger om Edistride
English: An overview of Edistride and why it is authorised in the EU
Danish: En oversigt over Edistride og hvorfor det er godkendt i EU
English: Edistride is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Danish: Edistride findes som tabletter (5 og 10 mg) og fås kun på recept.
English: What is Edistride and what is it used for?
Danish: Hvad er Edistride, og hvad anvendes det til?
English: For type 2 diabetes, the dose of Edistride is 10 mg once a day.
Danish: Ved type 2-diabetes er dosen af Edistride 10 mg én gang dagligt.
English: What measures are being taken to ensure the safe and effective use of Edistride?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Edistride?
English: Why is Edistride authorised in the EU?
Danish: Hvorfor er Edistride godkendt i EU?
English: Side effects reported with Edistride are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Edistride vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The Agency concluded that the benefits of Edistride outweigh its risks and recommended that it be granted marketing authorisation.
Danish: Agenturet konkluderede, at fordelene ved Edistride opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Edistride.
English: Both combinations reduced HbA1c levels by 0.52 percentage points after 52 weeks.
Danish: Begge kombinationer reducerede HbA1c-niveauet med 0,52 procentpoint efter 52 uger.
English: For more information about using Edistride, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Edistride, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Edistride is a diabetes medicine used for adults whose condition is not controlled well enough.
Danish: Edistride er et lægemiddel mod diabetes, der anvendes til voksne, hvis sygdom ikke er tilstrækkeligt reguleret.
English: The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Danish: Virkningen blev hovedsageligt målt på niveauet af glykosyleret hæmoglobin (HbA1c), der viser, hvor godt blodsukkeret reguleres.
English: The company that markets Edistride will provide information on precautions to prevent diabetic ketoacidosis in patients with type 1 diabetes, including a patient alert card, and a guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber's checklist.
Danish: Den virksomhed, der markedsfører Edistride, vil udlevere informationsmateriale om forholdsregler til forebyggelse af diabetisk ketoacidose hos patienter med type 1-diabetes, herunder et patientkort og en vejledning til patienter og deres omsorgspersoner samt en vejledning til sundhedspersoner, inklusive en tjekliste til ordinerende læger.
English: What are the risks associated with Edistride?
Danish: Hvilke risici er der forbundet med Edistride?
English: In type 2 diabetes, it is used with appropriate diet and exercise in patients who cannot take metformin (another diabetes medicine).
Danish: Ved type 2-diabetes anvendes det med passende kost og motion hos patienter, der ikke kan tage metformin (et andet lægemiddel mod diabetes).
English: Diabetes can occur when the body does not make enough insulin to control the amount of glucose (sugar) in the blood or when the body is cannot use insulin effectively.
Danish: Diabetes kan forekomme, når kroppen ikke producerer nok insulin til at regulere blodsukkeret, eller når kroppen ikke i stand til at udnytte insulinet effektivt.
English: The European Medicines Agency considered that Edistride was effective for treating type 2 diabetes when given alone or in combination with other diabetes medicines which work in different ways.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Edistride er effektivt til at behandle type 2diabetes, når det gives enten alene eller i kombination med andre diabeteslægemidler, der har andre virkningsmekanismer.
English: For the full list of side effects and restrictions with Edistride, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Edistride fremgår af indlægssedlen.
English: If it is used with insulin or medicines that help the body produce insulin, the doses of these other medicines may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Danish: Hvis Edistride tages sammen med insulin eller lægemidler, der øger insulinproduktionen, kan det være nødvendigt at nedsætte dosis af disse andre lægemidler for at undgå for lavt blodsukker (hypoglykæmi).
English: For type 1 diabetes, treatment with Edistride should be started and supervised by a specialist in type 1 diabetes.
Danish: Ved type 1-diabetes bør behandlingen med Edistride iværksættes og overvåges af en speciallæge i type 1-diabetes.
English: Edistride was found effective in several studies in patients with type 2 and type 1 diabetes.
Danish: Edistride blev i flere studier fundet effektivt til behandling af patienter med type 2- og type 1-diabetes.
English: Adding Edistride to insulin treatment in patients with type 1 diabetes whose diabetes could not be controlled well enough with insulin was also effective.
Danish: Edistride givet som tillægsbehandling til insulin hos type 1-diabetespatienter, hvis diabetes ikke blev reguleret tilstrækkeligt med insulin, var også effektivt.
English: Edistride's common side effects were related to the way the medicine works, such as increased genital and, to a smaller degree, urinary infection, and are considered manageable.
Danish: De hyppigste bivirkninger ved Edistride var knyttet til lægemidlets virkningsmekanismer, såsom øget forekomst af infektioner i kønsorganerne og, i mindre omfang, i urinvejene.
English: In a study involving 814 patients with type 2 diabetes, Edistride used in combination with metformin was at least as effective as a sulphonylurea (another type of diabetes medicines) used with metformin.
Danish: I et studie med deltagelse af 814 type 2-diabetespatienter var Edistride anvendt i kombination med metformin mindst lige så effektivt som et sulfonylurinstof (en anden type lægemiddel mod diabetes) anvendt i kombination med metformin.