FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Thymanax (see also under “How to take Thymanax” in section 3).
Danish: Ud fra en evaluering af disse undersøgelser vil lægen afgøre, om De bør fortsætte med at bruge Thymanax eller ej (se også punkt 3, 'Sådan skal De tage Thymanax').
English: [EU/1/08/498/002] 14 film-coated tablets [EU/1/08/498/003] 28 film-coated tablets [EU/1/08/498/005] 56 film-coated tablets [EU/1/08/498/006] 84 film-coated tablets [EU/1/08/498/007] 98 film-coated tablets [EU/1/08/498/008] 100 film-coated tablets
Danish: [EU/1/08/498/002] 14 filmovertrukne tabletter [EU/1/08/498/003] 28 filmovertrukne tabletter [EU/1/08/498/005] 56 filmovertrukne tabletter [EU/1/08/498/006] 84 filmovertrukne tabletter [EU/1/08/498/007] 98 filmovertrukne tabletter [EU/1/08/498/008] 100 filmovertrukne tabletter
English: Your doctor may continue to give you Thymanax when you are feeling better to prevent your depression from returning.
Danish: Lægen kan fortsætte med at give Dem Thymanax, efter De har fået det bedre, for at forebygge, at depressionen vender tilbage.
English: Treatment with Thymanax 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 Thymanax efter omhyggelig afvejning af fordele og risici hos patienter med risikofaktorer for leverskade f.eks.:
English: As a precautionary measure, it is preferable to avoid the use of Thymanax during pregnancy.
Danish: Som en forsigtighedsforanstaltning bør Thymanax undgås under graviditet.
English: Thymanax is used in adults.
Danish: Thymanax anvendes til voksne.
English: If Thymanax is initiated while tapering the dosage of the previous medicine, possible discontinuation symptoms should not be confounded with a lack of early effect of Thymanax.
Danish: Hvis Thymanax-behandlingen startes, mens dosis af det tidligere lægemiddel nedtrappes, må mulige abstinenssymptomer ikke forveksles med manglende tidlig virkning af Thymanax.
English: You should not take Thymanax together with certain medicines (see also under “Do not take Thymanax” 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 Thymanax sammen med visse andre lægemidler (se også under 'Tag ikke Thymanax' 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 Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Thymanax, 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 Thymanax, har patienthåndbøger tilrådighed til udlevering til de patienter, der får ordineret dette lægemiddel.
English: Do not take Thymanax - if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Thymanax - hvis De er allergisk over for agomelatin eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: You should discuss with your doctor on the best way of stopping your previous antidepressant medicine when starting Thymanax.
Danish: Tal med lægen om, hvordan De bedst kan stoppe med det tidligere lægemiddel mod depression, når De starter med Thymanax.
English: Following discontinuation of Thymanax therapy liver function tests should be repeated until serum transaminases return to normal.
Danish: Efter seponering af Thymanaxbehandling bør undersøgelser af leverfunktionen gentages indtil serumaminotransferaser vender tilbage det normale niveau.
English: Thymanax starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.
Danish: Hos de fleste mennesker begynder Thymanax at virke mod symptomer på depression i løbet af 2 ugers behandling.
English: Thymanax should not be used for the treatment of major depressive episodes in elderly patients with dementia since the safety and efficacy of Thymanax have not been established in these patients.
Danish: Thymanax bør ikke anvendes til behandling af major depression hos ældre patienter med demens, da Thymanaxs sikkerhed og virkning ikke er påvist hos disse patienter.
English: The recommended dose of Thymanax is one tablet (25 mg) at bedtime.
Danish: Den anbefalede dosis Thymanax er 1 tablet (25 mg) ved sengetid.
English: Effect of Thymanax is not documented in patients aged 75 years and older.
Danish: Det er ikke dokumenteret, at Thymanax virker hos patienter i alderen 75 år og ældre.
English: If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Thymanax.
Danish: Hvis De har dårlige nyrer, vil Deres læge foretage en individuel vurdering af, om det er sikkert for Dem at tage Thymanax.
English: Thymanax film-coated tablets may be taken with or without food.
Danish: Thymanax filmovertrukne tabletter kan tages uden for eller i forbindelse med et måltid.
English: INFORMATION IN BRAILLE Thymanax 25 mg
Danish: INFORMATION I BRAILLESKRIFT Thymanax 25 mg
English: You have been given Thymanax to treat your depression.
Danish: De har fået Thymanax til behandling af en depression.
English: The Marketing Authorisation Holder shall ensure that at launch and after launch all physicians who are expected to prescribe or use Thymanax 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 Thymanax, forsynes med opdateret informationsmateriale med følgende indhold:
English: Thymanax is not recommended in the treatment of depression in patients under 18 years of age since safety and efficacy of Thymanax have not been established in this age group.
Danish: Thymanax bør ikke anvendes til behandling af depression hos patienter under 18 år, da Thymanaxs sikkerhed og virkning ikke er påvist hos denne aldersgruppe.
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/
Danish: Yderligere oplysningerom Thymanax findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Thymanax 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: Thymanax 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 Thymanax, inklusive et skema for monitorering af leverfunktionen.
English: Thymanax is indicated for the treatment of major depressive episodes in adults.
Danish: Thymanax er indiceret til behandling af major depression (moderat til svær depression) hos voksne.
English: Thymanax 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: If you forget to take Thymanax
Danish: Hvis De har glemt at tage Thymanax
English: - If you have increased levels of liver enzymes before treatment, your doctor will decide if Thymanax is right for you.
Danish: - Hvis De har forhøjede leverenzymer før behandlingen, vil Deres læge beslutte, om Thymanax er den rette medicin for Dem.
English: Thymanax contains the active ingredient agomelatine.
Danish: Thymanax indeholder det aktive stof agomelatin.
English: Thymanax can be taken with or without food.
Danish: Thymanax kan tages alene eller sammen med et måltid.
English: Caution should be exercised when Thymanax 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 Thymanax administreres til patienter, der før behandling har forhøjede aminotransferaser (> den øvre grænse inden for normalområdet og ≤3 X den øvre grænse for normalområdet).
English: What Thymanax contains - The active substance is agomelatine.
Danish: Thymanax indeholder: - Aktivt stof: Agomelatin.
English: What you need to know before you take Thymanax
Danish: Det skal De vide, før De begynder at tage Thymanax
English: Caution should be exercised when prescribing Thymanax with moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) which may result in increased exposure of agomelatine.
Danish: Der bør udvises forsigtighed ved ordination af Thymanax sammen med moderate CYP1A2-hæmmere (fx propranolol, enoxacin), da det kan føre til øget eksponering for agomelatin.
English: It is not advisable to drink alcohol while you are being treated with Thymanax.
Danish: Brug af Thymanax sammen med alkohol De frarådes at indtage alkohol, mens De er i behandling med Thymanax.
English: Consequently, co-administration of Thymanax with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Danish: Samtidig administration af Thymanax og potente CYP1A2-hæmmere (fx fluvoxamin og ciprofloxacin) er derfor kontraindiceret.
English: If your doctor changes your previous antidepressant medicine from an SSRI or SNRI to Thymanax, he/she will advise you on how you should discontinue your previous medicine when starting Thymanax.
Danish: Sådan skiftes fra et lægemiddel mod depression (SSRI/SNRI) til Thymanax Hvis Deres læge ændrer Deres tidligere lægemiddel mod depression fra et SSRI eller SNRI til Thymanax, vil lægen vejlede Dem i, hvordan De skal stoppe med det tidligere lægemiddel, når De starter med Thymanax.
English: If you have taken more Thymanax 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 Thymanax-tabletter Kontakt straks Deres læge, hvis De har taget flere Thymanax-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 Thymanax.
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 Thymanax.
English: Therefore, clinical consequences of ECT performed concomitantly with agomelatine treatment, Thymanax are considered to be unlikely.
Danish: Det anses derfor for usandsynligt, at ECT udført samtidig med behandling med agomelatin skulle få kliniske konsekvenser.
English: During treatment period Thymanax 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 Thymanaxbehandling 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: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Thymanax indeholder lactose og bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Servier (Ireland) Industries Ltd,
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Servier (Ireland) Industries Ltd
English: NAME OF THE MARKETING AUTHORISATION HOLDER Servier (Ireland) Industries Ltd
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Servier (Ireland) Industries Ltd
English: Breastfeeding should be discontinued if you take Thymanax.
Danish: De bør holde op med at amme, hvis De tager Thymanax.
English: Thymanax contains sodium
Danish: Thymanax indeholder natrium
English: If you stop taking Thymanax 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: Thymanax contains lactose
Danish: Thymanax indeholder lactose
English: Thymanax 25 mg film-coated tablets are available in calendar blisters.
Danish: Thymanax 25 mg filmovertrukne tabletter fås som blisterkort med kalender.
English: The experience of overdoses with Thymanax 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 Thymanax, 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: Marketing Authorisation Holder Servier (Ireland) Industries Ltd Gorey road, Arklow, Co. Wicklow Ireland
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Servier (Ireland) Industries Ltd Gorey Road, Arklow, Co. Wicklow Irland
English: No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Thymanax 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 Thymanax, hos målpopulationen i kliniske fase I-studier:
English: 7 MARKETING AUTHORISATION HOLDER Servier (Ireland) Industries Ltd Gorey Road, Arklow, Co. Wicklow Ireland
Danish: Indehaver af markedsføringstilladelsen Servier (Ireland) Industries Ltd Gorey Road, Arklow, Co. Wicklow Irland
English: - If you are suffering from dementia, your doctor will make an individual evaluation of whether it is right for you to take Thymanax.
Danish: - Hvis De lider af demens, vil Deres læge undersøge Dem for at vurdere, om Thymanax er det rigtige lægemiddel for Dem.
English: What Thymanax looks like and contents of the pack Thymanax 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of ‘company logo'
Danish: Thymanax 25 mg filmovertrukne tabletter (tablet) er aflange orange til gule tabletter med firmalogoet trykt i blåt på den ene side.
English: Thymanax 25 mg film-coated tablets agomelatine
Danish: Thymanax 25 mg filmovertrukne tabletter agomelatin
English: How to take THYMANAX
Danish: Sådan skal De tage Thymanax
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicineThymanax.
Danish: Kontakt lægen, før De tager dette lægemiddel, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: NAME OF THE MEDICINAL PRODUCT Thymanax 25 mg tablets agomelatine
Danish: LÆGEMIDLETS NAVN Thymanax 25 mg tabletter agomelatin
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: 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 Thymanax.
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 Thymanax Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: 1 NAME OF THE MEDICINAL PRODUCT Thymanax 25 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Thymanax 25 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Thymanax 25 mg film-coated tablets agomelatine
Danish: LÆGEMIDLETS NAVN Thymanax 25 mg filmovertrukne tabletter agomelatin
English: What Thymanax is and what it is used for What you need to know before you take Thymanax How to take Thymanax
Danish: Det skal De vide, før De begynder at tage Thymanax Sådan skal De tage Thymanax Bivirkninger
English: Thymanax is for oral use.
Danish: Thymanax er beregnet til indtagelse gennem munden.
English: United Kingdom Servier Laboratories Ltd
Danish: Laboratorios Servier S.L.
English: 20122 Milano Italy
Danish: 20122 Milano Italien
English: Week 4 Week 8 Week 4 Week 8
Danish: Uge 4 Uge 8
English: Continue with your next dose as scheduled.
Danish: Fortsæt med din næste dosis som planlagt.
English: (picture 6).
Danish: (billede 6).
English: The majority of side effects occur generally in and around the eyes.
Danish: De fleste bivirkninger opstår generelt i og rundt om øjnene.
English: However, no dose adjustment is considered necessary in these populations.
Danish: Der anses dog ikke at være behov for dosisjustering ved disse populationer.
English: Patients should be instructed to wash their hands before use.
Danish: Patienter skal instrueres i at vaske hænder inden anvendelse.
English: No interaction studies with other medicinal products have been performed.
Danish: Der er ikke udført interaktionsstudier med andre lægemidler.
English: Special populations Elderly:
Danish: Særlige populationer Ældre:
English: Do not put in any more drops until it is time for your next regular dose.
Danish: Du må ikke komme flere dråber i, før det er tid til din næste sædvanlige dosis.
English: OXERVATE 56.5 % 69.6 % 58.0 % 74.0 % vehicle 37.5 % 29.2 % 19.6 % 43.1 % (p value) (0.191) (0.006) (0.001) (0.002)
Danish: OXERVATE 56,5 % 69,6 % 58,0 % 74,0 % vehikel 37,5 % 29,2 % 19,6 % 43,1 % (p-værdi) (0,191) (0,006) (0,001) (0,002)
English: It is recommended that these patients continue to be monitored for cancer progression during and after treatment with this medicinal product.
Danish: Det anbefales, at disse patienter fortsat kontrolleres for cancerudvikling under og efter behandling med lægemidlet.
English: If a dose is missed, treatment should be continued as normal, at the next scheduled administration.
Danish: Hvis en dosis glemmes, skal behandlingen fortsætte som normalt med næste planlagte administration.
English: Using more OXERVATE than is recommended is not likely to be harmful.
Danish: Det er ikke sandsynligt, at brug af mere OXERVATE end anbefalet, vil være skadeligt.
English: • irritation in or around the eye;
Danish: • Irritation i eller rundt om øjet
English: The following side effects have been reported:
Danish: Der er rapporteret om følgende bivirkninger:
English: It should be noted that the frozen medicinal product received from the pharmacy could need up to 30 minutes for thawing.
Danish: Det bør bemærkes, at det frosne lægemiddel fra apoteket kan være op til 30 minutter om at tø op.
English: This will help to avoid one eye drop diluting the other eye drop.
Danish: Det hjælper med at undgå, at den ene øjendråbe fortynder den anden øjendråbe.
English: Use a new disinfectant wipe and a new pipette each time.
Danish: Brug en ny desinfektionsserviet og en ny pipette hver gang.
English: The use of this medicine should be avoided during pregnancy.
Danish: Brug af lægemidlet bør undgås under graviditet.
English: - if you have an eye cancer, because this medicine might worsen your cancer.
Danish: - hvis du har kræft i øjet, fordi lægemidlet kan forværre kræft.
English: Pharmacotherapeutic Group: {not yet assigned}, ATC code: {not yet assigned}.
Danish: Farmakoterapeutisk klassifikation: {endnu ikke tildelt}, ATC-kode: {endnu ikke tildelt}.
English: Best corrected distance visual acuity
Danish: Bedste korrigerede afstand i synsstyrke
English: Make sure you do not touch your eye with the tip of the pipette.
Danish: Pas på, at du ikke rører ved øjet med pipettens spids.
English: * Recombinant form of human nerve growth factor produced in Escherichia Coli.
Danish: * Rekombinant form af human nervevækstfaktor produceret i Escherichia Coli.
English: Contact lenses could interfere with the correct use of this medicine.
Danish: Kontaktlinser kan forhindre korrekt brug af lægemidlet.
English: They are ranked according to system organ class and classified according to 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 (<1/10,000), or not known (cannot be estimated from the available data).
Danish: De er ordnet efter systemorganklasse i følgende grupperinger: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: An individual pipette should be used per application.
Danish: Der skal anvendes en særskilt pipette til hver anvendelse.
English: As soon as the patient is at home (and no later than 5 hours from when the patient receives the product at the pharmacy), the weekly carton should be placed into the refrigerator, at 2-8 °C.
Danish: Så snart patienten kommer hjem (og ikke senere end 5 timer efter, at patienten har modtaget produktet på apoteket), skal ugekartonen lægges i køleskabet ved 2-8 °C.
English: Precautions to be taken before administering the medicinal product:
Danish: Der skal tages forsigtighedsregler inden administration af lægemidlet:
English: In general, the systemic absorption of OXERVATE is negligible.
Danish: Generelt er den systemisk absorption af OXERVATE ubetydelig.
English: The patient should be advised to contact the doctor in case of concern or a more severe eye reaction.
Danish: Patienten skal tilrådes at kontakte lægen ved et formodet problem eller en mere alvorlig øjenreaktion.
English: Air bubbles may cause blockage and prevent the pipette from filling properly (especially at first withdrawal).
Danish: Luftbobler kan blokere pipetten og forhindre, at den bliver korrekt fyldt (især ved første fyldning).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal om lægemidler.
English: There are no data from the use of cenegermin in pregnant women.
Danish: Der er ingen data fra anvendelse af cenegermin til gravide kvinder.
English: The multi-dose vial containing the product should be prepared according to the following instructions:
Danish: Flerdosishætteglasset indeholdende lægemidlet skal klargøres i henhold til følgende anvisninger:
English: Pharmacokinetic profiling of patients included in studies found no accumulation effect of cenegermin.
Danish: Den farmakokinetiske profil af patienter, der var inkluderet i studier, fandt ingen akkumulation af cenegermin.