FrancophonIA/ELRC3.0 huggingface dataset:
English: Tasmar is supplied as film-coated tablets containing 200 mg tolcapone.
Danish: Tasmar findes som filmovertrukne tabletter indeholdende 200 mg tolcapon.
English: Tasmar is supplied as film-coated tablets containing 100 mg tolcapone.
Danish: Tasmar findes som filmovertrukne tabletter indeholdende 100 mg tolcapon.
English: While receiving treatment: During treatment, blood tests will be done in the following time intervals: every 2 weeks during the first 12 months of therapy, every 4 weeks during the following 6 months of therapy, every 8 weeks during further treatment.
Danish: Under behandlingen: Under behandlingen skal der tages blodpøver med følgende tidsintervaller: - hver 2. uge i de første 12 behandlingsmåneder - hver 4. uge i de efterfølgende 6 måneder - hver 8. uge derefter Behandlingen vil blive stoppet, hvis blodprøverne bliver unormale.
English: Tell your doctor or a pharmacist as soon as possible: if you do not feel well while you are taking Tasmar if you experience symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever, darkening of urine or jaundice since uncommonly disturbances in the way the liver works, sometimes severe hepatitis was observed, if you notice a darkening of your urine since this could be a sign of a muscular or liver injury.
Danish: Du skal så hurtigt som muligt fortælle din læge eller på apoteket: - hvis du føler dig utilpas, mens du tager Tasmar - hvis du får symptomer som f.eks. kvalme, opkastning, mavesmerter, appetitløshed, svaghed, feber, mørkfarvning af urinen eller gulsot (gulfarvning af hud eller øjne), da behandlingen nogle gange kan medføre forstyrrelser i leverfunktionen.
English: Hydroxypropylmethylcellulose Talc
Danish: Natriumstivelsesglycolat Lactosemonohydrat Talcum
English: Film-coat: Hydroxypropylmethylcellulose, Talc, Yellow iron oxide, Ethylcellulose, Titanium dioxide, Triacetin, Sodium lauril sulfate.
Danish: Filmovertræk: Hypromellose, talcum, gul jernoxid (E 172), ethylcellulose, titandioxid (E 171), triacetin, natriumlaurilsulfat.
English: This may include: o Strong impulse to gamble excessively despite serious personal or family consequences.
Danish: - Manglende evne til at modstå impulser til at udføre en handling, der kan være skadelig, som for eksempel: o Stærk impuls til at spille overdrevet på trods af personlige eller familiemæssige konsekvenser o Ændret eller øget seksuel interesse og adfærd af væsentlig betydning for dig eller for andre,
English: severe symptoms of muscle stiffening, fever or mental confusion (Neuroleptic Malignant Syndrome) when antiparkinsonian treatments are abruptly reduced or withdrawn.
Danish: Sjældne bivirkninger - svær muskelstivhed, feber eller mental forvirring (malignt neuroleptikas syndrom) efter pludselig nedsættelse af dosis af parkinsonmedicin eller pludseligt ophør med parkinsonmedicin.
English: The most common of these are increased dyskinesia, nausea, vomiting, abdominal pain, syncope, orthostatic complains, constipation, sleep disorders, somnolence, hallucination.
Danish: Den mest almindelige af disse er øget dyskinesi, kvalme, opkast, abdominal smerter, besvimelsesanfald, ortostatiske klager, forstoppelse, søvnforstyrrelser, somnolens, hallucination.
English: Liver injury:
Danish: Leverskade:
English: Inform your doctor about all prescription and non-prescription medications as the risk of NMS may be increased if you are taking some specific medications.
Danish: Fortæl din læge om al receptpligtig og ikke-receptpligtig medicin, du tager.
English: Common: chest pain, constipation, dyspepsia, stomach ache, vomiting, dry mouth, fainting increased sweating, influenza-like symptoms reduced voluntary and involuntary movement (hypokinesia) upper respiratory tract infection increase of specific liver enzymes, urine discoloration
Danish: Almindelige bivirkninger: - brystsmerter - forstoppelse, dyspepsi, mavesmerter, opkastning, tør mund - besvimelse - øget svedtendens - influenzalignende symptomer - ufrivilligt langsomme bevægelser (hypokinesi) - infektion i de øvre luftveje - øgede værdier for specifikke leverenzymer - misfarvning af urinen
English: Tolcapone does not accumulate with three times daily dosing of 100 or 200 mg. At these doses, Cmax is approximately 3 and 6 µg/ml, respectively.
Danish: Der forekommer ingen akkumulering af tolcapon ved en dosering på 100 eller 200 mg tre gange daglig.
English: Reducing the dose of levodopa (see section 4.2) may often mitigate these adverse reactions.
Danish: Disse bivirkninger kan ofte dæmpes ved at reducere dosis af levodopa (se 4.2).
English: Very common: involuntary movement (dyskinesia), nausea, decreased appetite, diarrhoea, headache, dizziness sleep problems, somnolence, feeling lightheaded while you stand, (orthostatic complaints),mental confusion and hallucinations, movement disorder with involuntary muscle spasms or malpositions (dystonia), dreaming excessive.
Danish: Meget almindelige bivirkninger: - ufrivillige bevægelser (dyskinesi) - kvalme, nedsat appetit, diarre - hovedpine, svimmelhed - søvnproblemer, søvnighed - følelse af svimmelhed, når du står oprejst (ortostatiske symptomer) - forvirring, hallucinationerbevægelsesforstyrrelser og ufrivillige bevægelser (dystoni) - overdrevne drømme
English: Very common: involuntary movement (dyskinesia), nausea, decreased appetite, diarrhoea, headache, dizziness sleep problems, somnolence, feeling lightheaded while you stand, (orthostatic complaints), mental confusion and hallucinations, movement disorder with involuntary muscle spasms or malpositions (dystonia).
Danish: Meget almindelige bivirkninger: - ufrivillige bevægelser (dyskinesi) - kvalme, nedsat appetit, diarre - hovedpine, svimmelhed - søvnproblemer, søvnighed - følelse af svimmelhed, når du står oprejst (ortostatiske symptomer) - forvirring, hallucinationer bevægelsesforstyrrelser og ufrivillige bevægelser (dystoni)
English: may affect up to 1 in 100 people
Danish: Forekommer hos mellem 1 og 10 ud af 100 behandlede
English: may affect up to 1 in 1,000 people
Danish: Forekommer hos mellem 1 og 10 ud af 1.000 behandlede
English: The frequency of possible side effects listed below is defined using the following convention:
Danish: Følgende frekvenser anvendes for bivirkninger:
English: may affect up to 1 in 10,000 people
Danish: Forekommer hos mellem 1 og 10 ud af 10.000 behandlede
English: Levodopa adjustments when Tasmar is discontinued:
Danish: Justering af levodopa efter seponering af Tasmar
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed (non-prescription medicines and herbals).
Danish: Fortæl din læge om al receptpligtig og ikke-receptpligtig medicin du tager.
English: What Tasmar looks like and contents of the pack Tasmar is an orange yellow to brown yellow, oval shaped, film-coated tablet.
Danish: Tasmar er en orange-gul til brun-gul, ovalformet, filmovertrukken tablet.
English: What Tasmar is and what it is used for What do you need to know before you take Tasmar How to take Tasmar
Danish: Det skal du vide, før du begynder at tage Tasmar Sådan skal du tage Tasmar Bivirkninger
English: Each film-coated tablet contains 200 mg tolcapone.
Danish: Hver filmovertrukken tablet indeholder 200 mg tolcapon.
English: Urine discoloration
Danish: Misfarvet urin
English: Hypersensitivity to tolcapone or any of its other ingredients listed in section 6.1.
Danish: 4.3 Kontraindikationer overfølsomhed overfor tolcapon eller over for et eller flere af hjælpestofferne anført i pkt.
English: Chest pain
Danish: Smerter i brystet
English: Each film-coated tablet contains 100 mg tolcapone.
Danish: Hver filmovertrukken tablet indeholder 100 mg tolcapon.
English: Reporting of side effects
Danish: Andre bivirkninger
English: What Tasmar looks like and contents of the pack Tasmar is a pale to light yellow, oval shaped, film-coated tablet.
Danish: Tasmar er en bleg til lys-gul, ovalformet, filmovertrukken tablet.
English: Each film-coated tablet contains 100 mg tolcapone
Danish: Hver filmovertrukken tablet indeholder 100 mg tolcapon
English: Tasmar 100 mg film-coated tablets
Danish: Tasmar 100 mg filmovertrukne tabletter.
English: Hepatobiliary disorders
Danish: Ortostatiske symptomer
English: How to store Tasmar Keep out of the sight and reach of children.
Danish: Opbevar Tasmar utilgængeligt for børn.
English: Tasmar 100 mg film-coated tablets Tolcapone
Danish: Tasmar 100 mg filmovertrukne tabletter Tolcapon
English: Tasmar 200 mg film-coated tablets Tolcapone
Danish: Tasmar 200 mg filmovertrukne tabletter Tolcapon
English: If you take more Tasmar than you should
Danish: Hvis du har taget for mange Tasmar
English: You should check with your doctor or pharmacist if you are unsure.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: - if you are pregnant or intend to become pregnant.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du tager Tasmar.
English: Each film-coated tablet contains 200 mg tolcapone tolcapone 200 mg
Danish: Hver filmovertrukken tablet indeholder 200 mg tolcapon
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Tasmar indeholder laktose Kontakt lægen før du tager Tasmar, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Tasmar 200 mg film coated tablets
Danish: Tasmar 200 mg filmovertrukne tabletter.
English: This medicine has been prescribed for you.
Danish: - Lægen har ordineret Tasmar til dig personligt.
English: Dyskinesia Dystonia Headache Dizziness
Danish: Svimmelhed Somnolens
English: if you have a special type of tumor in the adrenal medulla (Phaeochromocytoma) - if you take a certain medication to treat depression and anxiety, called non-selective mono amino oxidase (MAO) inhibitors
Danish: - hvis du tager visse lægemidler til behandling af depression og angst, såkaldte ikke- selektive monoaminoxidase hæmmere (MAO) - Hvis du er gravid eller planlægger at blive gravid.
English: Rare (≥1/10,000 to < 1/1,000)
Danish: Meget almindelig (>1/10) almindelig (>1/100, <1/10) ikke almindelig (>1/1000, <1/100) sjælden (>1/10.000, <1/1000) meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra tilgængelige data)
English: Titanium dioxide Triacetin
Danish: Hypromellose Talcum
English: This will help to protect against the diseases.
Danish: Dette er med til at beskytte mod sygdommene.
English: The swelling will resolve completely by the end of the third week.
Danish: Hævelsen forsvinder fuldstændigt ved slutningen af den tredje uge.
English: This summary was last updated on 7 September 2011.
Danish: Dette sammendrag blev sidst ajourført den 07/09/2011.
English: A temporary increase in body temperature of 1-2°C can occur.
Danish: Der kan forekomme en forbigående stigning i legemstemperaturen på 1-2 °C.
English: There may also be a small, painless swelling at the injection site within the first two weeks after vaccination.
Danish: Der kan ligeledes forekomme en lille, smertefri hævelse på injektionsstedet i løbet af de første to uger efter vaccinationen.
English: E-mail info@ema.europa.eu Website www.ema.europa.eu
Danish: E-mail info@ema.europa.eu Website www.em .europa.eu
English: In the future, if the rabbits are exposed to any of the viruses, the immune system will be able to respond more quickly.
Danish: Hvis kaninerne senere udsættes for nogen af viraene, vil immunsystemet hurtigere kunne reagere.
English: It is available as a lyophilisate (freeze-dried substance) and a solvent that are made up into a suspension for injection.
Danish: Det fås som et lyofilisat (et frysetørret stof) og en solvens, der anvendes til at fremstille en injektionsvæske, suspension.
English: It contains a weakened strain of the myxoma virus which has been genetically modified so that it can produce a protein of the RHD virus.
Danish: Det indeholder en svækket stamme af myxomavirus, der er blevet genetisk modificeret, så den kan danne et protein i RHD-virussen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobivac Myxo-RHD to Intervet International BV on 7 September 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobivac Myxo-RHD til Intervet International BV den 07/09/2011.
English: The studies showed that Nobivac Myxo-RHD was effective in providing immunity against myxomatosis and RHD three weeks after vaccination and that the immunty was still present after one year.
Danish: Undersøgelserne viste, at Nobivac Myxo-RHD var effektivt til at give immunitet mod myxomatose og RHD tre uger efter vaccinationen, og at der stadig var immunitet efter et år.
English: Nobivac Myxo-RHD, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Ligesom alle andre vacciner virker Nobivac Myxo-RHD ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal beskytte sig mod en sygdom.
English: When it is given to rabbits the immune system recognises the myxoma and RHD materials as ‘foreign' and makes antibodies against them.
Danish: Når vaccinen gives til kaniner, opfatter deres immunsystem myxoma- og RHD-materialerne som "fremmede" og reagerer ved at danne antistoffer imod dem.
English: Fifteen field and laboratory studies were carried out, in which rabbits vaccinated with Nobivac MyxoRHD were compared with unvaccinated rabbits to establish the onset and duration of immunity against myxoma and RHD viruses.
Danish: Der blev foretaget 15 felt- og laboratorieundersøgelser, hvor kaniner vaccineret med Nobivac MyxoRHD blev sammenlignet med ikke-vaccinerede kaniner for at fastlægge start og varighed af immunitet mod myxoma- og RHD-vira.
English: Nobivac Myxo-RHD is a vaccine that contains live myxoma vectored RHD virus strain 009.
Danish: Nobivac Myxo-RHD er en vaccine, der indeholder levende myxoma vector RHD virus stamme 009.
English: Live myxoma vectored RHD virus strain 009
Danish: Levende myxoma vector RHD virus stamme 009
English: Rabbits that were vaccinated with Nobivac Myxo-RHD had fewer signs of myxomatosis, more antibodies against RHD virus in their blood and a lower death rate than unvaccinated rabbits.
Danish: Kaniner, som blev vaccineret med Nobivac Myxo-RHD, havde færre tegn på myxomatose, flere antistoffer mod RHD-virus i blodet og en lavere dødelighed end ikke-vaccinerede kaniner.
English: Nobivac Myxo-RHD is used in rabbits aged five weeks or more to reduce number of deaths and clinical signs due to myxomatosis (skin tumours caused by the myxoma virus) and to prevent death due to rabbit haemorrhagic disease (RHD), a disease resulting in blood clot formation caused by the RHD virus.
Danish: Nobivac Myxo-RHD anvendes til kaniner fra 5-ugers alderen for at nedsætte dødeligheden og de kliniske symptomer ved myxomatose (hudkræft, der skyldes myxomavirus) og for at forebygge dødeligheden ved Rabbit Heamorrhagic Disease (RHD), som er en sygdom, der resulterer i blodpropdannelse som følge af RHD-virus.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Myxo-RHD exceed the risks when used to reduce the number of deaths and clinical signs due to myxomatosis and prevent death due to rabbit haemorrhagic disease.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Nobivac Myxo-RHD opvejer risiciene, når det anvendes til at nedsætte dødeligheden og de kliniske symptomer ved myxomatose og forebygge dødeligheden ved Rabbit Heamorrhagic Disease.
English: The withdrawal period for Nobivac Myxo-RHD is zero days.
Danish: Tilbageholdelsestiden for Nobivac Myxo-RHD er nul dage.
English: Other information about Nobivac Myxo-RHD:
Danish: Andre oplysninger om Nobivac Myxo-RHD:
English: The Committee recommended that Nobivac Myxo-RHD be given a marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Nobivac Myxo-RHD.
English: What is the risk associated with Nobivac Myxo-RHD?
Danish: Hvilken risiko er der forbundet med Nobivac Myxo-RHD?
English: Why has Nobivac Myxo-RHD been approved?
Danish: Hvorfor blev Nobivac Myxo-RHD godkendt?
English: What is Nobivac Myxo-RHD?
Danish: Hvad er Nobivac Myxo-RHD?
English: How has Nobivac Myxo-RHD been studied?
Danish: Hvordan blev Nobivac Myxo-RHD undersøgt?
English: What is Nobivac Myxo-RHD used for?
Danish: Hvad anvendes Nobivac Myxo-RHD til?
English: How does Nobivac Myxo-RHD work?
Danish: Hvordan virker Nobivac Myxo-RHD?
English: What benefit has Nobivac Myxo-RHD shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nobivac Myxo-RHD?
English: <Invented name> is contraindicated in the following situations:
Danish: <særnavn> er kontraindikeret i følgende situationer:
English: The daily dose should be divided into at least two single doses.
Danish: Den daglige dosis bør fordeles på mindst to enkeltdoser.
English: There are limited data on the long term outcomes.
Danish: Der er begrænsede data for langtidsvirkninger.
English: The higher the dose, the higher the risks but all doses carry a risk.
Danish: Jo højere dosis, jo højere risici, men alle doser indebærer en risiko.
English: This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%.
Danish: Dette er en højere risiko for alvorlige misdannelser end i den almindelige befolkning, hvor risikoen er ca. 2-3 %.
English: • The need for regular review of treatment.
Danish: • Nødvendigheden af regelmæssig gennemgang af behandlingen.
English: In particular the prescriber must ensure the patient understands:
Danish: Den ordinerende læge skal især sikre, at patienten forstår:
English: Your doctor will stop your treatment and advise you further.
Danish: Lægen vil stoppe din behandling og give dig yderligere rådgivning.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres af den relevante myndighed i medlemslandet, i samarbejde med referencemedlemslandet efter behov, i overensstemmelse med procedurerne som er beskrevet i kapitel 4 titel III i direktiv 2001/83/EC.
English: Afibrinogenemia has also been reported and may be fatal.
Danish: Afibrinogenæmi er også blevet rapporteret og kan være dødelig.
English: FIRST PRESCRIPTION
Danish: FØRSTE RECEPT
English: This compares to 2-3 babies in ever 100 born to women who don't have epilepsy.
Danish: Dette kan sammenlignes med 2-3 babyer ud af 100 født af kvinder, der ikke har epilepsi.
English: Valproate is excreted in human milk with a concentration ranging from 1% to 10% of maternal serum levels.
Danish: Valproat udskilles i human mælk med en koncentration mellem 1 % og 10 % af moderens serumniveau.
English: The exact gestational period of risk for these effects is uncertain and the possibility of a risk throughout the entire pregnancy cannot be excluded.
Danish: Den nøjagtige gestationale risikoperiode for disse effekter er usikker, og muligheden for risiko under hele graviditeten kan ikke udelukkes.
English: Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects.
Danish: Da valproat har været brugt i mange år, ved vi, at hos kvinder, der tager valproat, vil omkring 10 babyer ud af 100 have misdannelser.
English: • The nature and the magnitude of the risks of exposure during pregnancy, in particular the teratogenic risks and the risks of developmental disorders.
Danish: • Arten og omfanget af risici ved eksponering under graviditet, især de teratogene risici og risikoen for udviklingsmæssige forstyrrelser.
English: • It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development.
Danish: • Det skønnes, at op til 30-40 % af førskolebørn, hvis mødre har taget valproat under graviditeten, kan have problemer med den tidlige udvikling.
English: Do not stop taking your medicine until your doctor tells you to. [The text below should be inserted in all indications].
Danish: Du må ikke stoppe med at tage din medicin, før din læge siger det. [Nedenstående tekst skal indsættes for alle indikationer].
English: Children affected can be slow to walk and talk , intellectually less able than other children, and have difficulty with language and memory.
Danish: Disse børn kan være sene til at gå og tale, intellektuelt mindre dygtige end andre børn og have problemer med sprog og hukommelse.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Danish: Bilag III Ændringer til relevante afsnit af produktresumeer og indlægssedler
English: You should talk to your doctor well before you become pregnant so that you can put several actions in place so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible.
Danish: Du skal tale med din læge i god tid, før du bliver gravid, så du kan igangsætte flere ting, så din graviditet går så glat som muligt, og eventuelle risici for dig og dit ufødte barn reduceres så meget som muligt.
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Danish: Disse ændringer til de relevante afsnit af produktresumeer og indlægssedler er resultatet af referralproceduren.
English: If you do become pregnant you will be monitored very closely both for the management of your underlying condition and to check how your unborn child is developing.
Danish: Hvis du bliver gravid, vil du blive overvåget meget nøjet både med henblik på behandlingen af din sygdom og for at kontrollere, hvordan dit ufødte barn udvikler sig.
English: [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Danish: [For alle produkter i bilag I skal den eksisterende produktinformation ændres (indsætning, erstatning eller sletning af tekst afhængigt af, hvad der er relevant) for at afspejle den aftalte ordlyd, som er anført nedenfor]
English: What you need to know before you take <invented name>
Danish: Det skal du vide, før du begynder at tage <særnavn>
English: Available data show an increased incidence of minor and major malformations.
Danish: Tilgængelige data viser en øget forekomst af mindre og større misdannelser.
English: The prescriber must ensure that the patient is provided with comprehensive information on the risks alongside relevant materials, such as a patient information booklet, to support her understanding of the risks.
Danish: Den ordinerende læge skal sikre, at patienten er forsynet med omfattende oplysninger om risici og med relevant materiale, såsom en patientinformationsbrochure, for at støtte hendes forståelse af risici.
English: Case reports indicate that fertility dysfunctions are reversible after treatment discontinuation.
Danish: Enkeltrapporter viser, at fertilitetsdysfunktioner er reversible efter seponering af behandlingen.
English: If based on a careful evaluation of the risks and the benefits valproate treatment is continued during the pregnancy, it is recommended to: - Use the lowest effective dose and divide the daily dose valproate into several small doses to be taken throughout the day.
Danish: Hvis behandlingen med valproat fortsættes under graviditeten efter en omhyggelig vurdering af risici og fordele, anbefales det, at: - Bruge den laveste effektive dosis og opdele den daglige dosis valproat i flere små doser, der tages i løbet af dagen.