FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefit has Netvax shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Netwax?
English: These antibodies help the chicks to fight necrotic enteritis caused by C. perfringens type A if they are exposed to the bacterium after they have hatched.
Danish: Disse antistoffer hjælper kyllingerne til at bekæmpe nekrotisk enteritis forårsaget af C. perfringens type A, hvis de udsættes for bakterien, efter de er klækket.
English: In chicks hatched from vaccinated hens, the vaccine reduced the number of deaths, and the incidence and the severity of lesions caused by necrotic enteritis.
Danish: Hos kyllinger klækket af æg fra vaccinerede høner, reducerede vaccinen dødeligheden og forekomsten og alvoren af skader forårsaget af nekrotisk enteritis.
English: What is Netvax?
Danish: Hvad er Netwax?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Netvax exceed the risks for the active immunisation of chickens, to provide passive immunisation against necrotic enteritis to their progeny, during the laying period, to reduce mortality and the incidence and severity of lesions caused by C. perfringens type A-induced necrotic enteritis.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Netwax overstiger risiciene med hensyn til aktiv immunisering af kyllinger for, at de kan videregive en passiv immunisering mod nekrotisk enteritis til deres afkom i læggeperioden med det formål at nedbringe dødeligheden og forekomsten og alvoren af skader som følge af nekrotisk enteritis fremkaldt af C. perfringens type A. Udvalget anbefalede udstedelse af markedsføringstilladelse for Netwax.
English: Netvax contains one type of the toxoid from C. perfringens called the alpha toxoid.
Danish: Netwax indeholder en type toksoid fra C. perfringens kaldet alfatoksoid.
English: How has Netvax been studied?
Danish: Hvordan blev Netwax undersøgt?
English: Netvax is used to vaccinate chickens against necrotic enteritis caused by C. perfringens type A, so that they pass their immunity against the disease on to their chicks.
Danish: Netwax anvendes til at vaccinere kyllinger mod nekrotisk enteritis forårsaget af C. perfringens type A, så de videregiver deres immunitet mod sygdommen til deres afkom.
English: Netvax contains small amounts of a toxoid from C. perfringens type A. When it is given to a chicken, its immune system recognises the toxoid as ‘foreign' and makes antibodies against it.
Danish: Netwax indeholder små mængder af et toksoid fra C. perfringens type A. Når en kylling vaccineres med Netwax opfatter dyrets immunsystem toksoidet som "fremmed" og reagerer ved at danne antistoffer imod det. Antistofferne overføres fra høne til kyllinger via æggene.
English: How does Netvax work?
Danish: Hvordan virker Netwax?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tecfidera on 30 January 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tecfidera den 30. januar 2014.
English: The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day.
Danish: Dosis er 120 mg to gange dagligt i de første syv dage og øges derefter til 240 mg to gange dagligt.
English: The full EPAR for Tecfidera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tecfidera findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Tecfidera.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tecfidera.
English: Tecfidera dimethyl fumarate
Danish: Tecfidera dimethylfumarat
English: These side effects tend to start early during treatment, usually in the first month, and may continue intermittently throughout treatment.
Danish: Disse bivirkninger plejer at begynde tidligt i behandlingen, sædvanligvis i den første måned, og kan med afbrydelser fortsætte i hele behandlingsperioden.
English: Other information about Tecfidera
Danish: Andre oplysninger om Tecfidera
English: Tecfidera is available as oral capsules (120 and 240 mg) to be taken with food.
Danish: Tecfidera leveres som orale kapsler (120 og 240 mg), der tages med et måltid.
English: The number of relapses per patient per year for glatiramer acetate was 0.3.
Danish: Antallet af tilbagefald pr. patient pr. år for glatirameracetat var 0,3.
English: A risk management plan has been developed to ensure that Tecfidera is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Tecfidera anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Tecfidera's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Tecfidera opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Tecfidera is a medicine that contains the active substance dimethyl fumarate.
Danish: Tecfidera er et lægemiddel, der indeholder det aktive stof dimethylfumarat.
English: In addition, a number of studies with Tecfidera are planned or underway to provide further long-term safety data and to monitor the medicine.
Danish: Desuden er der planlagt eller igangsat en række undersøgelser med Tecfidera for at skaffe yderligere oplysninger om den langsigtede sikkerhed og overvåge lægemidlet.
English: What is Tecfidera and what is it used for?
Danish: Hvad er Tecfidera, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Tecfidera?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tecfidera?
English: Why is Tecfidera approved?
Danish: Hvorfor blev Tecfidera godkendt?
English: In a second main study involving 1,417 patients, patients were given Tecfidera, placebo or another medicine, glatiramer acetate.
Danish: I endnu en hovedundersøgelse fik 1 417 patienter enten Tecfidera, placebo eller et andet lægemiddel, glatirameracetat.
English: It is not intended to provide practical advice on how to use Tecfidera.
Danish: Det er ikke en praktisk vejledning i, hvordan Tecfidera bør anvendes.
English: The active substance, dimethyl fumarate, is thought to work by activating a protein called ‘Nrf2' that regulates certain ‘antioxidant' genes involved in protecting cells from damage.
Danish: dimethylfumarat, menes at virke ved at aktivere proteinet “Nrf2”, der regulerer visse “antioxidant”gener, som er med til at beskytte cellerne mod beskadigelse.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tecfidera, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Tecfidera, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Dimethyl fumarate, has been shown in studies to reduce the inflammation and modulate the activity of the immune system.
Danish: Dimethylfumarat har i undersøgelserne vist sig at nedsætte inflammation og tilpasse immunsystemets aktivitet.
English: This study showed Tecfidera to be more effective than placebo in reducing the number of relapses over the course of two years: the number of relapses per patient per year was around 0.2 with Tecfidera compared with 0.4 with placebo.
Danish: Undersøgelsen viste, at Tecfidera er mere effektivt end placebo til at nedsætte antallet af tilbagefald i løbet af to år: Antallet af tilbagefald pr. patient pr. år var cirka 0,2 med Tecfidera, sammenholdt med 0,4 med placebo.
English: The main risks identified with Tecfidera are considered to be manageable and include flushing and gastrointestinal problems (the most common side effects), as well as reduced levels of white blood cells and protein in the urine.
Danish: De vigtigste risici, der er påvist med Tecfidera, anses for at kunne håndteres og består i rødme og mave-tarm-problemer (de hyppigste bivirkninger), nedsat antal hvide blodlegemer og protein i urinen.
English: In a main study involving 1,234 patients, the proportion of patients who experienced a relapse over the course of two years was significantly lower with Tecfidera treatment than with placebo (a dummy treatment): 27% versus 46%.
Danish: I en hovedundersøgelse med 1 234 patienter var den andel af patienterne, der fik tilbagefald i løbet af to år, betydeligt lavere ved behandling med Tecfidera end med placebo (en virkningsløs behandling), nemlig 27 % mod 46 %.
English: What are the risks associated with Tecfidera?
Danish: Hvilke risici er der forbundet med Tecfidera?
English: In MS, the body's immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths.
Danish: Ved multipel sklerose fungerer kroppens immunsystem forkert og angriber dele af centralnervesystemet (hjernen og rygmarven), så der opstå inflammation, der beskadiger nervernes skeder.
English: For more information about treatment with Tecfidera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tecfidera, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Tecfidera can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.
Danish: Tecfidera udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af multipel sklerose.
English: It is used to treat multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Danish: Det anvendes til behandling af voksne med multipel sklerose, som er en sygdom, hvor inflammation ødelægger den beskyttende skede, der omgiver nerverne.
English: It is used specifically in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Danish: Det anvendes specielt hos voksne med den form af sygdommen, der kaldes recidiverende-remitterende multipel sklerose, hvor patienten gentagne gange har tilbagefald af symptomer (recidiv) efterfulgt af perioder uden symptomer (remission).
English: The most common side effects with Tecfidera (which may affect more than 1 in 10 people) are flushing (reddening of skin) and gastrointestinal problems (such as diarrhoea, nausea, and pain in the abdominal area).
Danish: De hyppigste bivirkninger ved Tecfidera (som optræder hos mere end 1 ud af 10 patienter) er rødme og mave-tarm-problemer (såsom diarré, kvalme og mavesmerter).
English: The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal problems.
Danish: Dosis kan midlertidigt nedsættes hos patienter, som får bivirkninger i form af rødme og mave-tarm-problemer.
English: For the full list of all side effects reported with Tecfidera, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Tecfidera fremgår af indlægssedlen.
English: For practical information about using Tecfidera, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tecfidera, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Tecfidera has been shown to reduce the number of relapses in patients with relapsing-remitting MS and to reduce the number of patients who have them.
Danish: Tecfidera er påvist at nedsætte antallet af tilbagefald hos patienter med recidiverende-remitterende multipel sklerose og at nedsætte det antal patienter, der får dem.
English: Tecfidera has been shown to be effective in reducing the number of relapses in patients with relapsingremitting MS and in reducing the number of patients who have relapses during treatment.
Danish: Tecfidera er påvist at være effektivt til at nedsætte antallet af tilbagefald hos patienter med recidiverende-remitterende multiple sklerose og at nedsætte det antal patienter, der får tilbagefald under behandlingen.
English: What benefits of Tecfidera have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Tecfidera?
English: How is Tecfidera used?
Danish: Hvordan anvendes Tecfidera?
English: How does Tecfidera work?
Danish: Hvordan virker Tecfidera?
English: <Linearity/non-linearity>
Danish: <Linearitet/non-linearitet>
English: You may need to read it again.
Danish: <De> <Du> kan få brug for at læse den igen.
English: < PC: {number} [product code]
Danish: <PC: {nummer} [produktkode]
English: <...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...>
Danish: <...> <6 måneder> <...> <1 år> <18 måneder> <2 år > <30 måneder> <3 år> <...>
English: <Other sources of information>
Danish: <Andre informationskilder>
English: <Precautions to be taken before handling or administering the medicinal product>
Danish: <Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet>
English: <Use in the paediatric population>
Danish: <Brug i den pædiatriske population>
English: Pharmacotherapeutic group: {group}, ATC code: {code} <not yet assigned>
Danish: Farmakoterapeutisk klassifikation: {kategori}, ATC-kode: {kode} <endnu ikke tildelt.>
English: <{(Invented) Name} is a biosimilar medicinal product.
Danish: <{X} er et biosimilært lægemiddel.
English: Package leaflet: Information for the <patient> <user>
Danish: Indlægsseddel: Information til <patienten> <brugeren>
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]>
Danish: NN: {nummer} [nationalt refusionsnummer eller andet nationalt nummer, der identificerer lægemidlet]>
English: <Interaction studies have only been performed in adults.>
Danish: <Interaktionsstudier er kun udført hos voksne.>
English: {Name}
Danish: {Navn}
English: <No interaction studies have been performed.>
Danish: <Der er ikke udført interaktionsstudier.>
English: <This medicinal product is authorised in the Member States of the EEA under the following names:>
Danish: <Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:>
English: <No special requirements <for disposal>.>
Danish: <Ingen særlige forholdsregler <ved bortskaffelse>.>
English: DOSIMETRY>
Danish: DOSIMETRI>
English: <Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.>
Danish: <Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.>
English: <Clinical efficacy and safety>
Danish: <Klinisk virkning og sikkerhed>
English: <This medicinal product is for diagnostic use only.>
Danish: <Dette lægemiddel er kun til diagnostisk brug.>
English: <Environmental Risk Assessment (ERA)>
Danish: <Miljørisikovurdering>
English: <The recommended dose is...>
Danish: <Den anbefalede dosis er {angivelse}.>
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS>
Danish: INSTRUKTIONER FOR FREMSTILLING AF RADIOAKTIVE LÆGEMIDLER>
English: <This medicine is subject to additional monitoring.
Danish: <Dette lægemiddel er underlagt supplerende overvågning.
English: <{Name of the Member State}> <{Name of the medicinal product}>
Danish: <{Medlemslandets navn}> <{Lægemidlets navn}>
English: <The following information is intended for healthcare professionals only:>
Danish: <Nedenstående oplysninger er til læger og sundhedspersonale:>
English: For referral procedures: Please refer to the guidance in the annotated QRD template for centralised procedures.]
Danish: [*For the printed material, please refer to the guidance of the annotated QRD template.]
English: <Any unused medicinal product or waste material should be disposed of in accordance with local requirements.>
Danish: <Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.>
English: <Date of latest renewal: {DD month YYYY}>
Danish: <Dato for seneste fornyelse: {DD måned ÅÅÅÅ}>
English: <ANNEX III> [For referral procedures]
Danish: <BILAG III> [For referral procedures]
English: <Do not take a double dose to make up for a forgotten <tablet> <dose> <…>.>
Danish: <<De> <du> må ikke tage en dobbeltdosis som erstatning for den glemte <tablet> <dosis> <...>.>
English: <The tablet can be divided into equal doses.>
Danish: <Tabletten kan deles i to lige store doser.>
English: 6.6 Special precautions for disposal <and other handling>
Danish: 6.6 Regler for bortskaffelse <og anden håndtering>
English: Children <and adolescents>
Danish: Børn <og unge>
English: <Not all pack sizes may be marketed.>
Danish: <Ikke alle pakningsstørrelser er nødvendigvis markedsført.> <Begge pakningsstørrelser er ikke nødvendigvis markedsført.>
English: <Read all of this leaflet carefully before you start <taking> <using> this medicine because it contains important information for you.
Danish: <Læs denne indlægsseddel grundigt, inden <De> <du> begynder at <tage> <bruge> dette lægemiddel, da den indeholder vigtige oplysninger.
English: <Fertility>
Danish: <Fertilitet>
English: <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.>
Danish: <Da der ikke foreligger studier af eventuelle uforligeligheder, må <{X}> <dette lægemiddel> ikke blandes med andre lægemidler.>
English: <{DD month YYYY}>
Danish: <{DD måned ÅÅÅÅ}>
English: <No data are available.> <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Danish: <4.8> <5.1> <5.2>, men der kan ikke gives nogen anbefalinger vedrørende dosering.>
English: X with <food> <and> <,> <drink> <and> <alcohol>
Danish: Brug af {X} sammen med <mad> <og> <,> <drikke> <og> <alkohol>
English: Pregnancy <and> <,> breast-feeding <and fertility>
Danish: Graviditet <og> <,> amning <og frugtbarhed>
English: <[See Annex I - To be completed nationally]> [For referral procedures, as appropriate]
Danish: <[Se bilag I - Udfyldes nationalt]> [For referral procedures, as appropriate]
English: PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING>
Danish: MÆRKNING, DER SKAL ANFØRES <PÅ DEN YDRE EMBALLAGE> <OG> <PÅ DEN INDRE EMBALLAGE>
English: <{X} is indicated in <adults> <neonates> <infants> <children> <adolescents> <aged {x to y}> <years> <months>.>
Danish: <{X} er indiceret til <voksne> <nyfødte> <spædbørn> <børn> <unge> <i alderen {x-y}> <år> <måneder>.>
English: See section 4.8 for how to report adverse reactions.> [For medicinal products subject to additional monitoring ONLY]
Danish: 4.8, hvordan bivirkninger indberettes.> [Kun for lægemidler, der er underlagt supplerende overvågning]
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc" Appendix V.*
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc" Appendiks V*.
English: <Pharmacodynamic effects>
Danish: <Farmakodynamisk virkning>
English: <This medicine has been authorised under “exceptional circumstances”.
Danish: <Dette lægemiddel er godkendt under ”særlige vilkår”.
English: <Date of first authorisation: {DD month YYYY}>
Danish: <Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ}>
English: {name MS/Agency} will review any new information on this medicine every year and this leaflet will be updated as necessary.>
Danish: Lægemiddelstyrelsen vil hvert år vurdere nye oplysninger om <{X}> <lægemidler>, og denne indlægsseddel vil om nødvendigt blive ajourført.>
English: See the end of section 4 for how to report side effects.> [For medicinal products subject to additional monitoring ONLY]
Danish: Se sidst i <afsnit> <punkt> 4, hvordan <De> <du> indberetter bivirkninger.> [Kun for lægemidler, der er underlagt supplerende overvågning]
English: <The score line is not intended for breaking the tablet.>
Danish: <Formålet med delekærven er ikke at kunne brække tabletten over.>
English: {Route of administration}
Danish: {Administrationsvej}
English: <Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:>
Danish: <Følgende bivirkninger er ikke observeret i kliniske studier, men er set i dyrestudier efter eksponering for plasmakoncentrationer, der svarer til human-terapeutiske doser, og kan muligvis være klinisk relevante:>
English: <[To be completed nationally]> [For referral procedures]
Danish: <[Udfyldes nationalt]> [For referral procedures]
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.>
Danish: <I prækliniske studier blev der kun iagttaget virkninger ved doser, der anses for at overstige den maksimale humane eksponering i væsentlig grad.
English: <Mechanism of action>
Danish: <Virkningsmekanisme>
English: <Pharmacokinetic/pharmacodynamic relationship(s)>
Danish: <Farmakokinetiske/farmakodynamiske forhold>
English: This means that <due to the rarity of the disease> <for scientific reasons> <for ethical reasons> it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det <af videnskabelige årsager> <af etiske grunde> ikke har været muligt at opnå fuldstændig dokumentation for <{X}> <lægemidlet> <, fordi det anvendes til en sjælden sygdom>.
English: <If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your <doctor> <or> <pharmacist> for advice before taking this medicine.>
Danish: <Hvis <De> <du> er gravid eller ammer, har mistanke om, at <De> <du> er gravid, eller planlægger at blive gravid, skal <De> <du> spørge <Deres> <din> læge> <eller apotekspersonalet> til råds, før <De> <du> <tager> <bruger> <{X}> <dette lægemiddel>.>
English: <Use in children <and adolescents>>
Danish: <Brug til børn <og unge>>
English: <Do not use this medicine if you notice {description of the visible signs of deterioration}.>
Danish: <<Tag> <Brug> ikke <{X}> <lægemidlet>, hvis {beskrivelse af synlige tegn på nedbrydning}.>
English: - <if you are allergic to {active substance(s)} or any of the other ingredients of this medicine (listed in section 6).>
Danish: - <hvis <De> <du> er allergisk over for {aktivt stof/aktive stoffer} eller et af de øvrige indholdsstoffer <i {X}> (angivet i <afsnit> <punkt> 6).>
English: <This medicinal product has been authorised under “Exceptional Circumstances”.
Danish: <<{X}> <Dette lægemiddel> er godkendt under ”særlige vilkår”.
English: <For instructions on <reconstitution> <dilution> of the medicinal product before administration, see section <6.6> <and> <12>.>
Danish: <For instruktioner om <rekonstitution> <fortynding> af lægemidlet før administration, se pkt.