FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or pharmacist before you or your child receives [PRODUCT NAME]: - if you or your child has weakened immune system (e.g. such as HIV infection).
Danish: Kontakt lægen eller apoteket, før du eller dit barn bliver vaccineret med [PRODUKT NAVN]: - hvis du eller dit barn har svækket immunsystem (f.eks. hiv-infektion).
English: Warnings and precautions The text of this section should be read as follows:
Danish: Advarsler og forsigtighedsregler Informationen i dette afsnit skal skrives på følgende måde:
English: The wording regarding pregnancy should read as follows: “[PRODUCT NAME] should not be administrated to pregnant women.
Danish: Information om graviditet skal skrives på følgende måde: “[PRODUKT NAVN] må ikke gives til gravide kvinder.
English: Whether you or your child receives the vaccine will depend upon the level of your immune defenses.
Danish: Hvorvidt du eller dit barn vaccineres afhænger af, hvor meget du/dit barns immunforsvar er svækket.
English: Section 4.6 Fertility, pregnancy and lactation The wording regarding pregnancy should read as follows:
Danish: Punkt 4.6 Fertilitet, graviditet og amning Informationen om graviditet skal skrives på følgende måde:
English: Also, it is important that you do not become pregnant within one month after having the vaccine.
Danish: Det er også vigtigt, at du ikke bliver gravid i 1 måned efter vaccinationen.
English: Section 4.3 Contraindications The wording regarding pregnancy and immunocompromised patients should read as follows:
Danish: Punkt 4.3 Kontraindikationer Informationen om graviditet og immunkompromitterede patienter skal skrives på følgende måde:
English: The wording regarding pregnancy and immunocompromised patients should read as follows: The text of this section should be read as follows:
Danish: Informationen om graviditet og immunkompromitterede patienter skal skrives på følgende måde: Informationen i dette afsnit skal skrives på følgende måde:
English: The wording regarding pregnancy and immunocompromised patients should read as follows:
Danish: Informationen om graviditet og immunkompromitterede patienter skal skrives på følgende måde:
English: Furthermore, pregnancy should be avoided for 1 month following vaccination (see section
Danish: Endvidere skal graviditet undgås i 1 måned efter vaccination (se pkt.
English: You or your child should be closely monitored as the responses to the vaccines may not be sufficient to ensure a protection against the illness (see section 2 “Do not use [PRODUCT NAME]”)
Danish: Du eller dit barn skal overvåges nøje, da virkningen af vaccinen muligvis ikke er tilstrækkelig til at beskytte mod sygdommene (se punkt 2 ” Du eller dit barn må ikke få [PRODUKT NAVN”)
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Danish: Bilag III Tilføjelser til relevante punkter i produktresumé, etikettering og indlægsseddel
English: Pregnancy should be avoided for 1 month following vaccination.
Danish: Graviditet skal undgås i 1 måned efter vaccination.
English: In case of inadvertent vaccination of pregnant women with [PRODUCT NAME], this should not be a reason for termination of pregnancy.
Danish: Utilsigtet vaccination af gravide kvinder med [PRODUKT NAVN] bør ikke være grund til svangerskabsafbrydelse.
English: In addition, pregnancy should be avoided for 1 month following vaccination.
Danish: Endvidere skal graviditet undgås i 1 måned efter vaccination.
English: These patients should be monitored carefully for signs of measles, parotitis and rubella.
Danish: Disse personer skal overvåges nøje for symptomer på mæslinger, parotitis og røde hunde.
English: These patients should be monitored carefully for signs of measles.
Danish: Disse personer skal overvåges nøje for symptomer på mæslinger.
English: However, fetal damage has not been documented when measles, mumps, rubella or varicella vaccines have been given to pregnant women.
Danish: Skadelige virkninger på fosteret er dog ikke dokumenteret efter administration af mæslinge-, fåresyge-, røde hunde eller skoldkoppe-vacciner til gravide kvinder.
English: However, fetal damage has not been documented when measles, mumps or rubella vaccines have been given to pregnant women.
Danish: Skadelige virkninger på fosteret er dog ikke dokumenteret efter administration af mæslinge-, fåresyge- eller røde hunde-vacciner til gravide kvinder.
English: These patients should be monitored carefully for signs of measles, parotitis, rubella and varicella.
Danish: Disse personer skal overvåges nøje for symptomer på mæslinger, fåresyge, røde hunde og skoldkopper.
English: Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent subjects, therefore some of these patients may acquire measles, mumps, rubella or varicella in case of contact, despite appropriate vaccine administration.
Danish: 4.3), vil muligvis ikke respondere lige så godt som immunkompetente personer og kan således ved kontakt få mæslinger, fåresyge, røde hunde og skoldkopper på trods af korrekt vaccination.
English: Therefore, inadvertent vaccination of unknowingly pregnant women with measles containing vaccines should not be a reason for termination of pregnancy.
Danish: Utilsigtet vaccination med en mæslinge-vaccine af gravide kvinder, som ikke har kendskab til graviditeten, skal derfor ikke give anledning til svangerskabsafbrydelse.
English: However, fetal damage has not been documented when measles or rubella vaccines have been given to pregnant women.
Danish: Skadelige virkninger på fosteret er dog ikke dokumenteret efter administration af mæslinge- eller røde hunde-vacciner til gravide kvinder.
English: Therefore, inadvertent vaccination of unknowingly pregnant women with mumps containing vaccines should not be a reason for termination of pregnancy.
Danish: Utilsigtet vaccination med en fåresyge-vaccine af gravide kvinder, som ikke har kendskab til graviditeten, skal derfor ikke give anledning til svangerskabsafbrydelse.
English: These patients should be monitored carefully for signs of measles and rubella.
Danish: Disse personer skal overvåges nøje for symptomer på mæslinger og røde hunde.
English: Amendments to be included in the relevant sections of the summary of product characteristics for multivalent measles, mumps, rubella and varicella containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i produktresuméet for multivalente mæslinge-, fåresyge-, røde hunde- og skoldkoppe-vacciner.
English: Therefore, inadvertent vaccination of unknowingly pregnant women with measles, mumps and rubella containing vaccines should not be a reason for termination of pregnancy.
Danish: Utilsigtet vaccination med en mæslinge-, fåresyge- og røde hunde-vaccine af gravide kvinder bør derfor ikke give anledning til svangerskabsafbrydelse.
English: Amendments to be included in the relevant sections of the package leaflet for multivalent measles, mumps, rubella and varicella containing vaccines 2.
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i indlægssedlen for multivalente mæslinge-, fåresyge-, røde hunde og skoldkoppe-vacciner.
English: However, fetal damage has not been documented when measles vaccines have been given to pregnant women.
Danish: Skadelige virkninger på fosteret er dog ikke dokumenteret efter administration af mæslingevacciner til gravide kvinder.
English: Amendments to be included in the relevant sections of the package leaflet for monovalent mumps containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i indlægssedlen for monovalente fåresyge-vacciner.
English: However, fetal damage has not been documented when mumps vaccines have been given to pregnant women.
Danish: Skadelige virkninger på fosteret er dog ikke dokumenteret efter administration af fåresygevacciner til gravide kvinder.
English: These patients should be monitored carefully for signs of parotitis.
Danish: Disse personer skal overvåges nøje for symptomer på røde hunde.
English: Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent subjects, therefore some of these patients may acquire mumps in case of contact, despite appropriate vaccine administration.
Danish: 4.3), vil muligvis ikke respondere lige så godt som immunkompetente personer og kan således ved kontakt få fåresyge på trods af korrekt vaccination.
English: However, fetal damage has not been documented when rubella vaccines have been given to pregnant women.
Danish: Skadelige virkninger på fosteret er dog ikke dokumenteret efter administration af røde hundevacciner til gravide kvinder.
English: Amendments to be included in the relevant sections of the summary of product characteristics for multivalent measles, mumps and rubella containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i produktresuméet for multivalente mæslinge-, fåresyge- og røde hunde-vacciner.
English: Amendments to be included in the relevant sections of the summary of product characteristics for monovalent varicella containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i produktresuméet for monovalente mæslinge-vacciner.
English: Amendments to be included in the relevant sections of the summary of product characteristics for multivalent measles and rubella containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i produktresuméet for multivalente mæslinge- og røde hunde-vacciner.
English: Amendments to be included in the relevant sections of the package leaflet for multivalent measles and rubella containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i indlægssedlen for multivalente mæslinge- og røde hunde-vacciner.
English: Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent subjects, therefore some of these patients may acquire measles in case of contact, despite appropriate vaccine administration.
Danish: 4.3), vil muligvis ikke respondere lige så godt som immunkompetente personer og kan således ved kontakt få mæslinger på trods af korrekt vaccination.
English: Amendments to be included in the relevant sections of the package leaflet for monovalent measles containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i indlægssedlen for monovalente skoldkoppe-vacciner.
English: Amendments to be included in the relevant sections of the summary of product characteristics for monovalent mumps containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i produktresuméet for monovalente fåresyge-vacciner.
English: Amendments to be included in the relevant sections of the package leaflet for multivalent measles, mumps and rubella containing vaccines 2.
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i indlægssedlen for multivalente mæslinge-, fåresyge- og røde hunde-vacciner.
English: Amendments to be included in the relevant sections of the package leaflet for monovalent rubella containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i indlægssedlen for monovalente røde hunde-vacciner.
English: Amendments to be included in the relevant sections of the package leaflet for monovalent varicella containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i indlægssedlen for monovalente mæslinge-vacciner.
English: Amendments to be included in the relevant sections of the summary of product characteristics for monovalent rubella containing vaccines
Danish: Tilføjelser, som skal inkluderes i de relevante punkter i produktresuméet for monovalente røde hunde-vacciner.
English: Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent subjects, therefore some of these patients may acquire measles or rubella in case of contact, despite appropriate vaccine administration.
Danish: 4.3), vil muligvis ikke respondere lige så godt som immunkompetente personer og kan således ved kontakt få mæslinger og røde hunde på trods af korrekt vaccination.
English: Betaferon received a marketing authorisation valid throughout the EU on 30 November 1995.
Danish: Betaferon fik en markedsføringstilladelse med gyldighed i hele EU den 30. november 1995.
English: Other information about Betaferon
Danish: Andre oplysninger om Betaferon
English: Further information on Betaferon can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/betaferon.
Danish: Yderligere information om Betaferon findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/betaferon.
English: In the other study, no delay in the time to disability progression was seen.
Danish: I det andet studie sås der ingen forsinkelse i tiden til progression af invaliditet.
English: What is Betaferon and what is it used for?
Danish: Hvad er Betaferon, og hvad anvendes det til?
English: As for all medicines, data on the use of Betaferon are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Betaferon løbende overvåget.
English: It is given by injection under the skin.
Danish: Betaferon gives ved indsprøjtning under huden.
English: Betaferon is used in patients:
Danish: Betaferon anvendes hos patienter:
English: Treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms given every other day.
Danish: Behandlingen bør påbegyndes med 62,5 mikrogram (en kvart dosis) hver anden dag og stige gradvist over 19 dage til den anbefalede dosis på 250 mikrogram hver anden dag.
English: Side effects are common at the beginning of treatment but usually decrease with further treatment.
Danish: I starten af behandlingen er bivirkninger almindelige, men generelt aftager de i takt med yderligere behandling.
English: Why is Betaferon authorised in the EU?
Danish: Hvorfor er Betaferon godkendt i EU?
English: What measures are being taken to ensure the safe and effective use of Betaferon?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Betaferon?
English: An overview of Betaferon and why it is authorised in the EU
Danish: En oversigt over Betaferon, og hvorfor det er godkendt i EU
English: The European Medicines Agency decided that Betaferon's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Betaferon opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: • who have experienced the signs of MS for the first time, and these are severe enough to need treatment with injected corticosteroids (anti-inflammatory medicines).
Danish: • der har oplevet tegn på dissemineret sklerose for første gang, og når disse tegn er alvorlige nok til at nødvendiggøre behandling med injicerede kortikosteroider (antiinflammatoriske lægemidler).
English: Side effects reported with Betaferon are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Betaferon vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Betaferon treatment should be stopped in patients whose condition does not improve.
Danish: Behandling med Betaferon bør ophøre hos patienter, hvis tilstand ikke bliver bedre.
English: • who have MS of the type known as ‘relapsing-remitting', when the patient has attacks (relapses) between periods with no symptoms (remissions), in patients with at least two relapses within the last two years;
Danish: • der har dissemineret sklerose af den type, der kaldes "recidiverende-remitterende", når patienten har attakker (recidiver) mellem perioder uden symptomer, hos patienter med mindst to recidiver inden for de sidste to år
English: For more information about using Betaferon, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Betaferon, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Betaferon is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
Danish: Betaferon fås som pulver og solvens, der blandes til en opløsning, som giver en dosis på 250 mikrogram.
English: Patients can inject Betaferon themselves once they have been trained.
Danish: Patienterne kan godt selv indsprøjte Betaferon, når de er blevet instrueret i det.
English: Betaferon must not be used in patients who have severe depression or have thoughts of suicide.
Danish: Betaferon må ikke anvendes hos patienter, der har alvorlig depression eller selvmordstanker.
English: What are the risks associated with Betaferon?
Danish: Hvilke risici er der forbundet med Betaferon?
English: One of the two studies showed a significant delay in the time to disability progression (31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (39%).
Danish: I ét af to studier blev der påvist en signifikant forsinkelse i tiden til progression af invaliditet (31 % reduktion af risikoen på grund af Betaferon) og i tiden til afhængighed af kørestol (39 %).
English: Betaferon must not be used in patients who have decompensated liver disease (when the liver is damaged and can no longer work adequately).
Danish: Betaferon må ikke anvendes hos patienter, der har dekompenseret leversygdom (når leveren er beskadiget og ikke længere fungerer normalt).
English: The most frequent side effects with Betaferon are flu-like symptoms (including fever, chills, joint pain, malaise [feeling unwell], sweating, headache and muscle pain) and reactions at the site of injection.
Danish: De hyppigste bivirkninger ved Betaferon er influenzalignende symptomer (herunder feber, kulderystelser, ledsmerter, utilpashed, svedtendens, hovedpine og muskelsmerter) og reaktioner på injektionsstedet.
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Danish: Dissemineret sklerose er en sygdom, hvor en betændelsesreaktion skader den beskyttende isolering omkring nerverne (demyelinisering) samt nerverne selv.
English: Betaferon was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27.
Danish: Betaferon var mere effektivt end placebo til at reducere antallet af recidiver pr. år: Patienter, der fik lægemidlet, havde i gennemsnit 0,84 recidiver pr. år, mens patienter på placebo havde 1,27.
English: In both studies, Betaferon showed a reduction (30%) in the number of clinical relapses.
Danish: I begge studier medførte Betaferon en reduktion på 30 % i antallet af kliniske recidiver.
English: For the full list of side effects and restrictions with Betaferon, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Betaferon fremgår af indlægssedlen.
English: • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Danish: • der har sekundær progressiv dissemineret sklerose (den type dissemineret sklerose, der kommer efter recidiverende-remitterende dissemineret sklerose), når deres sygdom er aktiv.
English: The active substance in Betaferon is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Danish: Det aktive stof i Betaferon er proteinet interferon beta-1b, der tilhører en gruppe interferoner, som dannes naturligt i kroppen for at hjælpe den med at bekæmpe bl.a. virusser.
English: Betaferon contains the active substance interferon beta-1b.
Danish: Betaferon indeholder det aktive stof interferon beta-1b.
English: Betaferon can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS.
Danish: Betaferon fås kun på recept, og behandlingen bør indledes og overvåges af en læge med erfaring i behandling af dissemineret sklerose.
English: The exact way that Betaferon works in MS is not yet known but the active substance, interferon beta-1b, seems to calm down the immune system, and prevents relapses of MS.
Danish: Det vides endnu ikke, præcist hvordan Betaferon virker ved dissemineret sklerose, men det aktive stof, interferon beta-1b, synes at berolige immunsystemet og forebygger recidiver af dissemineret sklerose.
English: How is Betaferon used?
Danish: Hvordan anvendes Betaferon?
English: Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with placebo.
Danish: Betaferon er også blevet undersøgt hos 1.657 patienter i to studier af sekundær progressiv dissemineret sklerose, som var i stand til at gå, hvor det blev sammenlignet med placebo.
English: Betaferon was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Betaferon developed MS, compared with 45% of those who received placebo.
Danish: Det blev påvist, at Betaferon reducerede risikoen for udvikling af klinisk definitiv dissemineret sklerose: 28 % af de patienter, der fik Betaferon, udviklede dissemineret sklerose, sammenholdt med 45 % af de patienter, der fik placebo.
English: Betaferon is a medicine used to treat adults who have multiple sclerosis (MS).
Danish: Betaferon er et lægemiddel til behandling af voksne, der har dissemineret sklerose.
English: Betaferon was also studied in 487 patients with a single demyelinating event, who received either Betaferon or placebo for two years.
Danish: Betaferon blev også undersøgt hos 487 patienter med et enkelt tilfælde af demyelinisering, der fik enten Betaferon eller placebo i to år.
English: What benefits of Betaferon have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Betaferon?
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Danish: Ved dissemineret sklerose opstår der fejl i immunsystemet (kroppens naturlige forsvar), som angriber dele af centralnervesystemet (hjernen, rygmarven og synsnerven), og det medfører betændelse, der beskadiger nerverne og det beskyttende lag omkring dem.
English: Betaferon was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where it was compared with placebo (a dummy treatment).
Danish: Betaferon blev undersøgt over en toårig periode hos 338 patienter med recidiverende-remitterende dissemineret sklerose, der var i stand til at gå uden hjælp, og det blev sammenlignet med placebo (en uvirksom behandling).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Betaferon have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Betaferon.
English: Betaferon is used when the patient is considered to be at high risk of developing MS. Before using Betaferon, doctors need to exclude other causes for the symptoms;
Danish: Før anvendelse af Betaferon skal lægen udelukke andre årsager til symptomerne
English: How does Betaferon work?
Danish: Hvordan virker Betaferon?
English: • an examination to check the nerves in your arms and legs
Danish: • en undersøgelse for at kontrollere nerverne i Deres arme og ben
English: • measurement of vitamin B12 levels
Danish: • måling af vitamin B12-niveauerne
English: ATC Code: A16AX06
Danish: ATC-kode: A16AX06
English: - The active substance is miglustat.
Danish: - Det aktive stof er miglustat.