FrancophonIA/ELRC3.0 huggingface dataset:
English: - PET-CT is now the state-of-the-art for FDG detection and does not show a deterioration in technical and diagnostic performances when compared to PET alone the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for GLUSCAN 500 and associated names (see Annex I).
Danish: - PET/CT er nu state-of-the-art for FDG-detektion og viser ikke nogen forringelse af de tekniske og diagnostiske ydelser, når der sammenlignes med PET alene anbefaler CHMP, at der udstedes markedsføringstilladelser for GLUSCAN 500 og tilknyttede navne (se bilag I).
English: The posology (in fact the injected activity) recommended in the Core SmPC, 100-400MBq with adaptation in children, is in line with the activity used in the reported clinical studies for infection/inflammation, whatever the machine used PET, CDET or PET-CT. No adaptation is necessary according to the clinical setting, while an adaptation is necessary (within the above range) according to the body weight of the patient and the type of PET(/CT) machine used for imaging.
Danish: Den dosering (dvs. den injicerede aktivitet), der anbefales i det grundlæggende produktresumé, nemlig 100-400MBq med tilpasning til børn, er på linje med den aktivitet, der bruges i de indberettede kliniske undersøgelser for infektion/inflammation, uanset hvilken maskine der bruges, PET, CDET eller PET-CT.
English: Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilladels e
English: at calibration time, Water for injection - 1.00g, Sodium citrate - 0.62% (v/v), Sodium chloride - 0.41% (v/v), Hydrochloric acid 0.39% (v/v), Ethanol 0.31% (v/v) Sodium hydroxide 0.24% (v/v)
Danish: kalibreringstidspunktet vand til injektion1,00g, natriumcitrat - 0,62% (v/v), natriumklorid - 0,41% (v/v), saltsyre 0,39% (v/v), ethanol 0,31% (v/v) natriumhydroxid 0,24% (v/v)
English: GLUSCAN PL 500MBq/mL at calibration time
Danish: GLUSCAN PL
English: Sodium hydroxide 0.24% (v/v)
Danish: (v/v), saltsyre 0,39% (v/v), ethanol 0,31% (v/v) natriumhydroxid 0,24% (v/v)
English: 27 June 2013
Danish: Den 27. juni 2013
English: (This does not apply to Zostavax, which has different strength and indications.)
Danish: (Dette gælder ikke for Zostavax, der har en anden styrke og andre indikationer).
English: The product information should be updated to reflect these changes.
Danish: Produktinformationen bør opdateres, så den afspejler disse ændringer.
English: The CHMP also considered available guidance from the World Health Organization.
Danish: CHMP tog desuden hensyn til den foreliggende vejledning fra Verdenssundhedsorganisationen.
English: What are MMRV?
Danish: Hvad er MMRV?
English: • In children with HIV infection, vaccination is contraindicated in those with age-specific CD4+ percentages of less than 25% below 12 months, less than 20% between 12 and 35 months, or less 15% between 36 and 59 months.
Danish: • Hos hiv-smittede børn er vaccination kontraindiceret ved en aldersspecifik CD4+ procent på under 25 % i alderen under 12 måneder, under 20 % mellem 12 og 35 måneder og under 15 % mellem 36 og 59 måneder.
English: MMRV contain weakened but live viruses.
Danish: MMRV indeholder svækkede, men levende virus.
English: The Committee also recommended that some changes be made to the product information to clarify the risks and precautions to be taken.
Danish: Udvalget anbefalede desuden, at der foretages visse ændringer af produktinformationen for at præcisere risiciene og de nødvendige forholdsregler.
English: Vax, Rouvax, Trivivac, Varilrix, Varivax, and associated names.
Danish: Vax, Rouvax, Trivivac, Varilrix, Varivax og relaterede navne.
English: They contain live attenuated (weakened) versions of the viruses responsible for these diseases.
Danish: De indeholder levende svækkede versioner af de virus, der forårsager disse sygdomme.
English: However, the evidence, including the follow-up of some of the cases, was not sufficient to allow the Committee to be certain there was no association.
Danish: Der var imidlertid ikke tilstrækkelig dokumentation og i nogle tilfælde heller ikke tilstrækkelig opfølgning til, at udvalget kunne være sikkert på, at der ikke var en sammenhæng.
English: For patients with immune deficiencies, the Committee looked at evidence from clinical studies and reports from post-marketing use.
Danish: For patienter med immundefekter gennemgik udvalget dokumentationen fra kliniske undersøgelser og indberetninger fra anvendelse efter markedsføring.
English: Why were MMRV reviewed?
Danish: Hvorfor blev MMRV vurderet igen?
English: The full changes made to the information to doctors and patients are detailed here for M-M-RVAXPRO, here for ProQuad, here for Zostavax and here for the nationally authorised products.
Danish: De fuldstændige ændringer af oplysningerne til læger og patienter er gengivet her for M-M-RVAXPRO, her for ProQuad, her for Zostavax og her for de nationalt godkendte produkter.
English: • Patients with severe weakness of their immune system must not receive these vaccines.
Danish: • Patienter med svært svækket immunsystem må ikke vaccineres med disse vacciner.
English: If a woman is, or thinks she may be, pregnant she should tell her doctor or nurse before receiving any of these vaccines.
Danish: Hvis en kvinde er gravid eller har mistanke om at være gravid, skal hun fortælle det til lægen eller sygeplejersken, før hun lader sig vaccinere med nogen af disse vacciner.
English: Other monovalent and multivalent vaccines against measles, mumps, rubella, and varicella have been available for many years and are authorised by national procedures in the EU Member States, under different trade names including Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R.
Danish: Andre monovalente og multivalente vacciner mod mæslinger, fåresyge, røde hunde og varicella har været på markedet i mange år og er godkendt ved nationale procedurer i EU's medlemsstater under handelsnavnene som f.eks. Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R.
English: At the same time, the European Commission asked the CHMP to extend their considerations to cover the centrally authorised products, and examine if their marketing authorisations should be varied or maintained.
Danish: Samtidig anmodede EuropaKommissionen CHMP om at udvide sin gennemgang til at omfatte centralt godkendte produkter og undersøge, om markedsføringstilladelserne for dem burde ændres eller opretholdes.
English: MMRV may be available as individual vaccines for each infection (monovalent) or as combination vaccines (multivalent).
Danish: MMRV kan fås som individuelle vacciner til hver enkelt infektion (monovalente) og som kombinerede vacciner (multivalente).
English: This included reports on over 3,500 women inadvertently given a rubellacontaining vaccine in early pregnancy, and over 1,800 who were given a varicella-containing vaccine during pregnancy.
Danish: Materialet omfattede indberetninger om over 3 500 kvinder, der utilsigtet fik en vaccine indeholdende rubella tidligt i graviditeten, og over 1 800, der fik en vaccine indeholdende varicella under graviditeten.
English: Some viruses are able to cross the placenta in pregnant women and infect their unborn babies.
Danish: Nogle virus er i stand til at krydse moderkagen hos gravide kvinder og smitte det ufødte barn.
English: As a result, the Belgian medicines agency asked the CHMP to carry out an assessment of the benefit-risk balance of vaccination in these groups and to issue an opinion on whether the marketing authorisations for MMRV should be varied or maintained.
Danish: Som følge heraf anmodede den belgiske lægemiddelstyrelse CHMP om at vurdere benefit/risk-forholdet for vaccination i disse grupper og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for MMRV burde ændres eller opretholdes.
English: The rate of malformations or spontaneous abortions in women who were exposed to MMRV during pregnancy was no higher than the expected rate in unvaccinated women.
Danish: Andelen af misdannelser og spontanaborter hos kvinder, der blev udsat for MMRV under graviditeten, var ikke højere end den forventede andel hos uvaccinerede kvinder.
English: The multivalent vaccines M-M-RVAXPRO and ProQuad, and the monovalent zoster (shingles) vaccine Zostavax, are centrally authorised for use throughout the European Union (EU).
Danish: De multivalente vacciner M-M-RVAXPRO og ProQuad og den monovalente vaccine mod helvedesild (zoster) Zostavax er centralt godkendt til anvendelse i hele EU.
English: The evidence did suggest that there was no need to delay pregnancy for more than one month after vaccination.
Danish: Dokumentationen viste dog, at der ikke var grund til at udskyde graviditet i mere end en måned efter vaccination.
English: • Vaccination with MMRV remains contraindicated in pregnancy and in patients with severe humoral or cellular immunodeficiency (such as severe combined immunodeficiency, agammaglobulinaemia, or AIDS).
Danish: • Vaccination med MMRV er fortsat kontraindiceret ved graviditet og hos patienter med svær humoral eller cellulær immundefekt (såsom svær kombineret immundefekt, agammaglobulinæmi eller aids).
English: On 13 December 2012, the European Medicines Agency completed a review of the use of monovalent and multivalent measles, mumps, rubella and/or varicella vaccines (MMRV) during pregnancy and in patients with immune deficiencies (weakened immune systems).
Danish: Den 13. december 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af anvendelsen af monovalente og multivalente vacciner mod mæslinger, fåresyge, røde hunde og varicella (MMRV) hos gravide og hos patienter med immundefekter (svækket immunsystem).
English: • If a woman becomes pregnant within one month after receiving one of these vaccines, it does not mean that her baby is definitely at risk, or that the pregnancy needs to be terminated.
Danish: • Bliver en kvinde gravid inden for en måned efter at have fået en af disse vacciner, at det ikke ensbetydende med, at der med sikkerhed er risiko for barnet, eller at graviditeten behøver afbrydes.
English: In addition MMRV should continue to be avoided in patients with the most severely weakened immune systems, but their use could be considered in less severe immune deficiency.
Danish: Desuden burde MMRV fortsat undgås hos patienter med de sværeste former for svækket immunsystem, men det kunne overvejes at anvende dem ved mindre svær immundefekt.
English: However, since these vaccines were authorised, new data from post-marketing use and from the published literature have become available on their safety in pregnancy and in patients with immune deficiencies.
Danish: Siden disse vacciner blev godkendt, er der imidlertid kommet nye data om sikkerheden ved graviditet og hos patienter med immundefekter.
English: The CHMP reviewed the available safety data on MMRV in pregnancy from post-marketing use and the published literature, focusing on the risk of spontaneous abortion, stillbirth, malformations, immaturity and low birth weight.
Danish: CHMP gennemgik de foreliggende sikkerhedsdata om MMRV ved graviditet fra kliniske undersøgelser, fra anvendelse efter markedsføring og fra den videnskabelige litteratur med særligt henblik på spontanabort, dødfødsel, misdannelser, ufuldbårenhed og lav fødselsvægt.
English: In patients with less severe immune weakness, vaccination may be considered, although it does not always give the same protection as in a person with a healthy immune system.
Danish: Hos patienter med mindre svære immundefekter kan vaccination overvejes, men giver ikke altid samme beskyttelse som hos en voksen med et raskt immunsystem.
English: • Immunocompromised patients who are vaccinated may not develop adequate immunity and should be monitored for subsequent development of measles, parotitis, rubella or varicella after contact with these diseases.
Danish: • Immunkompromitterede patienter, der vaccineres, opnår ikke nødvendigvis tilstrækkelig beskyttelse og bør overvåges for efterfølgende udvikling af mæslinger, fåresyge, røde hunde eller varicella efter udsættelse for smitte med disse sygdomme.
English: In particular, rubella can cause malformations and problems particularly with the ears, eyes and heart (known as ‘congenital rubella syndrome') and varicella can cause malformations affecting the limbs (known as ‘congenital varicella syndrome') in babies whose mothers become infected in early pregnancy.
Danish: Røde hunde kan således forårsage misdannelser og problemer især med ører, øjne og hjerte (“medfødt rubellasyndrom”), og varicella kan forårsage misdannelser at lemmerne (“medfødt varicellasyndrom”) hos børn af mødre, der smittes tidligt i graviditeten.
English: • Women should not be given monovalent or multivalent MMRV during pregnancy.
Danish: • Gravide kvinder bør ikke vaccineres med monovalent eller multivalent MMRV.
English: MMRV are also contraindicated in patients with immune deficiencies, in whom the vaccine may not work properly and who might be at risk of developing severe or widespread disease.
Danish: MMRV må desuden ikke anvendes hos patienter med immundefekter, hos hvem vaccinen kan risikere ikke at virke, som den skal, og som er udsat for at udvikle svær eller udbredt sygdom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that these vaccines should continue to be avoided during pregnancy, but that inadvertent vaccination of pregnant women with measles-, mumps- and/or rubella-containing vaccines should not be a reason for termination of pregnancy.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at disse vacciner fortsat burde undgås under graviditet, men at utilsigtet vaccination af gravide kvinder mod mæslinger, fåresyge, røde hunde og varicella ikke burde være grund til afbrydelse af graviditeten.
English: • Vaccination may be considered in patients with certain immune deficiencies where the benefits outweigh the risks of vaccination (e.g. asymptomatic HIV-infected patients, patients with selective IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease and complement deficiency diseases).
Danish: • Hos patienter med visse immundefekter kan vaccination overvejes, hvis fordelene ved vaccination overstiger risiciene (fx asymptomatisk hiv-infektion, selektive IgG-subklassedefekter, medfødt neutropeni, kronisk granulomatøs sygdom og sygdomme med komplementdefekt).
English: Inadvertent vaccination with rubella-containing vaccines during pregnancy is not a reason for termination.
Danish: Utilsigtet vaccination af gravide med vacciner indeholdende rubella er ikke grund til afbrydelse af graviditeten.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of MMRV do not outweigh their risks in pregnancy or in severe immune deficiencies, and recommended that vaccination should continue to be contraindicated in these groups.
Danish: Efter vurderingen af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved MMRV ikke er større end risiciene i forbindelse med graviditet eller svære immundefekter.
English: Vaccination may be considered in patients with minor immune deficiencies if the benefit outweighs the risk.
Danish: Hos patienter med mindre immundefekter kan vaccination overvejes, når fordelen ved vaccination overstiger risikoen.
English: Although these are too weak to cause health problems in healthy adults, their use in pregnant women has not been authorised due to a potential risk to the unborn baby, and women have been advised not to become pregnant for three months after vaccination.
Danish: Disse virus er for svage til at forårsage sundhedsproblemer hos raske voksne, men er ikke godkendt til brug hos gravide kvinder på grund af den eventuelle risiko for det ufødte barn.
English: However, women intending to become pregnant need only delay for one month after vaccination, and inadvertent rubella vaccination of women who are pregnant need not be a reason for termination of the pregnancy.
Danish: Kvinder, der planlægger graviditet, behøver dog kun udskyde graviditeten til en måned efter vaccinationen, og utilsigtet vaccination mod røde hunde af gravide kvinder er ikke grund til afbrydelse af graviditeten.
English: • Women should be advised to delay becoming pregnant for one month after MMRV vaccination.
Danish: • Kvinder skal have at vide, at de skal udskyde graviditet til en måned efter MMRV-vaccination.
English: MMRV are vaccines that help protect against the viral infections measles, mumps, rubella, and varicella (which may cause chickenpox or shingles [zoster]).
Danish: MMRV er vacciner, der er med til at beskytte mod virusinfektion med mæslinger, fåresyge, røde hunde og varicella (den sidste kan forårsage skoldkopper og helvedesild (zoster)).
English: Although a risk cannot be completely excluded, no cases of congenital rubella syndrome or congenital varicella syndrome have been reported among over 5,300 reports in women who were inadvertently given MMRV during pregnancy.
Danish: Der var ingen tilfælde af medfødt rubellasyndrom eller medfødt varicellasyndrom i de 5 300 indberetninger om kvinder, der utilsigtet fik MMRV under graviditet.
English: The European Commission issued a decision for M-M-RVAXPRO Article 20 on 20 February 2013.
Danish: Europa-Kommissionen traf en artikel 20-afgørelse vedrørende M-M-RVAXPRO den 20. februar 2013.
English: • Women who are given one of these vaccines should take the necessary precautions to avoid becoming pregnant for one month after vaccination.
Danish: • Kvinder, der får en af disse vacciner, bør beskytte sig mod graviditet i mindst en måned efter vaccinationen.
English: The European Commission issued a decision for MMRV Article 31 on 28 February 2013.
Danish: Europa-Kommissionen traf en artikel 31-afgørelse vedrørende MMRV den 28. februar 2013.
English: The European Commission issued a decision for ProQuad Article 20 on 18 February 2013
Danish: Europa-Kommissionen traf en artikel 20-afgørelse vedrørende ProQuad den 18. februar 2013.
English: Patients with severe immune deficiencies were at risk of serious adverse effects if given live virus vaccines, but in patients with minor immune deficiencies, including those with HIV infection but adequate blood counts of CD4 cells (a type of white blood cell important in fighting infection), the evidence suggested that MMRV could be given safely and might provide benefit.
Danish: Derimod viste dokumentationen, at MMRV kunne gives uden risiko og med fordel til patienter med lettere immundefekter, herunder patienter, der var hiv-smittede, men havde tilstrækkeligt med CD4-celler (en type hvide blodceller, der er vigtige til at bekæmpe infektioner).
English: The current European public assessment report for ProQuad can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Danish: Den gældende europæiske offentlige vurderingsrapport for ProQuad findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
English: The European Commission issued a correcting decision for MMRV Art 31 on 27 June 2013.
Danish: Europa-Kommissionen traf en berigtigende artikel 31-afgørelse vedrørende MMRV den 27. juni 2013.
English: The current European public assessment report for Zostavax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Danish: Den gældende europæiske offentlige vurderingsrapport for Zostavax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
English: The current European public assessment report for M-M-RVAXPRO can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Danish: Den gældende europæiske offentlige vurderingsrapport for M-M-RVAXPRO findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
English: The European Commission issued a decision for Zostavax Article 20 on 13 February 2013.
Danish: Europa-Kommissionen traf en artikel 20-afgørelse vedrørende Zostavax den 13. februar 2013.
English: Strength Pharmaceutical form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse tabletter
English: Exjade is taken once a day at around the same time.
Danish: Exjade tages én gang dagligt omkring samme tidspunkt.
English: Exjade received a marketing authorisation valid throughout the EU on 28 August 2006.
Danish: Exjade fik en markedsføringstilladelse med gyldighed i hele EU den 28. august 2006.
English: Other information about Exjade
Danish: Andre oplysninger om Exjade
English: Further information on Exjade can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Exjade findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: About half of the patients were under the age of 16 years, and 56 were less than 6 years old.
Danish: Omkring halvdelen af patienterne var under 16 år, og 56 var under seks år.
English: It must not be used in combination with other iron chelators.
Danish: Det må ikke anvendes sammen med andre jernchelerende midler.
English: As for all medicines, data on the use of Exjade are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Exjade løbende overvåget.
English: Treatment may need to be interrupted or stopped depending on the results of the tests.
Danish: Det kan være nødvendigt at afbryde eller standse behandlingen afhængig af prøveresultaterne.
English: Exjade was not as effective overall as the comparator medicine.
Danish: Samlet set var Exjade ikke lige så effektivt som det lægemiddel, som det blev sammenlignet med.
English: What measures are being taken to ensure the safe and effective use of Exjade?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Exjade?
English: What is Exjade and what is it used for?
Danish: Hvad er Exjade, og hvad anvendes det til?
English: Exjade must not be used in people whose creatinine clearance is less than 60 ml per minute.
Danish: Exjade må ikke anvendes hos patienter med en kreatinin-clearance på mindre end 60 ml pr. minut.
English: The European Medicines Agency decided that Exjade'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 Exjade opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Exjade are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Exjade vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: Why is Exjade authorised in the EU?
Danish: Hvorfor blev Exjade godkendt i EU?
English: An overview of Exjade and why it is authorised in the EU
Danish: En oversigt over Exjade, og hvorfor det er godkendt i EU
English: In more than half of these patients the iron level was reduced satisfactorily after a year of treatment with Exjade, including patients aged between 2 and 5 years.
Danish: Hos mere end halvdelen af disse patienter var jernniveauet reduceret i tilfredsstillende grad efter et års behandling med Exjade, herunder patienter i alderen 2-5 år.
English: For more information about using Exjade, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Exjade, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What are the risks associated with Exjade?
Danish: Hvilke risici er der forbundet med Exjade?