natgillin/translations-raw huggingface dataset:
Det blev konkluderet: at den iboende opløsning i en PET-scanner er dobbelt så god som den, der er i et gammakamera med en lavenergi-kollimator, som bruges til teknetium-99m, og over dobbelt så god med en mellemenergi-kollimator, som bruges til gallium-67 eller indium-111, at ventetiden for patienten (1 time mellem injektion og billedoptagelse) er den korteste af alle registrerede radiofarmaceutiske lægemidler på dette område, at de andre besværligheder/risici for patienten er færre end ved gallium-67 (besværlig patientforberedelse) eller ved mærkede hvide blodlegemer (white blood cells, WBC), som kræver tapning af en stor mængde blod og indebærer risiko for fejl ved reinjektion, at dosimetrien ved FDG PET svarer til dosimetrien ved technetium-99m-mærkede produkter og er mere gunstig end ved gallium-67 eller indium-111 radiofarmaceutiske lægemidler. 
It was concluded that: that the intrinsic resolution of a PET scanner is twice as good as that of a gamma-camera with a low energy collimator used for technetium-99m and more than twice with a medium energy collimator used for gallium-67 or indium-111, that the waiting time for the patient (1h between injection and image acquisition) is the shortest of all registered radiopharmaceuticals in this field, that the other inconveniences/risks for the patient are less than those of gallium-67 (cumbersome patient preparation) or of labelled white blood cells (WBC) which requires withdrawal of a large quantity of blood and encompasses risk of errors in re-injection; that the dosimetry of FDG PET is similar to that of technetium-99m labelled products and more favourable than that of gallium-67 or indium-111 radiopharmaceuticals.
500MBq/mL på kalibreringstidspunkte t 
GLUSCAN 500 500MBq/mL at calibration time
Som nævnt ovenfor ville det være imod optimeringsprincippet i Euratom-direktivet (som er gennemført i lovgivningen i alle EU-medlemsstater) at udelukke børn fra fordelen ved FDG PET i tilfælde af infektions-/inflammationssygdomme, da de andre scintigrafiske muligheder faktisk giver mere bestråling for barnet (gallium-67 scintigrafi, indium-111 leukocyt-scintigrafi) eller for personalet (in vitro-mærkning med technetium-99m HMPAO) uden nogen fordel i effekten. 
As mentioned above, it would be against the optimisation principle of the Euratom Directive (implemented in the law of all EU Member States) to exclude children from the benefit of FDG PET in infectious/inflammatory diseases, since the other scintigraphic options are actually more irradiating for the child (gallium-67 scintigraphy, indium-111 WBC scintigraphy) or for the personnel (in vitro labelling with technetium-99m HMPAO), without any benefit in efficacy.
For patienter, der er under behandling med specifik samtidig medicinering som f.eks. antibiotika og betændelseshæmmende midler, er det oplagt, at der ikke var nogen effekt i de tilsvarende hævdede sammenhænge ved langvarig eller kronisk sygdom (feber af ukendt oprindelse, kronisk knogleinfektion, mistanke om inficeret hofteprotese, aktiv inflammatorisk tarmsygdom osv.), da patienten blev henvist til FDG PET. 
For patients under specific concomitant medications such as antibiotics and anti-inflammatory drugs, common sense indicates that in the corresponding claimed settings in long lasting or chronic illness (fever of unknown origin (FUO), chronic infection of bone, suspicion of infected hip prosthesis, active inflammatory bowel disease (IBD) …), they were not effective since the patient was referred to FDG PET.
Lægemiddelfor m 
Pharmaceutical Form
Fludeoxyglukose (18F) akkumuleres i tumorer med høj glukoseomsætning. 
Fludeoxyglucose (18F) is accumulated in tumours with a high glucose turnover.
Det ville sandsynligvis være skadeligt og imod Euratom-direktiverne (optimering af bestråling) at udelukke børn fra fordelen ved FDG PET til behandling af infektion og betændelse (især feber af ukendt oprindelse eller inflammatorisk tarmsygdom), da andre scintigrafiske muligheder (gallium-67 scintigrafi, indium-111 leukocyt-scintigrafi) faktisk giver mere bestråling og/eller er mere krævende og ville føre til behandling af børn på en mindre fordelagtig måde end voksne. 
It would seem to be detrimental and against the Euratom Directives (optimisation of irradiation) to exclude children from the benefit of FDG PET in infection and inflammation (in particular FUO or IBD), since some other scintigraphic options (gallium-67 scintigraphy, indium-111 WBC scintigraphy) are actually more irradiating and/or more demanding and would lead to the management of children in a less convenient way than adults.
Tc HMPAO in vitromærkede leukocytter er åbenlys: tapning af en stor mængde blod fra et barn til in vitro-mærkning og anafylaksi. 
The inconveniences and risks of 99mTc HMPAO in vitro labelled leukocytes are obvious: withdrawal of a large quantity of blood in a child for in vitro labelling and anaphylaxia.
For 1 mL præparat: Fludeoxyglucose (18F) - 500MBq på 
Intravenous use For 1mL of drug product: Fludeoxyglucose (18F) - 500MBq
- 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). 
- 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).
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. 
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.
Indehaver af markedsføringstilladels e 
Marketing Authorisation Holder
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) 
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)
GLUSCAN PL 
GLUSCAN PL 500MBq/mL at calibration time
(v/v), saltsyre 0,39% (v/v), ethanol 0,31% (v/v) natriumhydroxid 0,24% (v/v) 
Sodium hydroxide 0.24% (v/v)
Den 27. juni 2013 
27 June 2013
(Dette gælder ikke for Zostavax, der har en anden styrke og andre indikationer). 
(This does not apply to Zostavax, which has different strength and indications.)
Produktinformationen bør opdateres, så den afspejler disse ændringer. 
The product information should be updated to reflect these changes.
CHMP tog desuden hensyn til den foreliggende vejledning fra Verdenssundhedsorganisationen. 
The CHMP also considered available guidance from the World Health Organization.
Hvad er MMRV? 
What are MMRV?
• 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. 
• 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.
MMRV indeholder svækkede, men levende virus. 
MMRV contain weakened but live viruses.
Udvalget anbefalede desuden, at der foretages visse ændringer af produktinformationen for at præcisere risiciene og de nødvendige forholdsregler. 
The Committee also recommended that some changes be made to the product information to clarify the risks and precautions to be taken.
Vax, Rouvax, Trivivac, Varilrix, Varivax og relaterede navne. 
Vax, Rouvax, Trivivac, Varilrix, Varivax, and associated names.
De indeholder levende svækkede versioner af de virus, der forårsager disse sygdomme. 
They contain live attenuated (weakened) versions of the viruses responsible for these diseases.
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. 
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.
For patienter med immundefekter gennemgik udvalget dokumentationen fra kliniske undersøgelser og indberetninger fra anvendelse efter markedsføring. 
For patients with immune deficiencies, the Committee looked at evidence from clinical studies and reports from post-marketing use.
Hvorfor blev MMRV vurderet igen? 
Why were MMRV reviewed?
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. 
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.
• Patienter med svært svækket immunsystem må ikke vaccineres med disse vacciner. 
• Patients with severe weakness of their immune system must not receive these vaccines.
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. 
If a woman is, or thinks she may be, pregnant she should tell her doctor or nurse before receiving any of these vaccines.
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. 
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.
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. 
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.
MMRV kan fås som individuelle vacciner til hver enkelt infektion (monovalente) og som kombinerede vacciner (multivalente). 
MMRV may be available as individual vaccines for each infection (monovalent) or as combination vaccines (multivalent).
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. 
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.
Nogle virus er i stand til at krydse moderkagen hos gravide kvinder og smitte det ufødte barn. 
Some viruses are able to cross the placenta in pregnant women and infect their unborn babies.
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. 
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.
Andelen af misdannelser og spontanaborter hos kvinder, der blev udsat for MMRV under graviditeten, var ikke højere end den forventede andel hos uvaccinerede kvinder. 
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.
De multivalente vacciner M-M-RVAXPRO og ProQuad og den monovalente vaccine mod helvedesild (zoster) Zostavax er centralt godkendt til anvendelse i hele EU. 
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).
Dokumentationen viste dog, at der ikke var grund til at udskyde graviditet i mere end en måned efter vaccination. 
The evidence did suggest that there was no need to delay pregnancy for more than one month after vaccination.
• Vaccination med MMRV er fortsat kontraindiceret ved graviditet og hos patienter med svær humoral eller cellulær immundefekt (såsom svær kombineret immundefekt, agammaglobulinæmi eller aids). 
• Vaccination with MMRV remains contraindicated in pregnancy and in patients with severe humoral or cellular immunodeficiency (such as severe combined immunodeficiency, agammaglobulinaemia, or AIDS).
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). 
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).
• 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. 
• 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.
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. 
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.
Siden disse vacciner blev godkendt, er der imidlertid kommet nye data om sikkerheden ved graviditet og hos patienter med immundefekter. 
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.
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. 
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.
Hos patienter med mindre svære immundefekter kan vaccination overvejes, men giver ikke altid samme beskyttelse som hos en voksen med et raskt immunsystem. 
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.
• 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. 
• 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.
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. 
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.
• Gravide kvinder bør ikke vaccineres med monovalent eller multivalent MMRV. 
• Women should not be given monovalent or multivalent MMRV during pregnancy.
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. 
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.
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. 
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.
• 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). 
• 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).
Utilsigtet vaccination af gravide med vacciner indeholdende rubella er ikke grund til afbrydelse af graviditeten. 
Inadvertent vaccination with rubella-containing vaccines during pregnancy is not a reason for termination.
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. 
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.
Hos patienter med mindre immundefekter kan vaccination overvejes, når fordelen ved vaccination overstiger risikoen. 
Vaccination may be considered in patients with minor immune deficiencies if the benefit outweighs the risk.
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. 
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.
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. 
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.
• Kvinder skal have at vide, at de skal udskyde graviditet til en måned efter MMRV-vaccination. 
• Women should be advised to delay becoming pregnant for one month after MMRV vaccination.
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)). 
MMRV are vaccines that help protect against the viral infections measles, mumps, rubella, and varicella (which may cause chickenpox or shingles [zoster]).
Der var ingen tilfælde af medfødt rubellasyndrom eller medfødt varicellasyndrom i de 5 300 indberetninger om kvinder, der utilsigtet fik MMRV under graviditet. 
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.
Europa-Kommissionen traf en artikel 20-afgørelse vedrørende M-M-RVAXPRO den 20. februar 2013. 
The European Commission issued a decision for M-M-RVAXPRO Article 20 on 20 February 2013.
• Kvinder, der får en af disse vacciner, bør beskytte sig mod graviditet i mindst en måned efter vaccinationen. 
• Women who are given one of these vaccines should take the necessary precautions to avoid becoming pregnant for one month after vaccination.
Europa-Kommissionen traf en artikel 31-afgørelse vedrørende MMRV den 28. februar 2013. 
The European Commission issued a decision for MMRV Article 31 on 28 February 2013.
Europa-Kommissionen traf en artikel 20-afgørelse vedrørende ProQuad den 18. februar 2013. 
The European Commission issued a decision for ProQuad Article 20 on 18 February 2013
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). 
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.
Den gældende europæiske offentlige vurderingsrapport for ProQuad findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports 
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
Europa-Kommissionen traf en berigtigende artikel 31-afgørelse vedrørende MMRV den 27. juni 2013. 
The European Commission issued a correcting decision for MMRV Art 31 on 27 June 2013.
Den gældende europæiske offentlige vurderingsrapport for Zostavax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports 
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
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 
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