natgillin/translations-raw huggingface dataset:
Hvis vaccinerne ikke gives samtidig, anbefales et interval på mindst én måned mellem administration af Priorix og andre levende svækkede vacciner. 
If not given at the same time, an interval of at least one month is recommended between administration of PRIORIX and other live attenuated vaccines.
Nogle vacciner, der kan administreres sammen med Priorix, er anført i produktresuméet i Belgien, Bulgarien, Cypern, Danmark, Estland, Frankrig, Luxembourg, Malta, Nederlandene, Polen, Rumænien og Det Forenede Kongerige. 
Some vaccines that can be co-administered with Priorix are listed in the SmPC of Belgium, Bulgaria, Cyprus, Denmark, Estonia, France, Luxemburg, Malta, The Netherlands, Poland, Romania and United Kingdom.
En seropositiv respons, bestemt ved ELISA, er ikke nødvendigvis ensbetydende med beskyttelse, navnlig mod fåresyge. 
A seropositive response by ELISA may not necessarily represent protection, especially for mumps.
Desuden blev produktinformationen fremlagt med anvendelse af den nyeste QRD-model, version 2, offentliggjort den 12. oktober 2011. 
In addition, the product information (PI) was presented using the latest version of the QRD template, version 2, published on 12 October 2011.
Den godkendte nedre aldersgrænse for anvendelse af Priorix varierede fra 9 måneder til 15 måneder mellem de enkelte EU-medlemsstater, hvilket i nogle tilfælde afspejler nationale anbefalinger for rutinemæssig MFRvaccination. 
The approved lower age limit indicated for the use of Priorix varied from 9 months to 15 months across the individual EU member states reflecting in some cases the national recommendations for routine MMR vaccination.
Da Priorix er kontraindiceret hos gravide, er der hverken iværksat interventionelle aktiviteter eller aktiv overvågning. 
As Priorix is contraindicated in pregnant women neither interventional nor active surveillance activities have been set up.
Ca. 85 % af alle graviditeter vil blive negativt påvirket ved infektion med røde hunde i første trimester. 
Approximately 85% of pregnancies will be negatively affected when rubella infection occurs during the first trimester.
I de to aldersgrupper var incidensen henholdsvis over 50 og over 45 tilfælde per 100 000. 
The incidence rates among the cases in both these age categories were above 50 and 45 cases per 100,000 respectively.
Desuden blev det nævnt, at anvisningerne om amning skulle være tydeligere hvad angår de forskellige anbefalinger om vaccination af mødre med børn med eller uden immundefekt. 
In addition it was stated that the advice on breastfeeding should be clearer with respect to the different recommendations for vaccinating mothers with children with or without immunodeficiency.
Formålet med denne artikel 30-indbringelse er at harmonisere produktresuméet på tværs af EU's medlemsstater for Priorix og relaterede navne. 
The purpose of this Art 30 referral is to harmonise the SmPC across EU member states for Priorix and associated names.
Punkt 4.6 - Fertilitet , graviditet og amning 
Section 4.6 - Fertility, pregnancy and lactation Fertility
Indehaveren af markedsføringstilladelsen blev anmodet om at tilføje nogle oplysninger om dette spørgsmål. 
The MAH was asked to add some information on this issue.
Immunogeniciteten af Priorix blev vurderet i flere kliniske undersøgelser hos børn i alderen 12-24 måneder, 11-23 måneder og 9-12 måneder. 
The immunogenicity of Priorix was evaluated in several clinical trials in children aged from 12 to 24 months, 11 to 23 months and 9 to 12 months.
Endelig blev betegnelsen “bivirkninger” erstattet med “uønskede reaktioner” i hele afsnittet i overensstemmelse med QRD-kommentarerne. 
Finally, the wording “adverse events” was replaced by “adverse reactions” in all the section as per the QRD comments.
For hiv er der ingen fælleseuropæisk vejledning om klassifikation af CD4+ efter % CD4+ eller celletal. 
As regards HIV, there is no common European guidance on the CD4+ classification for % CD4+ or the cell count number.
Det blev dog anset for nødvendigt at medtage aldersspecifik % CD4+ som foreskrevet i WHO-vejledningen, da vaccination er indiceret til børn fra 9-måneders alderen. 
However, it was considered necessary to include age specific %CD4+ as per WHO guidance since vaccination of children from the age of 9 months onwards is indicated.
Men da nye, meget komplekse børnevacciner er under udvikling, blev det anbefalet at anføre de vacciner, der kan administreres samtidigt, frem for en generel udtalelse om koadministration med andre vacciner. 
However, since new and very complex childhood vaccines are under development it was recommended to list vaccines applicable for co-administration rather than to give a general statement on co-administration with other vaccines.
Sådanne patienter bør vaccineres med forsigtighed og fortrinsvis ved subkutan administration”. 
These patients should be vaccinated with caution and preferably using subcutaneous route”.
Det blev besluttet at slette erklæringen om graviditet fra punkt 4.4, fordi der ifølge ”Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labeling” (EMEA/CHMP/203927/200) kun bør henvises til graviditet i punkt 4.3 og 4.6. 
It was decided to delete the statement on pregnancy from 4.4 because according to the guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labeling (EMEA/CHMP/203927/200), reference to pregnancy should only be made in section 4.3 and 4.6.
Af denne grund, og for at gengive de nyeste oplysninger, blev immunogenicitetsdata opdelt i to grupper: “Immunrespons hos børn over 12 måneder” og “Immunrespons hos børn fra 9 til 10 måneder”. 
For this reason and to reflect the most recent information, the immunogenicity data were differentiated between two groups: “Immune response in children 12 months and older” and “Immune response in children aged 9 to 10 months”.
at det lange afsnit om brugen af adrenalin indskrænkes til en generel erklæring om mulighed for passende lægelig behandling og overvågning efter administration af vaccinen, 
reduce a long paragraph about the use of epinephrine by a general statement about the availability of appropriate medical treatment and supervision following the administration of the vaccine.
De vigtigste forskelle mellem de foreslåede harmoniserede produktresuméer og den nationale produktinformation vedrører beskrivelsen af indberetninger efter markedsføring. 
The main divergences between the proposed harmonized SmPC and national product information relates to the description of post marketing reports.
Personer med immundefekter 
Subjects with immune deficiencies
Kvinder bør inden vaccinationen udspørges om en eventuel tidlig graviditet, men der kræves ikke screeningstest til udelukkelse af graviditet. 
Although women should be asked about the possibility of early pregnancy prior to vaccination, screening tests to exclude pregnancy are not required.
Den teoretiske teratogene risiko efter vaccination mod røde hunde er beregnet til 0,5 % i første trimester og er op til 1,6 % hvis vaccinen gives i perioden mellem 1-2 uger før og 4-6 uger efter konceptionen. 
The theoretical teratogenic risk following rubella vaccination has been estimated to be 0.5% during the first trimester and is up to 1.6%, if the vaccine is given between 1-2 weeks before and 4-6 weeks after conception.
CHMP konstaterede, at data fra et nyligt udbrud i Frankrig viser, at den højeste forekomst af mæslingeinfektioner fandtes hos børn under et år, efterfulgt af børn mellem et og to år. 
The CHMP noted that recent data from an outbreak in France indicate that the highest incidence of measles infections was observed in infants below 1 year of age, followed by children between one and two years old.
Som konklusion kan den nedre aldersgrænse for indikationen godkendes på grundlag af de kliniske data, men da immunresponsen efter en enkelt dosis af Priorix er svagere hos børn under 12 måneder, er der indsat en henvisning til punkt 4.2, 4.4 og 5.1. 
In conclusion, based on the clinical data the lower age limit of the indication is endorsed, however since the immune response following a single dose of Priorix is lower in children under 12 months of age a reference to sections 4.2, 4.4 and 5.1 has been included.
Den endeligt vedtagne ordlyd er: “Kvinder, der påtænker at blive gravide, bør tilrådes at vente til en måned efter vaccinationen med Priorix”. 
The final agreed wording is: “Women who intend to become pregnant should be advised to delay for 1 month following PRIORIX vaccination.
For den intramuskulære indgivelsesvej var der ingen oplysninger i den opdaterede kliniske dokumentation, men derimod i den oprindelige ansøgning om markedsføringstilladelse. 
As regards the intramuscular route of administration no information was provided in the updated clinical dossier, but was provided in the initial application for marketing authorisation.
WHO-klassificeringen af hiv-relateret sygdom hos voksne og børn, der blev offentliggjort i 2006, indeholder følgende ordlyd: “Immunologiske kriterier for diagnose af fremskreden hiv-infektion hos børn under fem år: %CD4+ <25 hos børn under 12 måneder %CD4+ <20 hos børn i alderen 12-35 måneder %CD4+ <15 hos børn i alderen 36-59 måneder” 
The WHO classification of HIV-related disease in adults and children published in 2006 states the following: “Immunological criteria for diagnosing advanced HIV in a child younger than five years of age with severe HIV infection: %CD4+ <25 among those younger than 12 months %CD4+ <20 among those aged 12-35 months %CD4+ <15 among those aged 36-59 months”
CHMP afgjorde, at sætningen vedrørende fruktoseintolerans bør ændres fra “Patienter med sjældne arvelige problemer med fruktoseintolerans bør ikke anvende dette lægemiddel.” til “Patienter med sjældne arvelige problemer med fruktoseintolerans bør ikke vaccineres med Priorix, da det indeholder sorbitol”. 
The CHMP agreed that the sentence regarding fructose intolerance should change from “Patients with rare hereditary problems of fructose intolerance should not take this medicine.” to “Patients with rare hereditary problems of fructose intolerance should not be vaccinated with PRIORIX since it contains sorbitol”.
Priorix indgives ved subkutan injektion, men kan dog også indgives intramuskulært. 
The method of administration of Priorix is subcutaneous injection, although it can also be given by intramuscular injection.
CHMP konstaterede, at der ikke er nogen teoretisk risiko ved vaccination i ammeperioden. 
The CHMP noted that there are no theoretical risks of vaccination during breastfeeding.
Dette blev godkendt af CHMP efter vurdering af den kliniske undersøgelsesrapport, der blev forelagt til støtte for koadministration af Priorix og denne vaccine. 
This was endorsed by the CHMP following review and assessment of the clinical study report that was submitted to support the coadministration of Priorix with this vaccine.
Accidentel vaccination med Priorix af kvinder med ikke erkendt graviditet bør ikke være grund til afbrydelse af graviditeten”. 
Inadvertent vaccination of unknowingly pregnant women with PRIORIX should not be a reason for termination of pregnancy”.
CHMP foreslog derfor at tilføje følgende information fra en nylig systematisk gennemgang: “Trombocytopeni i forbindelse med MFR er sjælden og sædvanligvis selvbegrænsende”. 
The CHMP therefore suggested adding the information from a recent systematic review that “MMR-associated thrombocytopenia is rare and generally self-limited”.
Generelt foreslog indehaveren af markedsføringstilladelsen en harmoniseret tekst, der hovedsagelig var baseret på den, der var godkendt ved den gensidige anerkendelsesprocedure, med visse ændringer. 
In general, the MAH proposed a harmonised text drafted mainly using as basis the one approved in the MRP procedure with some amendments.
På nuværende tidspunkt findes der ingen oplysninger, hvoraf det kan sluttes, at der er teratogen risiko efter vaccination med MFR-vacciner, men den teoretiske betænkelighed er fortsat tilstede. 
There is currently no information to conclude that there is a teratogenic risk following vaccination with MMR vaccines however the theoretical concern remains.
Den endeligt vedtagne ordlyd er: “Overførsel af mæslinge- og fåresygevirus fra den vaccinerede til modtagelige kontakter er aldrig dokumenteret. 
The final agreed wording is: “Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented.
Priorix er kontraindiceret ved graviditet. 
Priorix is contraindicated in pregnant women.
CHMP konstaterede, at de nuværende kliniske erfaringer med Priorix begrænser sig til børn, og at der ikke er udført undersøgelser hos unge og voksne. 
The CHMP noted that the current clinical experience with Priorix is limited to children and no trials were performed in adolescents and adults.
Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Af hensyn til overensstemmelsen med vejledningen for produktresuméer var det virksomhedens hensigt: 
Section 4.4 - Special warnings and precautions for use To be in line with the SmPC guideline the company proposed to:
Mere specifikt: “Vedrørende anvendelse hos børn fra ni til tolv måneder: Se punkt 4.2, 4.4 og 5.1.” Indehaveren af markedsføringstilladelsen havde under samme punkt desuden indsat sætningen “Anvendelsen af Priorix bør baseres på officielle anbefalinger”, men CHMP valgte at flytte denne bemærkning til begyndelsen af punkt 4.2, Dosering og indgivelsesmåde, fordi henvisninger til officielle anbefalinger skal placeres under punkt 4.2 i henhold til vejledningen for udarbejdelse af produktresuméer dateret september 2009. 
More specifically: “For use in children between 9 to 12 months of age see sections 4.2, 4.4 and 5.1.” The MAH had also included in this section the sentence “The use of PRIORIX should be based on official recommendations.” but the CHMP agreed to move it at the beginning of section 4.2 Posology and method of administration because as per the guideline on SmPC dated September 2009 the reference to official recommendations should be made under section 4.2.
Da sandsynligheden for trombocytopeni er langt større ved naturlig infektion, overstiger fordelene ved vaccination oftest risikoen for svær symptomatisk trombocytopeni som følge af vaccinationen. 
Because of the much higher likelihood of thrombocytopenia after natural infection, the benefits of vaccination most often exceed the risks of severe symptomatic thrombocytopenia caused by immunization.
Den teoretiske maksimale risiko for kongenit rubellasyndrom (CRS) efter administration af vaccinen er 1,6 % og dermed langt lavere end risikoen for alvorlige, ikke-CRS-forårsagede medfødte defekter under graviditeten (Bozzo et al., 2011). 
The theoretical maximum risk for CRS after administration of the vaccine at 1.6%, is much lower than the risk of major non-CRS induced congenital defects during pregnancy (Bozzo et al., 2011).
Vaccine mod fåresyge er desuden blevet antaget at være mindre effektiv under omstændigheder med høj sygdomsoverførsel (Brockhoff 2004). 
Mumps vaccine efficacy has also been suggested to be lower in high-transmission settings (Brockhoff 2004).
Risikoen ved mæslingevaccination (øget forekomst af spontanabort og dødfødsel) angives at være ukendt. 
The risk for measles vaccination (enhancement of spontaneous abortion of stillbirth) is indicated to be unknown.
Fødedygtige kvinder 
Women of Childbearing Potential
The CHMP anbefalede omordning af visse af erklæringerne og tilføjelse af underoverskrifter for at få en klar opdeling mellem de enkelte forsigtighedsregler (dvs. trombocytopeni, immunkompromitterede patienter og overførsel af sygdom). 
The CHMP recommended reordering of some of the statements and adding subtitles to clearly distinguish each precaution (i.e. thrombocytopenia, immunocompromised patients, and transmission).
Endelig anmodede CHMP om, at de forelagte serokonverteringsprocenter blev erstattet af nyere data for den HSA-fri (humant serumalbumin) formulering af Priorix, og udvalget ønskede oplyst, om der fandtes immunogenicitetsdata for den HSA-fri formulering hos børn under 12 måneder. 
Finally, the CHMP asked the seroconversion rates given to be replaced by more recent data reported for the Human Serum Albumin-free (HSA-free) formulation of Priorix and also asked the MAH if there are any immunogenicity data available from the Human Serum Albumin-free (HSAfree) formulation in children below 12 months of age.
De foreliggende data tyder ikke på, at koadministration har betydning for immunogeniciteten og sikkerheden af de testede antigener. 
The available data do not suggest that co-administration of these vaccines has an impact on the immunogenicity and safety of the antigens tested.
Indehaveren af markedsføringstilladelsen accepterede den nye tekst og tilføjede en sætning om overvågning af sådanne patienter, hvilket blev godkendt af CHMP. 
The MAH accepted the new text and also added a sentence on the monitoring of those patients which was endorsed by the CHMP.
Da der alligevel er en teoretisk teratogen risiko i forbindelse med vaccination mod røde hunde, blev det afgjort, at det bør undgås at udsætte denne meget sårbare gruppe for risiko. 
As there is still a theoretical teratogenic risk connected to rubella containing vaccines it was agreed that this very vulnerable group should not be put at risk.
Til patienter med trombocytopeni eller enhver form for koagulationsforstyrrelse anbefales subkutan indgift, og en erklæring herom er indsat. 
For patients with thrombocytopenia or any coagulation disorder subcutaneous administration is recommended and thus a statement has been included.
Som konklusion var CHMP af den opfattelse, at angivelsen af “graviditet” som kontraindikation var på linje med den godkendte kontraindikation for andre MFR-vacciner. 
In conclusion, the CHMP was of the opinion that the statement of “pregnancy” as a contraindication was in line with the approved contraindication of other MMR vaccines.
Vaccinerede med febrile kramper i anamnesen bør opfølges tæt.” 
Vaccinees with a history of febrile convulsions should be closely followed-up.”
Indehaveren af markedsføringstilladelsen bemærkede dog, at dataene er meget begrænsede som følge af den nuværende kontraindikation i produktinformationen. 
However, it was noted by the MAH that the data are very limited considering the contraindication currently in the label.
Ifølge produktresuméet for Bulgarien, Cypern, Estland, Malta og Det Forenede Kongerige skal graviditet undgås i en måned efter vaccinationen, mod tre måneder i de øvrige lande og i dem, der er omfattet af den gensidige anerkendelsesprocedure. 
In the SmPC of Bulgaria, Cyprus, Estonia, Malta and the United Kingdom, it is stated that pregnancy must be avoided for one month after vaccination as compared to the three months in the SmPC of the countries involved in the MRP and other countries.
Desuden var der en enkelt uoverensstemmelse med indlægssedlen, hvorfor indehaveren af markedsføringstilladelsen blev anmodet om at tilføje “atypiske milde eller svækkede mæslinger” i punkt 4.8 under infektioner og parasitangreb. 
In addition as there was one inconsistency with the package leaflet the MAH was asked to add “atypical mild or attenuated measles” in section 4.8 under infections and infestations.
Antistofresponsen over for mæslingevaccine forringes desuden ved stigende immunsuppression. 
Moreover the antibody response to measles vaccine decreases as the level of immunosuppression increases.
at ordlyden om hiv-positive personer og overfølsomhed for vaccinens bestanddele rettes ind efter punkt 4.3, 
adapt the wording about HIV+ subjects and hypersensitivity to vaccine components to align with section 4.3.
Hos børn under 1 år steg antallet af tilfælde fra 2009 til 2010 til mere end det tredobbelte, mens det femdobledes hos voksne i alderen 20-29 år i samme periode. 
Compared with 2009, the number of cases in 2010 more than tripled in infants below one year of age, and increased fivefold in adults 20-29 years old.
Immunogenicitetsdata viser imidlertid klart, at antistofresponsen over for mæslinger og fåresyge ved den primære vaccination er svagere hos børn i alderen 9-11 måneder end hos ældre børn, antagelig som følge af cirkulerende antistoffer fra moderen eller immunsystemets umodenhed. 
The immunogenicity data however clearly demonstrate that lower antibody responses against measles and mumps are observed in children aged 9 to 11 months at the time of primary immunization than in older children which is most likely due to circulating maternal antibodies or the immaturity of the immune system.
Vaccinen er et frysetørret præparat, der inden anvendelse rekonstitueres med den medfølgende sterile solvens (vand til injektionsvæske). 
The vaccine is a lyophilised vaccine preparation, which is reconstituted with separately supplied sterile diluent (water for injection) prior to use.
Den intramuskulære indgivelsesvej blev oprindelig undersøgt hos et lille antal personer (N=40) med en serokonverteringsprocent på henholdsvis 96,7 %, 97,5 % og 100 % for mæslinger, fåresyge og røde hunde. 
The intramuscular route of administration was initially investigated in a small number of subjects (N=40) with seroconversion rates of 96.7%, 97.5% and 100% against measles, mumps and rubella, respectively.
Den endeligt vedtagne ordlyd er: “Priorix kan gives samtidig (men på separate injektionssteder) med enhver af følgende monovalente eller kombinerede vacciner (herunder hexavalente vacciner (DTPa-HBV-IPV/Hib)): Difteri-tetanus-acellulær pertussisvaccine (DTPa), Haemophilus influenzae type b-vaccine (Hib), inaktiveret poliovaccine (IPV), hepatitis B-vaccine (HBV), hepatitis A-vaccine (HAV), meningokok serotype C konjugeret vaccine (MenC), varicella zoster-vaccine (VZV), oral poliovaccine (OPV) og 10-valent konjugeret pneumokokvaccine i overensstemmelse med lokale anbefalinger. 
The final agreed wording is: “PRIORIX can be given simultaneously (but at separate injection sites) with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hepatitis A vaccine (HAV), Meningococcal serotype C conjugated vaccine (MenC), varicella zoster vaccine (VZV), oral polio vaccine (OPV) and 10-valent pneumococcal conjugate vaccine in accordance with local recommendations.
Af hensyn til overensstemmelsen med de nugældende WHO-anbefalinger fandt CHMP, at udsættelsen af graviditet bør ændres fra 3 måneder til 1 måned efter vaccination. 
To be in line with current WHO recommendations the CHMP was of the opinion that delay in pregnancy should be changed from 3 months to 1 month after vaccination.
Indehaveren af markedsføringstilladelsen ændrede dette afsnit efter CHMP's anbefalinger og tilføjede endnu en vaccine (10-valent pneumokok-konjugatvaccine). 
The MAH amended this paragraph as per the CHMP's recommendation and also added in the list one more vaccine (10-valent pneumococcal conjugate vaccine).
CHMP kunne godkende doseringsanbefalingerne, men foreslog en mere struktureret ordlyd for at tydeliggøre anvisningerne til sundhedspersonalet (med anbefalingerne opdelt efter aldersgruppe). 
The CHMP agreed that the dosing recommendations are acceptable, however in order to provide clear instructions to health care professionals a more structured wording was proposed (i.e. to split the recommendations per age group).
Ordlyden af dette afsnit blev ændret som følger: “Hos personer, der har fået humant gammaglobulin eller blodtransfusion, bør vaccinationen udsættes i tre måneder eller længere (op til 11 måneder), afhængigt af den administrerede dosis humane globuliner, på grund af muligheden for vaccinesvigt forårsaget af passivt erhvervede antistoffer mod mæslinger, fåresyge og røde hunde”. 
The wording of this paragraph was amended as follows: “In subjects who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for three months or longer (up to 11 months) depending on the dose of human globulins administered because of the likelihood of vaccine failure due to passively acquired measles, mumps and rubella antibodies”.