FrancophonIA/ELRC3.0 huggingface dataset:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MENITORIX
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF MENITORIX
English: Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency as follows.
Danish: De bivirkninger, som anses for muligvis at være relateret til vaccination, er kategoriseret efter følgende frekvens.
English: In the event of either being observed, discard the vaccine.
Danish: I tilfælde af, at en af delene observeres, kasseres vaccinen.
English: Hib infection can also cause a life-threatening inflammation of the throat with severe swelling that can cause suffocation.
Danish: Infektion med Hib bakterier kan også give livstruende betændelse i halsen med alvorlige hævelser, der kan medføre kvælning.
English: The timing of the booster dose should be in accordance with available official recommendations and should usually be from the age of 12 months onwards and before the age of 2 years.
Danish: Tidspunktet for boostervaccination skal følge de tilgængelige nationale anbefalinger og gives normalt fra 12-måneders alderen og opefter og inden 2-års alderen.
English: Estimates of effectiveness based on a small number of cases to date indicate that there may also be waning protection in children who received a single priming dose as toddlers.
Danish: Estimater for effektiviteten, baseret på et lille antal tilfælde op til i dag, indikerer, at der også er faldende beskyttelse hos børn, som tidligere har modtaget en enkelt dosis i småbørnsalderen.
English: • Fever of 39.5°C or above
Danish: • Feber på 39,5 °C eller derover
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEET, ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
English: Estimates of vaccine effectiveness from the UK's routine immunisation programme (using various quantities of three meningococcal group C conjugate vaccines) covering the period from introduction at the end of 1999 to March 2004 have demonstrated the need for a booster dose after completion of the primary series (three doses administered at 2, 3 and 4 months).
Danish: Et estimat af vaccine-effektiviteten fra rutineimmuniseringsprogrammet i UK (som anvender forskellige kvantiteter af tre konjugerede meningokok gruppe C-vacciner), der dækker perioden fra introduktionen i slutningen af 1999 til marts 2004, har vist behovet for en boosterdosis efter det primære program (tre doser administreret ved 2, 3, og 4 måneder).
English: Read all of this leaflet carefully before your child starts receiving this vaccine.
Danish: Læs denne indlægsseddel grundigt, inden dit barn bliver vaccineret.
English: • if your child has a high temperature (38oC or above) or a severe infection.
Danish: • hvis dit barn har høj feber (over 38 °C) eller har en alvorlig betændelse (infektion).
English: GlaxoSmithKline, S.A Severo Ochoa, 2 Tres Cantos, Madrid Spain
Danish: GlaxoSmithKline, S.A Severo Ochoa, 2 Tres Cantos, Madrid Spanien
English: If the symptoms start after you have left the clinic, you should get medical help as soon as possible (for example, go to the nearest accident and emergency department).
Danish: Hvis dit barn får symptomer efter, at du har forladt klinikken, skal du søge lægehjælp så hurtigt som muligt (opsøg nærmeste læge eller skadestue).
English: Different injectable vaccines should always be given at different injection sites.
Danish: Forskellige injicerbare vacciner skal administreres på forskellige injektionssteder.
English: The VWP considered the new submitted data along with the already submitted data and agreed that the safety and immunogenicity data are adequate and satisfactory to support the approval of Menitorix.
Danish: VWP vurderede de nye, indsendte data sammen med de allerede indsendte data og var enig i, at sikkerheds- og immunogenicitetsdataene er tilstrækkelige og tilfredsstillende til at understøtte godkendelsen af Menitorix.
English: • Fever (temperature of 38oC or above)
Danish: • Feber (temperatur på 38 °C eller derover)
English: Information on the safety of the vaccine when used during pregnancy or lactation is not available.
Danish: Der foreligger ingen oplysninger om vaccinens sikkerhed under graviditet og amning.
English: The revised Product Information (Summary of Product Characteristics, Labelling and Package Leaflet) is set out in Annex II of the Opinion.
Danish: Den reviderede produktinformation (produktresumé, etikettering og indlægsseddel) findes i bilag III til udtalelsen.
English: No data are available on subcutaneous administration of Menitorix, therefore the possibility of any toxicity or reduced efficacy that might occur with this route of administration is unknown.
Danish: Der er ingen tilgængelige data for subkutan administration af Menitorix, og risikoen for toksisk virkning eller reduceret effekt som følge af denne administrationsvej er ikke kendt.
English: 5 micrograms conjugated to tetanus toxoid as carrier protein
Danish: 5 mikrogram konjugeret til tetanustoksin som bæreprotein
English: SBA-MenC results are available for 177 subjects, anti-PRP results for 178 subjects.
Danish: Der findes resultater for SBA-MenC fra 177 børn og for anti-PRP fra 178 børn.
English: Experimental data show that the reconstituted vaccine could also be kept to 24 hours at ambient temperature (25°C).
Danish: Eksperimentelle data viser, at den rekonstituerede vaccine også kan opbevares i op til 24 timer ved en temperatur på 25 °C.
English: Other possible symptoms of a severe allergic reaction include a drop in blood pressure and unconsciousness.
Danish: Andre symptomer på en alvorlig overfølsomhedsreaktion kan være blodtryksfald og bevidstløshed.
English: Any other vaccines that are given at the same time as Menitorix will be injected separately at different parts of the body.
Danish: Vacciner, som gives samtidig med Menitorix, vil blive indsprøjtet på forskellige steder på kroppen.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and single and repeated dose toxicity studies.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra hhv. konventionelle undersøgelser af sikkerhedsfarmakologi og toksicitets undersøgelser med enkelt og gentagne doser.
English: The incidence of grade 3 unsolicited symptoms considered to be related to vaccination or booster vaccination in the previously submitted data was very low and similar between study groups.
Danish: Incidensen af spontane grad 3-symptomer, som menes at have relation til vaccination eller boostervaccination i de tidligere indsendte data, var meget lav og ens i undersøgelsesgrupperne.
English: The CHMP considers that under the conditions of study, Menitorix elicits sufficient immune responses to both conjugate components to provide protection that is expected to be at least as good as that of licensed comparators.
Danish: CHMP mener, at Menitorix under undersøgelsesbetingelserne giver tilstrækkelig immunrespons hos begge konjugatkomponenter til at yde en beskyttelse, som forventes at være mindst lige så god som de godkendte sammenlignende præparaters.
English: Less commonly, the bacteria can infect other parts of the body, particularly the lungs (causing pneumonia) and the bones and joints.
Danish: Mere sjældent kan bakterierne give betændelse andre steder i kroppen, specielt i lungerne (lungebetændelse) og i knogler og led.
English: How to store Menitorix Further information
Danish: Sådan opbevarer du Menitorix Yderligere oplysninger
English: Your child will receive three doses of Menitorix.
Danish: Dit barn vil få tre vaccinationer med Menitorix.
English: The post-marketing data raised no new concerns and the satisfactory safety profile of the vaccine was supported by the safety data reported in PSUR 3 from use of Menitorix in approximately 0.6 million toddlers as a booster dose for Hib and MenC in the UK.
Danish: Data efter markedsføring gav ikke anledning til nye bekymringer, og vaccinens tilfredsstillende sikkerhedsprofil blev understøttet af sikkerhedsdata rapporteret i PSUR 3 på baggrund af brug af Menitorix hos cirka 0,6 millioner små børn som boosterdosis for Hib og MenC i Storbritannien.
English: *GlaxoSmithKline combination vaccine
Danish: * GlaxoSmithKline kombinations vaccine.
English: Menitorix must not be mixed with any other vaccine in the same syringe.
Danish: Menitorix må ikke blandes med andre vacciner i samme injektionssprøjte.
English: • Pain, redness or swelling at the site of the injection
Danish: • Smerte, rødme eller hævelse på indsprøjtningsstedet
English: Skin and subcutaneous tissue disorders: uncommon: dermatitis atopic rare: rash
Danish: Hud og subkutane væv Ikke almindelig: Dermatitis atopica Sjælden: Udslæt
English: In children 12 to 24 months of age, the vaccine may be administered in the deltoid region.
Danish: For børn i alderen 12 til 24 måneder kan vaccinen gives i regio deltoidea (se også pkt.
English: If you forget to take your child for vaccination with Menitorix Your doctor or nurse will advise when your child should attend for these injections.
Danish: Hvis du har glemt at få dit barn vaccineret med Menitorix Din læge eller sygeplejerske vil fortælle dig, hvornår dit barn skal vaccineres.
English: Other side effects which have occurred very rarely (in less than 1 per 10,000 doses of vaccine) in the days or weeks after vaccination with Menitorix include:
Danish: Andre bivirkninger, som meget sjældent er set (set ved mindre end 1 ud af 10000 vaccinationer) i de følgende dage og uger efter vaccination med Menitorix:
English: WHAT MENITORIX IS AND WHAT IT IS USED FOR
Danish: MENITORIX' VIRKNING OG HVAD DU SKAL BRUGE DET TIL
English: Based on the SBA-MenC titres and SBA GMT obtained in studies and because of the effectiveness of single doses of mono-component MenC conjugate vaccines in unprimed toddlers, the Applicant/MAH concluded that the long-term efficacy of Menitorix will be at least as good, if not better, as that observed in this age group in the UK and Canada.
Danish: Baseret på SBA-MenC-titre og SBA GMT fra undersøgelser og på grund af effektiviteten af mono-komponent-MenC konjugatvacciner i enkeltdoser hos små børn, som ikke har fået priming, konkluderede ansøgeren/indehaveren af markedsføringstilladelsen, at Menitorix' langsigtede effekt er mindst lige så god som den, som er observeret i denne aldersgruppe i Storbritannien og Canada, om ikke bedre.
English: The first dose should not be given before the age of 2 months and there should be a gap of at least four weeks between injections.
Danish: Den første vaccination bør ikke gives, før barnet er 2 måneder, og der skal være et interval på mindst fire uger mellem hver vaccination.
English: Also, if your child has HIV infection or any other illness that can reduce his or her immunity to infections.
Danish: Også hvis dit barn har HIV eller andre sygdomme, som kan nedsætte immunsystemet.
English: Therefore, the CHMP considered that the size of the safety database was already satisfactory before provision of the additional clinical study data and that the new information submitted brings the total to well above the minimum suggested in the CHMP guideline.
Danish: Derfor har CHMP vurderet, at størrelsen af sikkerhedsdatabasen allerede var tilfredsstillende, før data forelå fra den yderligere kliniske undersøgelse, og at det samlede omfang med den nye information, der er indsendt, ligger et stykke over det foreslåede minimum i CHMP's retningslinjer.
English: GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 Ireland
Danish: GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 Irland
English: Booster vaccination:
Danish: Boostervaccination:
English: An ongoing study will generate long-term SBA data while the Applicant/MAH also committed to monitor antibody persistence for five years in subsequent studies 023, 024, 025 and 026, in line with the “Note for guidance on clinical investigation of medicinal products in the paediatric population” (CPMP/ICH/2711/99).
Danish: E igangværende undersøgelse genererer langsigtede SBA-data, samtidig med at ansøgeren/indehaveren af markedsføringstilladelsen også har forpligtet sig til at overvåge forekomsten af antistoffer i de efterfølgende undersøgelser 023, 024, 025 og 026 i overensstemmelse med “Note for guidance on clinical investigation of medicinal products in the paediatric population” (CPMP/ICH/2711/99).
English: The following have not been reported in association with administration of Menitorix but have occurred very rarely during routine use of licensed meningococcal group C conjugate vaccines:
Danish: Følgende er ikke set i forbindelse med administration af Menitorix, men er ofte set ved almindelig brug af godkendte konjugerede meningokok gruppe C-vacciner:
English: In order to discuss the implication for long-term protection against MenC of the 18-month post booster data in study 022, in particular for those receiving primary vaccination with Menitorix, the Applicant/MAH reviewed the available data relating to antibody titres and vaccine effectiveness after the administration of a single dose of mono-component vaccines in the second year of life.
Danish: For at drøfte betydningen af 18-måneders post-booster-data i undersøgelse 022 for den langvarige beskyttelse imod MenC, især for dem, som får den primære vaccination med Menitorix, har ansøgeren /indehaveren af markedsføringstilladelsen gennemgået de foreliggende data om antistoftitre og vaccinens effektivitet efter administrering af en enkelt dosis mono-komponent-vaccine i det andet leveår.
English: Even after recovery from Hib meningitis there can be complications such as mental retardation, spastic paralysis, deafness or epilepsy.
Danish: Selv efter at man er blevet rask efter meningitis (Hib), kan der være komplikationer som psykisk udviklingshæmning, spastisk lammelse, døvhed eller epilepsi.
English: The Applicant/MAH considers that the extent of the total safety database is entirely consistent with the recommendations of the CHMP Guideline on Clinical Evaluation of New Vaccines and is sufficiently large to identify uncommon events.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen vurderer, at omfanget af den totale sikkerhedsdatabase er fuldstændigt i overensstemmelse med anbefalingerne i CHMP's Guideline on Clinical Evaluation of New Vaccines, og at den er tilstrækkeligt stor til at kunne identificere usædvanlige hændelser.
English: Menitorix can be given from the age of 2 months after birth onwards but it is not known if protection against Hib and MenC will be as good as in children born at term.
Danish: Menitorix kan gives fra 2 måneder efter fødslen, men det vides ikke, om beskyttelsen mod Hib og MenC er lige så god som hos børn født omkring terminen.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: United Kingdom Menitorix
English: This vaccine cannot cause MenC or Hib infections.
Danish: Denne vaccine kan ikke give MenC- eller Hib-infektioner.
English: Although symptoms of meningism such as neck pain/stiffness or photophobia have been reported following administration of other MenC conjugate vaccines, there is no evidence that MenC conjugate vaccines cause meningitis.
Danish: Selvom symptomer på meningitis, som nakkesmerter/stivhed eller photophobia er set som følge af administration af andre MenC konjugerede vacciner, er der ingen tegn på, at MenC konjugerede vacciner fremkalder meningitis.
English: The CHMP considered that the safety data submitted indicates that the local and systemic AEs observed during clinical studies were as expected in terms of types and rates for a polysaccharideprotein conjugate vaccine and showed similar reactogenicity to other mono-component MenC and Hib vaccines in various clinical studies.
Danish: CHMP har vurderet, at de indsendte sikkerhedsdata tyder på, at de lokale og systemiske uønskede hændelser, som blev observeret under de kliniske undersøgelser, var som forventet med hensyn til typer og frekvenser for en polysaccharid-protein konjugatvaccine og udviste samme reaktogenicitet som andre mono-komponent MenC- og Hib-vacciner i forskellige kliniske undersøgelser.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette præparat ikke blandes med andre præparater
English: After reconstitution, the vaccine should be administered promptly or kept in the refrigerator (2°C8°C).
Danish: Efter rekonstitution skal vaccinen anvendes straks eller opbevares i køleskab (2 °C - 8 °C).
English: The immunogenicity data indicates that Menitorix will be at least as effective as the licensed PRP-T and MenC conjugate vaccines when used for priming and/or for boosting in accordance with the SPC.
Danish: Immunogenecitetsdataene tyder på, at Menitorix er mindst lige så effektiv som de godkendte PRP-T og MenC-konjugatvacciner, når det anvendes til priming og/eller boosting i overensstemmelse med produktresuméet.
English: All subjects responded immunologically to a challenge dose of 10 µg of unconjugated group C meningococcal polysaccharide with a thirty-three-fold increase in SBA titres demonstrating the immune memory induced by the primary vaccination course.
Danish: Alle børn responderede immunologisk på en dosis på 10 µg ukonjugeret gruppe C meninggococ polysaccharid med 33 gange forøgelse i SBA-titer, hvilket demonstrerer immunmemory-inducering ved det primære vaccinationsprogram.
English: After the addition of the solvent, the mixture should be well shaken until the powder is completely dissolved in the solvent.
Danish: Efter tilsætning af solvens til pulveret skal sammenblandingen rystes godt, indtil pulveret er fuldstændig opløst i solvensen.
English: Psychiatric disorders: very common: irritability uncommon: crying
Danish: Psykiske forstyrrelser Meget almindelig: Irritabilitet Ikke almindelig: Gråd
English: Menitorix should be given by intramuscular injection only, preferably in the anterolateral thigh region.
Danish: Menitorix bør kun indgives som intramuskulær injektion, fortrinsvis i den anterolaterale del af låret.
English: Individuals with complement deficiencies and individuals with functional or anatomical asplenia may mount an immune response to Hib and MenC conjugate vaccines; however the degree of protection that would be afforded is unknown.
Danish: Personer med komplement sygdomme eller med funktionel eller anatomisk asplenia opnår et immunrespons for Hib og MenC konjugerede vacciner; graden af den opnåede beskyttelse er dog ukendt.
English: General disorders and administration site conditions: very common: fever (rectal ≥ 38°C), swelling, pain, rednesscommon: injection site reaction uncommon:fever (rectal > 39.5°C), malaise
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: Feber (rektal ≥ 38 °C), hævelse, smerte, rødme Almindelig: Reaktioner ved injektionssted Ikke almindelig: Feber (rekal > 39,5 °C), utilpashed
English: • Neisseria meningitidis group C (MenC): Like Hib bacteria, MenC bacteria most frequently cause meningitis.
Danish: • Neisseria meningitis gruppe C (MenC): Lige som Hib bakterier, giver MenC-bakterier oftest meningitis.
English: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration.
Danish: Den rekonstituerede vaccine skal undersøges visuelt for partikler og/eller variation i fysiske forhold inden administration.
English: Following the initial assessment, the CHMP considered that under the conditions of study, the safety and immunogenicity data provided were adequate to assess the risk-benefit relationship for the use of Menitorix for priming and/or boosting and could be used to assess the likely protection that will be afforded by the vaccine.
Danish: Efter den indledende bedømmelse mente CHMP, at de fremlagte sikkerheds- og immunogenicitetsdata under undersøgelsesbetingelserne var tilstrækkelige til at kunne bedømme risk/benefit-forholdet ved anvendelse af Menitorix til priming og/eller boosting, og at de kunne anvendes til bedømmelse af den sandsynlige beskyttelse, vaccinen vil give.
English: In the first 1-2 weeks after a dose of Menitorix it is possible that urine tests to detect Hib infection could give the wrong (false positive) results.
Danish: I de første 1-2 uger efter vaccination med Menitorix er der risiko for, at man ved en urintest til bestemmelse af en Hib infektion får et forkert resultat (falsk positivt resultat).
English: If your child receives more Menitorix than he/she should It is very unlikely that your child will receive too much or too little vaccine because each dose is provided in a separate vial and the vaccine is given by a doctor or nurse.
Danish: Det er meget usansynligt, at dit barn vil få for meget eller for lidt vaccine, da hver dosis leveres i separate hætteglas, som håndteres af en læge eller sygeplejerske.
English: In clinical trials, Menitorix was administered as a 3-dose primary series (N=1,171) or as a booster (N=991) dose.
Danish: I kliniske forsøg blev Menitorix administreret i et primærprogram (N = 1171) med 3 doser eller som boosterdosis (N = 991).
English: The Applicant/MAH is requested to commit to submitting for assessment, to the relevant national competent authorities, the results from the long-term antibody persistence data from the ongoing studies with Menitorix i.e. subjects from booster studies 013 and 022 are being followed up for antibody persistence as follows: o Over 4 years of follow up of subjects from study 013 in studies 027, 028 and 029. o Five years follow-up from 010/022 in subsequent studies 023, 024, 025 and 026.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen skal forpligte sig til at forsyne de relevante lokale, kompetente myndigheder med resultater til bedømmelse fra data om langsigtet persistens af antistoffer fra de igangværende undersøgelser af Menitorix, dvs. at der foretages opfølgning af personer fra boosterundersøgelse 013 og 022 med henblik på persistens af antistoffer som følger: o Over 4 års opfølgning af personer fra undersøgelse 013 i undersøgelserne 027, 028 og 029. o Fem års opfølgning fra 010/022 i de efterfølgende undersøgelser 023, 024, 025 og 026.
English: The vaccine must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder.
Danish: Vaccinen skal rekonstitueres ved at tilsætte hele indholdet af den medfølgende solvens til hætteglasset indeholdende pulveret.
English: please tell your doctor or pharmacist.
Danish: Tal med lægen eller sygeplejersken.
English: It cannot protect against meningitis caused by other bacteria or viruses, including other types and groups of Haemophilus or Neisseria bacteria.
Danish: Menitorix beskytter ikke mod meningitis, som skyldes andre bakterier eller virus, heller ikke andre typer og grupper af Haemophilus eller Neisseria bakterier.
English: ♦ Very common (in more than 1 per 10 doses of vaccine)
Danish: ♦ Meget almindelig (det sker ved flere end 1 ud af 10 vaccinationer)
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not inject intravenously.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Må ikke injiceres intravenøst.
English: Solvent: sodium chloride, water for injections.
Danish: Solvens: Natriumchlorid, vand til injektionsvæsker.
English: 12.5 micrograms
Danish: 12,5 mikrogram
English: In individuals with impaired immune responsiveness (whether due to the use of immunosuppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes) a protective immune response to Hib and MenC conjugate vaccines may not be obtained.
Danish: For personer med nedsat immunforsvar (uanset om det skyldes immunsuppresiv behandling, en genetisk fejl, HIV-infektion eller andre årsager) vil et beskyttende immunrespons for Hib and MenC konjugater muligvis ikke blive opnået.