FrancophonIA/ELRC3.0 huggingface dataset:
English: - S-PSUR submission to the Rapporteur and CHMP members on Day 45.
Danish: S-PSUR indsendes til Rapporteur og CHMP medlemmer på dag 45.
English: 2 % of subjects with titre ≥1:28
Danish: 2 andel af personer med en titer ≥ 1:28
English: Available epidemiological data in adults aged over 20 years have indicated approximately 1 additional case per 100,000 vaccinated subjects.
Danish: Tilgængelige epidemiologiske data for voksne over 20 år har indikeret ca. 1 yderligere tilfælde for hver 100.000 vaccinerede personer.
English: Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively.
Danish: Af de dyr, som havde fået adjuvans-vaccine var 87 % og 96 % beskyttet mod henholdsvis den letale homologe eller den heterologe eksposition.
English: In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Danish: Yderligere er der i forbindelse med overvågning efter markedsføring af interpandemiske, trivalente vacciner indberettet følgende bivirkninger:
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som ved alle andre injicerbare vacciner, skal passende medicinsk behandling og overvågning altid være til stede i tilfælde af, at en sjælden, anafylaktisk reaktion opstår efter administration af vaccinen.
English: 71 to 80 years
Danish: 71-80 år
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Danish: Rapporteurs assessment report fremsendes til CHMP medlemmer på dag 50.
English: This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det af videnskabelige årsager ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel.
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Danish: Data fra gravide kvinder, vaccineret med forskellige inaktiverede ikke-adjuverede sæson-vacciner, indikerer ikke misdannelser eller føtal/neonatal toksicitet.
English: To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
Danish: Skal en rapport over vaccinedistribution indgå og skal give nærmere oplysninger om antallet af distribuerede vaccinedoser i: i) EU´s medlemsstater i rapporteringsperioden pr. batchnummer, ii) EU's medlemsstater kumulativt og iii) resten af verden
English: The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Danish: Sygdomstegnene ved en pandemisk influenza er de samme som ved en "ordinær" influenza, men kan være alvorligere.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code: J07BB02.
Danish: Farmakoterapeutisk klassifikation: Influenzavacciner, ATC-kode: J07BB02.
English: OTHER Storage (2ºC-8ºC), do not freeze, protect from light
Danish: ANDET Opbevaring (2°C - 8°C), må ikke fryses, skal beskyttes mod lys
English: Adjupanrix is not intended to be given at the same time as some other vaccines.
Danish: Adjupanrix er ikke beregnet til at blive givet samtidig med visse andre vacciner.
English: However, in the case this needle size would not be available, a 21-G needle might be used.
Danish: Er denne kanylestørrelse ikke tilgængelig, kan en 21-G kanyle dog også anvendes.
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Danish: Sundhedspersonalet skal derfor vurdere fordele og potentielle risici ved administration af vaccinen til personer med trombocytopeni eller blødningsforstyrrelser, hvor intramuskulær injektion er kontraindiceret, med mindre den potentielle fordel opvejer risikoen for blødninger.
English: In children/adolescents (aged up to 20 years), these studies have indicated an additional 1.4 to 8 cases in 100,000 vaccinated subjects.
Danish: Hos børn/unge (op til 20 år) har disse studier indikeret 1,4 til 8 yderligere tilfælde for hver 100.000 vaccinerede personer.
English: Serum neutralising antibody
Danish: Serum neutraliserende antistof
English: All subjects achieved a neutralising antibody titre of at least 1:80 against each of the two strains regardless of the HA type in the vaccine and the previous number of doses.
Danish: Alle personer opnåede en neutraliserende antistoftiter på mindst 1:80 mod hver af de to stammer uanset HA-typen i vaccinen og det forudgående antal doser.
English: Adjupanrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Adjupanrix takes due account of the officially declared pandemic strain.
Danish: Adjupanrix kan kun markedsføres, hvis der findes en officiel WHO/EU-erklæring om en pandemisk influenza og kun på betingelse af at markedsføringstilladelsesindehaveren af Adjupanrix tager passende hensyn til den officielt erklærede pandemiske vaccinestamme.
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Danish: Du skal derfor fortælle lægen eller sygeplejersken, hvis du tidligere er besvimet i forbindelse med en injektion.
English: The following side effects may happen with this medicine:
Danish: Følgende bivirkninger kan opstå med denne vaccine:
English: It spreads rapidly around the world.
Danish: Den spreder sig hurtigt og rammer de fleste lande og områder i hele verden.
English: Neutralising antibody titres of at least 1:40 or at least 1:80 were achieved in 87% and 67%, respectively, of the 87 subjects tested.
Danish: Neutraliserende antistoftitere på mindst 1:40 eller mindst 1:80 blev opnået hos henholdsvis 87 % og 67 % af de 87 undersøgte personer.
English: The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
Danish: Rapporten skal omfatte følgende tabeller over samlede data (vha. de prædefinerede skabeloner, bilag i Annex II).
English: Octoxynol 10
Danish: Octoxinol 10
English: What Adjupanrix is and what it is used for
Danish: Hvad Adjupanrix er, og hvordan den anvendes
English: Pandemic preparedness vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Danish: Pandemiske beredskabsvacciner indeholder influenza-antigener, som er forskellige fra dem, der findes i den influenzavirus, der aktuelt er i omløb.
English: Month 24
Danish: måned 24
English: Allergic reactions which may cause you to have dangerously low blood pressure.
Danish: Allergiske reaktioner som kan medføre et alvorligt lavt blodtryk.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Danish: Dette kan være ledsaget af adskillige neurologiske tegn som f.eks. kortvarige synsforstyrrelser, paræstesier og tonisk-kloniske ekstremitetsbevægelser under opvågningen.
English: Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Danish: Pandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
English: narrow SMQ “Non-infectious encephalitis”
Danish: Snæver SMQ ”Ikke-infektiøs encephalitis”
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Danish: Under en pandemi indsamler ansøgerne data om klinisk sikkerhed og effektivitet for den pandemiske vaccine og indsender disse oplysninger til CHMP til vurdering.
English: - Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: - Tegn på en allergisk reaktion kan være kløende hududslæt, åndenød og hævet ansigt eller tunge.
English: Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Danish: Kontrolgrupperne omfattede fritter vaccineret med adjuvans alene med en ikke adjuveret vaccine (15 mikrogram HA) eller med en saltvandsopløsning indeholdende en phosphatbuffer.
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Danish: De forbigående falsk positive resultater kan skyldes dannelsen af IgM fremkaldt af vaccinen.
English: Persons previously vaccinated with one or two doses of Prepandrix containing HA derived from a different clade of the same influenza subtype as the pandemic influenza virus:
Danish: Personer, som tidligere er vaccineret med en eller to doser Prepandrix indeholdende HA fra en anden undergruppe af samme influenza-subtype som den pandemiske influenzavirus:
English: Currently available data are described in section 4.4, 4.8 and 5.1 but no recommendation on a posology can be made.
Danish: 4.4, 4.8 og 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: The frequency of side effects was lower in the group of children who received half of the adult dose.
Danish: Forekomsten af bivirkninger var lavere i gruppen af børn, som fik to halve voksendoser.
English: There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Danish: Der findes ingen data fra administration af AS03-adjuverede vacciner før eller efter andre typer af prepandemiske eller pandemiske influenzavacciner.
English: A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Danish: Et kort resumé over PSUR skal udarbejdes, hvor validerede signaler og problemstillinger markeres, hvor information fra det prospektive cohort forsøg beskrevet i afsnit 4.5 medtages i vurderingen.
English: They may also happen with Adjupanrix.
Danish: De kan også forekomme efter Adjupanrix.
English: This should include data from ongoing studies, or actual use if applicable, of the pandemic preparedness strains and any safety data relevant to the adjuvant system.
Danish: Denne evaluering skal inkludere data fra igangværende studier, eller fra praktisk anvendelse hvis relevant, af de pandemiske beredskabsvacciner, samt al sikkerhedsdata relevant for adjuvans systemet.
English: Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
Danish: Doser på 15, 5, 1,7 eller 0,6 mikrogram HA blev testet i det homologe ekspositionsforsøg og doser på 15, 7,5, 3,8 eller 1,75 mikrogram HA blev testet i det heterologe belastningsforsøg.
English: However, following two administrations of a double dose of vaccine, the seroprotection rate at day 42 was 75%.
Danish: Efter administration af to dobbeltdoser var seroprotektionsraten på dag 42 imidlertid 75 %.
English: Animal studies with Adjupanrix do not indicate reproductive toxicity (see section 5.3).
Danish: Dyrestudier med Adjupanrix indikerer ikke reproduktionstoksicitet (se pkt.
English: In particular, tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system.
Danish: Du skal især fortælle din læge eller sygeplejerske, hvis du får en behandling, som påvirker immunsystemet (f.eks. med kortikosteroid eller kemoterapi mod kræft).
English: The side effects listed below have happened in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Danish: Bivirkningerne nedenfor er set i dagene og ugerne efter vaccination med almindelig influenzavaccine, som gives en gang om året til forebyggelse af influenza.
English: After two priming doses
Danish: Efter to primære doser
English: Persons not previously vaccinated with Prepandrix Adults from the age of 18 years:
Danish: Personer, som ikke tidligere er vaccineret med Prepandrix Til voksne i alderen fra 18 år, som ikke tidligere er vaccineret:
English: If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature (for a minimum of 15 minutes) before each withdrawal.
Danish: Hvis den blandede vaccine opbevares i køleskab, skal vaccinen have antaget stuetemperatur (efter minimum 15 minutter) før hver udtagning.
English: Month 12
Danish: måned 12
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Danish: Prækliniske data viser ikke nogen risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter akutte og gentagne doser, lokal tolerance, fertilitet hos kvinder, toksicitet for foster/nyfødt barn (til og med afslutningen af ammeperioden).
English: Epidemiological studies relating to another AS03-adjuvanted vaccine (Pandemrix H1N1, also manufactured in the same facility as Adjupanrix), in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Danish: Epidemiologiske studier med en anden AS03-adjuveret vaccine (Pandemrix H1N1, som fremstilles på samme anlæg som Prepandrix) i flere europæiske lande har indikeret en øget risiko for narkolepsi med eller uden katapleksi hos vaccinerede sammenlignet med ikke-vaccinerede personer.
English: This section describes the clinical experience with the pandemic preparedness vaccines.
Danish: Dette afsnit beskriver den kliniske erfaring med pandemiske beredskabsvacciner.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants.
Danish: Uden for en pandemi opretholdes normale intervaller for indsendelse af PSUR samt format, med en specifik evaluering af AESI samt mulige bivirkninger relateret til adjuvans.
English: - Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Danish: Hyppigheden evalueres af indehaveren af markedsføringstilladelsen og (Co)-Rapporteur med 6 måneders interval.
English: For instructions on mixing of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: The anti-HA responses were as follows:
Danish: Anti-HA-respons var følgende:
English: Your doctors know that this might happen and will have emergency treatment ready to use.
Danish: Din læge er opmærksom på dette og har nødberedskab klar til brug.
English: Sächsisches Serumwerk Dresden Branch of GlaxoSmithKline Biologicals Zirkusstraße 40, D-01069 Dresden Germany
Danish: Sächsisches Serumwerk Dresden Branch of GlaxoSmithKline Biologicals Zirkusstraße 40, D-01069 Dresden Tyskland
English: There is currently no evidence to indicate that Adjupanrix may be associated with a risk of narcolepsy.
Danish: Der er på nuværende tidspunkt ikke evidens for, at Adjupanrix kan være forbundet med risiko for narkolepsi.
English: Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.
Danish: Derfor anbefales overvågning af temperatur og febernedsættende tiltag (såsom at give paracetamol eller anden febernedsættende medicin) efter hver dosis.
English: After one priming dose
Danish: Efter en primær dosis
English: Viral shedding into the upper respiratory tract was also reduced in vaccinated animals relative to controls, suggesting a reduced risk of viral transmission.
Danish: Virusudskillelsen i de øvre luftveje var også nedsat hos de vaccinerede dyr i forhold til kontrolgruppen, hvilket tyder på nedsat risiko for virustransmission.
English: - Vaccination failure:
Danish: - Vaccinationssvigt:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Adjupanrix in one or more subsets of the paediatric population in influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af studier med Adjupanrix hos en eller flere undergrupper af den pædiatriske population ved influenzainfektion forårsaget af en influenzastamme indeholdt i vaccinen eller relateret til en stamme indeholdt i vaccinen (se pkt.
English: See section 6.5 for the number of doses per vial.
Danish: 6.5, for antallet af doser pr. hætteglas.
English: The seroprotection rates were 2.2%, 4.7%, 2.4% and 7.8% at months 6, 12, 24 and 36, respectively.
Danish: Seroprotektionsraten var henholdsvis 2,2 %, 4,7 %, 2,4 % og 7,8 % ved måned 6, 12, 24 og 36.
English: Redness Swelling Fever (>38°C) Fever (>39°C) - per-dose frequency - per-subject frequency Drowsiness
Danish: Feber (> 38 °C) Feber (> 39 °C) - hyppighed pr. dosis - hyppighed pr. person
English: Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) post-vaccination.
Danish: Derfor anbefales overvågning af temperatur samt febernedsættende tiltag (såsom antipyretisk medicin som vurderes klinisk nødvendig) hos små børn (f.eks op til ca. 6 år) efter vaccination.
English: Children aged 3 to 9 years
Danish: Børn i alderen 3-9 år
English: This is because the vaccination may not be recommended, or may need to be delayed.
Danish: Det kan være, du ikke skal vaccineres, eller vaccinationen skal udsættes.
English: Booster factor3
Danish: Boosterfaktor3
English: At day 42, the anti-HA antibody seroconversion rate was 98%, all subjects were seroprotected and the seroconversion factor was 88.6.
Danish: På dag 42 var anti-HA-antistof serokonverteringsraten 98 %, alle personer var serobeskyttede, og serokonverteringsfaktoren var 88,6.
English: Date and time of mixing:
Danish: Dato og tidspunkt for rekonstitution:
English: As with all vaccines, Adjupanrix may not fully protect all persons who are vaccinated.
Danish: Som ved alle andre vacciner vil ikke alle vaccinerede personer være fuldstændig beskyttet mod infektion.
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Danish: Den kliniske relevans af hæmagglutinationshæmnings (HI) titer ≥ 1:40 hos børn er ukendt.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Adverse reactions from clinical trials with the pandemic preparedness vaccine are listed here below (see section 5.1 for more information on pandemic preparedness vaccines).
Danish: Bivirkninger set i kliniske studier med den pandemiske beredskabsvaccine findes nedenfor (se pkt 5.1 for yderligere oplysninger om pandemiske beredskabsvacciner).
English: However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Danish: Under en pandemi kan det dog være relevant at give vaccinen under forudsætning af, at der er genoplivningsudstyr inden for rækkevidde.
English: Based on very limited data, adults aged >80 years may require a double dose of Adjupanrix on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).
Danish: Baseret på meget få data kan ældre over 80 år have behov for dobbelt dosis Adjupanrix på en bestemt dag og igen efter mindst 3 uger, for at opnå immunrespons (se pkt.
English: The vaccine should be administered in accordance with the recommended posology (see section 3 “How Adjupanrix is given”).
Danish: Vaccinen skal administreres i overensstemmelse med den anbefalede dosis (se afsnit 3 ”Sådan bliver du behandlet med Adjupanrix”).
English: In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge.
Danish: Både i kontrolgruppen som fik non-adjuveret vaccine og kontrolgruppen, som blev vaccineret alene med adjuvans døde alle dyr eller måtte aflives, fordi de var døende 3-4 dage efter påbegyndt belastning.
English: If you have previously received one or two doses of Prepandrix
Danish: Hvis du tidligere har fået en eller to vaccinationer af Prepandrix.
English: If you have not previously received doses of Prepandrix
Danish: Hvis du ikke tidligere har fået vaccinationer af Prepandrix.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Danish: Synkope (besvimelse) kan opstå efter og endda før vaccination, som en psykogen reaktion over for kanylestik.
English: Furthermore, in the group of children that received a half dose of vaccine, the rate of subjects with a titre of neutralising antibodies above 1:80 remained high up to 24 months after the first dose.
Danish: I gruppen af børn, som havde fået halv vaccinedosis, forblev andelen af børn med en neutraliserende antistoftiter over 1:80 høj i op til 24 måneder efter første dosis.
English: The vaccine should not be administered intravascularly.
Danish: Vaccinen må ikke administreres intravaskulært.
English: Product-specific data can be evaluated during signal work-up.
Danish: Produktspecifikke data kan vurderes i udredningen af formodede årsagssammenhænge (signaler).
English: Dispose of in accordance with local regulations
Danish: Bortskaffes i henhold til lokale retningslinjer.
English: If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Danish: Hvis dit barn får vaccinen, skal du være opmærksom på, at bivirkningerne (især temperaturer over 38°C) kan være mere udtalte efter den anden dosis.
English: • Allergic reactions leading to a dangerously low blood pressure.
Danish: • Overfølsomhedsreaktioner, der kan medføre alvorligt blodtryksfald.
English: 1 Geometric Mean Titre
Danish: 1 geometrisk middeltiter
English: Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.
Danish: Med undtagelse af tabel 1, skal alle tabeller baseres på antal reaktioner (med foretrukket term, opført efter organklasser (SOC) og High Level Term (HLT)) og ikke antallet af tilfælde.
English: There are limited safety and immunogenicity data available on the administration of Adjupanrix and on administration of half a dose of the vaccine (i.e. 1.875 µg HA and half the amount of AS03 adjuvant) at 0 and 21 days in children aged 3 to 9 years.
Danish: Der er begrænsede sikkerheds- og immunogenicitetsdata tilgængelige for administration af Adjupanrix og for administration af halv vaccinedosis (dvs. 1,875 µg HA og halv mængde AS03-adjuvans) på dag 0 og dag 21 til børn i alderen 3-9 år.
English: After mixing: Use within 24 hours and do not store above 25°C.
Danish: Efter rekonstitution: Anvendes inden for 24 timer og må ikke opbevares over 25 °C.
English: What you need to know before you receive Adjupanrix
Danish: Det skal du vide, før du får Adjupanrix