FrancophonIA/ELRC3.0 huggingface dataset:
English: The immune response to routine paediatric vaccines co-administered with Prevenar at different injection sites was assessed in 7 controlled clinical studies.
Danish: Immunsvaret på rutinemæssige pædiatriske vacciner indgivet samtidig med Prevenar på forskellige injektionssteder blev vurderet i 7 kontrollerede kliniske undersøgelser.
English: It is important to follow the instructions from the doctor, pharmacist, or nurse so that your child completes
Danish: Det er vigtigt at følge lægens, apotekets eller sygeplejerskens vejledninger, således at Deres barn
English: • Erythema multiforme (a rash causing itchy red blotches)
Danish: • Erythema multiforme (et udslæt der viser sig som kløende, røde pletter)
English: Sufficient data regarding interference on the concomitant administration of other hexavalent vaccines with Prevenar are currently not available.
Danish: Tilstrækkelige data for samtidig indgivelse af andre hexavalente vacciner og Prevenar er for nuværende ikke til rådighed.
English: In the USA in the same time frame, there was a 94% reduction in vaccine type IPD in individuals under 5 years of age, compared to a pre-vaccine baseline (1998/99).
Danish: Inden for det samme tidsrum var der i USA et fald på 94 % af vaccinetypen mod invasiv pneumokokinfektion hos personer under 5 år sammenlignet med før-vaccine-baseline (1998/99).
English: No consistent increased local or systemic reactions within repeated doses were seen throughout the primary series or with the booster dose, the exceptions being a higher rate of transient tenderness (36.5 %) and tenderness that interfered with limb movement (18.5 %) were seen with the booster dose.
Danish: Der sås ikke konsistente, øgede lokale eller systemiske reaktioner ved gentagne doser i løbet af den primære serie eller ved booster dosis med undtagelse af en større frekvens af forbigående ømhed (36,5%), og ved booster dosis blev set ømhed, som indvirkede på bevægeapparatet (18,5%).
English: A higher rate of local reactions has been observed in children older than 24 months of age compared with infants.
Danish: Der er observeret en højere frekvens af lokale reaktioner hos børn over 24 måneder sammenlignet med spædbørn.
English: Therefore, in view of available data the PRAC considered that changes to the conditions of the marketing
Danish: I betragtning af de data, der er tilgængelige, anså PRAC det således for berettiget at ændre betingelserne for markedsføringstilladelsen.
English: Theoretically, Prevenar could prevent about 6080% of serotypes causing pneumococcal AOM.
Danish: Teoretisk set skulle Prevenar kunne forhindre ca. 60-80% af de serotyper, som forårsager pneumokok AOM.
English: Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Danish: Bakterier kan være ansvarlige for 60-70% af de kliniske tilfælde af AOM.
English: Prevenar is a pneumococcal vaccine.
Danish: Prevenar er en pneumokokvaccine.
English: In Quebec, Canada Prevenar was introduced at 2, 4 and 12 months of age with a single dose catch-up programme in children up to 5 years of age.
Danish: I Quebec i Canada blev Prevenar lanceret i alderen 2, 4 og 12 måneder med et catch-up-program bestående af en enkeltdosis for børn op til 5 år.
English: Children aged 24 months - 5 years: one single dose.
Danish: Børn i alderen 24 måneder - 5 år: En enkelt dosis.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: In Europe, the estimates of effectiveness in children less than 2 years of age range from 51 % to 79 % when considering vaccine coverage against serotypes causing invasive disease.
Danish: I Europa varierer bedømmelsen af effekt hos børn under 2 år fra 51% til 79%, når vaccinedækningen mod serotyper, der forårsager invasiv sygdom, tages i betragtning.
English: A fourth dose is recommended in the second year of life.
Danish: En fjerde dosis anbefales i det andet leveår.
English: The frequency is defined as follows: Very common(  1/10) Common ( 1/100 to < 1/10) Uncommon ( 1/1,000 to < 1/100) Rare ( 1/10,000 to < 1/1,000)
Danish: Meget almindelig ( 1/10) Almindelig ( 1/100 til < 1/10) Ikke almindelig ( 1/1.000 til < 1/100) Sjælden ( 1/10.000 til < 1/1.000)
English: The antibody response to Hib tetanus protein conjugate (PRP-T), tetanus and Hepatitis B (HepB) vaccines was similar to controls.
Danish: Antistofrespons på konjugeret Hib tetanus protein (PRP-T), tetanus og hepatitis B vacciner svarede til kontrolgruppen.
English: The immunogenicity of a two-dose primary series in infants plus a booster at about one year of age has been documented in several studies.
Danish: Immunogeniciteten af en serie af to doser primærvaccination til spædbørn, efterfulgt af en boosterdosis når barnet bliver ca. et år, er dokumenteret i en række undersøgelser.
English: Preliminary data from England and Wales reported less than 1 year following introduction of routine immunisation at 2, 4 and 13 months with a single dose catch-up programme for children 13 to 23 months of age have suggested that effectiveness of this schedule might be lower against serotype 6B than against
Danish: Foreløbige data fra England og Wales, som blev rapporteret mindre end 1 år efter indførelsen af standardimmunisering af børn i alderen 2, 4 og 13 måneder med et catch-up-program med en enkeltdosis til børn i alderen 13 til 23 måneder, indikerer, at effektiviteten af denne plan muligvis er lavere mod serotype 6B end mod de øvrige serotyper i vaccinen.
English: Detailed information on this product is available on the website of the European Medicines Agency
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs
English: Limited data have demonstrated that Prevenar induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups.
Danish: Begrænsede data har påvist, at Prevenar giver en acceptabel immunrespons hos børn med seglcellesygdom med en sikkerhedsprofil svarende til, hvad der er observeret i ikke-højrisikogrupper.
English: Prevenar is for intramuscular use only.
Danish: Prevenar er kun beregnet til intramuskulær brug.
English: Different injectable vaccines should always be given at different
Danish: Forskellige vacciner til injektion skal altid gives på forskellige
English: Different injectable vaccines should always be given at different injection sites.
Danish: Forskellige vacciner til injektion skal altid gives på forskellige injektionssteder.
English: Limited results from open label studies showed an acceptable response to MMR and varicella.
Danish: Begrænsede resultater fra åbne undersøgelser viste en acceptabel respons på MFR og skoldkopper.
English: In all studies, Prevenar was administered concurrently with the recommended childhood vaccines.
Danish: I alle undersøgelser blev Prevenar indgivet samtidig med de anbefalede børnevacciner.
English: A significant increase was seen in the concentrations of antibodies against the seven serotypes after the polysaccharide vaccination, suggesting that immunological memory was well established.
Danish: Der blev observeret en signifikant stigning i koncentrationerne af antistoffer mod de syv serotyper efter polysaccharid vaccinationen, indikerende at den immunologiske hukommelse var veletableret.
English: In European children between 2 to 5 years of age, Prevenar should cover about 62 % to 83 % of the clinical isolates responsible for invasive pneumococcal disease.
Danish: Blandt europæiske børn mellem 2 og 5 år skulle Prevenar dække ca. 62% til 83% af de kliniske isolater, som er ansvarlige for invasiv pneumokoksygdom.
English: A higher rate of local reactions has been observed in children older than 24 months of age compared with infants (see section 4.8).
Danish: Der er observeret en højere frekvens af lokale reaktioner hos børn over 24 måneder sammenlignet med spædbørn (se afsnit 4.8).
English: According to official recommendations in your country, an alternative schedule may be used by your health-care provider.
Danish: Ifølge officielle anbefalinger i Danmark kan sundhedsvæsenet anvende en anden vaccinationsplan.
English: The vaccine should be given by intramuscular injection.
Danish: Vaccinen skal gives som en intramuskulær injektion.
English: The other ingredients are sodium chloride and water for injections.
Danish: Øvrige indholdsstoffer: natriumchlorid og vand til injektion.
English: • Hypersensitivity reaction, including swelling of the face and/or lips, difficulty in breathing, rash,
Danish: • Overfølsomhedsreaktion, herunder hævelser i ansigtet og/eller af læberne, vejrtrækningsbesvær,
English: The interval between the pneumococcal conjugate vaccine (Prevenar) and the 23valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Danish: Intervallet mellem den konjugerede pneumokokvaccine (Prevenar) og 23-valent polysaccharid pneumokokvaccine bør ikke være under 8 uger.
English: The effectiveness of Prevenar against IPD (i.e. comprising the protection afforded by vaccination and from herd immunity due to reduced transmission of vaccine serotypes in the population) has been evaluated in national immunisation programmes that employ three-dose or two-dose infant series, each with booster doses.
Danish: Effektiviteten af Prevenar i forhold til IPD (invasiv pneumokokinfektion, dvs. bestående af den beskyttelse, som vaccination yder, samt flokimmunitet på grund af reduceret overførsel af vaccineserotyperne i befolkningen) er blevet vurderet i nationale immuniseringsprogrammer, hvor der blev anvendt serier med to eller tre doser til spædbørn, som hver blev fulgt op af booster-doser.
English: However, the overall benefit was a 34 % (95 % CI: 21, 45) reduction in the incidence of all pneumococcal AOM.
Danish: Imidlertid var det samlede udbytte en reduktion på 34% (95% CI: 21, 45) af incidensen af alle pneumokokrelaterede AOM.
English: If you forget to go back to the doctor or nurse at the scheduled time, ask the doctor or nurse for advice.
Danish: Hvis De har glemt at komme tilbage til lægen eller sygeplejersken på den aftalte tid, skal De bede
English: A 33 % (95 % CI: -1, 80) increase in AOM due to serogroups not included in the vaccine was observed in immunised subjects.
Danish: Der sås en stigning på 33% (95% CI: -1, 80) i AOM hos immuniserede personer på grund af serogrupper, som ikke var inkluderet i vaccinen.
English: When Prevenar is co-administered with hexavalent vaccines (DTaP/Hib(PRP-T)/IPV/HepB), the physician should be aware that data from clinical studies indicate that the rate of febrile reactions was higher compared to that occurring following the administration of hexavalent vaccines alone.
Danish: Indgives Prevenar samtidig med hexavalente vacciner (DTaP/Hib(PRP-T)/IPV/HepB), bør lægen være opmærksom på, at data fra kliniske undersøgelser indikerer, at hyppigheden af febrile reaktioner var højere end ved indgivelse af hexavalente vacciner alene.
English: As many pathogens other than pneumococcal serotypes represented in the vaccine may contribute to the burden of pneumonia in children, protection against all clinical pneumonia is expected to be lower than for invasive pneumococcal disease.
Danish: Da mange andre patogener end de pneumokokserotyper, der er repræsenteret i vaccinen, kan medvirke til pneumoni hos børn, forventes beskyttelsen mod al klinisk pneumoni at være lavere end for invasiv pneumokoksygdom.
English: Limited data have demonstrated that Prevenar (three dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see section 5.1).
Danish: Begrænsede data har påvist, at Prevenar (serie med tre doser primærvaccination) inducerer en acceptabel immunrespons hos børn med seglcellesygdom med en sikkerhedsprofil svarende til, hvad der er observeret i ikke-højrisikogrupper (se afsnit 5.1).
English: In the USA, generalised vaccination with Prevenar using a four-dose series in infants and a catch-up programme for children up to 5 years of age was introduced in 2000.
Danish: I år 2000 blev der i USA lanceret en universel vaccination med Prevenar med fire doser til børn samt et catch-up-program for børn op til 5 år.
English: This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of
Danish: Denne vaccine må ikke gives til spædbørn eller børn med trombocytopeni eller andre koagulationslidelser, som vil kontraindicere intramuskulær injektion, medmindre den potentielle fordel klart opvejer risikoen ved indgivelse.
English: Pack sizes of 1 and 10 with or without needle.
Danish: Pakningsstørrelser på 1 og 10 med eller uden nåle.
English: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Danish: Hos spædbørn, som er født meget for tidligt, (født i eller før 28. svangerskabsuge), kan der forekomme længere mellemrum end normalt mellem åndedragene i 2-3 dage efter vaccinationen.
English: A third dose is recommended in the second year of life.
Danish: En tredje dosis anbefales i det andet leveår.
English: Children were vaccinated with Prevenar (3 doses one month apart from the age of 2 months) and 46 of these children also received a 23-valent pneumococcal polysaccharide vaccine at the age of 15-18 months.
Danish: Børnene blev vaccinerede med Prevenar (3 doser med én måneds mellemrum efter at være fyldt 2 måneder) og 46 af disse børn fik også en 23-valent polysaccharid pneumokokvaccine i alderen 15-18 måneder.
English: The effectiveness of a two-dose primary series has not been established against pneumonia or acute otitis
Danish: Effektiviteten af en serie primærvaccinationer med 2 doser mod pneumoni eller akut otitis media kendes ikke.
English: Do not inject intravenously.
Danish: Må ikke injiceres intravenøst.
English: Antipyretic treatment should be initiated according to local treatment guidelines.
Danish: Febersænkende behandling bør indledes i henhold til gældende retningslinjer.
English: More than 37,816 infants were immunised with either Prevenar or a control vaccine (meningococcal conjugate group C vaccine), at 2, 4, 6 and 12-15 months of age.
Danish: Mere end 37.816 spædbørn blev immuniseret med enten Prevenar eller en kontrolvaccine (konjugeret meningokok gruppe C vaccine) i en alder af 2, 4, 6 og 12-15 måneder.
English: Efficacy of Prevenar against acute otitis media (AOM) was assessed in a randomised, double blind, clinical trial of 1,662 Finnish infants immunised with either Prevenar or a control vaccine (Hepatitis B vaccine), at 2, 4, 6 and 12-15 months of age.
Danish: Effekten af Prevenar over for akut otitis media (AOM) blev vurderet i en randomiseret dobbeltblind klinisk undersøgelse med 1.662 finske spædbørn, som blev immuniseret med enten Prevenar eller en kontrolvaccine (hepatitis B-vaccine), når de var 2, 4, 6 samt 12-15 måneder gamle.
English: Lymphadenopathy localised to the region of the injection site
Danish: Lymfeadenopati lokaliseret til området ved indstiksstedet.
English: However, antibody responses to booster doses in toddlers following two-dose or three-dose infant series were comparable for all 7 vaccine serotypes and indicated that both infant regimens had elicited adequate priming.
Danish: Antistofresponserne til booster-doserne hos småbørn efter en serie bestående af to eller tre doser var imidlertid sammenlignelige for alle 7 vaccineserotyper, og dette indikerede, at begge spædbørnsregimener fremkaldte en tilstrækkelig priming.
English: Manufacturing Authorisation Holder responsible for batch release:
Danish: Indehaver af virksomhedsgodkendelse, som er ansvarlig for batchfrigivelse:
English: As with any vaccine, Prevenar may not protect all individuals receiving the vaccine from pneumococcal disease.
Danish: Lige som det gælder for andre vacciner, beskytter Prevenar ikke nødvendigvis alle vaccinerede individer mod pneumokoksygdom.
English: As with other vaccines, the administration of Prevenar should be postponed in subjects suffering from acute, severe febrile illness.
Danish: Som med andre vacciner skal administrationen af Prevenar udskydes, hvis personen lider af en akut, svær febersygdom.
English: This indirect or herd effect is due to a reduction in transmission of vaccine serotypes from immunised young children to the rest of the population and coincides with decreased nasopharyngeal carriage of vaccine serotypes.
Danish: Denne indirekte effekt eller flokeffekt skyldes et fald i overførslen af vaccineserotyper fra immuniserede småbørn til resten af befolkningen og er sammenfaldende med nedsat nasopharyngeal bærertilstand af vaccineserotyperne.
English: Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation.
Danish: Børn med svækket immunforsvar, hvad enten det skyldes immunhæmmende behandling, en genetisk defekt, HIV-infektion eller andre årsager, kan have reduceret antistofrespons over for aktiv immunisering.
English: When Prevenar is co-administered with hexavalent vaccines (DTaP/Hib(PRP-T)/IPV/HepB), fever ≥ 38 °C per dose was reported in 28.3 % to 48.3 % of infants in the group receiving Prevenar and the hexavalent vaccine at the same time as compared to 15.6 % to 23.4 % in the group receiving the hexavalent vaccine alone.
Danish: Hvis Prevenar indgives samtidig med hexavalente vacciner (DTaP/Hib(PRP-T)/IPV/HepB), blev feber  38°C per dosis rapporteret hos 28,3% til 48,3% af børnene i gruppen, som fik Prevenar og hexavalent vaccine samtidig, sammenlignet med 15,6% til 23,4% i gruppen som fik hexavalent
English: In addition, GMCs were lower for antibodies to most serotypes after a twodose infant series than after a three-dose infant series.
Danish: Desuden var GMC-værdierne lavere, hvad angår antistoffer, for de fleste serotyper efter en spædbørnsvaccination bestående af to doser end efter en spædbørnsvaccination bestående af tre doser.
English: It is estimated that Prevenar could prevent 6-13% of all
Danish: Det vurderes, at Prevenar vil kunne forhindre 6-13% af alle kliniske tilfælde af AOM.
English: Vaccine effectiveness against IPD caused by vaccine serotypes was evaluated in 3- to 59-month old children within the first four years of the implementation of the programme.
Danish: Effekten af vaccinen i forhold til invasiv pneumokokinfektion forårsaget af vaccineserotyper blev vurderet hos børn, som var mellem 3 og 59 måneder, i løbet af programmets første fire år.
English: Redness or induration >2cm in diameter was reported in 22.6 % and 13.9 % of children respectively.
Danish: Rødme eller induration  2 cm i diameter blev set hos henholdsvis 22,6% og 13,9% af
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSERNE
English: Each 0.5 ml dose contains 2 micrograms of saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 micrograms of serotype 6B per dose (16 micrograms total saccharide) conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg).
Danish: Hver dosis på 0,5 ml indeholder 2 microgram saccharid af serotype 4, 9V, 14, 18C, 19F og 23F, og 4 mikrogram af serotype 6B pr. dosis (16 mikrogram saccharid i alt) konjugeret til CRM197 bærerprotein og adsorberet på aluminiumphosphat (0,5 mg).
English: Longterm persistence of antibodies has not been investigated after administration of a primary series in infants plus booster or after administration of single priming doses to older children.
Danish: Vedvarende antistoffer over lang tid er ikke undersøgt efter administration af en serie primærvaccinationer til spædbørn plus en booster dosis eller efter administration af enkelte priming-doser til ældre børn.
English: Prevenar has also been shown to elicit functional antibodies (measured by opsonophagocytosis) to all vaccine serotypes following the primary series.
Danish: Det er ligeledes påvist, at Prevenar fremkalder funktionelle antistoffer (målt ved hjælp af opsonofagocytose) i alle vaccineserotyper efter en serie primærvaccinationer.
English: Prevenar will not protect against other Streptococcus pneumoniae serotypes than those included in the vaccine or other micro-organisms that cause invasive disease or otitis media.
Danish: Prevenar beskytter ikke mod andre Streptococcus pneumoniae serotyper end dem, der er inkluderet i vaccinen, eller andre mikroorganismer, der forårsager invasive sygdomme eller mellemørebetændelse.
English: Please tell your doctor, nurse or pharmacist if your child is taking or has recently taken any other medicines including medicines obtained without prescription or has recently received any other vaccine.
Danish: Fortæl det altid til lægen eller på apoteket, hvis Deres barn bruger anden medicin eller har brugt det for nylig eller for nylig har fået andre vacciner.
English: Prevenar is given to children from 2 months to 5 years to help protect against diseases such as: meningitis, sepsis or bacteraemia (bacteria in blood stream), pneumonia and ear infection caused by seven types of the bacteria Streptococcus pneumoniae.
Danish: Prevenar gives til børn i alderen 2 måneder til 5 år for at hjælpe med at beskytte mod sygdomme som for eksempel: meningitis, blodforgiftning eller bakterier i blodbanen (bakteriæmi), lungebetændelse og infektioner i øret, som forårsages af syv typer af
English: 0.5 ml suspension for injection in pre-filled syringe (Type I glass) with a plunger rod (polypropylene), a plunger stopper (latex free grey butyl rubber) and a protective-tip cap (latex free grey butyl rubber)
Danish: 0,5 ml injektionsvæske, suspension, i en fyldt injektionssprøjte (type I glas) med stempelstang (polypropylen), stempelprop (latex-fri, grå butylgummi) og en beskyttelseshætte (latex-fri, grå butylgummi)
English: Significant increases in antibody (measured by ELISA) were seen for all vaccine serotypes following a three-dose primary series of Prevenar in infants and following booster doses although geometric mean concentrations varied between the 7 serotypes.
Danish: Der blev konstateret signifikante forøgelser i antistof (målt ved hjælp af ELISA) i alle vaccineserotyper efter en serie på tre doser Prevenar-primærvaccination hos spædbørn og efter booster-doser, selvom de geometriske middelkoncentrationer varierede mellem de 7 serotyper.
English: Significant increases in antibody (measured by ELISA) to all vaccine serotypes were seen after administration of single doses of Prevenar to children aged 2 to 5 years.
Danish: Der blev konstateret signifikante forøgelser i antistof (målt ved hjælp af ELISA) i alle vaccineserotyper efter administration af Prevenar-enkeltdoser til børn i alderen 2 til 5 år.
English: Data on concomitant administration of Prevenar with Infanrix hexa (DTaP/Hib(PRP-T)/IPV/HepB vaccine) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.
Danish: Data for samtidig indgivelse af Prevenar og Infanrix hexa (DTaP/Hib(PRP-T)/IPV/HepB vaccine) har ikke vist klinisk interferens i antistofresponsen på nogle af de individuelle antigener, hvis givet som en primær vaccination med 3 doser.
English: In the Kaiser Permanente trial, efficacy was 87.5 % (95 % CI: 7, 99) against bacteraemic pneumonia due to vaccine serotypes of S. pneumoniae.
Danish: I Kaiser Permanente undersøgelsen var effekten 87,5% (95% CI: 7, 99) over for bakteriæmisk pneumoni på grund af vaccine serotyper af S. pneumoniae.
English: Reactogenicity was higher in children receiving whole cell pertussis vaccines concurrently.
Danish: Reaktogeniciteten var højere hos børn, der samtidig fik helcelle pertussis vaccine.