FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions reported in clinical studies or from the postmarketing experience for all age groups are listed in this section per system organ class, in decreasing order of frequency and seriousness.
Danish: Bivirkninger, som er blevet indberettet for alle aldersgrupper i forbindelse med kliniske studier eller efter markedsføring, er opført i dette afsnit opdelt efter systemorganklasse i faldende orden efter frekvens og alvor.
English: • has any present or past medical problems after any dose of Prevenar or Prevenar 13 such as an allergic reaction or problems with breathing.
Danish: • har eller har haft medicinske problemer efter en dosis af Prevenar eller Prevenar 13, som f.eks. en allergisk reaktion eller problemer med vejrtrækningen.
English: Your child will receive an initial course of three injections.
Danish: Dit barn vil få en indledende serie på tre injektioner.
English: There was no reduction seen in serotype 3 and for serotype 5 the colonization was too infrequent to assess impact.
Danish: Der sås ingen reduktion i seroptype 3, og for serotype 5's vedkommende var kolonisering for sjælden til at eventuel indflydelse kunne vurderes.
English: OPA titres are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 %.
Danish: OPA-titre udtrykkes som den reciprokke værdi af den højeste serumfortynding, der reducerer overlevelsen af pneumokokkerne med mindst 50 %.
English: Five clinical studies were conducted in Europe and the USA evaluating the immunogenicity of Prevenar 13 in different age groups ranging from 18-95 years of age.
Danish: Der er udført 5 kliniske studier i Europa og USA, som vurderede immunogeniciteten af Prevenar 13 i forskellige aldersgrupper i intervallet 18-95 år.
English: IRR is calculated as the incidence in the placebo group minus the incidence in the vaccine group, and was mathematically equivalent to VE × the incidence in the placebo group.
Danish: IRR er beregnet som incidensen i placebogruppen minus incidensen i vaccinegruppen og var matematisk ækvivalent med VE × incidensen i placebogruppen.
English: Table 5: Vaccine efficacy (VE) for the primary and secondary endpoints of the CAPiTA study (per protocol population)
Danish: Tabel 5: Vaccineeffekt (VE) for de primære og sekundære endepunkter i CAPiTA-studiet (pr. protokol-population)
English: The need for revaccination with a subsequent dose of Prevenar 13 has not been established.
Danish: Behovet for revaccination med en efterfølgende dosis Prevenar 13 er ikke fastlagt.
English: The immunisation schedules for Prevenar 13 should be based on official recommendations.
Danish: Vaccinationsplanen for Prevenar 13 bør baseres på officielle anbefalinger.
English: The efficacy results from these studies (for invasive pneumococcal disease, pneumonia, and acute otitis media) are presented below (Table 3).
Danish: Resultater om den beskyttende effekt fra disse studier (for invasiv pneumokoksygdom, pneumoni og akut otitis media) præsenteres nedenunder (tabel 3).
English: In this age group, serotypes 1, 3, 5, 6A, 7F, and 19A account for 15.6% to 59.7% of invasive disease, depending on the country, the time period studied, and the use of Prevenar.
Danish: I denne aldersgruppe udgør serotyperne 1, 3, 5, 6A, 7F og 19A 15,6 % til 59,7 % af invasive sygdomme, afhængigt af land, den undersøgte tidsperiode, og anvendelsen af Prevenar.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på kartonen og etiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The active substances are polysaccharide CRM197 conjugates consisting of:
Danish: Aktive stoffer: Konjugeret CRM197 polysaccharid, der består af:
English: Bacteraemic pneumonia (approximately 80% of IPD in adults), bacteraemia without a focus, and meningitis are the most common manifestations of IPD in adults.
Danish: Bakteriæmisk pneumoni (ca. 80 % af IPD-tilfælde hos voksne), bakteriæmi uden fokus og meningitis er de hyppigste manifestationer af IPD hos voksne.
English: Prevenar 13 Relative to PPSV23, 60-64 Years
Danish: Prevenar 13 i forhold til PPSV23, 60-64 år
English: ≥65 years of age
Danish: ≥65 år
English: In a similar analysis, hospitalisations and ambulatory visits for all-cause pneumonia were reduced by 52.4 % and 41.1 %, respectively.
Danish: I en sammenlignelig analyse, blev indlæggelser og ambulante besøg for pneumoni af alle årsager reduceret med hhv. 52,4 % og 41,1 %.
English: Number needed to vaccinate
Danish: Nødvendig t antal vaccinemo dtagere
English: Prevenar 13 is for intramuscular use only.
Danish: Prevenar 13 er kun til intramuskulær anvendelse.
English: Effectiveness of Prevenar in a 3+1 schedule has also been observed against acute otitis media and pneumonia since its introduction in a national immunisation programme.
Danish: Effektiviteten af Prevenar i en 3+1 plan er også blevet observeret for akut otitis media og pneumoni siden vaccinen blev introduceret i et nationalt immuniseringsprogram.
English: Safety was assessed in 7 clinical studies including 91,593 adults ranging in age from 18 to 101 years.
Danish: Sikkerheden blev vurderet i 7 kliniske studier med deltagelse af 91.593 voksne i alderen 18-101 år.
English: Pyrexia (very common in adults aged 18 to 29 years)
Danish: Pyreksi (meget almindelig hos voksne i alderen 18-29 år).
English: See section 6.5 for the number of doses per container.
Danish: 6.5 vedrørende antal doser pr. beholder.
English: • has experienced seizures as medicines to lower fever may need to be taken before Prevenar 13 is given.
Danish: • har haft krampeanfald, da det kan det være nødvendigt at tage febernedsættende medicin, før Prevenar 13 gives.
English: Prevenar (7-valent vaccine) protective efficacy in infants and children
Danish: Beskyttende effekt af Prevenar (7-valent vaccine) hos spædbørn og børn
English: However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Danish: Tilstedeværelsen af en lettere infektion, såsom en forkølelse, bør dog ikke medføre, at vaccinationen udskydes.
English: A Poisson regression model with random effects was used to calculate VE.
Danish: Der blev anvendt en Poisson-regressionsmodel med stokastiske effekter til beregning af VE.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born  28 weeks of gestation), and particularly for those with a previous history of respiratory immaturity.
Danish: Den potentielle risiko for apnø og behovet for respiratorisk overvågning i 48-72 timer bør overvejes, når den primære immuniseringsserie administreres til børn, der er født meget for tidligt (født  28 ugers svangerskab), og især hos dem med en respiratorisk umodenhed i anamnesen.
English: Table 3: Summary of efficacy of 7-valent Prevenar
Danish: Tabel 3: Sammenfatning af effekten af 7-valent Prevenar
English: OPA geometric mean titers (GMTs) measured 1-month after each vaccination were calculated.
Danish: OPA-GMT (geometric mean titers), der blev målt 1 måned efter hver vaccination, blev beregnet.
English: A third dose is recommended in the second year of life.
Danish: En tredje dosis anbefales i barnets andet leveår.
English: 6A 7F 19A The serotype in Prevenar with the lowest percent response rate was 6B in study 006 (87.1 %).
Danish: 6A 7F 19A Serotypen i Prevenar med den laveste procentmæssige responsrate var 6B i studie 006 (87,1 %)
English: Acute otitis media (AOM) is a common childhood disease with different aetiologies.
Danish: Akut otitis media (Acute otitis media (AOM)) er en almindelig børnesygdom med forskellige ætiologier.
English: The preferred sites are the anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in children and adults.
Danish: De foretrukne steder er den anterolaterale side af låret (vastus lateralis-musklen) hos spædbørn eller i musculus deltoideus på overarmen hos børn og voksne.
English: Children and adolescents aged 2-17 years One single dose of 0.5 ml.
Danish: Børn og teenagere i alderen 2-17 år En enkelt dosis på 0,5 ml.
English: All seven common serotypes met pre-defined non-inferiority criteria for IgG ELISA GMCs.
Danish: Alle syv almindelige serotyper opfyldte de foruddefinerede kriterier for non-inferioritet for IgG ELISA GMC'er.
English: For the 7 common serotypes there were no differences between groups in the proportion of subjects with OPA titres ≥ 1:8.
Danish: For de 7 almindelige serotyper var der ingen forskel mellem grupperne på andelen af forsøgspersoner med OPA titre ≥ 1:8.
English: It is important to follow the instructions from the doctor, pharmacist, or nurse so that your child completes the course of injections.
Danish: Det er vigtigt at følge vejledningerne fra lægen, apoteket eller sygeplejersken, så Deres barn gennemfører vaccinationsserien.
English: Preterm infants (<37 weeks gestation)
Danish: Præmature spædbørn (< 37 svangerskabsuger)
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, local tolerance, and reproduction and developmental toxicity.
Danish: Prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter enkeltdosis og gentagne doser, lokal tolerance samt reproduktions- og udviklingstoksicitet.
English: Other medicines/vaccines and Prevenar 13
Danish: Brug af anden medicin/vacciner sammen med Prevenar 13
English: For 6 of the remaining 7 common serotypes, similar rates of NP acquisition were observed in both vaccine groups; for serotype 19F a significant reduction was observed.
Danish: For 6 af de resterende 7 fælles serotyper observeredes samme hyppighed af nasofanryngeal bærertilstand i de 2 vaccine-grupper; for serotype 19F observeredes en signifikant reduktion.
English: Prevenar 13 elicited functional antibodies to all 13 vaccine serotypes in studies 004 and 006.
Danish: Prevenar 13 fremkaldte funktionelle antistoffer over for alle 13 vaccineserotyper i studie 004 og 006.
English: Following the widespread use of Prevenar, the incidence of IPD has been consistently and substantially reduced.
Danish: Som følge af den udbredte anvendelse af Prevenar, er hyppigheden af IPD konstant blevet betydeligt reduceret.
English: First episode analysis
Danish: Analyse af første episode
English: Children < 2 years of age.
Danish: Børn < 2 år.
English: Talk to your doctor, pharmacist, or nurse before the vaccination if you or your child:
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken før vaccinationen, hvis De eller Deres barn:
English: 2-phenoxyethanol Water for injections
Danish: 2-phenoxyethanol Vand til injektionsvæsker
English: A third injection will be given in the second year of life.
Danish: En tredje indsprøjtning gives i barnets andet leveår.
English: Additional information in special populations
Danish: Yderligere information om særlige populationer
English: • Worsening or new pain in your joints, worsening or new pain in your muscles
Danish: • Forværring af eksisterende smerter eller nye smerter i led eller muskler
English: In children and adolescents aged 6 to 17 years, the incidence of pneumococcal disease is low, however, there is an increased risk of morbidity and mortality in those with underlying comorbidities.
Danish: Forekomsten af pneumokoksygdom hos børn og teenagere i alderen 5-17 år er lav, men der er en øget risiko for morbiditet og mortalitet ved underliggende komorbiditet.
English: In general, adverse events reported with overdose are consistent with those that have been reported with doses given in the recommended paediatric schedules of Prevenar 13.
Danish: Generelt er de uønskede hændelser, som blev indberettet ved overdosering, i overensstemmelse med de hændelser, som blev indberettet med doser givet i de anbefalede pædiatriske tidsplaner for Prevenar 13.
English: Overall, the frequency categories were similar for all age groups, with the exception of vomiting which was very common ( 1/10) in adults aged 18 to 49 years and common ( 1/100 to < 1/10) in all other age groups, and pyrexia was very common in adults aged 18 to 29 years and common in all other age groups.
Danish: Samlet set var frekvenskategorierne ens i alle aldersgrupper, med undtagelse af opkastning, som var meget almindelig ( 1/10) hos voksne i alderen 18-49 år og almindelig ( 1/100 til < 1/10) i alle andre aldersgrupper, og pyreksi, som var meget almindelig hos voksne i alderen 18-29 og almindelig i alle andre aldersgrupper.
English: The efficacy of 7-valent Prevenar was evaluated in two major studies - the Northern California Kaiser Permanente (NCKP) study and the Finnish Otitis Media (FinOM) study.
Danish: Virkningen af 7-valent Prevenar blev evalueret i to større studier - Northern California Kaiser Permanente (NCKP)-studiet, og det finske Otitis Media studie (FinOM).
English: As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness.
Danish: Som med andre vacciner skal administrationen af Prevenar 13 udskydes, hvis personer lider af en akut svær febersygdom.
English: S. pneumoniae is the most frequent cause of CAP, and is estimated to be responsible for approximately 30% of all CAP cases requiring hospitalisation in adults in developed countries.
Danish: S. pneumoniae er den hyppigste årsag til CAP, og den anslås at være ansvarlig for ca. 30 % af alle de indlæggelseskrævende tilfælde af CAP hos voksne i industrilandene.
English: In Table 6, NNV is a measure that quantifies the number of people that need to be vaccinated in order to prevent one clinical CAP case.
Danish: I tabel 6 er NNV et udtryk for antallet af personer, der skal vaccineres for at forebygge ét klinisk CAPtilfælde.
English: Since the introduction of 7-valent Prevenar in 2000, pneumococcal disease surveillance data have not shown that the immunity elicited by Prevenar in infancy has waned over time.
Danish: Siden markedsføringen af 7-valent Prevenar i 2000 har overvågningsdata for pneumokok-sygdomme ikke vist, at immuniteten, som blev fremkaldt af Prevenar i spædbarnsalderen, aftager med tiden.
English: Prevenar 13, provides protection against 13 types of Streptococcus pneumoniae bacteria, and replaces Prevenar, which provided protection against 7 types.
Danish: Prevenar 13 giver beskyttelse mod 13 typer af bakterien Streptococcus pneumoniae og erstatter Prevenar, som gav beskyttelse mod 7 typer.
English: Safety and immunogenicity data for Prevenar 13 are not available for individuals in other specific immuno-compromised groups (e.g., malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis.
Danish: Der findes ingen data for sikkerhed og immunogenicitet af Prevenar 13 for personer i andre specifikke immunkompromitterede grupper (f.eks. malignitet eller nefrotisk syndrom), og vaccination skal overvejes individuelt.
English: The annual overall pneumococcal incidence of OM declined from 9.6 to 2.1 cases per 1000 children (78%) between July 2004 (prior to the introduction of Prevenar) and June 2013 (post Prevenar 13 introduction).
Danish: Den samlede årlige hyppighed af pneumokok-OM faldt fra 9,6 til 2,1 tilfælde pr. 1.000 børn (78 %) mellem juli 2004 (før Prevenar blev introduceret) og juni 2013 (efter Prevenar 13 var introduceret).
English: NNV is not a rate but instead indicates the number of cases prevented for a given number of persons vaccinated.
Danish: NNV er ikke en rate men i stedet et udtryk for antallet af forebyggede tilfælde for et givet antal vaccinerede personer.
English: Prevenar 13 elicited comparable, although slightly lower, antibody levels than Prevenar for the 7 common serotypes.
Danish: Prevenar 13 fremkaldte sammenlignelige, om end lidt lavere, antistofniveauer end Prevenar for de 7 almindelige serotyper.
English: Invasive Pneumococcal Disease
Danish: Invasiv pneumokoksygdom
English: Additional Prevenar (7-valent) immunogenicity data: children with sickle cell disease The immunogenicity of Prevenar has been investigated in an open-label, multicentre study in 49 infants with sickle cell disease.
Danish: Yderligere Prevenar (7-valent) immunogenicitetsdata: børn med seglcelleanæmi Immunogeniciteten af Prevenar er blevet undersøgt i et open-label, multi-centerstudie med 49 spædbørn med seglcelleanæmi.
English: Confidence intervals (CIs) for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
Danish: Konfidensintervaller (CI) for ratioen er transformeret tilbage, af et konfidensinterval baseret på t-fordelingen for middeldifferensen af logaritmerne for målingerne.
English: In this study, reductions of S. pneumoniae serotypes 19A, 19F, and 6A not susceptible to a number of antibiotics were documented.
Danish: Dette studie dokumenterede en reduktion af S. pneumoniae 19A, 19F og 6A, som ikke var følsomme overfor forskellige antibiotika.
English: However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.
Danish: Nogle af de bivirkninger, der er nævnt under punkt 4 ”Bivirkninger”, kan dog midlertidigt påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: This vaccine should not be given as an intramuscular injection to individuals with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1).
Danish: Denne vaccine bør ikke gives som intramuskulær injektion til personer med trombocytopeni eller koagulopati, som kontraindicerer en intramuskulær injektion, men kan gives subkutant, hvis den potentielle fordel tydeligt opvejer risici (se pkt.
English: Correspondingly, OPA GMTs were similar in both groups, except for serotype 3, which was lower, and serotype 18C, which was higher, in the group that received Prevenar 13 with 2-PE.
Danish: Tilsvarende var OPA GMT'er ens i begge grupper undtagen for serotype 3, som var lavere, og serotype 18C som var højere i den gruppe, der fik Prevenar 13 med 2-PE.
English: Children (12-59 months) completely immunised with Prevenar (7-valent)
Danish: Børn i alderen 12-59 måneder, som er fuldt immuniseret med Prevenar (7-valent)
English: Prevenar 13 must not be mixed with any other vaccines in the same syringe.
Danish: Prevenar 13 må ikke blandes med andre vacciner i den samme injektionssprøjte.
English: - This vaccine has been prescribed for you or your child only.
Danish: - Lægen har ordineret denne vaccine til Dem eller Deres barn.
English: Conjugated to CRM197 carrier protein, adsorbed on aluminium phosphate.
Danish: Konjugeret til CRM197 bærerproteinet, adsorberet på aluminiumphosphat.
English: It is unknown whether pneumococcal 13-valent conjugate vaccine is excreted in human milk.
Danish: Det er ukendt, om 13-valent konjugeret pneumokokvaccine udskilles i human mælk.
English: The safety of the vaccine was assessed in controlled clinical studies where 14,267 doses were given to 4,429 healthy infants from 6 weeks of age at first vaccination and 11-16 months of age at booster dose.
Danish: Vaccinens sikkerhed blev vurderet i kontrollerede kliniske studier, hvor 14.267 doser blev givet til 4.429 raske spædbørn i alderen fra 6 uger ved første vaccination og i alderen 11-16 måneder ved booster-dosen.
English: After primary immunisation, 95.6 % of the subjects had antibody levels of at least 0.35 μg/ml for all seven serotypes found in Prevenar.
Danish: Efter primær immunisering havde 95,6 % af forsøgspersonerne antistofniveauer på mindst 0,35 μg/ml for alle syv serotyper, som findes i Prevenar.
English: There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women.
Danish: Der er ingen data fra anvendelse af 13-valent konjugeret pneumokokvaccine til gravide kvinder.
English: A post-hoc analysis was used to estimate the following public health outcomes against clinical CAP (as defined in the CAPiTA study, and based on clinical findings regardless of radiologic infiltrate or etiologic confirmation): vaccine efficacy (VE), incidence rate reduction (IRR), and number needed to vaccinate (NNV) (Table 6).
Danish: Der blev anvendt en post hoc-analyse til at estimere efterfølgende folkesundhedsresultater mod klinisk CAP (som defineret i CAPiTA-studiet og baseret på kliniske fund uanset radiologisk infiltrat eller ætiologisk bekræftelse): vaccineeffekt (VE), incidensratereduktion (IRR) og nødvendigt antal vaccinemodtagere (NNV) (tabel 6).
English: Limited data have demonstrated that Prevenar 7-valent (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 vist, at Prevenar 7-valent (primær serie med tre doser) inducerer et acceptabelt immunrespons hos børn med seglcelleanæmi med en sikkerhedsprofil svarende til, hvad der er observeret i ikke-højrisikogrupper (se pkt.
English: All serotypes: 73% Vaccine serotypes: 2-dose infant series: 99% Completed schedule:100%
Danish: Alle serotyper: 73 % Vaccineserotyper: Spædbørnsserie med 2 doser: 99 % Gennemført plan:100 %
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: En signifikant højere koncentration af antistoffer mod de syv serotyper sås efter polysaccharid-vaccinationen, hvilket tyder på, at den immunologiske hukommelse var veletableret.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23mg) pr. dosis, det vil sige at det praktisk taget er ”natriumfrit”.
English: The proportions of functional antibody responders (OPA titres ≥ 1:8) to serotypes 1, 3 and 5 were high.
Danish: Andelen af personer med funktionelle antistoffer (OPA titre ≥ 1:8) over for serotype 1, 3 og 5 var høj.
English: Responses to the booster dose administered at 12 months were unaffected.
Danish: Responset på boosterdosen indgivet efter 12 måneder blev ikke påvirket.
English: Table 6: Vaccine efficacy (VE) against clinical CAP
Danish: Tabel 6: Vaccineeffekt (VE) mod klinisk CAP
English: The effectiveness (both direct and indirect effect) of 7-valent Prevenar against pneumococcal disease has been evaluated in both three-dose and two-dose primary infant series immunisation programmes, each with booster doses (Table 4).
Danish: Effektiviteten (både direkte og indirekte virkning) af 7-valent Prevenar mod pneumokoksygdom er blevet evalueret i både immuniseringsprogrammer med primære spædbørnsserier med 3 og 2 doser, hver med booster-doser (tabel 4).
English: Unvaccinated infants and children ≥ 7 months of age
Danish: Ikke vaccinerede spædbørn og børn ≥ 7 måneder
English: In clinical studies, the safety profile of Prevenar 13 was similar to Prevenar.
Danish: I kliniske studier var sikkerhedsprofilen for Prevenar 13 sammenlignelig med sikkerhedsprofilen for Prevenar.
English: Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media.
Danish: Prevenar 13 vil kun beskytte mod de Streptococcus pneumoniae-serotyper, som er en del af vaccinen, og vil ikke beskytte mod andre mikroorganismer, som forårsager invasive sygdomme, pneumoni eller otitis media.
English: Prevenar 13 was administered to 48,806 adults; 2,616 (5.4%) aged 50 to 64 years, and 45,291 (92.8%) aged 65 years and older.
Danish: Prevenar 13 blev administereret til 48.806 voksne, 2.616 (5,4 %) i alderen 50-64 år og 45.291 (92,8 %) over 65 år.
English: See also section 4.
Danish: Se også punkt 4.