FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 9: OPA GMTs in pneumococcal polysaccharide vaccinated adults aged ≥ 70 years given either Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine (PPSV23)
Danish: Tabel 9 - OPA-GMT'er hos voksne i alderen ≥ 70 år, som er vaccineret med pneumokok polysaccharidvaccine, og som har fået enten Prevenar 13 eller 23-valent pneumokok polysaccharidvaccine (PPSV23)
English: In adults vaccinated with pneumococcal polysaccharide vaccine at least 5 years prior to the clinical study, OPA GMTs to Prevenar 13 were non-inferior to the 23-valent pneumococcal polysaccharide vaccine responses for the 12 serotypes in common.
Danish: Hos voksne, vaccineret med pneumokok polysaccharidvaccine mindst 5 år før det kliniske studie, var OPA-GMT'er for Prevenar 13 non-inferiore i forhold til den 23-valente polysaccharidpneumokokvaccine med hensyn til immunresponsene på de 12 serotyper, der var fælles for de 2 vacciner.
English: Adverse reactions from Prevenar 13 postmarketing experience Although the following adverse drug reactions were not observed in the Prevenar 13 clinical studies in infants and children, the following are considered adverse drug reactions for Prevenar 13 as they were reported in the postmarketing experience.
Danish: Selvom nedenstående bivirkninger ikke blev observeret i kliniske studier hos spædbørn og børn med Prevenar 13, anses de for at være bivirkninger ved Prevenar 13, da de er set efter markedsføring.
English: Table 7: OPA GMTs in adults aged 60-64 years given Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine (PPSV23) and in adults aged 50-59 years given Prevenar 13
Danish: Tabel 7 OPA-GMT'er hos voksne i alderen 60-64 år, som har fået Prevenar 13 eller 23-valent pneumokok polysaccharidvaccine (PPSV23), og hos voksne i alderen 50-59 år, som har fået en enkeltdosis Prevenar 13
English: Children and adolescents 5-17 years
Danish: Børn og teenagere i alderen 5-17 år
English: The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Danish: Den primære spædbørnsserie består af tre doser, hvor den første dosis normalt gives i 2-måneders alderen, og med et interval på mindst 1 måned mellem doserne.
English: Overdose with Prevenar 13 is unlikely due to its presentation as a pre-filled syringe.
Danish: Overdosering med Prevenar 13 er ikke sandsynlig, da vaccinen leveres i en fyldt injektionssprøjte.
English: Pre-filled syringes:
Danish: Flerdosisbeholdere:
English: Adults previously vaccinated with 23-valent pneumococcal polysaccharide vaccine HIV-infected adults ≥ 18 years of age with CD4 ≥ 200 cells/µL (mean 609.1 cells/µL) and viral load < 50,000 copies/ml (mean 330.6 copies/ml), who were free of active AIDS-related illness and were previously vaccinated with 23-valent pneumococcal polysaccharide vaccine administered at least 6 months prior to enrollment, received 3 doses of Prevenar 13, at enrollment, 6 months, and 12 months after the first dose of Prevenar 13.
Danish: Voksne, der tidligere er vaccineret med 23-valent pneumokok polysaccharidvaccine Hiv-inficerede voksne i alderen ≥ 18 år med CD4-tal ≥ 200 celler/µl (gennemsnit 609,1 celler/µl) og virusmængde i blodet < 50.000 kopier/ml (gennemsnit 330,6 kopier/ml), der var uden aktiv aidsrelateret sygdom, og som tidligere var vaccineret med 23-valent pneumokok polysaccharidvaccine, som blev indgivet mindst 6 måneder før inklusion i studiet, fik 3 doser Prevenar 13 ved inklusion samt 6 måneder og 12 måneder efter den første dosis Prevenar 13.
English: The vaccine is a white suspension for injection, provided in a single-dose vial (0.5 ml).
Danish: Vaccinen er en hvid suspension til indsprøjtning, som leveres i enkeltdosis-hætteglas (0,5 ml).
English: Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5.
Danish: Non-inferioritet blev defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 0,5.
English: Adults 18-49 years not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
Danish: Voksne i alderen 18-49 år, som ikke tidligere er vaccineret med 23-valent pneumokok polysaccharidvaccine
English: • Fever; irritability; pain, tenderness, redness, swelling or hardness at the vaccination-site;
Danish: • Feber, irritabilitet, smerter, ømhed, rødmen, hævelse eller hård infiltration på vaccinationsstedet,
English: The third (booster) dose is recommended between 11 and 15 months of age (see section 5.1).
Danish: Den tredje (booster) dosis anbefales i alderen 11-15 måneder (se pkt.
English: The following frequencies are based on adverse reactions assessed in Prevenar 13 clinical studies in adults:
Danish: Nedenstående frekvenser er baseret på bivirkninger, der blev vurderet i kliniske studier med Prevenar 13 til voksne.
English: Suspension for injection in multidose container 1 multidose container (4 x 0.5 ml doses) 5 multidose containers (4 x 0.5 ml doses per containers) 10 multidose containers (4 x 0.5 ml doses per containers) 25 multidose containers (4 x 0.5 ml doses per containers) 50 multidose containers (4 x 0.5 ml doses per containers)
Danish: 1 flerdosisbeholder (4 x 0,5 ml doser) 5 flerdosisbeholdere (4 x 0,5 ml doser pr. beholder) 10 flerdosisbeholdere (4 x 0,5 ml doser pr. beholder) 25 flerdosisbeholdere (4 x 0,5 ml doser pr. beholder) 50 flerdosisbeholdere (4 x 0,5 ml doser pr. beholder)
English: Infants aged 6 weeks to 6 months of age
Danish: Spædbørn i alderen fra 6 uger til 6 måneder
English: • Irritability; pain, tenderness, redness, swelling or hardness at the vaccination-site; drowsiness;
Danish: • Irritabilitet, smerter, ømhed, rødmen, hævelse eller hårdhed på vaccinationsstedet, døsighed,
English: Multidose Container Label
Danish: Etiket til flerdosisbeholder
English: Infants aged 6 weeks-6 months
Danish: Spædbørn i alderen 6 uger - 6 måneder
English: Immune responses following a two-dose primary infant series
Danish: Immunrespons hos spædbørn efter en primær serie med to doser
English: †, which is unique to Prevenar 13, a statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR being greater than 2.
Danish: †, som er unik for Prevenar 13, blev et statistisk signifikant større respons defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 2.
English: Adults with a blood-forming stem cell transplant had similar side effects however the frequencies were very common for fever and vomiting.
Danish: Voksne med bloddannende stamcelletransplantation havde de samme bivirkninger, dog var feber og opkastning meget almindelige.
English: Suspension for injection 1 single-dose (0.5 ml) vial 5 single-dose (0.5 ml) vials 10 single-dose (0.5 ml) vials 25 single-dose (0.5 ml) vials 50 single-dose (0.5 ml) vials
Danish: 1 enkeltdosis (0,5 ml) i hætteglas 5 enkeltdoser (0,5 ml) i hætteglas 10 enkeltdoser (0,5 ml) i hætteglas 25 enkeltdoser (0,5 ml) i hætteglas 50 enkeltdoser (0,5 ml) i hætteglas
English: Serotypes
Danish: Serotyper
English: Regardless of prior pneumococcal vaccination status, if the use of 23-valent pneumococcal polysaccharide vaccine is considered appropriate, Prevenar 13 should be given first (see sections 4.5 and 5.1).
Danish: Hvis brugen af 23-valent pneumokok polysaccharidvaccine anses for hensigtsmæssig, skal Prevenar 13 gives først uanset tidligere pneumokokvaccinationsstatus (se pkt.
English: Vomiting; diarrhoea
Danish: Opkastning, diarré.
English: Individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as sickle cell disease or HIV infection) including those previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine may receive at least one dose of Prevenar 13 (see section 5.1).
Danish: Personer, som har underliggende sygdomme, der kan disponere for invasiv pneumokoksygdom (Invasive Pneumococcal Disease (IPD)) (såsom personer med seglcelleanæmi eller hiv-infektion), herunder dem, der tidligere er vaccineret med en eller flere doser 23-valent pneumokok polysaccharidvaccine, må få mindst én dosis Prevenar 13 (se pkt.
English: Nervous system disorders: Common:
Danish: Nervesystemet: Almindelig:
English: An increase in vaccination-site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with Prevenar 13.
Danish: I den primære serie med Prevenar 13 blev der hyppigere indberettet reaktioner på vaccinationsstedet hos børn over 12 måneder sammenlignet med spædbørn.
English: Statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR was greater than 1.
Danish: Statistisk signifikant større respons blev defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 1.
English: Relative to 60-64 Years
Danish: 18-49 år i forhold til 60-64 år
English: Prevenar (7-valent) effectiveness
Danish: Effektivitet af 7-valent Prevenar
English: Immune responses to Prevenar 13 and 23-valent pneumococcal polysaccharide vaccine were compared in a head to head trial in adults aged ≥ 70 years, who had received a single dose of pneumococcal polysaccharide vaccine at least 5 years before study vaccination.
Danish: Voksne, der tidligere er vaccineret med 23-valent pneumokok polysaccharidvaccine Immunresponsene på Prevenar 13 og 23-valent pneumokok polysaccharidvaccine blev sammenlignet i et head-to-head forsøg blandt voksne ≥ 70 år, som havde fået en enkeltdosis pneumokok polysaccharidvaccine mindst 5 år før studievaccinationen.
English: The OPA geometric mean titres for serotypes 1, 3 and 5 were lower than the titres for each of the other additional serotypes; the clinical relevance of this observation is unknown.
Danish: De geometriske gennemsnitstitre for OPA for serotyperne 1, 3 og 5 var lavere end titrene for hver af de andre yderligere serotyper.
English: Children and adolescents aged 6 to 17 years
Danish: Børn og teenagere i alderen 6-17 år
English: Table 7 compares the OPA GMTs, 1-month post-dose, in 60-64 year olds given either a single dose of Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine, and in 50-59 year olds given a single dose of Prevenar 13.
Danish: I tabel 7 sammenlignes OPA-GMT'er 1 måned efter dosis hos 60-64-årige, som enten har fået en enkeltdosis Prevenar 13 eller 23-valent pneumokok polysaccharidvaccine, og hos 50-59-årige, som har fået en enkeltdosis Prevenar 13.
English: In these two studies pneumococcal immune responses were compared using a set of non-inferiority criteria including the percentage of subjects with serum anti-polysaccharide serotype-specific IgG ≥ 0.35 μg/ml one month after the primary series and the comparison of IgG geometric mean concentrations (ELISA GMCs); in addition, functional antibody titres (OPA) between subjects receiving Prevenar 13 and Prevenar were compared.
Danish: I disse to studier blev pneumokok-immunresponset sammenlignet ved hjælp af en række noninferioritetskriterier, herunder procentdelen af forsøgspersoner med serum-anti-polysaccharid serotypespecifik-IgG ≥ 0,35 μg/ml en måned efter de primære serier, samt sammenligning af IgG geometriske gennemsnitskoncentrationer (ELISA GMC'er).
English: 2 ml (4 x 0.5 ml doses) suspension for injection in a container (Type I glass) with a latex-free grey chlorobutyl rubber stopper and sealed with an aluminum flip-off seal and a polypropylene flip-off cap.
Danish: 2 ml (4 x 0,5 ml doser) injektionsvæske, suspension, i beholder (type I-glas) med en latexfri, grå chlorbutylgummiprop, aluminiumforsegling og et polypropylenlåg til at skubbe af.
English: For each of the seven common serotypes, > 96% and >90 % of the Prevenar 13 recipients reached an OPA titre ≥ 1:8 one month after the primary series in studies 006 and 004, respectively.
Danish: De syv fælles serotyper opnåede alle i studie 006 og 004, at henholdsvis > 96 % og > 90 % af personerne, der fik Prevenar 13, havde en OPA titre ≥ 1:8 en måned efter den primære serie.
English: 1 single-dose (0.5 ml) pre-filled syringe with separate needle 1 single-dose (0.5 ml) pre-filled syringe without needle 10 single-dose (0.5 ml) pre-filled syringes with separate needles 10 single-dose (0.5 ml) pre-filled syringes without needle 50 single-dose (0.5 ml) pre-filled syringes with separate needles 50 single-dose (0.5 ml) pre-filled syringes without needle
Danish: 1 enkeltdosis (0,5 ml) i fyldt injektionssprøjte med en separat kanyle 1 enkeltdosis (0,5 ml) i fyldt injektionssprøjte uden kanyle 10 enkeltdoser (0,5 ml) i fyldte injektionssprøjter med separate kanyler 10 enkeltdoser (0,5 ml) i fyldte injektionssprøjter uden kanyler 50 enkeltdoser (0,5 ml) i fyldte injektionssprøjter med separate kanyler 50 enkeltdoser (0,5 ml) i fyldte injektionssprøjter uden kanyler
English: All pneumococcal AOM
Danish: Alle pneumokok AOM Vaccineserotype AOM s effekt
English: Recommended schedule
Danish: 1Per protokol
English: In an open-label study in 592 healthy children and adolescents including those with asthma (17.4%) who may be predisposed to pneumococcal infection, Prevenar 13 elicited immune responses to all 13 serotypes.
Danish: Prevenar 13 fremkaldte antistofrespons for alle 13 serotyper i et open-labelstudie med 592 raske børn og teenagere, herunder hos dem med astma (17,4 %), som kan være præ-disponerede for pneumokokinfektion.
English: One year after vaccination with Prevenar 13 OPA titers had declined compared to one month after vaccination, however, OPA titers for all serotypes remained higher than levels at baseline:
Danish: Et år efter vaccination med Prevenar 13 var OPA-titrene faldet sammenlignet med niveauet en måned efter vaccinationen, men OPA-titrene for alle serotyper forblev højere end niveauerne ved baseline:
English: After the first vaccination, Prevenar 13 elicited antibody levels measured by both IgG GMCs and OPA GMTs that were statistically significantly higher when compared to levels prior to vaccination.
Danish: Efter den første vaccination fremkaldte Prevenar 13 et antistofniveau, der målt efter både IgG-GMC og OPAGMT var statistisk signifikant højere sammenlignet med niveauet inden vaccination.
English: Immune responses following a three-dose primary infant series
Danish: Immunrespons hos spædbørn efter en primær serie med tre doser
English: Table 9 compares the OPA GMTs, 1-month post-dose, in pneumococcal polysaccharide vaccinated adults aged ≥ 70 years given a single dose of either Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine.
Danish: I tabel 9 sammenlignes OPA-GMT'er 1 måned efter dosis hos voksne i alderen ≥ 70 år, som er vaccineret med pneumokok polysaccharidvaccine, og som har fået en enkeltdosis af enten Prevenar 13 eller 23-valent pneumokok polysaccharidvaccine.
English: Pneumococcal polysaccharide serotype 9V
Danish: Pneumokok polysaccharid serotype 9V
English: The primary infant series consists of three doses, with the first dose given at 2 months of age and with an interval of at least 1 month between doses.
Danish: Den primære spædbørnsvaccinationsserie består af tre doser, hvor den første dosis gives i 2-månedersalderen, med et interval på mindst 1 måned mellem doserne.
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode)
Danish: • Kollaps eller shocklignende tilstand (bevidstløshed/kontaktløshed)
English: Prevenar 13 suspension for injection IM
Danish: Prevenar 13 injektionsvæske, suspension i.m.
English: Pneumococcal polysaccharide serotype 18C
Danish: Pneumokok polysaccharid serotype 18C
English: Sodium chloride, succinic acid, polysorbate 80, 2-phenoxyethanol and water for injections
Danish: Natriumchlorid, ravsyre, polysorbat 80, 2-phenoxyethanol og vand til injektionsvæsker
English: EU/1/09/590/002 - pack of 1 with separate needle EU/1/09/590/001 - pack of 1 without needle EU/1/09/590/004 - pack of 10 with separate needles EU/1/09/590/003 - pack of 10 without needle EU/1/09/590/006 - pack of 50 with separate needles EU/1/09/590/005 - pack of 50 without needle
Danish: EU/1/09/590/002 - pakning med 1 med separat kanyle EU/1/09/590/001 - pakning med 1 uden kanyle EU/1/09/590/004 - pakning med 10 med separate kanyler EU/1/09/590/003 - pakning med 10 uden kanyler EU/1/09/590/006 - pakning med 50 med separate kanyler EU/1/09/590/005 - pakning med 50 uden kanyler
English: Pneumococcal polysaccharide serotype 19A
Danish: Pneumokok polysaccharid serotype 19A
English: Pack sizes of 1, 5, 10, 25 and 50 vials.
Danish: Pakningsstørrelse på 1, 5, 10, 25 og 50 beholdere.
English: One year after vaccination with Prevenar 13 OPA titers had declined compared to one month after vaccination, however OPA titers for all serotypes remained higher than levels at baseline.
Danish: Et år efter vaccination med Prevenar 13 var OPA-titre faldet i sammenligning med en måned efter vaccination, men OPA-titre for alle serotyper var højere end baselineniveauerne.
English: Adults with HIV infection had similar side effects however the frequencies were very common for fever, vomiting and common for nausea.
Danish: Voksne med hiv-infektion havde en tilsvarende hyppighed af bivirkninger, dog var feber og opkastning meget almindelige og kvalme almindelig.
English: Blood and lymphatic system disorders: Lymphadenopathy (localised to the region of the vaccination-site)
Danish: Lymfadenopati (lokaliseret til området omkring vaccinationsstedet).
English: The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown (see section 5.1).
Danish: Den kliniske relevans af denne observation med hensyn til induktion af den immunologiske hukommelse over for serotype 3 kendes ikke (se pkt.
English: The primary series consists of three doses, with the first dose given at 3 to 6 months after HSCT and with an interval of at least 1 month between doses.
Danish: Den primære serie består af tre doser, hvor den første dosis gives 3 til 6 måneder efter stamcelletransplantationen med et interval på mindst 1 måned mellem doserne.
English: Pneumococcal polysaccharide serotype 6A
Danish: Pneumokok polysaccharid serotype 6A
English: Incidence rate reduction (95% CI)
Danish: Incidensrat ereduktion (95 % CI)
English: 0.5 ml suspension for injection in a vial (Type I glass) with a latex-free grey chlorobutyl rubber stopper and sealed with an aluminum flip-off seal and a polypropylene flip-off cap.
Danish: 0,5 ml injektionsvæske, suspension, i hætteglas (type I-glas) med en latexfri, grå chlorbutylgummiprop, aluminiumforsegling og et polypropylenlåg til at skubbe af.
English: The other ingredients are sodium chloride, succinic acid, polysorbate 80, 2- phenoxyethanol and water for injections.
Danish: Øvrige indholdsstoffer: Natriumchlorid, ravsyre, polysorbat 80, 2- phenoxyethanol og vand til injektionsvæsker.
English: Adults with an haematopoietic stem cell transplant have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common.
Danish: Voksne, der har gennemgået en hæmatopoietisk stamcelletransplantation, har en tilsvarende bivirkningshyppighed med undtagelse af pyreksi og opkastning, som var meget almindelige.
English: Nausea
Danish: Kvalme.
English: After the first dose, Prevenar 13 elicited antibody levels, measured by both IgG GMCs and OPA GMTs that were statistically significantly higher when compared to levels prior to vaccination.
Danish: Efter den første dosis fremkaldte Prevenar 13 et antistofniveau, der målt efter både IgG-GMC og OPA-GMT var statistisk signifikant højere end niveauet inden vaccination.
English: • children from 6 weeks to 17 years to help protect against diseases such as: meningitis (inflammation around the brain), sepsis or bacteraemia (bacteria in the blood stream), pneumonia (lung infection) and ear infections
Danish: • børn i alderen fra 6 uger til 17 år mod sygdomme såsom: meningitis (hjernehindebetændelse),
English: The functional antibody (OPA) geometric mean titres for serotypes 1, 3 and 5 were lower than the titres for each of the other additional serotypes; the clinical relevance of this observation for protective efficacy is unknown.
Danish: De geometriske gennemsnitstitre for funktionelle antistoffer (OPA) for serotype 1, 3 og 5 var lavere end titrene for hver af de andre yderligere serotyper.
English: The most common side effects (these may occur with more than 1 in 10 doses of the vaccine) are:
Danish: De mest almindelige bivirkninger (disse kan forekomme ved mere end 1 ud af 10 vaccinationer):
English: Urticaria or urticaria-like rash
Danish: Urticaria eller urticaria-lignende udslæt.
English: Prevenar 13 Effectiveness
Danish: Effektivitet af Prevenar 13
English: Rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) are:
Danish: Sjældne bivirkninger (disse kan forekomme ved op til 1 ud af 1000 vaccinationer):
English: For children aged from 7 months to 5 years, age appropriate catch-up immunisation schedules (as described in section 4.2) result in levels of anti-capsular polysaccharide IgG antibody responses to each of the 13 serotypes that are at least comparable to those of a three-dose primary series in infants.
Danish: 4.2) i niveauer af anti-kapsulær polysaccharid IgG-antistofrespons over for hver af de 13 serotyper, der som minimum var sammenlignelige med dem fra en primær spædbørnsserie med 3 doser.
English: Pneumococcal polysaccharide serotype 23F
Danish: Pneumokok polysaccharid serotype 23F
English: (2006) 2, 4, + 13 months
Danish: 2, 4 og 13 måneder
English: Pneumococcal polysaccharide serotype 7F
Danish: Pneumokok polysaccharid serotype 7F
English: EU/1/09/590/012 - pack of 1 multidose container EU/1/09/590/013- pack of 5 multidose containers EU/1/09/590/014- pack of 10 multidose containers EU/1/09/590/015 - pack of 25 multidose containers EU/1/09/590/016- pack of 50 multidose containers
Danish: EU/1/09/590/012 - pakning med 1 flerdosisbeholder EU/1/09/590/013 - pakning med 5 flerdosisbeholdere EU/1/09/590/014 - pakning med 10 flerdosisbeholdere EU/1/09/590/015 - pakning med 25 flerdosisbeholdere EU/1/09/590/016 - pakning med 50 flerdosisbeholdere
English: What Prevenar 13 is and what it is used for What you need to know before you or your child receives Prevenar 13 How Prevenar 13 is given
Danish: Det skal De vide, før De eller Deres barn får Prevenar 13 Sådan vil De eller Deres barn få Prevenar 13 Bivirkninger
English: Pneumococcal polysaccharide serotype 6B
Danish: Pneumokok polysaccharid serotype 6B
English: Adults with HIV infection have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common and nausea common.
Danish: Voksne med hiv-infektion har en tilsvarende bivirkningshyppighed med undtagelse af pyreksi og opkastning, som var meget almindelige, og kvalme som var almindelig.
English: Pneumococcal polysaccharide serotype 19F
Danish: Pneumokok polysaccharid serotype 19F
English: Prevenar 13 suspension for injection in multidose container IM
Danish: Prevenar 13 injektionsvæske, suspension, i flerdosisbeholder i.m.
English: Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions, with or without fever, and HHE when comparing groups which reported use of Prevenar 13 with Infanrix hexa to those which reported use of Prevenar 13 alone.
Danish: En analyse af bivirkninger rapporteret efter markedsføring i grupper, der fik administreret Prevenar 13 samtidig med Infanrix hexa, sammenlignet med grupper, der alene fik administreret Prevenar 13, antyder en potentiel øget risiko for krampeanfald, med eller uden feber, og for hypotoniske hyporesponsive episoder.
English: Sodium chloride, succinic acid, polysorbate 80 and water for injections
Danish: Natriumchlorid, ravsyre, polysorbat 80 og vand til injektionsvæsker
English: The following side effects include those reported for Prevenar 13 in children and adolescents (6 to 17 years of age):
Danish: Følgende øvrige bivirkninger er set hos børn og unge (i alderen 6-17 år) ved brug af Prevenar 13:
English: The other ingredients are sodium chloride, succinic acid, polysorbate 80 and water for injections.
Danish: Øvrige indholdsstoffer: Natriumchlorid, ravsyre, polysorbat 80 og vand til injektionsvæsker.