FrancophonIA/ELRC3.0 huggingface dataset:
English: A third injection (booster) will be given in the second year of life with at least two months apart.
Danish: En tredje indsprøjtning (booster) skal gives i dit barns andet leveår mindst to måneder efter forrige indsprøjtning.
English: In the interim analysis (ATP cohort), the vaccine efficacy against first episodes of CAP with alveolar consolidation or pleural effusion (C-CAP, WHO definition) was 25.7% (95% CI: 8.4; 39.6) and against first episodes of clinically suspected CAP referred for X-ray was 6.7% (95% CI: 0.7; 12.3).
Danish: I interimanalysen (ATP-kohorte) var vaccinens effekt mod første tilfælde af CAP med alveolær konsolidering eller pleuraeffusion (C-CAP, WHO definition) 25,7 % (95 % CI 8,4; 39,6) og mod første tilfælde af klinisk mistænkt CAP henvist til røntgenundersøgelse 6,7 % (95 % CI 0,7; 12,3).
English: A clinical study conducted in South Africa assessed the immunogenicity of Synflorix after 3-dose (610-14 weeks of age) or 2-dose (6-14 weeks of age) priming followed by a booster dose at 9-10 months of age.
Danish: Et klinisk studie udført i Sydafrika vurderede Synflorix' immunogenicitet efter 3-dosisprogram (6-1014 ugers alderen) eller 2-dosisprogram (6-14 ugers alderen) efter primær vaccination, efterfulgt af en booster dosis ved 9-10 måneders alderen.
English: The percentage of subjects with OPA titres ≥ 8 and GMTs observed post-primary and postbooster were lower in the 2-dose schedule than that in the 3-dose schedule.
Danish: Procentdelen af børn med OPA-titer ≥ 8 og GMT observeret post-primærvaccination og post-boostervaccination var lavere i vaccinationsprogrammet med 2 doser end i vaccinationsprogrammet med 3 doser.
English: In children as of 2 years of age, syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Danish: Synkope kan opstå efter og endda før vaccination hos børn fra 2-årsalderen som en psykogen reaktion på kanylestik.
English: Any pneumococcal serotype
Danish: Alle pneumokokserotyper
English: After a single dose of Synflorix, administered during the 4th year of life, as a challenge dose, the fold increase in ELISA antibody GMCs and OPA GMTs, pre to post vaccination, was similar in 2-dose primed subjects to that in 3-dose primed subjects.
Danish: Efter administration af en enkelt dosis Synflorix som belastningsdosis i det 4. leveår var forøgelsen i ELISA-antistof-GMC og OPA-GMT forud for post-vaccination sammenlignelige i 2dosis-gruppen og 3-dosis-gruppen.
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals S.A.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline Biologicals S.A.
English: A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
Danish: Der kan forekomme et fint, hvidt bundfald med en klar, farveløs supernatant ved opbevaring af hætteglasset.
English: MARKETING AUTHORISATION NUMBER(S) EU//1/09/508/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/508/009
English: Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Danish: Konjugeret pneumokokpolysaccharid-vaccine (adsorberet)
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: Det primære børnevaccinationsprogram består af tre doser, hvor den første dosis gives i 2-måneders alderen og med et interval på mindst 1 måned mellem doserne.
English: Relative rate reduction % (95% CI)
Danish: Relativ reduktion i forekomst1) % (95 % CI)
English: After first opening of the 4-dose vial, the vaccine may be stored for a maximum of 28 days in a refrigerator (2°C - 8°C).
Danish: Efter anbrud af hætteglasset med 4 doser kan vaccinen opbevares i maksimalt 28 dage i køleskab (2 °C - 8 °C).
English: Synflorix schedule
Danish: Synflorix Program
English: After the booster dose a lower percentage of subjects with OPA titres ≥ 8 was observed in the 2-dose schedule for serotypes 5 (87.2% versus 97.5% for the 3dose primed subjects) and 6B (81.1% versus 90.3%), all other responses were comparable.
Danish: Efter boostervaccinationen sås en lavere procentdel af børn med OPA-titer ≥ 8 i 2-dosis-gruppen for serotyperne 5 (87,2 % versus 97,5 % for 3-dosis-gruppen) og 6B (81,1 % versus 90,3 %).
English: • The other ingredients are sodium chloride (see section 2 for further information) and water for injections
Danish: • Øvrige indholdsstoffer: natriumchlorid (se punkt 2 for yderligere information) og vand til injektionsvæsker
English: 3 conjugated to tetanus toxoid carrier protein
Danish: 3 konjugeret til tetanus-toksoid-bærerprotein
English: Multidose vial For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: Flerdosisbeholder Opbevaringsforhold efter anbrud, se pkt.
English: • Store in a refrigerator (2 °C - 8 °C).
Danish: • Opbevares i køleskab (2 °C - 8 °C).
English: Synflorix is a pneumococcal conjugate vaccine.
Danish: Synflorix er en konjugeret pneumokokvaccine, der er koblet til et bærerprotein (konjugeret).
English: Synflorix suspension for injection in pre-filled syringe Synflorix suspension for injection Synflorix suspension for injection in multidose container (2 doses) Synflorix suspension for injection in multidose container (4 doses)
Danish: Synflorix injektionsvæske, suspension i fyldt injektionssprøjte Synflorix injektionsvæske, suspension Synflorix injektionsvæske, suspension i flerdosisbeholder (2 doser) Synflorix injektionsvæske, suspension i flerdosisbeholder (4 doser)
English: Preterm newborn infants (born between 27-36 weeks gestation)
Danish: Præmature spædbørn (født i 27.
English: Post-primary antibody geometric mean concentrations (GMCs) elicited by Synflorix against the seven serotypes in common were lower than those elicited by 7-valent Prevenar.
Danish: De geometrisk gennemsnitlige antistofkoncentrationer (antistof-GMC) efter primær dosis, som Synflorix fremkaldte mod de fælles 7 serotyper, var lavere end dem, som 7-valent Prevenar fremkaldte.
English: In clinical studies the immunogenicity of Synflorix was evaluated after a 3-dose primary vaccination series (6941 subjects) according to different schedules (including 6-10-14 weeks, 2-3-4, 3-4-5 or 2-4-6 months of age) and after a fourth (booster) dose (5645 subjects) given at least 6 months after the last primary dose and from the age of 9 months onwards.
Danish: I kliniske studier er Synflorix' immunogenicitet blevet vurderet efter et primært vaccinationsprogram med tre doser (6.941 personer) i henhold til forskellige programmer (ved 6-10-14-ugers alderen, ved 2-3-4-, 3-4-5- eller 2-4-6-måneders alderen), og efter en fjerde dosis (boosterdosis) (5.645 personer) givet mindst 6 måneder efter den sidste dosis i det primære program, og den kan gives fra en alder på 9 måneder og opefter.
English: In COMPAS, serotypes 5 (2 cases), 18C (4 cases) and 23F (1 case) were detected in control group in addition to serotypes 6B and 14.
Danish: (2 tilfælde), 18C (4 tilfælde) og 23F (1 tilfælde) i kontrolgrupperne.
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: Det primære vaccinationsprogram til spædbørn 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: At the end of this IA or end-of-study ATP follow-up period, the mean age was 29 months (range from 4 to 41 months) and 36 months (range from 4 to 50 months), respectively.
Danish: Ved afslutning af opfølgningsperioden var gennemsnitsalderen henholdsvis 29 måneder (interval 4-41 måneder) og 36 måneder (interval 4-50 måneder) i interinanalysen og den endelige studieanalyse.
English: At the end-of-study analysis (ATP cohort), the vaccine efficacy (first episodes) against B-CAP was 18.2% (95% CI: 4.1; 30.3), against C-CAP 22.4% (95% CI: 5.7; 36.1) and against clinically suspected CAP referred for X-ray 7.3% (95% CI: 1.6; 12.6).
Danish: I den endelige studieanalyse (ATP-kohorte) var vaccinens effekt (første tilfælde) 18,2 % (95 % CI 4,1; 30,3) mod B-CAP, 22,4 % (95 % CI 5,7; 36,1) mod C-CAP og 7,3 % (95 % CI 1,6; 12,6) mod klinisk mistænkt CAP henvist til røntgenundersøgelse.
English: Overall, for each vaccine serotype at least 97.6% of subjects achieved ELISA antibody concentrations ≥ 0.20 µg/ml and at least 91.9% achieved OPA titres ≥ 8.
Danish: Generelt opnåede mindst 97,6 % af børnene ELISA-antistofkoncentation ≥ 0,20 µg/ml og mindst 91,9 % opnåede en OPA-titer ≥ 8 for hver vaccineserotype.
English: A booster (third) dose is recommended at least 6 months after the last primary dose and may be given from the age of 9 months onwards (preferably between 12 and 15 months of age) (see section 5.1).
Danish: Det anbefales at give en boosterdosis (tredje dosis) mindst 6 måneder efter den sidste dosis i det primære program, og den kan gives fra en alder på 9 måneder og opefter (optimalt i alderen 12-15 måneder) (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in multidose container (2 doses) 100 MULTIDOSE vials (2 doses per vial - 0.5 ml per dose)
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, suspension i flerdosisbeholder (2 doser) 100 hætteglas, FLERDOSISBEHOLDER (2 doser pr. hætteglas - 0,5 ml pr. dosis)
English: cohort, vaccine efficacy against first clinical AOM episode was 19% (95% CI: 4.4; 31.4).
Danish: Vaccineeffekten mod det første tilfælde af klinisk AOM var dog 19 % i TV-kohorten (95 % CI 4,4; 31,4).
English: ≥ 0.20 µg/ml (ELISA)
Danish: ≥0,20 µg/ml (ELISA) Efter primærprogram
English: After the booster dose the GMCs elicited by Synflorix were lower for most serotypes in common with 7-valent Prevenar.
Danish: Efter boostervaccinationen var de GMCs, som Synflorix fremkaldte, lavere for de fleste serotyper, som er fælles for 7-valent Prevenar og Synflorix.
English: Table 8: Percentage of 3-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Danish: Tabel 8: Procentdel af børn, som efter et primært program med 3 doser havde antistofkoncentrationer ≥ 0,20 µg/ml målt en måned efter hhv. primær- og boosterdosis
English: OPA titre ≥ 8 for each vaccine serotype was comparable or higher in the catch-up group than in the 3dose primed infants.
Danish: Andelen af børn med en ELISA-antistofkoncentration ≥ 0,20 µg/ml eller en OPA-titer ≥ 8 for hver vaccineserotype var sammenlignelig eller højere i catch-up-gruppen end hos de spædbørn, som havde fået et 3-dosis primærprogram.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL MULTIDOSE (4 DOSES), PACK OF 10, 100
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE HÆTTEGLAS, FLERDOSISBEHOLDER (4 DOSER), PAKNING MED 10, 100
English: In clinical studies the immunogenicity of Synflorix was evaluated after a 2-dose primary vaccination series (470 subjects) according to different schedules (including 6-14 weeks, 2-4 or 3-5 months of age) and after a third (booster) dose (470 subjects) given at least 6 months after the last primary dose and from the age of 9 months onwards.
Danish: I kliniske studier er Synflorix' immunogenicitet blevet vurderet efter et primært vaccinationsprogram med 2 doser (470 personer) i henhold til forskellige programmer (ved 6-14-ugers alderen, ved 2-4eller 3-5-måneders alderen), og efter en tredje dosis (boosterdosis) (470 personer) givet mindst 6 måneder efter den sidste dosis i det primære program, og den kan gives fra en alder på 9 måneder og opefter.
English: Each injection will be given at least two months apart.
Danish: Der skal være mindst to måneder mellem indsprøjtningerne.
English: Pack size of 1, 10 or 100.
Danish: Pakningsstørrelse på 1, 10 eller 100 hætteglas.
English: Very common (these may occur with more than 1 in 10 doses of the vaccine)
Danish: Meget almindelige (kan forekomme ved flere end 1 ud af 10 vaccinedoser):
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL MULTIDOSE (2 DOSES), PACK OF 100
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE HÆTTEGLAS, FLERDOSISBEHOLDER (2 DOSER), PAKNING MED 100
English: • Suspension for injection in multidose container (2 doses)
Danish: • Injektionsvæske, suspension i flerdosisbeholder (2 doser).
English: 50 doses (0.5 ml)
Danish: 50 doser (0,5 ml)
English: • Synflorix is available in vials for 2 doses in a pack of 100.
Danish: • Synflorix fås i hætteglas med 2 doser i pakninger på 100.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/012 - pack of 10
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/508/012 - pakning med 10
English: A different place for the injection will be used for each vaccine.
Danish: De forskellige vacciner vil blive indsprøjtet på forskellige steder.
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: Ved primær immunisering af meget for tidligt fødte børn (fødsel ≤ uge 28 i svangerskabet) skal den potentielle risiko for apnø og behov for respiratorisk overvågning i 48-72 timer overvejes, specielt for respiratorisk immature børn.
English: Anti-6B 63.1 Anti-7F 99.3 Anti-9V 99.3 Anti-14 100 Anti-18C 99.3 Anti-19F 96.1 Anti-23F 77.6
Danish: Anti-1 98,7 Anti-4 99,3 Anti-5 100 Anti-6B 63,1 Anti-7F 99,3 Anti-9V 99,3 Anti-14 100 Anti-18C 99,3 Anti-19F 96,1 Anti-23F 77,6
English: EU/1/09/508/013 - pack of 100
Danish: EU/1/09/508/013 - pakning med 100
English: CI Confidence Interval (1) In FinIP apart from serotypes 6B and 14, culture-confirmed vaccine serotype IPD cases included 7F (1 case in the Synflorix 2+1 clusters), 18C, 19F and 23F (1 case of each in the control clusters).
Danish: inkluderede 7F (1 tilfælde i Synflorix 2+1-grupperne), 18C, 19F og 23F (1 tilfælde af hver i kontrol-grupperne).
English: How Synflorix is given
Danish: Sådan gives Synflorix
English: In FinIP the overall observed VE against culture-confirmed IPD was 100% (95% CI: 85.6; 100; 0 versus 14 cases) for the 3+1 schedule, 85.8% (95% CI: 49.1; 97.8; 2 versus 14 cases) for the 2+1 schedule and 93.0% (95% CI: 74.9; 98.9; 2 versus 14 cases) regardless of the primary vaccination schedule.
Danish: 0 versus 14 tilfælde) for 3+1-vaccinationsprogrammet, 85,8 % (95 % CI 49,1-97,8; 2 versus 14 tilfælde) for 2+1-vaccinationsprogrammet og 93,0 % (95 % CI 74,9-98,9; 2 versus 14 tilfælde) uanset primært vaccinationsprogram.
English: Table 7: Percentage of 2-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Danish: Tabel 7: Procentdel af børn, som efter et primært program med 2 doser havde antistofkoncentrationer ≥ 0,20 µg/ml målt en måned efter hhv. primær- og boosterdosis
English: Pneumococcal polysaccharide serotype 18C1,3
Danish: Pneumokokpolysaccharid serotype 18C1,3
English: The vaccine should be allowed to reach room temperature before use.
Danish: Vaccinen skal have stuetemperatur, før den anvendes.
English: A booster (fourth) dose is recommended at least 6 months after the last primary dose and may be given from the age of 9 months onwards (preferably between 12 and 15 months of age) (see sections 4.4 and 5.1).
Danish: Det anbefales at give en boosterdosis (fjerde dosis) mindst 6 måneder efter den sidste dosis i det primære program, og den kan gives fra en alder på 9 måneder og opefter (optimalt i alderen 12-15 måneder) (se pkt.
English: • Suspension for injection in multidose container (4 doses)
Danish: • Injektionsvæske, suspension i flerdosisbeholder (4 doser).
English: Pneumococcal polysaccharide serotype 6B1,2
Danish: Pneumokokpolysaccharid serotype 6B1,2
English: 4 conjugated to diphtheria toxoid carrier protein
Danish: 4 konjugeret til difteri-toksoid-bærerprotein
English: Post-booster
Danish: Efter boosterdosis
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) for 1 dose with a plunger stopper (butyl rubber) with or without needles.
Danish: 0,5 ml suspension i fyldt injektionssprøjte (type I-glas) til 1 dosis med en stempelprop (butylgummi) med eller uden kanyler.
English: Pre-filled syringe EU/1/09/508/001 EU/1/09/508/002 EU/1/09/508/003 EU/1/09/508/004 EU/1/09/508/005 EU/1/09/508/010
Danish: EU/1/09/508/003 EU/1/09/508/004 EU/1/09/508/005 EU/1/09/508/010
English: Uncommon Diarrhoea, vomiting
Danish: Diarré, opkastning
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/006 - pack of 1
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/508/006 - pakningsstørrelse på 1
English: (5) in the ATP cohort VE was 100% (95% CI: 74.3; 100; 0 versus 16 cases)
Danish: (3) p-værdi < 0,0001 (4) p-værdi = 0,0009 (5) VE var 100 % (95 % CI 74,3-100; 0 versus 16 tilfælde) i ATP-kohorten
English: 92.7% of subjects achieved ELISA antibody concentrations ≥ 0.20 µg/ml and at least 81.7% achieved OPA titres ≥ 8 except serotype 1 (at least 58.8% with OPA titres ≥ 8).
Danish: En måned efter den primære vaccination (dvs. efter tredje dosis) havde mindst 92,7 % af børnene opnået ELISA-antistofkoncentration ≥ 0,20 µg/ml og mindst 81,7 % opnåede en OPA-titer ≥ 8 for hver vaccineserotype, bortset fra serotype 1 (mindst 58,8 % havde en OPA-titer ≥ 8).
English: • Synflorix is available in vials for 4 doses in packs of 10 or 100.
Danish: • Synflorix fås i hætteglas med 4 doser i pakninger på 10 eller 100.
English: Pneumococcal polysaccharide serotype 9V1,2
Danish: Pneumokokpolysaccharid serotype 9V1,2
English: Very rare ( these may occur with up to 1 in 10,000 doses of the vaccine)
Danish: Meget sjælden (kan forekomme ved op til 1 ud af 10.000 vaccinedoser)
English: 10 doses (0.5 ml)
Danish: 10 doser (0,5 ml)
English: The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 2 years of age with conditions (such as sickle cell disease,
Danish: Administration af konjugeret pneumokokvaccine erstatter ikke administration af 23-valent pneumokokpolysaccharidvaccine hos børn ≥ 2 år med høj risiko for invasive sygdomme forårsaget af Streptococcus pneumoniae (f.eks. børn med seglcelleanæmi, aspleni, hiv-infektion, kronisk sygdom eller som har andre immunkompromitterede tilstande).
English: Antibody
Danish: Antistof
English: Instructions for administration of the vaccine presented in pre-filled syringe 1.
Danish: Instruktion for administration af vaccine i fyldt injektionssprøjte:
English: • Synflorix is available in vials for 1 dose in packs of 1, 10 or 100
Danish: • Synflorix fås i hætteglas til 1 dosis i pakninger på 1, 10 eller 100.
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2 - 8 °C).
English: 2 ml of suspension in a vial (type I glass) for 4 doses with a stopper (butyl rubber).
Danish: 2 ml suspension i hætteglas (type I-glas) til 4 doser med en prop (butylgummi).
English: Pneumococcal polysaccharide serotype 19F1,4
Danish: Pneumokokpolysaccharid serotype 19F1,4
English: In clinical trials, Synflorix elicited an immune response to all ten serotypes included in the vaccine, but the magnitude of the responses varied between serotypes.
Danish: I kliniske studier blev et immunrespons fremkaldt for alle ti serotyper i vaccinen.
English: Following booster vaccination, children > 12 months of age are more likely to experience injection site reactions compared to the rates observed in infants during the primary series with Synflorix.
Danish: Der er større sandsynlighed for, at børn over 12 måneder oplever reaktioner på administrationsstedet efter boostervaccination, sammenlignet med sandsynligheden hos spædbørn under det primære vaccinationsprogram.
English: The content of the vial should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Danish: Før administration og både før og efter omrystning skal indholdet i hætteglasset inspiceres visuelt for fremmedlegemer og/eller usædvanligt fysisk udseende.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4 doses (0.5 ml/dose)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 4 doser (0,5 ml/dosis)
English: Local reactogenicity of primary vaccination course was similar in infants < 12 months of age and in children > 12 months of age except for injection site pain for which the incidence increased with increasing age: pain was reported by more than 39% of the infants < 12 months of age and by more than 58% of the children > 12 months of age.
Danish: Smerter blev rapporteret hos flere end 39 % af spædbørnene under 12 måneder og hos flere end 58 % af børnene over 12 måneder.
English: A booster (fourth) dose is recommended at least 6 months after the last primary dose (see sections 4.4 and 5.1).
Danish: Det anbefales at give en boosterdosis (fjerde dosis) mindst 6 måneder efter den sidste dosis i det primære program (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MULTIDOSE (4 DOSES)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS, FLERDOSISBEHOLDER (4 DOSER)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MULTIDOSE (2 DOSES)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS, FLERDOSISBEHOLDER (2 DOSER)
English: Each injection will be given at least one month apart.
Danish: Der skal være mindst en måned mellem indsprøjtningerne.
English: Two-dose primary series
Danish: Hætteglas med 2 doser
English: Pneumococcal polysaccharide serotype 23F1,2
Danish: Pneumokokpolysaccharid serotype 23F1,2
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (butyl rubber).
Danish: 1 ml suspension i hætteglas (type I-glas) til 2 doser med en prop (butylgummi).
English: For the cross-reactive serotype 19A, similar ELISA antibody GMCs were observed post-primary and post-booster for the 2-dose schedule [0.14 µg/ml (95% CI: 0.12; 0.17) and 0.73 µg/ml (95% CI: 0.58; 0.92)] and the 3-dose schedule [0.19 µg/ml (95% CI: 0.16; 0.24) and 0.87 µg/ml (95% CI: 0.69; 1.11)].
Danish: (95 % CI: 0,12; 0,17) og 0,73 μg/ml (95 % CI: 0,58; 0,92)] og efter vaccinationsprogrammet med 3 doser [0,19 μg/ml (95 % CI: 0,16; 0,24) og 0,87 μg/ml (95 % CI: 0,69; 1,11)].
English: Synflorix can be given concomitantly with any of the following monovalent or combination vaccines [including DTPa-HBV-IPV/Hib and DTPw-HBV/Hib]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), hepatitis B vaccine (HBV), inactivated polio vaccine (IPV), Haemophilus influenzae type b vaccine (Hib), diphtheria-tetanus-whole cell pertussis vaccine (DTPw), measles-mumps-rubella vaccine (MMR), varicella vaccine (V), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), oral polio vaccine (OPV) and oral rotavirus vaccine.
Danish: (Hib), difteri-tetanus-helcelle-pertussis-vaccine (DTPw), mæslinge-fåresyge-røde hunde-vaccine (MFR), skoldkoppevaccine (V), meningokokserogruppe C konjugeret vaccine (CRM197 og TTkonjugater), meningokokgruppe A, C, W-135 og Y-konjugeret vaccine (TT-konjugeret), oral poliovaccine (OPV) og oral rotavirus-vaccine.
English: 0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (butyl rubber).
Danish: 0,5 ml suspension i hætteglas (type I-glas) til 1 dosis med en prop (butylgummi).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses (0.5 ml/dose)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 2 doser (0,5 ml/dosis)
English: Pneumococcal polysaccharide serotype 7F1,2
Danish: Pneumokokpolysaccharid serotype 7F1,2
English: The last injection (booster)
Danish: Den sidste indsprøjtning
English: may be given from the age of 9 months onwards.
Danish: (booster) må gives, når dit barn er 9 måneder og derover.
English: EU/1/09/508/008 - pack of 100
Danish: EU/1/09/508/008 - pakningsstørrelse på 100