FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 8 shows OPA GMTs 1-month after a single dose of Prevenar 13 in 18-49 year olds compared to 60-64 year olds.
Danish: Tabel 8 viser OPA-GMT 1 måned efter en enkelt dosis Prevenar 13 hos voksne i alderen 18-49-år sammenlignet med voksne i alderen 60-64-år.
English: In children and adolescents aged 10 to 17 years of age OPA GMTs 1 month after vaccination were noninferior to OPA GMTs in the 5 to 10 year old age group for 12 of the 13 serotypes (except serotype 3).
Danish: Hos børn og teenagere i alderen 10-17 år var OPA-GMT 1 måned efter vaccination non-inferiør i forhold til OPA-GMT i aldersgruppen 5-10 år for 12 af de 13 serotyper (undtaget serotype 3).
English: One of the 7 studies included a group of adults (n=899) ranging from 18 to 49 years who received Prevenar 13 and who were not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
Danish: Et af de 7 studier inkluderede en gruppe voksne i alderen 18-49 år (n=899), der fik Prevenar 13, og som ikke tidligere var blevet vaccineret med 23-valent pneumokok polysaccharidvaccine.
English: The responses to all three TIV antigens were comparable when TIV was given alone or concomitantly with Prevenar 13.
Danish: Immunresponsene på alle tre TIV-antigener var sammenlignelige, når TIV blev givet alene og samtidig med Prevenar 13.
English: Individuals with a blood-forming stem cell transplant may receive three injections, with the first given at 3 to 6 months after the transplant and with an interval of at least 1 month between doses.
Danish: Personer med bloddannende stamcelletransplantation kan få tre indsprøjtninger, hvor den første gives 3 til 6 måneder efter transplantationen og med et interval på mindst 1 måned mellem doserne.
English: Each injection will be given at least two months apart.
Danish: Hver indsprøjtning gives med mindst to måneders mellemrum.
English: The clinical significance of this observation is unknown.
Danish: Den kliniske signifikans af denne observation kendes ikke.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om Prevenar 13 findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: No data are currently available regarding concomitant use with other vaccines.
Danish: Der foreligger ikke data for samtidig administration af andre vacciner i øjeblikket.
English: Immune responses were assessed in 259-270 evaluable subjects approximately 1 month after each dose of vaccine.
Danish: Immunresponset blev vurderet hos 259-270 evaluerbare forsøgspersoner ca. 1 måned efter hver dosis vaccine.
English: For serotype 6A †, 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 greater than 2.
Danish: For serotype 6A †, 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: Reductions were 53% (167 to 79 cases) (p<0.001) for CAP cases with pleural effusion and 63% (64 to 24 cases) (p<0.001) for microbiologically confirmed pneumococcal CAP cases.
Danish: Reduktionerne var på 53 % (167 til 79 tilfælde) (p<0,001) for CAP-tilfælde med pleural effusion og 63 % (64 til 24 tilfælde) (p<0,001) for mikrobologisk bekræftede tilfælde af pneumokok-CAP. I det andet år efter introduktion af Prevenar 13 var det samlede antal CAP-tilfælde forårsaget af de 6 yderligere vaccineserotyper i Prevenar 13 reduceret fra 27 til 7 isolater (74 %).
English: OPA GMTs after the toddler dose relative to those after the infant series were similar or lower for 4 serotypes (4, 14, 18C, and 19F) and were statistically significantly higher for 6 of 13 serotypes (1, 3, 5, 7F, 9V, and 19A) in preterm infants compared to 10 of 13 serotypes (1, 3, 4, 5, 6A, 7F, 9V, 18C, 19A, and 23F) in term infants.
Danish: OPA-GMT efter boosterdosen var i forhold til OPA-GMT efter spædbørneserien på samme niveau eller lavere for 4 serotyper (4, 14, 18C og 19F) og var statistisk set signifikant højere for 6 ud af 13 serotyper (1, 3, 5, 7F, 9V og 19A) blandt præmature spædbørn sammenlignet med 10 ud af 13 serotyper (1, 3, 4, 5, 6A, 7F, 9V, 18C, 19A og 23F) blandt spædbørnene født til terminen.
English: 1 dose (0.5 ml) contains 2.2 µg of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F and 4.4 µg for serotype 6B conjugated to CRM197 carrier protein, adsorbed on aluminium phosphate.
Danish: 1 dosis (0,5 ml) indeholder 2,2 mikrogram polysaccharid for serotyperne 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F og 4,4 mikrogram for serotype 6B konjugeret til CRM197 bærerproteinet, adsorberet på aluminiumphosphat.
English: 60-64 Years N=359-404
Danish: 60-64 år N=359-404
English: Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Prevenar 13 and Infanrix hexa (see section 4.8).
Danish: Der er rapporteret en øget forekomst af krampeanfald (med eller uden feber) og hypotoniske hyporesponsive episoder, når Prevenar 13 administreres samtidig med Infanrix hexa (se pkt.
English: The first dose may be given as early as six weeks of age.
Danish: Den første dosis kan gives så tidligt som i 6-ugers alderen.
English: An open label single arm study in France, Italy, UK, US, Lebanon, Egypt and Saudi Arabia with 2 doses of Prevenar 13 given 6 months apart was conducted in 158 children and adolescents ≥ 6 to < 18 years of age with sickle cell disease who were previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine at least 6 months prior to enrollment.
Danish: Et åbent, enkeltarmet studie i Frankrig, Italien, Storbritannien, USA, Libanon, Egypten og SaudiArabien med 2 doser Prevenar 13 indgivet med 6 måneders mellemrum blev udført hos 158 børn og unge i alderen fra ≥ 6 til <18 år med seglcelleanæmi, som tidligere var vaccineret med en eller flere doser 23-valent pneumokok polysaccharidvaccine mindst 6 måneder før inklusion i studiet.
English: In the study 162 subjects had received one prior dose of 23-valent pneumococcal polysaccharide vaccine, 143 subjects 2 prior doses and 26 subjects more than 2 prior doses of 23-valent polysaccharide vaccine.
Danish: Studiet inkluderede 162 forsøgspersoner, der tidligere havde fået 1 dosis 23-valent pneumokok polysaccharidvaccine, 143 forsøgspersoner, der tidligere havde fået 2 doser, og 26 forsøgspersoner, der tidligere havde fået mere end 2 doser 23-valent pneumokok polysaccharidvaccine.
English: Immune responses were assessed in 231-255 evaluable subjects approximately 1 month after each dose of Prevenar 13.
Danish: Immunrespons blev vurderet hos 231-255 evaluerbare forsøgspersoner ca. 1 måned efter hver dosis af Prevenar 13.
English: The most common adverse events in children and adolescents 6 to 17 years of age were:
Danish: De hyppigste bivirkninger hos børn i alderen 6-17 år:
English: 18C 1939 19A 19F 23F Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5.
Danish: 18C 19A 19F 23F Non-inferioritet blev defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 0,5.
English: No data are available regarding concomitant use with other vaccines.
Danish: Der foreligger ikke data for samtidig administration af andre vacciner.
English: Pivotal trials for Prevenar 13 were designed to show that functional OPA antibody responses for the 13 serotypes are non-inferior, and for some serotypes superior, to the 12 serotypes in common with the licensed 23-valent pneumococcal polysaccharide vaccine [1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A,
Danish: Pivotale forsøg af Prevenar 13 blev designet til at vise, at de funktionelle OPA antistofrespons for de 13 serotyper er non-inferiore og for visse serotyper superiore i forhold til de 12 serotyper, der er fælles med den markedsførte 23-valent pneumokok polysaccharidvaccine [1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] en måned efter vaccination.
English: Clinical studies with Prevenar 13 currently provide immunogenicity data in adults aged 18 years and older, including adults aged 65 and older previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine, 5 years prior to enrollment.
Danish: Kliniske studier af Prevenar 13 har for nylig leveret immunogenicitetsdata for voksne over 18 år, herunder voksne over 65 år, som tidligere er blevet vaccineret med en eller flere doser af 23-valent pneumokok polysaccharidvaccine 5 år før inklusion i studiet.
English: 1 dose (0.5 ml) contains approximately 32 µg CRM197 carrier protein, adsorbed on aluminium phosphate (0.125 mg aluminium).
Danish: 1 dosis (0,5 ml) indeholder ca. 32 µg CRM197 bærerprotein, adsorberet på aluminiumphosphat (0,125 mg aluminium).
English: • Enlarged lymph nodes or glands (lymphadenopathy) near the vaccination-site, such as under the arm
Danish: • Hævede lymfeknuder (lymfekirtler - lymfadenopati) tæt på vaccinationsstedet, såsom under armen.
English: Prevenar 13 contains the 7 pneumococcal capsular polysaccharides that are in Prevenar (4, 6B, 9V, 14, 18C, 19F, 23F) plus 6 additional polysaccharides (1, 3, 5, 6A, 7F, 19A) all conjugated to CRM197 carrier protein.
Danish: Prevenar 13 indeholder de 7 pneumokok kapsulære polysaccharider, som er indeholdt i Prevenar (4, 6B, 9V, 14, 18C, 19F, 23F), plus 6 yderligere polysaccharider (1, 3, 5, 6A, 7F, 19A) som alle er konjugeret til CRM197 bærerprotein.
English: Three-dose primary series
Danish: Primær serie med 3 doser
English: restless sleep; tenderness at the vaccination-site interfering with movement
Danish: urolig søvn, øget følsomhed på vaccinationsstedet, som påvirker bevægeligheden.
English: In individuals with an haematopoietic stem cell transplant (HSCT), the recommended immunisation series consists of four doses of Prevenar 13, each of 0.5 ml.
Danish: Hos personer, der har gennemgået en hæmatopoietisk stamcelletransplantation (HSCT), består den anbefalede vaccinationsserie af fire doser Prevenar 13 på hver 0,5 ml.
English: However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.
Danish: 4.8 ”Bivirkninger”, kan dog midlertidigt påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: • Redness, swelling, or hardness at the vaccination-site of more than 7 cm; crying
Danish: • Rødmen, hævelse eller hård infiltration på vaccinationsstedet i et område på mere end 7 cm,
English: Overdose with Prevenar 13 is unlikely due to its presentation as a single dose vial.
Danish: Overdosering med Prevenar 13 er ikke sandsynlig, da vaccinen leveres i et enkeltdosis-hætteglas.
English: After the second and third dose of Prevenar 13, immune responses were comparable or higher than those after the first dose.
Danish: Efter anden og tredje dosis Prevenar 13 var immunresponset sammenligneligt eller højere end efter første dosis.
English: The fourth (booster) dose is recommended between 11 and 15 months of age.
Danish: Den fjerde (booster) dosis anbefales i alderen 11-15 måneder.
English: Immune system disorders: Anaphylactic/anaphylactoid reaction including shock; angioedema
Danish: Anafylaktisk/anafylaktoid reaktion, herunder shock, angioødem.
English: Inspect visually for any foreign particulate matter and/or abnormal physical appearance; do not use if either are found.
Danish: Udfør en visuel inspektion for fremmedlegemer og partikler og/eller forandring af fysisk udseende.
English: Suspension for injection in single dose vial.
Danish: Injektionsvæske, suspension, i enkeltdosis-hætteglas.
English: After the second and third dose of Prevenar 13, immune responses were similar or higher than those after the first dose.
Danish: Efter anden og tredje dosis Prevenar 13 var immunresponset det samme eller højere end efter første dosis.
English: Infants and children who have previously received Prevenar may receive Prevenar 13 to complete the course of injections.
Danish: Spædbørn og børn, som tidligere er vaccineret med Prevenar, kan få Prevenar 13 til at fuldføre vaccinationsserien.
English: The immune responses to Prevenar 13 were noninferior when Prevenar 13 was given concomitantly with QIV compared to when Prevenar 13 was given alone.
Danish: Immunresponset på Prevenar 13 var non-inferiort, når Prevenar 13 blev givet samtidig med QIV, sammenlignet med Prevenar 13 givet alene.
English: Pack sizes of 1, 5, 10, 25 and 50.
Danish: Pakningsstørrelser på 1, 5, 10, 25 og 50.
English: Infants and children aged 6 weeks to 5 years
Danish: Spædbørn og børn i alderen 6 uger til 5 år
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaver af markedsføringstilladelsen og Fremstiller
English: 0.5 ml suspension for injection in pre-filled syringe (Type I glass) with a plunger stopper (latex-free chlorobutyl rubber) and protective-tip cap (latex-free isoprene bromobutyl rubber).
Danish: 0,5 ml injektionsvæske, suspension, i en fyldt injektionssprøjte (type I-glas) med en stempelprop (latexfri chlorbutylgummi) og en hætte til beskyttelse af spidsen (uklart latexfri isopren brombutylgummi).
English: The vaccine is a white suspension for injection, provided in a multidose container (4 x 0.5 ml doses).
Danish: Vaccinen er en hvid suspension til indsprøjtning, som leveres i en flerdosisbeholder (4 x 0,5 ml doser).
English: Children aged 2 to 17 years should receive one injection.
Danish: Børn i alderen fra 2 til 17 år skal have én indsprøjtning.
English: Pneumonia is the most common clinical presentation of pneumococcal disease in adults.
Danish: Voksne fra 18 år samt ældre personer Pneumoni er den hyppigste kliniske manifestation af pneumokoksygdom hos voksne.
English: Infants aged 7 to 11 months should receive two injections.
Danish: Spædbørn fra 7 til 11 måneder skal have to indsprøjtninger.
English: Skin and subcutaneous tissue disorders: Very common:
Danish: Hud og subkutane væv: Meget almindelig:
English: In adults aged 18-49 years, OPA GMTs to all 13 serotypes in Prevenar 13 were non-inferior to the Prevenar 13 responses in adults aged 60-64 years.
Danish: Hos voksne i alderen 18-49 år var OPA-GMT for alle 13 serotyper i Prevenar 13 non-inferiore i forhold til Prevenar 13-respons hos voksne i alderen 60-64 år.
English: • A rash causing itchy red blotches (erythema multiforme)
Danish: • Et udslæt, som giver kløende røde skjolder (erythema multiforme).
English: Individuals considered to be at a higher risk of pneumococcal infection (such as those with sickle cell disease or HIV infection), including those previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine, may receive at least one dose of Prevenar 13.
Danish: Personer, som anses for at have en højere risiko for pneumokokinfektion (f.eks. personer med seglcelleanæmi eller hiv-infektion), herunder dem, som tidligere er vaccineret med den 23-valente pneumokok polysaccharidvaccine, kan få mindst én dosis Prevenar 13.
English: In adults aged 50-59 years, OPA GMTs to all 13 serotypes in Prevenar 13 were non-inferior to the Prevenar 13 responses in adults aged 60-64 years.
Danish: Hos voksne i alderen 50-59 år var OPA-GMT'er for alle 13 serotyper i Prevenar 13 non-inferiore i forhold til Prevenar 13 respons hos voksne i alderen 60-64 år.
English: After the second dose immune responses were comparable to those after the first dose.
Danish: Efter den anden dosis var immunresponset sammenligneligt med responset efter den første dosis.
English: Children and adolescents with sickle cell disease, HIV infection, or an haematopoietic stem cell transplant have similar frequencies of adverse reactions, except that headaches, vomiting, diarrhoea, pyrexia, fatigue, arthralgia, and myalgia were very common.
Danish: Børn og unge med seglcelleanæmi eller hiv-infektion eller som har gennemgået en hæmatopoietisk stamcelletransplantation har en tilsvarende bivirkningshyppighed med undtagelse af hovedpine, opkastning, diarré, pyreksi, træthed, artralgi og myalgi, som var meget almindelige.
English: Vaccination-site erythema, induration/swelling > 7.0 cm; crying
Danish: Erytem, induration/hævelse > 7,0 cm på vaccinationsstedet, gråd.
English: Irritability; any vaccination-site erythema; induration/swelling or pain/tenderness; somnolence; poor quality sleep; vaccination-site tenderness (including impaired movement)
Danish: Irritabilitet, erytem på vaccinationsstedet, induration/hævelse eller smerte/ømhed på vaccinationsstedet (herunder nedsat bevægelighed), døsighed, dårlig søvnkvalitet.
English: • Seizures (or fits), including those caused by a high temperature
Danish: • Kramper, herunder kramper forårsaget af feber
English: • has a weakened immune system (such as due to HIV infection), you/she/he may not get the full benefit from Prevenar 13.
Danish: • har et svækket immunsystem (for eksempel på grund af hiv-infektion).
English: Prevenar 13 significantly reduced newly identified NP acquisition of the 6 additional serotypes (and serotype 6C) combined and of individual serotypes 1, 6A, 6C, 7F, 19A when compared with Prevenar.
Danish: Prevenar 13 reducerede signifikant nylig identificeret nasofaryngeal forekomst af de 6 yderligere serotyper (og serotype 6C) kombineret samt af serotype 1, 6A, 6C, 7F og 19A individuelt ved sammenligning med Prevenar.
English: Children and adults not previously vaccinated with a pneumococcal vaccine HIV-infected children and adults with CD4 ≥ 200 cells/µL (mean 717.0 cells/μL), viral load < 50,000 copies/ml (mean 2090.0 copies/ml), free of active AIDS-related illness and not previously vaccinated with a pneumococcal vaccine received 3 doses of Prevenar 13.
Danish: Børn og voksne, der ikke tidligere er vaccineret med en pneumokokvaccine Hiv-inficerede børn og voksne med CD4-tal ≥200 celler/µl (gennemsnit 717,0 celler/μl), virusmængde i blodet < 50.000 kopier/ml (gennemsnit 2090,0 kopier/ml), uden aktiv aids-relateret sygdom og ikke tidligere vaccineret med pneumokokvaccine fik 3 doser Prevenar 13.
English: 1, 5, 10, 25, 50 single dose vials
Danish: 1, 5, 10, 25, 50 enkeltdosishætteglas
English: Chills; fatigue; vaccination-site erythema; vaccination-site induration/swelling; vaccination-site pain/tenderness (severe vaccination-site pain/tenderness very common in adults aged 18 to 39 years); limitation of arm movement (severe limitation of arm movements very common in adults aged 18 to 39 years)
Danish: Kulderystelser, træthed, erytem på vaccinationsstedet, induration/hævelser på vaccinationsstedet, smerter/ømhed på vaccinationsstedet (svær smerte/ømhed på vaccinationsstedet meget almindelig hos voksne i alderen 18-39 år), begrænsning i armens bevægelighed (svær begrænsning i armens bevægelighed meget almindelig hos voksne i alderen 18-39 år).
English: In adults aged 60-64 years, OPA GMTs to Prevenar 13 were non-inferior to the OPA GMTs elicited to the 23-valent pneumococcal polysaccharide vaccine for the twelve serotypes common to both vaccines.
Danish: Hos voksne i alderen 60-64 år var OPA-GMT'er for Prevenar 13 non-inferiore i forhold til OPAGMT'er for 23-valent pneumokok polysaccharidvaccine for de tolv serotyper, der er fælles for begge vacciner.
English: Pneumococcal immune responses were compared using non-inferiority criteria, including the percentage of subjects with serum anti-polysaccharide serotype-specific IgG concentration ≥0.35 μg/ml and the comparison of IgG GMCs one month after the infant series.
Danish: Pneumokok-immunresponset blev sammenlignet vha. non-inferioritetskriterier, herunder procentdelen af forsøgspersoner med serum-anti-polysaccharid serotypespecifik IgG-koncentration ≥ 0,35 μg/ml samt sammenligning af IgG GMC'er en måned efter serierne med spædbørn.
English: Suspension for injection in multidose container (4 doses).
Danish: Injektionsvæske, suspension, i flerdosisbeholder (4 doser)..
English: Prevenar 13 significantly reduced NP carriage of the 6 additional serotypes (and serotype 6C) combined and individual serotypes 6C, 7F, 19A when compared with Prevenar.
Danish: Prevenar 13 reducerede signifikant hyppigheden af nasofaryngeal-bærere af de 6 yderligere serotyper (og serotype 6C) kombineret og af serotyperne 6C, 7F og 19A individuelt, når der sammenlignedes med Prevenar.
English: % Incidence reduction (95% CI*)
Danish: % reduktion i hyppighed (95 % CI*)
English: Subjects who received two or more previous doses of 23-valent pneumococcal polysaccharide vaccine showed a similar immune response compared with subjects who received a single previous dose.
Danish: De forsøgspersoner, der tidligere havde fået 2 eller flere doser 23-valent pneumokok polysaccharidvaccine, havde et tilsvarende immunrespons som de personer, der tidligere havde fået en enkelt dosis.
English: The first dose was administered at 3 to 6 months after HSCT.
Danish: Den første dosis blev indgivet 3-6 måneder efter stamcelletransplantationen.
English: One year after vaccination with Prevenar 13 in adults aged 70 years and over who were vaccinated with 23-valent pneumococcal polysaccharide vaccine, at least 5 years prior to study entry, 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 af voksne over 70 år, der var vaccineret med 23-valent pneumokok polysaccharidvaccine mindst 5 år inden inklusion i studiet, var OPA-titrene faldet sammenlignet med niveauet en måned efter vaccinationen, men OPA-titrene for alle serotyper forblev højere end niveauerne ved baseline:
English: The serotype specific reductions for each of the 5 additional serotypes in Prevenar 13 (no cases of serotype 5 IPD were observed) by age group are shown in Table 2 and ranged from 68% (serotype 3) to 100% (serotype 6A) for children less than 5 years of age.
Danish: De serotype-specifikke reduktioner for hver af de 5 yderligere serotyper i Prevenar 13 (der blev ikke observeret nogen tilfælde af serotype 5 IPD) vises efter aldersgruppe i tabel 2.
English: Adults ≥ 18 years and elderly
Danish: Voksne fra 18 år samt ældre personer
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på den fremstiller (fremstillere), der er ansvarlig(e) for batchfrigivelse
English: In clinical studies when Prevenar 13 was given 1 year after 23-valent pneumococcal polysaccharide vaccine the immune responses were lower for all serotypes compared to when Prevenar 13 was given to subjects not previously immunised with 23-valent pneumococcal polysaccharide vaccine.
Danish: I kliniske studier, hvor Prevenar 13 blev administreret 1 år efter 23-valent pneumokok polysaccharidvaccine, var immunresponset lavere for alle serotyper, sammenlignet med Prevenar 13 givet til personer, der ikke tidligere var blevet immuniseret med 23-valent polysaccharid pneumokokvaccine.
English: The following additional side effects have been seen with Prevenar 13 in infants and children up to 5 years of age in postmarketing experience
Danish: Følgende øvrige bivirkninger er set efter markedsføring hos spædbørn og børn i alderen op til 5 år ved brug af Prevenar 13:
English: In preterm infants, the recommended immunisation series consists of four doses, each of 0.5 ml.
Danish: Hos præmature spædbørn består den anbefalede vaccinationsserie af fire doser på hver 0,5 ml.
English: A fourth (booster) dose is recommended 6 months after the third dose (see section 5.1).
Danish: Det anbefales at give en fjerde dosis (booster) 6 måneder efter den tredje dosis (se pkt.
English: Each injection will be given at least one month apart.
Danish: Hver indsprøjtning gives med mindst en måneds mellemrum.
English: Booster responses following two-dose and three-dose primary infant series
Danish: Booster-respons hos spædbørn efter primære serier med to og tre doser
English: 1, 5, 10, 25, 50 multidose containers
Danish: 1, 5, 10, 25, 50 flerdosisbeholdere