FrancophonIA/ELRC3.0 huggingface dataset:
English: A decline in antibody titers to PorA P1.4 and fHbp antigens (reaching 9%-10% and 12%-20% of subjects with an hSBA ≥ 1:5, respectively) has been observed in an additional study in children 4 years of age who received a full priming and booster schedule as infants.
Danish: Der er observeret et fald i antistoftitre mod PorA P1.4- og fHbp-antigener (hos henholdsvis 9-10 % og 12-20 % af forsøgspersoner med hSBA ≥ 1:5) i et yderligere studie med 4-årige børn, der havde fået det fulde primære og booster-vaccinationsprogram som spæde.
English: Uncommon (these may affect up to 1 in 100 people) - high fever (≥40°C) - seizures (including febrile seizures) - dry skin - paleness (rare after booster)
Danish: Ikke almindelige (disse kan forekomme hos op til 1 ud af 100 personer) - høj feber (40° C eller derover) - anfald (herunder feberkramper) - tør hud - bleghed (sjælden efter booster)
English: Immunogenicity in children 2 to 10 years of age
Danish: Imunogenicitet hos børn fra 2 til 10 år
English: Recombinant Neisseria meningitidis group B NHBA fusion/NadA/fHbp fusion proteins
Danish: Rekombinant Neisseria meningitidis gruppe B-NHBA fusion/NadA/fHbp-fusionsproteiner
English: - A booster will be given in the second year of life after an interval of at least 2 months from the second injection.
Danish: - Boosteren gives i det andet leveår med et interval på mindst to måneder efter den anden injektion.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bexsero suspension for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Bexsero injektionsvæske, suspension
English: The immunogenicity after two doses administered two months apart in children 6 months to 23 months of age has been documented in two studies whose results are summarised in Table 4.
Danish: Immunogenicitet efter to doser administreret med to måneders mellemrum hos børn fra 6 til 23 måneder er blevet undersøgt i to studier, hvis resultater er opsummeret i tabel 4.
English: Yes, one dose between 12 and 15 months of age with an interval of at least 6 months between the primary series and booster dose b, c
Danish: Ja, en dosis mellem 12 og 15 måneders alderen med et interval på mindst 6 måneder mellem den primære serie og boosterdosenb, c
English: 0, 2 months fHbp
Danish: 0, 2 måneder fHbp
English: In the same study the response to an additional dose administered 2 to 3 years after the booster was indicative of immunological memory as shown by a robust antibody response against all Bexsero antigens, ranging from 81% to 100% and from 70% to 99%, respectively.
Danish: I samme studie var responsen på en yderligere dosis administreret 2 til 3 år efter boosteren indikativ for immunologisk hukommelse som vist ved et robust antistofrespons mod alle Bexsero-antigener, variererende henholdsvis fra 81 % til 100 % og fra 70 % til 99 %.
English: White opalescent liquid suspension.
Danish: Hvid, opaliserende flydende suspension.
English: - The interval between each injection should be at least 1 month.
Danish: - Intervallet mellem injektionerne skal være mindst 1 måned.
English: Very common (these may affect more than 1 in 10 people) - fever (≥38ºC) - loss of appetite - tenderness at the injection site (including severe injection site tenderness resulting in crying when injected limb is moved) - painful joints - skin rash (children aged 12 to 23 months) (uncommon after booster) - sleepiness - feeling irritable - unusual crying - vomiting (uncommon after booster) - diarrhoea - headache
Danish: Meget almindelige (disse kan forekomme hos mere end 1 ud af 10 personer) - feber (38 °C eller derover) - appetitløshed - ømhed ved injektionsstedet (herunder svær ømhed ved injektionsstedet, som resulterer i gråd ved bevægelse af den injicerede arm/ben) - smerter i led - hududslæt (børn i alderen 12 til 23 måneder) (ikke almindeligt efter booster) - søvnighed - irritabilitet - usædvanlig gråd - opkastning (ikke almindelig efter booster) - diarré - hovedpine
English: In the same study the response to a further dose was indicative of immunological memory as 81%-95% of subjects reached an hSBA ≥ 1:5 to PorA P1.4 and 97%-100% to fHbp antigens following further vaccination.
Danish: I det samme studie var responset på en yderligere dosis indikativt for immunologisk hukommelse, idet 81-95 % af forsøgspersonerne opnåede hSBA ≥ 1:5 mod PorA P1.4- og 97-100 % mod fHbp-antigener efter en yderligere vaccination.
English: - A booster will be given between 12 months and 15 months of age after an interval of at least 6 months from the last injection of the initial course.
Danish: - Boosteren gives, når barnet er mellem 12 og 15 måneder gammelt, efter et interval på mindst 6 måneder fra den sidste injektion af de indledende injektioner.
English: Persistence of the immune response one year after the booster dose is also presented in Table 3.
Danish: Immunrespons persistering et år efter boosterdosis er også vist i tabel 3.
English: 0.5 ml suspension in a pre-filled syringe (Type I glass) with a plunger stopper (Type I bromobutyl rubber) and with a protective tip cap (Type I or Type II rubber) with or without needles.
Danish: 0,5 ml suspension i en fyldt injektionssprøjte (type I-glas) med en stempelprop (type I-brombutylgummi) og med et beskyttende låg (type I- eller type II-gummi) med eller uden kanyler.
English: The seroresponse rates and hSBA GMTs were high after the two-dose schedule in children against each of the vaccine antigens (Table 5).
Danish: Serorespons raten og hSBA-GMT mod hver vaccineantigen var høje hos børn efter to-dosis skemaet (se tabel 5).
English: For adsorbent see section 2.
Danish: For adsorbent se pkt.
English: Bexsero is a suspension for injection in pre-filled syringe (Type I glass) with a plunger stopper (Type I bromobutyl rubber) and with a protective tip cap (Type I or Type II rubber) with or without needles.
Danish: Bexsero er en suspension til injektion i fyldt injektionssprøjte (type I-glas) med en stempelprop (type I-brombutylgummi) og med et beskyttende låg (type I- eller type II-gummi) med eller uden kanyler.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 0.5 ml dose contains:
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 0,5 ml dosis indeholder:
English: Study V72P13 2, 4, 6 months
Danish: Studie V72P13 2, 4 og 6 måneder
English: Percentage of adolescents with seroresponse and at least 4-fold rise in bactericidal titers one month after two doses of Bexsero administered according to different two-dose schedules - stratified by pre-vaccination titers
Danish: Procentdel af unge med serorespons og mindst firedobbelt stigning i baktericide titre en måned efter to doser Bexsero administreret i overensstemmelse med forskellige to-dosisregimer - stratificeret ved præ-vaccinationstitre
English: Suspension for injection (0.5 ml) 1 pre-filled syringe containing 0.5 ml suspension with needles 1 pre-filled syringe containing 0.5 ml suspension without needles
Danish: Injektionsvæske, suspension (0,5 ml) 1 fyldt injektionssprøjte, der indeholder 0,5 ml suspension - med kanyler 1 fyldt injektionssprøjte, der indeholder 0,5 ml suspension - uden kanyler
English: Study V72P16 2, 3, 4 months fHbp
Danish: Studie V72P16 2, 3 og 4 måneder fHbp
English: Bexsero can be given concomitantly with any of the following vaccine antigens, either as monovalent or as combination vaccines: diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, heptavalent pneumococcal conjugate, measles, mumps, rubella, varicella, and meningococcal groups A, C, W, Y conjugate.
Danish: Bexsero kan administreres samtidigt med et eller flere af følgende vaccineantigener, enten som monovalent- eller kombinationsvacciner: difteri, tetanus, acellulær pertussis, Haemophilus influenzae type b, inaktiveret poliomyelitis, hepatitis B, heptavalent konjugeret pneumokok, mæslinger, fåresyge, røde hunde, skoldkopper og konjugeret meningokok grupper A, C, W, Y.
English: Not known: syncope or vasovagal responses to injection, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination.
Danish: Ikke kendt: synkope eller vasovagale reaktioner på injektionen, meningeal irritation (tegn på meningeal irritation, såsom nakkestivhed eller fotofobi, er blevet rapporteret sporadisk kort efter vaccination.
English: The response to a booster dose administered 24-36 months after the primary series was indicative of immunological memory as the percentages of seropositive subjects ranged across strains from 93% to 100% in children 4-7 years of age and from 96% to 100% in children 8-12 years of age.
Danish: Respons på en boosterdosis administreret 24-36 måneder efter den primære serie, var indikativ for immunologisk hukommelse, da procendelen af seropositive forsøgspersoner varierede på tværs af stammer fra 93 % til 100 % hos børn i alderen 4-7 år og fra 96 % til 100 % hos børn i alderen 8-12 år.
English: Antibody persistence was evaluated in an extension study in children 3 to 4 years of age.
Danish: I et udvidet studie blev antistofpersistens evalueret hos børn i 3 til 4 års alderen.
English: 10 pre-filled syringes each containing 0.5 ml suspension with needles 10 pre-filled syringes each containing 0.5 ml suspension without needles
Danish: 10 fyldte injektionssprøjter, der hver indeholder 0,5 ml suspension - med kanyler 10 fyldte injektionssprøjter, der hver indeholder 0,5 ml suspension - uden kanyler
English: * pre-booster time point represents persistence of bactericidal antibody at 8 months after Bexsero vaccination at 2, 3 and 4 months of age and 6 months after Bexsero vaccination at 2, 4 and 6 months of age.
Danish: * præbooster-tidspunktet repræsenterer baktericid antistofpersistens otte måneder efter Bexsero-vaccination i 2-, 3- og 4-måneders-alderen og 6 måneder efter Bexsero-vaccination i 2-, 4- og 6-måneders-alderen.
English: Study V72P12 2, 3, 4 months
Danish: Studie V72P12 2, 3 og 4 måneder
English: Your child should receive an initial course of two or three injections of the vaccine followed by an additional injection (booster).
Danish: Dit barn bør indledningsvist have to eller tre injektioner af vaccinen efterfulgt af en supplerende injektion (booster).
English: Similar responses were also observed for adolescents administered two doses of Bexsero with an interval of six months.
Danish: Immunresponset var også sammenligneligt blandt unge, der modtog to doser Bexsero med et interval på seks måneder.
English: Bexsero can be given at the same time as any of the following vaccine components: diphtheria, tetanus, whooping cough (pertussis), Haemophilus influenzae type b, polio, hepatitis B, pneumococcus, measles, mumps, rubella, chickenpox, and meningococcus A, C, W, Y. Talk to your doctor or nurse for further information.
Danish: Bexsero kan gives på samme tid som en af følgende vaccinekomponenter: difteri, stivkrampe, kighoste (pertussis), Haemophilus influenzae type b, polio, hepatitis B, pneumokokker, mæslinger, fåresyge, røde hunde, skoldkopper og meningokok A, C, W, Y. Tal med lægen eller sundhedspersonalet, hvis du vil have flere oplysninger.
English: Immunogenicity in adolescents (from 11 years of age) and adults
Danish: Immunogenicitet hos unge (fra 11 år) og voksne
English: IM use
Danish: OG ANVENDELSE
English: The immunogenicity after two doses has been also documented in another study in infants 6 months to 8 months of age at enrolment (see Table 4).
Danish: Immunogenicitet efter to doser er også blevet dokumenteret i et andet studie af spædbørn som var mellem seks og otte måneder ved begyndelsen af studiet (se tabel 4).
English: - The first injection should be given no earlier than 3 months of age if two initial doses are given; the interval between injections should be at least 2 months.
Danish: - Den første injektion skal gives tidligst ved 3-måneders-alderen, hvis der gives to indledende doser; intervallet mellem injektionerne skal være mindst 2 måneder.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Bivirkningerne er opstillet efter faldende sværhedsgrad inden for hver enkelt frekvensgruppe.
English: 2, 4, 6, 12 months fHbp pre-booster* % seropositive** (95% CI) hSBA GMT*** (95% CI)
Danish: 2, 4, 6, 12 måneder fHbp præbooster* % seropositive** (95 % CI) hSBA-GMT*** (95 % CI)
English: Serum bactericidal antibody responses following a booster at 12 months after a primary series administered at 2, 3 and 4 or 2, 4 and 6 months of age, and persistence of bactericidal antibody one year after the booster
Danish: Serum-baktericidt antistofrespons på en booster efter 12 måneder efter en primær serie administreret i 2-, 3- og 4- eller 2-, 4- og 6-måneders-alderen, og persistensen af det baktericide antistof et år efter boosteren
English: Meningococcal B vaccine
Danish: Meningokok B-vaccine i.m.
English: - The first injection should be given no earlier than 2 months of age if three initial doses are given; the interval between injections should be at least 1 month.
Danish: - Den første injektion skal gives tidligst ved 2-måneders-alderen, hvis der gives tre indledende doser; intervallet mellem injektionerne skal være mindst 1 måned.
English: Adolescents (from 11 years of age) and adults should receive two injections of the vaccine.
Danish: Unge og voksne fra 11 år på tidspunktet for første dosis Unge (fra 11 år) og voksne skal have to injektioner af vaccinen.
English: How to use BEXSERO
Danish: Sådan skal du bruge BEXSERO
English: Data on bactericidal antibody persistence at 8 months after Bexsero vaccination at 2, 3 and 4 months of age, and at 6 months after Bexsero vaccination at 2, 4 and 6 months of age (pre-booster time point) and booster data after a fourth dose of Bexsero administered at 12 months of age are summarised in Table 3.
Danish: Data om baktericid antistofpersistens otte måneder efter Bexsero-vaccination i 2-, 3- og 4-måneders-alderen og seks måneder efter Bexsero-vaccination i 2-, 4- og 6-måneders-alderen (præ-booster) og boosterdata efter en fjerde dosis Bexsero givet i 12-måneders-alderen er opsummeret i tabel 3.
English: At approximately 7.5 years after the two-dose primary series, the percentages of subjects with hSBA ≥ 1:4 declined, ranging across strains from 29% to 84%.
Danish: Ca. 7,5 år efter den to-dosis primær serie, faldt procentdelen af forsøgspersoner med hSBA ≥ 1:4, der spænder over stammer, fra 29 % til 84 %.
English: The percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) across strains ranged from 46% to 95% at one month after the first dose and from 69% to 100% at one month after the second dose (Table 6).
Danish: opnåelse af et hSBA på mindst 1:4) på tværs af stammer, varierede fra 46 % til 95 % en måned efter den første dosis og fra 69 % til 100 % en måned efter den anden dosis (se table 6).
English: Children 12 months to 23 months of age at the time of first dose
Danish: Børn fra 12 måneder til 23 måneder på tidspunktet for første dosis
English: Yes, one dose in the second year of life with an interval of at least 2 months between the primary series and booster dose c
Danish: Ja, en dosis i det andet leveår med et interval på mindst 2 måneder mellem den primære serie og boosterdosenc
English: Bactericidal antibody responses one month after the third vaccination against meningococcal reference strains were high against the fHbp, NadA and PorA P1.4 antigens at both Bexsero vaccination schedules.
Danish: Efter den tredje vaccination var det baktericide antistofrespons mod meningokok-referencestammer, målt efter en måned, højt mod fHbp-, NadA- og PorA P1.4-antigener i begge Bexsero-vaccinationsprogrammer.
English: Children 12 months to 23 months of age should receive two injections of the vaccine followed by an additional injection (booster).
Danish: Børn fra 12 måneder til 23 måneder skal have to injektioner af vaccinen efterfulgt af en supplerende injektion (booster).
English: Two doses each of 0.5 ml
Danish: To doser a 0,5 ml
English: 6 to 10 years of age fHbp
Danish: 6 til 10 årsalderen fHbp
English: Immunogenicity results at one month after three doses of Bexsero administered at 2, 3, 4 and 2, 4, 6 months of age are summarised in Table 2.
Danish: Data for immunogenicitet en måned efter indgift af tre doser Bexsero i 2-, 3-, 4- samt 2-, 4- og 6-måneders-alderen er opsummeret i tabel 2.
English: Children 2 years to 10 years of age at the time of first dose
Danish: Børn fra 2 år til 10 år på tidspunktet for første dosis
English: Infants, 3 months to 5 months
Danish: Spædbørn, 3 til 5 måneder
English: At one month following a booster administered 6 months after the last dose, the percentages of seropositive subjects ranged from 87% to 100% for the two-dose schedule, and from 83% to 100% for the three-dose schedule.
Danish: En måned efter en booster administreret 6 måneder efter den sidste dosis, var 87 % til 100 % af individerne, der fik 2-dosis programmet, og 83 % til 100 % af individerne, der fik 3-dosis programmet, seropositive.
English: Infants up to 5 months of age at the time of first dose
Danish: Spædbørn op til 5 måneder på tidspunktet for første dosis
English: As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Som ved andre vacciner bør administration af Bexsero udsættes hos personer, der lider af akut alvorlig febril sygdom.
English: General disorders and administration site conditions Very common: injection site pain (including severe injection site pain defined as unable to perform normal daily activity), injection site swelling, injection site induration, injection site erythema, malaise
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelige: smerte på injektionsstedet (herunder svær smerte på injektionsstedet defineret som ude af stand til at udføre normale daglige aktiviteter), hævelse, induration, erytem på injektionsstedet, utilpashed
English: Serum bactericidal antibody responses in adolescents one month after two doses of Bexsero administered according to different two-dose schedules and persistence of bactericidal antibody 18 to 23 months after the second dose
Danish: Serum-baktericidt antistofrespons hos unge en måned efter to doser Bexsero administreret efter forskellige to-dosis-regimer og persistensen af det baktericide antistof 18-23 måneder efter den anden dosis
English: Adolescents (from 11 years) and adults*
Danish: Unge (fra 11 år) og voksne*
English: Yes, one dose with an interval of 12 months to 23 months between the primary series and booster dose c
Danish: Ja, en dosis med et interval på 12-23 måneder mellem den primære serie og boosterdosenc
English: The benefit-risk ratio must be examined before making the decision to immunise during breast-feeding.
Danish: Fordele og ulemper bør nøje overvejes, før det besluttes at vaccinere under amning.
English: Serum bactericidal antibody responses following Bexsero vaccination at 6 and 8 months of age or 13 and 15 months of age and persistence of bactericidal antibody one year after the two doses at 13 and 15 months of age
Danish: Serum-baktericidt antistofrespons på Bexsero-vaccination i 6- og 8-måneders-alderen eller 13- og 15-måneders-alderen og persistensen af det baktericide antistof et år efter de to doser i 13- og 15-måneders-alderen.
English: Infants, 6 months to 11 months
Danish: Spædbørn, 6 til 11 måneder
English: Musculoskeletal and connective tissue disorders Very common: myalgia, arthralgia
Danish: Knogler, led, muskler og bindevæv Meget almindelige: myalgi, artralgi
English: Serum bactericidal antibody responses in adults after two doses of Bexsero administered according to different two-dose schedules
Danish: Serum-baktericidt antistofrespons hos voksne efter 2 doser Bexsero administreret efter forskellige to-dosis-regimer
English: Infants 6 months to 11 months of age should receive two injections of the vaccine followed by an additional injection (booster).
Danish: Spædbørn i alderen 6 til 11 måneder bør have to injektioner af vaccinen efterfulgt af en supplerende injektion (booster).
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: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2
Danish: Ydre membranvesikler (OMV) fra Neisseria meningitidis gruppe B stamme NZ98/254 målt som mængden af totalt protein, der indeholder PorA P1.4 2
English: General disorders and administration site conditions Very common: fever (≥38°C), injection site tenderness (including severe injection site tenderness defined as crying when injected limb is moved), injection site erythema, injection site swelling, injection site induration, irritability
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelige: feber (≥38 °C), ømhed ved injektionsstedet (herunder svær ømhed ved injektionsstedet defineret som gråd ved bevægelse af den injicerede ekstremitet), erytem på injektionsstedet, hævelse på injektionsstedet, induration, irritabilitet Ikke almindelige: feber (≥40 °C)
English: What Bexsero is and what it is used for What you need to know before you or your child receive Bexsero How to use Bexsero
Danish: Det skal du vide, før du eller dit barn begynder at bruge Bexsero Sådan skal du bruge Bexsero
English: The response to a booster dose administered 4 years after the primary series was indicative of immunological memory as the percentages of subjects with hSBA ≥ 1:5 ranged across strains from 92% to 100%.
Danish: Respons på en boosterdosis administreret 4 år efter den primære serie var indikativ på immunologisk hukommelse, da procentdelen af forsøgspersoner med hSBA ≥ 1:5 varierede på tværs af stammer fra 92 % til 100 %.
English: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4
Danish: Ydre membranvesikler (OMV) fra Neisseria meningitidis gruppe B stamme NZ98/254 målt som mængden af totalt protein, som indeholder PorA P1.4
English: % seropositive (95% CI) hSBA GMT (95% CI) * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4.
Danish: % seropositive (95 % CI) hSBA GMT (95 % CI) * % seropositive = procentdelen af forsøgspersoner, der opnåede hSBA ≥1:4.
English: Neck stiffness or uncomfortable sensitivity to light (photophobia), indicating meningeal irritation, has been sporadically reported shortly after vaccination; these symptoms have been of mild and transient nature.
Danish: Nakkestivhed eller ubehagelig følsomhed over for lys (fotofobi), der indikerer meningeal irritation, er blevet rapporteret sporadisk, kort efter vaccinationen.
English: Very common: sleepiness, unusual crying, headache Uncommon: seizures (including febrile seizures)
Danish: Meget almindelige: søvnighed, usædvanlig gråd, hovedpine Ikke almindelige: anfald (herunder feberkramper) Ikke kendt: hypotonisk- hyporesponsiv episode, meningeal irritation (tegn på meningeal irritation,
English: Immunogenicity in infants 2 months to 5 months of age
Danish: Immunogenicitet hos spædbørn fra 2 til 5 måneder
English: The response to a booster dose administered 7.5 years after the primary series was indicative of immunological memory as the percentages of subjects reaching an hSBA ≥ 1:4 across strains ranged from 93% to 100%.
Danish: Respons på en boosterdosis administreret 7,5 år efter den primære serie var indikativ på immunologisk hukommelse, da procentdelen af forsøgspersoner, der nåede en hSBA ≥ 1:4 på tværs af stammer varierede fra 93 % til 100 %.
English: * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4 (against reference strains for fHbp, NadA, PorA P1.4 antigens) and an hSBA ≥ 1:5 (against reference strain for NHBA antigen).
Danish: hSBA GMT (95 % CI) * % seropositive = procentdel af forsøgspersoner der opnåede hSBA ≥1:4 (mod reference stammer for fHbp, NadA, PorA P1.4 antigener) og hSBA ≥ 1:5 (mod reference stammer for NHBA antigen).