FrancophonIA/ELRC3.0 huggingface dataset:
English: Following Bexsero vaccination, a high percentage of subjects were seropositive and achieved 4-fold increases in hSBA titers independent of pre-vaccination status.
Danish: Efter vaccination med Bexsero var en høj procentdel af personerne seropositive og opnåede firedobbelte stigninger i hSBA-titer uafhængigt af status før vaccinationen.
English: Via Fiorentina 1 53100 Siena Italy.
Danish: Via Fiorentina 1 53100 Siena Italien.
English: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Danish: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italien
English: LIST OF EXCIPIENTS Excipients: sodium chloride, histidine, sucrose, water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: natriumchlorid, histidin, saccharose, vand til injektionsvæsker.
English: Three doses each of 0.5 ml
Danish: Tre doser på hver 0,5 ml
English: The bactericidal responses against the NHBA antigen were also high in infants vaccinated at the 2, 4, 6-month schedule, but this antigen appeared to be less immunogenic at the 2, 3, 4-month schedule.
Danish: Baktericidt respons mod NHBA-antigen var også højt hos spædbørn vaccineret i 2-, 4- og 6-måneders programmet, men dette antigen viste sig at være mindre immunogent i 2-, 3- og 4-måneders programmet.
English: Bexsero is not expected to provide protection against all circulating meningococcal group B strains (see section 5.1).
Danish: Bexsero forventes ikke at beskytte mod alle cirkulerende meningokok gruppe B-stammer (se pkt.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Danish: Den potentielle risiko for apnø og behov for respiratorisk overvågning i 48-72 timer bør overvejes ved primære immuniseringsprogrammer til meget tidligt fødte børn (født ≤ 28 uger af svangerskabet),
English: Should concomitant administration of other vaccines be necessary, vaccines must be administered at separate injection sites.
Danish: Hvis samtidig administration af andre vacciner er nødvendig, skal vaccinerne administreres på separate injektionssteder.
English: The safe use of Bexsero in kanamycin-sensitive individuals has not been established.
Danish: Sikker brug af Bexsero hos personer, som er følsomme over for kanamycin, er ikke klarlagt.
English: Comparable percentages of subjects were seropositive at 2 to 3 years after being previously vaccinated with either two doses followed by a booster of Bexsero (ranging from 35% to 91%) or three doses followed by a booster (ranging from 36% to 84%).
Danish: Sammenlignelige procentdele af forsøgspersonerne var seropositive 2 til 3 år efter at de tidligere var vaccineret med enten to doser efterfulgt af en booster af Bexsero (fra 35 % til 91 %) eller tre doser efterfulgt af en booster (fra 36 % til 84 %).
English: Immunisation with Bexsero is intended to stimulate the production of bactericidal antibodies that recognize the vaccine antigens NHBA, NadA, fHbp, and PorA P1.4 (the immunodominant antigen present in the OMV component) and are expected to be protective against Invasive Meningococcal Disease (IMD).
Danish: Immunisering med Bexsero har til formål at stimulere produktionen af baktericide antistoffer, der genkender vaccineantigenerne NHBA, NadA, fHbp og PorA P1.4 (det immunodominerende antigen i OMV-komponenten), og som forventes at beskytte mod invasiv meningokoksygdom (IMD).
English: In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.
Danish: Hos unge og voksne var de mest almindelige lokale og systemiske observerede bivirkninger smerte på injektionsstedet, utilpashed og hovedpine.
English: In the extension study, in which two doses of Bexsero were administered one month apart in unvaccinated children, high percentages of subjects were seropositive one month after the second dose.
Danish: I forlængelsesstudiet, hvor to doser af Bexsero blev administreret en måned fra hinanden hos uvaccinerede børn, var en høj procentdel af forsøgpersonerne seropositive en måned efter den anden dosis.
English: * There are no data in adults above 50 years of age.
Danish: * Der foreligger ingen data for voksne over 50 år.
English: Immunogenicity in infants 6 to 11 months and children 12 to 23 months of age
Danish: Immunogenicitet hos spædbørn fra 6 til 11 måneder og børn fra 12 til 23 måneder
English: Your child may receive an additional injection (booster).
Danish: Dit barn kan få en ekstra injektion (booster).
English: In the study in adolescents, bactericidal responses following two doses of Bexsero were stratified by baseline hSBA less than 1:4 or equal to or greater than 1:4.
Danish: I studiet med unge blev baktericide responser efter to doser Bexsero stratificeret efter baseline hSBA mindre end 1:4 eller lig med eller større end 1:4.
English: Stopping breathing or irregular breathing for a short time may be more common in the first three days following vaccination in these babies and they may need special monitoring.
Danish: I de første tre dage efter vaccinationen, er det mere almindeligt at disse babyer kortvarrigt holder op med at trække vejret eller har uregelmæssig vejrtrækning, og de kan defor have behov for særlig overvågning.
English: Do not use this vaccine after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke vaccinen efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Antibody persistence data for the study in adolescents were obtained in an extension phase 3 study.
Danish: Antistof persistens data for studiet hos unge, blev opnået i et forlængelses fase 3-studie.
English: No adverse reactions were seen in vaccinated maternal rabbits or in their offspring through day 29 of lactation.
Danish: Der blev ikke konstateret bivirkninger hos vaccinerede hunkaniner eller deres afkom op til dag 29 af amningen.
English: Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection.
Danish: Besvimelse, følelse af svaghed eller andre stressrelaterede reaktioner kan opstå i forbindelse med enhver injektion med kanyle.
English: It will be injected into a muscle, usually the thigh for infants or the upper arm for children, adolescents and adults.
Danish: Det injiceres i en muskel, sædvanligvis i låret hos spædbørn eller overarmen hos børn, unge og voksne.
English: Immunogenicity data are available in individuals with complement deficiencies, asplenia, or splenic dysfunctions (see section 5.1).
Danish: Der er immunogenicitetsdata tilgængelig for personer med komplementdefekt, aspleni eller dysfunktion af milten (se pkt.
English: In an extension study the persistence of the immune response was assessed one year after the booster dose (see Table 3).
Danish: I et forlængelsesstudie blev persistens af immunresponset vurderet et år efter boosterdosis (se tabel 3).
English: Intervals between Primary Doses
Danish: Primær immunisering Intervaller mellem primære doser
English: The first dose should be given no earlier than 2 months of age.
Danish: Den første dosis bør gives tidligst ved 2-måneders-alderen.
English: There are no data on the use of Bexsero in subjects above 50 years of age and limited data in patients with chronic medical conditions.
Danish: Der er ingen data om brug af Bexsero hos forsøgspersoner over 50 år og begrænset data hos patienter med kroniske medicinske tilstande.
English: Very common: rash (children aged 12 to 23 months) (uncommon after booster) Common: rash (infants and children 2 to 10 years of age) Uncommon: eczema
Danish: Meget almindelige: udslæt (børn i alderen 12 til 23 måneder) (ikke almindelig efter booster) Almindelige: udslæt (spædbørn og børn i alderen 2 til 10 år) Ikke almindelige: eksem
English: 25 micrograms produced in E. coli cells by recombinant DNA technology adsorbed on aluminium hydroxide (0.5 mg Al³+) NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
Danish: 25 mikrogram produceret i E. coli-celler ved rekombinant DNA-teknologi adsorberet på aluminiumhydroxid (0,5 mg Al³+) NHBA (Neisserial heparinbindende antigen), NadA (Neisseria adhesin A), fHbp (faktor H-bindende protein)
English: Among Bexsero recipients, 6837 were infants and children (less than 2 years of age), 1051 were children (2 to 10 years of age) and 2677 were adolescents and adults.
Danish: Modtagerne af Bexsero omfattede 6.837 spædbørn og børn (under 2 år), 1.051 børn (2 til 10 år) samt 2.677 unge og voksne.
English: The Meningococcal Antigen Typing System (MATS) was developed to relate antigen profiles of different strains of meningococcal group B bacteria to killing of the strains in the serum bactericidal assay with human complement (hSBA).
Danish: Meningococcal Antigen Typing System (MATS) blev udviklet for at relatere antigenprofiler af forskellige stammer af meningokok gruppe B-bakterier til drab af stammerne i den serum-baktericide analyse med human komplement (hSBA).
English: 13, 15 months fHbp
Danish: 13, 15 måneder fHbp
English: - if you or your child have haemophilia or any other problem that may stop your blood from clotting properly, such as treatment with blood thinners (anticoagulants).
Danish: - hvis du eller dit barn har hæmofili eller andre problemer, der kan forhindre, at blodet størkner, såsom behandling med blodfortyndende medicin (koagulationshæmmende midler).
English: Bactericidal antibodies against these strains were measured by the Serum Bactericidal Assay using human serum as the source of complement (hSBA).
Danish: Baktericide antistoffer mod disse stammer blev målt ved serum-baktericidt assay ved anvendelse af humant serum som komplementkilde (hSBA).
English: Two-dose primary series followed by a booster
Danish: To-dosis primær serie efterfulgt af en booster
English: Children, 2 years to 10 years
Danish: Børn, 2 år til 10 år
English: Collapse (sudden onset of muscle floppiness), less responsive than usual or lack of awareness, and paleness or bluish skin discoloration in young children.
Danish: Kollaps (pludselig indsættende slaphed af musklerne), mindre kontaktbarhed eller manglende opmærksomhed, og bleghed eller blålig misfarvning af huden hos små børn.
English: When given at the same time with other vaccines Bexsero must be given at separate injection sites.
Danish: Når det gives samtidigt med andre vacciner, skal Bexsero gives på et separat injektionssted.
English: Common (these may affect up to 1 in 10 people) - skin rash (infants and children 2 to 10 years of age)
Danish: Almindelige (disse kan forekomme hos op til 1 ud af 10 personer) - hududslæt (spædbørn og børn i alderen 2 til 10 år)
English: A two-dose schedule followed by a booster has been evaluated in infants 3 months to 5 months of age in a clinical study.
Danish: Et to-dosis-regime efterfulgt af en booster, er blevet evalueret hos spædbørn fra 3 måneder til 5 måneder i et klinisk studie.
English: Children 2 years to 10 years of age should receive two injections of the vaccine.
Danish: Børn fra 2 år til 10 år skal have to injektioner af vaccinen.
English: 2 to 5 years of age
Danish: 2 til 5 årsalderen
English: Seroresponse rates and percentages of subjects with at least a 4-fold increase in hSBA titer from baseline to one month after the second dose of Bexsero are summarised in Table 8.
Danish: Seroresponsrater og procentdele af personer med mindst en firedobbelt stigning i hSBA-titer fra baseline til en måned efter den anden dosis Bexsero er opsummeret i tabel 8.
English: Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see section 4.8).
Danish: Angstrelaterede reaktioner, herunder vasovagale reaktioner (synkope), hyperventilering eller stressrelaterede reaktioner kan forekomme i forbindelse med vaccination som et psykogent respons på injektion med kanyle (se pkt.
English: Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to each of the vaccine antigens (see section Immunogenicity).
Danish: Vaccineeffektiviteten er blevet udledt ved at påvise induktionen af serum-baktericid antistofrespons efter hvert af vaccineantigenerne (se punktet Immunogenicitet).
English: Data on antibody persistence one year after the two doses at 13 and 15 months of age are also summarised in Table 4.
Danish: Data om antistofpersistens et år efter de to doser i 13- og 15-måneders-alderen er også opsummeret i tabel 4.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én dosis (0,5 ml) indeholder:
English: The following information is intended for healthcare professionals only: Upon storage a fine off-white deposit may be observed in the pre-filled syringe containing the suspension.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Ved opbevaring kan der observeres et fint råhvidt bundfald i den fyldte injektionssprøjte med suspensionen.
English: 35 to 47 months of age 4 to 7 years of age 8 to10 years of age fHbp
Danish: 4 til 7 års alderen 8 til 10 års alderen fHbp
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Bexsero in one or more subsets of the paediatric population in the prevention of meningococcal disease caused by Neisseria meningitidis group B (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Bexsero i en eller flere undergrupper af den pædiatriske population til forebyggelse af meningokoksygdom forårsaget af Neisseria meningitidis gruppe B (se pkt.
English: As with any vaccine, Bexsero may not fully protect all of those who are vaccinated.
Danish: Som for alle andre vacciner beskytter Bexsero ikke nødvendigvis alle personer fuldt ud, som bliver vaccineret.
English: Your doctor may still recommend that you receive Bexsero if you are at risk of exposure to meningococcal infection.
Danish: Lægen eller sundhedspersonalet kan anbefale, at du alligevel får Bexsero, hvis du er i risiko for at blive udsat for meningokokinfektion.
English: Other medicines and Bexsero
Danish: Brug af anden medicin sammen med Bexsero
English: Previously unvaccinated children also received two doses in the second year of life, with antibody persistence being measured at one year after the second dose (see Table 4).
Danish: Uvaccinerede børn fik desuden to doser i det andet leveår, hvor antistofpersistens blev målt et år efter den anden dosis (se tabel 4).
English: Clinical studies demonstrated that the immune responses of the co-administered routine vaccines were unaffected by concomitant administration of Bexsero, based on non-inferior antibody response rates to the routine vaccines given alone.
Danish: I kliniske studier var immunresponset efter co-administration af standardvacciner upåvirket af samtidig administration af Bexsero, baseret på ikke-inferiøre antistofsvarprocenter på standardvacciner, som gives alene.
English: Serum bactericidal antibody responses to each of the vaccine antigens NadA, fHbp, NHBA and PorA P1.4 was evaluated using a set of four meningococcal group B reference strains.
Danish: Serum-baktericide antistofresponser på hvert af vaccineantigenerne NadA, fHbp, NHBA og PorA P1.4 blev evalueret ved hjælp af et sæt bestående af fire meningokok gruppe B-referencestammer.
English: What you need to know before you or your child receive BEXSERO
Danish: Det skal du vide, før du eller dit barn begynder at bruge BEXSERO
English: After 24-36 months, the percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) declined, ranging across strains from 21% to 74% in children 4-7 years of age and from 47% to 86% in children 8-12 years of age.
Danish: Efter 24-36 måneder faldt andelen af seropositive forsøgspersoner (dvs. opnåelse af hSBA på mindst 1:4), der spænder over stammer, fra 21 % til 74 % hos børn i alderen 4-7 år og fra 47 % til 86 % hos børn i alderen 8-12 år.
English: In studies with adults, data were obtained after two doses of Bexsero with a one month or two month interval between doses (see Table 9).
Danish: I studier med voksne blev data indhentet efter to doser Bexsero med en eller to måneder imellem doserne (se tabel 9).
English: Against each of the vaccine antigens, seroresponse rates and hSBA GMTs were high and similar after the two-dose series in infants 6-8 months of age and children 13-15 months of age.
Danish: På baggrund af hvert af vaccineantigenerne var seroresponsrater og hSBA-GMT'er høje og sammenlignelige efter to-dosis-programmet hos spædbørn på 6-8 måneder og børn på 13-15 måneder.
English: 6.6 Special precautions for disposal and other handling Upon storage a fine off-white deposit may be observed in the pre-filled syringe containing the suspension.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ved opbevaring kan der observeres et fint råhvidt bundfald i den fyldte sprøjte med suspensionen.
English: Children, 12 months to 23 months
Danish: Børn, 12 til 23 måneder
English: - The interval between each injection should be at least 2 months.
Danish: - Intervallet mellem hver af injektionerne skal være mindst to måneder.
English: The immunogenicity after two primary doses (at 3 and a half and 5 months of age) or three primary doses (at 2 and a half, 3 and a half and 5 months of age) of Bexsero followed by a booster dose in infants starting vaccination between 2 and 5 months of age has been evaluated in an additional phase 3 clinical study.
Danish: Immunogeniciteten efter to primære doser (ved 3 ½ og ved 5 måneders alderen) og tre primære doser (ved 2 ½ , 3 ½- og 5 måneders alderen) af Bexsero efterfulgt af en boosterdosis hos spædbørn, der begyndte vaccinationen mellem 2 og 5 måneders alderen er blevet evalueret i et yderligere fase 3 klinisk studie.
English: In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.
Danish: Hos spædbørn og børn (under 2 år) var de hyppigste lokale og systemiske bivirkninger, som blev observeret i kliniske studier, ømhed og rødme på injektionsstedet, feber og irritabilitet.
English: The immunogenicity after two doses of Bexsero administered either one or two months apart in children 2 to 10 years of age has been evaluated in an initial phase 3 clinical study and its extension.
Danish: Immunogeniciteten efter to doser af Bexsero administreret enten en eller to måneder fra hinanden hos børn fra 2 til 10 år er blevet evalueret i et indledende fase 3 klinisk studie og dens forlængelse.
English: Bellaria-Rosia 53018 Sovicille (Siena) Italy.
Danish: Bellaria-Rosia 53018 Sovicille (Siena) Italien
English: Gastrointestinal disorders Very common: diarrhoea, vomiting (uncommon after booster)
Danish: Mave-tarm-kanalen Meget almindelige: diarré, opkastning (ikke almindelig efter booster)
English: As with any vaccine, vaccination with Bexsero may not protect all vaccine recipients.
Danish: I lighed med andre vacciner vil vaccination med Bexsero muligvis ikke beskytte alle, der bliver vaccineret.
English: There are no data in adults above 50 years of age.
Danish: Der foreligger ingen data for voksne på over 50 år.
English: In a phase 3 clinical study, children and adolescents 2 through 17 years of age with complement deficiencies (40), with asplenia or splenic dysfunction (107), and age-matched healthy subjects (85) received two doses of Bexsero two months apart.
Danish: I et klinisk fase 3-studie, modtog børn og unge i alderen 2 til 17 år med komplementdefekt (40), med aspleni eller dysfunktion af milten (107) og alder-matchede raske personer (85), to doser af Bexsero med to måneders mellemrum.
English: Ask your doctor or nurse how to throw away medicines you no longer use.
Danish: Spørg lægen eller sundhedspersonalet, hvordan du skal bortskaffe medicinrester.
English: Three-dose primary series followed by a booster
Danish: Tre-dosis primær serie efterfulgt af en booster.
English: Bellaria-Rosia IT-53018 Sovicille-Siena Italy
Danish: Bellaria-Rosia IT-53018 Sovicille-Siena Italien
English: Via Fiorentina, 1 IT-53100 Siena Italy
Danish: Via Fiorentina, 1 IT-53100 Siena Italien
English: The percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) ranged from 44% to 100% one month after the second dose and from 55% to 100% one month after the third dose.
Danish: Procentdelen af seropositive forsøgspersoner (dvs. opnåelse af hSBA på mindst 1:4) varierede fra 44 % til 100 % en måned efter den anden dosis og fra 55 % til 100 % en måned efter den tredje dosis.
English: In clinical studies in infants vaccinated at 2, 4 and 6 months of age, fever (≥ 38°C) was reported by 69% to 79% of subjects when Bexsero was co-administered with routine vaccines (containing the following antigens: pneumococcal 7-valent conjugate, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b) compared with 44% to 59% of subjects receiving the routine vaccines alone.
Danish: I kliniske studier med spædbørn, der blev vaccineret i en alder af 2, 4 og 6 måneder, blev der rapporteret feber (≥38 °C) hos 69-79 % af forsøgspersonerne, når Bexsero blev co-administreret med standardvacciner (indeholdende følgende antigener: pneumokok 7-valent konjugat, difteri, tetanus, acellulær pertussis, hepatitis B, inaktiveret poliomyelitis og Haemophilus influenzae type b) sammenlignet med 44-59 % af de forsøgspersoner, der alene fik standardvacciner.
English: Very common (these may affect more than 1 in 10 people) - pain at the injection site resulting in inability to perform normal daily activity - painful muscles and joints - nausea - generally feeling unwell - headache
Danish: Meget almindelige (disse kan forekomme hos mere end 1 ud af 10 personer) - smerter på injektionsstedet, som resulterer i manglende evne til at udføre normale daglige aktiviteter - smertefulde muskler og led - kvalme - generel utilpashed - hovedpine
English: The percentages of healthy subjects with hSBA ≥1:5 were 98% for antigen fHbp, 99% for antigen NadA, 83% for antigen PorA P1.4, and 99% for antigen NHBA.
Danish: Procentdelen af raske forsøgspersoner med hSBA ≥1: 5 var 98% mod antigen fHbp, 99% mod antigen NadA, 83% mod antigen PorA P1.4 og 99% mod antigen NHBA.
English: In infant studies, participants received three doses of Bexsero either at 2, 4 and 6 or 2, 3 and 4 months of age and a booster dose in their second year of life, as early as 12 months of age.
Danish: I studierne af spædbørn modtog deltagerne tre doser Bexsero i enten 2-, 4- og 6- eller 2-, 3- og 4-måneders-alderen og en boosterdosis i deres andet leveår, så tidligt som i 12-måneders-alderen.
English: Before use, the pre-filled syringe should be well shaken in order to form a homogeneous suspension.
Danish: Den fyldte sprøjte skal inden brug omrystes grundigt før brug, indtil der dannes en homogen suspension.
English: Information on the safety of the vaccine to women and their children during breast-feeding is not available.
Danish: Sikkerheden for kvinder og deres børn under amning er ukendt.
English: At 1 month following the 2-dose vaccination course, the percentages of subjects with hSBA ≥1:5 in individuals with complement deficiencies and asplenia or splenic dysfunction were 87% and 97% for antigen fHbp, 95% and 100% for antigen NadA, 68% and 86% for antigen PorA P1.4, 73% and 94% for antigen NHBA, respectively, indicating an immune response in these immunocompromised subjects.
Danish: Ved den 1. måned i vaccinationsprogrammet med 2-doser, var procentdelen hos forsøgspersonerne med hSBA ≥1: 5 hos personer med komplementdefekt og aspleni eller dysfunktionen af milten henholdsvis 87% og 97% mod antigen fHbp, 95% og 100% for antigen NadA, 68% og 86% mod antigen PorA P1.4, 73% og 94% mod antigen NHBA, hvilket indikerer et immunrespons hos disse immunkompromitterede personer.