FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.
Danish: Vaccinen må ikke injiceres intravenøst, subkutant eller intradermalt og må ikke blandes med andre vacciner i samme sprøjte.
English: Immunogenicity was evaluated in infants, children, adolescents and adults.
Danish: Immunogeniciteten blev evalueret hos spædbørn, børn, unge og voksne.
English: Not less than 2 months
Danish: Ikke mindre end to måneder
English: Adsorbed on aluminium hydroxide (0.5 mg Al³+).
Danish: Adsorberet på aluminiumhydroxid (0,5 mg Al³+).
English: Ask your doctor for advice whether it is beneficial for you to receive Bexsero.
Danish: Spørg lægen til råds med hensyn til om det kan være en fordel for dig at få Bexsero.
English: Bexsero contains sodium chloride
Danish: Bexsero indeholder natriumchlorid
English: 50/50/50 micrograms
Danish: 50/50/50 mikrogram
English: Data are not available from all vaccine schedules using the reference strain for NHBA.
Danish: Der foreligger ikke data fra alle vaccineprogrammer, som anvender referencestammen for NHBA.
English: The suspension is white opalescent liquid.
Danish: Suspensionen er en hvid opaliserende væske.
English: Name and address of the manufacturers of the biological active substances (NHBA, NadA, fHbp):
Danish: Navn og adresse på fremstillere af de biologisk aktive stoffer (NHBA, NadA, fHbp):
English: Antipyretic medication should be initiated according to local guidelines in infants and children (less than 2 years of age).
Danish: Anvendelse af antipyretika bør ske i henhold til lokale retningslinjer for spædbørn og småbørn (under to år).
English: The effect of antipyretics other than paracetamol on the immune response has not been studied.
Danish: Virkningen af andre antipyretika ud over paracetamol på immunreaktionen er ikke undersøgt.
English: In case of delay, the booster should not be given later than 24 months of age.
Danish: I tilfælde af udsættelse bør boosteren ikke gives senere end ved 24-måneders-alderen.
English: Overall, 78% (95% confidence limits from 63-90%) of the approximately 1,000 strains were potentially susceptible to vaccine-induced antibodies.
Danish: Alt i alt var 78 % (95 % konfidensgrænser fra 63-90 %) af de omkring 1.000 stammer potentielt modtagelige for vaccineinducerede antistoffer.
English: Infants and children (up to 10 years of age)
Danish: Spædbørn og børn (op til 10 år)
English: In addition to reports in clinical trials, worldwide voluntary reports of adverse reactions received for Bexsero since market introduction are included in the list.
Danish: Ud over de rapporterede bivirkninger fra kliniske studier er globale frivillige bivirkningsindberetninger, der er modtaget for Bexsero siden markedsføring, med på listen.
English: Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
Danish: Alligevel bør vaccination ikke tilbageholdes, når der er klar risiko for udsættelse for meningokokinfektion.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Danish: Som ved alle injicerbare vacciner skal passende nødhjælpsbehandling og overvågning altid være let tilgængelig i tilfælde af en anafylaktisk reaktion efter administration af vaccinen.
English: Pharmacotherapeutic group: meningococcal vaccines, ATC code: J07AH09
Danish: Farmakoterapeutisk klassifikation: meningokokvacciner, ATC-kode: J07AH09
English: The safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established.
Danish: Bexseros sikkerhed og virkning hos spædbørn under 8 uger er endnu ikke klarlagt.
English: As these antigens are variably expressed by different strains, meningococci that express them at sufficient levels are susceptible to killing by vaccine-elicited antibodies.
Danish: Da disse antigener udtrykkes forskelligt af forskellige stammer, kan de meningokokker, der udtrykker dem i tilstrækkelig mængde, dræbes af vaccine-fremkaldte antistoffer.
English: Name and address of the manufacturers of the biological active substance (OMV):
Danish: Navn og adresse på fremstillere af det biologisk aktive stof (OMV):
English: Rare (these may affect up to 1 in 1,000 people) - Kawasaki disease which may include symptoms such as fever that lasts for more than five days,
Danish: Sjældne (disse kan forekomme hos op til 1 ud af 1.000 personer) - Kawasakis sygdom, der kan omfatte symptomer som feber, der varer i mere end fem dage,
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun intramuskulær anvendelse.
English: Non-clinical data reveal no special hazard for humans based on repeated dose toxicity and reproductive and developmental toxicity studies.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Bexsero is given.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får Bexsero.
English: The efficacy of Bexsero has not been evaluated through clinical trials.
Danish: Virkningen af Bexsero er ikke blevet evalueret i kliniske studier.
English: Children and adolescents with complement deficiencies, asplenia, or splenic dysfunction
Danish: Børn og unge med komplementdefekt, aspleni eller dysfunktion af milten
English: - if you or your child have an allergy to the antibiotic kanamycin.
Danish: - hvis du eller dit barn har allergi over for antibiotikummet kanamycin.
English: A booster dose should be considered in individuals at continued risk of exposure to meningococcal disease, based on official recommendations d
Danish: En boosterdosis bør overvejes hos personer med fortsat risiko for at blive udsat for meningokoksygdom, baseret på officielle anbefalingerd
English: The clinical consequences of the reduced immunogenicity of the NHBA antigen at this schedule are not known.
Danish: De kliniske konsekvenser af NHBA-antigenets reducerede immunogenicitet i dette program kendes ikke.
English: This vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.
Danish: Vaccinen bør ikke gives til personer med trombocytopeni eller andre koagulationslidelser, som kontraindicerer intramuskulær injektion, medmindre den potentielle fordel klart opvejer risikoen.
English: 12 to 23 months of age Age of vaccination 6, 8 months
Danish: 12 til 23 måneder Alder ved vaccination 6, 8 måneder
English: There were no effects on female fertility in animal studies.
Danish: Der var ingen indvirkning på hunners fertilitet i dyrestudier.
English: If you or your child have weakened immunity (for example, due to the use of immunosuppressive medications, or HIV infection, or hereditary defects of the body's natural defence system), it is possible that the effectiveness of Bexsero is reduced.
Danish: Hvis du eller dit barn har svækket immunforsvar (for eksempel på grund af brugen af immunundertrykkende lægemidler, HIV-infektion eller arvelige defekter i kroppens naturlige forsvarssystem), kan Bexseros effektivitet muligvis være nedsat.
English: Bexsero has no or negligible influence on the ability to drive and use machines.
Danish: Bexsero påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Serum bactericidal response to NHBA antigen has not been evaluated.
Danish: Serum-baktericidt respons mod NHBA-antigen er ikke blevet evalueret.
English: • Periodic safety update reports
Danish: • Periodiske, opdaterede sikkerhedsrapporter (PSUR'er)
English: Sodium chloride, histidine, sucrose and water for injections (see section 2 for further information on sodium and latex).
Danish: Natriumchlorid, histidin, saccharose og vand til injektionsvæsker (se punkt 2 for yderligere information om natrium og latex).
English: The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor or nurse first.
Danish: Mindre infektioner, f.eks. en forkølelse, bør ikke kræve udsættelse af vaccinationen, men tal med lægen eller sundhedspersonalet først.
English: Bexsero must not be mixed with other vaccines in the same syringe.
Danish: Bexsero må ikke blandes med andre vacciner i samme sprøjte.
English: Uncommon: pallor (rare after booster) Rare: Kawasaki syndrome
Danish: Ikke almindelige: bleghed (sjælden efter booster) Sjældne: Kawasakis syndrom
English: associated with a skin rash on the trunk of the body, and sometimes followed by a peeling of the skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue - Itchy rash, skin rash
Danish: forbundet med hududslæt på kroppen og nogle gange efterfulgt af hudafskalning på hænder og fingre, hævede kirtler i halsen, røde øjne, læber, hals og tunge - kløende udslæt, hududslæt
English: A survey of approximately 1,000 different invasive meningococcal group B isolates collected during 2007-2008 in 5 European countries showed that, depending on the country of origin, between 73% and 87% of meningococcal group B isolates had an appropriate MATS antigen profile to be covered by the vaccine.
Danish: Et studie af ca. 1.000 forskellige invasive meningokok gruppe B-isolater indsamlet i 2007-2008 i fem europæiske lande viste, at mellem 73 % og 87 % af meningokok gruppe B-isolater afhængigt af oprindelsesland havde en relevant MATS-antigenprofil, der dækkes af vaccinen.
English: Sera were obtained both before vaccination, one month after the third vaccination (see Table 2) and one month after booster vaccination (see Table 3).
Danish: Der blev udtaget sera både før vaccinationen, en måned efter den tredje vaccination (se tabel 2) og en måned efter boostervaccinationen (se tabel 3).
English: No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the vaccination series.
Danish: Der blev ikke konstateret stigning i forekomst eller sværhedsgrad af bivirkninger ved de efterfølgende doser i vaccinationsprogrammet.
English: Prophylactic administration of antipyretics at the time and closely after vaccination can reduce the incidence and intensity of post-vaccination febrile reactions.
Danish: Profylaktisk administration af antipyretika inden vaccination eller lige efter, kan reducere forekomst og intensitet af febril reaktion efter vaccination.
English: Although the risk for developing allergic reactions is very small, healthcare professionals should consider the benefit-risk prior to administering this vaccine to subjects with known history of hypersensitivity to latex.
Danish: Selv om risikoen for at udvikle allergiske reaktioner er meget lille, bør sundhedspersonalet overveje fordele og ulemper inden administration af denne vaccine til personer med kendt overfølsomhed over for latex.
English: Due to an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when Bexsero was co-administered with the above vaccines, separate vaccinations can be considered when possible.
Danish: På grund af øget risiko for feber, ømhed på injektionsstedet, ændrede spisevaner og irritabilitet ved administration af Bexsero samtidig med ovennævnte vacciner kan separate vaccinationer overvejes om muligt.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination.
Danish: Tilstedeværelse af milde infektioner som forkølelse bør dog ikke resultere i udskydelse af vaccination.
English: Immune system disorders Not known: allergic reactions (including anaphylactic reactions)
Danish: Immunsystemet Ikke kendt: allergiske reaktioner (inklusive anafylaktiske reaktioner)
English: If present, the kanamycin level in the vaccine is low.
Danish: Niveauet af kanamycin i vaccinen er lavt, hvis det er til stede.
English: Immunogenicity in infants and children
Danish: Immunogenicitet hos spædbørn og børn
English: You may receive an additional injection (booster).
Danish: Du kan få en ekstra injektion (booster).
English: These observations are consistent with adequate priming in infancy with both a two-dose and a threedose primary series followed by a booster of Bexsero.
Danish: Disse observationer er i overensstemmelse med tilstrækkelig påvirkning i barndommen med både to-dosis og tre-dosis primære serier efterfulgt af en booster af Bexsero.
English: Frequencies are defined as follows: Very common:
Danish: Frekvenserne er defineret som følger: Meget almindelig: (≥1/10) Almindelig:
English: 1 month after 2nd dose
Danish: 1 måned efter 2. dosis
English: Of the subjects who received primary infant series of Bexsero, 3285 received a booster dose in the second year of life.
Danish: Blandt de forsøgspersoner, der fik en primær serie af Bexsero til spædbørn, fik 3.285 en boosterdosis i det andet leveår.
English: Inconsistent results were seen across studies for responses to inactivated poliovirus type 2 and pneumococcal conjugate serotype 6B and lower antibody titers to the pertussis pertactin antigen were also noted, but these data do not suggest clinically significant interference.
Danish: Der blev observeret inkonsistente resultater på tværs af studier for svar på inaktiveret poliovirus type 2 og konjugeret pneumokok serotype 6B, og der blev desuden konstateret lavere antistoftitre til pertussis pertactinantigen, men disse data tyder ikke på nogen klinisk signifikant interferens.
English: Tell your doctor or nurse if you or your child are taking, have recently taken, or might take any other medicines, or have recently received any other vaccine.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis du eller dit barn bruger anden medicin eller har gjort det for nylig, eller for nylig har fået en anden vaccine.
English: In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.
Danish: Hvis der observeres fremmede partikler og/eller afvigende fysisk udseende, må vaccinen ikke administreres.
English: However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.
Danish: Visse af de virkninger, der er omtalt i punkt 4 ”Bivirkninger”, kan dog midlertidigt påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group B, even if they develop antibodies following vaccination with Bexsero.
Danish: Personer med familiær komplementdefekt (f.eks. C3 eller C5 defekt) og personer, der modtager behandling, som inhiberer den terminale komplement aktivering (f.eks. eculizumab), forbliver i øget risiko for invasiv sygdom forårsaget af Neisseria meningitidis gruppe B, også hvis de udvikler antistoffer efter vaccination med Bexsero.
English: Bexsero contains four different components from the surface of the bacteria Neisseria meningitidis group B.
Danish: Bexsero indeholder fire forskellige komponenter fra overfladen af bakterien Neisseria meningitidis gruppe B.
English: Adverse reactions (following primary immunisation or booster dose) considered as being at least possibly related to vaccination have been categorised by frequency.
Danish: De bivirkninger (efter primær immunisering eller boosterdosis), der anses for at have mindst en mulig sammenhæng med vaccinationen, er kategoriseret efter frekvens.
English: ** GMT = geometric mean titer.
Danish: ** GMT = geometrisk middeltiter.
English: The risk for developing an allergic reaction is very small, but your doctor or nurse needs to be aware of your allergy when deciding if you or your child should receive Bexsero.
Danish: Risikoen for at udvikle en allergisk reaktion er meget lille, men lægen eller sundhedspersonalet skal kende til en sådan allergi for at kunne tage stilling til, om du eller dit barn kan vaccineres med Bexsero.
English: Allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash, loss of consciousness and very low blood pressure.
Danish: Allergiske reaktioner, som kan omfatte alvorlig hævelse af læber, mund og/eller hals (hvilket kan gøre det svært at synke), vejrtrækningsproblemer med hvæsen eller hoste, udslæt, bevidstløshed og meget lavt blodtryk.
English: *** GMT = geometric mean titer.
Danish: *** GMT = geometrisk middeltiter.
English: Your doctor or nurse may ask you to give your child medicines that lower fever at the time and after Bexsero has been given.
Danish: Lægen eller sundhedspersonalet kan bede dig om at give dit barn febersænkende medicin på tidspunktet for vaccinationen og efter at Bexsero er givet.
English: Higher rates of antipyretic use were also reported for infants vaccinated with Bexsero and routine vaccines.
Danish: Der blev også rapporteret om et højere forbrug af antipyretika hos spædbørn, der blev vaccineret med Bexsero og standardvacciner.
English: Concomitant administration of Bexsero with vaccines other than those mentioned above has not been studied.
Danish: Samtidig administration af Bexsero og andre vacciner end nævnt ovenfor er ikke undersøgt.
English: Bexsero is a Meningococcal group B Vaccine.
Danish: Bexsero er en Meningokok gruppe B-vaccine.
English: When Bexsero was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials.
Danish: Når Bexsero blev givet alene, var hyppigheden af feber den samme som i forbindelse med standardvacciner til spædbørn, der blev administreret under de kliniske studier.
English: When Bexsero is given to you or your child, the very common side effects (may affect more than 1 in 10 people) that you or your child may get (reported in all age groups) are: - pain/tenderness at the injection site, redness of the skin at the injection site, swelling of the skin at the injection site, hardness of the skin at the injection site.
Danish: Når du eller dit barn har fået Bexsero, er de mest almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 personer), som du eller dit barn kan opleve (indberettet i alle aldersgrupper): - smerter/ømhed på injektionsstedet, rødme af huden på injektionsstedet, hævelse af huden på injektionsstedet, hårdhed af huden på injektionsstedet.
English: The safety of Bexsero was evaluated in 17 studies including 10 randomised controlled clinical trials with 10565 subjects (from 2 months of age) who received at least one dose of Bexsero.
Danish: Bexseros sikkerhed blev evalueret i 17 studier, herunder 10 randomiserede, kontrollerede kliniske studier med 10.565 forsøgspersoner (fra 2-måneders-alderen), der fik mindst én dosis Bexsero.
English: Prophylactic use of paracetamol reduces the incidence and severity of fever without affecting the immunogenicity of either Bexsero or routine vaccines.
Danish: Profylaktisk brug af paracetamol nedsætter forekomst og sværhedsgrad af feber uden påvirkning af immunogeniciteten af Bexsero og andre standardvacciner.
English: The same study also evaluated antibody persistence data from an additional phase 3 initial study in adolescents.
Danish: Samme studie evaluerede også antistof persistens data fra et yderligere fase 3-indledende studie hos unge.
English: For instructions on the handling of the vaccine before administration, see section 6.6.
Danish: Med hensyn til håndtering af vaccinen før administration, se pkt.
English: Metabolism and nutrition disorders Very common: eating disorders
Danish: Metabolisme og ernæring Meget almindelige: spiseforstyrrelser
English: Tell your doctor or nurse if you know that you or your child is allergic to latex.
Danish: Fortæl altid til lægen eller sundhedspersonalet, hvis du ved, at du eller dit barn er allergisk over for latex.
English: Bexsero was immunogenic in maternal animals vaccinated prior to lactation, and antibodies were detected in the offspring, but antibody levels in milk were not determined.
Danish: Bexsero var immunogent hos moderdyr, som blev vaccineret inden amning, og antistoffer kunne måles hos deres afkom, men antistofniveauer i mælk blev ikke undersøgt.
English: If two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular administration.
Danish: Hvis pakningen indeholder to kanyler i forskellige længder, skal den bedst egnede kanyle til at sikre intramuskulær administration vælges.
English: There are limited data on the use of Bexsero in patients with chronic medical conditions or with weakened immunity.
Danish: Der er begrænset data om brugen af Bexsero hos patienter med kroniske medicinske tilstande eller svækket immunforsvar.
English: Contents of the pack and other information What Bexsero contains
Danish: Pakningsstørrelser og yderligere oplysninger Bexsero indeholder:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: • Risikostyringsplan (RMP) Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Individuals with impaired immune responsiveness, whether due to the use of immune-suppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation.
Danish: Personer med svækket immunforsvar, hvad enten det skyldes brugen af immunsuppresiv behandling, en genetisk sygdom eller andre årsager, kan have reduceret antistofrespons over for aktiv immunisering.
English: There are no data on the use of Bexsero in adults above 50 years of age.
Danish: Der er ingen data om brugen af Bexsero hos voksne over 50 år.
English: The same extension study also evaluated antibody persistence and the response to a booster dose in children who received the two-dose primary series at 2-5 or 6-10 years of age.
Danish: Det samme forlængelsesstudie evaluerede også antistof persistensen og antistofresponset på en boosterdosis hos børn, der fik to-dosis primær serien ved alderen 2-5 år eller 6-10 år.
English: The vaccine is given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older subjects.
Danish: Vaccinen gives ved dyb intramuskulær injektion, fortrinsvis i den anterolaterale side af låret hos spædbørn eller i området omkring musculus deltoideus på overarmen hos ældre personer.
English: When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.
Danish: Ved forekomst af feber var feberforløbet i reglen forudsigeligt, idet feberen i de fleste tilfælde fortog sig senest dagen efter vaccinationen.
English: In the initial study, whose results are summarised in Table 5, participants received two doses of Bexsero two months apart.
Danish: I det indlende studie, hvis resultater er opsummeret i tabel 5, modtog forsøgspersonerne to doser af Bexsero to måneder fra hinanden.