FrancophonIA/ELRC3.0 huggingface dataset:
English: Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.
Danish: Ikke desto mindre anbefales vaccination af personer med kroniske immundefekter, såsom hiv-infektion, selvom antistofresponsen kan være begrænset.
English: Lower FHA, PRN, IPV1 and IPV3 immune responses were observed after a 2-dose primary schedule (2, 4 months), although the clinical relevance of these data remain uncertain.
Danish: Der blev observeret lavere immunrespons på FHA, PRN, IPV1 og IPV3 efter en primær vaccinationsplan med 2 doser (2, 4 måneder), selvom den kliniske relevans af disse data er uvis.
English: Diarrhoea Uncommon Abdominal pain
Danish: Almindelig Diaré Ikke almindelig Abdominalsmerter
English: Regarding PT and FIM, similar response rates and higher GMCs were observed both post-primary and post-booster in comparison to control vaccine.
Danish: Hvad angår PT og FIM blev der observeret tilsvarende responsrater og højere GMC'er både efter den primære dosis og booster-dosis sammenlignet med kontrolvaccinen.
English: Infection can also cause inflammation and swelling of the throat, leading to difficulties in swallowing and breathing, and infection can affect other parts of the body such as the blood, lungs, skin, bones, and joints.
Danish: Infektionen kan også føre til betændelse og hævelse af svælgets bagside, hvilket kan resultere i synkebesvær og åndedrætsbesvær, og infektionen kan påvirke andre dele af kroppen såsom blod, lunger, knogler og led.
English: Very Common Decreased appetite Uncommon Increased appetite
Danish: Ikke almindelig Øget appetit
English: Uncommon Sleep disorders including insomnia, restlessness
Danish: Ikke almindelig Søvnforstyrrelser, herunder insomni og rastløshed
English: History of an anaphylactic reaction after a previous administration of Vaxelis or a vaccine containing the same components or constituents.
Danish: Anamnese med anafylaktisk reaktion efter tidligere administration af Vaxelis eller en vaccine, der indeholdt de samme komponenter eller indholdsstoffer.
English: The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4
Danish: Risikoen afhænger tilsyneladende af antal forudgående doser af vaccine, der indeholder acellulær pertussis, med en større risiko efter 4. og 5. dosis.
English: Vaxelis will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Danish: Vaxelis vil blive givet til dit barn af en læge eller sygeplejerske, der er trænet i brugen af vacciner, og som er udstyret til at håndtere en uventet, svær allergisk reaktion på injektionen (se afsnit 4, Bivirkninger).
English: At the end of this period Vaxelis should be used or discarded.
Danish: Derefter skal Vaxelis bruges eller kasseres.
English: •is receivinga treatment (such as steroids, chemotherapy or radiotherapy) or has a disease that suppressesor weakensthe body's ability to fight infections.
Danish: •Barnet får en behandling (for eksempel steroider, kemoterapi eller strålebehandling) eller har en sygdom, der undertrykker eller svækker kroppens evne til at bekæmpe infektioner.
English: Sanofi Pasteur SA 1541 Avenue Marcel Mérieux 69280 Marcy l'Etoile France
Danish: Sanofi Pasteur SA 1541 Avenue Marcel Mérieux 69280 Marcy l'Etoile Frankrig
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Danish: Som det er tilfældet med enhver vaccine, er det ikke sikkert, at der fremkaldes et beskyttende immunrespons hos alle vaccinerede.
English: • Persistent crying lasting ≥3 hours, occurring within 48 hours of vaccination
Danish: • Vedvarende gråd, der varer ≥ 3 timer og opstår inden for 48 timer efter vaccination
English: • has an uncontrolled condition or severe illness affecting the brain and nervous system (uncontrolled neurologic disorder) or uncontrolled epilepsy.
Danish: • Har en ukontrolleret tilstand eller svær sygdom, der påvirker hjernen og nervesystemet (ukontrolleret, neurologisk forstyrrelse) eller ukontrolleret epilepsi.
English: The most frequently reported adverse reactions after Vaxelis administration were irritability, crying, somnolence, injection site reactions (pain, erythema, swelling), pyrexia (≥38
Danish: De hyppigst indberettede bivirkninger efter administration af Vaxelis var irritabilitet, gråd, somnolens, reaktioner på injektionsstedet (smerter, erythem, hævelse), pyreksi (≥ 38
English: The recommended injection sites are the anterolateral aspect of the thigh or the deltoid region of the upper arm if there is adequate muscle mass.
Danish: De anbefalede injektionssteder er den anterolaterale del af låret eller overarmens deltoideus, hvis der er tilstrækkelig muskelmasse.
English: After approximately 4 years, the percentages of children with anti-pertussis antibodies above LLOQ were as follows: anti-PT 58.4%, anti-FHA 80.9%, anti-PRN 66.1% and anti-FIM 94.3%.
Danish: Efter cirka 4 år var procentdelen af børn med antistoffer mod pertussis over LLOQ som følger: anti-PT 58,4%, anti-FHA 80,9%, anti-PRN 66,1% og anti-FIM
English: If any of the following events have occurred after administration of a pertussis-containing vaccine, the decision to administer further doses of a pertussis-containing vaccine should be carefully considered:
Danish: Hvis en eller flere af følgende hændelser er indtruffet efter administration af en pertussis-holdig vaccine, skal beslutningen om at give yderligere doser af en pertussis-holdig vaccine overvejes nøje:
English: Your doctor or nurse will inject Vaxelis into your child's thigh (in infants from the age of 6 weeks) or arm (in children older than one year).
Danish: Lægen eller sygeplejersken vil injicere Vaxelis ind i barnets lår (hos spædbørn fra 6-ugers-alderen) eller arm (hos børn over 1 år).
English: Table 1: List of Adverse Reactions
Danish: Tabel 1: Liste over bivirkninger
English: If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Danish: Hvis der er behov for en ny dosis hepatitis B-vaccine inden denne alder, skal der anvendes monovalent hepatitis B-vaccine.
English: Tell your doctor or nurse if your child is taking or has recently taken or might take any other medicines or vaccines.
Danish: Fortæl altid lægen eller sygeplejersken, hvis barnet bruger anden medicin eller har gjort det for nylig eller har fået andre vacciner for nylig.
English: The immunogenicity of Vaxelis administered to children over 15 months of age has not been studied in clinical trials.
Danish: Immunogeniciteten af Vaxelis administreret til børn over 15 måneder er ikke undersøgt i kliniske studier.
English: The other ingredients are: Sodium phosphate, water for injections
Danish: Øvrige indholdsstoffer: natriumphosphat, vand til injektion
English: It is recommended to postpone vaccination until the end of such treatment or disease.
Danish: Det anbefales at udsætte vaccinationen, til en sådan behandling eller sygdom er overstået.
English: • Haemophilus influenzae type b infections (often just called Hib infections ): serious bacterial infections causing meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness.
Danish: • Haemophilus influenzae type b-infektioner (ofte bare kaldet Hib): Alvorlige bakterieinfektioner, der kan give meningitis (betændelse i hjernens ydre hinder), hvilket kan føre til hjerneskade, døvhed, epilepsi eller delvis blindhed.
English: Encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine.
Danish: Encefalopati af ukendt ætiologi, der er opstået inden for 7 dage efter en tidligere vaccination med en pertussis-holdig vaccine.
English: Vaxelis does not protect your child against diseases caused by other bacteria and viruses that may cause similar symptoms.
Danish: Vaxelis beskytter ikke dit barn mod sygdomme, der skyldes andre bakterier og virusser, som kan give de samme symptomer.
English: The suspension should be visually inspected, prior to administration, for foreign particulate matter and/or variation of physical appearance.
Danish: Inden administration skal suspensionen kontrolleres visuelt for fremmedstoffer og/eller variationer i udseendet.
English: The proportion of children seroprotected (anti-HBsAg ≥ 10 mIU/mL) after those vaccination schedules was 98.1% and 99.6%, respectively, and decreased to 65.7% and 70.2% approximately 4 years later.
Danish: Andelen af børn, som var serobeskyttede (anti-HBsAg ≥ 10 mIE/ml) efter disse vaccinationsplaner, var henholdsvis 98,1% og 99,6%, og den faldt til 65,7% og 70,2% cirka 4 år senere.
English: Other medicines or vaccines and Vaxelis
Danish: Brug af anden medicin eller vaccine sammen med Vaxelis
English: Pertussis response rates were similar to the control vaccine for all pertussis antigens after the booster dose.
Danish: Responsraterne for pertussis var de samme som for kontrolvaccinen for alle pertussis-antigener efter booster-dosis.
English: Immunosuppressive therapy may interfere with the development of expected immune response (see section 4.4)
Danish: Immunsupprimerende behandling kan bryde forstyrrende ind i udviklingen af det forventede immunrespons (se pkt.
English: The primary vaccination schedules used in clinical studies were: 2, 4 months of age without hepatitis B vaccination at birth; 2, 3, 4 months of age without hepatitis B vaccination at birth; and 2, 4, 6 months of age with and without hepatitis B vaccination at birth.
Danish: De primære vaccinationsplaner, der blev brugt i kliniske studier, var: 2-, 4-måneders alderen uden hepatitis B-vaccination ved fødslen; 2-, 3-, 4-måneders alderen uden hepatitis B-vaccination ved fødslen og 2-, 4-, 6-måneders alderen med og uden hepatitis B-vaccination ved fødslen.
English: What Vaxelis contains
Danish: Vaxelis indeholder:
English: Premature infants
Danish: Præmature spædbørn
English: Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Danish: På grund af den lange inkubationstid for hepatitis B er det muligt, at en hepatitis B-infektion, der ikke er påvist, kan være til stede på vaccinationstidspunktet.
English: Anti-HBs Ag (≥ 10 IU/mL)
Danish: Anti-HBsAg (≥ 10 IE/ml)
English: Bordetella pertussis antigens Pertussis Toxoid (PT)
Danish: Bordetella pertussis-antigener Pertussistoksoid (PT)
English: Uniform, cloudy, white to off-white suspension.
Danish: Ensartet, uklar, hvid til offwhite suspension.
English: Tetanus Toxoid not less than 40 IU
Danish: Tetanustoksoid ikke under 40 IE
English: • has had any of the following events after receiving a vaccine against pertussis (whooping cough), as the decision to give further doses of pertussis containing vaccine will need to be carefully considered: had a fever of 40.5°C or above within 48 hours not due to another identifiable cause.
Danish: • Hvis en eller flere af følgende hændelser er opstået, efter at barnet har fået en kighoste-vaccine, da beslutningen om at give yderligere doser af vacciner, der indeholder pertussis, så skal overvejes nøje: Barnet har haft feber på 40,5 °C eller mere inden for 48 timer, som ikke skyldes en anden påviselig grund.
English: Almost all fevers were mild or moderate (<39.5°C) and transient (duration of ≤2 days).
Danish: Næsten alle tilfælde af feber var milde eller moderate (< 39,5 °C) og forbigående (varighed ≤ 2 dage).
English: Co-administration of Vaxelis with other injectable vaccines must be carried out at separate injection sites and, preferably, separate limbs.
Danish: Samtidig administration af Vaxelis og andre injektionsvacciner skal foregå på forskellige injektionssteder og helst også forskellige lemmer.
English: Sodium phosphate Water for injections
Danish: Natriumphosphat Vand til injektion
English: • Diphtheria: a bacterial infection that usually first affects the throat, causing pain and swelling which can lead to suffocation.
Danish: • Difteri: En bakterieinfektion, der normalt først angriber svælget og medfører smerter og hævelse, der kan føre til kvælning.
English: General disorders and administration site conditions Extensive swelling of the vaccinated limb from the injection site beyond one or both joints, has been reported in children.
Danish: Almene symptomer og reaktioner på administrationsstedet Der er indberettet omfattende hævelse af vaccinerede lemmer fra injektionsstedet ud over et eller begge led hos børn.
English: • Vaxelis will only help to prevent these diseases caused by the bacteria and viruses targeted by the vaccine.
Danish: • Vaxelis forebygger kun disse sygdomme, hvis de stammer fra de bakterier eller virusser, som denne vaccine er rettet imod.
English: The following adverse events have been reported with other vaccines containing the components or constituents of Vaxelis without regard to causality or frequency.
Danish: Nedenstående bivirkninger er indberettet for andre vacciner, der indeholdt de samme komponenter eller hjælpestoffer som Vaxelis uden hensyntagen til kausalitet eller hyppighed.
English: A history of febrile convulsions, a family history of convulsions, or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Vaxelis.
Danish: En anamnese med feberkramper eller en familieanamnese med kramper eller vuggedød (SIDS) er ikke en kontraindikation for anvendelse af Vaxelis.
English: • previously had Guillain-Barré syndrome (temporary loss of feeling and movement) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin).
Danish: •Barnet har tidligere haft Guillain-Barrés syndrom (midlertidigt tab af følesans og bevægelsesevne) efter at have fået en vaccine, der indeholdt tetanustoksoid (en inaktiveret form af tetanustoksin).
English: The bacteria also make a toxin (poison) that can damage the heart, kidneys and nerves.
Danish: Bakterierne producerer også et toksin (gift), der kan skade hjertet, nyrerne og nerverne.
English: In a clinical study where Vaxelis was administered concomitantly with Prevenar 13 (PCV13) as a booster dose of both vaccines, fever ≥38.0°C was reported in 54.3% of children, compared to 33.1% to 40.7% of children during the primary series.
Danish: I et klinisk studie, hvor Vaxelis blev administreret samtidig med Prevenar 13 (PCV13) som en booster-dosis af begge vacciner, blev der indberettet feber på ≥ 38,0 °C hos 54,3% af børnene sammenlignet med 33,1% til 40,7% af børnene under den primære serie.
English: • Poliomyelitis (often just called polio): caused by viruses that affect the nerves.
Danish: • Poliomyelitis (ofte bare polio eller børnelammelse): Stammer fra virus, der påvirker nerverne.
English: •suffers from any undiagnosed illness of the brain or epilepsy which is not controlled.
Danish: • Barnet lider af en ikke-diagnosticeret sygdom i hjernen eller ukontrolleret epilepsi.
English: Data from a clinical study indicate that, when Vaxelis is co-administered with pneumococcal conjugate vaccine (PCV13), the rate of fever is higher following the booster dose in the second year of life compared to the primary series.
Danish: Data fra et klinisk studie viser, at når Vaxelis administreres samtidig med pneumokokkonjugatvaccine (PCV13), er forekomsten af feber højere efter booster-dosen i 2-års-alderen sammenlignet med den primære serie.
English: Did not receive hepatitis B vaccine at birth
Danish: Fik ikke hepatitis B-vaccine ved fødslen
English: As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine (see section 4.3).
Danish: Som ved enhver injektionsvaccine skal relevant medicinsk behandling og overvågning altid være umiddelbart til rådighed i det sjældne tilfælde, at der opstår en anafylaktisk reaktion efter administration af vaccinen (se pkt.
English: Uncommon Rhinitis
Danish: Ikke almindelig Rhinitis
English: 3 µg conjugated to meningococcal protein
Danish: 3 µg konjugeret til meningokokprotein
English: After the first course of injections, your child will receive a booster dose, in accordance with local recommendations, at least 6 months after the last dose of the first course.
Danish: Efter de første injektioner vil barnet få en opfølgende dosis (booster-dosis) i overensstemmelse med de lokale anbefalinger og mindst 6 måneder efter den sidste dosis i det første vaccinationsforløb.
English: Anti-Polio type 1 (≥ 1:8 dilution) Anti-Polio type 2 (≥ 1:8 dilution) Anti-Polio type 3 (≥ 1:8 dilution)
Danish: Antipolio type 1 (fortynding ≥ 1:8) Antipolio type 2 (fortynding ≥ 1:8) Antipolio type 3 (fortynding ≥ 1:8)
English: The active substances per dose (0.5 mL):
Danish: Aktive stoffer pr. dosis (0,5 ml):
English: After a 2-dose or a 3-dose primary series vaccination with Vaxelis , a booster dose should be given at least 6 months after the last priming dose.
Danish: Efter en primær vaccinationsserie med 2 eller 3 doser Vaxelis bør der gives en booster-dosis mindst 6 måneder efter den sidste primære dosis.
English: • has suffered from a severe reaction affecting the brain (encephalopathy) within 7 days of a prior dose of a pertussis vaccine (acellular or whole cell pertussis).
Danish: • Har haft en alvorlig reaktion, der påvirker hjernen (encefalopati) inden for 7 dage efter en tidligere dosis pertussis-vaccine (acellulær eller helcelle-pertussis).
English: Table 3: Seroprotection/Vaccine Response Rates One Month After Booster Vaccination
Danish: Tabel 3: Serobeskyttelses-/vaccineresponsrater 1 måned efter booster-vaccination
English: Booster at 12 months after primary doses at 2, 3, 4 months
Danish: Booster ved 12 måneder efter primære doser ved 2, 3, 4 måneder
English: The booster dose in clinical studies was given at 11-12 months after a 2-dose primary series, at 12 months of age after a 3-dose primary series (2, 3, 4 months), and at 15 months of age after a 3-dose primary series (2, 4, 6 months).
Danish: Booster-dosis i kliniske studier blev givet i 11-12-måneders alderen efter en primær serie med 2 doser, i 12-måneders alderen efter en primær serie med 3 doser (2, 3, 4 måneder) og i 15-måneders alderen efter en primær serie med 3 doser (2, 4, 6 måneder).
English: The safety of Vaxelis in children over 15 months of age has not been studied in clinical trials.
Danish: Sikkerheden ved anvendelse af Vaxelis til børn over 15 måneder er ikke undersøgt i kliniske studier.
English: • has a moderate to severe acute disease, with or without fever (e.g. sore throat, cough, cold or flu).
Danish: • Har en moderat eller alvorlig sygdom med eller uden feber (fx ondt i halsen, hoste, forkølelse eller influenza).
English: Vaxelis does not protect against disease caused by Haemophilus influenzae other than type b or by other microorganisms that cause invasive disease such as meningitis or sepsis, including N. meningitidis.
Danish: Vaxelis beskytter ikke mod sygdom, der skyldes Haemophilus influenzae, bortset fra type b, eller mod andre mikroorganismer, der skyldes invasiv sygdom, for eksempel meningitis eller sepsis, herunder N. meningitidis.
English: Individuals with a history of febrile convulsions should be closely followed up as febrile convulsions may occur within 2 to 3 days post vaccination.
Danish: Personer med feberkramper i anamnesen skal følges tæt, da sådanne kramper kan optræde inden for 2 til 3 dage efter vaccination.
English: Your doctor will decide whether to give Vaxelis to your child.
Danish: Lægen vil beslutte, om Vaxelis skal gives til dit barn.
English: Booster at 11-12 months, after primary doses at 2, 4, months
Danish: Booster ved 11-12 måneder efter primære doser ved 2, 4 måneder
English: The vaccine may not prevent hepatitis B infection in such cases.
Danish: I sådanne tilfælde forebygger vaccinen muligvis ikke en hepatitis B-infektion.
English: • suffers from fits during a fever, or there is family history of fits occurring during a fever.
Danish: • Barnet lider af krampeanfald i forbindelse med feber, eller der har i familien været tilfælde af krampeanfald i forbindelse med feber.
English: ≥ 20 IU
Danish: ≥ 20 IE
English: The needle must be fitted firmly on to the pre-filled syringe, rotating it by a one-quarter turn.
Danish: Kanylen skal sættes godt fast på den fyldte injektionssprøjte ved at dreje den en kvart omgang.
English: Table 2: Seroprotection/Vaccine Response Rates One Month After the Primary Vaccination Series
Danish: Tabel 2: Serobeskyttelses-/vaccineresponsrater 1 måned efter den primære vaccinationsserie
English: • Convulsions with or without fever, occurring within 3 days of vaccination.
Danish: • Kramper med eller uden feber, der opstår inden for 3 dage efter vaccination
English: Almost all fevers after primary and booster doses were mild or moderate (<39.5°C) and transient (duration of ≤2 days).
Danish: Næsten alle tilfælde af feber efter den primær dosis og booster-dosen var milde eller moderate (< 39,5 °C) og forbigående (varighed ≤ 2 dage).
English: The bacteria make a toxin (poison) that causes spasms of the muscles, leading to inability to breathe and the possibility of suffocation.
Danish: Bakterierne producerer et toksin (gift), der giver muskelsammentrækninger og fører til manglende evne til at trække vejret og risiko for kvælning.
English: became floppy, unresponsive or unconscious after the previous vaccination, within 48 hours of vaccination.
Danish: Barnet har været slapt, passivt eller bevidstløst inden for 48 timer efter en tidligere vaccination.
English: Vaxelis will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or by other liver pathogens.
Danish: Vaxelis beskytter ikke mod hepatitis-infektion, der skyldes andre patogener, såsom hepatitis A, hepatitis C og hepatitis E eller andre leverpatogener.
English: Where a dose of hepatitis B vaccine is given at birth, Vaxelis can be used for supplementary doses of hepatitis B vaccine from the age of 6 weeks.
Danish: Hvis en dosis hepatitis B-vaccine er givet ved fødslen, kan Vaxelis anvendes som supplerende doser hepatitis B-vaccine fra 6-ugers-alderen.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: If your child gets any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis dit barn oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: EXP: {MM/YYYY}
Danish: EXP: {MM/ÅÅÅÅ}
English: Aluminium phosphate and amorphous aluminium hydroxyphosphate sulphate are included in the vaccine as adjuvants.
Danish: Vaccinen indeholder aluminiumphosphat og amorf aluminiumhydroxyphosphatsulfat som adjuvanser.
English: Filamentous Haemagglutinin (FHA)
Danish: Filamentøs hæmagglutinin (FHA)
English: Nervous system disorders Convulsion, febrile convulsion.
Danish: Nervesystemet Kramper, feberkramper.
English: The recommended injection sites are the anterolateral area of the thigh (preferred site for infants under one year of age) or the deltoid muscle of the upper arm.
Danish: De anbefalede injektionssteder er det anterolaterale område af låret (foretrukket sted for spædbørn under 1 år) eller overarmens deltoideus.
English: Antibody Thresholds
Danish: Tærskelværdier for antistoffer
English: Common (1/100 to <1/10)
Danish: (1/100 til <1/10)
English: Hypersensitivity (such as rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (such as urticaria, angioedema, edema, face edema, shock).
Danish: Overfølsomhed (for eksempel udslæt, urticaria, dyspnø, erythema multiforme), anafylaktisk reaktion (for eksempel urticaria, angioødem, ødem, ansigtsødem, shock).
English: Anti-diphtheria (≥ 0.01 IU/mL) Anti-tetanus (≥ 0.01 IU/mL) Anti-PT (vaccine response) Anti-FHA (vaccine response) Anti-PRN (vaccine response)
Danish: Antidifteri (≥ 0,01 IE/ml) Antitetanus (≥ 0,01 IE/ml) Anti-PT (vaccinerespons) Anti-FHA (vaccinerespons) Anti-PRN (vaccinerespons)