FrancophonIA/ELRC3.0 huggingface dataset:
English: • Hexacima must be administered intramuscularly.
Danish: • Hexacima skal administreres intramuskulært.
English: Hexacima 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: Hexacima 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 punkt 4 ”Bivirkninger”).
English: Tell your doctor or nurse if your child is taking, 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 nyligt eller har fået andre vacciner for nyligt.
English: If any of the following events are known to have occurred after receiving any pertussis containing vaccine, the decision to give further doses of pertussis containing vaccine should be carefully considered:
Danish: Hvis det er kendt, at en eller flere af følgende hændelser er indtruffet efter modtagelse af vaccine, der indeholder pertussis, skal beslutningen om at give yderligere doser vaccine, der indeholder pertussis, nøje overvejes:
English: • Poliovirus (Inactivated) Types 1/2/3
Danish: • Poliovirus (inaktiveret) type 1/2 /3
English: Hexacima can be considered for the booster.
Danish: Hexacima kan anvendes som booster.
English: The safety of Hexacima in children over 24 months of age has not been studied in clinical trials.
Danish: Sikkerheden af Hexacima hos børn over 24 måneder er ikke blevet undersøgt i kliniske forsøg.
English: • Shake the vial so that the contents become homogeneous.
Danish: • Ryst hætteglasset, så indholdet bliver homogent.
English: Hexacima is a whitish, cloudy suspension.
Danish: Hexacima er en hvidlig, uklar suspension.
English: Associated symptoms may include cyanosis, redness, transient purpura and severe crying.
Danish: Tilknyttede symptomer kan omfatte cyanose, rødme, transient purpura og svær gråd.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine.
Danish: Som ved enhver injektionsvaccine skal passende medicinsk behandling og overvågning altid være umiddelbart til rådighed i tilfælde af en anafylaktisk reaktion efter administration af vaccinen.
English: Pyrexia (body temperature ≥ 38.0°C)
Danish: Pyreksi (legemstemperatur ≥ 38,0°C)
English: • Swelling or inflammation of the brain (encephalopathy/encephalitis).
Danish: • Hævelse eller inflammation af hjernen (encephalopati/encephalitis).
English: Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.
Danish: Alligevel anbefales vaccination af individer med kronisk immundefekt, såsom HIV-infektion, skønt antistofrespons kan være begrænset.
English: It is important to follow the instructions from the doctor or nurse so that your child completes the course of injections.
Danish: Det er vigtigt at følge din læges eller sygeplejerskes vejledninger, så dit barn fuldfører rækken af injektioner.
English: Keep the container in the outer carton in order to protect from light.
Danish: Beholderen opbevares i den ydre karton for at beskytte den mod lys.
English: As with all injectable vaccines, the vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
Danish: Som ved enhver injektionsvaccine skal vaccinen administreres med omhu til individer med thrombocytopeni eller en blødningsforstyrrelse, idet blødning kan indtræffe efter intramuskulær administration.
English: Table 1: Adverse Reactions from clinical trials and reported during commercial use System Organ Class
Danish: Tabel 1: Bivirkninger fra kliniske forsøg samt rapporterede bivirkninger under kommerciel brug
English: • Diphtheria is an infectious disease that usually first affects the throat.
Danish: • Difteri er en smitsom sygdom, der normalt først angriber svælget.
English: If your child misses a scheduled injection, it is important that you discuss with your doctor or nurse who will decide when to give the missed dose.
Danish: Hvis dit barn ikke modtager en planlagt injektion, er det vigtigt, at du diskuterer med din læge eller sygeplejerske, hvornår den manglende dosis skal gives.
English: When given at the same time with other vaccines, Hexacima will be given at different injection sites.
Danish: Hvis det gives samtidigt med andre vacciner, vil Hexicima blive givet på forskellige injektionssteder.
English: Talk to your doctor, pharmacist or nurse before vaccination if your child:
Danish: Kontakt lægen, apoteket eller sundhedspersonalet inden vaccinationen, hvis barnet
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination;
Danish: • Kollaps eller shock-lignende tilstand (hypotonisk-hyporesponsiv episode) inden for 48 timer efter vaccination;
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, som blod, lunger, knogler og led.
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate injections sites.
Danish: Hvis samtidig administration med en anden vaccine overvejes, skal immuniseringen foretages på to forskellige injektionssteder.
English: No significant clinical interaction with other treatments or biological products has been reported except in the case of immunosuppressive therapy (see section 4.4).
Danish: Der er ikke blevet indberettet nogen signifikant klinisk interaktion med andre behandlinger eller biologiske præparater med undtagelse af immunsuppressiv terapi (se pkt.
English: History of an anaphylactic reaction after a previous administration of Hexacima.
Danish: Anamnese med anafylaktisk reaktion efter tidligere administration af Hexacima.
English: In the throat, the infection causes pain and swelling which can lead to suffocation.
Danish: I svælget er infektionen årsag til smerte og hævelse, som kan føre til kvælning.
English: These reactions start within 24-72 hours after vaccination, may be associated with redness, warmth, tenderness or pain at the injection site, and get better within 3-5 days without the need for treatment.
Danish: Disse reaktioner begynder inden for 24-72 timer efter vaccination, kan sammenknyttes med rødme, varme, ømhed eller smerte på injektionsstedet og bliver bedre inden for 3-5 dage uden behov for behandling.
English: Immunisation must be carried out by intramuscular (IM) injection.
Danish: Immunisering skal udføres via intramuskulær (i.m.)
English: There may be a clinically relevant interference in the antibody response of Hexacima and a varicella vaccine and these vaccines should not be administered at the same time.
Danish: Der kan forekomme en klinisk påvirkning af antistofrespons på Hexacima og varicellavaccination, og disse vacciner må ikke administreres samtidigt.
English: • suffers from any undiagnosed illness of the brain or epilepsy which is not controlled.
Danish: • lider af en ikke-diagnosticeret hjernesygdom eller epilepsi, der ikke er under kontrol.
English: Other medicines or vaccines and Hexacima
Danish: Brug af anden medicin eller vaccine sammen med Hexacima
English: The intradermal or intravenous routes must not be used.
Danish: Intradermal og intravenøs administration må ikke anvendes.
English: At the end of this period, Hexacima should be used or discarded.
Danish: Hexacima skal administreres inden for denne periode eller kasseres.
English: • has a moderate or high temperature or an acute illness (e.g. fever, sore throat, cough, cold or flu).
Danish: • har en moderat eller høj temperatur eller en akut sygdom (f.eks. feber, ondt i halsen, hoste, forkølelse eller influenza).
English: After shaking, the normal appearance of the vaccine is a whitish cloudy suspension.
Danish: Efter omrystning er vaccinens normale udseende en hvidlig, uklar suspension.
English: Tetanus Toxoid not less than 40 IU2,3
Danish: Tetanus toxoid ikke mindre end 40 IE
English: Keep the vaccine in the outer carton in order to protect from light.
Danish: Vaccinen opbevares i den ydre karton for at beskytte den mod lys.
English: Do not administer by intravascular, intradermal or subcutaneous injection.
Danish: Må ikke indgives ved intravaskulær, intradermal eller subkutan injektion.
English: At the very least, a dose of Hib vaccine must be administered.
Danish: Som et absolut minimum skal der administreres en dosis Hib-vaccine.
English: Individuals with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
Danish: Patienter med en anamnese med feberkramper skal følges tæt, idet sådanne bivirkninger kan optræde inden for 2 til 3 dage efter vaccination.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv
English: These reactions start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3-5 days.
Danish: Disse reaktioner begynder inden for 24-72 timer efter vaccination, kan omfatte erytem, varme, ømhed eller smerte på injektionsstedet og stopper spontant inden for 3-5 dage.
English: • Haemophilus influenzae type b polysaccharide
Danish: • Haemophilus influenzae type b polysaccharid
English: • Tetanus (often called lock jaw) is usually caused by the tetanus bacteria entering a deep wound.
Danish: • Tetanus (ofte kaldet stivkrampe) stammer normalt fra tetanus bakterier, der kommer ind gennem et dybt sår.
English: Extensive limb swelling: Large injection-site reactions (>50 mm), including extensive limb swelling from the injection site beyond one or both joints, have been reported in children.
Danish: Omfattende hævelse af lemmer: Store reaktioner på injektionssted (>50 mm), herunder omfattende hævelse af lemmer fra injektionsstedet ud over et eller begge led, er indberettet hos børn.
English: • This vaccine does not protect against infections caused by other types of Haemophilus influenzae nor against meningitis due to other micro-organisms.
Danish: • Denne vaccine beskytter ikke mod smitte fra andre typer af Haemophilus influenzae eller mod meningitis, der stammer fra andre mikroorganismer.
English: Primary 2-4-6 months and booster at 12-24 months
Danish: Primærvaccination 24-6 måneder og booster ved 12-24 måneder
English: 12 µg conjugated to Tetanus protein
Danish: 12 µg konjugeret til tetanus protein
English: The bacteria that cause the disease also make a toxin (poison) that can damage the heart, kidneys and nerves.
Danish: Bakterierne, der er årsag til sygdommen, producerer også et toksin (gift), der kan skade hjertet, nyrerne og nerverne.
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Danish: Ikke almindelig (≥1/1.000 til <1/100) Sjælden (≥1/10.000 til <1/1000) Meget sjælden (<1/10.000)
English: Interference with laboratory testing: see section 4.4.
Danish: Interferens med laboratorieundersøgelser: Se pkt.
English: Immune responses to Hib and pertussis antigens after 2 doses at 2 and 4 months of age
Danish: Immunresponser på Hib- og pertussis-antigener efter 2 doser ved 2 og 4-månedersalderen
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 første vaccinationsforløb skal dit barn have en opfølgningsdosis i overensstemmelse med lokale anbefalinger mindst 6 måneder efter den sidste dosis i første omgang.
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 muskelkramper og fører til manglende evne til at trække vejret og risiko for kvælning.
English: All events should resolve spontaneously without sequel within 24 hours.
Danish: Alle bivirkninger bør ophøre spontant uden følgesygdomme inden for 24 timer.
English: 3 Or equivalent activity determined by an immunogenicity evaluation 4 Produced on Vero cells
Danish: Eller ækvivalent aktivitet bestemt ved en immunogenicitetsevaluering Produceret på Vero-celler
English: • Poliomyelitis (often just called polio) is caused by viruses that affect the nerves.
Danish: • Poliomyelitis (ofte bare polio eller børnelammelse) stammer fra virus, der påvirker nerverne.
English: 22-36 micrograms
Danish: 22-36 mikrogram
English: Very common Vomiting Common
Danish: Meget almindelig Opkastning Almindelig
English: • suffers from an acute or chronic illness including chronic renal insufficiency or failure (inability of the kidneys to work properly).
Danish: • lider af en akut eller kronisk sygdom, herunder kronisk, nedsat nyrefunktion eller nyresvigt (nyrernes manglende evne til at fungere korrekt).
English: The vaccine effectiveness against Hib invasive disease of DTaP and Hib combination vaccines (pentavalent and hexavalent including vaccines containing the Hib antigen from Hexacima) has been demonstrated in Germany via an extensive (over five years follow-up period) post-marketing surveillance study.
Danish: Vaccinens effekt mod Hib invasiv sygdom fra DTaP og Hib kombinationsvacciner (pentavalente og hexavalente, herunder vacciner, der indeholder Hib-antigenet fra Hexacima er påvist i Tyskland via et omfattende studie (over fem års opfølgning) efter markedsføringen.
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 Hexacima.
Danish: En anamnese med feberkramper, en familieanamnese med kramper eller vuggedød (SIDS) er ikke en kontraindikation for anvendelse af Hexacima.
English: • has had respiratory disorder or swelling of the face (anaphylactic reaction) after administration of Hexacima
Danish: • Har haft luftvejsbesvær eller hævelse i ansiget (anafylaktisk reaktion) efter administration af Hexacima
English: - persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination.
Danish: - vedvarende, utrøstelig gråd, der varer 3 timer eller mere og indtræffer inden for 48 timer efter vaccination.
English: Table 1: Seroprotection/Seroconversion rates* one month after primary vaccination with 2 or 3 doses of Hexacima
Danish: Tabel 1: Serobeskyttelse/serokonversionsrate* én måned efter en primærvaccination med 2 eller 3 doser Hexacima
English: All vaccination schedules including the WHO Expanded Program on Immunisation (EPI) at 6, 10, 14 weeks of age can be used whether or not a dose of hepatitis B vaccine has been given at birth.
Danish: Alle vaccinationsserier, herunder det WHO-udvidede program for immunisering (EPI) ved 6, 10, 14 uger, kan anvendes, uanset om en dosis hepatitis B-vaccine er indgivet ved fødslen.
English: Poliovirus (Inactivated)4 Type 1 (Mahoney)
Danish: Poliovirus (inaktiveret) Type 1 (Mahoney)
English: • Haemophilus influenzae type b infections (often just called Hib) are serious bacterial infections and can cause 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) er alvorlige bakterieinfektioner og kan give meningitis (betændelse i hjernens ydre hinder), hvilket kan føre til hjerneskade, døvhed, epilepsi eller delvis blindhed.
English: Precautions for use
Danish: Forsigtighedsregler ved brug
English: Otherwise, post-vaccination antibody concentration should be ≥ pre immunisation level
Danish: Ellers bør antistofkoncentrationen efter vaccination være ≥ niveauet før vaccination
English: In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, poliomyelitis and Hib vaccines.
Danish: I sådanne tilfælde skal pertussis vaccination afbrydes, og vaccinationsforløbet bør fortsættes med difteri, tetanus, hepatitis B, poliomyelitis og HiB-vacciner.
English: Hexacima does not protect against infectious diseases caused by other types of Haemophilus influenzae or against meningitis of other origins.
Danish: Hexacima beskytter ikke mod infektionssygdomme, der stammer fra andre typer Haemophilus influenzae eller mod meningitis af anden oprindelse.
English: Studies on long-term persistence of vaccine induced antibodies following varying infant / toddler primary series and following Hepatitis B vaccine given at birth or not have shown maintenance of levels above the recognized protective levels or antibody thresholds for the vaccine antigens (see Table 3).
Danish: Studier af langvarig virkning af vaccineinducerede antistoffer efter forskellige primærvaccinationer af spædbørn/børn og efter hepatitis B-vaccine givet ved fødslen eller ej, har vist vedligeholdelse af niveauer over de anerkendte beskyttende niveauer eller antistoftærskelværdierne for vaccineantigener (se tabel 3).
English: • 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 fået alvorlig reaktion, der påvirker hjernen (encefalopati) inden for 7 dage efter en forrig dosis pertussis vaccine (acellulær eller helcelle pertussis).
English: The safety and efficacy of Hexacima in infants less than 6 weeks of age have not been established.
Danish: Hexacimas sikkerhed og virkning hos spædbørn under 6 uger er ikke klarlagt.
English: • Because symptoms of hepatitis B take a long time to develop, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Danish: • På grund af at symptomerne for hepatitis B tager lang tid om at udvikle sig, er det muligt for en ikke-erkendt hepatitis B infektion at være til stede på vaccinationstidspunktet.
English: 1541 avenue Marcel Mérieux 69280 Marcy L'Etoile France
Danish: 1541 avenue Marcel Mérieux 69280 Marcy L'Etoile Frankrig
English: In individuals with chronic renal failure, an impaired hepatitis B response is observed and administration of additional doses of hepatitis B vaccine should be considered according to the antibody level against hepatitis B virus surface antigen (anti-HBsAg).
Danish: Hos individer med kronisk nyresvigt ses en nedsat hepatitis B respons, og administration af yderligere doser hepatitis B-vaccine skal overvejes ud fra antistofniveauet for hepatitis B virus overfladeantigen (anti-HBsAg).
English: For instructions on handling see section 6.6.
Danish: Se punkt 6.6 for vejledninger angående håndtering.
English: Hexacima may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or a pentavalent DTaP-IPV/Hib vaccine associated with a monovalent hepatitis B vaccine.
Danish: Hexacima kan anvendes som en booster hos individer, som tidligere er blevet vaccineret med en anden hexavalent vaccine eller en pentavalent DTaP-IPV/HiB-vaccine i forbindelse med en monovalent hepatitis B-vaccine.
English: Immune memory against Hepatitis B had been demonstrated by the presence of an anamnestic response to a challenge Hepatitis B vaccination at the age of 9 years in 93% of vaccinees with development of geometric mean concentrations at 3692 (95% CI: 1886 - 7225) mIU/ml after vaccination.
Danish: Immunhukommelse mod hepatitis B blev påvist ved tilstedeværelsen af et anamnestisk respons på en udfordring af hepatitis B-vaccinationen i en alder af 9 år i 93 % af de vaccinerede med udvikling af geometriske middelkoncentrationer på 3.692 (95 % CI: 1.886 til 7.225) mIE/ml efter vaccination.
English: Very common Anorexia (decreased appetite)
Danish: Metabolisme og ernæring Meget almindelig Anorexi (nedsat appetit) Nervesystemet
English: Vaccine efficacy of the acellular pertussis (aP) antigens contained in Hexacima against the most severe WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) is documented in a randomised double-blind study among infants with a 3 dose primary series using a DTaP vaccine in a highly endemic country (Senegal).
Danish: Vaccinens effektivitet af acellulær pertussis- (aP) antigener i Hexacima, i forhold til den sværeste WHO-definerede, typiske pertussis (≥ 21 dages paroxysmal hoste) er dokumenteret i et randomiseret dobbeltblindt studie blandt spædbørn med primærserie på 3 doser ved brug af en DTaP-vaccine i et højt-endemisk land (Senegal).
English: • For syringes without attached needle, the needle must be fitted firmly to the syringe, rotating it by a one-quarter turn.
Danish: • For sprøjter uden monterede nåle skal nålen skrues fast på sprøjten ved at dreje den en kvart omgang.
English: The recommended injection site is preferably the antero-lateral area of the upper thigh and the deltoid muscle in older children (possibly from 15 months of age).
Danish: Det anbefalede injektionssted er fortrinsvis det øvre anterolaterale område på overlåret og deltoideus hos større børn (muligvis fra 15måneders alderen).
English: • Convulsions with or without fever, occurring within 3 days of vaccination.
Danish: • Kramper med eller uden feber, som optræder inden for 3 dage efter vaccination.
English: • swelling of the face or throat
Danish: • hævelse af ansigt eller svælg
English: Anti-HBs (≥ 10 mIU/ml)
Danish: Anti-HBs ( 10 mIE/ml)
English: If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Danish: Hvis dosis nr. 2 hepatitis B-vaccine er påkrævet inden denne alder, skal monovalent hepatitis B-vaccine anvendes.
English: After a 3-dose WHO EPI schedule with Hexacima (6, 10, 14 weeks) and in the absence of hepatitis B vaccination at birth, a hepatitis B vaccine booster must be given.
Danish: Efter en 3-dosis WHO EPI-serie med Hexacima (6, 10, 14 uger) og ved manglende hepatitis Bvaccination ved fødslen, skal der administreres en hepatitis B-vaccine booster-dosis.
English: The immune responses to Hib (PRP) and pertussis antigens (PT and FHA) were evaluated after 2 doses in a subset of subjects receiving Hexacima (N=148) at 2, 4, 6 months of age.
Danish: Immunresponser på Hib- (PRP) og pertussis-antigener (PT og FHA) blev evalueret efter 2 doser i en undergruppe af patienter, som fik Hexacima (N = 148) ved 2-, 4-, 6-månedersalderen.
English: The long term capability of the acellular pertussis (aP) antigens contained in Hexacima to reduce pertussis incidence and control pertussis disease in the childhood has been demonstrated in a 10-year national pertussis surveillance on pertussis disease in Sweden with the pentavalent DTaP-IPV/Hib vaccine using a 3, 5, 12 months schedule.
Danish: Langtideffekten af acellulær pertussis (aP) antigener i Hexacima til at reducere pertussis-forekomst og kontrollere pertussis-tilfælde i barndommen er påvist i en 10 års overvågning af pertussis-tilfælde i Sverige med pentavalent DTaP-IPV/Hib-vaccineserie ved 3, 5, 12 måneder.
English: • Shake the pre-filled syringe so that the contents become homogeneous.
Danish: • Den fyldte injektionssprøjte omrystes, så at indholdet bliver homogent.
English: Booster vaccination at 11-12 months of age after a two doses primary course
Danish: Boostervaccination ved 11-12måneders alderen efter primærvacc ination på to doser