FrancophonIA/ELRC3.0 huggingface dataset:
English: It is possible that your child will have no side effects from vaccination.
Danish: Det er muligt at dit barn ikke vil få nogen bivirkninger ved vaccinationen.
English: If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give subsequent doses of a vaccine containing the pertussis component should be carefully considered:
Danish: Hvis nogle af de følgende forhold opstår i tidsmæssig relation til modtagelsen af Quintanrix, skal beslutningen, om at give efterfølgende doser af en vaccine indeholdende kighoste komponenten, overvejes nøje:
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som for alle injicerbare vacciner skal passende medicinsk behandling og tilsyn altid være umiddelbart til rådighed i tilfælde af en sjælden anafylaktisk reaktion efter administration af vaccinen.
English: As Quintanrix is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.
Danish: Da Quintanrix ikke er tilsigtet brug for voksne, er information om sikkerhed af vaccinen, ved brug under graviditet eller amning, ikke tilgængelig.
English: As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.
Danish: Som med andre vacciner, skal en dosis vaccine trækkes tilbage under strenge aseptiske forhold og der skal tages forholdsregler for at undgå at indholdet kontamineres.
English: Seroprotection and vaccine response rates were similar for the three schedules used, with the exception of anti-HBs.
Danish: Serobeskyttelse og vaccine respons hyppigheder var ens for de tre programmer der blev anvendt, med undtagelse af anti-HB'erne.
English: The seroprotection rates for anti-HBs (≥10 mlU/ml) observed with the 6, 10, 14 week schedule was lower as shown in the table below, but is unlikely to be clinically relevant due to the small sample size:
Danish: Serobeskyttelseshyppighederne for anti-HB'erne (≥ 10 mlU/ml), observeret ved 6, 10, 14 ugers programmet, var lavere som vist i tabellen herunder, men det er sandsynligvis ikke klinisk relevant pga. den lille prøvestørrelse:
English: The use of Quintanrix should be determined on the basis of official recommendations.
Danish: Brug af Quintanrix bør besluttes på basis af officielle anbefalinger.
English: As shown with other vaccines, the booster dose is potentially associated with an increased incidence of minor adverse events such as fever and local reactions.
Danish: Som det er vist med andre vacciner, er boosterdosis potentielt associeret med en øget forekomst af mindre alvorlige bivirkninger såsom feber og lokale reaktioner.
English: A fine needle can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least two minutes following administration.
Danish: En fin nål kan anvendes til vaccinationen og et fast tryk på administrationsstedet (uden at gnide) i mindst 2 minutter efter administration.
English: Quintanrix can be given to children who have received hepatitis B vaccine at birth.
Danish: Quintanrix kan gives til børn som har modtaget hepatitis B vaccine ved fødslen.
English: When using a multidose vial, each 0.5 ml dose of the reconstituted suspension should be taken with a sterile needle and syringe.
Danish: Når der bruges et flerdosis hætteglas, skal hver 0,5 ml dosis, af den rekonstituerede suspension, tages med en steril nål og en sprøjte.
English: Both components are presented in a glass vial for 1 dose and must be mixed together before your child receives the vaccine.
Danish: Begge komponenter er præsenteret i et glas hætteglas til 1 dosis og skal blandes sammen før dit barn modtager vaccinen.
English: The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Danish: Det forventede immunrespons opnås muligvis ikke efter vaccination af immunosuppressive patienter.
English: The muscle spasms can be strong enough to cause bone fractures of the spine.
Danish: Muskelspasmerne kan være stærke nok til at medføre brud på rygsøjlen.
English: The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white suspension and should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Danish: DTPw HBV komponenten skal rystes godt for at opnå en homogen uklar hvid suspension, og skal undersøges visuelt for fremmede partikler og/eller udsædvanligt udseende.
English: Inactivated Bordetella pertussis 2
Danish: Inaktiveret Bordetella kighoste 2
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
Danish: • Kollaps eller shock-lignende tilstand (hypotonisk-hyporesponsiv episode) inden for 48 timer.
English: As with other vaccines it may be expected that an adequate response may not be achieved in patients receiving immunosuppressive therapy or patients with immunodeficiency.
Danish: Som med andre vacciner kan det forventes at et tilstrækkeligt respons måske ikke opnås hos patienter der modtager immunosuppressiv behandling eller patienter med nedsat immunforsvar.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering 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 immuniseringprogrammer til meget tidligt fødte børn (fødsel ≤ uge 28 af svangerskabet) og specielt for tidligere respiratorisk immature børn.
English: • Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
Danish: • Vedholdende gråd der varer ≥ 3 timer, og opstår inden for 48 timer.
English: Quintanrix is available in the following pack sizes:
Danish: Quintanrix findes i følgende pakningsstørrelser
English: The reconstituted vaccine is a homogeneous turbid white suspension.
Danish: Den rekonstituerede vaccine er en homogen uklar hvid suspension.
English: Lyophilised HIB component:
Danish: Frysetørret HIB komponent:
English: There will be some type of serious complications such as: mental retardation, cerebral palsy, deafness, epilepsy or partial blindness.
Danish: Der vil være nogle typer af alvorlige komplikationer såsom: mental retardering, cerebral parese, døvhed, epilepsi eller delvis blindhed.
English: BEFORE YOUR CHILD RECEIVES QUINTANRIX
Danish: FØR DIT BARN MODTAGER QUINTANRIX
English: After the completion of the primary series, a booster should be administered preferably before the end of the second year of life.
Danish: Efter afslutningen af de primære vaccinationer, skal en booster gives og helst før slutningen af 2. leveår.
English: The immune response after a three-dose primary vaccination course was evaluated in five trials: 297 infants were evaluated after vaccination at 6, 10 and 14 weeks of age, 685 after vaccination at 2, 4, and 6 months of age and 107 after vaccination at 3, 4 and 5 months of age.
Danish: Immunresponset efter et 3 dosis primært vaccinationsprogram blev evalueret i 5 studier: 297 spædbørn blev undersøgt efter vaccination ved 6, 10 og 14 ugers alder, 685 efter vaccination ved 2, 4, og 6 måneders alder og 107 efter vaccination ved 3, 4 og 5 måneders alderen.
English: FURTHER INFORMATION
Danish: YDERLIGERE INFORMATION
English: Make sure your child finishes the complete vaccination course of three injections.
Danish: Vær sikker på at dit barn fuldfører hele vaccinationsprogrammet med tre vaccinationer.
English: - The other ingredients in the vaccine are: lactose, thiomersal (preservative), sodium chloride and water for injections.
Danish: - De andre indholdsstoffer i vaccinen er: laktose, thiomersal (konserveringsmiddel), natriumchlorid og vand til injektion.
English: • if your child has previously had any allergic reaction to Quintanrix, or any ingredient contained in this vaccine.
Danish: • hvis dit barn tidligere har haft allergiske reaktioner overfor Quintanrix, eller overfor nogle af indholdsstofferne i denne vaccine.
English: Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters.
Danish: Sår der er særlig tilbøjelige til infektion er brandsår, knoglebrud, dybe sår eller sår forurenet med jord, støv, hestegødning/møg eller træsplinter.
English: Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.
Danish: Quintanrix blev administreret til cirka 1,340 raske spædbørn fra 6 ugers alderen som et primært vaccinationsprogram i adskillelige kliniske studier.
English: Data from clinical trials show that Quintanrix, when given as a booster dose in the second year of life, induces a greater than 10-fold increase in mean antibody titre with respect to prebooster levels for all vaccine components.
Danish: Data fra kliniske studier viser at Quintanrix, når den gives som en boosterdosis i andet leveår, inducerer en mere end 10-foldig øgning i gennemsnitlige antistoftitre i forhold til præbooster niveauer for alle vaccine komponenter.
English: It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Danish: Det kan forventes at hepatitis D også vil forebygges ved immunisering med Quintanrix da hepatitis D (forårsaget af delta komponenten) ikke forekommer i fravær af hepatitis B infektion.
English: Quintanrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Danish: Quintanrix skal administreres med forsigtighed til personer med trombocytopeni eller en blødningslidelse, da blødning kan opstå efter en intramuskulær administration hos disse personer.
English: Important information about some of the ingredients of Quintanrix
Danish: Vigtig information om nogle af indholdsstofferne i Quintanrix
English: Liquid DTPw-HBV component:
Danish: Flydende DTPw-HBV komponent:
English: Bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets have been reported very rarely (less than 1 per 10,000 doses of vaccine) with the hepatitis B component of Quintanrix.
Danish: Blødning eller større tendens end normalt til at få blå mærker, som følge af et fald i en type af blodceller kaldet blodplader, er rapporteret meget sjældent (mindre end 1 ud af 10,000 doser vaccine) med hepatitis B komponenten i Quintanrix.
English: Vaccinees 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: Vaccinerede personer med en anamnese med feberkramper skal følges tæt da sådanne bivirkninger muligvis opstår indenfor 2 til 3 dage efter vaccination.
English: However, you should seek immediate treatment in any event.
Danish: Nødvendig behandling skal iværksættes med det samme.
English: The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.
Danish: Vaccinen vil ikke forebygge infektion forårsaget af andre patogener der vides at inficere leveren såsom hepatitis A, hepatitis C og hepatitis E virus.
English: The disease affects the airways causing severe spells of coughing that may interfere with normal breathing.
Danish: Sygdommen påvirker luftvejene hvilket medfører alvorlige hosteanfald og kan derfor interferere med den normale vejrtrækning.
English: Although no data are available on the immune response to the Bacille-CalmetteGuérin (BCG) antigen, no interference is expected.
Danish: Selvom der ikke er data tilgængelige på immunresponset overfor Bacille-Calmette-Guérin (BCG) antigenet, forventes der ikke interferens.
English: Thiomersal Sodium chloride Water for injections
Danish: Thiomersal Natriumchlorid Vand til injektion
English: Results from one pilot study showed that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to diphtheria, tetanus, HBs and PRP at levels considered to be protective.
Danish: Resultater fra et pilotforsøg viste, at for 63 spædbørn, vaccineret i overensstemmelse med et 6, 10, 14 ugers program, havde > 80 % stadig antistoffer mod difteri, stivkrampe, HB'er og PRP ved niveauer der betragtes som værende beskyttende.
English: Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.
Danish: Generelt bliver luftvejene inflammeret (opsvulmede) hvilket medfører alvorlig åndedrætsbesvær og nogle gange kvælning.
English: The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Danish: Virus er til stede i kropsvæsker såsom blod, sæd, vaginalsekret, eller spyt fra smittede personer.
English: - Keep this leaflet until your child has finished the complete vaccination course.
Danish: - Gem denne indlægsseddel indtil dit barn har fuldført hele vaccinationsprogrammet.
English: After reconstitution, it is recommended to inject the vaccine promptly.
Danish: Efter rekonstitution, anbefales det at injicere vaccinen med det samme.
English: Quintanrix should not be given to subjects with hypersensitivity to the active substances or to any of the excipients.
Danish: Quintanrix bør ikke gives til personer der er overfølsomme overfor de aktive substanser eller overfor nogen af hjælpestofferne.
English: (<1/10,000) including isolated reports
Danish: Meget sjælden (<1/10,000) inklusiv enkeltstående rapporter.
English: Booster administration should be in accordance with official recommendations.
Danish: Booster doser bør gives i overensstemmelse med de officielle anbefalinger.
English: Adverse reactions reported after booster vaccination are listed below.
Danish: Bivirkninger rapporteret efter booster vaccination er opstillet herunder.
English: • Pain, redness or swelling at the injection site
Danish: • Smerte, rødme eller hævelse på injektionsstedet
English: GlaxoSmithKline Biologicals S.A. 2100 Gödöllö, Táncsics Mihály út 82 Hungary
Danish: GlaxoSmithKline Biologicals S.A 2100 Gödöllö,Táncsics Mihály út 82 Ungarn
English: Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.
Danish: Mindre almindeligt kan bakterien også inficere blodet, hjertet, lungerne, knoglerne, ledene og vævene i øjnene og munden.
English: • Haemophilus influenzae type b (HIB): HIB infection most frequently causes brain inflammation (swelling).
Danish: • Haemophilus influenzae type b (HIB): HIB infektion medfører meget hyppigt hjerne inflammation (hævelse).
English: Upon storage, a white deposit and clear supernatant may be observed for the DTPw-HBV component.
Danish: Under opbevaring kan der observeres et hvidt bundfald og en klar supernatant for DTPw HBV komponenten.
English: During post marketing surveillance studies with other hepatitis B containing vaccines, serum sickness like disease and thrombocytopenia have been reported very rarely.
Danish: Under post marketing studier med andre vacciner indeholdende hepatitis B, blev serum syge lignende sygdom og trombocytopeni rapporteret meget sjældent.
English: Forty-one percent had antibodies to pertussis.
Danish: 41 % havde antistoffer mod kighoste.
English: • Hepatitis B: Infection with the hepatitis B virus may cause the liver to become swollen (inflamed).
Danish: • Hepatitis B: Infektion med hepatitis B virus kan forårsage at leveren bliver opsvulmet (inflammeret).
English: • Fever (more than 37.5°C)
Danish: • Feber (mere end 37,5 °C)
English: Side effects that occurred during clinical trials with Quintanrix were as follows:
Danish: Følgende bivirkninger blev set i kliniske undersøgelser med Quintanrix:
English: Frequencies are reported as: Very common:
Danish: Hyppigheder er rapporteret som:
English: • if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of this
Danish: • hvis dit barn har tendens til anfald/kramper ved feber, eller hvis der er tilfælde af dette i familien
English: Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine.
Danish: Fjern og smid nålen, brugt til rekonstitution, væk og erstat den med en anden nål til administration af vaccinen.
English: The first injection can be given from the age of 6 weeks onwards.
Danish: Den første injektion kan gives fra 6 ugers alderen og fremefter.
English: HOW QUINTANRIX IS GIVEN
Danish: HVORDAN QUINTANRIX GIVES
English: • if your child has any known allergies.
Danish: • hvis dit barn har allergi.
English: Results from different studies show that, overall, 95.5% and 99.9% of subjects had anti-diphtheria and anti-tetanus titres ≥ 0.1 IU/ml one month after completion of the primary vaccination course.
Danish: Resultater fra forskellige studier viser at overordnet havde 95,5 % og 99,9 % af individerne anti-difteri og antistivkrampe titre ≥ 0,1 IU/ml én måned efter afslutningen på det primære vaccinationsprogram.
English: The immunoprophylactic measures for hepatitis B should not be modified for children born to hepatitis B virus carrying mothers.
Danish: De immunoprofylaktiske målinger for hepatitis B skal ikke modificeres til børn født af hepatitis B virus bærende mødre.
English: The hepatitis B and Haemophilus influenzae type b components of Quintanrix can only help to protect your child against infections with hepatitis B or Haemophilus influenzae type b viruses.
Danish: Hepatitis B og Haemophilus influenzae type b komponenterne i Quintanrix kan kun hjælpe til med at beskytte dit barn mod infektioner med hepatitis B eller Haemophilus influenzae type b virus.
English: • Tetanus (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Danish: • Stivkrampe (krampe i tyggemusklerne): Stivkrampe bakterien kommer ind i kroppen via snit, rifter eller sår i huden.
English: GlaxoSmithKline Biologicals S.A. 89 rue de I'Institut-1330 Rixensart Belgium
Danish: GlaxoSmithKline Biologicals S.A 89 rue de I'institut-1330 Rixensart Belgien
English: It cannot protect your child against other infections that can affect the liver or against infections due to other bacteria than Haemophilus influenzae type b or against meningitis caused by other organisms.
Danish: Det kan ikke beskytte dit barn mod andre infektioner, som kan påvirke leveren eller mod infektioner forårsaget af andre bakterier end Haemophilus influenzae type b eller mod meningitis forårsaget af andre organismer.
English: What Quintanrix is and what it is used for Before your child receives Quintanrix How Quintanrix is given Possible side effects
Danish: Hvad er Quintanrix, og hvad det anvendes til Før dit barn modtager Quintanrix Hvordan Quintanrix gives Mulige bivirkninger
English: In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines.
Danish: Under disse omstændigheder skal vaccinationsprogrammet fortsættes med difteri, stivkrampe, hepatitis B og HIB vacciner.
English: 6, 10, 14 weeks schedule N = 97
Danish: 6, 10, 14 måneders program N=97
English: Read all of this leaflet carefully before your child starts receiving this medicine.
Danish: Læs hele denne indlægsseddel omhyggeligt før dit barn modtager denne vaccine.
English: This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction.
Danish: Dette lægemiddel indeholder thiomersal som konserveringsmiddel og det er muligt at dit barn kan få en allergisk reaktion.
English: 2, 4, 6 months schedule N = 672
Danish: 2, 4, 6 måneders program N=672
English: Hepatitis B carriers are at risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer.
Danish: Hepatitis B virusbærere er i risiko for at få alvorlige leversygdomme, såsom cirrhose (skrumpelever) og levercancer.
English: • Fever (more than 39°C)
Danish: • Feber (mere end 39 °C)
English: Dispose of in accordance with local regulations.
Danish: Bortskaffes i henhold til lokale anbefalinger.
English: Hypersensitivity to the active substances or to any of the excipients.
Danish: Overfølsomhed over for de aktive substanser eller over for et eller flere af hjælpestofferne.
English: Powder and suspension for suspension for injection 1 Vial: Powder
Danish: Pulver og væske til suspension til injektion 1 Hætteglas: Pulver
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore it is possible that sensitisation reactions may occur (see section 4.3).
Danish: Dette medicinalprodukt indeholder thiomersal (en organisk kviksølvforbindelse) som konserveringsmiddel, og derfor er det muligt at overfølsomhedsreaktioner opstår(se afsnit 4.3).
English: • if your child has experienced any health problems after previous administration of a vaccine.
Danish: • hvis dit barn tidligere har haft sundhedsmæssige problemer efter tidligere vaccinationer.
English: Diphtheria toxoid1
Danish: Difteri toxoid1
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Danish: ADVARSEL OM AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Limited information exists on the persistence of the immune response after primary vaccination with Quintanrix as well as on the immunogenicity of booster doses.
Danish: Der findes begrænset information om vedholdenheden af immunresponset efter primær vaccination med Quintanrix såvel som om immunogeniteten fremkaldt af booster doserne.
English: • if your child has a bleeding problem or bruises easily
Danish: • hvis dit barn har blødningsforstyrrelser eller let får blå mærker.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: Tegn på en allergisk reaktion kan omfatte kløende hududslæt, stakåndethed og opsvulmet ansigt eller tunge.
English: The vaccine is reconstituted by withdrawing the contents of the vial containing the DTPw-HBV component by means of a syringe and by adding it to the vial containing the HIB powder.
Danish: Vaccinen rekonstitueres ved at opsuge indholdet af hætteglasset indeholdende DTPw HBV komponenten vha. en sprøjte og tilsætte det til hætteglasset indeholdende HIB pulveret.
English: 3, 4, 5 months schedule N = 107
Danish: 3, 4, 5 måneders program N=107
English: Allergic reactions, including anaphylactoid reactions and urticaria, have been reported very rarely following vaccination with DTP, hepatitis B and HIB containing vaccines.
Danish: Allergiske reaktioner, inklusiv anafylaktiske reaktioner og nældefeber, er blevet rapporteret meget sjældent som følge af vaccination med vacciner indeholdende DTP, hepatitis B og HIB.
English: Haemophilus influenzae type b polysaccharide
Danish: Haemofilus influenzae type b polysakkarid
English: Quintanrix is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Danish: Quintanrix er kontraindiceret hvis barnet har haft encephalopati med ukendt ætiologi, der er opstået inden for 7 dage efter tidligere vaccination med vaccine indeholdende kighoste.
English: The lyophilised Haemophilus influenzae type b (HIB) component is a white powder.
Danish: Den frysetørrede Haemophilus influenzae type b (HIB)komponent er et hvidt pulver.
English: Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).
Danish: Inden vaccination skal der skal være overblik over anamnesen (specielt med hensyn til tidligere vaccination og mulig forekomst af bivirkninger).