FrancophonIA/ELRC3.0 huggingface dataset:
English: • Polio: a viral infection.
Danish: • Polio: en virusfremkaldt infektion.
English: 1adsorbed on Al(OH)3
Danish: 1 adsorberet på Al(OH)3
English: Talk to a doctor straight away if they happen after leaving the doctor's surgery.
Danish: Tal straks med lægen, hvis det opstår efter, at du har forladt lægens konsultation.
English: • Your child will have a total of two or three injections with at least 1 month between each injection.
Danish: • Dit barn vil få i alt to eller tre injektioner med et tidsinterval på mindst 1 måned imellem hver injektion.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En mindre infektion, som for eksempel forkølelse, er normalt ikke noget problem, men tal alligevel med lægen først.
English: Antibody (cut-off)
Danish: Antistof (cut-off)
English: Collapse or shock-like state (hypotonichyporesponsive episode)2
Danish: Kollaps eller shocklignende tilstand (hypoton-hyporesponsiv episode)2
English: Tell your doctor if your child has had an allergic reaction to these ingredients.
Danish: Fortæl lægen, hvis dit barn har haft en allergisk reaktion over for disse stoffer.
English: Very common Crying abnormal, irritability, restlessness Common
Danish: Meget almindelig Unormal gråd, irritabilitet, uro Almindelig
English: 25, 25, 8 micrograms
Danish: 25, 25, 8 mikrogram
English: The presence of a minor infection is not a contraindication.
Danish: Tilstedeværelse af en mindre infektion er ikke en kontraindikation.
English: Efficacy study (NIH sponsored)
Danish: Effektivitetstudie (NIH-sponsoreret)
English: A booster dose must be given.
Danish: Der skal gives en boosterdosis.
English: See your doctor straight away if your child has any of the following serious side effects:
Danish: Kontakt straks lægen, hvis dit barn får nogle af følgende alvorlige bivirkninger:
English: The safety and efficacy of Infanrix hexa in children over 36 months of age have not been established.
Danish: Sikkerheden og virkningen af Infanrix hexa hos børn over 36 måneder er ikke klarlagt.
English: If not, your child may not be fully protected against the diseases.
Danish: Ellers vil dit barn ikke være fuldstændigt beskyttet mod de nævnte sygdomme.
English: The following drug-related adverse reactions were reported in clinical studies (data from more than 16,000 subjects) and during post-marketing surveillance.
Danish: Følgende lægemiddelrelaterede bivirkninger er rapporteret i kliniske studier (data fra mere en 16.000 personer) og under overvågningen efter markedsføringen.
English: The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Danish: Den forventede immunologiske reaktion opnås muligvis ikke ved vaccination af immunsupprimerede patienter.
English: The arms or legs affected by the disease may be painfully twisted (deformed).
Danish: Arme og ben, som er angrebet af sygdommen, kan blive smertefuldt krogede (deformerede).
English: The immune responses were unaffected.
Danish: Immunresponset blev ikke påvirket.
English: • You will be told by the doctor or nurse when your child should come back for their next injections.
Danish: • Lægen eller sygeplejersken vil give dig besked om, hvornår dit barn skal komme igen og have næste injektion.
English: • The vaccine cannot cause the diseases that it protects your child from.
Danish: • Vaccinen kan ikke forårsage de sygdomme, som den beskytter mod.
English: Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions.
Danish: Profylaktisk administration af antipyretika, før eller umiddelbart efter administration af vaccinen, kan reducere forekomsten og intensiteten af febrile reaktioner efter vaccinen.
English: Children at 7-8 years of age
Danish: Børn i alderen 7-8 år n n
English: Poliovirus (inactivated) type 1, 2, 3
Danish: Poliovirus (inaktiveret) type 1, 2, 3
English: Booster doses should be given in accordance with the official recommendations, but, as a minimum, a dose of Hib conjugate vaccine must be administered.
Danish: Boosterdosis skal gives i overensstemmelse med de officielle anbefalinger, men der bør som minimum gives en dosis Hib-konjugeret vaccine.
English: Primary vaccination Booster vaccination
Danish: Primær vaccination Boostervaccination
English: The reconstituted vaccine appears as a slightly more cloudy suspension than the liquid component alone.
Danish: Den rekonstituerede vaccine fremtræder som en lidt mere uklar suspension end væskekomponenten alene.
English: not less than 40 International Units (IU)
Danish: ikke mindre end 40 internationale enheder (IE)
English: The signs may include:
Danish: Tegn på dette kan være:
English: not less than 30 International Units (IU)
Danish: ikke mindre end 30 internationale enheder (IE)
English: 32 D-antigen unit
Danish: 32 antigen D enheder
English: • Diphtheria: a serious bacterial infection that mainly affects the airways and sometimes the skin.
Danish: • Difteri: en alvorlig bakterieinfektion, som hovedsageligt angriber luftvejene og undertiden huden.
English: Efficacy in protecting against pertussis
Danish: Beskyttende virkning mod pertussis
English: Infanrix hexa will confer an anti-PRP immune response (cut-off ≥ 0.15µg/ml) in at least 84% of the infants.
Danish: Infanrix hexa vil give et anti-PRP-immunrespons (cut-off ≥ 0,15 µg/ml) hos minimum 84 % af spædbørnene.
English: ≥ 30 IU
Danish: ≥ 30 IE
English: Germany 3,4,5 months 88.7% Based on data collected from secondary contacts in households where there was an index case with typical pertussis
Danish: 88,7 % Baseret på data indsamlet fra sekundære kontakter i husstande, hvor der var et registreret tilfælde af typisk pertussis
English: Antipyretic treatment should be initiated according to local treatment guidelines.
Danish: Febernedsættende behandling bør påbegyndes i henhold til lokale retningslinjer.
English: • if your child has an undiagnosed or progressive disease of the brain or epilepsy which is not controlled.
Danish: • hvis dit barn har en ikke-diagnosticeret eller fremskridende lidelse i hjernen, eller en ikke-kontrolleret epilepsi.
English: Immunogenicity in preterm infants
Danish: Immunogenicitet hos præmature spædbørn
English: After reconstitution: an immediate use is recommended.
Danish: Efter rekonstitution: Det anbefales, at vaccinen anvendes straks.
English: • Infanrix hexa helps your child's body make its own protection (antibodies).
Danish: • Infanrix hexa hjælper dit barn til at danne kroppens egen beskyttelse (antistoffer).
English: • Infanrix hexa will be given as an injection into a muscle.
Danish: • Infanrix hexa vil blive givet som en injektion i en muskel.
English: Post marketing experience
Danish: Erfaring efter markedsføring
English: The effectiveness of the Hib component of Infanrix hexa was investigated via an extensive postmarketing surveillance study conducted in Germany.
Danish: Effektiviteten af Hib-komponenten i Infanrix hexa blev undersøgt via en ekstensiv post-marketing overvågningsundersøgelse i Tyskland.
English: Infanrix hexa is a vaccine used to protect your child against six diseases:
Danish: Infanrix hexa er en vaccine, der beskytter dit barn mod seks sygdomme:
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code: J07CA09
Danish: Farmakoterapeutisk klassifikation: Kombinerede bakterielle og virus vacciner, ATC kode: J07CA09.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity, repeated dose toxicity and compatibility of ingredients.
Danish: Prækliniske data har ikke vist nogen speciel risiko for mennesker, baseret på konventionelle studier af sikkerhedsforhold, specifik toksicitet, toksicitet ved flergangsdosering og af forligeligheder af indholdsstoffer.
English: ≥ 40 IU
Danish: ≥ 40 IE
English: The coughing often has a “whooping” sound.
Danish: Kighoste er ofte ledsaget af en ”kigende” (hivende) lyd.
English: Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
Danish: Vaccinationen skal forudgås af en gennemgang af anamnesen (især hvad angår tidligere vaccinationer og eventuel forekomst af bivirkninger) samt en klinisk undersøgelse.
English: The use of Infanrix hexa should be in accordance with official recommendations.
Danish: Brugen af Infanrix Hexa bør være i overensstemmelse med officielle anbefalinger.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2000
Danish: Dato for første markedsføringstilladelse: 23. oktober 2000 Dato for sidste fornyelse af tilladelsen: 31. august 2010
English: • Hepatitis B: is caused by the hepatitis B virus.
Danish: • Hepatitis B: er forårsaget af hepatitis B-virus.
English: Persistence of the immune response
Danish: Persistensen af immunresponset
English: Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1-2 weeks following vaccination.
Danish: Da Hib-kapsulær polysaccharid-antigen udskilles i urinen, kan en positiv urintest ses inden for 1-2 uger efter vaccination.
English: • Store in a refrigerator (2°C - 8°C).
Danish: • Opbevares i køleskab (2 °C - 8 °C).
English: As Infanrix hexa is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Danish: Eftersom Infanrix hexa ikke er beregnet til brug hos voksne, foreligger der ikke adækvate humane data vedrørende brug under graviditet eller amning samt adækvate data vedrørende reproduktion hos dyr.
English: Interference with laboratory testing
Danish: Påvirkning af laboratorieundersøgelser
English: This can help to lower some of the side effects (febrile reactions) of Infanrix hexa.
Danish: Dette kan medvirke til at nedsætte nogle af bivirkningerne (feberreaktioner) ved Infanrix hexa.
English: 0.32 milligrams Al3+
Danish: 0,32 milligram Al3+
English: • Tetanus: tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Danish: • Stivkrampe (Tetanus): tetanusbakterier kommer ind i kroppen gennem snitsår, rifter eller sår på huden.
English: Very common Appetite lost
Danish: Meget almindelig Appetitløshed
English: The lyophilised Haemophilus influenzae type b (Hib) component is a white powder.
Danish: Den lyofiliserede Haemophilus influenzae type b (Hib)-komponent er et hvidt pulver.
English: Tell your doctor or pharmacist if your child is taking, has recently taken, might take any other medicines or has recently received any other vaccine.
Danish: Fortæl det altid til lægen eller på apoteket, hvis dit barn bruger anden medicin eller har gjort det for nylig eller for nylig er blevet vaccineret med en anden vaccine.
English: • if your child tends to have fits when they have a fever, or if there is a history of this in the family.
Danish: • hvis dit barn har tendens til krampeanfald i forbindelse med feber, eller hvis der i familien er tilfælde af dette
English: • As with all vaccines, Infanrix hexa may not fully protect all children who are vaccinated.
Danish: • Lige som andre vacciner beskytter Infanrix hexa ikke alle børn, som bliver vaccineret.
English: HIV infection is not considered as a contraindication.
Danish: HIV-infektion udgør ikke en kontraindikation.
English: • a sudden drop in blood pressure and loss of consciousness.
Danish: • pludselig blodtryksfald og besvimelse.
English: If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Danish: Hvis det er nødvendigt at give en dosis af hepatitis B før denne alder, bør monovalent hepatitis B vaccine anvendes.
English: • if your baby was born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Danish: • hvis dit barn er født meget for tidligt (i eller før 28. svangerskabsuge) kan der forekomme længere mellemrum end normalt mellem vejrtrækningerne 2-3 dage efter vaccination.
English: These babies may require respiratory monitoring for 48-72h following the administration of the first two or three doses of Infanrix hexa.
Danish: Disse børn kan have brug for overvågning af vejrtrækningen i 48-72 timer efter indgift af de første to eller tre doser Infanrix hexa.
English: • if your child has had problems of the nervous system within 7 days after previous vaccination with a vaccine against whooping cough
Danish: • hvis dit barn har haft problemer med nervesystemet inden for 7 dage efter at være blevet vaccineret med vaccine mod kighoste.
English: It can also cause swelling of the throat.
Danish: Sygdommen kan også forårsage, at halsen hæver op.
English: 1adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
Danish: 1 adsorberet på aluminiumhydroxydhydrat (Al(OH)3)
English: As with other vaccines, administration of Infanrix hexa should be postponed in subjects suffering from acute severe febrile illness.
Danish: Som ved andre vacciner bør administration af Infanrix hexa udsættes hos personer med svær akut febril sygdom.
English: Convulsions (with or without fever)
Danish: Meget sjælden Kramper (med og uden feber)
English: The incidence and severity of fever following co-administration of the two vaccines in the primary series was lower than that observed after the booster dose.
Danish: Hyppigheden og alvorligheden af feber efter samtidig administration af de to vacciner i det primære program var lavere end efter boosterdosen.
English: As with other vaccines it may be expected that in patients receiving immunosuppressive therapy, an adequate response may not be achieved.
Danish: Som med andre vacciner må det forventes, at patienter i immunosuppressiv behandling ikke med sikkerhed kan opnå tilstrækkelig respons.
English: Hepatitis B immunological memory was confirmed in children 4 to 15 years of age.
Danish: Der blev vist immunologisk hukommelse mod hepatitis B hos børn i alderen 4 til 15 år.
English: At least 25.4% (anti-PT), 97.5% (anti-FHA) and 87.0% (anti-PRN) of children were seropositive against the pertussis components.
Danish: Mindst 25,4 % (anti-PT), 97,5 % (antiFHA) og 87,0 % (anti-PRN) af børnene blev seropositive for pertussiskomponenterne.
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 ved alle injicerbare vacciner skal sufficient medicinsk behandling og overvågning altid være let tilgængelig i tilfælde af en sjældent forekommende anafylaktisk reaktion efter indgift af vaccinen.
English: Clinical data generated with paracetamol and ibuprofen suggest that the prophylactic use of paracetamol might reduce the fever rate, while prophylactic use of ibuprofen showed a limited effect in reducing fever rate.
Danish: Kliniske data med paracetamol og ibuprofen antyder, at anvendelse af paracetamol profylaktisk kan reducere forekomsten af feber, mens anvendelse af ibuprofen profylaktisk viste en begrænset effekt på forekomsten af feber.
English: • Haemophilus influenzae type b (Hib): can cause brain swelling (inflammation).
Danish: • Haemophilus influenzae type b (Hib): kan forårsage hævelse i hjernen (hjernebetændelse).
English: Very common: (≥1/10) Common:
Danish: Meget almindelig: (≥ 1/10)
English: The vaccine is reconstituted by adding the entire contents of the pre-filled syringe to the vial containing the powder.
Danish: Vaccinen rekonstitueres ved at tilsætte hele indholdet i den fyldte injektionssprøjte til hætteglasset indeholdende pulveret.
English: The pre-filled syringe can be supplied with either a ceramic coated treatment (CCT) of the luer tip or with a plastic rigid tip cap (PRTC) luer lock adaptor.
Danish: Den fyldte injektionssprøjte kan leveres med enten en 'ceramic coated treatment (CCT)' af luer-spidsen, eller med en 'plastic rigid tip cap (PRTC)' luer-lock adapter.
English: Full-term infants 3-dose
Danish: Fuldbårne spædbørn 3-dosis
English: • Infanrix hexa is available in packs of 1 and 10 with or without needles, and a multipack of 5 packs,
Danish: • Infanrix hexa fås i pakninger med 1 og 10 stk. med eller uden nåle, samt i en multipakning med 5
English: • The Hib component is a white powder presented in a glass vial.
Danish: • Hib-komponenten er et hvidt pulver, som leveres i et hætteglas.
English: The vaccine was assessed in 2-dose and 3-dose priming schedules, including the schedule for the Expanded Program on Immunisation, and as a booster dose.
Danish: Vaccinen blev vurderet i henholdsvis 2- og 3-dosisprogrammer, herunder dosisprogrammet for Expanded Program on Immunisation, og som boosterdosis.
English: Other tests should be performed in order to confirm Hib infection during this period.
Danish: For at få en Hib-infektion bekræftet skal andre test anvendes i denne periode.
English: However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 month's schedule.
Danish: Data indikerer dog, at beskyttelsen mod pertussis muligvis er faldende hos børn i alderen 7-8 år efter administration af 3-5-12-månedersprogrammet.
English: • Instructions for use of pre-filled syringe if supplied with a PRTC luer lock adaptor
Danish: • Instruktion til en fyldt injektionssprøjte, hvis de leveres med en PRTC luer-lock adaptor
English: • If your child misses an injection which is due, it is important that you make another appointment.
Danish: • Hvis dit barn går glip af en planlagt injektion, er det vigtigt at du aftaler et nyt besøg hos lægen.
English: Infanrix hexa contains neomycin and polymyxin This vaccine contains neomycin and polymyxin (antibiotics).
Danish: Infanrix hexa indeholder neomycin og polymyxin Denne vaccine indeholder neomycin og polymyxin (antibiotika).
English: 0.5 milligrams Al3+
Danish: 0,5 milligram Al3+
English: Over a six year period starting in 2006, where Infanrix hexa was the principal Hib-containing vaccine in use with vaccination coverage exceeding 95%, Hib invasive disease continued to be well controlled, with four confirmed Hib cases reported in Italian children aged less than 5 years through passive surveillance.
Danish: Over en periode på seks år fra 2006, hvor Infanrix hexa var den primært anvendte Hib-vaccine, med en vaccinationsdækning på over 95 %, forblev den invasive Hib-sygdom velkontrolleret med fire rapporterede bekræftede Hib-tilfælde hos italienske børn under 5 år.
English: Due to an increased risk of fever, pain at the injection site, appetite lost and irritability when Infanrix hexa was co-administered with MenB vaccine and 7-valent pneumococcal conjugate vaccine, separate vaccinations can be considered when possible.
Danish: På grund af en øget risiko for feber, smerte på injektionsstedet, tab af appetit og irritabilitet ved samtidig administration af Infanrix hexa med MenB-vaccine og 7-valent konjugeret pneumokokvaccine, kan separate vaccinationer overvejes, når det er muligt.
English: Experience with hepatitis B vaccine
Danish: Erfaring med hepatitis B-vaccine
English: (≥1/100 to <1/10)
Danish: (≥ 1/100 til < 1/10)
English: If your child has an allergic reaction, see your doctor straight away.
Danish: Hvis dit barn får en allergisk reaktion skal du straks kontakte din læge.
English: • Not all pack sizes may be marketed.
Danish: • Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: The vaccine may contain traces of formaldehyde, neomycin and polymyxin which are used during the manufacturing process (see section 4.3).
Danish: Denne vaccine kan indholde spormængder af formaldehyd, neomycin og polymyxin, som anvendes i fremstillingsprocessen (se pkt.
English: The immunogenicity of a booster dose at 18 to 24 months of age was evaluated in approximately 200 preterm infants.
Danish: Immunogeniciteten af en boosterdosis ved 18-24-måneders-alderen blev evalueret hos ca. 200 præmature spædbørn.
English: The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.
Danish: EPI-programmet (Expanded Program on Immunisation; ved 6-, 10-, 14 ugers-alderen) kan kun anvendes, såfremt en dosis af hepatitis B-vaccine er blevet givet ved fødslen.
English: The airways become swollen causing serious breathing problems and sometimes suffocation.
Danish: Luftvejene hæver op, hvilket medfører alvorlige vejrtrækningsproblemer og undertiden kvælning.
English: The immunogenicity of Infanrix hexa has been evaluated in clinical studies from 6 weeks of age.
Danish: Immunogeniciteten af Infanrix hexa er blevet undersøgt i kliniske studier hos børn fra 6-ugersalderen.
English: GSK Vaccines GmbH Emil-von-Behring-Str. 76, D-35041 Marburg Germany
Danish: GSK Vaccines GmbH Emil-von-Behring-Str. 76, D-35041 Marburg Tyskland
English: • Whooping cough (Pertussis): a highly infectious illness that affects the airways.
Danish: • Kighoste (Pertussis): en meget smitsom sygdom, som angriber luftvejene.
English: • times when they lose consciousness or have a lack of awareness
Danish: • perioder med bevidstløshed eller sløring af bevidstheden
English: Very rare (these may happen with up to 1 in 10,000 doses of the vaccine): itching (dermatitis).
Danish: Meget sjælden (disse kan forekomme ved op til 1 ud af 10.000 vaccinedoser): hudkløe (eksem).
English: Protective immunity against the three poliovirus types and PRP was observed in at least 91.0% of children and against diphtheria and tetanus in at least 64.7% of children.
Danish: Der blev observeret beskyttende immunrespons mod de tre typer poliovirus og PRP hos mindst 91,0 % af børnene og mod difteri og tetanus hos mindst 64,7 % af børnene.
English: However the stability has been demonstrated for 8 hours at 21°C after reconstitution.
Danish: Vaccinen er dog stabil i op til 8 timer efter rekonstitution ved 21 °C.
English: As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix hexa with respect to the primary course.
Danish: Som det er rapporteret for DTPa og DTPa-holdige kombinationer, blev der rapporteret en stigning i lokal reaktivitet og feber efter boostervaccination med Infanrix hexa i forhold til det primære program.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section
Danish: Som for andre vacciner opnås et beskyttende immunrespons ikke hos alle vaccinerede (se pkt.
English: These children had received Infanrix hexa as primary and booster vaccination in infancy, and when an additional dose of monovalent HBV vaccine was administered, protective immunity was observed in at least 93% of subjects.
Danish: Disse børn havde fået Infanrix hexa som primær vaccination og boosterdosis som spædbørn, og når der blev administreret en ekstra dosis monovalent HBV-vaccine, blev den beskyttende immunitet observeret hos mindst 93 % af personerne.
English: However, as the immune response to pertussis antigens following Infanrix hexa administration is equivalent to that of Infanrix (DTPa), the protective efficacy of the two vaccines is expected to be equivalent.
Danish: Da immunresponset for pertussis-antigener efter administration af Infanrix hexa er ækvivalent med det, som ses efter Infanrix (DTPa), anses den beskyttende effekt af de to vacciner imidlertid for at være ækvivalent.
English: • rashes that may be itchy or blistering
Danish: • udslæt, som kan være kløende eller danne blærer
English: • if your child has a bleeding problem or bruises easily
Danish: • hvis dit barn har blødningstendens eller let får blå mærker
English: The causal relationship to the vaccine has not been established.
Danish: Årsagssammenhængen med vaccinen er ikke påvist.
English: The mixed appearance is a white, slightly milky liquid.
Danish: Blandingen fremstår som en hvid, let mælket væske.