FrancophonIA/ELRC3.0 huggingface dataset:
English: Medium 199 containing principally amino acids, mineral salts, vitamins
Danish: Medium 199 indeholdende hovedsageligt aminosyrer, mineralsalte, vitaminer
English: 8 D-antigen unit 32 D-antigen unit
Danish: 8 antigen D unit 32 antigen D unit
English: Pack sizes of 1, 10, 20 and 50 with or without needles.
Danish: Pakkestørrelse på 1, 10, 20 og 50 med eller uden kanyler.
English: months N= 1146)
Danish: måneder n = 1146)
English: Antibody levels were not different from what was observed in a parallel cohort administered 4 doses of monovalent hepatitis B vaccine.
Danish: Antistof niveauet var ikke forskellig fra hvad der blev set i en parallel kohorte, som fik administreret 4 doser af monovalent hepatitis B-vaccine.
English: Date of latest renewal: 23 October 2005
Danish: Dato for første markedsføringstilladelse: 23. oktober 2000 Dato for sidste fornyelse af tilladelsen: 23. oktober 2005
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: • 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: Infanrix Penta can be considered for the booster if the composition is in accordance with the official
Danish: Infanrix Penta kan overvejes som booster, hvis kompositionen er i overensstemmelse med de officielle
English: 25 micrograms 25 micrograms
Danish: 25 mikrogram 25 mikrogram
English: If any of the above apply to your child (or you are not sure), talk to your doctor or pharmacist before
Danish: Hvis noget af ovenstående passer på dit barn (eller hvis du er i tvivl), skal du tale med lægen eller
English: 1adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
Danish: 1 adsorberet på aluminiumhydroxydhydrat (Al(OH) 3)
English: As Infanrix Penta 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 Penta 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: However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Danish: Beskyttelse mod hepatitis D kan dog forventes ved immunisering, da hepatitis D (forårsaget af delta agentia) ikke optræder uden, at der også er en hepatitis B-infektion.
English: • Infanrix Penta helps your child's body make its own protection (antibodies).
Danish: • Infanrix Penta hjælper dit barn til at danne kroppens egen beskyttelse (antistoffer).
English: 8 micrograms 10 micrograms
Danish: 8 mikrogram 10 mikrogram
English: In extremely rare cases, paralysis, neuropathy, Guillain-Barré syndrome, encephalopathy, encephalitis and meningitis have been reported.
Danish: I ekstremt sjældne tilfælde er der rapporteret om paralyser, neuropati, Guillain-Barré syndrom, encefalopati, encefalitis og meningitis.
English: Novartis Vaccines and Diagnostics GmbH & Co. KG
Danish: Novartis Vaccines and Diagnostics GmbH & Co.
English: • your child tends to have fits when they have a fever, or if there is a history of this in the family.
Danish: • dit barn har tendens til krampeanfald i forbindelse med feber, eller hvis der i familien er tilfælde af
English: Protective antibodies against hepatitis B have been shown to persist for at least 3.5 years in more than 90% of children administered four doses of a combined vaccine containing the same HBs antigen as Infanrix Penta.
Danish: Beskyttende antistof mod hepatitis B har vist sig at vare ved i mindst 3,5 år hos mere end 90 % af børn, som har fået 4 doser af en kombinationsvaccine indeholdende samme HBs-antigen som i Infanrix Penta.
English: The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.
Danish: Sprøjten bør omrystes omhyggeligt for at opnå en homogen uklar hvid suspension.
English: 6.6 Special precautions for disposal and other handling Upon storage, a white deposit and clear supernatant may be observed.
Danish: 6.6 Regler for destruktion og anden håndtering Efter opbevaring kan et hvidt bundfald og en klar supernatant observeres.
English: Check with your doctor or pharmacist before your child is given this vaccine if:
Danish: Kontakt din læge eller apoteket, før dit barn får denne vaccine, hvis:
English: Detailed information on this medicinal product is available on the website of the European Medicines
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs
English: Important information about some of the ingredients of Infanrix Penta This vaccine contains neomycin and polymyxin (antibiotics).
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Infanrix Penta Denne vaccine indeholder neomycin eller polymyxin (antibiotika).
English: Read all of this leaflet carefully before your child receives this vaccine.
Danish: Læs denne indlægsseddel grundigt inden dit barn bliver vaccineret med vaccinen.
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: As the immune response to pertussis antigens following Infanrix Penta administration is equivalent to that of Infanrix, the protective efficacy of the two vaccines is expected to be equivalent.
Danish: Da immunresponset over for pertussis antigen efter administration af Infanrix Penta er ækvivalent med det som ses efter Infanrix, anses den beskyttende effekt af de to vacciner at være ækvivalent.
English: • Infanrix Penta is available in packs of 1, 10, 20 and 50 with or without needles.
Danish: • Infanrix Penta leveres i pakninger på 1, 10, 20 og 50 med eller uden nåle.
English: If your child has an allergic reaction, see your doctor straight away.
Danish: Hvis dit barn får en overfølsomhedsreaktion (allergisk reaktion) skal du straks kontake din læge.
English: In the event of either being observed, discard the container.
Danish: I tilfælde af afvigelser kasseres beholderen.
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 yderligere dosis af hepatitis B før denne alder, bør monovalent hepatitis B vaccine anvendes.
English: Any unused product of waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt vaccine samt affald heraf bør destrueres i henhold til lokale retningslinjer.
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 Infanrix Penta.
Danish: En anamnesen tilfælde af feberkramper eller en familieanamnese med kramper eller tilfælde af pludselig spædbarnsdød syndrom (SIDS) er ikke en kontraindikation for anvendelse af Infanrix Penta.
English: If you are not sure, talk to your doctor or pharmacist before your child is given Infanrix Penta.
Danish: Hvis du er i tvivl, skal du tale med lægen eller apoteket, inden dit barn får Infanrix Penta.
English: In these clinical studies, the injectable vaccines were given at
Danish: I disse forsøg blev de injicerbare vacciner givet på forskellige injektionssteder.
English: Infanrix Penta is contraindicated if the infant has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Danish: Infanrix Penta er kontraindiceret, hvis spædbarnet har haft encephalopati af ukendt ætiologi, opstået indenfor 7 dage efter tidligere vaccination med en pertussisholdig vaccine.
English: The virus is found in body fluids such as in the vagina, blood, semen, or spit (saliva) of infected people.
Danish: Virus findes i kropsvæsker f.eks. vaginalsekret, blod, sæd eller spyt fra smittede personer.
English: • Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination;
Danish: • Kollaps eller shock-lignende tilstand (hypotonisk-hyporesponsiv episode) inden for 48 timer efter vaccinationen;
English: In a follow-up of the same cohort, the efficacy was confirmed up to 60 months after completion of primary vaccination without administration of a booster dose of pertussis.
Danish: I en follow-up undersøgelse af den samme kohorte blev effektiviteten bekræftet i op til 60 måneder efter afslutning af den primære vaccination uden indgift
English: 2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AlPO4)
Danish: 2fremstillet på gærceller (Saccharomyces cerevisiae) ved rekombinant DNA-teknologi 3adsorberet på aluminiumphosphat (AlPO4)
English: There is no relevant use of Infanrix Penta in children over 36 months.
Danish: Administration af Infanrix Penta til børn over 36 måneder er ikke relevant.
English: • your child has a bleeding problem or bruises easily
Danish: • dit barn har blødningstendens eller let får blå mærker
English: However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 months schedule.
Danish: Data indikerer dog faldende beskyttelse mod pertussis hos børn i alderen 7-8 år efter administration af 3-5-12 månedersprogram.
English: Very common: fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain, redness Common: fever >39.5°C, local swelling at the injection site (> 50 mm)*, injection site reactions,
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: feber ≥ 38 °C, lokal hævelse ved injektionsstedet (≤ 50 mm), træthed, smerte, rødme Almindelig: feber > 39,5 ºC, lokal hævelse ved injektionsstedet (> 50 mm)*, reaktioner på administrationsstedet inklusive indurationIkke almindelig: diffus hævelse af armen eller benet, som er
English: months N= 326
Danish: måneder n = 326
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 for alle vaccinerede (se pkt.
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 Penta with respect to the
Danish: Som det er rapporteret ved DTPa vaccine og vaccinekombinationer indeholdende DTPa, blev der rapporteret en stigning i lokal reaktivitet og feber efter boostervaccination med Infanrix Penta med hensyn til det primære forløb.
English: • Whooping cough (Pertussis) - a highly infectious illness that affects the airways.
Danish: • Kighoste (Pertussis) − en meget smitsom sygdom, som angriber luftvejene.
English: Results of long term follow-up in Sweden demonstrate that acellular pertussis vaccines are efficacious in infants when administered according to the 3 and 5 months primary vaccination schedule, with a booster dose administered at approximately 12 months.
Danish: Resultatet af en langtids follow-up undersøgelse i Sverige viser, at acellulær pertussisvaccine er effektiv hos børn, efter administration af 3 og 5 måneders primærprogram, med efterfølgende boosterdosis administreret efter ca. 12 måneder.
English: The muscle spasms can be strong enough to cause bone fractures of the spine.
Danish: Muskelkramperne kan være så stærke, at de medfører brud af rygsøjlen.
English: • As with all vaccines, Infanrix Penta may not fully protect all children who are vaccinated.
Danish: • Lige som andre vacciner beskytter Infanrix Penta ikke alle børn, som bliver vaccineret.
English: • Convulsions with or without fever, occurring within 3 days of vaccination.
Danish: • Kramper med eller uden feber, optrædende inden for 3 dage efter vaccinationen.
English: Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days
Danish: Personer, som tidligere har haft feberkramper skal overvåges nøje, da denne bivirkning kan opstå inden for 2-3
English: Collapse or shock-like state (hypotonic-hyporesponsiveness episode) Respiratory, thoracic and mediastinal disorders:
Danish: Kollaps eller shocklignende tilstand (hypotonisk-hyporesponsiv episode) Luftveje, thorax og mediastinum:
English: As for any vaccination, the risk-benefit of immunising with Infanrix Penta or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
Danish: Som ved alle vaccinationer skal risiko og fordele ved immunisering med Infanrix Penta vurderes og udskydelse af vaccination skal overvejes nøje for spædbørn og børn, som lider af et nyt eller et fremskridende tilfælde af en alvorlig neurologisk lidelse.
English: Infanrix Penta is a vaccine used to protect your child again five diseases:
Danish: Infanrix Penta er en vaccine, der beskytter dit barn mod fem sygdomme:
English: Like all medicines, Infanrix Penta can cause side effects, although not everybody gets them.
Danish: Infanrix Penta kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: months N= 884
Danish: månder n = 884
English: • Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination;
Danish: • Vedvarende, utrøstelig gråd varende ≥ 3 timer, optrædende inden for 48 timer efter vaccinationen;
English: The other ingredients in Infanrix Penta are: sodium chloride (NaCl), medium 199 containing principally amino acids, mineral salts, vitamins and water for injections.
Danish: Øvrige indholdsstoffer: Natriumchlorid (NaCl), medium 199 indeholdende hovedsageligt aminosyrer, mineralsalte, vitaminer og vand til injektionsvæsker.
English: Where a dose of hepatitis B vaccine is given at birth, Infanrix Penta can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks.
Danish: I de tilfælde, hvor en dosis af hepatitis B er blevet givet ved fødslen, kan Infanrix Penta anvendes til erstatning for den efterfølgende dosis af hepatitis B-vaccine fra 6 ugers alderen.
English: FI.PT@gsk.com
Danish: es-ci@gsk.com
English: • Infanrix Penta will be given as an injection into a muscle.
Danish: • Lægen vil give Infanrix Penta som en injektion i en muskel.
English: • Infanrix Penta is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).
Danish: • Infanrix Penta er en hvid, let mælket væske, som leveres i en fyldt injektionssprøjte (0,5 ml).
English: - a high temperature (over 40°C) within 48 hours of vaccination - a collapse or ‘shock-like' state within 48 hours of vaccination - persistent crying lasting 3 hours or more within 48 hours of vaccination - fits with or without a high temperature within 3 days of vaccination
Danish: - høj feber (over 40 °) inden for 48 timer efter vaccinationen - kollaps eller shock-lignende tilstand inden for 48 timer efter vaccinationen - vedvarende gråd i 3 timer eller mere inden for 48 timer efter vaccinationen.
English: • your child has had problems of the nervous system within 7 days after previous vaccination with a vaccine against whooping cough.
Danish: • dit barn har haft problemer med nervesystemet inden for 7 dage efter at være blevet vaccineret med
English: Infanrix Penta 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: Infanrix Penta skal indgives med forsigtighed til individer med thrombocytopeni eller blødningsforstyrrelse, eftersom blødning kan forekomme efter en intramuskulær injektion hos disse
English: Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently had any other vaccine.
Danish: Fortæl det altid til lægen eller på apoteket, hvis dit barn bruger anden medicin eller har brugt det for nylig, eller fornylig er blevet vaccineret med en anden vaccine.
English: Infanrix Penta should under no circumstances be administered intravascularly or intradermally.
Danish: Infanrix Penta må under ingen omstændigheder indgives intravaskulært eller intrakutant.
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with plunger stoppers (butyl).
Danish: 0,5 ml suspension til injektion i en fyldt injektionssprøjte (type I glas) med stempelprop (butyl).
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette lægemiddel ikke
English: In virtually all instances, Infanrix Penta was administered at the same time as a Hib vaccine.
Danish: I stort set alle tilfælde, blev Infanrix Penta givet samtidigt med en HIB-vaccine.
English: As with other vaccines, administration of Infanrix Penta should be postponed in subjects suffering from acute severe febrile illness.
Danish: Som ved andre vacciner bør indgift af Infanrix Penta udsættes hos personer med svær akut febril sygdom.
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 terapi ikke med sikkerhed kan
English: The DTPa-HBV-IPV suspension should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Danish: DTPa-HBV-IPV suspensionen bør inspiceres visuelt for eventuelle fremmede uopløste partikler og/eller forandringer i fysisk fremtræden.
English: Infanrix Penta Suspension for injection DTPa-HBV-IPV IM
Danish: Infanrix Penta Injektionsvæske, suspension DTPa-HBV-IPV i.m.
English: • Clinical trials
Danish: • Kliniske forsøg:
English: After vaccination with 3 doses (e.g. 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose and preferably before 18
Danish: Efter vaccination med 3 doser (f.eks. 2, 3, 4 måneder; 3, 4, 5 måneder; 2, 4, 6 måneder) af Infanrix Penta skal der mindst 6 måneder efter den sidst indgivne dosis og helst før barnets 18. måned ingives en
English: This suggests that a second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously been vaccinated following this particular schedule.
Danish: Dette antyder at anden boosterdosis af pertussis-vaccinen bør gives til børn i alderen 5-7 år efter administration af det nævnte vaccinationsprogram.
English: Infanrix Penta will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus or poliovirus.
Danish: Infanrix Penta beskytter ikke mod sygdomme forårsaget af andre patogene end Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus eller poliovirus.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 20 PRE-FILLED SYRINGES WITHOUT NEEDLES 50 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 20 PRE-FILLED SYRINGES WITH 20 NEEDLES 50 PRE-FILLED SYRINGES WITH 50 NEEDLES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 1 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 1 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 10 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 20 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 50 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 1 FYLDT INJEKTIONSSPRØJTE MED 1 KANYLE 10 FYLDT INJEKTIONSSPRØJTE MED 10 KANYLER 20 FYLDT INJEKTIONSSPRØJTE MED 20 KANYLER
English: Thrombocytopenia has been reported with hepatitis B vaccine.
Danish: Trombocytopeni er rapportert i forbindelse med hepatitis B vaccination.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En mild infektion, som for eksempel forkølelse, er normalt ikke noget problem, men tal alligevel
English: After a vaccination with 2 doses (e.g. 3, 5 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose, preferably between 11 and 13 months of age.
Danish: Efter en vaccination med 2 doser (f.eks. 3, 5 måneder) af Infanrix Penta skal der mindst 6 måneder efter den sidst indgivne dosis ingives en boosterdosis, helst mellem barnets 11. og 13. måned.
English: * Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines.
Danish: * Børn, som er førstegangsvaccinerede med acellulær pertussisvaccine er mere udsatte for at få hævelser efter boostervaccination end børn, som er førstegangsvaccineret med helcellevacciner.
English: months N=554
Danish: månders n = 554
English: The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) suspension should be inspected visually for any foreign particulate matter and/or variation of physical aspect.
Danish: Difteri, tetanus, acellulær pertussis, hepatitis B, inaktiveret poliomyelitis (DTPa-HBV-IPV) suspensionen bør inspiceres visuelt for eventuelle fremmede uopløste partikler og/eller forandringer i fysisk fremtræden.
English: Hypersensitivity to the active substances or to any of the excipients or neomycin and polymyxin.
Danish: Overfølsomhed over for de aktive indholdsstoffer, et eller flere af hjælpestofferne eller neomycin og
English: Percentage of subjects with antibody titres ≥ assay cut-off one month after booster vaccination
Danish: Procentdelen af personer med antistof titer ≥ assay cut-off en måned efter boostervaccination med Infanrix Penta
English: They usually happen within 2 to 3 days after vaccination.
Danish: svangerskabsuge eller før) kan forekomme 2-3 dage efter vaccination
English: • your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping
Danish: • dit barn har haft en allergisk reaktion over for en vaccine mod difteri, stivkrampe, kighoste,
English: Allergic reactions, including anaphylactic and anaphylactoid reactions
Danish: Immunsystemet Allergiske reaktioner, anafylaktiske og anafylaktoide reaktioner
English: Infanrix Penta, Suspension for injection
Danish: Infanrix Penta, injektionsvæske, suspension.
English: Talk to a doctor straight away if they happen after leaving the doctor's surgery.
Danish: Tal straks med lægen, hvis det opstår
English: • fits - this may be when they have a fever These side effects have happened very rarely with other vaccines against whooping cough.
Danish: • perioder med bevidstløshed eller sløring af bevidstheden Disse bivirkninger er set meget sjældent efter andre vacciner mod kighoste.
English: In these circumstances pertussis vaccination should be discontinued and the vaccination should be continued with diphtheria-tetanus, hepatitis B and polio vaccines.
Danish: Under disse omstændigheder skal pertussisvaccinationen afbrydes, og vaccinationsprogrammet fortsættes med difteri- tetanus, hepatitis
English: This can cause nerve damage, heart problems, and even death.
Danish: Dette kan ødelægge nerver, give hjerteproblemer og
English: • after previously having Infanrix Penta or another vaccine against whooping cough, your child
Danish: • dit barn, efter tidligere at have fået Infanrix Penta eller nogen anden vaccine mod kighoste, har haft
English: 0.5 milligrams Al3+
Danish: 0,5 miligram Al3+
English: • If you have any further questions, ask your doctor or your pharmacist.
Danish: • Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
English: 0.2 milligrams Al3+
Danish: 0,2 miligram Al3+
English: 0.5 milligrams Al3+ 0.2 milligrams Al3+
Danish: 0,5 miligram Al3+ 0,2 miligram Al3+