FrancophonIA/ELRC3.0 huggingface dataset:
English: Infanrix hexa can be given concomitantly with pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), meningococcal serogroup B vaccine (MenB), oral rotavirus vaccine and measles-mumps-rubella-varicella (MMRV) vaccine.
Danish: Infanrix hexa kan administreres samtidig med konjugerede pneumokokvacciner (PCV7, PCV10 og PCV13), konjugeret meningokokvaccine serotype C (CRM197- og TT-konjugater), konjugeret meningokokvaccine serotype A, C, W-135 og Y (TT-konjugater), meningokokvaccine serotype B (MenB), oral rotavirusvaccine og vacciner mod mæslinge-fåresyge-røde hunde-skoldkopper (MFRV).
English: Data from clinical studies show similar incidences of fever when Infanrix hexa is co-administered with other pneumococcal saccharide conjugated vaccine.
Danish: Data fra kliniske studier viste sammenlignelig forekomst af feber, når Infanrix hexa blev administeret samtidig med andre konjugerede saccharid pneumokokvacciner.
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine): bronchitis, rash, swollen glands in the neck, armpit or groin (lymphadenopathy), bleeding or bruising more easily than normal (thrombocytopenia), in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination, temporarily stopping breathing (apnoea), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), swelling of the whole injected limb, blisters.
Danish: Sjælden (disse kan forekomme ved op til 1 ud af 1.000 vaccinedoser): bronkitis, udslæt; hævede kirtler i halsen, armhulerne eller lysken (lymfadenopati); nemmere dannelse af blødning eller blå mærker end normalt (trombocytopeni), længere mellemrum mellem vejrtrækningerne hos meget for tidligt fødte børn (født i 28. svangerskabsuge eller før) kan forekomme 2-3 dage efter vaccination, midlertidigt vejrtrækningsstop (apnø); hævelser i ansigt, læber, mund, tunge eller svælg, hvilket kan medføre synkebesvær eller åndenød (angioødem); hævelse af hele den vaccinerede arm eller hele det vaccinerede ben, blærer.
English: Talk to your doctor or pharmacist before your child is given Infanrix hexa:
Danish: Kontakt lægen eller apotekspersonalet, før dit barn får Infanrix hexa:
English: Poliovirus (inactivated) type 1 (Mahoney strain)4
Danish: Poliovirus (inaktiveret) type 1 (mahoney-stamme)4
English: N
Danish: I
English: Data have shown no clinically relevant interference in the antibody response to each of the individual antigens, although inconsistent antibody response to poliovirus type 2 in co-administration with Synflorix was observed (seroprotection ranging from 78% to 100%) and the immune response rates to the PRP (Hib) antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age were higher if coadministered with a tetanus toxoid conjugate pneumococcal or meningococcal vaccine (see section 5.1).
Danish: Data har ikke vist nogen klinisk relevant påvirkning af antistofresponset for de individuelle antigener, selvom der er observeret inkonsistent antistofrespons for poliovirus type 2 ved administration samtidig med Synflorix (serobeskyttelse fra 78 % til 100 %), og at immunresponsraten for PRP (Hib)-antigen i Infanrix hexa var højere efter 2 doser, givet ved en alder på 2 og 4 måneder, ved administration samtidig med en tetanustoksoid-konjugeret pneumokok- eller meningokokvaccine (se pkt.
English: • The booster dose should be given at least 6 months after the last priming dose and preferably before 18 months of age.
Danish: • Boosterdosen skal gives mindst 6 måneder efter den sidste primærdosis, og helst før barnet er 18 måneder.
English: With regards to hepatitis B, seroprotective antibody concentrations (≥10 mIU/ml) following a 3-dose primary and booster schedule with Infanrix hexa have been shown to persist in ≥ 85% of subjects 4-5 years of age, in ≥72% of subjects 7-8 years of age, in ≥60% of subjects 12-13 years of age and in 53.7% of subjects 14-15 years of age.
Danish: For hepatitis B er der vist serobeskyttende antistofkoncentrationer (≥10 mIE/ml) efter primær vaccination med 3 doser og boosterdosis med Infanrix hexa hos ≥ 85 % af personerne i alderen 4-5 år, ≥ 72 % af personerne i alderen 7-8 år, ≥60% af personerne i alderen 12-13 år og hos 53,7 % af personerne i alderen 14-15 år.
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 boosterdosis nummer to af pertussis-vaccinen bør gives til børn i alderen 5-7 år efter administration af det nævnte vaccinationsprogram.
English: Tetanus toxoid1
Danish: Tetanustoksoid1
English: Anaphylactic reactions2, anaphylactoid reactions (including urticaria)2
Danish: Anafylaktiske reaktioner2, anafylaktoide reaktioner (inklusive urticaria)2, allergiske reaktioner (inklusive pruritus)2
English: • The booster dose should be given at least 6 months after the last priming dose and preferably between 11 and 13 months of age.
Danish: • Boosterdosen skal gives mindst 6 måneder efter den sidste primærdosis, og helst når barnet er mellem 11 og 13 måneder.
English: Filamentous Haemagglutinin (FHA)1
Danish: Filamentøs hæmagglutinin (FHA)1
English: In extremely rare cases the following side effects have been reported with hepatitis B vaccine: paralysis, numbness or weakness of the arms and legs (neuropathy), inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain-Barré syndrome), swelling or infection of the brain (encephalopathy, encephalitis), infection around the brain (meningitis).
Danish: I meget sjældne tilfælde er følgende bivirkninger indberettet med hepatitis B-vaccine: lammelser, følelsesløshed eller svaghed i arme og ben (neuropati); betændelser i nogle nerver, hvilket kan være med stikken og prikken eller følelsesløshed eller tab af de normale bevægelser (Guillain-Barré syndrom); hævelse eller infektion i hjernen (encefalopati, encefalitis), hjernehindebetændelse (meningitis).
English: Common (these may occur with up to 1 in 10 doses of the vaccine): diarrhoea, being sick (vomiting), high temperature of more than 39.5°C, swelling larger than 5 cm or hard lump where the injection was given, feeling nervous.
Danish: Almindelig (disse kan forekomme ved op til 1 ud af 10 vaccinedoser): diarré, opkastning, feber over 39,5 °C, hævelse større end 5 cm eller hård knude, der hvor injektionen blev givet, nervøsitet.
English: N = number of subjects * Samples tested by ELISA to have anti-diphtheria antibody concentrations < 0.1 IU/ml were re-tested using Vero-cell neutralisation assay (seroprotection cut-off ≥ 0.016 IU/ml): 96.5% of the subjects were seroprotected § Number of subjects from 2 clinical studies
Danish: Anti-PRP (0,15 µg/ml) n = antal personer * prøver, målt ved hjælp af ELISA, hvor anti-difteri-antistofkoncentrationer < 0,1 IE/ml blev gentestet ved hjælp af vero-celle-neutraliseringsbestemmelse (serobeskyttelse cut-off ≥ 0,016 IE/ml): 96,5 % af personerne var serobeskyttede § antal personer fra de 2 kliniske studier
English: The physician should be aware that the rate of febrile reactions is higher when Infanrix hexa is coadministered with a pneumococcal conjugate vaccine (PCV7, PCV10, PCV13), or with a measlesmumps-rubella-varicella (MMRV) vaccine, compared to that occurring following the administration of Infanrix hexa alone.
Danish: Lægen skal være opmærksom på, at hyppigheden af febrile reaktioner er højere, når Infanrix hexa administreres samtidig med en konjugeret pneumokokvaccine (PCV7, PCV10, PCV13), eller med en mæslinge-fåresyge-røde hunde-skoldkoppe (MFRV)-vaccine, sammenlignet med forekomsten, når Infanrix hexa administreres alene.
English: N = number of subjects * in a subgroup of infants not administered hepatitis B vaccine at birth, 77.7% of subjects had anti-HBs titres ≥ 10 mIU/ml ** Post booster, 98.4% of subjects had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection † cut-off accepted as indicative of protection
Danish: Anti-PRP (0,15 µg/ml) † n = antal personer * i en undergruppe af børn, som ikke fik hepatitis B-vaccine ved fødslen, havde 77,7 % af personerne anti-HBs-titre ≥ 10 mIE/ml ** efter boosterdosis havde 98,4 % af personerne en anti-PRP-koncentration ≥ 1 µg/ml, hvilker indikerer langtidsbeskyttelse † cut-off accepteret som vejledende for beskyttelse
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH DTPA HBV IPV SUSPENSION
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER FYLDTE INJEKTIONSSPRØJTER MED DTPA-HBV-IPV-SUSPENSION
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hib for Infanrix hexa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Hib til Infanrix hexa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 VIAL AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 1 HÆTTEGLAS OG 1 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 10 HÆTTEGLAS OG 10 FYLDTE INJEKTIONSSPRØJTER UDEN KANYLER 1 HÆTTEGLAS OG 1 FYLDT INJEKTIONSSPRØJTER MED 2 KANYLER 10 HÆTTEGLAS OG 10 FYLDTE INJEKTIONSSPRØJTER MED 20 KANYLER
English: • if your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping cough, hepatitis B, polio or Haemophilus influenzae type b.
Danish: • hvis dit barn har haft en allergisk reaktion over for en vaccine mod difteri, stivkrampe, kighoste, hepatitis B, polio eller Haemophilus influenzae type b.
English: Do not administer the vaccine intravascularly or intradermally.
Danish: Vaccinen må ikke indgives intravaskulært eller intrakutant.
English: Swelling of the entire injected limb1, 2, extensive swelling reactions2, injection site mass2, injection site vesicles2 1 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: Hævelse af hele den vaccinerede arm eller hele det vaccinerede ben1,2, omfattende hævelsesreaktioner2, væskeudfyldning2 og blærer ved injektionsstedet2 1 Børn, som er førstegangsvaccinerede med acellulær pertussisvaccine, er mere udsatte for at få hævelser efter boostervaccination end børn, som er førstegangsvaccineret med helcellevacciner.
English: The mixture should be well shaken until the powder is completely dissolved prior to administration.
Danish: Før administration skal blandingen omrystes omhyggeligt, indtil pulveret er fuldstændigt opløst.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPa HBV IPV for Infanrix hexa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) DTPa HBV IPV til Infanrix hexa
English: Uncommon Diffuse swelling of the injected limb, sometimes involving the adjacent joint1
Danish: Ikke almindelig Diffus hævelse af den vaccinerede arm eller det vaccinerede ben og nogle gange af det tilstødende led1
English: If you are not sure, talk to your doctor or pharmacist before your child is given Infanrix hexa.
Danish: Hvis du er i tvivl, skal du tale med lægen eller apoteket, inden dit barn får Infanrix hexa.
English: Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions (with or without fever) and HHE when comparing groups which reported use of Infanrix hexa with Prevenar 13 to those which reported use of Infanrix hexa alone.
Danish: Analyse af rapporteringsfrekvenser fra postmarketingovervågningen tyder på en potentiel øget risiko for kramper (med og uden feber) og hypoton-hyporesponsiv episode, når gruppen, som fik både Infanrix hexa og Prevenar 13, sammenlignes med gruppen, som fik Infanrix hexa alene.
English: In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4th) dose of both vaccines, fever ≥ 38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone.
Danish: I kliniske studier, hvor nogle af de vaccinerede personer fik Infanrix hexa samtidig med Prevenar (PCV7) som den fjerde boosterdosis for begge vacciner, blev feber ≥ 38,0 °C rapporteret hos 43,4 % af de børn, som fik Prevenar og Infanrix hexa samtidig, sammenlignet med hos 30,5 % af de spædbørn, som fik den hexavalente vaccine alene.
English: Infanrix hexa is indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b.
Danish: Infanrix hexa er indiceret til primær vaccination og boostervaccination af spædbørn og småbørn mod difteri, tetanus, pertussis, hepatitis B, poliomyelitis og sygdomme forårsaget af Haemophilus influenzae type b.
English: Infanrix hexa will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. 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: Infanrix hexa beskytter ikke mod sygdomme forårsaget af andre patogene end Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B-virus, poliovirus og Haemophilus influenzae type b. Beskyttelse mod hepatitis D kan dog forventes ved immunisering, da hepatitis D (forårsaget af delta-virus) ikke optræder i fravær af hepatitis B-infektion.
English: Bronchitis, apnoea2 [see section 4.4 for apnoea in very preterm infants (≤ 28 weeks of gestation)]
Danish: 4.4 for apnø hos meget for tidligt fødte børn (≤ 28 uger af svangerskabet)]
English: months N= 196 (2 studies)
Danish: måneder n= 196 (2 studier)
English: Bordetella pertussis antigens Pertussis toxoid (PT)1
Danish: Bordetella pertussis antigener Pertussistoksoid (PT)1
English: Lymphadenopathy2, thrombocytopenia2
Danish: Lymfadenopati2, trombocytopeni2
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Efter rekonstitution indeholder 1 dosis (0,5 ml): Difteritoksoid1
English: Additionally, following a 2-dose primary and booster schedule, seroprotective antibody concentrations against hepatitis B persisted in ≥ 48% of subjects 11-12 years of age.
Danish: Desuden var der fortsat serobeskyttende antistofkoncentrationer mod hepatitis B efter primær vaccination med 2 doser og en boosterdosis hos ≥ 48 % af personerne i alderen 11-12 år.
English: Pre-filled syringe: suspension
Danish: Fyldt injektionssprøjte: suspension
English: 3-5-11 months of age N=530 (4 studies)
Danish: Alder 3-5-11 måneder n=530 (4 studier)
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline Biologicals s.a.
English: Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.
Danish: Kighoste kan også medføre øreinfektioner, længerevarende bronkitis, lungebetændelse, krampeanfald, hjerneskade og endda død.
English: In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio and Hib vaccines.
Danish: Under disse omstændigheder skal pertussisvaccinationen afbrydes, og vaccinationsprogrammet fortsættes med difteri-, tetanus-, hepatitis B-, polio- og Hib-vacciner.
English: The bacteria also release a poison.
Danish: Bakterierne udskiller også et toksin (en gift).
English: In a clinical study in which some of the vaccinees received a booster dose of Infanrix hexa concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine, fever ≥ 38.0°C was reported in 76.6% of children receiving MMRV vaccine and Infanrix hexa at the same time, as compared to 48% of children receiving Infanrix hexa alone and 74.7% of children receiving MMRV vaccine alone.
Danish: I et klinisk studie, hvor nogle af de vaccinerede personer fik en boosterdosis af Infanrix hexa samtidig med mæslinge-fåresyge-røde hunde-skoldkoppe (MFRV)-vaccine, blev der rapporteret feber ≥ 38,0 °C hos 76,6 % af de børn, som fik MFRV-vaccine og Infanrix hexa samtidig, sammenlignet med 48 % af børnene, som fik Infanrix hexa alene, og 74,7 % af børnene, som fik MFRV-vaccine alene.
English: 2-4-12 months of age N=223 (1 study)
Danish: Alder 2-4-12 måneder n=223 (1 studie)
English: Hepatitis B surface antigen2,3
Danish: Hepatitis B-overfladeantigen2,3
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES FOR MULTIPACK OF 50 (5 X 10) (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 10 HÆTTEGLAS OG 10 FYLDTE INJEKTIONSSPRØJTER UDEN KANYLER TIL BRUG I EN MULTIPAKNING MED 50 (5 X 10) (UDEN BLUE BOX)
English: Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines.
Danish: Overfølsomhed ved tidligere administration af difteri, tetanus, pertussis, hepatitis B, polio eller Hibvacciner.
English: Hib powder: lactose anhydrous
Danish: Hib-pulver: laktose, vandfri
English: In comparative clinical studies, similar rates of symptoms were observed in preterm and full-term infants (refer to section 4.4 for information on apnoea).
Danish: I sammenlignende kliniske studier blev der observeret samme forekomst af symptomer hos præmature spædbørn og fuldbårne spædbørn (se pkt.
English: Filamentous Haemagglutinin1
Danish: Filamentøs hæmagglutinin1
English: Pack sizes of 1 and 10 with or without needles and a multipack of 5 packs, each containing 10 vials and 10 pre-filled syringes, without needles.
Danish: Pakningsstørrelser på 1 og 10 stk. med eller uden kanyler, samt en multipakning med 5 pakninger, hver indeholdende 10 hætteglas og 10 fyldte injektionssprøjter uden kanyler.
English: Fever of greater than 39.5°C was reported in 18% of children receiving Infanrix hexa with MMRV vaccine, as compared to 3.3% of children receiving Infanrix hexa alone and 19.3% of children receiving MMRV alone (see sections 4.4 and 4.5).
Danish: Der blev rapporteret feber over 39,5 °C hos 18 % af de børn, som fik Infanrix hexa samtidig med MFRV-vaccine, sammenlignet med 3,3 % af børnene, som fik Infanrix hexa alene, og 19,3 % af børnene, som fik MFRVvaccine alene (se pkt.
English: 2-dose
Danish: 2-dosis
English: At the end of this period Infanrix hexa should be used or discarded.
Danish: Infanrix hexa skal administreres inden for denne periode eller kasseres.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 dosis (0,5 ml)
English: Anti-HBs (10 mIU/ml)
Danish: Anti-HBs (10 mIE/ml)
English: Uncommon Somnolence Rare
Danish: Ikke almindelig Døsighed Sjælden
English: • difficulty in breathing or swallowing
Danish: • åndedrætsbesvær eller synkebesvær
English: Very common (these may occur with more than 1 in 10 doses of the vaccine): feeling tired, loss of appetite, high temperature of 38°C or higher, swelling, pain, redness where the injection site was given, unusual crying, feeling irritable or restless.
Danish: Meget almindelig (disse kan forekomme ved flere end 1 ud af 10 vaccinedoser): træthed, appetitløshed, feber på 38 °C eller derover; hævelse, smerte, rødme, der hvor injektionen blev givet; unormal gråd, irritabilitet eller uro.
English: Powder and suspension for suspension for injection in a pre-filled syringe Vial: powder
Danish: Pulver og suspension til injektionsvæske, suspension i fyldt injektionssprøjte Hætteglas: pulver
English: Hepatitis B surface antigen2
Danish: Hepatitis B-overfladeantigen2
English: If your child misses a dose
Danish: Hvis du glemmer en injektion
English: N = number of subjects † cut-off accepted as indicative of protection * Post booster, 94.4% of subjects in the 2-4-12 months schedule and 97.0% of subjects in the 3-5-11 months schedule had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection.
Danish: Anti-PRP (0,15 µg/ml) † n = antal personer † cut-off accepteret som vejledende for beskyttelse * efter boosterdosis havde 94,4 % af personerne i 2-4-12 måneders doseringen og 97,0 % af personerne i 3-5-11 måneders doseringen anti-PRP-koncentrationer ≥ 1 µg/ml, hvilket indikerer langtidsbeskyttelse.
English: 2-4-12 months of age N=196 (1 study)
Danish: Alder 2-4-12 måneder n=196 (1 studie)
English: Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Infanrix hexa and Prevenar 13 (see section
Danish: Kramper (med og uden feber) og hypotonisk-hyporesponsiv episode blev rapporteret hyppigere ved samtidig administration af Infanrix hexa og Prevenar 13 (se pkt.
English: 3-5-11 months of age N=532 (3 studies)
Danish: Alder 3-5-11 måneder n=532 (3 studier)
English: For adjuvants, see section 2.
Danish: For adjuvans, se pkt.
English: Considerations
Danish: Kommentarer
English: The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension.
Danish: Difteri, tetanus, acellulær pertussis, hepatitis B, inaktiveret poliomyelitis (DTPa-HBV-IPV) komponenten er en uklar hvid suspension.
English: Store in the original package, in order to protect from light.
Danish: Opbevares i den originale yderpakning for at beskytte mod lys.
English: • The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV
Danish: • Difteri, tetanus, acellulær pertussis, hepatitis B, inaktiveret poliomyelitis (DTPa-HBV-IPV)
English: Bordetella pertussis antigens Pertussis toxoid1
Danish: Bordetella pertussis antigener Pertussistoksoid1
English: Anti-HBs (10 mIU/ml) †
Danish: Anti-HBs (10 mIE/ml) †
English: Serological correlates of protection have been established for diphtheria, tetanus, polio, Hepatitis B and Hib.
Danish: Serologiske korrelater for beskyttelse er fastlagt for difteri, tetanus, polio, hepatitis B og Hib, men ikke for pertussis.
English: (≥1/10,000 to <1/1,000)
Danish: (≥ 1/10.000 til < 1/1.000) Meget sjælden: (< 1/10.000)
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine): upper respiratory tract infection, feeling sleepy, cough, large swelling at the injected limb.
Danish: Ikke almindelig (disse kan forekomme ved op til 1 ud af 100 vaccinedoser): infektion i de øvre luftveje, søvnighed, hoste, stor hævelse hvor injektionen blev givet i armen eller i benet.
English: • if your child is allergic to: - Infanrix hexa or any of the ingredients of this vaccine (listed in section 6).
Danish: • hvis dit barn er allergisk over for: - Infanrix hexa eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6) - formaldehyd - neomycin eller polymyxin (antibiotika).
English: months N= 1693 (6 studies)
Danish: måneder n= 1.693 (6 studier)
English: • if your child should become unresponsive or experience seizures (fits) after the vaccination, please contact your doctor immediately.
Danish: • hvis du efter vaccinationen ikke kan få kontakt med dit barn, eller dit barn får kramper, skal du straks kontakte lægen.
English: including induration, local swelling at the injection site (> 50 mm)1
Danish: Feber > 39,5 ºC, reaktion ved injektionsstedet inklusive induration, lokal hævelse ved injektionsstedet (> 50 mm)1
English: • collapse
Danish: • kollaps
English: Uncommon Cough Rare
Danish: Ikke almindelig Hoste Sjælden