▪ Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination ▪ Temperature of ≥ 40.0☌ within 48 hours of vaccination, not due to another identifiable cause If any of the following events are known to have occurred in temporal relation to receipt of pertussis-containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered: 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. 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. 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.Īs with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1). ![]() Infanrix hexa is for deep intramuscular injection, preferably at alternating sites for subsequent injections.įor instructions on reconstitution of the medicinal product before administration, see section 6.6. The safety and efficacy of Infanrix hexa in children over 36 months of age have not been established. Locally established immunoprophylactic measures against hepatitis B should be maintained. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used. Where a dose of hepatitis B vaccine is given at birth, Infanrix hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks. 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. Preterm infants born after at least 24 weeks of gestational age The booster dose should be given at least 6 months after the last priming dose and preferably between 11 and 13 months of age.There should be an interval of at least 2 months between primary doses.The booster dose should be given at least 6 months after the last priming dose and preferably before 18 months of age.There should be an interval of at least 1 month between primary doses.The vaccine may contain traces of formaldehyde, neomycin and polymyxin which are used during the manufacturing process (see section 4.3).įor the full list of excipients, see section 6.1. Haemophilus influenzae type b polysaccharideĬonjugated to tetanus toxoid as carrier proteinġadsorbed on aluminium hydroxide, hydrated (Al(OH) 3)Ģproduced in yeast cells ( Saccharomyces cerevisiae) by recombinant DNA technologyģadsorbed on aluminium phosphate (AlPO 4) Not less than 40 International Units (IU) ![]() Not less than 30 International Units (IU) Date of first authorisation/renewal of the authorisation
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