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Infanrix hexa 6 in 1 vaccine4/27/2023 These reactions were mostly moderate (less than or equal to 39☌) and transient (see sections 4.5 and 4.8). The physician should be aware that the rate of febrile reactions is higher when Infanrix hexa is co-administered with a pneumococcal conjugate vaccine (PCV7, PCV10, PCV13), or with a measles-mumps-rubella-varicella (MMRV) vaccine, compared to that occurring following the administration of Infanrix hexa alone. 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. Infanrix hexa should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.ĭo not administer the vaccine intravascularly or intradermally.Ī 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 hexa. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.Īs 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.Īs for any vaccination, the risk-benefit of immunising with Infanrix hexa 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. ▪ Convulsions with or without fever, occurring within 3 days of vaccination. ▪ Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination ![]() ▪ 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 ![]()
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