Infanrix Hexa

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), H. influenzae type b conjugate vaccine (adsorbed)

Primary & booster vaccination of infants & toddlers against diphtheria, tetanus, pertussis (DTP), hepatitis B, poliomyelitis & disease caused by HIB.

IM Full-term infant 3-dose primary vaccination Three 0.5-mL doses w/ at least 1 mth interval between primary doses. Give booster dose at least 6 mth after the last priming dose, preferably before 18 mth of age. 2-dose primary vaccination Two 0.5-mL doses w/ at least 2 mth interval between primary doses. Give booster dose at least 6 mth after the last priming dose, preferably between 11 & 13 mth of age. Preterm infant born after at least 24 wk of gestational age 3-dose primary vaccination Three 0.5-mL doses w/ at least 1 mth interval between primary doses. Give booster dose at least 6 mth after the last priming dose, preferably before 18 mth of age. 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 6 wk.

Hypersensitivity to the active substances, to any of the excipients, to formaldehyde, neomycin & polymyxin, or after previous administration of DTP, hepatitis B, polio or HIB vaccines. Encephalopathy of unknown aetiology, occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine. Postpone vaccination in case of acute severe febrile illness.

Rare anaphylactic event following vaccination. Do not administer intravascularly or intradermally. Will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, HBV, poliovirus or HIB. Carefully consider the decision to give further doses of pertussis-containing vaccine in case of temp ≥40°C (not due to another identifiable cause), w/in 48 hr of vaccination; collapse or shock-like state, w/in 48 hr of vaccination; persistent inconsolable crying lasting ≥3 hr, w/in 48 hr of vaccination; convulsions w/ or w/o fever, w/in 3 days of vaccination. Administer w/ caution to subjects w/ thrombocytopenia or bleeding disorder since bleeding may occur following IM administration. Closely follow up vaccinees w/ history of febrile convulsions, or family history of convulsions or Sudden Infant Death Syndrome. Use of prophylactic antipyretics is recommended for childn w/ seizure disorders or w/ prior history of febrile seizures. Consider potential risk of apnoea & need for resp monitoring for 48-72 hr when administering primary immunisation series to very preterm infants (born ≤28 wk of gestation) & those w/ previous history of resp immaturity. +ve urine test for HIB capsular polysaccharide antigen w/in 1-2 wk following vaccination. Co-administration w/ pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine. Expected immunological response may not be obtained after vaccination of immunosuppressed patients. Not intended for use in adults. Safety & efficacy in childn >36 mth of age have not been established. Infant or child w/ new onset or progression of a severe neurological disorder.

Appetite loss; abnormal crying, irritability, restlessness; fever ≥38°C, local swelling at inj site (≤50 mm), fatigue, pain, redness. Nervousness; diarrhoea, vomiting; fever >39.5°C, inj site induration, local swelling at inj site (>50 mm).

Higher rate of febrile reactions w/ pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine. Increased risk of fever, pain at inj site, appetite loss & irritability w/ meningococcal serogroup B vaccine & 7-valent pneumococcal conjugate vaccine; consider separate vaccinations when possible. Adequate response may not be achieved w/ immunosuppressive therapy.

Vaccines, Antisera & Immunologicals

J07CA09 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B ; Belongs to the class of combined bacterial and viral vaccines.

P₁S₁S₃, A