Indication

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age.

Important Safety Information

  • In clinical studies, adverse events in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite
  • Contraindications: Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; Progressive neurologic disorder
  • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines
  • The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-BarrĂ© syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events have occurred in temporal relation to receipt of a pertussis-containing vaccine
  • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination
  • The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals. The vial stopper is latex-free
  • Vaccination with PEDIARIX may not protect 100% of susceptible individuals

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