ActHIB (Aventis Pasteur) - Marketed Lyophilized Drug Products

INDICATIONS AND USAGE
ActHIB? or ActHIB? combined with AvP DTP vaccine by reconstitution is indicated for the active immunization of infants and children 2 through 18 months of age for the prevention of invasive disease caused by H. influenzae type b and/or diphtheria, tetanus and pertussis.
TriHIBit?, ActHIB? combined with Tripedia? by reconstitution, is indicated for the active immunization of children 15 to 18 months of age for prevention of invasive disease caused by H. influenzae type b and diphtheria, tetanus and pertussis.
Antibody levels associated with protection may not be achieved earlier than two weeks following the last recommended dose.
Only AvP whole-cell DTP, Tripedia? or 0.4% Sodium Chloride diluent may be used for reconstitution of lyophilized ActHIB?. TriHIBit?, ActHIB? combined with Tripedia? by reconstitution, should not be administered to infants younger than 15 months of age.
As with any vaccine, vaccination with ActHIB? reconstituted with AvP DTP or ActHIB? reconstituted with Tripedia? (TriHIBit?) or 0.4% Sodium Chloride diluent may not protect 100% of susceptible individuals.
A single injection containing diphtheria, tetanus, pertussis and Haemophilus b conjugate antigens may be more acceptable to parents and may increase compliance with vaccination programs. Therefore, in these situations it may be the judgment of the physician that it is of benefit to administer a single injection of whole-cell DTP or DTaP Haemophilus b conjugate vaccines.
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