Caution: Federal (USA) law prohibits dispensing without prescription.

NOTE: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) - ActHIB^® is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) - OmniHIB^® (distributed by SmithKline Beecham Pharmaceuticals); and is manufactured by Pasteur Mérieux Sérums Vaccins S.A.

ActHIB^®, Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), produced by Aventis Pasteur SA, is a sterile, lyophilized powder which is reconstituted at the time of use with either saline diluent (0.4% Sodium Chloride) or Aventis Pasteur Inc. (AvP) Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell pertussis vaccine D.P. or Tripedia^®, AvP Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) (when reconstituted known as TriHIBit^TM) for intramuscular use only. The vaccine consists of the Haemophilus b capsular polysaccharide (polyribosyl- ribitol- phosphate, PRP), a high molecular weight polymer prepared from the Haemophilus influenzae type b strain 1482 grown in a semi-synthetic medium, covalently bound to tetanus toxoid.¹ The lyophilized ActHIB^® powder and saline diluent contain no preservative. The tetanus toxoid is prepared by extraction, ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium.² The toxoid is filter sterilized prior to the conjugation process. Potency of ActHIB^® is specified on each lot by limits on the content of PRP polysaccharide and protein in each dose and the proportion of polysaccharide and protein in the vaccine which is characterized as high molecular weight conjugate.

When ActHIB^® is reconstituted with saline diluent, each single dose of 0.5 mL is formulated to contain 10 µg of purified capsular polysaccharide conjugated to 24 µg of inactivated tetanus toxoid, and 8.5% of sucrose.

When ActHIB^® is combined with AvP DTP vaccine by reconstitution, each single dose (0.5 mL) is formulated to contain 10 µg of purified capsular polysaccharide conjugated to 24 µg of inactivated tetanus toxoid 8.5% of sucrose 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, and an estimate of 4 protective units of pertussis vaccine. Thimerosal (mercury derivative) 1:10,000 is added as a preservative to AvP DTP vaccine. (Refer to product insert for AvP whole-cell DTP.)

When ActHIB^® is combined with Tripedia^® (TriHIBit^TM) by reconstitution for booster dose, each single dose (0.5 mL) is formulated to contain 10 µg of purified capsular polysaccharide conjugated to 24 µg of inactivated tetanus toxoid, 8.5% of sucrose, 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid and 46.8 µg of pertussis antigens. Thimerosal (mercury derivative) 1:10,000 is added as a preservative to Tripedia^®. (Refer to product insert for Tripedia^®.)

The reconstituted vaccine, using saline diluent, appears clear and colorless. The reconstituted vaccine, using AvP DTP vaccine, appears whitish in color. TriHIBit^TM, the reconstituted vaccine, using Tripedia^® is a homogenous white suspension.

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