Haemophilus b conjugate vaccine description
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Description
HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] is a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent for intramuscular injection. HIBERIX contains Haemophilus b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]), a high molecular weight polymer prepared from the Haemophilusinfluenzaetype b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi-synthetic medium, is detoxified with formaldehyde and purified. The capsular polysaccharide is covalently bound to the tetanus toxoid. After purification, the conjugate is lyophilized in the presence of lactose as a stabilizer. The diluent for HIBERIX is a sterile saline solution (0.9% sodium chloride) supplied in prefilled TIP-LOK syringes.
When HIBERIX is reconstituted with the accompanying saline diluent, each dose is formulated to contain 10 mcg of purified capsular polysaccharide conjugated to approximately 25 mcg of tetanus toxoid, 12.6 mg of lactose, and ≤0.5 mcg of residual formaldehyde.
HIBERIX does not contain preservatives.
The tip caps of the prefilled syringes may contain natural rubber latex. The rubber plungers of the prefilled syringes and the vial stoppers do not contain latex. [See How Supplied/Storage and Handling]. [1]
References
Adapted from the FDA Package Insert.