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HIBERIX [Haemophilus b Conjuga
te 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
RP]), a high molecular weight polymer prepared from the
type b strain 20,752 grown in a synt
hetic medium that undergoes heat
inactivation and purification.
tetanus toxin, prepared from
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 lact
ose 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 capsu
lar 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 ma
y contain natural rubber latex