Date shown reflects the date that the evidence was documented
2022-01-19
HIB-Vaccine-Package-Insert-HIBERIX
"(page 10) HIBERIX contains Haemophilus b capsular
polysaccharide (polyribosyl-ribitol-phosphate [PRP]), a high molecular weight polymer prepared
from the H. influenzae type 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 vials.
After reconstitution, each 0.5-mL 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."
https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert---HIBERIX.pdf
https://www.fda.gov/media/74395/download
https://www.fda.gov/media/80438/download
HIB-Vaccine-Package-Insert-HIBERIX
"(page 10) HIBERIX contains Haemophilus b capsular
polysaccharide (polyribosyl-ribitol-phosphate [PRP]), a high molecular weight polymer prepared
from the H. influenzae type 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 vials.
After reconstitution, each 0.5-mL 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."
https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert---HIBERIX.pdf
https://www.fda.gov/media/74395/download
https://www.fda.gov/media/80438/download