Hiberix
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FDA Labeling Changes
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Uses
HIBERIX® is indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilusinfluenzae type b. HIBERIX is approved for use in children 15 months through 4 years of age (prior to fifth birthday).
HIBERIX is to be used as a booster dose in children who have received a primary series with a Haemophilus b Conjugate Vaccine that is licensed for primary immunization. HIBERIX is not approved for primary immunization.
The evaluation of effectiveness of HIBERIX as a booster dose was based on immune responses in children using serological endpoints that predict protection from invasive disease due to H. influenzae type b [see Clinical Pharmacology (12.1) and Clinical Studies (14.1)]. These protective antibody levels have not been evaluated in clinical trials in which a booster dose of HIBERIX is compared to a booster dose of a US-licensed Haemophilus b Conjugate Vaccine in children who previously received a primary series with a US-licensed Haemophilus b Conjugate Vaccine [see Clinical Studies (14.1)].
History
There is currently no drug history available for this drug.
Other Information
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 (16).]
Sources
Hiberix Manufacturers
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Glaxosmithkline Biologicals Sa
![Hiberix (Haemophilus B Conjugate Vaccine (Tetanus Toxoid Conjugate)) Injection, Powder, Lyophilized, For Solution [Glaxosmithkline Biologicals Sa]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hiberix | Glaxosmithkline Biologicals Sa
2.1 Reconstitution InstructionsHIBERIX is to be reconstituted only with the accompanying saline diluent. The reconstituted vaccine should be a clear and colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
Figure 1. Cleanse vial stopper. Attach appropriate needle to accompanying prefilled syringe of saline diluent and insert into vial.
Figure 2. Transfer entire contents of prefilled syringe into vial. With needle still inserted, vigorously shake the vial.
Figure 3. After reconstitution, withdraw entire contents of vial (approximately 0.5 mL) and administer by intramuscular injection.
After reconstitution, HIBERIX should be administered promptly or stored refrigerated between 2° and 8°C and administered within 24 hours. If the vaccine is not administered promptly, shake the solution vigorously again before injection.
2.2 Dose and AdministrationHIBERIX is administered as a single dose (approximately 0.5 mL) by intramuscular injection into the anterolateral aspect of the thigh or deltoid.
Do not administer this product intravenously, intradermally, or subcutaneously.
HIBERIX is to be used as a booster dose in children who have received a primary series with a Haemophilus b Conjugate Vaccine that is licensed for primary immunization [see Indications and Usage (1)].
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