Hiberix: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate): patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HIBERIX safely and effectively. See full prescribing information for HIBERIX.

See full insert sheet at this link at the Natural News Reference website.

HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]

Solution for Intramuscular Injection

Initial U.S. Approval: 2009

INGREDIENTS AND EXCIPIENTS

HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] is a solution for intramuscular injection, supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. HIBERIX contains Haemophilus b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]), a high molecular weight polymer prepared from the Haemophilus 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.

HIBERIX does not contain a preservative.

The lyophilized vaccine and saline diluent vial stoppers are not made with natural rubber latex.

INDICATIONS AND USAGE

HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday). (1)

No clinical data are available from controlled studies comparing booster immunization with HIBERIX and a US-licensed Haemophilus b Conjugate Vaccine. (1)

DOSAGE AND ADMINISTRATION

A 4-dose series (0.5 mL each) given by intramuscular injection (2.3):

– Primary series: One dose each at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age.

– Booster: One dose at 15 through 18 months of age

DOSAGE FORMS AND STRENGTHS

Solution for injection supplied as a vial of lyophilized vaccine to be reconstituted with the accompanying vial of saline diluent. A single dose, after reconstitution, is 0.5 mL. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of HIBERIX. (4)

WARNINGS AND PRECAUTIONS

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give HIBERIX should be based on potential benefits and risks. (5.1)

Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. (5.2)

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including HIBERIX, to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination. (5.3)

ADVERSE REACTIONS

Common solicited adverse events (≥20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

DRUG INTERACTIONS

Do not mix HIBERIX with any other vaccine in the same syringe or vial. (7.2)

USE IN SPECIFIC POPULATIONS

Pregnancy

Animal reproduction studies have not been conducted with HIBERIX. It is also not known whether HIBERIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity

Pediatric Use

Safety and effectiveness of HIBERIX in children younger than 6 weeks of age and in children 5 to 16 years of age have not been established.

Revised: XX/XXXX

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM179530.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Hiberix-Haemophilus-b-Conjugate-Vaccine.pdf