ActHIB Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Solution for Intramuscular Injection: 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 ActHIB safely and effectively. See full prescribing information for ActHIB.

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

ActHIB® Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Solution for Intramuscular Injection

Initial U.S. Approval: 1993

INGREDIENTS AND EXCIPIENTS

ActHIB vaccine is a sterile, lyophilized powder to be reconstituted with saline diluent (0.4% Sodium Chloride) for intramuscular administration only. The vaccine consists of the Haemophilus influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate, PRP), a high-molecular-weight polymer prepared from the H influenzae type b strain 1482 grown in a semi-synthetic medium, covalently bound to tetanus toxoid. (10) The lyophilized ActHIB vaccine powder and saline diluent contain no preservative. The tetanus toxoid is prepared by extraction, ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. (11) The culture medium contains milk-derived raw materials (casein derivatives). Further manufacturing process steps reduce residual formaldehyde to levels below 0.5 micrograms (mcg) per dose by calculation. The toxoid is filter sterilized prior to the conjugation process. Potency of ActHIB vaccine is specified on each lot by limits on the content of PRP polysaccharide and protein in each dose and the proportion of polysaccharide and protein in the vaccine that is characterized as high molecular weight conjugate.

When ActHIB is reconstituted with saline diluent (0.4% Sodium Chloride), each 0.5 mL dose is formulated to contain 10 mcg of purified capsular polysaccharide conjugated to 24 mcg of inactivated tetanus toxoid and 8.5% of sucrose.

The vial stoppers for ActHIB vaccine and diluent are not made with natural rubber latex.

INDICATIONS AND USAGE

ActHIB is a vaccine indicated for the prevention of invasive disease caused by Haemophilus influenzae type b. ActHIB vaccine is approved for use as a four dose series in infants and children 2 months through 5 years of age (1)

DOSAGE AND ADMINISTRATION

Four dose series (0.5 mL each) by intramuscular injection:

– A three dose primary series administered at 2, 4 and 6 months of age. (2.1)

– A single booster dose administered at 15-18 months of age. (2.1)

DOSAGE FORMS AND STRENGTHS

Solution for injection: lyophilized powder to be reconstituted in supplied 0.4%

Sodium Chloride 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 ActHIB vaccine. (4)

WARNINGS AND PRECAUTIONS

If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the potential benefits and risks of giving ActHIB vaccine must be evaluated. (5.2)

ADVERSE REACTIONS

Following administration of ActHIB vaccine in children 2-20 months of age, rates of adverse reactions varied by dose number and age of recipients:

– In children 15-20 months of age tenderness (20%) was the most common local reaction following a single dose. (6.1)

– The most frequent systemic reactions after any dose for children 2 months to 16 months of age were fussiness/irritability (75%), inconsolable crying (58%) and decreased activity/lethargy (51%). (6.1)

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy category C: Animal reproduction studies have not been conducted with ActHIB vaccine. It is also not known whether ActHIB vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Pediatric Use

Safety and effectiveness of ActHIB vaccine in infants below the age of 6 weeks have not been established.

Revised: XXXX XXXX

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109841.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/ActHIB-Haemophilus-b-Conjugate-Vaccine-Tetanus-Toxoid-Conjugate.pdf