ACTHIB- haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: FLV5I5W26R) (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN - UNII:FLV5I5W26R)

Available from:

Sanofi Pasteur Inc.

INN (International Name):

HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

Composition:

HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL

Therapeutic indications:

ActHIB® is a vaccine indicated for the prevention of invasive disease caused by Haemophilus influenzae (H. influenzae) type b. ActHIB is approved for use in children 2 months through 5 years of age. 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 the vaccine is a contraindication to administration of ActHIB vaccine [see DESCRIPTION (11)] . ActHIB is not approved for use in individuals 6 years of age and older. No human or animal data are available to assess vaccine-associated risks in pregnancy. ActHIB is not approved for use in individuals 6 years of age and older. Human or animal data are not available to assess the impact of ActHIB on milk production, its presence in breast milk, or its effects on the breastfed infant. Safety and effectiveness of ActHIB have not been established in infants below the age of 6 weeks and children and adolescents 6 years of age and older [see DOSAGE AND ADMINISTRATION (2.1)] .

Product summary:

Single-dose, lyophilized vaccine vial (vial 1 of 2) (NDC 49281-547-58) packaged with single-dose diluent vial (vial 2 of 2) (NDC 49281-546-58). Supplied as package of 5 vials each (NDC 49281-545-03). The vial stoppers for ActHIB vaccine and diluent are not made with natural rubber latex. Store lyophilized ActHIB vaccine packaged with saline diluent (0.4% Sodium Chloride) at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard unused portion.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ACTHIB- HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR
POLYSACCHARIDE
TETANUS TOXOID CONJUGATE ANTIGEN
SANOFI PASTEUR INC.
----------
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.
ACTHIB [HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)]
SOLUTION FOR
INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 1993
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
FOR INTRAMUSCULAR ADMINISTRATION ONLY
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 _Haemophilus 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:
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)
In children 15-20 months of age tenderness (20%) was the most common
local reaction following a
single dose. (6.1)