DOSAGE AND ADMINISTRATION
For intramuscular injection only
The ActHIB vaccine, reconstituted with saline diluent
(0.4% Sodium Chloride), appears clear and colorless. TriHIBit vaccine, the
reconstituted vaccine using Tripedia vaccine, is a homogenous white suspension.
Parenteral drug products should be inspected visually for
particulate matter and/or discoloration prior to administration, whenever
solution and container permit. If these conditions exist, the vaccine should
not be administered.
ActHIB is to be reconstituted only with the accompanying
saline diluent (0.4% Sodium Chloride) or Tripedia vaccine to formulate TriHIBit
vaccine. TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by
reconstitution, should not be administered to infants younger than 15 months of
To prepare ActHIB vaccine, withdraw 0.6 mL of saline
diluent (0.4% Sodium Chloride) and inject into the vial of lyophilized ActHIB
vaccine. Agitate the vial to ensure complete reconstitution. The vaccine will
appear clear and colorless. Withdraw a 0.5 mL dose of the reconstituted vaccine
and inject intramuscularly. After reconstitution with saline diluent (0.4% Sodium
Chloride), ActHIB vaccine should be administered promptly or stored
refrigerated between 2° to 8°C (35° to 46°F) and administered within 24 hours.
If the vaccine is not administered promptly, agitate the vial again before
injection. Refer to Figures 1, 2, 3, 4, and 5.
To prepare TriHIBit vaccine, thoroughly agitate the vial
of Sanofi Pasteur Inc. Tripedia vaccine then withdraw 0.6 mL and inject into
the vial of lyophilized ActHIB vaccine. After reconstitution and thorough
agitation, the combined vaccines will appear whitish in color. Withdraw a 0.5 Ml
dose of the combined vaccines and inject intramuscularly. TriHIBit vaccine
(ActHIB reconstituted with Tripedia vaccine) should be administered within 30
minutes of reconstitution.
Refer to Figures 1, 2, 3, 4, and 5.
Instructions for Reconstitution of ActHIB Vaccine with
Saline Diluent (0.4% Sodium Chloride) or Tripedia Vaccine (TriHIBit Vaccine)
Figure 1. Agitate vial prior to disinfecting the vial
stopper to avoid possible contamination.
Figure 2. Withdraw 0.6 mL of 0.4% Sodium Chloride or Tripedia
vaccine as indicated.
Figure 3. Cleanse the ActHIB vaccine stopper, insert the
syringe needle into the vial, and inject the total volume of diluent.
Figure 4. Agitate vial thoroughly.
Figure 5. After reconstitution, cleanse vial stopper.
Using a new needle and syringe, withdraw 0.5 mL of reconstituted vaccine and administer
Before injection, the skin over the site to be injected
should be cleansed with a suitable germicide.
Each dose of ActHIB vaccine reconstituted with saline
diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine) is
administered intramuscularly in the outer aspect of the vastus lateralis
(mid-thigh) or deltoid. The vaccine should not be injected into the gluteal
area or areas where there may be a nerve trunk.
A 0.5 mL dose of ActHIB is approved for intramuscular
administration in infants and children, 2 months through 5 years of age as a
4-dose series. The series consists of a primary immunization course of 3 doses
administered at 2, 4, and 6 months of age, followed by one booster dose, administered
at 15-18 months of age. The booster dose at 15-18 months of age may be given as
TriHibit vaccine (ActHIB reconstituted with Tripedia).
For previously unvaccinated children, the number of doses
of Haemophilus b Conjugate Vaccine needed depends on the age at which the
immunization series is begun. A previously unvaccinated infant, 7 to 11 months
of age, should receive as primary immunizations, two doses of Haemophilus b
Conjugate Vaccine at 8-week intervals, followed by a booster dose at 15 to 18 months
of age. A previously unvaccinated child 12 to 14 months of age should receive
one dose of Haemophilus b Conjugate Vaccine followed by a booster dose at 15 to
18 months of age (doses to be separated by an interval of 8 weeks). A
previously unvaccinated child 15 months through 5 years of age should receive
one dose of ActHIB vaccine.
Preterm infants should be vaccinated according to their
chronological age from birth.19
Interruption of the recommended schedule with a delay
between doses should not interfere with the final immunity achieved with ActHIB
vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or with
Tripedia vaccine (TriHIBit vaccine). There is no need to start the series over again,
regardless of the time elapsed between doses.
ActHIB Vaccine Reconstituted with Saline Diluent (0.4%
Single-dose, lyophilized vaccine vial (NDC 49281-547-58)
packaged with single-dose diluent vial (NDC 49281-546-05). Supplied as package
of 5 vials each (NDC 49281-545-05).
TriHIBit Vaccine, ActHIB Vaccine Reconstituted with
Single-dose, lyophilized vaccine vial (NDC 49281-545-50)
packaged with single-dose diluent vial of Tripedia vaccine (NDC 49281-298-01).
Supplied as package of 5 vials each (NDC 49281-59705).
Store lyophilized vaccine packaged with saline diluent
(0.4% Sodium Chloride) or Tripedia vaccine at 2° to 8°C (35° to 46°F). DO NOT
19 American Academy of Pediatrics. Immunization in
Special Clinical Circumstances. In: Peter G, ed. 1994 Red Book: Report of the
Committee on Infectious Diseases. 23rd ed. Elk Grove Village, IL 51-52, 1994.
Manufactured by: Sanofi Pasteur SA, Lyon France, US Govt
License #1724. Distributed by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA, 1-800-VACCINE
(1-800-822-2463). Revised: Jan 2014