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Acthib

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ActHIB

Indications
Dosage
How Supplied

INDICATIONS

ActHIB vaccine is indicated for the active immunization of infants and children 2 months through 5 years of age for the prevention of invasive disease caused by H influenzae type b.

TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, is indicated for the active immunization of children 15 through 18 months of age for prevention of invasive disease caused by H influenzae type b and diphtheria, tetanus and pertussis.

Vaccination with ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine) may not protect 100% of individuals.

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.

Reconstitution

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 age.

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.

Agitate vial - Illustration

Figure 2. Withdraw 0.6 mL of 0.4% Sodium Chloride or Tripedia vaccine as indicated.

Withdraw 0.6 mL - Illustration

Figure 3. Cleanse the ActHIB vaccine stopper, insert the syringe needle into the vial, and inject the total volume of diluent.

Insert the syringe needle into the vial - Illustration

Figure 4. Agitate vial thoroughly.

Agitate vial thoroughly - Illustration

Figure 5. After reconstitution, cleanse vial stopper. Using a new needle and syringe, withdraw 0.5 mL of reconstituted vaccine and administer intramuscularly.

Withdraw 0.5 mL of reconstituted vaccine - Illustration

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.

HOW SUPPLIED

ActHIB Vaccine Reconstituted with Saline Diluent (0.4% Sodium Chloride)

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 Tripedia Vaccine

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).

Storage

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 FREEZE.

REFERENCES

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

Last reviewed on RxList: 8/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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