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ActHIB

ActHIB

INDICATIONS

ActHIB (haemophilus b conjugate vaccine) ® or ActHIB (haemophilus b conjugate vaccine) ® combined with AvP DTP vaccine by reconstitution is indicated for the active immunization of infants and children 2 through 18 months of age for the prevention of invasive disease caused by H. influenzae type b and/or diphtheria, tetanus and pertussis.

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

Antibody levels associated with protection may not be achieved earlier than two weeks following the last recommended dose.

Only AvP whole-cell DTP, Tripedia® or 0.4% Sodium Chloride diluent may be used for reconstitution of lyophilized ActHIB (haemophilus b conjugate vaccine) ® . TriHIBit® , ActHIB (haemophilus b conjugate vaccine) ® combined with Tripedia® by reconstitution, should not be administered to infants younger than 15 months of age.

As with any vaccine, vaccination with ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® (TriHIBit® ) or 0.4% Sodium Chloride diluent may not protect 100% of susceptible individuals.

A single injection containing diphtheria, tetanus, pertussis and Haemophilus b conjugate antigens may be more acceptable to parents and may increase compliance with vaccination programs. Therefore, in these situations it may be the judgment of the physician that it is of benefit to administer a single injection of whole-cell DTP or DTaP and Haemophilus b conjugate vaccines.

DOSAGE AND ADMINISTRATION

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:

Using Connaught Laboratories Inc. DTP, cleanse both the DTP and ActHIB (haemophilus b conjugate vaccine) ® vial rubber stoppers with a suitable germicide prior to reconstitution. Thoroughly agitate the vial of AvP DTP then withdraw a 0.6 mL dose and inject into the vial of lyophilized ActHIB (haemophilus b conjugate vaccine) ®. After reconstitution and thorough agitation, the combined vaccines will appear whitish in color. Withdraw and administer 0.5 mL dose of the combined vaccines intramuscularly. Vaccine should be used within 24 hours after reconstitution. Refer to Figures 1, 2, 3, 4, and 5.

To prepare TriHIBit®, cleanse both the Tripedia® and ActHIB (haemophilus b conjugate vaccine) ® vial rubber stoppers with a suitable germicide prior to reconstitution. Thoroughly agitate the vial of AvP Tripedia® then withdraw a 0.6 mL dose and inject into the vial of lyophilized ActHIB (haemophilus b conjugate vaccine) ®. After reconstitution and thorough agitation, the combined vaccines will appear whitish in color. Withdraw and administer 0.5 mL dose of the combined vaccines intramuscularly. Vaccine should be used immediately (within 30 minutes) after reconstitution. Refer to Figures 1, 2, 3, 4, and 5.

Using saline diluent (0.4% Sodium Chloride) cleanse the vaccine vial rubber stopper with a suitable germicide and inject the entire volume of diluent contained in the vial or syringe into the vial of lyophilized vaccine. Thorough agitation is advised to ensure complete reconstitution. The entire volume of reconstituted vaccine is then drawn back into the syringe before injecting one 0.5 mL dose intramuscularly. The vaccine will appear clear and colorless. Vaccine should be used within 24 hours after reconstitution. Refer to Figures 1, 2, 3, 4, and 5.

INSTRUCTIONS FOR RECONSTITUTION OF ActHIB® WITH AvP DTP OR RECONSTITUTION OF ActHIB® WITH TRIPEDIA® (TriHIBit® ) OR SALINE DILUENT (0.4% SODIUM CHLORIDE):

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

DO NOT INJECT INTRAVENOUSLY

Each dose of ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® (TriHIBit® )or saline diluent (0.4% Sodium Chloride) 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. During the course of primary immunizations, injections should not be made more than once at the same site.

When ActHIB (haemophilus b conjugate vaccine) ® is reconstituted with AvP DTP the combined vaccines are indicated for infants and children 2 through 18 months of age for intramuscular administration in accordance with the schedule indicated in Table 8. 14 When ActHIB (haemophilus b conjugate vaccine) ® is reconstituted with Tripedia® (TriHIBitTM), it the combined vaccines are indicated for children 15 to 18 months of age for intramuscular administration in accordance with the schedule in Table 8. 14



TABLE 8 14

RECOMMENDED IMMUNIZATION SCHEDULE FOR ActHIB (haemophilus b conjugate vaccine) AND DTP OR TRIPEDIA

For Previously Unvaccinated Children

DOSE

AGE

IMMUNIZATION

First, Second and Third

At 2, 4 and 6 months

ActHIB (haemophilus b conjugate vaccine) ® / reconstituted with DTP or with

saline diluent (0.4% Sodium Chloride)

Fourth

At 15 to 18 months

ActHIB (haemophilus b conjugate vaccine) ® reconstituted with DTP or with Tripedia ® (TriHIBitTM ) or with saline diluent (0.4% Sodium Chloride)

Fifth

At 4 to 6 years

DTP or Tripedia ®

For Previously Unvaccinated Children

The number of doses of Haemophilus b Conjugate Vaccine indicated depends on the age at which immunization is begun. A child 7 to 11 months of age should receive 2 doses of Haemophilus b Conjugate Vaccine at 8-week intervals and a booster dose at 15 to 18 months of age. A child 12 to 14 months of age should receive 1 dose of Haemophilus b Conjugate Vaccine followed by a booster 2 months later.

Preterm infants should be vaccinated according to their chronological age from birth. 35

Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with ActHIB (haemophilus b conjugate vaccine) ® reconstituted with AvP DTP or ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia® (TriHIBit®) or saline diluent (0.4% Sodium Chloride). There is no need to start the series over again regardless of the time elapsed between doses

It is acceptable to administer a booster dose of TriHIBit®, ActHIB (haemophilus b conjugate vaccine) ® reconstituted with Tripedia®, following a primary series of Haemophilus b conjugate and whole-cell DTP vaccines, or a primary series of a combination vaccine containing whole-cell DTP.

HOW SUPPLIED

ActHIB (haemophilus b conjugate vaccine) ® RECONSTITUTED WITH WHOLE-CELL DTP

Vial, 1 Dose, lyophilized vaccine (10 x 1 Dose vials per package), packaged with one 7.5 mL vial of Connaught Laboratories, Inc. Diphtheria and Tetanus Toxoids and Pertussis Vaccine as Diluent - Product No. 49281-549-10.

ActHIB (haemophilus b conjugate vaccine) ® RECONSTITUTED WITH 0.4% SODIUM CHLORIDE DILUENT

Vial, 1 Dose, lyophilized vaccine (5 x 1 Dose vials per package), packaged with 0.6 mL vial containing diluent (5 x 0.6 mL vials per package) - Product No. 49281-545-05

Administer vaccine within 24 hours after reconstitution.

TriHIBit®, ActHIB (haemophilus b conjugate vaccine) ® RECONSTITUTED WITH TRIPEDIA®

Vial, 1 Dose, lyophilized vaccine (5 x 1 Dose vials per package), packaged with five 0.6 mL vials of Tripedia® as Diluent (5 x 0.6 mL vials per package) (contains NO preservative) - Product No. 49281-597-05

Administer vaccine immediately (within 30 minutes) after reconstitution.

STORAGE

Store lyophilized vaccine packaged with saline diluent, Diphtheria and Tetanus Toxoids and Pertussis or Tripedia® between 2° - 8°C (35° - 46°F).

DO NOT FREEZE

REFERENCES

1. Chu CY, et al. Further studies on the immunogenicity of Haemophilus influenzae type b and pneumococcal type 6A polysaccharide-protein conjugate. Infect Immun 40: 245-246, 1983

2. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40: 21-32, 1941

3. Adams WG, et al. Decline of Childhood Haemophilus influenzae Type b (Hib) Disease in the Hib Vaccine Era. JAMA 269: 221-226, 1993

4. Recommendations of the Immunization Practices Advisory Committee (ACIP). Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older. MMWR 40: No. RR-1, 1991

5. Broome CV. Epidemiology of Haemophilus influenzae type b infections in the United States. Pediatr Infect Dis J6: 779-782, 1987

6. ACIP. Polysaccharide vaccine for prevention of Haemophilus influenzae type b disease. MMWR 34: 201-205, 1985.

7. Istre GR, et al. Risk factors for primary invasive Haemophilus influenzae disease: Increased risk from day care attendance and school-aged household members. J Pediatr 106: 190-195, 1985

8. Redmond SR, et al.Haemophilus influenzae type b disease. An epidemiologic study with special reference to day-care centers. JAMA 252: 2581-2584, 1984

9. Murphy TV, et al. County-wide surveillance of invasive Haemophilus infections: Risk of associated cases in Child Care Programs (CCPs). Twenty-third Interscience Conference on Antimicrobial Agents and Chemotherapy (Abstract #788) 229, 1983

10. Fleming D, et al. Haemophilus influenzae b (Hib) disease - secondary spread in day care. Twenty-fourth Interscience Conference on Antimicrobial Agents and Chemotherapy (Abstract #967) 261, 1984

11. C.C. Prevention of secondary cases of Haemophilus influenzae type b disease. MMWR 31: 672-680, 1982

12. Michaels RH, et al. Pharyngeal colonization with Haemophilus influenzae type b: A longitudinal study of families with a child with meningitis or epiglottitis due to H. influenzae type b. J Infec Dis 136: 222-227, 1977

13. Holmes SJ, et al. Immunogenicity of four Haemophilus influenzae type b conjugate vaccines in 17- to 19-month-old children. J Pediatr 118: 364-371, 1991

14. Data on file, Pasteur Mérieux Sérums & Vaccins S.A.

15. Peltola H, et al. Prevention of Haemophilus influenzae type b bacteremic infections with the capsular polysaccharide vaccine. N Engl J Med 310: 1561-1566, 1984

16. Decker MD, et al. Comparative trial in infants of four conjugate Haemophilus influenzae type b vaccines. J Pediatr 120: 184-189, 1992

17. Granoff DM, et al. Differences in the immunogenicity of three Haemophilus influenzae type b conjugate vaccines in infants. J Pediatr 121: 187-194, 1992

18. Data on file, Connaught Laboratories, Inc.

19. Kaplan SL, et al. Immunogenicity of Haemophilus influenzae type b polysaccharide-tetanus protein conjugate vaccine in children with sickle hemoglobinopathy or malignancies, and after systemic Haemophilus influenzae type b infection. J Pediatr 120: 367-370, 1992

20. Clemens JD, et al. Impact of Haemophilus influenzae Type b Polysaccharide-Tetanus Protein Conjugate Vaccine on responses to concurrently administered Diphtheria-Tetanus-Pertussis Vaccine. JAMA 267: 673-678, 1992

21. Steinhoff MC, et al. Antibody responses to Haemophilus influenzae type b vaccines in men with human immunodeficiency virus infection. N Engl J Med 325 (26): 1837-1842, 1991

22. ACIP. General recommendations on immunization. MMWR 38: 205-227, 1989

23. ACIP. Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures. MMWR 40: No. RR-10, 1991

24. FDA Workshop on Haemophilus b Polysaccharide Vaccine - A Preliminary Report. MMWR 36: 529-531, 1987

25. I.M. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Haemophilus influenzae Type b Vaccines. In: Stratton KR, Howe CJ, Johnston Jr. RB, eds. 1993. National Academy Press. Washington DC, pp. 236-273, 1993

26. Rothstein EP, et al. Comparison of antigenuria after immunization with three Haemophilus influenzae type b conjugate vaccines. Pediatr Infect Dis J 10: 311-314, 1991

27. Vaccine Adverse Event Reporting System - United States. MMWR 39: 730-733, 1990

28. C.C. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197-200, 1988

29. National Childhood Vaccine Injury Act of 1986 (Amended 1987)

30. Cody CL, et al. Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children. Pediatr 68: 650-660, 1981

31. Barkin RM, et al. Diphtheria-tetanus-pertussis vaccine: reactogenicity of commercial products. Pediatr 63: 256-260, 1979

32. Baraff LJ, et al. DTP-associated reactions: an analysis by injection site, manufacturer, prior reactions and dose. Pediatr 73: 31-39, 1984

33. Long SS, et al. Longitudinal study of adverse reactions following diphtheria-tetanus-pertussis vaccine in infancy. Pediatr 85: 294-302, 1990

34. D'Cruz OF, et al. Acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré Syndrome) after immunization with Haemophilus influenzae type b conjugate vaccine. J Pediatr 115: 743-746, 1989

35. 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

Product information as of September 2000

Manufactured by:
Aventis Pasteur SA
Lyon France
US Govt License #1279

Distributed by:
Aventis Pasteur Inc.
Swiftwater PA 18370 USA
1-800-VACCINE (1-800-822-2463)

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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