Recommended Topic Related To:

Prohibit

"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no"...

Prohibit

Indications
Dosage
How Supplied

INDICATIONS

ProHIBiT (haemophilus b conjugate vaccine) ® is indicated for immunization against invasive diseases caused by Haemophilus influenzaetype b.25,26 ProHIBiT (haemophilus b conjugate vaccine) ® may be administered as a booster vaccination at 12 to 15 months of age in children who received primary immunization with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) or Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate) as illustrated in Tables 2, 3, 4 and 5. This vaccine also may be administered as primary immunization at 15 months of age in children who have not received primary immunization with any licensed Haemophilus b Conjugate Vaccine.

TABLE 215: ProHIBiT (haemophilus b conjugate vaccine) ® Booster Induced Anti-PRP Antibody Responses in 12-Month-Old Children Primed with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)

  Geometric Mean Titers (GMT) % of Infants Anti-PRP Antibody Titer ≥ 0.15 g/mL % of Infants Anti-PRP Antibody Titer ≥ 1.00 g/mL
Pre-immunization N=24 0.322 71% 17%
Post-immunization N=24 21.277* 100% 96%**

TABLE 315: ProHIBiT (haemophilus b conjugate vaccine) ® Booster Induced Anti-PRP Antibody Responses in 15-Month-Old Children Primed with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)

  Geometric Mean Titers (GMT) % of Infants Anti-PRP Antibody Titer ≥ 0.15 g/mL % of Infants Anti-PRP Antibody Titer ≥ 1.00 g/mL
Pre-immunization N=29 0.526 86% 28%
Post-immunization N=29 31.314* 100% 100%**
* Comparison of the booster immunogenicity data at 12 and 15 months showed equivalent antibody titers (p = 0.3115), analysis of variance.
**Comparison of the percentages of 12- and 15-month-old infants who responded with a PRP antibody response ≥ 1.00 g/mL showed no significant difference (p = 0.267), Chi-square test.

TABLE 415: ProHIBiT (haemophilus b conjugate vaccine) ® Booster Induced Anti-PRP Antibody Responses in 12-Month-Old Children Primed with Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate)

  Geometric Mean Titers (GMT) % of Infants Anti-PRP Antibody Titer ≥ 0.15 g/mL % of Infants Anti-PRP Antibody Titer ≥ 1.00 g/mL
Pre-immunization N=29 0.911 93% 34%
Post-immunization N=29 26.062* 100% 97%**

TABLE 515: ProHIBiT (haemophilus b conjugate vaccine) ® Booster Induced Anti-PRP Antibody Responses in 15-Month-Old Children Primed with Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate)

  Geometric Mean Titers (GMT) % of Infants Anti-PRP Antibody Titer ≥ 0.15 g/mL % of Infants Anti-PRP Antibody Titer ≥ 1.00 g/mL
Pre-immunization N=32 0.675 86% 40.6%
Post-immunization N=32 44.156* 100% 100%**
* Comparison of the booster immunogenicity data at 12 and 15 months showed equivalent antibody titers (p = 0.1104), analysis of variance.
** Comparison of the percentages of 12 and 15-month-old infants who responded with a PRP antibody response ≥ 1.00 g/mL showed no significant difference (p = 0.290), Chi-square test.

Children With Symptomatic Human Immunodeficiency Virus (Hiv) Infection

Immunization with Haemophilus b Conjugate Vaccine is recommended by the American Academy of Pediatrics (Red Book) and Immunization Practices Advisory Committee (ACIP) for children who are immunosuppressed in association with AIDS or any other immunodeficiency disease.26,27

ProHIBiT (haemophilus b conjugate vaccine) ® will not protect against Haemophilus influenzae other than type b or other microorganisms that cause meningitis or septic disease.

No impairment of the immune response to the individual antigens was demonstrated when ProHIBiT (haemophilus b conjugate vaccine) ® and Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP) were given at the same time in separate syringes at different sites.15,28

Limited data are available on concomitant administration of ProHIBiT (haemophilus b conjugate vaccine) ® with MMR, and OPV (IPV). Fourteen-month-old Finnish children boosted with PRP-D received MMR concomitantly. Pre and 4 weeks post sera from a small subset (11 patients), showed no significant difference in antibody response to Measles, Mumps, or Rubella antigens when compared to a group that received MMR alone. A group of 25 Finnish infants received concomitant DTP, PRP-D, and IPV was compared to a group of 25 receiving DTP and IPV only. No significant difference in response to Type 1, Type 2, or Type 3 polio antigens was noted. Response to oral Polio Vaccine was evaluated in 31 infants immunized with PRP-D who also received OPV concomitantly. No difference in response to Type 1, Type 2, or Type 3 antigens was observed when compared to 22 infants receiving placebo and OPV.15,29

ProHIBiT (haemophilus b conjugate vaccine) ® IS NOT RECOMMENDED FOR USE IN CHILDREN YOUNGER THAN 12 MONTHS OF AGE.

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration whenever solution and container permit. If these conditions exist, the vaccine should not be administered.

The immunizing dose is a single injection of 0.5 mL given intramuscularly in the outer aspect area of the vastus lateralis (mid-thigh) or deltoid.

Each 0.5 mL dose contains 25 g of purified capsular polysaccharide and 18 g of conjugated diphtheria toxoid protein.

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.

A booster dose of ProHIBiT (haemophilus b conjugate vaccine) ® should be administered to children 12 to 15 months of age previously immunized with any licensed Hib conjugate vaccine. A single dose of ProHIBiT (haemophilus b conjugate vaccine) ® should be administered to children 15 months of age and older, not previously immunized with a Hib conjugate vaccine.

HOW SUPPLIED

Vial, 1 Dose (5 per package) – Product No. 49281-541-01

Vial, 5 Dose – Product No. 49281-541-05

Vial, 10 Dose – Product No. 49281-541-10

Storage

Store between 2° – 8°C (35° – 46°F). DO NOT FREEZE.

REFERENCES

15. Unpublished data available from Connaught Laboratories, Inc.

20. Lepow ML, et al. Safety and immunogenicity of Haemophilus influenzae type b-polysaccharide diphtheria toxoid conjugate vaccine in infants 9 to 15 months of age. J Pediatr 106:185-189,1985

25. ACIP - Update. Prevention of Haemophilus influenzae type b disease. MMWR 37:13-16,1988

26. Report of the Committee on Infectious Diseases, ed 22. Elk Grove Village, IL, American Academy of Pediatrics, 1991

27. ACIP Immunization of children infected with human immunodeficiency virus - Supplementary ACIP statement. MMWR 37: 181-183, 1988

28. Hendley JO, et al. Immunogenicity of Haemophilus influenzae type b capsular polysaccharide vaccines in 18-month-old infants. Pediatr 80: 351-354,1987

29. Eskola J, et al. Simultaneous administration of Haemophilus influenzae type b capsular polysaccharide-diphtheria toxoid conjugate vaccine with routine diphtheria-tetanus-pertussis and inactivated poliovirus vaccinations of childhood. Pediatr Infect Dis J 7: 480- 484,1988

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

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

34. Berkowitz CD, et al. Safety and immunogenicity of Haemophilus influenzae type b polysaccharide and polysaccharide diphtheria toxoid conjugate vaccines in children 15 to 24 months of age. J Pediatr 110:509-514,1987

35. Eskola J, et al. Efficacy of Haemophilus influenzae type b polysaccharide diphtheria toxoid conjugate vaccine in infancy. N Engl J Med 317: 717-722,1987

36. 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

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

Manufactured by: Connaught Laboratories, Inc. Swiftwater, Pennsylvania 18370, USA. Product Information as of July 1992.

Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.