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PedvaxHIB

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Pedvax HIB

Warnings
Precautions

WARNINGS

No information provided.

PRECAUTIONS

General

As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactoid reaction occur.

Special care should be taken to ensure that the injection does not enter a blood vessel.

It is important to use a separate sterile syringe and needle for each patient to prevent transmission of hepatitis B or other infectious agents from one person to another.

As with other vaccines, Liquid PedvaxHIB may not induce protective antibody levels immediately following vaccination.

As reported with Haemophilus b Polysaccharide Vaccine36 and another Haemophilus b Conjugate Vaccine37, cases of Hib disease may occur in the week after vaccination, prior to the onset of the protective effects of the vaccines.

There is insufficient evidence that Liquid PedvaxHIB given immediately after exposure to natural Haemophilus influenzae type b will prevent illness.

The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices (ACIP) has recommended that vaccination should be delayed during the course of an acute febrile illness. All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.46

If PedvaxHIB is used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.

Instructions to Healthcare Provider

The healthcare provider should determine the current health status and previous vaccination history of the vaccinee.

The healthcare provider should question the patient, parent, or guardian about reactions to a previous dose of PedvaxHIB or other Haemophilus b Conjugate Vaccines.

Laboratory Test Interactions

Sensitive tests (e.g., Latex Agglutination Kits) may detect PRP derived from the vaccine in urine of some vaccinees for at least 30 days following vaccination with lyophilized PedvaxHIB;38 in clinical studies with lyophilized PedvaxHIB, such children demonstrated normal immune response to the vaccine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Liquid PedvaxHIB has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with PedvaxHIB. Liquid PedvaxHIB is not recommended for use in individuals 6 years of age and older.

Pediatric Use

Safety and effectiveness in infants below the age of 2 months and in children 6 years of age and older have not been established. In addition, Liquid PedvaxHIB should not be used in infants younger than 6 weeks of age because this will lead to a reduced anti-PRP response and may lead to immune tolerance (impaired ability to respond to subsequent exposure to the PRP antigen).49-51 Liquid PedvaxHIB is not recommended for use in individuals 6 years of age and older because they are generally not at risk of Hib disease.

Geriatric Use

This vaccine is NOT recommended for use in adult populations.

REFERENCES

36. Mortimer, E. A.: Efficacy of Haemophilus b polysaccharide vaccine: An enigma. JAMA 260: 1454, 1988.

37. Meekison, W., et al: Post-marketing surveillance of adverse effects following ProHIBiT vaccine. British Columbia Canada Diseases Weekly Report 15-28: 143-145, 1989.

38. Goepp, J. G., et al: Persistent urinary antigen excretion in infants vaccinated with Haemophilus influenzae type b capsular polysaccharide conjugated with outer membrane protein from Neisseria meningitidis. Pediatr Infect Dis J 11(1): 2-5, 1992.

46. Recommendations of the Immunization Practices Advisory Committee. General Recommendations on Immunization. MMWR 43(RR-1), 1994.

47. Vaccine Adverse Event Reporting System - United States. MMWR 39(41): 730-733, October 19, 1990.

48. Institute of Medicine Adverse Events Associated With Childhood Vaccines Evidence Bearing on Causality. National Academy Press, Washington, D.C., 260-261, 1994.

49. Keyserling, H.L., et al: Program and Abstracts of the 30th ICAAC, (Abstract #63), 1990.

50. Ward, J.I., et al: Program and Abstracts of the 32nd ICAAC, (Abstract #984), 1992.

51. Lieberman, J.M., et al: Infect Dis, (Abstract #1028), 1993.

Last reviewed on RxList: 12/19/2007
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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