Neomycin, streptomycin, polymyxin B, 2-phenoxyethanol, and formaldehyde are used in the production of this vaccine. Although purification procedures eliminate measurable amounts of these substances, traces may be present (see DESCRIPTION section) and allergic reactions may occur in persons sensitive to these substances (see CONTRAINDICATIONS section).

Systemic adverse reactions reported in infants receiving IPV concomitantly at separate sites or combined with DTP have been similar to those associated with administration of DTP alone.¹¹ Local reactions are usually mild and transient in nature.

Although no causal relationship between IPOL vaccine and Guillain-Barré Syndrome (GBS) has been established,²⁸ GBS has been temporally related to administration of another inactivated poliovirus vaccine. Deaths have been reported in temporal association with the administration of IPV (see ADVERSE REACTIONS section).

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient´s history with respect to possible sensitivity to the vaccine or similar vaccines.

Health-care providers should question the patient, parent or guardian about reactions to a previous dose of this product, or similar product.

Epinephrine Injection (1:1000) and other appropriate agents should be available to control immediate allergic reactions. Health-care providers should obtain the previous immunization history of the vaccinee, and inquire about the current health status of the vaccinee.

Immunodeficient patients or patients under immunosuppressive therapy may not develop a protective immune response against paralytic poliomyelitis after administration of IPV.

Administration of IPOL vaccine is not contraindicated in individuals infected with HIV.^33,34,35

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

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.

PREGNANCY

REPRODUCTIVE STUDIES — PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with IPOL vaccine. It is also not known whether IPOL vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IPOL vaccine should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether IPOL vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when IPOL vaccine is administered to a nursing woman.

PEDIATRIC USE

SAFETY AND EFFECTIVENESS OF IPOL VACCINE IN INFANTS BELOW SIX WEEKS OF AGE HAVE NOT BEEN ESTABLISHED.^12,20 (See DOSAGE AND ADMINISTRATION section.)

In the US, infants receiving two doses of IPV at 2 and 4 months of age, the seroprevalence to all three types of poliovirus was demonstrated in 95% to 100% of these infants after two doses of vaccine.^12,13

REFERENCES

11. Unpublished data available from Aventis Pastuer SA

12. Unpublished data available from Aventis Pasteur Inc.

13. Faden H, et al. Comparative evaluation of immunization with live attenuated and enhanced potency inactivated trivalent poliovirus vaccines in childhood: Systemic and local immune responses. J Infect Dis 162: 1291-1297, 1990

20. Wehrle PF, et al. Transmission of poliovirus; III. Prevalence of polioviruses in pharyngeal secretions of infected household contacts ofpatients with clinical disease. Pediatrics 27: 762-764, 1961

28. ACIP. Poliomyelitis prevention in the United States: introduction ofa sequential vaccination schedule ofInactivated Poliovirus Vaccine followed by Oral Poliovirus Vaccine. MMWR 46: No. RR-3, 1997

33. ACIP. General recommendations on immunization. MMWR 43: No. RR-1, 1994

34. Barbi M, et al. Antibody response to inactivated polio vaccine (eIPV) in children born to HIV positive mothers. Eur J Epidemiol 8: 211-216, 1992

35. Varon D, et al. Response to hemophilic patients to poliovirus vaccination: Correlation with HIV serology and with immunological parameters. J Med Virol 40: 91-95, 1993

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