Allergic reactions have been reported rarely in the post-marketing experience (see ADVERSE REACTIONS section).

The safety and immunogenicity of Typhim Vi vaccine in children under two years of age has not been established. As with other polysaccharide vaccines, the antibody response may be inadequate. The decision whether to vaccinate children under 2 years of age depends upon the risk incurred by the child on the basis of the epidemiological context.

Typhim Vi vaccine provides protection against the risk of infection related to Salmonella typhi, but gives no protection against Salmonella paratyphi A or B.

If the vaccine is used in persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy, the expected immune response may not be obtained. This includes patients with asymptomatic or symptomatic HIV-infection, severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation.¹⁶

As with any intramuscular injection, Typhim Vi vaccine should be given with caution to individuals with thrombocytopenia or

any coagulation disorder that would contraindicate intramuscular injection (see DRUG INTERACTIONS section).

As with any vaccine, vaccination with Typhim Vi vaccine may not protect 100% of individuals.

General

Care is to be taken by the health-care provider for the safe and effective use of Typhim Vi vaccine.

EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE FOLLOWING IMMUNIZATION SHOULD AN ANAPHYLACTIC OR OTHER ALLERGIC REACTIONS OCCUR DUE TO ANY COMPONENT OF THE VACCINE.

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 hypersensitivity to the vaccine or similar vaccines.

Acute infection or febrile illness may be reason for delaying use of Typhim Vi vaccine except when in the opinion of the physician, withholding the vaccine entails a greater risk.

A separate, sterile syringe and needle or a sterile disposable unit must be used for each patient to prevent the transmission of infectious agents from person to person. Needles should not be recapped and should be properly disposed.

Special care should be taken to ensure that Typhim Vi vaccine is not injected into a blood vessel.

Safety and immunogenicity data from controlled trials are not available for Typhim Vi vaccine following previous immunization with whole-cell typhoid or live, oral typhoid vaccine (see ADVERSE REACTIONS section).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Typhim Vi vaccine has not been evaluated for its carcinogenic potential, mutagenic potential or impairment of fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Typhim Vi vaccine. It is not known whether Typhim Vi vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Typhim Vi vaccine should be given to a pregnant woman only if clearly needed.¹⁴

When possible, delaying vaccination until the second or third trimester to minimize the possibility of teratogenicity is a reasonable precaution.¹⁸

Nursing Mothers

It is not known if Typhim Vi vaccine is excreted in human milk.

There is no data to warrant the use of this product in nursing mothers for passive antibody transfer to an infant.

Pediatric Use

Safety and effectiveness of Typhim Vi vaccine have been established in children 2 years of age and older.^10,11 (See DOSAGE AND ADMINISTRATION section.) FOR CHILDREN BELOW THE AGE OF 2 YEARS, SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED.

REFERENCES

10. Unpublished data available from Sanofi Pasteur Inc., compiled 1991

11. Unpublished data available from Sanofi Pasteur SA

14. Recommendations of the Immunization Practices Advisory Committee (ACIP). Typhoid Immunization. MMWR 43: No. RR-14, 1994

16. ACIP: Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR 42: No. RR-4, 1993

18. ACIP: Update on Adult Immunization. MMWR 40: No. RR-12, 1991 Product Information as of December 2005 Manufactured by: Distributed by:

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