July 31, 2016
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Typhim

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Typhim




Warnings
Precautions

WARNINGS

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, non-S typhi species of Salmonella enterica serovar Typhi, or other bacteria that cause enteric disease.

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

PRECAUTIONS

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.

Syncope (fainting) has been reported following vaccination with Typhim Vi. Procedures should be in place to prevent falling injury and manage syncopal reactions.

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.

Do not administer intravenously.

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).

Information For Vaccine Recipients Or Parents/Guardians

Before administration, healthcare providers should inform patients, parents or guardians of the benefits and risks of immunization with Typhim Vi vaccine.

Prior to administration of Typhim Vi vaccine, healthcare providers should ask patients, parents and guardians about the recent health status of the patient to be immunized.

Typhim Vi vaccine is indicated in persons traveling to endemic or epidemic areas. Current CDC advisories should be consulted with regard to specific locales.

Travelers should take all necessary precautions to avoid contact with or ingestion of contaminated food and water.

One dose of vaccine should be given at least 2 weeks prior to expected exposure.

Reimmunization consisting of a single-dose for US travelers every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time.14

As part of the child's or adult's immunization record, the date, lot number, and manufacturer of the vaccine administered should be recorded.17

Carcinogenesis, Mutagenesis, Impariment 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 whether Typhim Vi vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Typhim Vi vaccine is administered to a nursing woman.

There is no data on the use of this product in nursing mothers.

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

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

18 ACIP: Update on Adult Immunization. MMWR 40: No. RR-12, 1991 Product Information as of March 2014.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/1/2015

Warnings
Precautions

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.


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