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Imovax

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Imovax

Imovax

WARNINGS

Rabies Vaccine in this package is a unit dose to be delivered intramuscularly in the deltoid area.8

This vaccine must not be used intradermally or as a multiple dose dispensing unit. In both pre-exposure and postexposure immunization, the full 1.0 mL dose should be given intramuscularly.

In the case of pre-exposure immunization, recently a significant increase has been noted in “immune complex-like” reactions in persons receiving booster doses of HDCV.16 The illness characterized by onset 2-21 days post-booster, presents with a generalized urticaria and may also include arthralgia, arthritis, angioedema, nausea, vomiting, fever, and malaise. In no cases were the illnesses life-threatening. Preliminary data suggest this “immune complex-like” illness may occur in up to 6% of persons receiving booster vaccines and much less frequently in persons receiving primary immunization. Additional experience with this vaccine is needed to define more clearly the risk of these adverse reactions.8, 17

Two cases of neurologic illness resembling Guillain-Barré syndrome18, 19 a transient neuroparalytic illness, that resolved without sequelae in 12 weeks and a focal subacute central nervous system disorder temporally associated with HDCV, have been reported.20

All serious systemic neuroparalytic or anaphylactic reactions to a rabies vaccine should be immediately reported to the state health department or Sanofi Pasteur Inc., 1-800-VACCINE (1-800-822-2463).8

PRECAUTIONS

IN ADULTS AND CHILDREN THE VACCINE SHOULD BE INJECTED INTO THE DELTOID MUSCLE. IN INFANTS AND SMALL CHILDREN THE MID-LATERAL ASPECT OF THE THIGH MAY BE PREFERABLE.

General

When a person with a history of hypersensitivity must be given rabies vaccine, antihistamines may be given; epinephrine (1:1000) should be readily available to counteract anaphylactic reactions, and the person should be carefully observed after immunization.

While the concentration of antibiotics in each dose of vaccine is extremely small, persons with known hypersensitivity to any of these agents could manifest an allergic reaction. While the risk is small, it should be weighed in light of the potential risk of contracting rabies.

Usage in pregnancy

Pregnancy Category C

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

Because of the potential consequences of inadequately treated rabies exposure and limited data that indicate that fetal abnormalities have not been associated with rabies vaccination, pregnancy is not considered a contraindication to postexposure prophylaxis.8,21 If there is substantial risk of exposure to rabies, pre-exposure prophylaxis may also be indicated during pregnancy.8

Pediatric use

Both safety and efficacy in children have been established.

REFERENCES

8. CDC. Recommendations of the Immunization Practices Advisory Committee (ACIP). Rabies Prevention—United States, 1984, MMWR 33: 393-402, 407-8 (1984).

16. CDC. Systemic allergic reactions following immunization with human diploid cell rabies vaccine. MMWR 33:185-7 (1984).

17. Rubin RH, Hattwick MAW, Jones S, Gregg MB, Schwartz VD. Adverse reactions to duck embryo rabies vaccine. Ann Intern Med 78: 643-9 (1973).

18. Boe E, Nyland H. Guillain-Barré syndrome after vaccination with human diploid cell rabies vaccine. Scand J Infect Dis 12: 231-2 (1980).

19. CDC. Adverse reactions to human diploid cell rabies vaccine. MMWR 29: 609-10 (1980).

20. Bernard KW, Smith PW, Kader FJ, Moran MJ. Neuroparalytic illness and human diploid cell rabies vaccine. JAMA 248: 3136-8 (1982).

21. Varner MW, McGuinness GA, Galask RP. Rabies vaccination in pregnancy. Am J of Obst and Gyn 143: 717-18 (1982).

Last reviewed on RxList: 11/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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