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Imovax

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Imovax

Warnings
Precautions

WARNINGS

  • Do not inject the vaccine into the gluteal area as administration in this area may result in lower neutralizing antibody titers.11
  • The product is provided in a single dose vial. Because the single dose vial contains no preservative, it is not to be used as a multidose vial for intradermal injection.
  • In both pre-exposure and post-exposure immunization, the full 1.0 mL dose should be given intramuscularly.
  • Serum sickness type reactions have been reported in persons receiving booster doses of rabies vaccine for pre-exposure prophylaxis. The reaction is characterized by onset approximately 2 to 21 days post-booster, presents with a generalized urticaria, and may also include arthralgia, arthritis, angioedema, nausea, vomiting, fever, and malaise. None of the reported reactions were life-threatening. This has been reported in up to 7% of persons receiving booster vaccination.13
  • Rare cases of neurologic illness resembling Guillain-Barre syndrome,14,15 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.16
  • This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

All serious systemic neuroparalytic or anaphylactic reactions to a rabies vaccine should be immediately reported to VAERS at 1-800-822-7967 (http://vaers.hhs.gov) or Sanofi Pasteur Inc., 1-800-VACCINE (1-800-822-2463).

PRECAUTIONS

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

When a person with a history of hypersensitivity must be given rabies vaccine, antihistamines may be given. Epinephrine (1:1000) and other appropriate agents 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, or any other component of the vaccine, 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

Pre-exposure

Pregnancy Category C. Animal reproduction studies have not been conducted with Imovax Rabies vaccine. It is also not known whether Imovax Rabies vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Imovax Rabies vaccine should be given to a pregnant woman only if potential benefits outweigh potential risks. If there is substantial risk of exposure to rabies, pre-exposure prophylaxis may also be indicated during pregnancy.11

Post-exposure

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 post-exposure prophylaxis.11,17

Usage In Nursing Mothers

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

Pediatric Use

Both safety and efficacy in children have been established.

REFERENCES

11 Manning SE, Rupprecht CE, Fishbein D, Hanlon CA, Lumlertdacha B, Guerra M, et al. Human rabies prevention - United States 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR. 2008 May 23;57(RR-3):1-28.

13 CDC. Systemic allergic reactions following immunization with human diploid cell rabies vaccine. MMWR. 1984 Apr 13;33(14):185-7.

14 Boe E, Nyland H. Guillain-Barre syndrome after vaccination with human diploid cell rabies vaccine. Scand J Infect Dis. 1980;12(3):231-2.

15 CDC. Adverse reactions to human diploid cell rabies vaccine. MMWR. 1980;29:609-10.

16 Bernard KW, Smith PW, Kader FJ, Moran MJ. Neuroparalytic illness and human diploid cell rabies vaccine. JAMA. 1982 Dec 17;248(23):3136-8.

11 Manning SE, Rupprecht CE, Fishbein D, Hanlon CA, Lumlertdacha B, Guerra M, et al. Human rabies prevention - United States 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR. 2008 May 23;57(RR-3):1-28.

17 Varner MW, McGuinness GA, Galask RP. Rabies vaccination in pregnancy. Am J of Obstet Gynecol. 1982 Jul 15;143(6):717-8.

Last reviewed on RxList: 9/19/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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