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Rabavert

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Rabavert

WARNINGS

Serious systemic anaphylactic reactions have been reported and neuroparalytic events have been reported in temporal association with RabAvert (rabies vaccine) , rabies vaccine, administration. Against the background of 11.8 million doses distributed worldwide as of June 30, 1995, 10 cases of encephalitis (1 death) or meningitis, 7 cases of transient paralysis (including 2 cases of Guillain-Barré Syndrome), 1 case of myelitis, 1 case of retrobulbar neuritis, and 2 cases of suspected multiple sclerosis have been temporally associated with the use of RabAvert (rabies vaccine) . Also 2 cases of anaphylactic shock have been reported. Such events pose a dilemma for the attending physician. A patient's risk of developing rabies must be carefully considered, however, before deciding to discontinue immunization.

Rabavert (rabies vaccine) must not be used subcutaneously or intradermally!

RabAvert (rabies vaccine) must be injected intramuscularly. For adults, the deltoid area is the preferred site of immunization; for small children, administration into the anterolateral zone of the thigh is preferred. The use of the gluteal region should be avoided, since administration in this area may result in lower neutralizing antibody titers (2).

Do not inject intravascularly!

Unintentional intravascular injection may result in systemic reactions, including shock. Immediate measures include catecholamines, volume replacement, high doses of corticosteroids, and oxygen.

Development of active immunity after vaccination may be impaired in immune-compromised individuals. Please refer to DRUG INTERACTIONS, under PRECAUTIONS.

PRECAUTIONS

General

Care is to be taken by the health care provider for the safe and effective use of the product. The health care provider should also question the patient, parent or guardian about 1) the current health status of the vaccinee; and 2) reactions to a previous dose of RabAvert (rabies vaccine) , or a similar product. Preexposure vaccination should be postponed in the case of sick and convalescent persons, and those considered to be in the incubation stage of an infectious disease. A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis and other infectious agents from person to person. Needles should not be recapped and should be properly disposed of. As with any vaccine, vaccination with RabAvert (rabies vaccine) may not protect 100% of susceptible individuals.

Hypersensitivity

RabAvert (rabies vaccine) is produced in chick embryo cell culture. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion should not be immunized with this vaccine. At present there is no evidence that persons are at increased risk if they have egg hypersensitivities that are not anaphylactic or anaphylactoid in nature; however, in this case, HDCV rabies vaccines or RVA should be administered. There is no evidence to indicate that persons with allergies to chickens or feathers are at increased risk of reaction to vaccines produced in chick embryo cell culture.

Since reconstituted RabAvert (rabies vaccine) contains traces of processed bovine gelatin, chicken protein, neomycin, chlortetracycline and amphotericin B, the possibility of allergic reactions in individuals sensitive to these substances should be considered when administering the vaccine.

Epinephrine injection (1:1000) must be immediately available should anaphylactic or other allergic reactions occur.

When a person with a history of hypersensitivity must be given RabAvert (rabies vaccine) , antihistamines may be given; epinephrine (1:1000), volume replacement, corticosteroids and oxygen should be readily available to counteract anaphylactic reactions.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies with RabAvert (rabies vaccine) have not been conducted to assess the potential for carcinogenesis, mutagenesis, or impairment of fertility.

REFERENCES

2. Eighth Report of the WHO Expert Committee on Rabies. WHO Technical Report Series, no. 824; 1992.

Last reviewed on RxList: 2/23/2009
This monograph has been modified to include the generic and brand name in many instances.

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