Rabdomun 1 Vaccine

Manufacturer: Intervet/Schering-Plough Animal Health

Rabies Vaccine, Killed Virus

U.s. Vet. Lic. No.

189

Active Ingredient(s)

The vaccine is prepared form cell-culture grown, chemically-inactivated rabies virus.

The seed virus is a highly immunogenic, fixed strain of rabies virus which originated from Louis Pasteur's original isolate in 1882.

The inactivated virus is formulated with a highly purified adjuvant and is packaged in liquid form.

The vaccine contains gentamicin as a preservative.

Rabdomun 1 Vaccine Indications

RABDOMUN^® 1 is used for the vaccination of healthy dogs and cats as an aid in the prevention of rabies.

Rabdomun 1 Vaccine Dosage And Administration

1. General Directions: Shake well. Aseptically administer 1 mL subcutaneously. Dogs may be vaccinated intramuscularly or subcutaneously.

2. Primary Vaccination: Healthy dogs and cats should receive a single dose at three (3) months of age or older. A repeat dose should be administered one (1) year later.

3. Revaccination: Annual revaccination with a single dose is recommended.

Precaution(s)

Store at 2°-7°C. Prolonged exposure to higher temperatures may adversely affect potency. Do not freeze.

Rabdomun 1 Vaccine Caution(s)

1. Use the entire contents when first opened.

2. As with any vaccine, anaphylactic reactions may occur after use. An initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.

3. The product has been tested under laboratory conditions and shown to meet all federal standards for safety and ability to immunize normal healthy animals. The level of performance may be affected by conditions of use such as stress, weather, nutrition, disease, parasitism, other treatments, individual idiosyncrasies or impaired immunological competency. These factors should be considered by the user when evaluating product performance or freedom from reaction.

4. Restricted to use by or under the direction of a licensed veterinarian.

Discussion

Rabies is a worldwide, high mortality disease affecting mammalian species. Wild animals are common vectors of the disease and the major source of transmission to humans and domestic animals. Despite successful attempts to reduce the incidence of rabies, recent published reports indicate that in the U.S. more than 30,000 people undergo treatment every year for possible exposure.¹ Domestic animals are the major source of exposure for humans. Since 1980, the most commonly reported of rabies in domestic animals have been cats, cattle and dogs.

In 1980, a total of 4,881 cases of animal rabies were reported to the Center for Disease Control by all 50 states, the District of Columbia and Puerto Rico.² Susceptibility to rabies varies according to pet species. Rabies is not a treatable disease and suspect pets are usually quarantined until a clinical diagnosis is made, at which time they are destroyed.

The route of infection can be oral, respiratory, or parenteral. Following injection, a paralytic syndrome ensues, emerging as either the “furious” or “dumb” form. “Furious rabies” is characterized by unusual aggression, “dumb rabies” by lethargy and a desire to avoid contact. Respiratory failure is the immediate cause of death.

Trial Data

Because RABDOMUN^® 1 is produced on an established cell line, it has safety advantages over inactivated brain-origin rabies vaccines. Tissue-origin vaccines contain extraneous protein in addition to rabies antigen that can lead to autoimmune disease.

The established cell line used in RABDOMUN^® 1 has been extensively tested for freedom from contaminating agents. In addition, use of an established cell line yields a vaccine of consistent potency from serial to serial. RABDOMUN^® 1 has proven to be uniformly safe in experimental tests, and significant adverse reactions were not reported in extensive clinical trials of the vaccine.

A duration of immunity study, conducted in accordance with federal regulation and under U.S. Department of Agriculture direction, demonstrated that a 1 mL dose met federal guidelines for protection of dogs and cats against virulent challenge administered more than a year after vaccination.

References

Available upon request.

Presentation

5 x 10 dose (10 mL) vials/box.

Nac No.

10471661