Nobivac 3-Rabies CA

Company: Intervet/Merck Animal Health

RABIES VACCINE

Killed Virus

IN THE ABSENCE OF A VETERINARIAN-CLIENT-PATIENT RELATIONSHIP, FEDERAL REGULATIONS PROHIBIT THE RELABELING, REPACKAGING, RESALE, OR REDISTRIBUTION OF THE INDIVIDUAL CONTENTS OF THIS PACKAGE.

DIRECTIONS FOR USE - PLEASE READ CAREFULLY

FOR ANIMAL USE ONLY

APPROVED FOR SALE IN CALIFORNIA.

This product has been shown to be effective for the vaccination of healthy dogs, cats, cattle and sheep 12 weeks of age or older against rabies. Duration of immunity of at least 1 year has been demonstrated in cattle and sheep, and at least 3 years in dogs and cats after repeat dose. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

Product Description

Nobivac^® 3-Rabies is prepared from 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.

Disease Description

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. Domestic animals are the major source of exposure for humans. Since 1980, the most commonly reported rabid domestic animals have been cats, cattle and dogs. During 2018, a total of 4,951 cases of animal rabies were reported to the Center for Disease Control by 54 jurisdictions.¹ 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 infection, 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.

Safety And Efficacy

Because Nobivac 3-Rabies vaccine 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 Nobivac 3-Rabies 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. Nobivac 3-Rabies has proven to be uniformly safe in experimental tests and no significant adverse reactions were reported in extensive clinical trials of the vaccine.

Duration of immunity studies, 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 3 years after vaccination. Cattle and sheep were likewise protected one year after receiving a 2 mL dose of Nobivac 3-Rabies.

PRECAUTIONS

1. Store at 2°-8°C (35°-46°F). Prolonged exposure to higher temperatures may adversely affect potency. Do not freeze.

2. Use entire contents when first opened. (10 mL)

3. Do not mix with other products.

4. In case of human exposure, contact a physician.

5. This product has not been tested in pregnant animals.

6. Sterilized syringes and needles should be used to administer this vaccine.

7. Do not vaccinate within 21 days before slaughter. (10 mL)

8. Contains gentamicin and thimerosal as preservatives.

9. As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.

10. This product has been tested under laboratory conditions and shown to meet all Federal Standards for safety and ability to immunize normal healthy animals. This 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 reactions.

Directions:

Following the advice of the American Veterinary Medical Association on Vaccination Principles, an appropriate revaccination program for individual animals should be made based upon veterinarian-client-patient relationships.

Dogs and Cats:

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

2. Primary Vaccination: Administer a single 1 mL dose at 12 weeks of age or older to healthy dogs and cats. A repeat dose should be administered 1 year later.

3. Revaccination: Subsequent revaccination every 3 years with a single dose is recommended.

Cattle and Sheep:

1. General Directions: Shake well. Aseptically administer 2 mL intramuscularly.

2. Primary Vaccination: Administer a single 2 mL dose at 12 weeks of age or older to healthy cattle and sheep. A repeat dose should be administered 1 year later.

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

REFERENCES

1. Ma X., Monroe B.P., Cleaton J.M., et al: Rabies surveillance in the United States during 2018. JAVMA 256: 195-208, 2020.

FOR ANIMAL USE ONLY

To report suspected adverse events, contact Merck Animal Health at 1-800-224-5318.

Manufactured by:

Zoetis Inc., Kalamazoo, MI 49007, USA

VLN 190/PCN 1905.24

1 888 963-8471 (USA)

Distributed by:

Intervet Inc., Omaha, NE 68103 USA

VLN 165A

1 800 224-5318 (USA)

CPN: 1047491.3