Leptoferm-5

Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

See product.data.aphis.usda.gov for summary of the studies approved by the USDA for licensing this product. The package insert also contains additional information developed by the licensee.

This product has been shown to be effective for the vaccination of healthy swine and cattle against disease caused by Leptospira canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, and L. pomona. Duration of immunity has not been established. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

SAFETY AND EFFICACY:

During developmental tests and in extensive field use of Leptoferm-5, no significant postvaccination reactions were reported.

Historic reports identified a method to induce clinical L. hardjo infection in cattle and identified 2 distinct genotypes of L. hardjo in cattle. Accordingly, challenge-of-immunity tests were conducted to determine the effect of Leptoferm-5 against both L. hardjo genotypes. Seventeen healthy heifers were divided into 2 groups of 6 vaccinates each and a group of 5 nonvaccinated controls. Vaccinates were administered the L. hardjo fraction of Leptoferm-5 in 1- or 2-dose regimens. Subsequently all cattle were challenged with disease-causing strains of both L. hardjo genotypes (Hardjo bovis and Hardjo prajitno). After challenge, leptospires were recovered from the urine of all controls, which continued shedding leptospires in the urine until necropsy at 31-49 days after challenge. Three out of 5 controls (60%) also experienced fever and developed leptospires in the blood. Conversely, leptospires were not recovered from the urine or kidneys of any vaccinates, and leptospires were recovered from the blood of only 1 out of 12 vaccinates (8%) for 1 day. Thus, the effect of the L. hardjo fraction against both genotypes Hardjo bovis and Hardjo prajitno in cattle was confirmed. These results are similar to results of previously conducted challenge-of-immunity tests on the other 4 fractions of Leptoferm-5 in cattle. In those studies, vaccinated animals remained healthy after challenge, while nonvaccinated animals developed clinical signs of leptospirosis.

Directions For Use

General Directions: Vaccination of healthy swine and cattle is recommended. Shake well. Aseptically administer 2 mL intramuscularly. In accordance with Beef Quality Assurance guidelines, this product should be administered in the muscular region of the neck.

Primary Vaccination: Administer a single 2-mL dose to healthy cattle. Healthy swine should receive 2 doses administered 3-6 weeks apart.

Revaccination: For advice on revaccination frequency, contact a veterinarian or the manufacturer.

Good animal husbandry and herd health management practices should be employed.

Precautions

Store at 2°-8°C. Prolonged exposure to higher temperatures and/or direct sunlight may adversely affect potency. Do not freeze.

Use entire contents when first opened.

Do not vaccinate within 21 days before slaughter.

Contains thimerosal as a preservative.

This product has not been tested in pregnant animals.

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

Do not mix with other products.

In case of human exposure, contact a physician.

Technical inquiries should be directed to Zoetis Inc. Technical Services, (888) 963-8471.

This product has been shown to be efficacious in healthy animals. A protective immune response may not be elicited if animals are incubating an infectious disease, are malnourished or parasitized, are stressed due to shipment or environmental conditions, are otherwise immunocompromised, or the vaccine is not administered in accordance with label directions.

For veterinary use only

VLN 190/PCN 2665.01

Zoetis Inc.

Kalamazoo, MI 49007, USA

40038300

Presentation: 10 dose and 50 dose vials.

CPN: 3690057.3