ER Bac/L5 GOLD

Erysipelothrix Rhusiopathiae-Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

For use in swine only

PRODUCT DESCRIPTION: ER Bac/L5 GOLD is for vaccination of healthy breeding swine as an aid in preventing erysipelas caused by Erysipelothrix rhusiopathiae and leptospirosis caused by Leptospira canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae and L. pomona. An 18-week duration of immunity following vaccination has been demonstrated against erysipelas. ER Bac/L5 GOLD is a liquid preparation of a serum-free, clarified E. rhusiopathiae culture, and whole cell cultures of the 5 Leptospira serovars identified above. The antigens have been chemically inactivated and adjuvanted with 2 adjuvants, including Amphigen^®, to enhance the immune response.

DISEASE DESCRIPTION: Leptospira are common agents of reproductive loss in swine. Infection by Leptospira during the second half of pregnancy may cause abortions and stillbirths; late-term abortions are the most important economic effect of leptospirosis. Leptospirosis caused by any of the serovars represented here cannot be clinically differentiated. Abortions may also occur in sows infected with E. rhusiopathiae during pregnancy.

SAFETY AND EFFICACY: The safety of ER Bac/L5 GOLD was demonstrated under field conditions in approximately 1,340 sows and gilts receiving single or multiple doses. No serious systemic or allergic reactions were observed following vaccination.

Efficacy of the fractions of ER Bac/L5 GOLD was demonstrated in controlled challenge-of-immunity and immunogenicity tests. Additionally, duration-of-immunity studies demonstrated that ER Bac/L5 GOLD protected pigs against E. rhusiopathiae challenge 18 weeks after the second vaccination.

Directions For Use

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

Primary Vaccination: Healthy swine should receive 2 doses 3-5 weeks apart with the second dose administered 2-4 weeks prior to breeding. Healthy gilts, however, should receive the second dose as near as possible to 14 days prior to breeding.

Revaccination: Revaccination with a single dose is recommended prior to subsequent breedings. Boars should be revaccinated semiannually.

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

Precautions

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

Use entire contents when first opened.

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

Do not vaccinate within 21 days before slaughter.

Transient injection site swelling and/or inappetance may occur following vaccination.

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

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.

Technical inquiries should be directed to Zoetis Inc. Veterinary Services, (888) 963-8471 (USA), (800) 461-0917 (Canada).

For veterinary use only

U.S. Veterinary License No. 190

Zoetis Inc., Kalamazoo, MI 49007, USA

CPN: 3690242.3