StayBred VL5

ZOETIS INC.
333 PORTAGE STREET, KALAMAZOO, MI, 49007
Telephone: 269-359-4414
Customer Service: 888-963-8471
Website: www.zoetis.com
THIS SERVICE AND DATA ARE PROVIDED "AS IS". DVMetrics assumes no liability, and each user assumes full risk, responsibility, and liability, related to its use of the DVMetrics service and data. See the Terms of Use for further details.
STAYBRED™ VL5

Zoetis

Campylobacter Fetus-Leptospira Canicola-Grippotyphosa-Hardjo- Icterhaemorrhagiae-Pomona Bacterin

U.S. Vet. Lic. No.: 190

Description: STAYBRED VL5™ is a chemically inactivated, oil-adjuvanted suspension of Campylobacter fetus combined with chemically inactivated Leptospira cultures of Leptospira canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, and L. pomona.

Indications: STAYBRED VL5™ is for vaccination of healthy cows and heifers as an aid in preventing campylobacteriosis (vibriosis) caused by Campylobacter fetus; and leptospirosis caused by Leptospira canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, and L. pomona.

Directions:

1. General Directions: Vaccination of healthy cows and heifers 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.

2. Primary Vaccination: Administer two 2-mL doses 2-4 weeks apart to all breeding-age cows and heifers 30-60 days before exposure or being added to the breeding herd.

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

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

Precaution(s): 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.

Caution(s): Occasional hypersensitivity reactions may occur up to 18 hours postvaccination. Owners should be advised to observe animals during this period. While this event appears to be rare overall, dairy cattle may be affected more frequently than other cattle. Animals affected may display excessive salivation, incoordination, and/or dyspnea. Animals displaying such signs should be treated immediately with epinephrine or equivalent. In nonresponsive animals, other modes of treatment should be considered.

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.

Warning(s): Do not vaccinate within 21 days before slaughter.

For veterinary use only.

Discussion: Disease Description: Campylobacteriosis (vibriosis) is a venereal disease of cattle transmitted during breeding, either through coitus or artificial insemination with contaminated semen. Although the disease is often subclinical, in cows it causes temporary infertility, irregular estrus cycles, delayed conception, and occasionally, abortion.

Leptospirosis may be caused by several serovars of Leptospira, of which L. canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, and L. pomona are the most common that affect cattle. Leptospira localize in the kidneys, are shed in the urine, and cause anemia, bloody urine, fever, loss of appetite, and prostration in calves. Signs are usually subclinical in adult cattle. Infected pregnant cows, however, often abort, and dairy cows may exhibit a marked decrease in milk production. Leptospira spp. are known zoonotic pathogens.

Trial Data: Safety and Efficacy: Because the fractions of STAYBRED VL5™ are inactivated, they cannot replicate in vaccinated animals. Vaccine fractions stimulated satisfactory geometric mean antibody titers for protection. In safety studies of the STAYBRED VL5™ fractions, no adverse reactions to vaccination were reported.

Efficacy of each fraction of STAYBRED VL5™ was demonstrated in challenge-of-immunity tests. Cattle vaccinated with any fraction of STAYBRED VL5™, followed by challenge with a disease-causing strain of that fraction, showed no clinical signs or had significantly fewer signs than nonvaccinated control cattle. Serologic studies also demonstrated no immunologic interference among the fractions of STAYBRED VL5™.

75-4890-05

Presentation: 10 dose and 50 dose vials.

CPN: 3690070.3