ScourGuard 4K

Bovine Rotavirus-Coronavirus Vaccine

Killed Virus

Escherichia Coli Bacterin

This product has been shown to be effective for the vaccination of healthy, pregnant cows and heifers to provide passive immunity against diarrhea caused by bovine rotavirus (serotypes G6 and G10), bovine coronavirus, and enterotoxigenic strains of Escherichia coli having the K99 pili adherence factor in their calves. Duration of immunity has not been established. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

ScourGuard 4K contains a liquid preparation of inactivated bovine rotavirus (serotypes G6 and G10) and coronavirus propagated on established cell lines and a K99 E. coli bacterin. The vaccine is adjuvanted to enhance the immune response.

EFFICACY: ScourGuard 4K has been demonstrated to be effective against diarrhea caused by bovine rotavirus (serotypes G6 and G10), bovine coronavirus, E. coli and Cl. perfringens type C in calves of vaccinated dams.

Efficacy of the bovine rotavirus (BRV) fraction of ScourGuard 4K was demonstrated in 2 challenge studies conducted by Zoetis Inc. Healthy neonatal calves were removed from their dams prior to nursing and were fed colostrum collected from heifers previously vaccinated with either ScourGuard 4K or a placebo. When challenged with either BRV serotype G6 or G10, calves fed colostrum from ScourGuard 4K-vaccinated heifers showed reductions in abnormal fecal consistency scores when compared to calves consuming colostrum from control cows. Appetite, attitude, and dehydration scores demonstrated a difference in calves fed colostrum from vaccinated dams when compared to calves consuming colostrum from control cows.

Efficacy of the bovine coronavirus (BCV) fraction of ScourGuard 4K was demonstrated in a challenge study. Calves were removed from their dams prior to nursing and were fed colostrum obtained from heifers previously vaccinated with the BCV fraction contained in ScourGuard 4K or a placebo. Following challenge, 13 out of 20 (65%) calves consuming colostrum from control cows died. In contrast, only 2 out of 18 (11.1%) calves that received colostrum from vaccinated cows died. Fecal consistency, appetite, attitude, and dehydration scores demonstrated a difference in calves fed colostrum from vaccinated dams when compared to calves consuming colostrum from control cows.

Efficacy of the E. coli K99 fraction of ScourGuard 4K was demonstrated in an additional study, designed similarly to the previous studies. Following challenge, 8 of 8 (100%) of calves receiving colostrum from control cows died within 48 hours of challenge. In contrast, only 1 of 20 (5%) of calves receiving colostrum from cows previously vaccinated with the E. coli fraction of ScourGuard 4K died.

SAFETY: The safety of ScourGuard 4K in pregnant cows and heifers was demonstrated in 3 field safety studies conducted in 3 different geographic locations. Only 2 animals had adverse events due to vaccination: depression/soreness in one and inappetence/soreness in the other. No injection site swellings, or other vaccine-related local or systemic reactions, were reported.

Directions For Use

General Directions: Shake well. Aseptically administer 2 mL intramuscularly (IM) only. In accordance with Beef Quality Assurance guidelines, this product should be administered in the muscular region of the neck.

Primary Vaccination: Healthy, pregnant cattle should receive 2 doses administered 3 weeks apart with the second dose given 3-6 weeks before calving.

Revaccination: Revaccination with a single dose 3-6 weeks before each subsequent calving is recommended.Good animal husbandry and herd health management practices, including annual revaccination, should be employed.

Precautions

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

Use entire contents when first opened.

Do not vaccinate within 21 days before slaughter.

Contains gentamicin and merthiolate as preservatives.

Transient temperature increases may occur following vaccination.

Do not mix with other products.

In case of human exposure, contact a physician.

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

Technical inquiries should be directed to Zoetis Inc. Veterinary 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 4585.22

Zoetis Inc., Kalamazoo, MI 49007, USA

40044013

Presentation: 10 dose and 50 dose vials.

CPN: 3690230.4