Bovi-Shield GOLD FP 5 L5 HB

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.
Bovi-Shield GOLD® FP® 5 L5 HB

Zoetis

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza3-Respiratory Syncytial Virus Vaccine

Modified Live Virus

Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

INDICATIONS: Bovi-Shield GOLD FP 5 L5 HB is for vaccination of healthy cows and heifers prior to breeding to prevent persistently infected calves caused by BVD Types 1 and 2; and as an aid in preventing abortion caused by infectious bovine rhinotracheitis (IBR, bovine herpesvirus Type 1) virus; fetal infection caused by BVD Types 1 and 2; respiratory disease caused by IBR, BVD Types 1 and 2, parainfluenza3 (PI3), and bovine respiratory syncytial virus (BRSV); BVD Type 2 testicular infection; and leptospirosis caused by Leptospira canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, and L. pomona.

A 12-month duration of immunity has been demonstrated against IBR-induced abortion and persistently infected calves caused by BVD Types 1 and 2. In addition, Bovi-Shield GOLD FP 5 L5 HB is especially recommended to prevent establishment of L. hardjo in the kidney, thus shedding in the urine, for at least 12 months. Vaccination with this product also prevents establishment of L. hardjo in the genital tract and aids in preventing infection of the fetus.

Bovi-Shield GOLD FP 5 L5 HB may be administered to pregnant cattle provided they were vaccinated, according to label directions, with any Bovi-Shield GOLD FP or PregGuard® GOLD FP vaccine within the past 12 months. Bovi-Shield GOLD FP 5 L5 HB may also be administered to calves nursing pregnant cows provided their dams were vaccinated within the past 12 months as described above. To help ensure safety in pregnant cattle, heifers must receive at least 2 doses of any Bovi-Shield GOLD FP or PregGuard GOLD FP product with the second dose administered at least 30 days prebreeding.

PRODUCT DESCRIPTION: The freeze-dried vaccine is a preparation of modified live virus (MLV) strains of IBR, BVD Types 1 and 2, PI3 and BRSV. The liquid fraction contains a specially prepared, inactivated and adjuvanted unique strain of Leptospira borgpetersenii serovar hardjo-bovis together with inactivated and adjuvanted cultures of L. pomona, L. grippotyphosa, L. canicola, and L. icterohaemorrhagiae.

DIRECTIONS:

General Directions: Vaccination of healthy cattle is recommended. Aseptically rehydrate the freeze-dried vaccine with the liquid bacterin provided, shake well, and administer 2 mL subcutaneously or intramuscularly. In accordance with Beef Quality Assurance guidelines, this product should be administered SC in the neck region.

Primary Vaccination: Administer a single 2-mL dose to all breeding cows approximately 1 month prior to breeding or being added to the herd, followed by a single dose of Spirovac® L5 4-6 weeks later. To help ensure safety in pregnant cattle, heifers must receive at least 2 doses of any Bovi-Shield GOLD FP or PregGuard GOLD FP product with the second dose administered at least 30 days prebreeding.

Revaccination: Historically this product recommended annual revaccination. The need for annual booster vaccinations has not been established for this product; consultation with a veterinarian is recommended. Good animal husbandry and herd health management is recommended.

PRECAUTIONS:

Do not use in pregnant cows (abortions can result) unless they were vaccinated, according to label directions, with any Bovi-Shield GOLD FP or PregGuard GOLD FP vaccine within the past 12 months. Do not use in calves nursing pregnant cows unless their dams were vaccinated within the past 12 months as described above.

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.

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

Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine.

Inactivate unused contents before disposal.

Do not vaccinate within 21 days before slaughter.

Contains gentamicin and thimerosal as preservatives.

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

Fetal health risks associated with vaccination of pregnant animals with modified live vaccines cannot be unequivocally determined by clinical trials conducted for licensure. Management strategies based on vaccination of pregnant animals with modified live vaccines should be discussed with a veterinarian.

Do not mix with other products, except as specified above.

In case of human exposure, contact a physician.

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

VLN 190/PCN 4469.24

Zoetis Inc., Kalamazoo, MI 49007

10-dose vial of vaccine, rehydrate to 20 mL

20-mL vial of sterile diluent

50029900

50-dose vial of vaccine, rehydrate to 20 mL

100-mL vial of sterile diluent

CPN: 3690257.6