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

COLORADO SERUM COMPANY4950 YORK STREET, P.O. BOX 16428, DENVER, CO, 80216-0428Telephone: 303-295-7527Order Desk: 800-525-2065Fax: 303-295-1923Website: www.colorado-serum.comEmail: colorado-serum@colorado-serum.comTHIS 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.

TETANUS TOXOID-CONCENTRATED

Colorado Serum

Adjuvanted

GENERAL INFORMATION: This product has been shown to be effective for the vaccination of healthy horses, cattle, sheep, goats, and swine against tetanus. This product was licensed prior to the requirement to establish a minimum age for use. The duration of immunity is unknown. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Safety in pregnant animals is unknown.

Tetanus Toxoid is prepared by detoxifying tetanus toxin in such a manner as to allow the antigenic properties to remain intact. Product is purified, concentrated and adjuvanted to provide a low dose effective immunizing agent.

Each serial is tested for purity, safety, and potency in accordance with USDA requirements.

Tetanus is caused by a neurotoxin produced by growth of Clostridium tetani, an anaerobic (lives without air) micro-organism, in necrotic tissue. Affected animals become stiff, have difficulty swallowing, and have an increased pulse rate. Breathing is labored. Spasmodic contractions of the muscular system occur, such as contracting muscles of the jaw.

Spasmodic contractions of the muscular system occur, such as contracting muscles of the jaw. Thus, the term “lockjaw” is often used. Legs and tail are often stiff with abdominal muscles contracted. Tetanus stricken animals may be unusually sensitive to light and heat. Temperature of the animal generally remains normal, elevating only shortly before death.

Protective antibody levels usually occur about two weeks after the second injection of the primary immunization series. In contrast, administration of Tetanus Antitoxin is recommended for immediate, emergency, passive treatment of exposed animals with unknown vaccination history or with signs of tetanus infection.

DIRECTIONS: Do not vaccinate within 21 days before slaughter. Store at 2-8° C. Do not freeze. Do not mix with other products. Shake well before use. Use entire contents when first opened.

PRECAUTIONS: A transitory local reaction may occur at injection site. Anaphylactoid reaction may occur following administration of products of this nature. If noted, administer adrenalin or equivalent. In case of human exposure, consult a physician.

DOSAGE & ADMINISTRATION: For primary immunization, two doses should be administered subcutaneously or intramuscularly approximately 30 days apart. Use intramuscularly for horses as local reactions are more likely to occur if injected subcutaneously.

Horses: 1 ml IM

Cattle: 1 ml SC or IM

Sheep, Goats, Swine: 0.5 ml SC or IM

Historically, annual single dose revaccination has been recommended. Contact veterinarian for advice.

OTHER INFORMATION: Contains thimerosal and formalin as preservatives. Tetanus Toxoid Concentrate is available in single dose size packaged 10 vials to the carton, and in 10 dose vials.

THE PEAK OF QUALITY SINCE 1923

VLN: 188 / PCN: 8601.00

COLORADO SERUM COMPANY, 4950 York Street, Denver, Colorado 80216

303-295-752

www.colorado-serum.com

Contact us for information on other Colorado Serum Company products. Fine Veterinary Products since 1923.

FOR VETERINARY USE ONLY

Order #

10 - 1 ml vials

10 - 1 dose vials

11411

10 ml

10 doses

11415

CPN: 1101033.3