BOVIGEN Platinum 3 LP

Company: Virbac

See productdata.aphis.usda.gov for a summary of the studies approved by the USDA for licensing this product. This document also contains additional information developed by the licensee.

Bovine Rhinotracheitis-Virus Diarrhea Vaccine

Modified Live Virus

Leptospira Pomona Bacterin

CONTENTS:

Infectious Bovine Rhinotracheitis Virus (IBR), Modified Live Virus

Bovine Virus Diarrhea Virus (BVD), Modified Live Virus

Leptospira Pomona

BOVIGEN Platinum 3 LP Indications

This product has been shown to be effective for the vaccination of healthy cattle against infectious bovine rhinotracheitis virus (IBR), bovine virus diarrhea virus Type I (BDV), bovine virus diarrhea virus Type II (BVD) and Leptospira pomona. The duration of immunity has not been determined. This product was licensed prior to the requirement to establish a minimum age for use. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

BOVIGEN Platinum 3 LP may be used in pregnant cows and calves nursing pregnant cows provided they were vaccinated, 30 to 60 days pre-breeding, with BOVIGEN Platinum 3, BOVIGEN Platinum 3 LP, BOVIGEN Platinum 5, or BOVIGEN Platinum 5 L5.

This product contains BVD Type I and BVD Type II.

DIRECTIONS AND DOSAGE: Rehydrate the desiccated vial with accompanying diluent and shake well. Inject 2 mL subcutaneously using aseptic technique. The need for annual booster vaccinations has not been established for this product. The presence of maternal antibody is known to interfere with the development of active immunity in calves and additional boosters will be required in most young animals. For advice on revaccination frequency, consult your veterinarian. Do not mix with other products, except as specified on the label.

CAUTIONS: Fetal health risks associated with the vaccination of pregnant animals with this vaccine cannot be unequivocally determined during clinical trials conducted for licensure. Appropriate strategies to address the risks associated with vaccine use in pregnant animals should be discussed with a veterinarian. Failure to follow label direction may result in abortions. Store at 35-46°F (2-8°C). DO NOT FREEZE. Use entire contents when first opened. Do not vaccinate within 21 days of slaughter. In case of human exposure, contact a physician. Inactivate unused contents before disposal. Allergic reactions may follow the use of vaccines; ANTIDOTE: Epinephrine. Contains thimerosal as a preservative.

PRODUCT DESCRIPTION:

BOVIGEN Platinum 3 LP contains desiccated Bovine Rhinotracheitis-Virus Diarrhea Vaccine and a bacterin diluent. The three viral antigens are combined in the proper ratio, stabilized and desiccated into one cake. The desiccated viral fractions are rehydrated for use with a specially processed liquid Leptospira Pomona Bacterin (LP).

DISEASE:

The viruses listed below are considered contributors to the respiratory disease complex of cattle. Multiple infections do occur, and secondary bacterial infections may exacerbate the disease signs.

Infectious Bovine Rhinotracheitis Virus

IBR is an acute upper respiratory disease. Signs of IBR may include elevated temperature, hyperpnea, dyspnea, excessive nasal and ocular discharge, rapid breathing, cough and depression. Reproductive problems including abortions have been observed.

Bovine Virus Diarrhea Virus

BVD is often obscured or confused with other conditions of the respiratory disease complex. Clinical signs may include fever, anorexia, coughing, depression, diarrhea, and occasional lameness. BVD may be inapparent, chronic, or a fatal mucosal disease. BVD may cause suppression of the immune system. Affected animals have increased susceptibility to secondary infections. BVD in pregnant animals may cause abortions or malformed and weak calves at birth. Chronic disease with erosions in the alimentary tract is referred to as “Mucosal Disease” and is usually fatal.

Leptospira Pomona

Leptospirosis is widespread in the animal population of the United States and is considered one of the most infectious diseases of farm animals.

Man can become infected either from animals with the disease or from an infective environmental source. In animals, the disease is known to cause reproduction disorders, loss of weight, decreased milk production and sometimes death. The economic losses suffered are very large. The disease can be caused by several specific leptospires.

IMMUNE RESPONSES:

Research demonstrated BOVIGEN Platinum 3 LP is safe and efficacious; however, individual animals may be unable to develop an adequate immune response following vaccination due to concurrent disease, malnutrition, parasitism, or stress due to shipment or environmental conditions. For more information on revaccination in the face of stress or an exposure, contact your veterinarian.

SAFETY:

Safety in pregnant heifers and cows was demonstrated in trials conducted at three separate sites. The heifers and cows were vaccinated prior to breeding with BOVIGEN Platinum 5 L5, followed by a post-breeding vaccination at the first, second or third trimester of pregnancy. The cows were observed from pregnancy vaccination through calving for fetal loss. Heifers and cows vaccinated with BOVIGEN Platinum 5 L5 had abortions and calving rates similar to the control cows.

Calving Rates (normal calves delivered/total deliveries)

The fetal loss in the two groups was similar with 4% in the BOVIGEN Platinum 5 L5 vaccinated groups and 5% in the control groups. Following calving, each calf’s health was monitored for 4 weeks. The health of the calves in the BOVIGEN Platinum 5 L5 vaccinated dams was similar to the health of calves born to the control dams.

Warning

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

FOR VETERINARY USE ONLY

SUPPLIED:

Manufactured by:

Diamond Animal Health, Inc., Des Moines, Iowa 50327 U.S.A.

U.S. Veterinary License No. 213

Product Code No.: 4389.21

Distributed by:

Virbac AH, Inc., Fort Worth, TX 76161

1-800-338-3659

© 2024 Virbac Corporation. All rights reserved.

BOVIGEN is a trademark of the Virbac Group of Companies.

Rev. 01

002BP3LP-0125

66732, 66733

CPN: 1023196.0