BOVIGEN Platinum 5

Company: Virbac

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

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

Modified Live Virus

CONTENTS:

Infectious Bovine Rhinotracheitis Virus (IBR), Modified Live Virus

Bovine Virus Diarrhea Virus (BVD), Modified Live Virus

Bovine Parainfluenza₃ Virus (Pl₃), Modified Live Virus

Bovine Respiratory Syncytial Virus Vaccine (BRSV), Modified Live Virus

BOVIGEN Platinum 5 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 (BVD), bovine virus diarrhea virus Type II (BVD), bovine parainfluenza₃ virus (PI₃), and bovine respiratory syncytial virus (BRSV). 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 5 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, followed by a second dose of monovalent bovine respiratory syncytial virus vaccine (BOVIGEN Platinum BRSV) to be given 14 to 28 days after the first dose. 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 directions 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.

PRODUCT DESCRIPTION:

BOVIGEN Platinum 5 contains desiccated Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza₃-Respiratory Syncytial Virus Vaccine and a sterile diluent to use as a diluent. The five viral antigens are combined in the proper ratio, stabilized and desiccated.

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.

Bovine Parainfluenza₃ Virus

Parainfluenza₃ infections may cause few noticeable signs. Disease signs caused by Pl₃ virus generally appear within 14 days after shipment and arrival of calves at their destination. Signs are weakness, depression, watery to mucopurulent nasal discharge, fever, coughing, and weight loss. Pl₃ is a contributor to the Bovine Respiratory Disease Complex.

Bovine Respiratory Syncytial Virus

BRSV infections occur in dairy and beef cattle of all ages, including nursing calves. BRSV signs follow an incubation of 5 to 7 days. Infected calves and adult animals exhibit signs of acute respiratory disease that may include fever, cough, rapid breathing, subcutaneous edema of the throat, subcutaneous emphysema of the neck, depression, nasal depression, nasal discharge, ocular discharge, anorexia, hyperpnea, pulmonary edema and emphysema. BRSV may predispose cattle to secondary infections, particularly bacterial pneumonia. In an acute outback, sudden death has been reported. Enzootic pneumonia of dairy calves associated with BRSV may occur at 10 days of age. BRSV signs vary in severity but may rapidly progress to a crisis phase.

Recovery of adult animals is rapid and usually uneventful. Diagnosis is difficult in the field and laboratory. After the animal exhibits signs of disease, the virus usually is not isolated. Paired serum samples may assist in determining existing herd infections.

IMMUNE RESPONSES:

Research demonstrated BOVIGEN Platinum 5 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.: 1181.20

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. 01/24

02351

CPN: 1023188.0