CattleMaster GOLD FP 5

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

Modified Live and Killed Virus

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.

This product has been shown to be effective for the vaccination of healthy cattle, including pregnant cows, against respiratory disease caused by infectious bovine rhinotracheitis (IBR, bovine herpesvirus Type 1) virus; bovine virus diarrhea (BVD) Type 1, including 1b, and Type 2 virus; parainfluenza₃ (PI₃) virus and bovine respiratory syncytial virus (BRSV) and reproductive disease caused by IBR and BVD Types 1 and 2. Duration of immunity has not been established. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

This product has been shown to be effective against abortion due to IBR; and persistently infected calves caused by BVD Types 1 and 2.

SAFETY AND EFFICACY: In safety studies of the fractions of CattleMaster GOLD FP 5, no significant adverse reactions to vaccination were observed and vaccinated pregnant cattle delivered normal, healthy calves. Safety was demonstrated in pre-breeding and pregnant cows in all 3 trimesters. Transient local swelling was occasionally observed at the injection site.

Efficacy of the IBR and BVD Type 1 and 2 fractions of CattleMaster GOLD FP 5 were demonstrated in challenge-of-immunity studies. The effectiveness of the IBR fraction of CattleMaster GOLD FP 5 in preventing IBR-induced abortion was demonstrated by vaccinating susceptible heifers approximately 5 and 2 weeks prior to breeding. The vaccinated heifers, along with a group of nonvaccinated controls, were challenged with virulent IBR virus (Cooper strain) at approximately 180 days postbreeding. Following challenge, > 90% of vaccinated cows gave birth to healthy calves whereas >90% of the nonvaccinated controls aborted.

A similar study design was used to demonstrate the effectiveness of CattleMaster GOLD FP 5 in preventing persistently infected calves with both BVD Types 1 and 2. In these studies, cows were challenged at approximately 82 days postbreeding using virulent strains of BVD. In nonvaccinated controls, challenge with BVD Type 1 resulted in 100% cows with persistent infected calves, and challenge with BVD Type 2 resulted in 88% cows with persistent infected calves. Conversely, 100% of calves born to cows vaccinated with CattleMaster GOLD FP 5 were protected from persistent infection following challenge by both BVD Types 1 and 2.

The latency and subsequent excretion of the IBR virus fraction of CattleMaster GOLD FP 5 was determined in a supplemental study in which cattle were vaccinated intramuscularly with the attenuated, temperature-sensitive IBR virus component and subsequently given corticosteroid to reactivate latent herpesvirus. Vaccination resulted in a characteristic serological response that remained unaltered even after corticosteroid treatment, indicating a lack of viral reactivation. Also, no BHV1 was recovered from mucosal swabs collected postvaccination or postcorticosteroid treatment, nor was it transmitted to nonvaccinated sentinel calves commingled with the vaccinates for the duration of the study. Further, no BHV1 DNA or latency-related RNA was detected in trigeminal or iliosacral spinal dorsal root ganglia collected after the administration of corticosteroid. Both nucleic acids were detected in a single cervical ganglion sample, suggesting a direct or proximate intraneural injection. BHV1 given by intramuscular (IM) injection could not be reactivated from trigeminal ganglia, the primary site of BHV1 latency, demonstrating a lack of efficient viral replication in those sensory neurons. Excluding possible injection into nervous tissue (from which reactivation was not observed), the IBR fraction of CattleMaster GOLD FP 5 given by the IM route showed no propensity to establish latent herpesvirus infections.

Directions For Use

General Directions: Aseptically rehydrate the freeze-dried vaccine with the liquid component provided, mix well, and administer 2 mL subcutaneously.

Primary Vaccination: Healthy cattle should receive an initial 2 doses 3 weeks apart. When vaccinating against reproductive disease caused by IBR and BVD, administer a single 2-mL dose at approximately 5 and 2 weeks prior to breeding. The presence of maternal antibody is known to interfere with the development of active immunity in cattle and additional boosters will be required in most young animals.

Revaccination: Historically, annual revaccination with this product was recommended. The need for annual booster vaccinations has not been established. For advice on revaccination frequency, consult your veterinarian or the manufacturer.

Good animal husbandry and herd health management practices should be employed.

Precautions

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.

Transient local reactions may be observed at the injection site.

Inactivate unused contents before disposal.

Do not vaccinate within 21 days before slaughter.

Contains gentamicin and thimerosal as preservatives.

Routine handling of lactating dairy cattle, including administration of vaccines such as CattleMaster GOLD FP 5, has been associated with transient reduction of milk production.

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.

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 persistently infected with BVD virus or 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.

VLN 190/PCN 1187.25

Zoetis Inc.

Kalamazoo, MI 49007, USA

50386101

Presentation: 5 dose, 10 dose and 25 dose vials.

CPN: 3690218.5