CattleMaster 4+VL5

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

Modified Live and Killed Virus

Campylobacter Fetus-Leptospira Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

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 disease caused by infectious bovine rhinotracheitis (IBR) virus, bovine virus diarrhea (BVD) virus Type 1, including 1b, parainfluenza3 (PI3) virus, bovine respiratory syncytial virus (BRSV), Campylobacter fetus, Leptospira canicola, L. grippotyphosa, L. hardjo, L. icterohaemorrhagiae, and L. pomona. Duration of immunity has not been established. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

SAFETY AND EFFICACY: In safety studies of the fractions of CattleMaster 4+VL5, no adverse reactions to vaccination were observed and vaccinated pregnant cattle delivered normal, healthy calves.

Efficacy of each fraction of CattleMaster 4+VL5 was demonstrated in challenge-of-immunity studies. Cattle vaccinated with any fraction of CattleMaster 4+VL5, followed by challenge with a disease-causing strain of that fraction, showed no signs or had significantly fewer clinical signs than nonvaccinated control cattle. Serologic studies also demonstrated no immunologic interference among the fractions of CattleMaster 4+VL5. Antibody response was not significantly different between cattle vaccinated with an individual fraction and cattle vaccinated with the combined fractions.

The latency and subsequent excretion of the IBR virus fraction of CattleMaster 4+VL5 was determined in a supplemental study in which cattle were inoculated 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 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 4+VL5 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 5 mL intramuscularly. In accordance with Beef Quality guidelines, this product should be administered in the muscular region of the neck.

Primary Vaccination: Healthy cattle should receive 2 doses administered 2-4 weeks apart. 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 this product. For advice on revaccination frequency, consult your veterinarian or the manufacturer.

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.

Inactivate unused contents before disposal.

Do not vaccinate within 21 days before slaughter.

Contains gentamicin and thimerosal as preservatives.

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.

Occasional hypersensitivity reactions may occur up to 18 hours postvaccination. Owners should be advised to observe animals during this period. While this event appears to be rare overall, dairy cattle may be affected more frequently than other cattle. Animals affected may display excessive salivation, incoordination, and/or dyspnea. Animals displaying such signs should be treated immediately with epinephrine or equivalent. In nonresponsive animals, other modes of treatment should be considered.

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. Technical Services, (888) 963-8471.

For veterinary use only

VLN 190/PCN 44B9.22

Zoetis Inc.

Kalamazoo, MI 49007, USA

50385601

Presentation: 10 and 25 dose vials.

CPN: 3690046.7