PROTIVITY MICOPLASMA BOVIS VACCINE – ZOETIS

Safety Information

A field safety study was conducted to demonstrate the safety of Protivity™ in dairy and beef calves of varying sources, including those raised in high population densities, high-stress situations and intensive calf-raising facilities. Only antimicrobials that had no activity against M. bovis were allowed. In this study, a total of 1,069 calves (355 unvaccinated controls and 714 vaccinated with Protivity) were enrolled at three distinct geographical locations. The age range of the calves enrolled were between 8 days of age and younger and approximately 30 days of age. The calves were administered Protivity (n = 714) by subcutaneous route on Day 0 and Day 21 of the experiment design. The frequency of adverse events (mainly neonatal diarrhea and respiratory infections, which are common in this age of calves) in the control and vaccinated groups were similar. One out of 714 (0.14%) vaccinated calves developed arthritis where the vaccine strain was isolated from the affected joint.³

Protivity™, as the first modified live vaccine for M. bovis, demonstrates effective protection against respiratory disease. Despite different tools available to manage disease challenges, respiratory disease caused by M. bovis continues to be a problem.¹

Precautions

This modified-live M. bovis strain may disseminate into joint synovial fluid and may cause arthritis.

1. This product may cause transient injection site swellings that resolve within 21 days of vaccination.
2. This product has not been tested in pregnant or lactating animals.
3. Store at 2° C to 8° C. Prolonged exposure to higher temperatures and/or direct sunlight may adversely affect potency. Do not freeze.
4. Use entire contents when first opened.
5. Sterilized syringes and needles should be used to administer this vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine.
6. Inactivate unused contents before disposal.
7. Do not vaccinate within 21 days before slaughter.
8. As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.
9. Do not mix with other products, except as specified on this label.

In case of human exposure, contact a physician.