Zoetis Inc.

SynovexPlus trenbolone acetate and estradiol benzoate TRENBOLONE ACETATE TRENBOLONE ESTRADIOL BENZOATE ESTRADIOL

One implant (eight pellets), containing 200 mg of trenbolone acetate and 28 mg of estradiol benzoate, is administered to each steer or heifer by subcutaneous implantation in the middle one‑third of the ear. The ten-dose cartridge of Synovex Plus is designed to be used exclusively with a Synovex implanting device.

No withdrawal period is required when used according to labeling.
Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.
Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Implant pellets subcutaneously in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food.

Not for use in humans. Keep out of reach of children.

Bulling has occasionally been reported in implanted steers and heifers. Vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered SYNOVEX Plus® implants.

Administer one SYNOVEX Plus® implant (eight pellets), containing 200 mg trenbolone acetate and 28 mg estradiol benzoate, to each steer or heifer by subcutaneous implantation in the middle-third of the ear. If using in a reimplantation program, reimplant steers or heifers with a SYNOVEX Plus® implant 60 to 120 days after administering a SYNOVEX Choice® implant.

Use only a SYNOVEX applicator. Approved implantation technique is fully described in the foldout carton section. Never sacrifice careful, clean technique for speed of implantation.

Store unopened product at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat and humidity. Use product before the expiration date on the label.

Once the pouch is opened, unused product may be stored in the end-folded pouch (away from light) for up to six months under refrigerated conditions 2°-8°C (36°-47°F) or at room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F) for up to one month.

SYNOVEX Plus® waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

• For increased rate of weight gain and improved feed efficiency in growing beef steers fed in confinement for slaughter and for increased rate of weight gain in growing beef heifers fed in confinement for slaughter. SYNOVEX Plus® is not more effective than SYNOVEX Choice® (100 mg trenbolone acetate and 14 mg estradiol benzoate per implant) for increased rate of weight gain in growing beef steers fed in confinement for slaughter.
• For increased rate of weight gain for up to 200 days in growing beef steers and heifers fed in confinement for slaughter in a reimplantation program where SYNOVEX Choice® is the first implant and a SYNOVEX Plus® implant is administered 60 to 120 days later.
• Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter as safety and effectiveness have not been evaluated.

Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established.
Do not use in animals intended for subsequent breeding, or in dairy cows

For a copy of the Safety Data Sheet or to report side effects, contact Zoetis Inc. at 1-888-963-8471. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

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