Synovex Choice: Product Information

SYNOVEX CHOICE- trenbolone acetate and estradiol benzoate implant
Zoetis Inc.

SUBCUTANEOUS IMPLANTS FOR GROWING BEEF STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER
SYNOVEX Choice®
(trenbolone acetate and estradiol benzoate implants)
100 mg trenbolone acetate and 14 mg estradiol benzoate per implant

SYNOVEX Choice® (trenbolone acetate and estradiol benzoate implants) is a growth promoting implant containing 100 mg of trenbolone acetate and 14 mg of estradiol benzoate per implant. Each implant consists of 4 pellets. Ten implants are provided in each cartridge.
NOTE: Administration of a single SYNOVEX Choice® implant or its use in a reimplantation program with a SYNOVEX Choice®, SYNOVEX Plus®, or SYNOVEX® ONE Feedlot implant may result in decreased marbling scores when compared to non-implanted steers and heifers.

WITHDRAWAL PERIODS AND RESIDUE WARNINGS

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.

USER SAFETY WARNINGS

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

ANIMAL SAFETY WARNINGS

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 Choice® implants.

DIRECTIONS

Administer one SYNOVEX Choice® implant (four pellets), containing 100 mg of trenbolone acetate and 14 mg of 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 60 to 120 days later with a SYNOVEX Choice®, SYNOVEX Plus®, or SYNOVEX® ONE Feedlot implant.
Use only a SYNOVEX applicator. Approved implantation technique is fully described in the fold-out carton section. Never sacrifice careful, clean technique for speed of implantation.

STORAGE

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.

DISPOSAL

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

INDICATIONS FOR USE

•For increased rate of weight gain in growing beef steers fed in confinementfor slaughter and for increased rate of weight gain and improved feedefficiency in growing beef heifers fed in confinement for slaughter.
•For increased rate of weight gain for up to 200 days in growing beef steersand heifers fed in confinement for slaughter in a reimplantation programwhere SYNOVEX Choice® is the first implant and a SYNOVEX Choice®,SYNOVEX Plus®, or SYNOVEX® ONE Feedlot implant is administered60 to 120 days later.
•Other than as described on the labeling, this implant is not approved forrepeated implantation (reimplantation) with any other cattle ear implant ingrowing beef steers and heifers fed in confinement for slaughter as safetyand 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.

QUESTIONS/COMMENTS?

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

SYNOVEX Plus® (trenbolone acetate and estradiol benzoate implants) and SYNOVEX® ONE Feedlot (trenbolone acetate and estradiol extended-release implants) are owned by Zoetis.


Manufactured By A Non-Sterilizing Process
Restricted Drug (California)—Use Only As Directed.

IMPORTANT

Read ALL sides of carton

NET CONTENTS: 10 CARTRIDGES
Each Cartridge Contains 10 implants (100 implants total)

Approved by FDA under NADA # 141-043
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 4900740037661

PRINCIPAL DISPLAY PANEL — 10 Cartridge Implant Carton

How To 1
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How To 2
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Carton Label
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SYNOVEX CHOICE trenbolone acetate and estradiol benzoate implant
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:54771-3908
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRENBOLONE ACETATE (TRENBOLONE) TRENBOLONE ACETATE 100 mg
ESTRADIOL BENZOATE (ESTRADIOL) ESTRADIOL BENZOATE 14 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-3908-1 1 POUCH in 1 BOX contains a POUCH
1 10 CARTRIDGE in 1 POUCH This package is contained within the BOX (54771-3908-1) and contains a CARTRIDGE
1 10 IMPLANT in 1 CARTRIDGE This package is contained within a POUCH and a BOX (54771-3908-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141043 02/22/1996
Labeler — Zoetis Inc. (828851555)

Revised: 08/2022 Zoetis Inc.

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