Synovex One: Product Information

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

SYNOVEX® ONE FEEDLOT
(trenbolone and estradiol extended release implant)
200 mg trenbolone acetate and 28 mg estradiol benzoate per implant

SUBCUTANEOUS IMPLANTS FOR STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER

SYNOVEX ONE Feedlot (trenbolone and estradiol extended release implant) is a growth promoting implant containing 200 mg of trenbolone acetate and 28 mg of estradiol benzoate with a porous polymer film coating that extends the pay-out period of the final formulation up to 200 days. Each implant consists of 8 pellets. Ten implants are provided in each cartridge.

NOTE

Studies have demonstrated that the administration of SYNOVEX ONE Feedlot can result in decreased marbling scores when compared to non-implanted steers and heifers.

DOSAGE

One implant (8 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 ONE Feedlot is designed to be used exclusively with a Synovex SX10 Gun.

WITHDRAWAL PERIOD

No withdrawal period is required when used according to labeling.

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Implant pellets 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.

FOR ANIMAL USE ONLY.

ANIMAL SAFETY WARNING

Bulling, vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in eifers administered SYNOVEX ONE Feedlot implants.

DIRECTIONS

Implant complete contents of one cartridge cell per steer or heifer. Approved implantation technique is fully described in the fold-out carton section.

NOTE: 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 ONE Feedlot waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

INDICATIONS FOR USE

For increased rate of weight gain and improved feed efficiency for up to 200 days in steers and heifers fed in confinement for slaughter.
Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.
Not for use in dairy or beef replacement heifers.

NET CONTENTS

One pouch contains ten 10-dose cartridges (100 implants).

Manufactured By A Non-Sterilizing Process

Keep this and all drugs out of the reach of children.

Restricted Drug (California)—Use Only As Directed.

IMPORTANT

Read ALL sides of carton

NADA 141-348, Approved by FDA
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
6213A
13797601

PRINCIPAL DISPLAY PANEL — 10 Cartridge Implant Carton

PRINCIPAL DISPLAY PANEL -- 10 Cartridge Implant Carton
(click image for full-size original)
SYNOVEX ONE
trenbolone acetate and estradiol benzoate implant
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:54771-2010
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
trenbolone acetate (trenbolone) trenbolone acetate 200 mg
estradiol benzoate (estradiol) estradiol benzoate 28 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-2010-1 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE
1 10 IMPLANT in 1 CARTRIDGE This package is contained within the CARTON (54771-2010-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141348 06/10/2014
Labeler — Zoetis Inc. (828851555)

Revised: 05/2020 Zoetis Inc.

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