Synovex One: Product Information

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

SYNOVEX® ONE GRASS
(trenbolone and estradiol extended release implant)
150 mg trenbolone acetate and 21 mg estradiol benzoate per implant

SUBCUTANEOUS IMPLANTS FOR PASTURE STEERS AND HEIFERS (SLAUGHTER, STOCKER AND FEEDER)

Description

SYNOVEX ONE Grass (trenbolone and estradiol extended release implant) is a growth promoting implant containing 150 mg of trenbolone acetate and 21 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 6 pellets. Ten implants are provided in each cartridge.

DOSAGE

One implant (six pellets), containing 150 mg of trenbolone acetate and 21 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 Grass 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.

Warnings

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 heifers administered SYNOVEX ONE Grass 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 Grass waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

INDICATIONS FOR USE

For increased rate of weight gain for up to 200 days in pasture steers and heifers (slaughter, stocker and feeder).

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).

IMPORTANT: Read ALL sides of carton
NADA 141-348, Approved by FDA
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
6203A
13797901

PRINCIPAL DISPLAY PANEL — 10 Cartridge Implant Carton

SYNOVEX® ONE
GRASS
(trenbolone and estradiol extended release implant)
150 mg trenbolone acetate and 21 mg estradiol benzoate per implant

SUBCUTANEOUS IMPLANTS FOR PASTURE STEERS AND HEIFERS (SLAUGHTER, STOCKER AND FEEDER)

NOT FOR USE IN HUMANS.
FOR ANIMAL USE ONLY.

INDICATIONS FOR USE: For increased
rate of weight gain for up to 200 days in
pasture steers and heifers (slaughter,
stocker and feeder).

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

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

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:54771-2011
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRENBOLONE ACETATE (TRENBOLONE) TRENBOLONE ACETATE 150 mg
ESTRADIOL BENZOATE (ESTRADIOL) ESTRADIOL BENZOATE 21 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-2011-1 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE
1 10 IMPLANT in 1 CARTRIDGE This package is contained within the CARTON (54771-2011-1)
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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