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

----------

SYNOVEX® ONE GRASS

SYNOVEX® ONE GRASS
(trenbolone acetate and estradiol benzoate extended-release implants)
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 acetate and estradiol benzoate extended-release implants) 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 Applicator.

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

Approved by FDA under NADA 141-348

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

6203A
40030750

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

SYNOVEX® ONE
GRASS
(trenbolone acetate and estradiol benzoate extended-release implants)
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

Approved by FDA under NADA 141-348

zoetis

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

Synovex One Grass
SYNOVEX ONE 
trenbolone acetate and estradiol benzoate implant
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-2011
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRENBOLONE ACETATE (UNII: RUD5Y4SV0S) (TRENBOLONE - UNII:P53R4420TR) TRENBOLONE ACETATE150 mg
ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE21 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54771-2011-110 in 1 CARTON
110 in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14134806/10/2014
Labeler - Zoetis Inc. (828851555)

Revised: 10/2020
Document Id: 750655b2-663c-4136-9c31-1e46ab940ccb
Set id: 33abd9eb-4fa3-45da-91b9-f3162d0710b2
Version: 3
Effective Time: 20201026
 
Zoetis Inc.