SYNOVEX ONE- trenbolone acetate and estradiol benzoate implant

Synovex One by

Drug Labeling and Warnings

Synovex One by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc., Boehringer Ingelheim Vetmedica, Inc., Industrias Químicas Falcón de México, S.A. de C.V. (DR. REDDY'S MEXICO). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

NADA 141-348, Approved by FDA

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.

VETERINARY INDICATIONS

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.

DOSAGE & ADMINISTRATION

DOSAGE: One implant (6 pellets), containing 150 mg 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.

FOOD SAFETY WARNING

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.

DOSAGE & ADMINISTRATION

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 AND HANDLING

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.

ENVIRONMENTAL WARNING

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

SPL UNCLASSIFIED SECTION

Manufactured By A Non-Sterilizing Process

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

Restricted Drug (California)—Use Only As Directed.

See top of pouch for lot and expiration date.

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

6202A
13798001

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

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Pouch

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)

zoetis

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

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
trenbolone acetate (UNII: RUD5Y4SV0S) (trenbolone - UNII:P53R4420TR)	trenbolone acetate	150 mg
estradiol benzoate (UNII: 1S4CJB5ZGN) (estradiol - UNII:4TI98Z838E)	estradiol benzoate	21 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-2011-1	10 in 1 CARTON
1		10 in 1 CARTRIDGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141348	06/10/2014

Labeler - Zoetis Inc. (828851555)

Establishment
Name	Address	ID/FEI	Business Operations
Boehringer Ingelheim Vetmedica, Inc.		832511005	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Industrias Químicas Falcón de México, S.A. de C.V. (DR. REDDY'S MEXICO)		812915445	API MANUFACTURE