SYNOVEX PLUS- trenbolone acetate and estradiol benzoate implant

Synovex by

Drug Labeling and Warnings

Synovex by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc., AML Riverside LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

IMPLANTS FOR STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER

200 mg trenbolone acetate and 28 mg estradiol benzoate

NADA 141-043, Approved by FDA

DESCRIPTION

Synovex Plus (trenbolone acetate and estradiol benzoate) is a growth promoting implant containing 200 mg of trenbolone acetate and 28 mg of estradiol benzoate. Each implant consists of 8 pellets. Ten implants are provided in each cartridge.

Indications for Use

Synovex Plus is recommended for increased rate of weight gain and improved feed efficiency in steers and for increased rate of weight gain in heifers fed in confinement for slaughter. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established

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.

NOTE: Synovex Plus is not better for increased average daily gain than Synovex Choice (100 mg trenbolone acetate/14 mg estradiol benzoate) in steers fed in confinement for slaughter. Studies have demonstrated that the administration of Synovex Plus can result in decreased marbling scores when compared to non-implanted steers and heifers.

Dosage

One implant (eight 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 Plus is designed to be used exclusively with a Synovex implanting device.

Warning

Not for use in humans. For animal use only. Not for dairy or beef replacement heifers. 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.

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

Caution

DO NOT USE IN VEAL CALVES.

NOT FOR USE IN HUMANS.

FOR ANIMAL USE ONLY.

 Bulling, vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered Synovex Plus 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.

 

Synovex SX10 Gun diagram

 

Instructions

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.

SPL UNCLASSIFIED SECTION

Distributed by:

Zoetis Inc.

Kalamazoo, MI 49007

NET CONTENTS: 10 CARTRIDGES Each Cartridge Contains 10 Rows of 8 Pellets

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Pouch

IMPLANTS FOR STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER

SYNOVEX Plus
(trenbolone acetate and estradiol implant)

200 mg trenbolone acetate and 28 mg estradiol benzoate

zoetis

NET CONTENTS: One pouch contains

ten 10-dose cartridges (100 implants)

Image of Foil Pouch

INGREDIENTS AND APPEARANCE

SYNOVEX  PLUS
trenbolone acetate and estradiol benzoate implant

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 54771-3904
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRENBOLONE ACETATE (UNII: RUD5Y4SV0S) (TRENBOLONE - UNII:P53R4420TR)	TRENBOLONE ACETATE	200 mg
ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL BENZOATE	28 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-3904-1	1 in 1 BOX
1		10 in 1 POUCH
1		10 in 1 CARTRIDGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141043	11/07/2014

Labeler - Zoetis Inc. (828851555)

Establishment
Name	Address	ID/FEI	Business Operations
AML Riverside LLC		089899815	MANUFACTURE