SYNOVEX S- progesterone and estradiol benzoate implant

Synovex by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

200 mg progesterone and 20 mg estradiol benzoate per implant

STEER IMPLANTS For Increased Rate

of Weight Gain

and Improved

Feed Efficiency

NADA 9-576, Approved by FDA

DESCRIPTION

Synovex S (progesterone and estradiol benzoate) is recommended for use in steers weighing 400 lbs or more. When properly administered, Synovex S implants increase rate of weight gain and improve feed efficiency. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

Store at controlled room temperature 20°-25°C (68°- 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.

Indications for Use

STEER IMPLANTS For Increased Rate of Weight Gain and Improved Feed Efficiency For additional improvement in rate of weight gain in steers fed in confinement for slaughter, reimplant at approximately 70 days.

NOTE: Studies have demonstrated that reimplantation of Synovex S can decrease marbling scores when compared to non-implanted controls.

This product was manufactured by a non‑sterilizing process.

Do Not Use In Veal Calves

Not For Use In Humans

For Animal Use Only

Dosage

Implant complete contents of one cartridge cell per steer. Approved implantation technique is fully described in the package insert.

.

Warning

Not for use in humans. For animal use only. Implant pellets in the ear only. Any other ocation is in 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 pre-ruminating calves. Do not use in calves to be processed for veal.

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

Caution

 Bulling, rectal prolapse, ventral edema and elevated tailheads have occasionally been reported in steers administered with Synovex S implants.

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

Restricted Drug (California)—

Use Only as Directed.

Directions

 Implant complete contents of one cartridge cell per steer. Approved implantation technique is fully described in the package insert.

NOTE: Never sacrifice careful, clean technique for speed of implantation.

Storage

Store at controlled room temperature 20°-25°C (68°- 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.

SPL UNCLASSIFIED SECTION

Distributed by:

Zoetis Inc.

Kalamazoo, MI 49007

NET CONTENTS: 10 CARTRIDGES (100 DOSES) Each Cartridge Contains 10 Rows of 8 Pellets.

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Pouch

STEER IMPLANTS For increased rate of weight gain and improved feed efficiency

SYNOVEX S

(progesterone and estradiol benzoate)

200 mg progesterone and 20 mg estradiol benzoate per implant

zoetis

NET CONTENTS: 10 CARTRIDGES (100 DOSES)

Each Cartridge Contains 10 Rows of 8 Pellets.

INGREDIENTS AND APPEARANCE

SYNOVEX  S
progesterone and estradiol benzoate implant

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 54771-3902
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)	PROGESTERONE	200 mg
ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL BENZOATE	20 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-3902-1	10 in 1 BOX
1		10 in 1 CARTRIDGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA009576	11/07/2014

Labeler - Zoetis Inc. (828851555)