SYNOVEX H- testosterone propionate and estradiol benzoate implant

Synovex H by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Synovex H

200 mg testosterone propionate and 20 mg estradiol benzoate per implant

HEIFER IMPLANTS

For increased rate of weight gain and improved feed efficiency

This product was manufactured by a non-sterilizing process.

Important: Read ALL sides of carton

For Heifers Only

Do Not Use In Veal Calves

Not For Use In Humans

For Animal Use Only

For subcutaneous ear implantation only.

NADA 11-427, Approved by FDA

DESCRIPTION

Synovex H (testosterone propionate and estradiol benzoate) is recommended for use in heifers weighing 400 lbs or more.

When properly administered, Synovex H 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° to 25°C (68° to 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.

Indications for Use

For Heifers Only Not For Use In Humans

Do Not Use In Veal Calves For Animal Use Only

Synovex H Heifer Implants contain two pure steroid hormones, testosterone propionate and estradiol benzoate. This formulation provides a complementary amount of each hormone for maximal growth stimulation. Study the enclosed instructions carefully and use this product only as illustrated.

Dosage

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

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

Warning

Not for use in humans. For animal use only. Not for dairy or beef replacement heifers. Implant pellets in the ear only. Any other location 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.

Caution

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

HEIFER IMPLANTS

For increased rate of weight gain and improved feed efficiency

SYNOVEX H

(testosterone propionate and estradiol benzoate)

200 mg testosterone propionate and 20 mg estradiol benzoate per implant

zoetis

NET CONTENTS: One pouch contains

ten 10-dose cartridges (100 implants)

INGREDIENTS AND APPEARANCE

SYNOVEX H 
testosterone propionate and estradiol benzoate implant

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 54771-3901
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TESTOSTERONE PROPIONATE (UNII: WI93Z9138A) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE PROPIONATE	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: 54771-3901-1	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	NADA011427	11/07/2014

Labeler - Zoetis Inc. (828851555)