SYNOVEX C- progesterone and estradiol benzoate implant

Synovex C by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

100 mg progesterone and 10 mg estradiol benzoate per implant

CALF IMPLANTS. For increased rate of weight gain. For subcutaneous ear implantation only.

NADA 9-576, Approved by FDA

Description

Synovex C Calf Implants contain two pure steroid hormones, progesterone and estradiol benzoate. This formulation provides a complementary amount of each hormone for maximal growth stimulation.

Indications

Calf implants for increased rate of weight gain. Synovex C is recommended for use in suckling beef calves up to 400 lbs of body weight. Synovex C is also recommended for improvement in rate of weight gain in steers weighing greater than 400 pounds and fed in confinement for slaughter when used as part of a re-implant program in which an initial Synovex C implant is followed at approximately 70 days by Synovex S. . Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

Dosage & Administration

Implant complete contents of one cartridge cell per calf at each implanting. 100 mg progesterone and 10 mg estradiol benzoate per implant

The twenty-dose cartridge of Synovex C is designed to be used exclusively with a Synovex SX10 Gun.

Food Safety Warning

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

Implant pellets in the ear only. Any other location is in violation of federal law.

Warnings

Not for use in humans. For animal use only.

SPL UNCLASSIFIED SECTION

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

PRECAUTIONS

CAUTION: Bulling, rectal and vaginal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in calves administered with Synovex C implants.

Dosage and Administration

DOSAGE: One implant (four pellets), containing 100 mg of progesterone and 10 mg of estradiol benzoate, is administered to each calf by subcutaneous implantation in the middle one-third of the ear.

The twenty-dose cartridge of Synovex C is designed to be used exclusively with a Synovex SX10 Gun.

Implant complete contents of one cartridge cell per calf at each implanting. Approved implantation technique is fully described in the package insert.

Storage and Handling

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.

Environmental Warning

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

SPL UNCLASSIFIED SECTION

This product was manufactured by a non-sterilizing process.
Restricted Drug (California) — Use Only as Directed

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

NET CONTENTS: 2 CARTRIDGES (20 DOSES)
Each Cartridge Contains 10 Rows of 4 Pellets.

PRINCIPAL DISPLAY PANEL - 2 Cartridge Implant Carton

SYNOVEX® C
(progesterone and estradiol benzoate)
100 mg progesterone and 10 mg estradiol benzoate per implant

CALF IMPLANTS

For increased rate of weight gain

This product was manufactured by
a non-sterilizing process.

TAKE TIME
OBSERVE LABEL
DIRECTIONS

Important: Read ALL sides of carton
Do Not Use In Veal Calves
Not For Use In Humans
For Animal Use Only
For subcutaneous ear implantation only.

NADA 9-576, Approved by FDA

zoetis

NET CONTENTS: 2 CARTRIDGES (20 DOSES)
Each Cartridge Contains 10 Rows of 4 Pellets.

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

SYNOVEX® C
(progesterone and estradiol benzoate)
100 mg progesterone and 10 mg estradiol benzoate per implant

CALF IMPLANTS

For increased rate of weight gain

This product was manufactured by a
non-sterilizing process.

TAKE TIME
OBSERVE LABEL
DIRECTIONS

Important: Read ALL sides of carton
Do Not Use In Veal Calves
Not For Use In Humans
For Animal Use Only
For subcutaneous ear implantation only.

NADA 9-576, Approved by FDA

zoetis

NET CONTENTS: 10 CARTRIDGES (100 DOSES)
Each Cartridge Contains 10 Rows of 4 Pellets.

INGREDIENTS AND APPEARANCE

SYNOVEX C 
progesterone and estradiol benzoate implant

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 54771-3903
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)	PROGESTERONE	100 mg
ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL BENZOATE	10 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-3903-1	2 in 1 CARTON
2	NDC: 54771-3903-2	10 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA009576	02/20/1956

Labeler - Zoetis Inc. (828851555)