SYNOVEX PRIMER- trenbolone acetate and estradiol benzoate implant

Synovex Primer by

Drug Labeling and Warnings

Synovex Primer 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 Primer®
(trenbolone acetate and estradiol benzoate implants)
50 mg trenbolone acetate and 7 mg of estradiol benzoate per implant

SUBCUTANEOUS IMPLANTS FOR GROWING BEEF STEERS AND HEIFERS IN A DRY LOT

DESCRIPTION

SYNOVEX® PRIMER™ (trenbolone acetate and estradiol benzoate implants) is a growth promoting implant containing 50 mg of trenbolone acetate and 7 mg of estradiol benzoate per implant. Each implant consists of 2 pellets. Ten implants are provided in each cartridge.

WITHDRAWAL PERIODS AND RESIDUE WARNINGS

No withdrawal period is required when used according to labeling.

Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.

Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.

Implant pellets subcutaneously in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food.

USER SAFETY WARNINGS

Not for use in humans. Keep out of reach of children.

ANIMAL SAFETY WARNINGS

Bulling has occasionally been reported in implanted steers and heifers. Vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered SYNOVEX® PRIMER™ implants.

DIRECTIONS

Administer one SYNOVEX® PRIMER™ implant (two pellets), containing 50 mg of trenbolone acetate and 7 mg of estradiol benzoate, to each steer or heifer by subcutaneous implantation in the middle-third of the ear.

Use only a SYNOVEX applicator. Approved implantation technique is fully described in the fold-out carton section. Never sacrifice careful, clean technique for speed of implantation.

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.

DISPOSAL

SYNOVEX® PRIMER™ waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

INDICATIONS FOR USE

For increased rate of weight gain in growing beef steers and heifers in a dry lot.
Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef steers and heifers in a dry lot as safety and effectiveness have not been evaluated.

Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established.

Do not use in animals intended for subsequent breeding, or in dairy cows.

QUESTIONS/COMMENTS?

For a copy of the Safety Data Sheet or to report side effects, contact Zoetis Inc. at 1-888-963-8471. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

SPL UNCLASSIFIED SECTION

Manufactured By A Non-Sterilizing Process

Restricted Drug (California)—Use Only As Directed.

IMPORTANT

Read ALL sides of carton

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 141-043

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

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

40044978

HOW TO IMPLANT

HOW TO IMPLANT
For use with a SYNOVEX Applicator

Study the following instructions carefully, then proceed step by step, until the technique becomes routine. Many head can be implanted per hour by an experienced team, one member of which should be assigned to do nothing but the implantation.
Care should be taken to insure the hands of the person administering the implant are clean and only sanitary instruments are used.

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PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

40044978

INGREDIENTS AND APPEARANCE

SYNOVEX PRIMER 
trenbolone acetate and estradiol benzoate implant

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 54771-6870
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRENBOLONE ACETATE (UNII: RUD5Y4SV0S) (TRENBOLONE - UNII:P53R4420TR)	TRENBOLONE ACETATE	50 mg
ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL BENZOATE	7 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-6870-1	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	07/01/2024

Labeler - Zoetis Inc. (828851555)