Animal NDC 54771-3904-1 Synovex Plus
Trenbolone Acetate And Estradiol Benzoate

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-3904-1
Proprietary Name Synovex Plus What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Trenbolone Acetate And Estradiol Benzoate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Otc Animal Drug
Usage Information
    Administer one SYNOVEX Plus® implant (eight pellets), containing 200 mg trenbolone acetate and 28 mg estradiol benzoate, to each steer or heifer by subcutaneous implantation in the middle-third of the ear. If using in a reimplantation program, reimplant steers or heifers with a SYNOVEX Plus® implant 60 to 120 days after administering a SYNOVEX Choice® implant.Use only a SYNOVEX applicator. Approved implantation technique is fully described in the foldout carton section. Never sacrifice careful, clean technique for speed of implantation.
Active Ingredient(s)
  • Estradiol Benzoate
  • Trenbolone Acetate
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141043 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Synovex Plus Images

Synovex Plus Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


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 Plus® implants.


Directions



Administer one SYNOVEX Plus® implant (eight pellets), containing 200 mg trenbolone acetate and 28 mg estradiol benzoate, to each steer or heifer by subcutaneous implantation in the middle-third of the ear. If using in a reimplantation program, reimplant steers or heifers with a SYNOVEX Plus® implant 60 to 120 days after administering a SYNOVEX Choice® implant.

Use only a SYNOVEX applicator. Approved implantation technique is fully described in the foldout 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 Plus® waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.


Indications For Use



• For increased rate of weight gain and improved feed efficiency in growing beef steers fed in confinement for slaughter and for increased rate of weight gain in growing beef heifers fed in confinement for slaughter. SYNOVEX Plus® is not more effective than SYNOVEX Choice® (100 mg trenbolone acetate and 14 mg estradiol benzoate per implant) for increased rate of weight gain in growing beef steers fed in confinement for slaughter.
• For increased rate of weight gain for up to 200 days in growing beef steers and heifers fed in confinement for slaughter in a reimplantation program where SYNOVEX Choice® is the first implant and a SYNOVEX Plus® implant is administered 60 to 120 days later.
• 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 fed in confinement for slaughter 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.


Important



Read ALL sides of carton


Principal Display Panel - 10 Cartridge Implant Carton





* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.