Label: SYNOVEX ONE- trenbolone acetate and estradiol benzoate implant

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated October 26, 2020

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  • SPL UNCLASSIFIED SECTION

    SYNOVEX® ONE GRASS
    (trenbolone acetate and estradiol benzoate extended-release implants)
    150 mg trenbolone acetate and 21 mg estradiol benzoate per implant

    SUBCUTANEOUS IMPLANTS FOR PASTURE STEERS AND HEIFERS (SLAUGHTER, STOCKER AND FEEDER)

  • Description

    SYNOVEX ONE Grass (trenbolone acetate and estradiol benzoate extended-release implants) is a growth promoting implant containing 150 mg of trenbolone acetate and 21 mg of estradiol benzoate with a porous polymer film coating that extends the pay-out period of the final formulation up to 200 days. Each implant consists of 6 pellets. Ten implants are provided in each cartridge.

  • DOSAGE

    One implant (six pellets), containing 150 mg of trenbolone acetate and 21 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 ONE Grass is designed to be used exclusively with a Synovex Applicator.

  • WITHDRAWAL PERIOD

    No withdrawal period is required when used according to labeling.

    A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

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

  • Warnings

    NOT FOR USE IN HUMANS.

    FOR ANIMAL USE ONLY.

  • ANIMAL SAFETY WARNING

    Bulling, vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered SYNOVEX ONE Grass implants.

  • DIRECTIONS

    Implant complete contents of one cartridge cell per steer or heifer. Approved implantation technique is fully described in the fold-out carton section.

    NOTE: 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 ONE Grass waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

  • INDICATIONS FOR USE

    For increased rate of weight gain for up to 200 days in pasture steers and heifers (slaughter, stocker and feeder).

    Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

    Not for use in dairy or beef replacement heifers.

  • NET CONTENTS

    One pouch contains ten 10-dose cartridges (100 implants).

  • SPL UNCLASSIFIED SECTION

    IMPORTANT: Read ALL sides of carton

    Approved by FDA under NADA 141-348

    zoetis

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    6203A
    40030750

  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

    SYNOVEX® ONE
    GRASS
    (trenbolone acetate and estradiol benzoate extended-release implants)
    150 mg trenbolone acetate and 21 mg estradiol benzoate per implant

    SUBCUTANEOUS IMPLANTS FOR PASTURE STEERS AND HEIFERS (SLAUGHTER, STOCKER AND FEEDER)

    NOT FOR USE IN HUMANS.
    FOR ANIMAL USE ONLY.

    INDICATIONS FOR USE: For increased
    rate of weight gain for up to 200 days in
    pasture steers and heifers (slaughter,
    stocker and feeder).

    Do not use in veal calves. Effectiveness
    and animal safety in veal calves have not
    been established.

    Not for use in dairy or beef replacement
    heifers.

    NET CONTENTS: One pouch contains
    ten 10-dose cartridges (100 implants).

    Manufactured By A
    Non-Sterilizing Process

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

    Restricted Drug (California)—
    Use Only As Directed.

    IMPORTANT:
    Read ALL sides of carton

    Approved by FDA under NADA 141-348

    zoetis

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

    Synovex One Grass
  • INGREDIENTS AND APPEARANCE
    SYNOVEX ONE 
    trenbolone acetate and estradiol benzoate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-2011
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRENBOLONE ACETATE (UNII: RUD5Y4SV0S) (TRENBOLONE - UNII:P53R4420TR) TRENBOLONE ACETATE150 mg
    ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE21 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-2011-110 in 1 CARTON
    110 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14134806/10/2014
    Labeler - Zoetis Inc. (828851555)