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 September 12, 2014

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    FEEDLOT
    (trenbolone and estradiol extended release implant)
    200 mg trenbolone acetate and 28 mg estradiol benzoate per implant

    SUBCUTANEOUS IMPLANTS FOR STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER

    NADA 141-348, Approved by FDA

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  • DESCRIPTION

    SYNOVEX ONE Feedlot (trenbolone and estradiol extended release implant) is a growth promoting implant containing 200 mg of trenbolone acetate and 28 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 8 pellets. Ten implants are provided in each cartridge.

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  • VETERINARY INDICATIONS

    INDICATIONS FOR USE: For increased rate of weight gain and improved feed efficiency for up to 200 days in steers and heifers fed in confinement for slaughter.

    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.

    NOTE: Studies have demonstrated that the administration of SYNOVEX ONE Feedlot can result in decreased marbling scores when compared to non-implanted steers and heifers.

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  • DOSAGE & ADMINISTRATION

    DOSAGE: One implant (8 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 ONE Feedlot is designed to be used exclusively with a Synovex SX10 Gun.

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  • SPL UNCLASSIFIED SECTION

    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.

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  • 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 Feedlot implants.

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  • SPL UNCLASSIFIED SECTION

    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.

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  • STORAGE AND HANDLING

    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.

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  • ENVIRONMENTAL WARNING

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

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  • SPL UNCLASSIFIED SECTION

    Manufactured By A Non-Sterilizing Process

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

    Restricted Drug (California)—Use Only As Directed.

    See top of pouch for lot and expiration date.

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    6212A
    13797701

    NET CONTENTS: 10 cartridges
    Each cartridge contains 10 implants (100 implants total)

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  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Foil Pouch

    SYNOVEX® ONE
    FEEDLOT
    (trenbolone and estradiol extended release implant)
    200 mg trenbolone acetate and 28 mg estradiol benzoate per implant

    SUBCUTANEOUS IMPLANTS FOR STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER

    zoetis

    NET CONTENTS: 10 cartridges
    Each cartridge contains 10 implants (100 implants total)

    PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Foil Pouch
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  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

    SYNOVEX® ONE
    FEEDLOT
    (trenbolone and estradiol extended release implant)
    200 mg trenbolone acetate and 28 mg estradiol benzoate per implant

    SUBCUTANEOUS IMPLANTS FOR STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER

    NOT FOR USE IN HUMANS.
    FOR ANIMAL USE ONLY.

    INDICATIONS FOR USE: For increased
    rate of weight gain and improved feed
    efficiency for up to 200 days in steers and
    heifers fed in confinement for slaughter.

    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

    NADA 141-348, Approved by FDA

    zoetis

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

    PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton
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  • INGREDIENTS AND APPEARANCE
    SYNOVEX ONE 
    trenbolone acetate and estradiol benzoate implant
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:54771-2010
    Route of Administration SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    trenbolone acetate (UNII: RUD5Y4SV0S) (trenbolone - UNII:P53R4420TR) trenbolone acetate 200 mg
    estradiol benzoate (UNII: 1S4CJB5ZGN) (estradiol - UNII:4TI98Z838E) estradiol benzoate 28 mg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54771-2010-1 10 in 1 CARTON
    1 10 in 1 CARTRIDGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA141348 06/10/2014
    Labeler - Zoetis Inc. (828851555)
    Establishment
    Name Address ID/FEI Business Operations
    Boehringer Ingelheim Vetmedica, Inc. 832511005 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Industrias Químicas Falcón de México, S.A. de C.V. (DR. REDDY'S MEXICO) 812915445 API MANUFACTURE
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