SYNOVEX PLUS (TRENBOLONE ACETATE AND ESTRADIOL BENZOATE) IMPLANT [ZOETIS INC.]

SYNOVEX PLUS (TRENBOLONE ACETATE AND ESTRADIOL BENZOATE) IMPLANT [ZOETIS INC.]
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NDC 54771-3904-1
Set ID 149e1253-5760-4813-9d91-bfeb1c1fa942
Category OTC ANIMAL DRUG LABEL
Packager Zoetis Inc.
Generic Name
Product Class
Product Number
Application Number NADA141043
  • SPL UNCLASSIFIED SECTION

    Synovex Plus® (trenbolone acetate and estradiol benzoate implants)

    IMPLANTS FOR STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER

    200 mg trenbolone acetate and 28 mg estradiol benzoate

  • DESCRIPTION

    Synovex Plus (trenbolone acetate and estradiol benzoate implants) is a growth promoting implant containing 200 mg of trenbolone acetate and 28 mg of estradiol benzoate. Each implant consists of 8 pellets. Ten implants are provided in each cartridge.

  • NOTE

    Synovex Plus is not better for increased average daily gain than Synovex Choice (100 mg trenbolone acetate/14 mg estradiol benzoate) in steers fed in confinement for slaughter. Studies have demonstrated that the administration of Synovex Plus can result in decreased marbling scores when compared to non-implanted steers and heifers.

  • 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.

  • WARNING

    Not for use in humans. For animal use only. Not for dairy or beef replacement heifers. 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.

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

    DO NOT USE IN VEAL CALVES.
    NOT FOR USE IN HUMANS.
    FOR ANIMAL USE ONLY.

  • CAUTION

    Bulling, vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered Synovex Plus 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.

  • INDICATIONS FOR USE

    Synovex Plus is recommended for increased rate of weight gain and improved feed efficiency in steers and for increased rate of weight gain in heifers fed in confinement for slaughter. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

  • NET CONTENTS

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

  • 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.

    IMPORTANT: Read ALL sides of carton

    Approved by FDA under NADA 141-043

    zoetis

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    6053J
    40030982

  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

    10 Cartridge Implant Carton

    Ear diagram instructionsSynovex SX10 Gun

  • INGREDIENTS AND APPEARANCE
    SYNOVEX  PLUS
    trenbolone acetate and estradiol benzoate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-3904
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRENBOLONE ACETATE (UNII: RUD5Y4SV0S) (TRENBOLONE - UNII:P53R4420TR) TRENBOLONE ACETATE200 mg
    ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE28 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-3904-11 in 1 BOX
    110 in 1 POUCH
    110 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14104311/07/2014
    Labeler - Zoetis Inc. (828851555)

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