SYNOVEX S (PROGESTERONE AND ESTRADIOL BENZOATE) IMPLANT [ZOETIS INC.]

SYNOVEX S (PROGESTERONE AND ESTRADIOL BENZOATE) IMPLANT [ZOETIS INC.]
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NDC 54771-3902-1
Set ID 6d4c6678-278b-4242-b56d-286686d9875f
Category OTC ANIMAL DRUG LABEL
Packager Zoetis Inc.
Generic Name
Product Class
Product Number
Application Number NADA009576
  • SPL UNCLASSIFIED SECTION

    200 mg progesterone and 20 mg estradiol benzoate per implant

    STEER IMPLANTS For Increased Rate

    of Weight Gain

    and Improved

    Feed Efficiency

    Approved by FDA under NADA # 009-576

  • DESCRIPTION

    Synovex S (progesterone and estradiol benzoate implants) is recommended for use in steers weighing 400 lbs or more. When properly administered, Synovex S implants increase rate of weight gain and improve feed efficiency. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

    Store at controlled room temperature 20°-25°C (68°- 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.

  • Indications for Use

    STEER IMPLANTS For Increased Rate of Weight Gain and Improved Feed Efficiency For additional improvement in rate of weight gain in steers fed in confinement for slaughter, reimplant at approximately 70 days.

    NOTE: Studies have demonstrated that reimplantation of Synovex S can decrease marbling scores when compared to non-implanted controls.

    This product was manufactured by a non‑sterilizing process.

    Do Not Use In Veal Calves

    Not For Use In Humans

    For Animal Use Only

  • Dosage

    Implant complete contents of one cartridge cell per steer. Approved implantation technique is fully described in the package insert.

    .

  • Warning

    Not for use in humans. For animal use only. Implant pellets in the ear only. Any other ocation is in 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 pre-ruminating calves. Do not use in calves to be processed for veal.

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

  • Caution

     Bulling, rectal prolapse, ventral edema and elevated tailheads have occasionally been reported in steers administered with Synovex S implants.

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

    Restricted Drug (California)—

    Use Only as Directed.

  • Directions

     Implant complete contents of one cartridge cell per steer. Approved implantation technique is fully described in the package insert.

    NOTE: Never sacrifice careful, clean technique for speed of implantation.

    Dosing and instruction diagram
  • Storage

    Store at controlled room temperature 20°-25°C (68°- 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    NET CONTENTS: 10 CARTRIDGES (100 DOSES) Each Cartridge Contains 10 Rows of 8 Pellets.

  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Pouch

    STEER IMPLANTS For increased rate of weight gain and improved feed efficiency

    SYNOVEX S

    (progesterone and estradiol benzoate implants)

    200 mg progesterone and 20 mg estradiol benzoate per implant


    zoetis

    NET CONTENTS: 10 CARTRIDGES (100 DOSES)

    Each Cartridge Contains 10 Rows of 8 Pellets.

    Synovex S Extended Content Label (2)Synovex S Extended Content Label (1)

  • INGREDIENTS AND APPEARANCE
    SYNOVEX  S
    progesterone and estradiol benzoate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-3902
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE200 mg
    ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE20 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-3902-110 in 1 BOX
    110 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA00957611/07/2014
    Labeler - Zoetis Inc. (828851555)

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