Label: SYNOVEX H- testosterone propionate and estradiol benzoate implant

  • Category: OTC ANIMAL DRUG LABEL

Drug Label Information

Updated June 23, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Synovex H

    200 mg testosterone propionate and 20 mg estradiol benzoate per implant

    HEIFER IMPLANTS

    For increased rate of weight gain and improved feed efficiency

    This product was manufactured by a non-sterilizing process.

    Important: Read ALL sides of carton

    For Heifers Only

    Do Not Use In Veal Calves

    Not For Use In Humans

    For Animal Use Only

    For subcutaneous ear implantation only.

    Approved by FDA under NADA 011-427

  • DESCRIPTION

    Synovex H (testosterone propionate and estradiol benzoate implants) is recommended for use in heifers weighing 400 lbs or more.

    When properly administered, Synovex H 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° to 25°C (68° to 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.

  • Indications for Use

    For Heifers Only Not For Use In Humans

    Do Not Use In Veal Calves For Animal Use Only

    Synovex H Heifer Implants contain two pure steroid hormones, testosterone propionate and estradiol benzoate. This formulation provides a complementary amount of each hormone for maximal growth stimulation. Study the enclosed instructions carefully and use this product only as illustrated.

  • Dosage

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

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

    dosage instructions diagrams
  • Warning

    Not for use in humans. For animal use only. Not for dairy or beef replacement heifers. Implant pellets in the ear only. Any other location 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.

  • Caution

    Bulling, vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have been occasionally reported in heifers administered with Synovex H 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 heifer. Approved implantation technique is fully described in the package insert.

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

  • 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

    HEIFER IMPLANTS

    For increased rate of weight gain and improved feed efficiency

    SYNOVEX H

    (testosterone propionate and estradiol benzoate implants)

    200 mg testosterone propionate and 20 mg estradiol benzoate per implant


    zoetis

    NET CONTENTS: One pouch contains

    ten 10-dose cartridges (100 implants)

    Synovex H Extended Content Label (1)
    Synovex H Extended Content Label (2)
  • INGREDIENTS AND APPEARANCE
    SYNOVEX H 
    testosterone propionate and estradiol benzoate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-3901
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TESTOSTERONE PROPIONATE (UNII: WI93Z9138A) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE PROPIONATE200 mg
    ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE20 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-3901-11 in 1 BOX
    110 in 1 POUCH
    110 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA01142711/07/2014
    Labeler - Zoetis Inc. (828851555)