Label: SYNOVEX PRIMER- trenbolone acetate and estradiol benzoate implant

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

Drug Label Information

Updated April 8, 2024

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

  • SPL UNCLASSIFIED SECTION

    SYNOVEX Primer®
    (trenbolone acetate and estradiol benzoate implants)
    50 mg trenbolone acetate and 7 mg of estradiol benzoate per implant

    SUBCUTANEOUS IMPLANTS FOR GROWING BEEF STEERS AND HEIFERS IN A DRY LOT

  • DESCRIPTION

    SYNOVEX® PRIMER™ (trenbolone acetate and estradiol benzoate implants) is a growth promoting implant containing 50 mg of trenbolone acetate and 7 mg of estradiol benzoate per implant. Each implant consists of 2 pellets. Ten implants are provided in each cartridge.

  • WITHDRAWAL PERIODS AND RESIDUE WARNINGS

    No withdrawal period is required when used according to labeling.

    Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.

    Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.

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

  • USER SAFETY WARNINGS

    Not for use in humans. Keep out of reach of children.

  • ANIMAL SAFETY WARNINGS

    Bulling has occasionally been reported in implanted steers and heifers. Vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered SYNOVEX® PRIMER™ implants.

  • DIRECTIONS

    Administer one SYNOVEX® PRIMER™ implant (two pellets), containing 50 mg of trenbolone acetate and 7 mg of estradiol benzoate, to each steer or heifer by subcutaneous implantation in the middle-third of the ear.

    Use only a SYNOVEX applicator. Approved implantation technique is fully described in the fold-out carton section. 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® PRIMER™ waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

  • INDICATIONS FOR USE

    • For increased rate of weight gain in growing beef steers and heifers in a dry lot.
    • Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef steers and heifers in a dry lot as safety and effectiveness have not been evaluated.

    Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established.

    Do not use in animals intended for subsequent breeding, or in dairy cows.

  • QUESTIONS/COMMENTS?

    For a copy of the Safety Data Sheet or to report side effects, contact Zoetis Inc. at 1-888-963-8471. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

  • SPL UNCLASSIFIED SECTION

    Manufactured By A Non-Sterilizing Process

    Restricted Drug (California)—Use Only As Directed.

  • IMPORTANT

    Read ALL sides of carton

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under NADA # 141-043

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

    zoetis

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    40044978

  • HOW TO IMPLANT

    HOW TO IMPLANT
    For use with a SYNOVEX Applicator

    Study the following instructions carefully, then proceed step by step, until the technique becomes routine. Many head can be implanted per hour by an experienced team, one member of which should be assigned to do nothing but the implantation.
    Care should be taken to insure the hands of the person administering the implant are clean and only sanitary instruments are used.

    fimplant instructions graphic

  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

    40044978

    carton label
  • INGREDIENTS AND APPEARANCE
    SYNOVEX PRIMER 
    trenbolone acetate and estradiol benzoate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-6870
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRENBOLONE ACETATE (UNII: RUD5Y4SV0S) (TRENBOLONE - UNII:P53R4420TR) TRENBOLONE ACETATE50 mg
    ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE7 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-6870-11 in 1 BOX
    110 in 1 POUCH
    110 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14104307/01/2024
    Labeler - Zoetis Inc. (828851555)