Label: COMPONENT E-S WITH TYLAN- progesterone, estradiol benzoate, tylosin tartrate implant

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

Drug Label Information

Updated January 13, 2020

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

  • DESCRIPTION:

    Each cartridge belt holds 20 doses of Component E-S with Tylan (progesterone and estradiol and tylosin implant) Implants. Each dose of 9 pellets consists of 8 pellets containing a total of 200 mg progesterone USP and 20 mg estradiol benzoate plus 1 pellet containing 29 mg tylosin tartrate as a local antibacterial. Component E-S (progesterone and estradiol implant) Implants are recommended for use in steers weighing 400 lbs or more for INCREASED RATE OF WEIGHT GAIN AND IMPROVED FEED EFFICIENCY.

    Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

  • DOSAGE:

    Administer 1 implant per animal according to the following instructions.

  • GENERAL INSTRUCTIONS:

    Study the instructions which should be followed carefully at all times, avoiding short cuts. Skin infection can be avoided by properly preparing implant site and implanter. During fly season use fly repellent on implant site. One designated team member should always do the implanting. Cleanliness of hands and instruments is important at all times.

  • WARNING:

    Not to be used in animals intended for subsequent breeding, or in dairy animals. Implant one dose — 9 pellets (entire contents of one cartridge cell) — in the ear subcutaneously. Any other site of implantation is in violation of Federal Law. DO NOT attempt to salvage implantation site for animal feed or human 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.

    RESTRICTED DRUG (CALIFORNIA) — USE ONLY AS DIRECTED — FOR USE IN ANIMALS ONLY — NOT FOR HUMAN USE — KEEP OUT OF REACH OF CHILDREN

    CAUTION:

    Bulling, rectal prolapse, ventral edema and elevated tail-heads have occasionally been reported in animals implanted with progesterone and estradiol benzoate.

  • IMPLANTING INSTRUCTIONS:

    Loading the Implanter

    Load the implanter following the instructions supplied with each implanter.

    Figure

    Restrain the Animal

    Speed of implantation as well as safety of handlers is best achieved by restraining animal in a squeeze chute using head restraint. When implanting horned cattle, better control is obtained with additional use of nose tongs.

    Figure

    Prepare the Implant Site

    Scrub the back side of the ear (implant site) with a piece of clean absorbent cotton which has been soaked with topical germicidal solution. Follow manufacturer's directions on germicide for correct strength and preparation of solution. Avoid getting disinfectant in animal's eyes.

    Where to Implant

    The full contents of one cartridge cell should be implanted beneath the skin on the back side of the middle one-third of the ear as illustrated in the drawing. The implant must not be closer to the head than the edge of the auricular cartilage ring farthest from the head. The location for insertion of the needle is a point toward the tip of the ear and at least a needle length away from the intended deposition site. Avoid injuring the large arteries, veins and cartilage of the ear.

    Figure

    Insert the Needle

    With one hand firmly grasp the ear. With other hand insert needle point through the skin and ease forward on a lateral plane until the entire length of the needle is under the skin.

    Figure

    Implant the Pellets

    After inserting the needle fully in the correct position, squeeze the trigger fully as the needle is withdrawn from the ear. This properly deposits the implant in the needle track. This procedure should prevent breakage or crushing of pellets if otherwise forced into contact with tough fibrous-tissue underlying the skin. The length and total contact area of a single dose are designed to permit absorption of the hormones after implantation to stimulate good weight gain. Broken or crushed pellets may interfere with rates of gain and may lead to undesirable side effects such as noted in the CAUTION.

    Clean the Needle

    Clean the implanter needle with alcohol or a properly diluted germicidal solution prior to implanting the next animal.

  • Storage Conditions

    Store at controlled room temperature 15° to 30° C (59° to 86° F)

    DO NOT refrigerate – avoid excessive heat and humidity. Discard open foil pouches.

    NADA 110-315, Approved by FDA

    Manufactured by a non-sterilizing process.

    Component E-S with Tylan (progesterone and estradiol and tylosin implant) is covered by U.S. Patent No. 5,874,098

    Component, Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

    Distributed by Elanco US, Inc., Greenfield, IN 46140, USA

    Tylosin: Product of the United Kingdom

    To report adverse events, access medical information, or to obtain additional product information, call 1-800-428-4441

  • Principal Display Panel - Component E-S With Tylan Cartridge Label

    Elanco™

    Component™

    E-S with Tylan™

    (progesterone and estradiol and tylosin implant)

    STEERS

    Principal Display Panel - Component E-S With Tylan Cartridge Label
  • Principal Display Panel - Component E-S With Tylan Pouch Label

    Elanco™

    Component™

    E-S with Tylan™

    (progesterone and estradiol and tylosin implant)

    STEERS

    Each implant consists of 200 mg progesterone USP
    and 20 mg estradiol benzoate and 29 mg tylosin tartrate

    STEER IMPLANTS

    20 dose Cartridge Belt

    Principal Display Panel - Component E-S With Tylan Pouch Label
  • Principal Display Panel - Component E-S With Tylan Carton Label

    Elanco™

    Component™

    E-S with Tylan™

    (progesterone and estradiol and tylosin implant)

    STEERS

    Principal Display Panel - Component E-S With Tylan Carton Label
  • INGREDIENTS AND APPEARANCE
    COMPONENT E-S WITH TYLAN 
    progesterone, estradiol benzoate, tylosin tartrate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:58198-0328
    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
    tylosin tartrate (UNII: 5P4625C51T) (tylosin - UNII:YEF4JXN031) tylosin tartrate29 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    WATER (UNII: 059QF0KO0R)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-0328-25 in 1 CARTON
    11 in 1 POUCH
    120 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA11031512/09/2013
    Labeler - Elanco US Inc. (966985624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ivy Animal Health, Inc.088106096MANUFACTURE, PACK, LABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmacia and Upjohn Company618054084API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer AG314398484API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Elanco Speke Operations230761368API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Aspen API Inc.152349742API MANUFACTURE