Label: COMPONENT E-H WITH TYLAN- testosterone and estradiol and tylosin tartrate implant

  • NDC Code(s): 0986-0338-29
  • Packager: Elanco Animal Health Co
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated December 9, 2013

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

  • SPL UNCLASSIFIED SECTION

    Heifers

    E-H with Tylan®

    (testosterone and estradiol and tylosin implant)

    Each implant consists of 200 mg testosterone
    progesterone USP and 10 mg estradiol benzoate
    and 29 mg tylosin tartrate

    HEIFER IMPLANTS

    20 dose Cartridge Belt

    Use with a Component Implanter

    For Use In Animals Only

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  • DESCRIPTION:

    Each cartridge belt holds 20 doses of Component E-H with Tylan (testosterone and estradiol and tylosin implant)Implants. Each dose of 9 pellets consists of 8 pellets containing a total of 200 mg testosterone propionate USP and 20 mg estradiol benzoate plus 1 pellet containing 29 mg tylosin tartrate as a local antibacterial. Component E-H (testosterone and estradiol implant) Implants are recommended for use in heifers 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.

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  • DOSAGE:

    Administer 1 implant per animal according to the following instructions.

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  • 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.

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  • 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

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  • CAUTION:

    For use in heifers only. Bulling, vaginal and rectal prolapse, udder development, ventral edema and elevated tail-heads have occasionally been reported in animals implanted with testosterone propionate and estradiol benzoate.

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  • 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 a 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 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 the 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 135-906, Approved by FDA

    Manufactured by a non-sterilizing process.

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

    Elanco, Component, Tylan and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

    Distributed by Elanco Animal Health, a Division of Eli Lilly and Company, Indianapolis, IN 46285, USA

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

    PA086880AMX
    AH0338

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  • Principal Display Panel - Pouch Label

    ElancoTM

    Component®

    Heifers

    E-H with Tylan®

    (testosterone and estradiol and tylosin implant)

    One 20-Dose Cartridge Belt

    Principal Display Panel - Pouch Label
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  • Principal Display Panel - Carton Label

    ElancoTM

    Component®

    Heifers

    E-H with Tylan®

    (testosterone and estradiol and tylosin implant)

    100 IMPLANTS

    Principal Display Panel - Carton Label
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  • INGREDIENTS AND APPEARANCE
    COMPONENT E-H WITH TYLAN 
    testosterone and estradiol and tylosin tartrate implant
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:0986-0338
    Route of Administration SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    testosterone propionate (UNII: WI93Z9138A) (testosterone - UNII:3XMK78S47O) testosterone propionate 200 mg
    estradiol benzoate (UNII: 1S4CJB5ZGN) (estradiol - UNII:4TI98Z838E) estradiol benzoate 20 mg
    tylosin tartrate (UNII: 5P4625C51T) (tylosin - UNII:YEF4JXN031) tylosin tartrate 29 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    WATER (UNII: 059QF0KO0R)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0986-0338-29 5 in 1 CARTON
    1 1 in 1 POUCH
    1 20 in 1 CARTRIDGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA135906 12/09/2013
    Labeler - Elanco Animal Health Co (807447169)
    Establishment
    Name Address ID/FEI Business Operations
    Ivy Animal Health Inc 088106096 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Pharmacia and Upjohn Company 829076566 API MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Gedeon Richter Plc. 644781932 API MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Bayer Pharma AG 341322131 API MANUFACTURE
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