Label: COMPUDOSE- estradiol, oxytetracycline implant

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

Drug Label Information

Updated July 29, 2020

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  • SPL UNCLASSIFIED SECTION

    Elanco

    AH0327

    Compudose

    (estradiol implant)

    Each implant consists of 25.7 mg estradiol

    200 Day Controlled Release Implants

  • DESCRIPTION:

    Each Compudose (estradiol implant) silicone rubber implant contains 25.7 mg estradiol and is coated with not less than 0.5 mg of oxytetracycline powder as a local antibacterial.

    For subcutaneous ear implantation in steers and heifers only.

  • INDICATIONS:

    For increased rate of weight gain in suckling and pastured growing steers; for improved feed efficiency and increased rate of weight gain in confined steers and heifers. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

  • USE:

    Compudose Controlled Release Implant will provide an effective daily dose of estradiol for at least 200 days. No additional effectiveness may be expected from reimplanting in less than 200 days.

  • DIRECTIONS:

    Insert one implant under the skin of the ear as directed in this leaflet.

    WHEN TO IMPLANT Compudose:

    Suckling steers

    At castration or later

    Pastured growing steers

    At weaning or later

    Finishing steers and heifers

    At arrival in feedlot

  • WARNING:

    Keep out of reach of children.

    A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

  • EQUIPMENT:

    A Compudose (estradiol implant) or Encore (estradiol implant) Implanter must be used to implant cattle.

    Figure
  • DIRECTIONS FOR IMPLANTATION:

    Insert one implant under the skin of the ear.

    1. Confine animal in a squeeze chute.
    2. To reduce the possibility of infection and resulting implant loss, hygienic and antiseptic procedures should be followed during implantation. The ear should be clean and dry. The skin should be cleansed with a suitable antiseptic soap and dried prior to implanting. This is particularly important if the ears are contaminated with urine or feces.
    3. To load the Compudose/Encore Implanter remove the cartridge from the package, release the latch on the magazine, open and insert the cartridge. (Figure 1)

      Close the magazine and latch. Advance the cartridge to the next implant by inserting the thumb into the magazine opening and turning the cartridge to the next stop.

      Use a sharp needle. The needle should be cleaned and sterilized between each injection by wiping the exterior with a sponge, cloth, or gauze saturated with an appropriate disinfectant. The presence of excessive moisture inside the needle may result in dissolving the oxytetracycline (OTC) from the implant surface and contribute to accumulation of OTC inside the needle.

      Figure 1

      Figure 1

    4. The implant should be deposited under the skin on the back side of the middle third of the ear. It should be placed between the skin and cartilage, avoiding major blood vessels.

      Grasping the tip of the ear with one hand and the implanter in the other, penetrate the skin in the outer third of the ear. (see Figure 2)

      Figure 2

      Figure 2

      IMPORTANT: Do not penetrate cartilage.

    5. Upon penetration, the needle should be fully inserted (Figure 3) between the skin and cartilage, avoiding major blood vessels. Full insertion of the needle is important to maximize implant retention.

      Figure 3

      Figure 3

    6. Pull the needle back as the implant is being deposited by squeezing the lever on the implanter grip. Figure 4 shows the implant in proper position in the middle third of the ear where the skin is tight.
    7. After repeated use, sufficient oxytetracycline (OTC) from the implant may accumulate inside the needle to impede implant passage. Periodic removal of the needle from the device and washing it in water will prevent such accumulation. Before reusing, the needle should be disinfected and allowed to dry after shaking vigorously to remove excess water or disinfectant.

      Proper Position

      Figure 4

      Figure 4

    8. If reimplantation is desired, it is not necessary to remove the existing Compudose (estradiol implant) implant. Place the second implant at the same level and parallel to, but not in contact with the existing implant or place it in the unimplanted ear in accordance with paragraphs 1-7 of these directions.

    CAUTION: To maximize implant retention:

    1. Fully insert the needle.
    2. Deposit the implant in the middle third of the ear where the skin is tight.
    3. Do not deposit the implant where the skin is loose in the third of the ear closest to the head.

    The needle has been scientifically designed to maximize retention. When it becomes dull, use a new needle. If the needle is resharpened, sharpen only the point.

    Failure to follow antiseptic implanting procedures, particularly when the ears are contaminated with fecal material, may result in infection and excessive implant loss. Implanting cattle during wet weather may increase infection and implant loss.

    Carefully check the ears for implant loss approximately 4 weeks after implantation. If loss occurs, reimplant using recommended procedures.

    CAUTION: Increased sexual activity (bulling, riding and excitability) has been reported in animals implanted with Compudose. Implanted animals should be observed for such signs particularly during the first few days after implanting and animals being excessively ridden (bullers) should be removed to prevent physical injury. Vaginal and rectal prolapse have been reported in heifers implanted with Compudose.

    CAUTION: Do not use in animals intended for breeding purposes.

  • Side Effects:

    Udder development, swollen or enlarged vulva and high tailheads may be observed in implanted heifers.

  • How Supplied:

    Compudose Implants are supplied in cartridges of 20 implants each.

    NADA 118-123, Approved by FDA

    Manufactured by a non-sterilizing process.

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

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

    Product of Germany

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

  • Principal Display Panel - Encore Carton Label

    Elanco™

    AH0327

    Compudose™

    (estradiol implant)

    Each implant consists of 25.7 mg estradiol

    200 DAY CONTROLLED RELEASE IMPLANTS

    Principal Display Panel - Encore Carton Label
  • Principal Display Panel - Compudose Cartridge Label

    AH0327

    Elanco™

    Compudose™

    (estradiol implant)

    Each implant consists of 25.7 mg estradiol

    200 DAY CONTROLLED RELEASE IMPLANTS

    20 IMPLANTS

    Principal Display Panel - Compudose Cartridge Label
  • INGREDIENTS AND APPEARANCE
    COMPUDOSE 
    estradiol, oxytetracycline implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:58198-0327
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    estradiol (UNII: 4TI98Z838E) (estradiol - UNII:4TI98Z838E) estradiol25.7 mg
    oxytetracycline (UNII: X20I9EN955) (oxytetracycline anhydrous - UNII:SLF0D9077S) oxytetracycline0.5 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-0327-15 in 1 CARTON
    120 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA11812303/12/1982
    Labeler - Elanco US Inc. (966985624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ivy Animal Health, Inc.088106096MANUFACTURE, PACK, LABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer AG314398484API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Hebei Jianmin Starch Glucose Co., Ltd. 529723751API MANUFACTURE