Label: INTEPRITY- avilamycin granule

  • Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated July 11, 2022

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  • SPL UNCLASSIFIED SECTION

    Elanco™

    AF0375

    BG230612X

    Inteprity™

    Net Weight: 25 kg (55.12 lb)

    (Avilamycin Type A Medicated Article)

    CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

    For Use in Type C Medicated Broiler Chicken Feed Only

    Do Not Use to Manufacture Type B Medicated Feed

    Do not feed undiluted.

    Active Drug Ingredient: Avilamycin 45.4 g per lb (100 g per kg).

    Inert Ingredients: Roughage products and mineral oil.

  • Description:

    Inteprity Type A Medicated Article is a formulation of the antibiotic avilamycin. Avilamycin is in the orthosomycin class of antibiotics.

  • Indication:

    For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens.

  • Feeding Directions:

    Avilamycin is to be fed at 13.6 to 40.9 grams per ton of Type C medicated feed (15 to 45 ppm) as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens.

  • Mixing Directions:

    First, prepare an intermediate pre-blend by thoroughly mixing the required amount of Inteprity Type A medicated article in a convenient quantity of feed ingredients, and then thoroughly mix the pre-blend with non-medicated chicken feed to provide a complete Type C medicated feed containing 13.6 to 40.9 grams avilamycin per ton (15 to 45 ppm).

    Starting concentration of Inteprity Type A Medicated Article

    Amount of Type A Medicated Article to add per ton

    Resulting concentration in Type C Medicated Feed

    grams per pound

    pounds

    grams per ton

    45.4

    0.30

    13.6

    0.60

    27.2

    0.90

    40.9

    Caution: To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. The Veterinary Feed Directive (VFD) expiration date must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled.

  • WARNINGS:

    Withdrawal Period: No withdrawal period is required.

    User Safety Warnings: Avilamycin may be irritating to the eyes and may cause allergic reactions in those hypersensitive to avilamycin. Avoid inhalation, oral exposure, and direct contact with skin or eyes. Operators mixing and handling Inteprity Type A medicated article should use protective clothing, impervious gloves, goggles, and an approved dust mask. Wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water and seek medical attention. If wearing contact lenses, rinse the eyes first, then remove contact lenses and continue to rinse the eyes thoroughly and seek medical attention. If accidental skin contact occurs, wash all exposed areas of skin with soap and water, and seek medical attention if irritation develops. If accidental inhalation occurs, seek medical attention if breathing difficulty occurs. Not for human consumption. If accidental ingestion occurs, call a physician or poison control center. Do not induce vomiting. Keep out of reach of children. The Safety Data Sheet contains more detailed occupational safety information. To report adverse effects in users, to obtain more information, or to obtain a Safety Data Sheet, call 1-800-428-4441.

  • Adverse Drug Reactions:

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

  • Storage Information:

    Store at less than or equal to 25°C (77°F). Excursions to 40°C (104°F) are acceptable.

    Avoid excessive moisture.

    Not to be used after the date printed on the bag.

    Restricted Drug (California) - Use Only as Directed

    Approved by FDA under NADA # 141-439

    Manufactured For:

    Elanco US Inc. Greenfield, IN 46140

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

    TAKE TIME
    OBSERVE LABEL DIRECTIONS

    BG230612X

  • Principal Display Panel – 25 kg Bag Label

    Elanco™

    AF0375

    Inteprity™

    Net Weight: 25 kg (55.12 lb)
    (Avilamycin Type A Medicated Article)

    Principal Display Panel – 25 kg Bag Label
  • INGREDIENTS AND APPEARANCE
    INTEPRITY 
    avilamycin granule
    Product Information
    Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:58198-0375
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    avilamycin (UNII: 720WDX56D3) (avilamycin - UNII:720WDX56D3) avilamycin100 g  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-0375-925 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14143904/25/2016
    Labeler - Elanco US Inc. (966985624)
    Establishment
    NameAddressID/FEIBusiness Operations
    TriRx Speke Limited228138655API MANUFACTURE, MEDICATED ANIMAL FEED MANUFACTURE, PACK, LABEL
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