Animal NDC 58198-0375-9 Inteprity

Avilamycin

Animal Product Information

Field Name	Field Value
Animal NDC Code	58198-0375-9
Proprietary Name	Inteprity What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name	Avilamycin What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name	Elanco Us Inc.
Product Type	Vfd Type A Medicated Article Animal Drug
Usage Information	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.
Active Ingredient(s)	Avilamycin
Marketing Category	NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number	NADA141439 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Inteprity Images

Principal Display Panel – 25 kg Bag Label - 230612AP BG230612X P1a 01

Inteprity Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Other
Description:
Indication:
Feeding Directions:
Mixing Directions:
Adverse Drug Reactions:
Storage Information:
Principal Display Panel – 25 Kg Bag Label

Other

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.

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.

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.

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.

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