Kavault (Avilamycin) Powder [Elanco Us Inc.] -

KAVAULT (AVILAMYCIN) POWDER [ELANCO US INC.]
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NDC	58198-0374-9
Set ID	486263b6-d642-415e-90fe-372faf87d297
Category	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Packager	Elanco US Inc.
Generic Name
Product Class
Product Number
Application Number	NADA141438

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SPL UNCLASSIFIED SECTION

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 Swine Feed Only

Do Not Use to Manufacture Type B Medicated Feed

Do not feed undiluted.
Active Drug Ingredient:

Avilamycin 90.7 g per lb (200 g per kg)
Inert ingredients:

Roughage products and mineral oil
Description:

Kavault Type A medicated article is a formulation of the antibiotic avilamycin. Avilamycin is in the orthosomycin class of antibiotics.
Indication:

For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in groups of weaned pigs.
Feeding Directions:

Feed at 73 grams avilamycin per ton of Type C medicated feed (80 ppm) as the sole ration for 21 consecutive days. The veterinarian may direct feeding for up to a total of 42 consecutive days, based on the clinical assessment. Feed to pigs that are at risk of developing, but not yet showing clinical signs of, diarrhea in the presence of pathogenic Escherichia coli.

IMPORTANT: Must be thoroughly mixed in swine feed before use.

Mixing Directions:

Thoroughly mix Kavault Type A medicated article with a complete swine feed according to the table below to obtain the proper concentration in the Type C medicated feed. First, prepare an intermediate pre-blend by thoroughly mixing the required amount of Kavault Type A medicated article in a convenient quantity of feed ingredients, and then add the pre-blend to the remaining feed ingredients to make complete feed.

Starting concentration of Kavault 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
90.7	0.8	73

Caution:

To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older. Do not administer medicated feed containing avilamycin to pigs for more than a lifetime total of 42 days.

Avilamycin has not been demonstrated to be effective in pigs showing clinical signs of diarrhea prior to the start of medication.

The safety of avilamycin has not been established in swine intended for breeding purposes.

Veterinary Feed Directive (VFD) expiration date must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled.
WARNINGS:

Residue Warning: 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 Kavault should use protective clothing, impervious gloves, goggles, and an approved dust mask. Wash hands 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 thoroughly 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

NADA # 141-438, Approved by FDA

Product of the United Kingdom

Manufactured For:
Elanco US, Inc, Greenfield, IN 46140, USA
Kavault, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

Net Weight: 25 kg (55.12 lb)

TAKE TIME TO
OBSERVE LABEL
DIRECTIONS

BG101321X
Principal Display Panel – 25 kg Bag Label

Elanco™ AF0374

Kavault™

Avilamycin

INGREDIENTS AND APPEARANCE

KAVAULT
avilamycin powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC:58198-0374
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
avilamycin (UNII: 720WDX56D3) (avilamycin - UNII:720WDX56D3)	avilamycin	200 g in 1 kg

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
SOYBEAN (UNII: L7HT8F1ZOD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58198-0374-9	25 kg in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NADA	NADA141438	05/08/2015

Labeler - Elanco US Inc. (966985624)

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Medic