Animal NDC 58198-0374-9 Kavault
Avilamycin

Animal Product Information

Field Name Field Value
Animal NDC Code 58198-0374-9
Proprietary Name Kavault 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
    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.
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 NADA141438 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.

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Kavault 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.

Table of Contents



Other



Type A Medicated Article

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.


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.

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.


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


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 # 141-438

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

BG230613X


Principal Display Panel – 25 Kg Bag Label



Elanco™ AF0374

Kavault™

Avilamycin


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.