Label: KAVAULT- avilamycin powder
- NDC Code(s): 58198-0374-9
- Packager: Elanco US Inc.
- 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
- Caution:
- Active Drug Ingredient:
- Inert ingredients:
- Description:
- Indication:
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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.
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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
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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.
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WARNINGS:
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.
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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)
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OBSERVE LABEL
DIRECTIONSBG230613X
- Principal Display Panel – 25 kg Bag Label
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INGREDIENTS AND APPEARANCE
KAVAULT
avilamycin powderProduct Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:58198-0374 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength avilamycin (UNII: 720WDX56D3) (avilamycin - UNII:720WDX56D3) avilamycin 200 g in 1 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-0374-9 25 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141438 05/08/2015 Labeler - Elanco US Inc. (966985624) Establishment Name Address ID/FEI Business Operations TriRx Speke Limited 228138655 API MANUFACTURE, MANUFACTURE, PACK, LABEL
