Aivlosin 17% (Tylvalosin Type A Medicated Article)

Company: Pharmgate Animal Health

Approved by FDA under NADA # 141-460

Aivlosin 17% (Tylvalosin 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

Do Not Feed Undiluted

For Further Manufacturing Only

For Use in Swine Feed Only

ACTIVE DRUG INGREDIENT:

Tylvalosin 17% w/w (77.12 g tylvalosin/lb, equivalent to tylvalosin tartrate 19.4% w/w)

INDICATION:

Swine: Control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE.

Directions For Use

MIXING DIRECTIONS:

Control of Porcine Proliferative Enteropathy

Preparation of Type B medicated feed containing 3,856 grams per ton (4,250 ppm) tylvalosin:

Prepare tylvalosin Type B medicated feed in mash form only.

To manufacture one ton of Type B medicated feed containing 3,856 g/ton (4,250 ppm) tylvalosin, mix 50 pounds of Aivlosin^® 17% Type A Medicated Article with 1950 pounds of non-medicated feed.

Preparation of Type C medicated feed containing 38.6 grams per ton (42.5 ppm) tylvalosin:

To manufacture one ton of Type C medicated feed containing 38.6 g/ton (42.5 ppm) tylvalosin, mix 0.5 pound of Aivlosin^® 17% Type A Medicated Article with 1999.5 pounds of non-medicated feed.

To aid in the even distribution of drug in the finished feed, add the full amount of Aivlosin^® 17% Type A Medicated Article into a small portion of the feed and mix. Blend this mixture into the remainder of the feed and mix thoroughly.

Pelleted Type C medicated feeds must bear an expiration date of 30 days after the date of manufacture.

Crumbled Type C medicated feeds must bear an expiration date of 7 days after the date of manufacture.

FEEDING DIRECTIONS: Feed Type C medicated feed containing 38.6 grams tylvalosin/ton as the sole ration for 14 consecutive days.

Aivlosin 17% (Tylvalosin Type A Medicated Article) Caution

To assure both food safety and responsible use in swine, concurrent use of tylvalosin Type A medicated article in medicated feed and tylvalosin or another macrolide in medicated drinking water or by any other route of administration should be avoided. Not for use in swine intended for breeding. The effects of tylvalosin on swine reproductive performance, pregnancy, and lactation have not been determined. VFDs for tylvalosin shall not be refilled.

Warnings

WITHDRAWAL PERIOD:

ANTIBACTERIAL WARNINGS:

Use of antibacterial drugs in the absence of a susceptible bacterial infection is unlikely to provide benefit to treated animals and may increase the development of drug-resistant bacteria.

USER SAFETY WARNINGS:

Not for use in humans. Keep out of reach of children.

May cause skin irritation. Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals.

People with known hypersensitivity to tylvalosin should avoid contact with this product. In case of accidental ingestion or inhalation, seek medical attention. When handling Aivlosin^® 17% Type A Medicated Article and preparing medicated feeds, avoid direct contact with the eyes and skin. Wear a dust mask, coveralls and impervious gloves when mixing and handling this product. Eye protection is recommended. In case of accidental eye exposure, wash eyes immediately with water and seek medical attention. If wearing contact lenses, immediately rinse the eyes first, then remove contact lenses and continue to rinse the eyes thoroughly and seek medical attention. In case of accidental skin exposure, wash contaminated skin thoroughly.

The Safety Data Sheet contains more detailed occupational safety information.

Storage

Store in a cool dry place at or below 25°C (77°F).

Restricted Drug (California) - Use only as directed.

Distributed in the USA by: Pharmgate Animal Health, LLC, 14040 Industrial Road, Omaha, Nebraska 68144.

For sales, technical assistance or to obtain a Safety Data Sheet, call Pharmgate Animal Health at 1-800-380-6099

To report suspected adverse reactions in animals, contact Pharmgate Animal Health LLC. at 1-833-531-0114.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or at www.fda.gov/reportanimalae.

Aivlosin^® is a registered trademark of ECO Animal Health Ltd.

ECO Animal Health Limited, 78 Coombe Road, New Malden, Surrey, KT3 4QS, UK.

CPN: 1635020.5