Aivlosin

Generic name: tylvalosin
Dosage form: VETERINARY USE ONLY

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)

NADA 141-460 Approved by FDA.

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:

Swine:

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.

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:

No withdrawal period is required before slaughter for human consumption.

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.