Aivlosin: Product Information

AIVLOSIN- tylvalosin tartrate granule, for solution
Pharmgate Animal Health LLC

Approved by FDA under NADA # 141-336

AIVLOSIN®

(62.5% w/w Tylvalosin as Tylvalosin Tartrate)

Water Soluble Granules

For use only in the drinking water of swine intended for slaughter.

Not for use in lactating or pregnant females, or males and females intended for breeding.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

PRODUCT DESCRIPTION:

Aivlosin® (Tylvalosin Tartrate) Water Soluble Granules is a water soluble granular powder for oral use by administration in the drinking water. Each gram of Aivlosin® Water Soluble Granules contains 0.625 grams of tylvalosin as tylvalosin tartrate.

ANTIBIOTIC CLASSIFICATION: Tylvalosin, the active ingredient in Aivlosin® Water Soluble Granules, is a macrolide antibiotic.

INDICATIONS:

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

Control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups of swine intended for slaughter in buildings experiencing an outbreak of SRD.

DOSAGE AND ADMINISTRATION:

Prepare drinking water medicated with 50 parts per million Tylvalosin as shown in the following table.

Aivlosin® Water Soluble Granules sachet size 160 grams 400 grams
Tylvalosin content of sachet (grams) 100 250
Recommended volume of stock solution (US gallons) 4 10
Volume of drinking water (US gallons) 528 1320
Final tylvalosin inclusion rate in drinking water 50 parts per million (ppm)

Administer continuously in drinking water for five (5) consecutive days.

Keep water supply equipment clean and in good operating condition. Clean water medication equipment before and after each use. Do not mix or administer Tylvalosin medicated water using equipment made of galvanized metal. Galvanized metal adversely affects the stability of Tylvalosin in water and may reduce the effectiveness of the product. Prepare a fresh batch of medicated stock solution or medicated drinking water daily.

MIXING DIRECTIONS:

Aivlosin® Water Soluble Granules may be mixed directly into the drinking water system or first mixed as a stock solution in a smaller amount of water, which is then added to the drinking water system, for example, using an automatic water proportioner.

Direct mixing:

When mixing the product directly into the drinking water system, the contents of the sachet should be sprinkled onto the surface of the water and mixed slowly and thoroughly for at least 3 minutes. Prepare a fresh batch of medicated drinking water daily.

Stock solution:

When preparing a stock solution, the recommended concentration is one 40-gram sachet per US gallon, or one 160-g sachet per four (4) US gallons or one 400-gram sachet per 10 US gallons. Sprinkle sachet contents onto the surface of the water of the stock solution and mix slowly and thoroughly for at least 10 minutes. Use the stock solution for dilution into the drinking water system as soon as it is prepared. Add one (1) fluid ounce of this stock solution per 131 fluid ounces (1 US gallon, 3 fluid ounces) of drinking water to provide a final concentration of 50 ppm. If using an automatic water proportioner, set the flow rate to add stock solution at a rate of 1 fluid ounce per 131 fluid ounces of drinking water (1:131). Prepare a fresh batch of medicated stock solution daily.

WARNINGS:

WITHDRAWAL PERIOD:

When used in accordance with label directions, 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 pathogenic bacteria.

USER SAFETY WARNINGS:

NOT FOR USE IN HUMANS.
KEEP OUT OF REACH OF CHILDREN.

May cause skin irritation. Tylvalosin Tartrate has been shown to cause hypersensitivity reactions in laboratory animals. People with known hypersensitivity to Tylvalosin Tartrate should avoid contact with this product. In case of accidental ingestion, seek medical advice.

When handling Aivlosin® Water Soluble Granules and preparing medicated drinking water, 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. If irritation persists, seek medical attention. Avoid eating, chewing gum and smoking during handling. Wash contaminated skin.

The Safety Data Sheet contains more detailed occupational safety information.

To report adverse effects in users, to obtain more information or obtain a Safety Data Sheet, call Pharmgate Animal Health LLC. at 1-833-531-0114.

PRECAUTIONS:

Not for use in lactating or pregnant females, or males and females intended for breeding. The effects of Tylvalosin on swine reproductive performance, pregnancy and lactation have not been determined. The safety and efficacy of this formulation in species other than swine have not been determined.

To assure both food safety and responsible use in swine, concurrent use of tylvalosin in medicated drinking water and tylvalosin or another macrolide in medicated feed or by any other route of administration should be avoided. Tylvalosin belongs to the macrolide antimicrobial drug class. Macrolides are ranked as a critically important drug in human medicine; therefore, minimizing the risk of development of antimicrobial resistance to this class of drug is very important. The following conditions of use and restrictions listed below are critical for
the FDA’s strategy of risk management associated with tylvalosin:

Always treat the fewest number of animals necessary to control a respiratory disease or PPE outbreak.

Do not immediately follow this macrolide treatment with another macrolide treatment via any route.

Prescriptions should not be renewed or refilled for animals already treated with one course of therapy with tylvalosin asdirected (See Dosage and Administration above).

ADVERSE REACTIONS IN ANIMALS:

No adverse reactions related to the drug were observed during clinical or target animal safety trials. 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.

CLINICAL PHARMACOLOGY:

Tylvalosin is a 16-membered semi-synthetic macrolide antibiotic. Macrolides are generally considered to be bacteriostatic agents that exert their antibiotic effect by reversibly binding to the 23S rRNA of the 50S ribosomal subunit, thereby inhibiting bacterial protein synthesis. The spectrum of activity of most available macrolides used in veterinary medicine is primarily against Gram-positive bacteria and Mycoplasmas, with some activity against Gram-negative fastidious bacteria. These compounds have no activity against the naturally resistant Enterobacteriaceae including Escherichia coli and Salmonella spp. Typically, macrolides achieve higher concentrations in tissues than in plasma.

EFFECTIVENESS:

Page 1 of 3 1 2 3

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2021. All Rights Reserved.