tylvalosin

Control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups of swine intended for slaughter and female swine intended for breeding in buildings experiencing an outbreak of SRD. Not for use in male swine intended for breeding.

AIVLOSIN®

Control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine intended for slaughter and female swine intended for breeding in buildings experiencing an outbreak of PPE. Not for use in male swine intended for breeding.

AIVLOSIN®

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

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 interided for breeding. The effects of tylvalosin on swine reproductive performance, pregnancy, and lactation have not been determined. VFDs for tylvalosin shall not be refilled.

Aivlosin® 17%

INDICATION:

Aivlosin®17%(Tylvalosin Type A Medicated Article)

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.

FDA application 141-336

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.

Aivlosin®17%(Tylvalosin Type A Medicated Article)

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.

FDA application 141-336

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.

FDA application 141-336

WITHDRAWAL PERIOD: When used in accordance with label directions, no withdrawal period is required before slaughter for human consumption.

FDA application 141-336

WARNINGS:

Aivlosin®17%(Tylvalosin Type A Medicated Article)

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.

FDA application 141-336

Administer 38.6 grams tylvalosin per ton of Type C medicated feed (42.5 ppm) as the sole ration for 14 consecutive days.

Oral

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 interided for breeding. The effects of tylvalosin on swine reproductive performance, pregnancy, and lactation have not been determined. VFDs for tylvalosin shall not be refilled.

Aivlosin® 17%

Administer 50 ppm tylvalosin continuously in drinking water for five consecutive days.

Oral

AIVLOSIN®

DIRECTIONS FOR USE:

ORAL

Aivlosin®17%(Tylvalosin Type A Medicated Article)