Aivlosin

Pharmgate Animal Health LLC

AIVLOSIN

FULL PRESCRIBING INFORMATION: CONTENTS*

• CAUTION
• PRODUCT AIVLOSIN DESCRIPTION
  • TYLVALOSIN TARTRATE CHEMICAL NOMENCLATURE AND STRUCTURE
  • ANTIBIOTIC CLASSIFICATION
• INDICATIONS
  • Swine
• AIVLOSIN DOSAGE AND ADMINISTRATION
  • Swine
• MIXING DIRECTIONS
  • Direct mixing
  • Stock solution
• WARNINGS
• WITHDRAWAL PERIOD
• ANTIBACTERIAL WARNINGS
• USER SAFETY WARNINGS
• PRECAUTIONS
• AIVLOSIN ADVERSE REACTIONS IN ANIMALS
• CLINICAL PHARMACOLOGY
• EFFECTIVENESS
  • Swine
• ANIMAL SAFETY
  • Swine
• STORAGE
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 40 g Packet
• PRINCIPAL DISPLAY PANEL - 160 g Packet
• PRINCIPAL DISPLAY PANEL - 400 g Packet

FULL PRESCRIBING INFORMATION

(62.5% w/w Tylvalosin as Tylvalosin Tartrate)

Water Soluble Granules

Use only as directed.

For use only in the drinking water of pigs.

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

CAUTION

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.

TYLVALOSIN TARTRATE CHEMICAL NOMENCLATURE AND STRUCTURE

(4R,5S,6S,7R,9R,11E,13E,15R,16R)-15-{[(6-deoxy-2,3-di-O-methyl-β-D-allopyranosyl)oxy]methyl}-6-({3,6-dideoxy-4-O-[2,6-dideoxy-3-C-methyl-4-O-(3-methylbutanoyl)-α-L-ribo-hexopyranosyl]-3-(dimethylamino)-β-D-glucopyranosyl}oxy)-16-ethyl-5,9,13-trimethyl-2,10-dioxo-7-(2-oxoethyl)oxacyclohexadeca-11,13-dien-4-yl acetate (2R,3R)-2,3-dihydroxybutanedioate.

ANTIBIOTIC CLASSIFICATION

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

INDICATIONS

Swine

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

AIVLOSIN DOSAGE AND ADMINISTRATION

Swine

Control of Porcine Proliferative Enteropathy

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

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

NOT FOR HUMAN USE.

KEEP OUT OF REACH OF CHILDREN.

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

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 Material Safety Data Sheet contains more detailed occupational safety information.

To report adverse effects in users, to obtain more information or obtain a Material Safety Data Sheet, call the ASPCA Animal Product Safety Service at 1-800-345-4735.

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.

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 the ASPCA Animal Product Safety Service at 1-800-345-4735 or the FDA at 1-888-FDA-VETS.

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

Swine

Control of Porcine Proliferative Enteropathy (PPE)

A multi-location challenge model study was conducted to confirm the effectiveness of AIVLOSIN^® Water Soluble Granules for the control of PPE associated with Lawsonia intracellularis. Pigs were challenged by intragastric gavage with a mucosal homogenate containing a North American isolate of Lawsonia intracellularis isolated in 2005 that induces representative disease in challenged pigs. When at least 15% of the study pigs were showing signs of infection based on abnormal fecal scores, pigs were provided water containing tylvalosin at an inclusion rate of 50 ppm for five consecutive days, or were provided non-medicated water.

Effectiveness was evaluated using clinical scores (pig demeanor score, abdominal appearance score, and fecal score) and clinically-validated gross PPE lesion scores. A conclusion of the effectiveness of 50 ppm tylvalosin for the control of PPE was determined based on a statistically significant (p = 0.0103) improvement in the clinically-validated gross PPE lesion scores in the 50 ppm tylvalosin-treated group compared to the non-medicated group.

ANIMAL SAFETY

Swine

Margin of safety

Aivlosin^® Water Soluble Granules given orally in drinking water at 0, 50, 150 and 250 ppm tylvalosin (0, 1×, 3× and 5× the labeled dose, respectively) to 8 healthy pigs per treatment group over 15 days (3× the labeled duration) did not result in drug-induced clinical signs, gross pathologic lesions, histopathologic lesions or clinically-relevant clinical pathology abnormalities.

STORAGE

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

HOW SUPPLIED

Aivlosin^® Water Soluble Granules is packaged in 40-, 160- and 400-gram sachets supplied in boxes holding 20, 10 and 5 sachets respectively.

LOT NO.: Printed on label.
EXPIRY: Printed on label.

Distributed in the USA by:
Pharmgate Animal Health.
161 North Franklin Turnpike,
Ramsey, NJ 07446
www.pharmgateah.com

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

To report suspected adverse drug events, contact the ASPCA Animal Product Safety Service at 1-800-345-4735 or
FDA at 1-888-FDA-VETS.

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

NADA 141- 336
Approved by FDA.

PRINCIPAL DISPLAY PANEL - 40 g Packet

NDC 51429-625-04

A I V LOSIN^®
(62.5% w/w Tylvalosin as
Tylvalosin Tartrate)
Water Soluble Granules

For use only in the drinking water of pigs. Not for use in lactating or pregnant
females, or males and females intended for breeding.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
INDICATIONS: Control of porcine proliferative enteropathy (PPE) associated with Lawsonia
intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE.
Read Product Information provided in the package insert carefully for complete
details.

DOSAGE AND ADMINISTRATION:
Swine: Control of Porcine Proliferative Enteropathy
Prepare drinking water containing 50 parts per million Tylvalosin. Add Aivlosin^® Water
Soluble Granules to drinking water as illustrated in the following table.

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: See Product Information provided in the package insert for details.

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

To report suspected adverse drug events, contact the ASPCA Animal Product
Safety Service at 1-800-345-4735 or FDA at 1-888-FDA-VETS.

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

Net contents: 40 grams
Aivlosin^® Water Soluble Granules

NADA 141- 336 Approved by FDA.

PharmGate
Animal Health

US01LM-1

LOT NO.:

EXP:

PRINCIPAL DISPLAY PANEL - 160 g Packet

NDC 51429-625-16

A I V LOSIN^®
(62.5% w/w Tylvalosin as
Tylvalosin Tartrate)
Water Soluble Granules

For use only in the drinking water of pigs. Not for use in lactating or pregnant
females, or males and females intended for breeding.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
INDICATIONS: Control of porcine proliferative enteropathy (PPE) associated with
Lawsonia intracellularis infection in groups of swine in buildings experiencing an
outbreak of PPE.
Read Product Information provided in the package insert carefully for complete details.

DOSAGE AND ADMINISTRATION:
Swine: Control of Porcine Proliferative Enteropathy
Prepare drinking water containing 50 parts per million Tylvalosin. Add Aivlosin^®
Water Soluble Granules to drinking water as illustrated in the following table.

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: See Product Information provided in the package insert for details.

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

To report suspected adverse drug events, contact the
ASPCA Animal Product Safety Service at
1-800-345-4735 or FDA at 1-888-FDA-VETS.

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

Net contents: 160 grams
Aivlosin^® Water Soluble Granules

NADA 141- 336 Approved by FDA.

PharmGate
Animal Health

US02LM-3

LOT NO.:

EXP:

PRINCIPAL DISPLAY PANEL - 400 g Packet

NDC 51429-625-40

A I V LOSIN^®
(62.5% w/w Tylvalosin as
Tylvalosin Tartrate)
Water Soluble Granules

For use only in the drinking water of pigs. Not for use in lactating or pregnant
females, or males and females intended for breeding.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
INDICATIONS: Control of porcine proliferative enteropathy (PPE) associated with Lawsonia
intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE.
Read Product Information provided in the package insert carefully for complete details.

DOSAGE AND ADMINISTRATION:
Swine: Control of Porcine Proliferative Enteropathy
Prepare drinking water containing 50 parts per million Tylvalosin. Add Aivlosin^® Water
Soluble Granules to drinking water as illustrated in the following table.

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: See Product Information provided in the package insert for details.

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

To report suspected adverse drug events, contact the
ASPCA Animal Product Safety Service at
1-800-345-4735 or FDA at 1-888-FDA-VETS.

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

Net contents: 400 grams
Aivlosin^® Water Soluble Granules

NADA 141- 336 Approved by FDA.

PharmGate
Animal Health

US03LM-3

LOT NO.:

EXP: