AIVLOSIN®
Product Type: PRESCRIPTION ANIMAL DRUG LABEL
Autor Name: Pharmgate Animal Health LLC
Code Source: 51429-400
Route of Administration: ORAL
(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.
Chemical Structure
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.
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.
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.
NDC 51429-100-03
US04PIM-2
NADA 141-336 Approved by FDA.
AIVLOSIN ®
(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
NDC 51429-040-10
PharmGate Animal Health US??SM-0
LOT NO. / EXP:
PRINCIPAL DISPLAY PANEL 40 grams Packet Label
AIVLOSIN ®
(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
NDC 51429-160-10
PharmGate Animal Health US??SM-0
LOT NO. / EXP:
PRINCIPAL DISPLAY PANEL 160 grams Packet Label
AIVLOSIN ®
(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
NDC 51429-400-10
PharmGate Animal Health US??SM-0
LOT NO. / EXP:
PRINCIPAL DISPLAY PANEL 400 grams Packet Label
Autor Name: Pharmgate Animal Health LLC
Code Source: 51429-400
Route of Administration: ORAL
Aivlosin
Generic: Tylvalosin tartrateIngredients:
- Tylvalosin tartrate Tylvalosin : Active ingredient - moiety is basis of strength - 62.5 g in 100 g
- Lactose monohydrate : Inactive ingredient
Package Description:
- 40 g in 1 PACKET
Aivlosin
Generic: Tylvalosin tartrateIngredients:
- Tylvalosin tartrate Tylvalosin : Active ingredient - moiety is basis of strength - 62.5 g in 100 g
- Lactose monohydrate : Inactive ingredient
Package Description:
- 160 g in 1 PACKET
Aivlosin
Generic: Tylvalosin tartrateIngredients:
- Tylvalosin tartrate Tylvalosin : Active ingredient - moiety is basis of strength - 62.5 g in 100 g
- Lactose monohydrate : Inactive ingredient
Package Description:
- 400 g in 1 PACKET
(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
(4 R ,5 S ,6 S ,7 R ,9 R ,11 E ,13 E ,15 R ,16 R )-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 (2 R ,3 R )-2,3-dihydroxybutanedioate.ANTIBIOTIC CLASSIFICATION
Tylvalosin, the active ingredient in Aivlosin ® Water Soluble Granules, is a macrolide antibiotic.Chemical Structure
INDICATIONS Swine
Control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE.DOSAGE AND ADMINISTRATION Swine
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
ANIMAL SAFETY Swine
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.
NDC 51429-100-03
US04PIM-2
NADA 141-336 Approved by FDA.
PRINCIPAL DISPLAY PANEL 40 grams Packet Label
NADA 141-336 Approved by FDA.AIVLOSIN ®
(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.
| Aivlosin ® Water Soluble Granules sachet size | 40 grams |
|---|---|
| Tylvalosin content of sachet (grams) | 25 |
| Volume of drinking water (liters) | 500 |
| Volume of drinking water (US gallons) | 132 |
| Tylvalosin inclusion rate in water | 50 parts per million (ppm) |
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
NDC 51429-040-10
PharmGate Animal Health US??SM-0
LOT NO. / EXP:
PRINCIPAL DISPLAY PANEL 40 grams Packet Label
PRINCIPAL DISPLAY PANEL 160 grams Packet Label
NADA 141-336 Approved by FDA.AIVLOSIN ®
(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.
| Aivlosin ® Water Soluble Granules sachet size | 160 grams |
|---|---|
| Tylvalosin content of sachet (grams) | 100 |
| Volume of drinking water (liters) | 2000 |
| Volume of drinking water (US gallons) | 528 |
| Tylvalosin inclusion rate in water | 50 parts per million (ppm) |
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
NDC 51429-160-10
PharmGate Animal Health US??SM-0
LOT NO. / EXP:
PRINCIPAL DISPLAY PANEL 160 grams Packet Label
PRINCIPAL DISPLAY PANEL 400 grams Packet Label
NADA 141-336 Approved by FDA.AIVLOSIN ®
(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.
| Aivlosin ® Water Soluble Granules sachet size | 400 grams |
|---|---|
| Tylvalosin content of sachet (grams) | 250 |
| Volume of drinking water (liters) | 5000 |
| Volume of drinking water (US gallons) | 1320 |
| Tylvalosin inclusion rate in water | 50 parts per million (ppm) |
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
NDC 51429-400-10
PharmGate Animal Health US??SM-0
LOT NO. / EXP:
PRINCIPAL DISPLAY PANEL 400 grams Packet Label