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Aivlosin Water Soluble Granules (Canada)

This page contains information on Aivlosin Water Soluble Granules for veterinary use.
The information provided typically includes the following:
  • Aivlosin Water Soluble Granules Indications
  • Warnings and cautions for Aivlosin Water Soluble Granules
  • Direction and dosage information for Aivlosin Water Soluble Granules

Aivlosin Water Soluble Granules

This treatment applies to the following species:
Manufacturer: Pharmgate Animal Health

DIN: 02373505

Veterinary use only

62.5% w/w tylvalosin (as tylvalosin tartrate)

Description

Aivlosin® Water Soluble Granules is a water soluble granular powder containing 62.5% w/w tylvalosin (as tylvalosin tartrate) for oral use by administration in the drinking water.

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

Aivlosin Water Soluble Granules Indications

For the treatment of Porcine Proliferative Enteropathy (PPE) associated with Lawsonia intracellularis in pigs.

TARGET SPECIES: Pigs.

Dosage and Administration

For use in drinking water of swine only.

Administer continuously in drinking water. Medicated water should be the only source of drinking water during the treatment period. If improvement is not observed within 5 days, the diagnosis should be reconfirmed. Keep water supply equipment clean and in good operating condition. Clean water medication equipment before and after each use. Only a sufficient amount of medicated drinking water should be prepared to cover daily requirements.

Do not mix or administer 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.

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.

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 until a clear solution is produced (usually within 3 minutes).

When preparing a stock solution for an automatic water proportioner, the recommended maximum concentration is one-40 g sachet per 2 L (~2 US quarts), one-160 g sachet per 8 L (~2 US gallons) or one-400 g sachet per 20 L (~5 US gallons). Sprinkle contents onto the surface of the water and mix slowing and thoroughly for 10 minutes. After this time, any remaining cloudiness will not affect tylvalosin concentration. Use the stock solution for dilution into the drinking water system as soon as it is prepared.

Prepare drinking water medicated with 50 parts per million tylvalosin as shown in the following table:

Aivlosin® Water Soluble Granules sachet size

40 g

160 g

400 g

Tylvalosin content of sachet (g)

25

100

250

Volume of drinking water (L)

500

2000

5000

Volume of drinking water (US gallons)

132

528

1320

Tylvalosin inclusion rate in water

50 parts per million (ppm)

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

Based on a theoretical daily water consumption rate of 10% body weight, 50 ppm tylvalosin in drinking water will provide a dose rate of 5 mg tylvalosin/kg body weight per day.

CAUTIONS: Not for use in breeding animals. The effects of tylvalosin on swine reproductive performance, pregnancy and lactation have not been determined.

Warnings

Treated swine must not be slaughtered for use in food for at least 24 hours after the latest treatment with this drug.

Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals; therefore, people with known hypersensitivity to tylvalosin tartrate should avoid contact with this product. When mixing Aivlosin® Water Soluble Granules and handling the medicated water, direct contact with eyes, skin and mucous membranes should be avoided. Keep out of reach of children.

Adverse Reactions

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

Clinical Pharmacology

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.

Mechanism of Action:

Tylvalosin is a 16-membered macrolide ring structure. Macrolides inhibit bacterial protein synthesis. They penetrate the bacterial cell wall and cell membrane to reach the cytoplasm, where they bind to the 50S ribosomal sub-unit with a specific target in the 23S ribosomal RNA molecule. Consequently, they prevent peptide chain elongation by interfering with the formation of the peptide bonds. The macrolide class of antimicrobials is used therapeutically.

MICROBIOLOGY: 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 but no activity against the naturally resistant Enterobacteriaceae including Escherichia coli and Salmonella spp. MIC data for Lawsonia intracellularis have been generated (Table 1). The MIC of each antibiotic was defined as the lowest concentration tested which consistently inhibited growth (<1% of the control growth).

Table 1. MIC Data for Tylvalosin against Lawsonia intracellularis

Strain Tested

Intracellular MIC (µg/ml)

Reference

51/89

32

McOrist (2002)

KM 01

32

916/91a

32

Gebhart (2000)

VP4b

>64 (cytopathic activity)

aUK strain, bUS strain

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.

HANDLING PRACTICES: When handling animals, the possibility of spreading infections between facilities and contracting zoonoses should be considered. The use of Good Infection Control Practices is recommended, and should include the use of impermeable gloves and clean clothing at each facility visited. Washing hands after each facility visit is recommended.

Storage

Store at or below 25°C.

How Supplied

Aivlosin® Water Soluble Granules is packaged in cartons containing either 20 x 40 g, 10 x 160 g or 5 x 400 g sachets.

ECO Animal Health Limited, 78 Coombe Road, New Malden, Surrey, KT3 4QS, UK.

Distributed in Canada by: Pharmgate Animal Health Canada Inc., 5204 Tenth Line, R.R. #2, Erin, ON N0B 1T0

For technical service: call 1 800 465 2450

To report adverse events: call 1 800 465 2450

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

Date on which the package leaflet was last approved: June 2011

ACA001-0

NAC No.: 16180001

PHARMGATE ANIMAL HEALTH CANADA INC.
5204 TENTH LINE, R.R. #2, ERIN, ON, N0B 1T0
Toll-Free:   800-465-2450
Website:   www.pharmgateah.com
General Inquires:   info@pharmgate.com
Support:   customerservice@pharmgate.com
Every effort has been made to ensure the accuracy of the Aivlosin Water Soluble Granules information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2016 North American Compendiums. Updated: 2016-10-31

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