Aivlosin 17% (Canada)

Company: Pharmgate Animal Health

Tylvalosin Medicated Premix

DIN 02419491

CONTAINS ANTIMICROBIAL

USE RESPONSIBLY

Antibiotic

Veterinary use only

Warnings

No withdrawal period is required when treated according to the label. 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 and handling Aivlosin^® 17%, avoid inhalation, oral exposure and direct contact with skin or eyes. Keep out of reach of children.

Description

Aivlosin^® 17% contains 170 g/kg tylvalosin (supplied as tylvalosin tartrate) for oral use in medicating complete feed for swine.

THERAPEUTIC CLASSIFICATION:

Tylvalosin, the active ingredient in Aivlosin^® 17%, is a macrolide antibiotic.

Aivlosin 17% Indications

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

TARGET SPECIES: Pigs.

Dosage and Administration

To reduce the development of antimicrobial resistance and maintain effectiveness, use this antibiotic prudently.

For Feed Manufacturing Use Only.

Do not feed undiluted.

Aivlosin^® 17% must be thoroughly mixed into feeds before use. Thoroughly mix 0.25 kg Aivlosin^® 17% with 999.75 kg of complete feed to obtain a medicated feed with tylvalosin concentration of 0.00425% (42.5 g/1000 kg).

To aid in the even distribution of drug in the finished feed, add the full amount of Aivlosin^® 17% into a small portion of the feed (at least 10 kg per tonne of finished feed) and mix. Blend this mixture into the remainder of the feed and mix thoroughly. Feed as the sole ration for 14 consecutive days.

CAUTIONS: Not for use in breeding animals.

The effects of tylvalosin on male and female reproductive performance, including pregnancy and lactation, have not been determined.

Do not use in feeds containing pellet binding agents with the exception of Lignosol (4%) and Agri-Colloid (0.3%).

Do not use in feeds containing bentonite.

Acute cases and severely diseased pigs with reduced food and water intake should be treated with a suitable injectable product. It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria. Use of the product deviating from the instructions may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the potential for cross-resistance.

Adverse Reactions

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

Clinical Pharmacology

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

^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.

DATE OF PREPARATION:

December 1, 2017

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

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 & MSDS, call: 1 800 465 2450

To report adverse events, call: 1 800 345 4735

CPN: 1618001.2