A clear sterile yellow aqueous solution. Each ml contains 200 mg tylosin and 41.66mg Benzyl Alcohol as preservative.

For the treatment of diseases in pigs involving organisms sensitive to tylosin, such as swine erysipelas (Erysipelothrix rhusiopathiae) and pneumonia (Mycoplasma hyopneumoniae).

0.5 ml/10 kg bodyweight, equivalent to 10 mg of tylosin per kg bodyweight, by deep intramuscular injection every 12 hours, up to a maximum of 6 injections. Do not inject more than 5 ml at a single injection site.

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid under dosing.

Not to be used in animals known to be hypersensitive to the active ingredient.

Not recommended for horses.

Official, national and regional antimicrobial policies should be taken into account when the product is used.

Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek medical attention immediately. In the event of accidental skin contact, wash thoroughly with soap and water. Wash hands after use. Tylosin may induce irritation. Macrolides, such as tylosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tylosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

Tolerance studies and toxicity studies suggest that undesirable effects are unlikely. Occasionally, swelling at the injection site may occur but this effect is transient.

Reports of adverse reproductive effects have not been noted. Use with care in pregnant animals.

Tolerance studies of up to 156% of the recommended dosage rate have been carried out with localised swelling at the injection site being the only adverse effect. The lowest recorded LD50 for tylosin from other acute toxicity studies was 400mg/kg bodyweight (40 times the recommended dosage rate) by intravenous injection in mice.

Pigs should not be slaughtered for human consumption during treatment or for 46 days following the last injection.

Do not store above 25°C and protect from light. Following withdrawal of the first dose use the product within 28 days. Discard unused material.

Any unused veterinary medicinal products or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

For animal treatment only.

Keep out of the reach of children.

Multidose 100ml amber Type II glass vials sealed with a bromobutyl rubber stopper and capped with an aluminium overseal.

Tylosin is a macrolide antibiotic which acts by interfering with bacterial protein synthesis. It has a spectrum of activity and mode of action similar to that of erythromycin, being usually bacteriostatic and largely active against Gram-positive aerobes like Erysipelothrix. Macrolides are well absorbed and often concentrate within cells and macrophages thereby targeting intracellular pathogens including Mycoplasmas. Unlike most antibiotics, its use is restricted to the veterinary field.

Cross Vetpharm Group Ltd

Broomhill Road

Tallaght

Dublin 24