Target species
Pigs.
Indications for use, specifying the target species
For the prevention and control of enzootic pneumonia.
For the treatment and control of Lawsonia intracellularis, the organism associated with Porcine Intestinal Adenomatosis (Ileitis) and Porcine Haemorrhagic Enteropathy.
Contraindications
Do not use in known cases of hypersensitivity.
Special warnings for each target species
None.
Special precautions for use
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Special precautions for use in animals
For use in pig feeds only.
To ensure thorough dispersion of the product it should first be mixed with a small quantity of feed ingredients before incorporation into the final mix.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
To avoid exposure during preparation of the medicated feed, wear overalls, safety glasses, impervious gloves and wear either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143. Wash hands after use.
In the event of accidental skin contact, wash thoroughly with soap and water. In case of accidental eye contact, flush the eyes with plenty of clean, running water.
Do not handle the product if you are allergic to ingredients in the product.
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.
Only to be incorporated by a manufacturer who is approved to mix at a rate of below 2 kg per tonne of final feed.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
No adverse effects to tylosin have been seen in fertility, multi-generation or teratology studies.
Interaction with other medicinal products and other forms of interaction
None observed.
Amounts to be administered and administration route
For incorporation into dry feed at the registered mill.
A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products must be responsible for mixing when incorporation is less than 2kg per tonne for final feed.
For oral administration.
Prevention and control of enzootic pneumonia:
3-6 mg tylosin activity/kg bodyweight, which may normally be achieved by adding the product at the rate of 2 kg per tonne, giving 100 g tylosin base per tonne. Feed as the only ration for 21 days.
Treatment and control of Lawsonia intracellularis:
3-6 mg tylosin activity/kg bodyweight, which may normally be achieved by adding the product at the rate of 2 kg per tonne, giving 100 g tylosin base per tonne. Feed as the only ration for 21 days.
The required levels of tylosin are obtained by mixing the appropriate quantity of premix with 20-50 kg of a suitable feed component, prior to incorporation into the bulk of the feed to be prepared.
The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of Tylan G50 has to be adjusted accordingly.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Produced no adverse effects when fed to pigs at 600 ppm in the feed (six times the recommended maximum level) for 28 days.
The LD 50 for both the rat and the mouse is >6200 mg tylosin activity/kg.
Withdrawal period
Meat: Zero days.