Target species
Pigs
Indications for use
Pigs: Treatment and metaphylaxis of clinical signs of porcine proliferative enteritis (porcine intestinal adenomatosis, proliferative hemorrhagic enteropathy, ileitis) associated with Lawsonia intracellularis when the disease has been diagnosed at the group level.
Contra-indications
Do not use in animals with known hypersensitivity to the active substance and/or to any of the excipients of the product.
Do not use in animals with known hypersensitivity to tylosin and other macrolides.
Do not use where cross-resistance to other macrolides (MLS resistance) is suspected.
Do not use in animals vaccinated with tylosin-sensitive vaccines either at the same time or within 1 week previously.
Do not use in animals with hepatic disorders.
Do not use in horses – danger of inflammation of the cecum.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
This product is only for administration in small quantities of feed for immediate consumption, to individual animals. Animals with acute infections may have a reduced feed intake and should be treated with a suitable injectable product first. Due to likely variability (time, geographical) in susceptibility of bacteria to tylosin, bacteriological sampling and sensitivity testing are recommended. Inappropriate use of the veterinary medicinal poduct may increase the prevalence of bacteria resistant to Tylosin and other macrolides.
Special precautions for the person administering the veterinary medicinal product to animals
Tylosin may induce irritation. Macrolides, such a 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 mixing and handling of the veterinary medicinal product wear 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.
Adverse reactions
In pigs, adverse reactions have been observed, including diarrhoea, pruritus, erythema, rectal oedema and prolapse.
Use during pregnancy, lactation or lay
No adverse effects to tylosin have been seen in fertility, multi-generation teratology studies. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interactions
Lincosamides and aminoglycoside antibiotics antagonize the activity of tylosin.
Amounts to be administered and administration route
For use in individual pigs on farms where only a small number of pigs are to receive the medicine. Larger groups should be treated with medicated feeding stuff containing the premix.
Individual pigs should receive 5 mg tylosin per kg bodyweight, corresponding to 250 mg Pharmasin 20 mg/g Oral Granules/kg bodyweight, once a day for 3 weeks. This is achieved by thoroughly mixing the product into the daily ration for each individual pig. The required amount of product should be added to the estimated quantity of daily ration for each pig in a bucket or similar receptacle and thoroughly mixed. The product should only be added to dry non-pelleted feed.
The pig to be treated should be weighed to prevent underdosing.
Should there be no clear response to treatment within 3 days the treatment approach should be reconsidered.
Overdose
The product has been shown to produce no adverse effects when fed to pigs at 600 ppm in the feed (three to six times the recommended dose level) for 28 days. At high levels diarrhoea, apathy, convulsions may occur. The therapy is symptomatic.
Withdrawal periods
Pigs (meat) – 1 day