Aivlosin® 625 mg/g Granules for Use in Drinking Water for Pigs is a white granular powder containing 625 mg/g tylvalosin (as tylvalosin tartrate).

Treatment and metaphylaxis of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis.

Treatment and metaphylaxis of Swine Enzootic Pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae.

The presence of the disease in the group must be established before metaphylaxis.

For use in drinking water.

To ensure a correct dosage, bodyweight should be determined as accurately as possible. Water consumption should be monitored, and the concentration of the product adjusted if needed to avoid underdosing.

The product should be added to a volume of water that the pigs will consume in one day. No other source of drinking water should be available during treatment.

The dose is 5 mg tylvalosin per kg bodyweight per day in drinking water for 5 consecutive days.

Calculate the total amount of product required with the following formula:

Total weight of product in grams = total bodyweight of the heaviest pig to be treated in kg x number of pigs x 5 / 625.

Select the correct number of sachets according to the amount of product required.

The 40 g sachet is sufficient to treat a total of 5,000 kg of pigs (e.g. 250 pigs with the heaviest pig weighing 20 kg) for one day.

The 160 g sachet is sufficient to treat a total of 20,000 kg of pigs (e.g. 400 pigs with the heaviest pig weighing 50 kg) for one day.

The 400 g sachet is sufficient to treat a total of 50,000 kg of pigs (e.g. 1,000 pigs with the heaviest pig weighing 50 kg) for one day.

The dose is 10 mg tylvalosin per kg bodyweight per day in drinking water for 5 consecutive days.

Calculate the total amount of product required with the following formula:

Total weight of product in grams = total bodyweight of the heaviest pig to be treated in kg x number of pigs to be treated x 10 / 625.

Select the correct number of sachets according to the amount of product required.

The 40 g sachet is sufficient to treat a total of 2,500 kg of pigs (e.g. 125 pigs with the heaviest pig weighing 20 kg) for one day.

The 160 g sachet is sufficient to treat a total of 10,000 kg of pigs (e.g. 200 pigs with the heaviest pig weighing 50 kg) for one day.

The 400 g sachet is sufficient to treat a total of 25,000 kg of pigs (e.g. 500 pigs with the heaviest pig weighing 50 kg) for one day.

In order to achieve a correct dose, accurate and properly calibrated equipment should be used for weighing out the required amount of product.

The veterinary medicinal product may be mixed directly into the drinking water system or first mixed as a stock solution into a smaller amount of water, which is then added into the drinking water system.

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

When preparing a stock solution, the maximum concentration should be 40 g of product per 1,500 ml, 160 g of product per 6,000 ml or 400 g of product per 15,000 ml water and it is necessary to mix the solution for 10 minutes. After this time, any remaining cloudiness will not affect the efficacy of the veterinary medicinal product.

Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements.

Medicated drinking water should be replaced every 24 hours.

After end of the medication period, the water supply system should be cleaned appropriately to avoid intake of subtherapeutic amounts of the active substance.

As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the build-up of resistance.

No signs of intolerance have been observed in pigs at up to 100 mg tylvalosin per kg bodyweight per day for 5 days.

Meat and offal: 2 days.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation in pigs. Use only in accordance with benefit-risk assessment by the responsible veterinarian.

Laboratory studies in animals have not produced any evidence of a teratogenic effect. Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.

In severely diseased pigs, if water intake is reduced, pigs should be treated with a suitable injectable veterinary medicinal product prescribed by a veterinarian. At the recommended dose, lung lesions and clinical signs are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.

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

Good management and hygiene practices should be followed to reduce the risk of re-infection.

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 veterinary medicinal product deviating from the instructions in the SPC 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. An antibacterial with a lower risk of antimicrobial resistance selection, if available for the same indication, should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.

Tylvalosin has been shown to cause hypersensitivity (allergic) reactions in laboratory animals; therefore, people with known hypersensitivity to tylvalosin should avoid contact with this product.

When mixing the veterinary medicinal product and handling the medicated water, direct contact, with eyes, skin and mucous membranes should be avoided. Personal protective equipment consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 should be worn when mixing product. Wash contaminated skin.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

40 g sachet: Do not store above 25°C.

160 g sachet: Do not store above 25°C.

400 g sachet: Do not store above 25°C.

Shelf life of the veterinary medicinal product as packaged for sale:

40 g sachet - 3 years.

160 g sachet - 2 years.

400 g sachet - 2 years.

Shelf life after first opening of the immediate packaging: 5 weeks.

Shelf life of the medicated drinking water: 24 hours.

Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements.

40 g, 160 g or 400 g sachets.

Not all pack sizes may be marketed.

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

VM 13277/5004

EU/2/04/044/009 – 40 g

EU/2/04/044/010 – 160 g

EU/2/04/044/017 – 400 g