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Pigs: treatment of enzootic pneumonia.
Chickens (broilers): treatment of necrotic enteritis and avian mycoplasmosis caused by tylosin-sensitive bacteria.
Tylosin tartrate 600 mg/g
Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.
None known.
SINTIL 60%, will be administered orally in drinking water, for 5 consecutive days, in different doses depending on species, age, body weight, clinical and physiological conditions. For the mass treatment we recommend the correct calculation of the total body weight and the amount of product to be administered.
Ø Pigs: the recommended dosage is 10 - 20 mg active substance / kg body weight / day, equivalent to 17-34 mg SINTIL 60% / kg b.w. / day.
Ø Chickens (broilers): the recommended dosage is 50 - 100 mg active substance /kg body weight / day, equivalent to 84-168 mg SINTIL 60%/kg b.w./day.
Ingestion of the medicated water depends on the clinical condition of the animals. In case of insufficient ingestion of medicated water, the treatment schedule will be reviewed.
Medicated water must be renewed every 24 hours.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Meat and offal:
Pigs: 1 days.
Chickens (broilers): 5 days.
Do not use in birds producing eggs for human consumption.
Keep out of the sight and reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place.
Protect from direct sunlight. Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 28 days.
Shelf life after reconstitution into drinking water: 24 hours.
Special precautions for use in animals
Use of the product should be based on susceptibility testing of bacteria isolates from the animal. If not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tylosin and may decrease the effectiveness of treatment with other macrolides due to potential of cross-resistance.
A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Special precautions to be taken by the person administering the medicinal product to animals
Tylosin may cause irritation of the respiratory tract and eyes following inhalation or contact.
Special precaution measures should be taken when handling the product.
Personal protective equipment consisting of safety glasses and dust mask should be worn when using the product. In case of accidental eye contact, wash the affected area with soap and water.
Do not smoke, eat or drink while handling this product.
In case of accidental ingestion, seek medical advice and show the physician the package leaflet.
Use during pregnancy, lactation or lay
Do not use in birds producing eggs for human consumption.
Laboratory studies in mice and rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the product has not been demonstrated during pregnancy and lactation in the target species. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The recommended doses will be followed.
Major incompatibilities
The absorption of the active substance is reduced by iron and acids containing calcium and / or magnesium.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
The medicinal product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Laminated foil bags (PET) / Low-density polyethylene of 25g, 50g, 100g, 1kg and 5kg.
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