TYLOPLUS 20%

COMPOSITION

Each g of product contains Tilmicosin phosphate 200 mg

TARGET SPECIES

Pigs and broilers

INDICATIONS

Broilers

The product is recommended for the prevention (in populations where the diagnosis has been confirmed) and the treatment of respiratory infections associated with Mycoplasma gallisepticum and Mycoplasma sinoviae.

Pigs

The product is recommended for the prevention (in populations where the diagnosis has been confirmed) and the treatment of respiratory infections associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

CONTRAINDICATIONS

Avoid access of horses to water containing tilmicosin. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS

None known.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION 

Pigs Administer a dose of 8-20 mg active substance/kg body weight/day, i.e., 40-100 mg of Tyloplus 20%/kg of body weight/day, for 7-10 days. 

Broilers Administer a dose of 10-25 mg active substance/kg body weight/day, i.e., 50-125 mg of Tyloplus 20%/kg of body weight/day, the duration of treatment being 3-5 days. 

The product is orally administered in drinking water or liquid fodder.

The weight of the animal will be assessed as accurately as possible to ensure a correct dose and avoid under-/overdosing.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

The treatment consists of oral administration of Tyloplus 20% in drinking water, individually or in mass, at different doses, depending on species, age, body weight, physiological status and state of health. Do not administer for more than 21 days.

WITHDRAWAL PERIOD(S)

Pigs Meat and offal: 14 days

Broilers Meat and offal: 12 days

Do not use in poultry laying eggs for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light. Do not use after the expiry date printed on the label.

SHELF LIFE

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 in drinking water: 24 hours.

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on the results of susceptibility testing of isolated bacteria. If this is not possible, therapy will be based on epidemiological information on the susceptibility of isolated bacteria.

Using the product in violation of the instructions in the SmPC may increase the prevalence of tilmicosin resistance and may decrease the effectiveness of antimicrobial treatments in the macrolide group as a result of cross-resistance. The ingestion of medicated water by the animal may be affected by the disease. In case of insufficient water ingestion, the treatment schedule will be reviewed. Medicated drinking water should be freshly prepared every 24 hours.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT

Tilmicosin may cause irritation of the respiratory tract and eyes in case of inhalation or contact. Adequate protective measures should be taken during handling of the product. The personnel handling the product must wear goggles and protective masks. In case of accidental contact with eyes, wash with water and soap. Do not smoke, drink or eat while handling the product. In the case of accidental ingestion, seek advice from a physician, presenting the package leaflet.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Do not use in poultry laying eggs for human consumption.

Do not use in pregnant or lactating animals.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

None known.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

There were no symptoms of overdose.

INCOMPATIBILITIES

Do not mix in bentonite-containing water. Bentonite can affect the effectiveness of tilmicosin.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements. Medicines should not be disposed of via waste water or household waste. The manufacturer recommends that the manure from the treated animals be handled and inactivated in accordance with the legislation in force to avoid contamination of the environment. Treated animals will be kept in shelters throughout the treatment period, and the manure collected will not be used for soil fertilisation.

PRESENTATION/PACKAGE

50g, 100g, 1kg, 5kg laminated terephthalate polyethylene foil/low-density polyethylene bags. 10kg, 25kg, 50kg laminated terephthalate polyethylene foil/aluminium/low-density polyethylene bags sealed by heat-sealing.