TYLOPLUS 25%

COMPOSITION

Each mL of product contains 250 mg of Tilmicosin (as phosphate)

TARGET SPECIES

Pigs and chickens (broilers)

INDICATIONS

Chickens (broilers) - For the treatment of respiratory diseases in chickens (broilers) caused by Mycoplasma gallisepticum and Mycoplasma synoviae.

Pigs - For the treatment of respiratory diseases in pigs, associated with Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae.

CONTRAINDICATIONS

Do not administer to horses. Do not use in cases of hypersensitivity to tilmicosin or to any of the excipients. Do not use in poultry laying eggs for human consumption.

ADVERSE REACTIONS

In some cases there may be a decrease in water consumption.

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

Administration: oral, in drinking water. To ensure a proper dose, the exact body weight will be determined to avoid underdosing or overdosing.

Pigs - Administer a dose of 15-20 mg active substance/kg live body weight/day, for 5 consecutive days.

Chicken (broilers) - Administer a dose of 15-20 mg active substance/kg live weight/day, for 3 consecutive days. 

The amount of Tyloplus 25% solution (CST) will be calculated based on the Total Body Weight (TBW) of the population to be treated and the Total Water Consumption (TWC) of the population in 24 hours using the following formula: CST (L) =[15-20xTBW(kg)]/[250xTWC(L)] per 1,000 L of medicated tank water. 15-20 = dose/kg bw, 250 = mg tilmicosin/1 mL Tyloplus 25% oral solution. The consumption of medicated water depends on the clinical condition of the animals. In order to obtain a correct dose, the tilmicosin concentration should be adjusted accordingly.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

The product should be diluted before use in animals.

Water consumption should be monitored to ensure adequate dose. If the water consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the Tyloplus 25% concentration should be adjusted so that the animals assimilate the recommended dose. Otherwise another medication should be considered.

WITHDRAWAL PERIOD(S)

Pigs - meat and offal: 14 days

Chickens (broilers) - Meat and offal: 12 days

Use in poultry laying eggs for human consumption is not authorised.

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: 1 year.

Shelf-life after first opening the immediate packaging: 28 days.

Shelf-life after reconstitution in drinking water: 24 hours.

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. Ingestion of medicated water by animals may be impaired by the disease. In case of insufficient medicated 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. It may cause allergies following injection, inhalation, ingestion or contact with skin or eyes. Those with known sensitivity to active substance or excipients will avoid contact with the product. Allergic reactions to tilmicosin may be severe. To avoid exposure during medicated solution preparation, wear suitable protective equipment (overalls, goggles and waterproof gloves). Do not eat, drink or smoke during product handling. Wash hands after use. In case of accidental ingestion, immediately wash mouth with water and seek medical attention. In case of accidental contact with skin, wash the area with water and soap. In case of accidental contact with eyes, rinse abundantly with clean tap water. If irritation occurs on the skin after exposure, you should seek medical attention and present the package leaflet to your doctor. Swelling of the face, lips and eyes or difficulty breathing are severe symptoms and require urgent medical attention.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

The effect of tilmicosin on reproduction, gestation and lactation has not been established and as such the benefit/risk ratio will be taken into account for these cases. 

Do not use in poultry during laying periods.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

No data are available.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Pigs - In the event of overdose, decrease in water consumption is seen, which, in extreme conditions, can lead to dehydration. In such situations it is recommended to remove the medicated drinking water and replace it with fresh, non-medicated water.

Chickens (broilers) - There have been no symptoms of overdose in those who received 5 times the recommended concentration.

INCOMPATIBILITIES

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

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.

PRESENTATION/PACKAGE

The product is packaged in white 50mL and 100mL HDPE vials and 1L, 5L, 10L, 20L HDPE cans.