TIAGEN 80% PREMIX

COMPOSITION

Each gram of product contains Tiamulin hydrogen fumarate 800 mg

TARGET SPECIES

Pigs and broilers

INDICATIONS

Pigs - For the treatment of anaerobic dysentery, swine enzootic pneumonia, mycoplasma infections, secondary infections, caused by germs susceptible to tiamulin hydrogen fumarate.

Broilers - For the treatment of chronic respiratory disease, mycoplasmosis and infectious arthritis produced by germs susceptible to tiamulin hydrogen fumarate.

CONTRAINDICATIONS

Do not administer to herbivores. Do not use in animals with known hypersensitivity to the active substance or to the excipient.

ADVERSE REACTIONS

Occasionally, hypersensitivity reactions to tiamulin may occur, manifested as erythema. 

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

The treatment consists of oral administration of TIAGEN 80%, individually or in mass (by incorporation in fodder), for 3-7 consecutive days at different doses, depending on species, age, body weight, physiological status and state of health. To ensure a correct dose, the body weight of the animals should be accurately determined, whenever possible, to avoid underdosing. For mass treatment, the animals should be grouped according to body weight and should be dosed appropriately to avoid under- or overdosing. To ensure good homogenisation of the product, it must first be mixed with a suitable amount of fodder to obtain a premix before it is incorporated into the final fodder.

Pigs - Administer a dose of 8-10 mg active substance/kg body weight/day, equivalent to 10-12.5 mg of Tiagen 80%/kg of body weight/day. 

Broilers - Administer a dose of 15-20 mg active substance/kg body weight/day, equivalent to 19-25 mg of Tiagen 80%/kg of body weight/day. Throughout treatment, animals should consume only medicated fodder.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Fodder consumption should be monitored to ensure adequate dose. If the fodder consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the TIAGEN 80% 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: 6 days

Broilers Meat and offal: 4 days

Do not use the product in poultry whose eggs are intended for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Keep 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 incorporation into fodder: 28 days.

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

The ingestion of medicated fodder by the animal may be affected by the disease. 

If animals do not ingest enough fodder to provide their medication, the treatment schedule will be reviewed and the animals treated adequately parenterally.

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 tiamulin resistance and may decrease the effectiveness of antimicrobial treatments in the pleuromutilin group as a result of cross-resistance.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Those with known hypersensitivity to any of the product components should avoid any contact with the product. The product may cause irritation of the respiratory tract and eyes in case of inhalation or contact. If irritation persists, consult a physician and show the package leaflet or product label. Appropriate protection measures should be taken during product incorporation into fodder. Specialised personnel must wear goggles and masks. In case of contact with eyes, rinse with plenty of water. Do not eat, drink or smoke during product handling. Wash hands after use.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Studies in laboratory animals have revealed no embryotoxic or teratogenic potential. Product safety has not been demonstrated during the gestation and lactation period. Product can be administered during gestation and lactation after the risk-benefit ratio has been assessed by a veterinarian.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Do not administer in combination with monensin, narasin, salinomycin.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Do not exceed the recommended dose. In case of overdose, salivation or vomiting may occur.

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. 

The treated animals will be kept in shelters throughout the treatment and the manure from them will be collected and SHALL NOT be used for soil fertilisation. Medicines should not be disposed of via waste water or household waste.

PRESENTATION/PACKAGE

100g, 1 kg, 5 kg laminated terephthalate polyethylene foil/low-density polyethylene bags.

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