TIAGEN 10%

COMPOSITION

Each mL of product contains Tiamulin hydrogen fumarate 100 mg

TARGET SPECIES

Pigs and broilers

INDICATIONS

Pigs - For the prevention (in populations where diagnosis was confirmed) and treatment of anaerobic dysentery, swine enzootic pneumonia, Mycoplasma spp. infections, secondary infections caused by tiamulin-susceptible germs.

Broilers - For the prevention (in populations where diagnosis has been confirmed) and treatment of chronic respiratory disease, mycoplasmosis and infectious arthritis.

CONTRAINDICATIONS

Do not administer to herbivores. Do not administer in cases of hypersensitivity to tiamulin.

ADVERSE REACTIONS

Occasionally, erythema and hypersensitivity reactions may occur.

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

Administration: oral, in drinking water. The treatment consists of oral administration of TIAGEN 10%, individually or by mass (by incorporation in drinking water), for 3-7 consecutive days at different doses, depending on species, age, body weight, physiological status and state of health. 

Pigs - Administer a dose of 8-10 mg a.s./kg bw/day, respectively 0.08-0.1 mL Tiagen 10%/kg bw /day.

Broilers - Administer a dose of 15-20 mg a.s./kg bw/day, respectively 0.15-0.2 mL Tiagen 10%/kg bw /day. 

WARNINGS/ADVICE FOR CORRECT ADMINISTRATION For mass treatment, in drinking water, we recommend the correct calculation of the total body weight and the amount of product to be administered, as well as the preparation of premixes, for proper homogenisation.

WITHDRAWAL PERIOD(S)

Pigs - meat and offal: 6 days

Broilers - meat and offal: 5 days

Do not use 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. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light. 

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

If the animals do not ingest sufficient amount of medicated water to provide their medication, they should be treated parenterally.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the veterinary medicinal product should be based on the results of susceptibility testing and the official and local policies concerning antimicrobial measures shall be observed. Using the product in violation of the instructions in the SmPC may increase the prevalence of resistance to tiamulin hydrogen fumarate and may decrease the effectiveness of antimicrobial treatments in the pleuromutilin 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:

The product may cause irritation of the respiratory tract and eyes in case of inhalation or contact. Adequate protective measures should be taken during product incorporation, when administered in drinking water. Specialised personnel must wear goggles and masks. In case of contact with eyes, wash with water and soap. 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. Do not use in poultry whose eggs are intended for human consumption.

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, the symptoms are: salivation, vomiting and lethargy.

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

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