TIAGEN 800 WSP

COMPOSITION

Each gram of product contains Tiamulin hydrogen fumarate 800 mg

TARGET SPECIES

Pigs

INDICATIONS

for the treatment of swine dysentery produced by tiamulin-susceptible brachyspira hyodysenteriae for the treatment of enzootic pneumonia caused by tiamulin-susceptible mycoplasma hyopneumoniae.

CONTRAINDICATIONS

Do not use in cases of known hypersensitivity to tiamulin or to excipients. Do not use in known cases of resistance to tiamulin. Do not use with products containing ionophores such as monensin, salinomycin or narasin during or for at least 7 days before or after treatment with tiamulin.

ADVERSE REACTIONS

In rare cases, hypersensitivity to tiamulin following oral administration was reported, exhibiting increased salivation, mild swelling, acute dermatitis with cutaneous erythema and intense rash. Adverse reactions are often mild and transient. If these typical adverse reactions occur, stop treatment immediately.

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

Administration: oral, in drinking water. The treatment consists of oral administration of TIAGEN 80% in drinking water, for 5 consecutive days at different doses, depending on species, age, body weight, physiological status and state of health. For mass treatment, in drinking water, we recommend the correct calculation of the total live weight and the amount of product to be administered, as well as the preparation of premixes, for proper homogenisation.

In pigs - Administer a dose of 10 mg a.s./kg bw/day, respectively 12.5 mg Tiagen WSP 800/kg bw /day.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

To ensure proper dosing, the exact body weight should be determined to avoid underdosing or overdosing. Water consumption should be monitored to ensure adequate dosage. If the water consumption does not correspond to the quantities for which the recommended concentrations have been calculated, the TIAGEN WSP 800 concentration should be adjusted so that the animals assimilate the recommended dose. Otherwise another medication should be considered. Medicated drinking water should be freshly prepared every 24 hours. Medicated water should be the only source of drinking water for the entire duration of the treatment. After the end of the drug administration period, the water supply system should be properly cleaned to avoid intake of therapeutic amounts of the active substance.

WITHDRAWAL PERIOD(S)

Pigs - meat and offal:  2 days   

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. Keep away from light. 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 original packaging: 28 days. Shelf-life after reconstitution in drinking water: 24 hours.

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

Ingestion of medicated water by animals may be impaired by the disease. If animals do not ingest enough water to provide their medication, the treatment schedule will be reviewed and the animals shall be treated adequately by parenteral administration.

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:

Avoid direct contact with skin, eyes and mucous membranes by wearing overalls, waterproof rubber gloves and goggles when preparing or handling the product.

In case of accidental contact with eyes, rinse eyes thoroughly with clean water immediately. Seek medical advice if irritation persists.

When handling the product, dust inhalation should be avoided by wearing a disposable breathing mask. Contaminated clothing should be removed. In case of exposure or contact

with the skin, the affected area should be washed immediately with water and soap. 

Accidental ingestion should be avoided. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Those with known hypersensitivity to tiamulin should avoid contact with the product.

Do not eat, drink or smoke during product handling. Wash hands after use.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

The product can be used during gestation and lactation.

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

1kg laminated PET foil/low-density polyethylene bags.