Do not administer to animals susceptible to tiamulin.

Animals should not receive products containing ionophores (monensin, narasin or salinomycin) during or for at least seven days before or after treatment with tiamulin. Severe growth depression or death may result.

Local (digestive) and systemic reactions are infrequently and transient. In pigs, in some animals, erythema was noticed.

Store in original packaging, at temperature bellow 25^oC, protected from moisture and direct sunlight.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after dilution in drinking water, according to directions: 24 hours.

Shelf-life after first opening of package: 30 days.

Do not use after expiry date which is stated on the label.

During treatment, the animals should drink only medicated water. Medicated drinking water should be freshly prepared every 24 hours. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The uptake of medicated water is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted.

Meat and offal

Pigs: 9 days.

Chickens: 7 days.

Eggs: 8 days.

Due to variability (time, geographical) in susceptibility of bacteria for tiamulin, bacteriological sampling and susceptibility testing of microorganisms from diseased animals on farm are highly recommended. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in gloves, goggles and protective dust masks should be worn when handling or mixing the product. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as face swelling, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.

Laboratory studies on rodents have not produced any evidence of teratogenic, fetotoxic or maternotoxic effects. Although, the administration in pregnant sows or breeding boars should be avoided, if is necessary, the administration should be evaluated based on risk/benefit ratio.

In pigs, when medicated water is administered in dosage up to 5 times higher than recommended dosages (40mg tiamulin/kg bw), some animals could drink less water than others. The water intake will become normally in maximum 3 days. When the pigs were given 100 mg tiamulin/kg bw, hyperpnoea and abdominal discomfort were noticed. At 150 mg tiamulin/kg bw no effects on CNS were observed, except sedation. At 55 mg/kg bw, administered for 14 consecutive days, leads to transitory hypersalivation and intestinal irritation (tenesmus and diarrhea).

The clinical signs of acute toxicity in chickens are – vocalization, clonic cramps and lateral recumbency. In turkeys signs of acute toxicity include clonic cramps, lateral or dorsal recumbency, salivation and ptosis. If signs of intoxication do occur promptly remove the medicated drinking water, replace with fresh unmedicated water and apply supportive, symptomatic therapy. In chickens, the LD₅ for chickens is 1290mg/kg and turkeys 840 mg/kg bodyweight.

Pharmacodynamic incompatibility with beta-lactamides.

For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.