Pigs:

i) Treatment of Swine dysentery caused by Brachyspira hyodysenteriae susceptible to tiamulin. The presence of the disease in the herd must be established before the product is used.

ii) Treatment of Porcine Colonic Spirochaetosis (spirochaetal diarrhoea or colitis) caused by Brachyspira pilosicoli susceptible to tiamulin. The presence of the disease in the herd must be established before the product is used.

iii) Treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis, susceptible to tiamulin. The presence of the disease in the herd must be established before the product is used.

iv) Treatment and metaphylaxis of Enzootic pneumonia caused by Mycoplasma hyopneumoniae, including infections complicated by Pasteurella multocida susceptible to tiamulin. The presence of the disease in the herd must be established before the product is used.

Laying hens:

Treatment and metaphylaxis of Chronic Respiratory Disease caused by Mycoplasma gallisepticum and Airsacculitis and Infectious Synovitis caused by Mycoplasma synoviae susceptible to tiamulin. The presence of the disease in the flock must be established before the product is used.

Do not use in animals that could receive products containing monensin, narasin or salinomycin during or for at least seven days before or after treatment with tiamulin. Severe growth depression or death may result.

Do not use in cases of hypersensitivity to the active substance or to the excipients.

Water intake may be depressed during the administration of tiamulin in birds. It appears to be concentration-dependent with 500 mg tiamulin hydrogen fumarate (equivalent to 4ml of product) in 4 litres of water reducing intake by approximately 10% and 500 mg tiamulin hydrogen fumarate (equivalent to 4 ml of product) in 2 litres of water by 15% in chickens. It does not appear to have any adverse effect on overall performance of the birds or efficacy of the veterinary medicinal product but water intake should be monitored at frequent intervals, especially in hot weather.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tiamulin.

Ingestion of the product or medicated water should be avoided. In the event of accidental ingestion, rinse mouth with plenty of clean water and seek medical advice immediately

Pigs: On very rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin.

Chickens (laying hens): none known

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Can be used in laying hens.

Tiamulin has been shown to interact with ionophores such as monensin, salinomycin and narasin and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive products containing monensin, salinomycin or narasin during or at least 7 days before or after treatment with tiamulin. Severe growth depression, ataxia, paralysis or death may result. If signs of an interaction do occur, stop both the administration of tiamulin-medicated drinking water and also the administration of ionophore-contaminated feed immediately. The feed should be removed and replaced with fresh feed not containing the anticoccidials monensin, salinomycin or narasin. Concomitant use of tiamulin and the divalent ionophore anticoccidials lasalocid and semduramicin do not appear to cause any interaction, however the concomitant use of maduramicin may lead to a mild to moderate growth depression in chickens. The situation is transient and recovery normally occurs within 3- 5 days following withdrawal of tiamulin treatment.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The intake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of tiamulin has to be adjusted accordingly.

The dosage of the product to be incorporated should be established according to the following formula:

Use a sufficiently accurate commercially available device to measure the required amount of product. Only use clean containers for preparation of the medicated drinking water. Stir the medicated drinking water prepared with the product for at least 1 minute after preparation in order to assure homogeneity.

When medicating large volumes of water, prepare a concentrated solution first and then dilute to the required final concentration. The maximum solubility of the product is 200 mL/L.

Medicated drinking water should be refreshed or replaced every 24 hours.

In order to avoid interactions between the ionophores and tiamulin, the veterinarian and farmer should check that the feed label does not state that it contains salinomycin, monensin and narasin.

For chickens, in order to avoid interactions between the incompatible ionophores monensin, narasin and salinomycin and tiamulin, the feed mill supplying the birds feed should be notified that tiamulin will be used and that these anticoccidials should not be included in the feed or contaminate the feed.

The feed should be tested for the ionophores prior to use if there is any suspicion that contamination of the feed might occur.

If an interaction does occur, stop tiamulin medication immediately and replace with fresh drinking water. Remove contaminated feed as soon as possible and replace with feed not containing the tiamulin- incompatible ionophores.

i) For the treatment of Swine Dysentery caused by Brachyspira hyodysenteriae.

The dosage is 8.8 mg tiamulin hydrogen fumarate/kg body weight (equivalent to 7 ml of product/100 kg body weight) administered daily in the drinking water of pigs for 3 to 5 consecutive days depending on the severity of the infection and/or the duration of the disease.

ii) For the treatment of Porcine Colonic Spirochaetosis (colitis) caused by Brachyspira pilosicoli. The dosage is 8.8 mg tiamulin hydrogen fumarate /kg body weight (equivalent to 7 ml of product/100 kg body weight) administered daily in the drinking water of pigs for 3 to 5 consecutive days depending on the severity of the infection and/or the duration of the disease.

iii) For the treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis. The dosage is 8.8 mg tiamulin hydrogen fumarate /kg body weight (equivalent to 7 ml of product/100 kg body weight) administered daily in the drinking water of pigs for 5 consecutive days.

iv) For the treatment and metaphylaxis of Enzootic Pneumonia caused by Mycoplasma hyopneumoniae,including infections complicated by Pasteurella multocida susceptible to tiamulin. The dosage is 20 mg tiamulin hydrogen fumarate/kg body weight (equivalent to 16 ml of product/100 kg body weight) administered daily for 5 consecutive days.

For the treatment and metaphylaxis of Chronic Respiratory Disease caused by Mycoplasma gallisepticum and Airsacculitis and Infectious Synovitis caused by Mycoplasma synoviae. the dosage is 25 mg tiamulin hydrogen fumarate/kg body weight (equivalent to 20 ml of product/100 kg body weight) administered daily for the period of 3 to 5 consecutive days.

Single oral doses of 100 mg tiamulin hydrogen fumarate/kg body weight in pigs caused hyperpnoea and abdominal discomfort. At 150 mg tiamulin hydrogen fumarate/kg body weight no central nervous system effects were noted except for sedation. At 55 mg tiamulin hydrogen fumarate/kg body weight given daily for 14 days, a transient salivation and slight gastric irritation occurred. Tiamulin hydrogen fumarate is considered to have an adequate therapeutic index in the pig and a minimum lethal dose has not been established.

The LD50 is 1090 mg/kg body weight for chickens. There is a relatively high therapeutic index with tiamulin hydrogen fumarate and the likelihood of an overdose is considered remote especially as water intake and hence tiamulin hydrogen fumarate intake is reduced if abnormally high concentrations are given. The clinical signs of acute toxicity in chickens are vocalisation, clonic cramps and lying in a lateral position.

If signs of intoxication do occur promptly remove the medicated water and replace with fresh unmedicated water and apply supportive, symptomatic therapy.

Pigs:

Meat and offal: 2 days (8.8 mg tiamulin hydrogen fumarate/ kg body weight equivalent to 7 ml of product/100 kg body weight)

Meat and offal: 4 days (20 mg tiamulin hydrogen fumarate/ kg body weight, equivalent to 16 ml product)/100 kg body weight)

Meat and offal: 2 days

Eggs: zero days