Pigs, chickens (pullets, breeders, layer hens) and turkeys (breeders, layer hens).

Treatment of Swine Dysentery caused by Brachyspira hyodysenteriae susceptible to tiamulin.

Treatment of Porcine Colonic Spirochaetosis (colitis) caused by Brachyspira pilosicoli susceptible to tiamulin.

Treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis susceptible to tiamulin.

Treatment and metaphylaxis of Enzootic Pneumonia caused by Mycoplasma hyopneumoniae, including infections complicated by Pasteurella multocida susceptible to tiamulin.

Treatment of Pleuropneumonia caused by Actinobacillus pleuropneumoniae susceptible to tiamulin.

The presence of the disease in the herd must be established before the veterinary medicinal product is used.

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 veterinary medicinal product is used.

Treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis caused by Mycoplasma gallisepticum, Mycoplasma synoviae and Mycoplasma meleagridis susceptible to tiamulin.

The presence of the disease in the flock must be established before the veterinary medicinal product is used.

Do not use in pigs and birds that could receive veterinary medicinal 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 any of the excipients.

See Interactions for information regarding interaction between tiamulin and ionophores.

Pigs with reduced water intake and/or in a debilitated condition should be treated parenterally.

The water intake of birds should be monitored at frequent intervals during treatment, especially in hot weather, because water intake may be depressed during the administration of tiamulin. This appears to be a concentration-dependent effect and does not appear to have any adverse effect on the overall performance of the birds or efficacy of the veterinary medicinal product. 500 mg tiamulin hydrogen fumarate in 4 litres of water may reduce intake by approximately 10% and 500 mg tiamulin hydrogen fumarate in 2 litres of water by 15% in chickens. In turkeys, this effect is more marked, with approximately a 20% reduction observed and therefore it is recommended not to exceed a concentration of 500 mg tiamulin hydrogen fumarate in 2 litres of the drinking water.

Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria. In some European regions, an increasing proportion of Brachyspira hyodysenteriae isolates from clinical cases demonstrate significantly reduced in vitro susceptibility to tiamulin. Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to tiamulin.

This veterinary medicinal product may cause skin and eye irritation. When mixing, direct contact with the skin and eyes should be avoided by wearing impermeable rubber gloves and safety glasses.

In case of accidental eye contact, irrigate the eyes thoroughly with clean running water immediately. Seek medical advice if irritation persists.

Contaminated clothing should be removed and any splashes on to the skin should be washed off immediately.

Wash hands after use.

a It appears to be concentration-dependent with 0.025% tiamulin reducing intake by approximately 15% in chickens and 20% in turkeys. A concentration with 0.0125% tiamulin reduces intake by approximately 10% in chickens. It does not appear to have any adverse effect on overall performance of the birds or efficacy of the product.

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for contact details.

Pregnancy and lactation:

Can be used in pigs during pregnancy and lactation.

Laying birds:

Can be used in laying chickens and in breeding chickens and turkeys.

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 veterinary medicinal products containing nomensin, 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.

In drinking water use.

The veterinary medicinal product should be administered using suitably calibrated equipment.

Guidance for preparing veterinary medicinal product solutions:

When medicating large volumes of water, prepare a concentrated solution first and then dilute to the required final concentration.

The veterinary medicinal product is soluble and stable from low concentration up to maximum concentration of the vetrinary medicinal product of 500 ml/l (1:2 dilution) in water of at least 4°C.

Fresh solutions of tiamulin-medicated drinking water should be made up each day. Any medicated drinking water remaining from the previous day should be discarded.

To ensure a 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.

Make sure the animals do not have access to non-medicated water during the period when the medicated water is given.

After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.

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 or narasin.

For chickens and turkeys, in order to avoid interactions between the incompatible ionophores monensin, narasin or 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.

Based on the recommended dose and the number and weight of animals to be treated, the exact daily concentration of the veterinary medicinal product should be calculated according to the following formula:

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

The dosage is 8.8 mg tiamulin hydrogen fumarate (equivalent to: Tialin 125 mg/ml - 0.07 ml solution; Tialin 250 mg/ml - 0.035 ml solution)/kg body weight administered daily in the drinking water of pigs for 3-5 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 (equivalent to: Tialin 125 mg/ml - 0.07 ml solution; Tialin 250 mg/ml - 0.035 ml solution)/kg body weight administered daily in the drinking water of pigs for 3-5 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 (equivalent to: Tialin 125 mg/ml - 0.07 ml solution; Tialin 250 mg/ml - 0.035 ml solution)/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 (equivalent to: Tialin 125 mg/ml - 0.16 ml solution; Tialin 250 mg/ml - 0.08 ml solution)/kg body weight administered daily for 5 consecutive days.

v) For the treatment of Pleuropneumonia caused by Actinobacillus pleuropneumoniae susceptible to tiamulin.

The dosage is 20 mg tiamulin hydrogen fumarate (equivalent to: Tialin 125 mg/ml - 0.16 ml solution; Tialin 250 mg/ml - 0.08 ml solution)/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 (equivalent to: Tialin 125 mg/ml - 0.2 ml solution; Tialin 250 mg/ml - 0.1 ml solution)/kg body weight administered daily for the period of 3-5 consecutive days.

For the treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis caused by Mycoplasma gallisepticum, Mycoplasma synoviae and Mycoplasma meleagridis.

The dosage is 40 mg tiamulin hydrogen fumarate (equivalent to: Tialin 125 mg/ml - 0.32 ml solution; Tialin 250 mg/ml - 0.16 ml solution)/kg body weight administered daily for the period of 3-5 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 tranquillisation. At 55 mg tiamulin hydrogen fumarate/kg body weight given daily for 14 days, a transient salivation and slight gastric irritation occured. Tiamulin hydrogen fumarate is considered to have an adequate therapeutic index in the pig and a minimum lethal dose has not been established.

Regarding poultry, 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 LD50 is 1090 mg/kg body weight for chickens and 840 mg/kg body weight for turkeys.

The clinical signs of acute toxicity in chickens are - vocalisation, clonic cramps and lying in a lateral position, and in turkeys - clonic cramps, lying in a lateral or dorsal position, salivation and ptosis.

If signs of intoxication do occur, promptly remove the medicated water and replace with fresh water.

Meat and offal: 2 days (8.8 mg tiamulin hydrogen fumarate (equivalent to: Tialin 125 mg/ml - 0.07 ml solution; Tialin 250 mg/ml - 0.035 ml solution)/kg body weight)

Meat and offal: 4 days (20 mg tiamulin hydrogen fumarate (equivalent to: Tialin 125 mg/ml - 0.16 ml solution; Tialin 250 mg/ml - 0.08 ml solution)/kg body weight)

Meat and offal: 2 days

Eggs: Zero days

Meat and offal: 6 days