Target species
Pigs
Indications for use
For treatment and metaphylaxis of swine dysentery caused by Brachyspira hyodysenteriae.
For the treatment of enzootic pneumonia caused by tiamulin-susceptible Mycoplasma hyopneumoniae and mycoplasmal arthritis caused by tiamulin-susceptible Mycoplasma hyosynoviae.
Contra-indications
Do not use in cases of known hypersensitivity to the active ingredient or any of the excipients. Do not use in cases of known resistance to tiamulin.
Special warnings for each target species
Inflammation/scarring may occur at the site of injection. For this reason, it is recommended that the product should be administered into the muscle of the neck.
Special precautions for use
Special precautions for use in animals
Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for tiamulin, the use of the product should be based on bacteriological sampling and susceptibility testing taking into account official and local antimicrobial policies. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tiamulin and may decrease the effectiveness of treatment with other pleuromutilins due to the potential for cross-resistance.
Long term or repeated use should be avoided by improving management practice and thorough cleansing and disinfection.
In the absence of a satisfactory response to treatment, the diagnosis should be reconsidered.
Special precautions for the person administering the veterinary medicinal product to animals
People with known hypersensitivity to tiamulin should handle the product carefully.
Care should be taken to avoid self-injection. Direct contact with the skin, eyes and mucous membranes should be avoided when handling the product.
In case of accidental eye contact, irrigate the eyes thoroughly with clean running water immediately. Seek medical advice if irritation persists.
In case of skin contact, wash immediately with running water in order to minimise absorption through the skin.
Wash hands after use.
This product contains sesame oil. Accidental self injection may result in severe localised reactions, particularly if injected into a joint or finger. In case of accidental injection, seek medical advice immediately. Show the package leaflet or the label to the physician.
Adverse reactions
In rare cases, hypersensitivity to tiamulin is reported in terms of acute dermatitis with cutaneous erythema and intense pruritus. The adverse reactions are usually mild and transient but in very rare cases may be serious. Symptomatic treatment such as electrolyte therapy and an anti-inflammatory therapy may be useful.
Use during pregnancy, lactation or lay
The product can be used during pregnancy and lactation.
Interactions
Tiamulin is known to produce clinically important (often lethal) interactions with ionophore antibiotics, including monensin, narasin, salinomycin. Therefore, pigs should not receive products containing such compounds during or for at least seven days before or after treatment with this product. Severe growth depression or death may result.
Tiamulin may lessen the antibacterial activity of beta-lactam antibiotics, whose action is dependent on bacterial growth.
Amounts to be administered and administration route
For intramuscular use.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
For the treatment of clinical swine dysentery:
8.1 mg tiamulin base per kg bodyweight (equivalent to 1 ml per 20 kg bodyweight) to be administered in a single treatment followed by tiamulin in the water or feed.
For the treatment of enzootic pneumonia or mycoplasmal arthritis:
12.1 mg tiamulin base per kg bodyweight (equivalent to 1.5 ml/20 kg bodyweight) daily for 3 consecutive days. Depending on the severity of disease it may be necessary to continue treatment by orally administered tiamulin until 2 days after signs of disease have subsided.
The closures should not be broached more than 5 times. In order to prevent excessive broaching of the stopper, a suitable multiple dosing device should be used.
Overdose
A single oral dose of 100 mg/kg bodyweight caused hyperpnoea and abdominal discomfort in pigs. At a dose of 150 mg/kg the only effect on the central nervous system was lethargy. A dose of 55 mg/kg for 14 days caused increased salivation and a mild irritation of the stomach. Tiamulin hydrogen fumarate has a relatively high therapeutic index in pigs. The minimum lethal dose has not been established in pigs.
Withdrawal periods
Meat and offal: 21 days