Target species
Pigs (weaned piglets and fattening pigs).
Indications for use
Tilmovet 100 mg/g Granules is indicated for the treatment of pneumonia in weaned fattening pigs, caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida sensitive to tilmicosin.
Contra-indications
Do not use in animals hypersensitive to tilmicosin and when there is resistance to tilmicosin or cross resistance to other macrolides like tylosin, erythromycin or lincomycin.
Tilmicosin is known to be toxic for horses. Do not allow horses or other equines access to feeds containing tilmicosin.
Special warnings for each target species
If for an individual animal, feed intake is such that the recommended dosage is not realized, medication should be carried out by parenteral treatment.
Special precautions for use
Special precautions for use in animals
Cross-resistance between tilmicosin and other macrolide antibiotic has been observed. Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Due to likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended. Inappropriate use of the product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin related substances.
Special precautions for the person administering the veterinary medicinal product to animals
Accidental ingestion should be avoided by humans. People with known hypersensitivity to macrolide antibiotics should avoid contact with the veterinary medicinal product. May cause sensitisation by skin contact. May cause skin and eye irritation. Avoid direct skin contact. Wear overalls, safety glasses and impervious gloves when mixing and handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water. In case of accidental ingestion, or if you develop symptoms following exposure such as skin rash, seek medical advice immediately and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. If the operations involve the risk of exposure to dust, wear either a disposable filter and half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 fitted with a filter to EN143. This warning is particularly relevant to on-farm mixing, where the risk of exposure to dust is likely to be enhanced.
Adverse reactions
Occasionally, feed intake may decrease (including feed refusal) in animals receiving medicated feed. This effect is transient.
In case of occurrence of allergic reaction, the treatment should be withdrawn.
Use during pregnancy, lactation or lay
Laboratory studies in rats have not produced any evidence of a teratogenic, foetotoxic/embryotoxic effect of tilmicosin, however, a maternotoxicity was observed at doses that were close to the therapeutic dosage. The product can be used in sows whatever the pregnancy stages.
The safety of tilmicosin has not been established in boars used for breeding purposes.
Interactions
Do not use simultaneously with other macrolides and lincosamides.
Do not use simultaneously with bacteriostatic antimicrobial agents.
Tilmicosin may lessen the antibacterial activity of β-lactam antibiotics.
Amounts to be administered and administration route
For oral administration after incorporation into feed.
The product should be administered to small quantities of feed for immediate consumption by individual animals. For treatment of groups of pigs, use an appropriate premix incorporated into medicated feedingstuff by an authorised feed manufacturer. Pigs to be treated should be separated and treated individually. The required quantity of the product should be thoroughly mixed into the daily ration for each individual pig. The feed containing the oral granules should be provided as the sole ration for the periods recommended. Individual pigs should receive 16 mg tilmicosin per kg bodyweight, corresponding to 160 mg Tilmovet 100 mg/g Oral Granules/kg bodyweight, once a day for 15 days. The pig to be treated should be weighed and the amount of feed that the pig is likely to consume should be estimated. The correct quantity of the product should be added to the estimated quantity of daily ration for each pig, in a bucket or similar receptacle, and thoroughly mixed. The product should only be added to dry non pelleted feed.
Overdose
Vomiting and cardio-vascular collapse are symptoms of overdosing.
Withdrawal periods
Pig: meat and offal 21 days.