Target species
Pigs (Weaned piglets and fattening pigs) and rabbits.
Indications for use
Pigs:
Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.
Rabbits:
Prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
Contra-indications
Horses or other Equidae, must not be allowed access to feeds containing tilmicosin. Horses fed with tilmicosin medicated feeds may present signs of toxicity with lethargy, anorexia, reduction of feed consumption, loose stools, colic, distension of the abdomen and death.
Do not use in case of hypersensitivity to tilmicosin or to any of the excipients.
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.
Special warnings for each target species
With regard to the management of respiratory disease outbreaks, it should be noted that acutely ill animals are likely to be inappetant and therefore require parenteral treatment.
Special precautions for use
i)Special precautions for use in animals
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.
Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended.
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, national and regional antimicrobial policies. 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.
ii)Special precautions for the person administering the veterinary medicinal product to animals
The handling of the product in case of known hypersensitivity to macrolide antibiotics must be avoided.
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
In very rare cases (less than 1 animal in 10,000 animals), feed intake may decrease (including feed refusal) in animals receiving medicated feed. This effect is transient.
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 is safe in sows whatever the pregnancy stages.
The safety of the veterinary medicinal product 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 less the antibacterial activity of β-lactam antibiotics
Amounts to be administered and administration route
The uptake of medicated feed depends on the clinical condition of the animals. In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
Use the following formula:
| | Dose rate (mg/kg BWt) | x | BWt (kg) | |
kg product per tonne of feed | = | ________________________________ | |
| | Daily feed intake (kg) | x | Premix strength (g/kg) | |
Pigs
Administer in the feed at a dose of 8 to 16 mg/kg body weight/day of tilmicosin (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days.
Administration Guide: Tilmovet Premix - Pigs |
Indication | Dose of Tilmicosin | Duration of treatment | Inclusion rate in feed |
Prevention & treatment of respiratory disease | 8-16 mg/kg bodyweight/day | 15 to 21 days | 2-4 kg product/tonne |
Rabbits
Administer in the feed at 12 mg/kg body weight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
Administration Guide: Tilmovet Premix - Rabbits |
Indication | Dose of tilmicosin | Duration of treatment | Inclusion rate in feed |
Prevention & treatment of respiratory disease | 12 mg/kg bodyweight/day | 7 days | 2 kg product/tonne |
To ensure thorough dispersion of the product, it should first be mixed with a suitable quantity of feed before incorporation into the finished feed.
This product can be incorporated into pelleted feed, preconditioned for the minimum time-period at a temperature not exceeding 75°C.
Overdose
No symptoms of overdose have been seen in pigs fed a ration containing levels of tilmicosin up to 80 mg/kg bodyweight (equivalent to 2000 ppm in the feed or ten times the recommended dose) for 15 days.
Withdrawal periods
Pigs: meat and offal: 21 days
Rabbits: meat and offal: 4 days