Target species
Pigs (weaned piglets and fattening pigs) and rabbits.
Indications for use for each target species
Pigs:
Treatment and metaphylaxis of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin
Rabbits:
Treatment and metaphylaxis of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin. The presence of the disease in the group must be established before the veterinary medicinal product is used.
Contraindications
Tilmicosin is known to be toxic for horses. Do not allow horses or other equines access to feeds containing tilmicosin. 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 cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
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.
Repeated use of the veterinary medicinal product should be avoided by improving management practices and thorough cleansing and disinfection.
Cross-resistance has been shown between tilmicosin and other macrolides (like tylosin, erythromycin) or lincomycin. Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to other macrolides or lincosamides because its effectiveness may be reduced.
Special precautions for use
Special precautions for safe use in the target species:
Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended.
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin related substances.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Do not use for prophylaxis.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental ingestion should be avoided by humans.
People with known hypersensitivity to tilmicosin should avoid contact with the veterinary medicinal product.
May cause sensitisation by skin contact. May cause skin and eye irritation. Avoid direct skin contact. Personal protective equipment consisting of overalls, safety glasses and impervious gloves should be worn when handling the veterinary medicinal 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 nondisposable 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.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Pigs and rabbits:
Very rare (<1 animal / 10,000 animals treated, including isolated report(s)): | Reduced food intake, food refusal1 |
1 - this effect is transient 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 respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
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 veterinary medicinal product is safe in sows whatever the pregnancy stages.
Fertility:
The safety of the veterinary medicinal product has not been established in boars used for breeding purposes.
Interaction with other medicinal products and other forms of interaction
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.
Administration routes and dosage
Oral use. To be administered orally through the medicated feed. The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of tilmicosin may need to be adjusted accordingly.
Use the following formula:
| | Dose rate (mg/kg bodyweight) | x | bodyweight (kg) | |
kg veterinary medicinal 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.
Indication | Dose of Tilmicosin | Duration of treatment | Inclusion rate in feed |
Treatment and metaphylaxis of respiratory disease | 8-16 mg/kg bodyweight/day | 15 to 21 days | 1-2 kg veterinary medicinal 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.
Indication | Dose of tilmicosin | Duration of treatment | Inclusion rate in feed |
Treatment and metaphylaxis of respiratory disease | 12 mg/kg bodyweight/day | 7 days | 1 kg veterinary medicinal product/tonne |
To ensure thorough dispersion of the veterinary medicinal product, it should first be mixed with a suitable quantity of feed before incorporation into the finished feed. This veterinary medicinal product can be incorporated into pelleted feed, preconditioned for the minimum time-period at a temperature not exceeding 75°C.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
This veterinary medicinal product is intended to be used for the preparation of medicated feed.
Withdrawal periods
Pigs: meat and offal: 21 days
Rabbits: meat and offal: 4 days