Target species
Pigs and rabbits.
Indications for use, specifying the target species
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.
Contraindications
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 the active substance or to any of the excipients
Special warnings for each target species
Under practical conditions, the management of respiratory disease outbreaks recognises that acutely ill animals are inappetant and require parenteral therapy.
Special precautions for use
Special precautions for use in animals
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.
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 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 should be taken into account when the product is used.
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Tilmicosin may induce irritation. Macrolides, such as tilmicosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tilmicosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.
Personal protective equipment consisting of overalls, safety glasses, impervious gloves and either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143 should be worn when handling the veterinary medicinal product.
Do not eat, drink or smoke when handling this veterinary medicinal product. Wash hands after use.
In case of accidental ingestion, wash out mouth immediately with water and seek medical advice immediately and show the label to the physician.
In case of accidental spillage onto skin, wash thoroughly with soap and water and seek medical advice immediately and show the label to the physician.
In case of accidental eye contact, flush the eyes with plenty of clean, running water and seek medical advice immediately and show the label to the physician.
People with known hypersensitivity to tilmicosin should avoid contact with the veterinary medicinal product.
If you develop symptoms following exposure, such as skin rash, seek medical advice and show the label to the physician. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Special precautions for the protection of the environment:
The primary route of environmental exposure is from manure applied to agricultural land as fertilizer. Tilmicosin degrades/declines slowly in the soil. Therefore, to protect soil and ground water, pig manure not to be spread onto the grass land and when spread onto arable land plough to a depth of 30 cm. Environmental assessments have demonstrated that the use of the veterinary medicinal product as indicated is not expected to have any impact on the environment.
Other precautions:
Not applicable
Adverse reactions (frequency and seriousness)
Pigs and rabbits:
Very rare (< animal/ 10,000 animals treated, including isolated reports): | Reduced food intake1 |
1 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 the national competent authority via the national reporting system. See the label for respective contact details.
Use during pregnancy, lactation or lay
Pigs:
The safety of the veterinary medicinal product has not been established during pregnancy. Do not use in breeding animals.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
In feed use.
The intake of medicated feed depends on the clinical condition of the animals. In order to obtain a correct dosage, the concentration of tilmicosin may need to be adjusted accordingly.
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:
mg veterinary medicinal product/kg body weight day | X | average body weight (kg) of animals to be treated | |
| | | = kg veterinary medicinal product per tonne of feed |
average daily feed intake (kg/animal) | X | veterinary medicinal product 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 rate | Duration of treatment | Inclusion rate in feed |
Prevention & treatment of respiratory disease | 8-16 mg/kg bodyweight /day | 15-21 days | 2-4 kg of the veterinary medicinal product/tonne |
Rabbits
Indication | Dose rate | Duration of treatment | Inclusion rate in feed |
Preventation & treatment of respiratory disease | 12.5 mg/kg bodyweight/day | 7 days | 2 kg of he veterinary medicinal product/tonne |
To ensure thorough dispersion of the veterinary medicinal product, it should first be mixed with a suitable quantity of feed ingredients (20-50 kg) 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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