Target species
Chickens (broilers and pullets), turkeys, pigs and cattle (calves).
Indications for use for each target species
Pigs: For the treatment and prevention of respiratory infections associated with Mycoplasma hyopneumoniae, Pasturella multocida and Actinobacillus pleuropneumoniae when the disease has been diagnosed at the herd level.
Chickens: For the treatment and prevention of respiratory infections in poultry flocks associated with Mycoplasma gallisepticum and Mycoplasma synoviae when the disease has been diagnosed at the herd level.
Turkeys: For the treatment and prevention of respiratory infections in turkey flocks associated with Mycoplasma gallisepticum and Mycoplasma synoviae when the disease has been diagnosed at the erd level.
Cattle (calves): For the treatment and prevention of respiratory infections associated with Mannheimia haemolytica, P. multocida, Mycoplasma bovis and M. dispar when the disease has been diagnosed at the herd level.
Contraindications
Do not administer to ruminating animals with active rumen function.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not allow horses or other equines access to drinking water containing tilmicosin. Horses fed with water containing tilmicosin may present signs of toxicity with lethargy, anorexia, reduction of feed consumption, loose stools, colic, distension of the abdomen and death.
Special warnings
Tilmicosin should not be administered by injection to pigs. The veterinary medicinal product contains disodium edetate. The uptake of medicated water can be altered as a consequence of illness. If the uptake is insufficient alternative treatment may be required.
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:
Do not use when there is resistance to tilmicosin or cross resistance to other macrolides (like tylosin, erythromycin) or lincomycin.
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 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. 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
People with known hypersensitivity to tilmicosin should avoid contact with the veterinary medicinal product. The veterinary medicinal product may cause irritation or sensitisation by skin contact.
Avoid skin and ocular contact. Personal protective equipment consisting of protective gloves and protective clothes should be worn when handling the veterinary medicinal product.
Do not eat, drink or smoke when handling this product.
In case of contact with skin or eyes, rinse abundantly with fresh water. If irritation persists and in case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician, or call a poison centre (dangers linked to disturbances in cardiac conduction).
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Chickens (broilers and pullets), turkeys, pigs and cattle (calves):
Very rare (<1 animal / 10,000 animals treated, including isolated reports) | Decreased drinking | |
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:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only in accordance with risk/benefit assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Tilmicosin may lessen the antibacterial activity of β-lactam antibiotics
Do not use simultaneously with bacteriostatic antimicrobial agents.
Administration routes and dosage
For oral use only. The veterinary medicinal product must be diluted in drinking water or milk replacer before administration.
To ensure a correct dosage, body weight should be determined as accurately as possible. The intake of medicated water 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.
Pigs:
15-20mg tilmicosin per kg body weight for 5 days, i.e. 6-8ml of product for 100kg body weight corresponding to 80ml of product per 100 litres of drinking water for 5 days.
Chickens (broilers and pullets):
15-20mg tilmicosin per kg body weight for 3 days, i.e. 6-8ml of product for 100kg body weight corresponding to 30ml of product per 100 litres of drinking water for 3 days.
Turkeys:
10-27mg tilmicosin per kg body weight for 3 days, i.e. 4-11ml of product for 100kg body weight corresponding to 30ml of product per 100 litres of drinking water for 3 days.
Calves:
12.5mg tilmicosin per kg body weight two times per day for 3-5days, i.e. 1ml of product for 20kg body weight two times per day for 3-5 days.
One 960ml bottle is sufficient to medicate 1200 litres of drinking water for pigs or 3200 litres of drinking water for broilers, turkeys or pullets.
One 960ml bottle is sufficient to medicate drinking water or milk replacer for 48-80 calves (40kg b.w.)
One 240ml bottle is sufficient to medicate drinking water or milk replacer for 8 calves (60kg b.w.)
Medicated drinking water should be prepared fresh every 24 hours using only clean water.
Medicated milk replacer should be prepared fresh every 4 hours using only clean water.
If signs of disease do not significantly improve within 3-5 days, the diagnosis should be re-evaluated and treatment changed.
Do not administer to pigs in a wet feeding system.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Pigs drink less water when a dose of 300 to 400 mg/litre (1.5 to 2 times the recommended dose) is administered. Although this will result in less intake of tilmicosin, it might lead to dehydration of the animals. Replace with untreated water when needed.
No symptoms were seen in poultry treated at 375 mg/litre during 5 days. A dose of 75 mg/litre during 10 days resulted in less consistent faeces.
No symptoms of overdose were noticed in turkeys treated at 375 mg/litre of drinking water during 3 days. No symptoms were noticed at 75 mg/litre during 6 days.
Except for a slight decrease in milk intake, no symptoms of overdose were seen in calves treated at 5 times the recommended dose or during twice the recommended treatment period.
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
Not applicable
Withdrawal periods
Meat and offal: Pigs: 14 days
Cattle (calves): 42 days
Chickens (broilers and pullets): 12 days
Turkeys: 19 days
Not for use in birds producing eggs for human consumption.
Do not use within 2 weeks before the start of the laying period.
Not authorised for use in animals producing milk for human consumption.