Description
TILMICOSOL
Tilmicosin (as phosphate) 250 mg/ml
TILMICOSOL
Active substance: Tilmicosin (as phosphate) 250 mg/ml
Pharmacotherapeutic Group: Antibacterial for systemic use, macrolides
PHARMACEUTICAL FORM:
Concentrate for oral solution for use in drinking water or milk replacer.
Clear yellow to amber coloured solution.
CLINICAL PARTICULARS:
Target species:
Chickens (except hens producing eggs for human consumption),
Turkeys, Calves (non ruminant)
Indications for use, specifying the target species:
Chickens: For the treatment and metaphylaxis of respiratory disease in chicken flocks,
associated with Mycoplasma gallisepticum and M. synoviae.
Turkeys: For the treatment and metaphylaxis of respiratory disease in turkey flocks,
associated with Mycoplasma gallisepticum and M. synoviae.
Calves: For the treatment of bovine respiratory disease, associated with Mannheimia
haemolytica, Pasteurella multocida, Mycoplasma bovis, M. dispar.
Contraindications:
Do not allow horses and other equines access to drinking water containing tilmicosin.
Do not use in case of hypersensitivity to tilmicosin or to any of the excipients.
Do not administer to ruminating animals with active rumen function.
Special precautions for use
Special precautions for use in animals:
For oral use only. Contains disodium edetate; do not inject.
Severely ill individuals tend to drink less and may need simultaneous treatment, preferably by parenteral medication.
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. The use of the product should be based on susceptibility tests.
Medicated drinking water or milk replacer should be prepared fresh every 24 hours.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Adverse reactions (frequency and seriousness):
In very rare cases (less than 1 animal in 10,000 animals, including isolated reports), a
decrease in water intake has been observed.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Withdrawal period(s):
Meat and offal of:
Chickens – 12 days
Turkeys – 19 days
Calves – 42 days
Pharmacodynamic properties:
Tilmicosin is a semi-synthetic antibiotic of the macrolide group, and is believed to affect
protein synthesis. It has bacteriostatic action but at high concentrations it may be
bactericidal.
This antibacterial activity is predominantly against Gram-positive microorganism with
activity against certain Gram-negative ones and Mycoplasma of a bovine, porcine, ovine
and avian origin.
Shelf life:
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
Shelf-life after first opening the immediate packaging: 3 months
Shelf-life after dilution or reconstitution according to directions: 24 hours
Nature and composition of immediate packaging:
250 ml in white high density polyethylene bottle with polypropylene screw cap
1000 ml in white high density polyethylene bottle with polypropylene screw cap and calibrated polypropylene measuring cup
Not all pack sizes may be marketed.
LAVET, Hungary