TILMICOSOL 250 mg/ml

TILMICOSOL 250 mg/ml

Oral solution for use in drinking water or milk replacer

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