SUMMARY OF PRODUCT CHARACTERISTICS

Colibird 2 MIU/ml solution for use in drinking water for chickens

Each ml contains

Active substance:

Colistin (as colistin sulphate) 2 000 000 International Units

Excipients:

Benzyl alcohol 10 mg

For the full list of excipients see section 6.1

Solution for use in drinking water

Clear yellow solution.

Chickens

Treatment and metaphylaxis of enteric infections caused by non-invasive Escherichia coli susceptible to colistin.

The presence of the disease in the flock should be established before metaphylactic treatment.

Do not use in known cases of hypersensitivity to the active substance or any of the excipients.

Do not use in known cases of resistance to polymyxins.

Do not use in horses since colistin, due to a shift in the gastrointestinal microflora balance could lead to the development of antimicrobial associated colitis (colitis X), typically associated with Clostridium difficile, which may be fatal.

Colistin exerts concentration-dependent activity against Gram-negative bacteria. Following oral administration high concentrations are achieved in the gastrointestinal tract, i.e. the target site, due to the poor absorption of the substance. These factors indicate that a longer duration of treatment than the one indicated in section 4.9, leading to unnecessary exposure, is not recommended.

4.5 Special precautions for use

Do not use colistin as a substitute for good management practices.

Colistin is a last resort drug in human medicine for treatment of infections caused by certain multi-drug resistant bacteria. In order to minimise any potential risk associated with widespread use of colistin, its use should be limited to treatment or treatment and metaphylaxis of diseases, and should not be used for prophylaxis.

Whenever possible, colistin should only be used based on susceptibility testing.

Use of the product deviating from the instructions given in the SPC may lead to treatment failures and increase the prevalence of bacteria resistant to colistin.

People with known hypersensitivity to polymyxins, such as colistin, should avoid contact with the veterinary medicinal product.

Do not eat, drink or smoke while handling the product.

In case of accidental eye exposure, wash with plenty of water. If irritation occurs seek medical advice immediately and show the label to the physician.

Wash hands after use.

None known.

The product can be used during lay.

The combination with aminoglycosides should be avoided.

Administration via drinking water.

Chickens:75 000 IU of colistin per kg body weight per day for 3-5 consecutive days by oral route, i.e. 37.5 ml of product per tonne of body weight per day for 3-5 consecutive days.

Duration of treatment should be limited to the minimum time necessary for the treatment of the disease.

The quantity of product to be mixed in drinking water depends on the total weight of the animals to be treated:

Total number of birds x Average body weight in tonne x 37.5 = Total volume of product (ml) to be used per day.

This volume of product should be added to the actual volume of drinking water consumed by the animals for each day of the treatment period.

The medicated water should be the only source of drinking water for the birds for the entire duration of the treatment period.

The uptake of medicinal water depends on the physiological and clinical conditions of the animals. In order to obtain the correct dosage, it is essential to record the live weight and actual water consumption accurately.

None.

Meat and offal: 1 day.

Eggs: zero days.

Pharmacotherapeutic group:intestinal antiinfectives, antibiotics.

ATC vet code:QA07AA10.

Colistin is a polypeptide antibiotic belonging to the polymyxin class.

Colistin exerts a bactericidal action on susceptible bacteria strains by disruption of the bacteria cytoplasmic membrane leading to an alteration of cell permeability and then a leakage of intracellular materials.

Colistin exerts concentration-dependent activity against Gram-negative bacteria. Following oral administration high concentrations are achieved in the gastrointestinal tract, i.e. the target site, due to the poor absorption of the substance.

Colistin possesses virtually no activity against gram positive bacteria and fungi.

Gram-positive bacteria are naturally resistant to colistin, as are some species of Gram-negative bacteria such as Proteus and Serratia.

However, acquired resistance of gram-negative enteric bacteria to colistin is rare and explained by a single step mutation.

The in vitrosusceptibility of Escherichia colistrains isolated from poultry to colistin has been determined. The MIC₅₀and MIC₉₀values were 0.25 µg/ml and 0.38 µg/ml, respectively.

Colistin is poorly absorbed from the gastro-intestinal tract. In contrast to the very low concentrations of colistin in serum and tissues, high and persistent amounts are present within the different sections of the gastro intestinal tract.

No significant metabolism is observed.

Colistin is almost exclusively eliminated via the faeces.

Benzyl alcohol.

Water, purified

None known.

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after opening the immediate packaging: 3 months.

Shelf life after dilution according to directions: 24 hours after dilution in drinking water.

This veterinary medicinal product does not require any special storage conditions.

Nature of container:

• High density polyethylene bottle.

• Polypropylene screw caps fitted with a polypropylene dosing device and a poly(vinyl chloride/vinyl acetate) seal.

Package sizes:

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

Vm:15052/4042

Date:01 July 2010

Date:June 2015

Approved: 09 June 2015