Introduction

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

A solution for oral administration containing 2 MIU Colistin (as colistin sulphate) per 1 ml.

Uses

Colistin is a polymyxin antimicrobial that is used in the treatment of severe Gram negative infections, especially those due to Escherichia coli and Salmonella spp. It is used by the oral route for the treatment of gastro-intestinal infections or for selective decontamination of the gastro-intestinal tract in animals at high risk of endogenous infections. The development of resistance to colistin is rare.

It is indicated for use in pigs (in particular sucking and post weaning) for the treatment of colibacillosis.

Dosage and administration

Oral use. Administration via drinking water or direct application by mouth, after dilution with drinking water.

Dosage: 50 000 IU of colistin per kg bodyweight twice a day for 5 days, i.e. 0.25 ml of Coliscour® solution per 10 kg of bodyweight twice a day for 5 consecutive days.

Individual administration

For sucking piglets the product should be administered only on an individual basis. Coliscour® solution should be diluted in drinking water. Take 1 ml of Coliscour® solution and dilute to 40 ml with drinking water. Administration of this diluted solution is by direct application in the mouth with a syringe: 1 ml per kg bodyweight twice a day for 5 consecutive days.

The syringe used must allow a precision of 0.2 ml.

Administration via drinking water

The medicated water should be the only source of drinking water for the animals for the entire duration of the treatment period (2 to 6 hours). In order to ensure that the product is effectively consumed in less than 6 hours, it might be advised to:       

•restrict water for one hour just before the distribution period, if the clinical condition of the animals allows this,

•or to slightly underestimate the consumption of water which will result in a shortened treatment period.

Administration without a dosing pump

The treatment is distributed in a tank in a pulse mode over a period of 2 to 6 hours, twice a day, for 5 consecutive days. Coliscour® solution is added to a volume of the drinking water corresponding to the volume consumed by the animals over the treatment period (2 to 6 hours) to achieve a dose rate of 50 000 IU of colistin per kg bodyweight.

The following sequential steps should be followed:

•From the dosage regimen and the total weight of pigs to be treated, determine the necessary quantity of active ingredient, and deduce the necessary quantity of commercial product.

•Determine the mean water consumption of the animals to be treated over the treatment period (2 to 6 hours), and deduce the total quantity of supplemented water to prepare.

The following formulae can be applied:

•Calculation of Coliscour® solution volume at each distribution (V):

V (ml) = (50 000*W)/(2 000 000)

where W (kg) = total weight of pigs to treat, or 0.025 ml x W (kg) total bodyweight.

•Calculation of the quantity of supplemented drinking water to prepare (Q) : Q (l) =A x N

Where A = mean individual water consumption of the animals during the scheduled distribution period in litres and N = number of animals to be treated.

Administration via a dosing pump

The treatment is distributed in a pulse mode over a period of 2 to 6 hours, twice a day, for 5 consecutive days. A dosing pump is used to add a stock solution at a pre-determined concentration to the drinking water. The pumped volume is constant, but the drinking frequency depends on the flow rate of the circuit. The flow rate (F) through the pump is a percentage.

Thus, the concentration of the stock solution corresponds to the concentration of the solution to be distributed to the animals divided by the flow rate through the pump. If the product is administered with an automated drinking water system, the following sequential steps should be followed:          

•Determine the quantity of Coliscour® solution to achieve a dose rate of 50 000 IU colistin per kg body weight.

•Determine the mean water consumption of the animals to be treated over the scheduled treatment period (2 to 6 hours).

•Calculate the concentration of the solution to be distributed to the animals   

•Calculate from this, the concentration of the stock solution, knowing the flow rate of the dosing pump.

1ml of Coliscour® solution contains 2 000 000 IU.

The following calculation must be applied:

•Calculation of Coliscour® solution volume at each distribution (V) :

V (ml) = (50 000 x W)/(2 000 000)

where W (kg) = total weight of pigs to treat or 0.025 ml x W( kg) total bodyweight.        

•Calculation of the drinking water concentration (C): C (ml/l) = V/B

where B = total volume of water consumed by the pigs during the scheduled treatment period (2 to 6 hours)

•Calculation of the stock solution volume (V’): V’ (l) = B*F

where F= flow rate through the dosing pump as a percentage.

•Calculation of the stock solution concentration (C’): C’ (ml/l) = C/F

Contra-indications, warnings, etc

Use is not recommended during pregnancy and lactation. Avoid use of the product by people sensitive to polymyxins. When preparing the solution, wash any splashes from eyes with water. Wash hands and exposed skin after use.

For animal treatment only.

Keep out of reach and sight of children.

Withdrawal period

Meat and offal: 1 day

Pharmaceutical precautions

Do not store above 25 °C.

Legal category

POM-V

Packaging Quantities

250 ml, 500 ml, 1 litre, 2 litre and 5 litre high density polyethylene bottles.

Not all pack sizes may be marketed.

Further information

Nil.

Marketing authorisation number

Vm 15052/4017.