Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Dicural oral solution is a yellowish clear aqueous solution.

Each ml of the oral solution contains:

Difloxacin (as hydrochloride) 100 mg.

Uses

The fluoroquinolones exert their antibacterial effect against both replicating and non replicating micro-organisms. Difloxacin hydrochloride is bactericidal in activity and acts by inhibition of bacterial DNA gyrase.

Strains of Escherichia coli, Pasteurella multocida, Mycoplasma gallisepticum isolated from broilers and turkeys have been shown to be sensitive to difloxacin.

Target species

Chickens (broilers and future breeders) and turkeys (young turkeys up to 2 Kg body weight).

Indications

In chickens and turkeys Dicural* oral solution is indicated for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.

In turkeys Dicural* oral solution is also indicated for the treatment of infections caused by Pasteurella multocida.

Dicural* oral solution should only be used based on susceptibility testing.

Dosage and administration

For oral administration via the drinking water.

Taking into account the 10% content of difloxacin in the bottle, the following calculation should be made to determine the quantity in ml to be added per 1000 litres of water:

number × weight × 100 ÷ water

where

number = number of animals in the house

weight = mean weight of individual animal in kg

water = total water consumption of the house on the previous day in litres

The solution should be prepared freshly each day.

Dicural oral solution must be administered daily via the drinking water in such a concentration that the dose is 10mg/kg bodyweight.

The administration must be continued for 5 days.

The solution should be prepared freshly each day.

No other source of drinking water should be available during the medication period.

No additional chlorine, for example by use of water chlorinators, nor hydrogen peroxide should be added in the drinking water used for the preparation of medicated water.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in laying hens.

Since no studies were performed in clinically lame birds, Dicural oral solution should not be used in birds with existing leg weakness or in birds suffering from osteoporosis.

Withdrawal period

Meat: 24 hours for both chickens and turkeys

Pharmaceutical precautions

Store between 15°C and 25°C, protect from light.

Shelf life after first opening of the product: 1 month.

Legal category

POM-V

Packaging Quantities

Dicural oral solution is supplied in plastic white bottles with a screw cap containing 250 or 1000 ml oral solution.

The screw cap on the 1 litre bottle can be used as measuring device. If filled to the brim the measuring device provides 50 ml. For the 250 ml bottle a separate measuring device is placed on the screw cap. Measuring lines indicate the volume supplied.

Further information

Target animal safety studies in chickens and turkeys demonstrated that when administered in the drinking water at 30 mg/kg (chickens) or 22 mg/kg (turkeys) for three times the recommended duration (15 consecutive days) difloxacin hydrochloride appeared to be safe for the animals.

At concentrations of 300 ppm or greater in the water, palatability for turkeys may be affected.

Persons with known hypersensitivity to quinolones should avoid any contact with the product. In order to avoid irritation of skin and/or eyes use gloves and face-protecting device, when handling this product.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

Marketing authorisation number

EU/2/97/003/002.