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DICURAL 100 ml/ml, Oral solution for Chickens and Turkeys
- Dicural Oral contain difloxacin (as the hydrochloride), which is an antibiotic of the fluoroquinolone group. Fluoroquinolones exert their antibacterial effect against both replicating and dormant microorganisms. Difloxacin hydrochloride can be bactericidal in activity against many Gram-negative micro-organisms and a selection of Grampositive microorganisms. Difloxacin acts primarily through inhibition of bacterial DNA gyrase.
- Fluoroquinolone therapeutic in chicken and turkeys for drinking water application as from day 1.Presented in 250 and 1000 ml plastic (HDPE) white bottles with tamper evident polypropylene screw caps.
- 10 mg/kg/day, rapid absorption, rapid bactericidal effect, very short withdrawal time for meat (24 hrs), instantaneous and total dissolution in drinking water, no plasmidic resistance.
Description
Dicural oral solution is a clear yellowish solution containing by each ml:
| Active Ingredient | |
|---|---|
| Difloxacin (as hydrochloride) | 100 mg |
| Excipients: | |
| Propylene glycol Benzyl alcohol Potassium hydroxide Edetic acid Purified water | q.s. ad. 1 ml |
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.
CONTRAINDICATIONS
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.
Do not use in birds in lay and/or within 4 weeks before the onset of the laying period.
ADVERSE REACTIONS
None known.
Target animal safety studies in chickens and turkeys demonstrated that, when administered in
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 birds.
TARGET SPECIES
Chickens (broilers and future breeders)
Turkeys (young turkeys up to 2 kg body weight).
DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
Dicural oral solution must be administrated daily via the drinking water in such a
concentration that the dose is 10 mg/kg bodyweight. The administration must be continued for
5 days.
Taking into account the content of difloxacin in the oral solution (10% w/v), the following
calculation should be made to determine the quantity in ml to be added per 1000 litres of
water:
| number of animals in the house X mean weight of individual animal (kg) X 100 |
| Total water consumption of the house at the previous day (litres) |
No other source of drinking water should be available during the medication period.
At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys may be affected.
WITHDRAWAL PERIOD
Meat and offal (chickens and turkeys): 24 hours.
Not authorized for use in laying birds producing eggs for human consumption.
SHELF LIFE
Shelf life of the finished product: 36 months when stored below 25 °C.
Medicated water must be freshly prepared daily.
Shelf life after first opening of the container: 1 month.
SPECIAL STORAGE PRECAUTIONS
Do not store above 25°C.
Protect from light.
Do not freeze.
SPECIAL WARNINGS
Special precautions for use in animals
Heavy reliance on a single class of antibiotics may result in the induction of resistance in a
bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical
conditions that have responded poorly, or are expected to respond poorly, to other classes of
antibiotics.
Official and local antimicrobial policies should be taken into account when the product is
used. Whenever possible, fluoroquinolones should only be used based on susceptibility
testing.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
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 a face-protecting device when
handling this product.
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.
OTHER INFORMATION
ATCVet code: QJ01MA94
Nature and composition of immediate packaging
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.
Detailed information on this veterinary medicinal product is available on the website of the
European Medicines Agency (EMEA) www.emea.europa.eu
