Active substance

Florfenicol 500 mg/g

Excipients

For the full list of excipients, see section “Pharmaceutical particulars”.

Premix for medicated feeding stuff.

A white free flowing powder.

Atlantic salmon.

For the treatment of furunculosis (Aeromonas salmonicida) infection of Atlantic salmon.

Do not use in brood stock.

Use of the product should be based on susceptibility testing of the strain of bacteria isolated from the fish. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Chloramphenicol type antibacterials may prolong the effects of anaesthetics.

Wear either a disposable half-mask respirator conforming to European standard EN 149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143, chemically resistant gloves, protective coveralls and goggles while incorporating the premix into the feed.

Wear gloves and do not smoke or eat while handling the product or medicated feed.

Wash hands thoroughly with soap and water after use of the product or medicated feed.

Thoroughly clean all equipment used in medicating feed.

In the UK, it is essential to obtain a discharge consent from the local regional office of the Environment Agency or SEPA.

None known.

None known.

In-feed use.

Dose: 10 mg/kg bodyweight.

The incorporation rate in feed must be calculated to achieve this dosage.

Affected fish should receive the medicated feed daily for 10 consecutive days.

The intake of medicated feed depends on the clinical condition of the fish. In order to ensure the correct dosage is administered the concentration of Florocol in feed must be adjusted accordingly.

Table: Examples of incorporation rates:

For incorporation into dry feed at a registered mill.

A manufacturer who is approved to incorporate veterinary medicinal products, or premixtures containing such products, directly at any concentration must be responsible for mixing when incorporation is less than 2 kg per tonne for final feed.

The premix should be mixed with oil before incorporation into dry feed. To ensure thorough dispersion, the product should first be mixed with, or surface-coated onto, a suitable quantity of feed before incorporation in the final mix.

No adverse effects were seen at up to ten times the recommended dose.

150 degree days. (15 days from the last treatment at 10 °C)

ATCvet code: QJ01BA90

Antibacterials for systemic use; amphenicols; florfenicol

Florfenicol is a broad-spectrum antibiotic which is active against both Gram-positive and Gram-negative bacteria isolated from domestic animals.

Florfenicol is a bacteriostatic antibiotic. Its activity is due to inhibition of protein synthesis and results from the binding of bacterial ribosomes in such a way as to prevent ongoing translation of mRNA into protein. In vitro studies have shown florfenicol to have a broad spectrum of activity which includes aerobic and anaerobic bacteria which are either Gram positive or Gram negative. Aeromonas salmonicida has been shown to be sensitive to florfenicol concentrations of 1.6 µg/ml or less.

Pharmacokinetic studies have been conducted with florfenicol following oral administration to Atlantic salmon. After oral administration florfenicol reached a peak plasma concentration of 4 µg/ml at 10.3 hours after administration. The drug was well distributed in body fluids and tissues as demonstrated by a volume of distribution of 0.9 L/kg. Florfenicol had an oral bioavailability of 96.5%.

Lactose monohydrate

Povidone.

None known.

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

Shelf life after incorporation into meal or pelleted feed: 3 months.

Special precautions for storage

Do not store above 30 °C. Protect from light.

Store in a dry place. Store away from food, drink and animal feeding stuff.

Laminated sachet consisting of polypropylene/low density polyethylene/aluminium foil. Package size: 2 kg.

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

UK: Vm 01708/4591

13 September 1999

July 2021

For animal treatment only.

Keep out of the sight and reach of children.