SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Florocol Premix for Medicated Feeding stuff 500mg/g for Atlantic Salmon

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance(s) mg/g

Florfenicol 500

For a full list of excipients see section 6.1

3. PHARMACEUTICAL FORM

Premix for medicated feeding stuff

A white free flowing powder

4. CLINICAL PARTICULARS

4.1 Target species

Atlantic Salmon

4.2 Indications for use, specifying the target species

Florocol is indicated for the treatment of furunculosis (Aeromonas salmonicida) infection of Atlantic Salmon

4.3 Contra-indications

Do not use in brood stock

4.4 Special warnings for target species

None

4.5 Special precautions for use

i. Special precautions for use in animals

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.

ii. Special Precautions to be taken by the Person Administering the Product to Animals

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.

iii. Other Precautions

UK only: it is essential to obtain a discharge consent from the local

regional office of the Environment Agency or SEPA.

4.6 Adverse reactions (frequency and seriousness)

None known

4.7 Use during pregnancy, lactation and lay

Not applicable

4.8 Interactions with other medicinal products and other forms of interactions

None known

4.9 Amounts to be administered and administration route

Florocol should be mixed into fish feed at a rate to deliver 10 mg of florfenicol per kg of bodyweight. The premix should be mixed with oil before incorporation in to 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. Affected fish should receive Florocol medicated feed daily for 10 consecutive days.

The intake of medicated feed depends on the clinical condition of the fish. In order to obtain the correct dosage the concentration of Florocol has to be adjusted accordingly.

For incorporation into dry feed at the registered mill.

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

Florocol has been given to Atlantic salmon at doses up to ten times the recommended dose without adverse effects, therefore no symptoms of overdosage are known.

4.11 Withdrawal period(s)

Salmon must not be slaughtered for human consumption for 15 days at 10 °C (or 150 °day) after the last treatment.

5. PHARMACOLOGICAL PROPERTIES

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 1.6µg/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%.

ATC Vet Code:QJ01BA90

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose Monohydrate

Povidone

6.2 Incompatibilities

None known

6.3 Shelf life

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

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

6.4 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.

6.5 Nature and composition of immediate packaging

Laminated sachet consisting of polypropylene/lowdensity polyethylene/ aluminium foil. Each sachet holds 2 kg of white free flowing powder. Eight 2 kg pouches are packaged in a fibreboard shipper.

6.6 Special precautions for the disposal of unused product or waste materials

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

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm01708/4591

9. DATE OF FIRST AUTHORISATION

Date:13 September 1999

10. DATE OF REVISION OF THE TEXT

Date:May 2012