SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each g contains:

Active substance: Florfenicol 500 mg Excipients:

Qualitative composition of excipients and other constituents

Lactose monohydrate

Povidone K29-32

A white free flowing powder.

3. CLINICAL INFORMATION

3.1 Target species

Atlantic salmon.

3.2 Indications for use for each target species

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

3.3 Contraindications

Do not use in brood stock.

3.4 Special warnings

None.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Use of the veterinary medicinal 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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Avoid inhalation of dust. 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.

Avoid contact with the skin and eyes. Wear chemically resistant gloves, protective overalls and safety glasses while incorporating the premix into the feed.

Wear gloves and do not smoke, drink or eat while handling the veterinary medicinal product or medicated feed.

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

Clean thoroughly all equipment used for medicating feed.

In case of accidental self-ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment: Not applicable.

Other precautions:

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

3.6 Adverse events

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Not applicable.

3.8 Interaction with other medicinal products and other forms of interaction

None known.

3.9 Administration routes and dosage

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 animals. In order to obtain the correct dosage, the concentration of florfenicol may need to be adjusted accordingly.

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 veterinary medicinal product should first be mixed with, or surface-coated onto, a suitable quantity of feed before incorporation in the final mix.

Table: Examples of incorporation rates:

Feeding rate (as % of fish bodyweight)	Quantity (kg) of the veterinary medicinal product per tonne of medicated feed	Fish (kg) medicated daily per tonne of medicated feed
0.5	4	200 000 kg
1.0	2	100 000 kg
2.0	1	50 000 kg

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

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

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

This veterinary medicinal product is intended to be used for the preparation of medicated feed.

3.12 Withdrawal periods

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

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QJ01BA90

4.2 Pharmacodynamics

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.

4.3 Pharmacokinetics

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%.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

None known.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after incorporation into pelleted feed: 3 months.

5.3 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.

5.4 Nature and composition of immediate packaging

Laminated bag consisting of polypropylene/low density polyethylene/aluminium foil.

Pack size:

Bag of 2 kg.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Intervet International B.V.

7. MARKETING AUTHORISATION NUMBER

Vm 06376/4130

8. DATE OF FIRST AUTHORISATION

13 September 1999

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

January 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 22 February 2026