SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nuflor 40 mg/g Premix for Medicated Feeding Stufffor Swine

Nuflor 40 mg/g Premix for Medicated Feeding Stufffor Swine (EE, IE, IT, LT, LV, FI, NO, UK)

Nuflor 40 mg/g Premezcla Porcino (ES)

Nuflor40 mg/g Φαρμακούχο πρόμιγμα για χοίρους(CY, EL)

Nuflor 4% premiks do przygotowania paszy leczniczej dla świń (PL)

Nuflor 40mg/g premix sertések medikált takarmányához (HU)

Nuflor 40 mg/g Predmešanica za pripravo zdravilne krmne mešanice za prašiče (SI)

Nuflor 40 mg/g premix pre ošípané (SK)

Nuflor 40 mg/g gemedicineerd voormengsel voor varkens (BE, NL, LU)

Nuflor 40 mg/g prémélange médicamenteux pour les porcs (BE, NL, LU)

Nuflor 40 mg/g pré-mistura para alimento medicamentoso para suínos (PT)

Nuflor Premix Porc (FR)

Nuflor Premix for Swine (DK)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Composition per gram:

Active substance:

Florfenicol 40 mg

Excipients:

Propylene Glycol (E 1520) 10 mg

Ground Limestone qs to 1g

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Premix for medicated feeding stuff.

White to off-white, free flowing powder with red and/or black grains dispersed throughout

4. CLINICAL PARTICULARS

4.1 Target species

Pigs (Fattening pigs)

4.2 Indications for use, specifying the target species

For the treatment and prevention of swine respiratory disease caused by Pasteurella multocidasusceptible to florfenicolin infected herds. The presence of the disease should be established in the herd before initiating preventive treatment.

4.3 Contraindications

Do not administer to boars intended for breeding.

Do not use in case of hypersensivity to the active substance or any of the excipients.

4.4 Special warnings for each target species

Animals showing a decreased appetite and/or a poor general condition should be treated by the parenteral route.

The product should be used in conjunction with susceptibility testing and take into account official and local policy relating to the use of antimicrobials.

This premix is intended for the manufacturing of solid medicated feed and cannot be used as it is; the incorporation rate of the premix in feed cannot be lower than 5kg/ton.

This premix contains ground limestone, which can lead to a decrease in food consumption and to a phosphorus calcium imbalance in feed intake. Care should therefore be taken to consider the calcium content of the final medicated feed.

Treatment should not exceed 5 days.

In a field clinical study, within a week after the administration of the last dose, the incidence of pigs presenting either mild depression and/or mild dyspnea and/or pyrexia (40°C) was approx. 20 % in the initially severely ill animals.

Skin sensitisation may occur.

Avoid skin contact.

Do not handle this product in case of known sensitization to active substance or any of the excipients.

Handle this product with care to avoid exposure during incorporation of premix intofeed and administration of feed to animals, taking all recommended precautions.

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 feed.

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

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

Rinse thoroughly with water in case of exposure.

If you develop symptoms following exposure such as skin rash, you should seek medical advice and take the package leaflet or the label with you.

Manure from treated swine must be stored for a minimum of one month before being spread and incorporated in fields.

4.6 Adverse reactions (frequency and seriousness)

Commonly observed adverse effects are diarrhoea perianal inflammation and rectal eversion. Increased serum calcium may also be observed. These effects are transient, resolving on cessation of treatment.

4.7 Use during pregnancy, lactation or lay

The safety of the product during pregnancy and lactation has not been studied in sows. Use of the product during pregnancy and lactation is therefore not recommended.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amount(s) to be administered and administration route

To be administered orally, in medicated feeding stuff.

Dosage:

10 mg of florfenicol per kg body weight (bw) (equivalent to 250 mg Nuflor premix) per day administered for 5 consecutive days.

Administration:

For a daily feed intake of 50g/kg body weight, this dosage corresponds to a rate of incorporation of 5 kg of premix per ton of feed, i.e. 200 ppm of florfenicol.

The rate of incorporation of the medicated premix in the feed may be increased in order to achieve the required dosage on a mg/kg body weight basis and to take into account the actual feed intake. Thus, the inclusion level may need adjusting as follows to give the correct dose.

The maximum rate of incorporation is 12.5 kg/ton (500 ppm of florfenicol), higher rates of inclusion may lead to poor palatability and decreased food consumption.

Under no circumstances should the incorporation rate of the premix be below 5 kg/ton of feed.

In all cases the recommended dose of 10mg of florfenicol per kg of body weight per day, for 5 consecutive days has to be respected.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing. The required doses should be measured by suitably calibrated weighing equipment.

A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff. It is recommended that the product is added to the mixer containing the feeding stuff ingredients and mixed thoroughly to produce a homogeneous medicated feeding stuff. Medicated feed may also then be pelleted. Pelleting conditions include a pre-conditioning step with steam and then the mixture is passed through a pelleter or extruder under normal conditions.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the event of overdose, a reduction in food and water consumption, together with a decrease in bodyweight may be observed. There may be an increase in refused feed and an increase in serum calcium.

4.11 Withdrawal periods

Meat and offal: 14 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic Group:Antibiotic, member of the phenicol family

ATC vet code:QJ01BA90

Florfenicol is a broad-spectrum synthetic antibiotic in the phenicol group that is active against most Gram-positive and Gram-negative bacteria isolated from domestic animals. Florfenicol acts by inhibition of protein synthesis at the ribosomal level and is bacteriostatic. However, bactericidal activity has been demonstrated in-vitroagainst Pasteurella multocida when florfenicol is present at concentrations above the MIC for 4 to 12 hours.

In-vitrotesting has shown that florfenicol is active against the bacterial

pathogens most commonly isolated in respiratory diseases in pigs, including Pasteurella multocida.

A total of 193 Pasteurella multocida isolates from the respiratory tract of swine were collected between 2002 and 2003 in France, Spain, Greece, Germany, the United Kingdom and Belgium. The Minimal Inhibitory Concentration (MIC) of florfenicol against the target pathogen ranges from 0.25 to 1µg/ml with a MIC₉₀of 0.5µg/ml.

The only mechanisms of chloramphenicol resistance that are known to have significant clinical relevance are CAT (Chloramphenicol Acetyl Transferase)-mediated inactivation and efflux-pump resistance. Of these, only some of the efflux mediated resistance would also confer resistance to florfenicol and thus have the potential to be affected by florfenicol use in animals.

After administration to pigs by gavage at 10 mg/kg under experimental conditions, absorption of florfenicol was variable but peak serum concentrations of approximately 5 µg/ml were reached approximately 3 hours after dosing. The terminal half-life was between 3 and 4 hours. When pigs were given free access, for 5 days, to feed medicated with Nuflor Premix at the recommended dose of 10 mg/kg serum florfenicol concentrations exceeds 1 µg/ml for more than 16 hours each day of treatment.

Florfenicol is well absorbed when administered orally and following distribution it is rapidly eliminated in the urine and faeces in a ration of 3:1. A fraction is excreted unchanged and the rest is metabolised into 5 major metabolites.

After parenteral dosing of florfenicol to pigs, it has been shown that lung concentrations are similar to serum concentrations.

6 PHARMACEUTICAL PARTICULARS

Propylene Glycol (E 1520)

Ground Limestone

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 first opening the immediate packaging: 28 days

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

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

LDPE/HDPE/paper sealed bag containing 5 kg premix.

LDPE/paper/paper/paper sealed bag containing 25 kg premix.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

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

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

MK7 7AJ

Vm01708/4575

Date:05 June 2007

Date:February 2012