SUMMARY OF PRODUCT CHARACTERISTICS

Fenflor 300 mg/ml solution for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Florfenicol…………300 mg

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection

A light yellow to yellow, clear, viscous liquid.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs.

4.2 Indications for use, specifying the target species

Treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniaeand Pasteurella multocidasusceptible to florfenicol.

4.3 Contraindications

Do not administer to boars intended for breeding.

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

Do not use in the cases of known resistance to the active substance.

None

4.5 Special precautions for use

Wipe the stopper before removing each dose. Use a dry, sterile syringe and needle.

Do not use in piglets of less than 2 kg.

The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies.

Use a suitable draw-off needle or automatic dosing syringe to avoid excessive puncturing of the closure.

Care should be taken to avoid accidental self-injection.

In the case of self-injection, seek medical advice and show the label to the doctor.

Do not use the product in known cases of sensitivity to florfenicol, propylene glycol and polyethylene glycols.

In case of accidental contact with eyes, rinse immediately with plenty of water.

4.6 Adverse reactions (frequency and seriousness)

Commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/ oedema which may affect 50% of the animals. These effects can be observed for one week.

Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen up to 28 days.

4.7 Use during pregnancy, lactation or lay

Studies in laboratory animals have not revealed any evidence of embryo- or foeto-toxic potentialfor florfenicol. However, the safety of the product in sows during pregnancy and lactation has not been demonstrated. Use of the product during pregnancy and lactation is therefore not recommended.

4.8 Interaction with other medicinal products and other forms of interaction

No data available.

4.9 Amounts to be administered and administration route

15 mg/kg bodyweight (1 ml per 20 kg) by intramuscular injection into the neck muscle twice at 48 hour intervals using a dry, sterile 16-gauge needle.

The volume administered per injection site should not exceed 3 ml.

It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 48 hours after the second injection.

If clinical signs of respiratory disease persist 48 hours after the last injection, treatment should be changed using another formulation or another antibiotic and continued until clinical signs have resolved.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

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

In swine after administration of 3 times the recommended dose or more a reduction in feeding, hydration and weight gain has been observed.

After administration of 5 times the recommended dose or more vomiting has also been noted.

4.11 Withdrawal period

Meat and offal: 18 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:Antibacterials for systemic use

ATCVet Code:QJ01BA90

5.1 Pharmacodynamic properties

Florfenicol is a broad-spectrum synthetic antibiotic 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 Actinobacillus pleuropneumoniaeand Pasteurella multocida.

In-vitrotesting has shown that florfenicol is active against the bacterial pathogens most commonly isolated in respiratory diseases in pigs, including Actinobacillus pleuropneumoniaeand Pasteurella multocida.

Acquired resistance to florfenicol is mediated by efflux pump resistance associated with a floRgene. In target pathogens, such resistance has only been identified in Pasteurella multocida. Cross resistance with chloramphenicol can occur.

5.2 Pharmacokinetic particulars

After a single intramuscular administration of the recommended dose of 15 mg/kg maximum plasma concentrations of 2.08 µg/ml were reached after 2 hours.

The harmonic mean elimination half life was 10.37 hours.

After administration to pigs by the intramuscular route, florfenicol is rapidly excreted, primarily in urine. The florfenicol is extensively metabolised.

Serum concentrations persist above 1 µg/ml for 12 to 24 hours following IM administration. Florfenicol concentrations achieved in lung tissue reflect plasma concentrations, with a lung: plasma concentration ratio of approximately 1.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Dimethyl sulfoxide

Propylene glycol

Macrogol 400

6.2 Incompatibilities

In the absence of incompatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.

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.

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

50, 100 and 250 ml Type I amber glass bottle closed with a bromobutyl rubber stopper and aluminium seal.

1 bottle (50 ml) in cardboard box.

1 bottle (100 ml) in cardboard box.

1 bottle (250 ml) in cardboard box.

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

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

7. MARKETING AUTHORISATION HOLDER

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

8. MARKETING AUTHORISATION NUMBER

Vm01656/4027

9. DATE OF FIRST AUTHORISATION

Date:04/07/2007

10. DATE OF REVISION OF THE TEXT

Date: March 2013

Approved: 21/03/2013