SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Enrofloxacin 100mg

Excipient:

n-butanol 30mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear light yellow solution free from particulate matter.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle and Pigs.

4.2 Indications for use, specifying the target species

Treatment of bacterial infections caused by strains susceptible to enrofloxacin.

Cattle

Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp. Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.

Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.

Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old.

Pigs

Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mycoplasma spp. and Actinobacillus pleuropneumoniae.

Treatment of infections of the urinary tract caused by enrofloxacin susceptible strains of Escherichia coli.

Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by enrofloxacin susceptible strains of Escherichia coli and Klebsiella spp.

Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.

Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.

4.3 Contraindications

Do not use for prophylaxis.

Do not use when resistance / cross resistance to (Fluoro)quinolones is known to occur. Refer to section 4.5. Do not use in the case of known hypersensitivity to fluoroquinolones or to any of the excipients

Do not use in growing horses because of possible deleterious damage on articular cartilage.

4.4 Special warnings for each target species

None known.

4.5 Special precautions for use

Special precautions for use in animals Do not exceed the recommended dose.

Repeat injections should be made at different sites.

The safety of the product has not been established in pigs or calves when administered by the intravenous route and use of this route of administration is not recommended in these animal groups.

Official and local antimicrobial policies should be taken into account when the product is used.

Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.

Whenever possible, fluoroquinolones should only be used based on susceptibility testing.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction.

Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg bw during 14 days.

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

The product is an alkaline solution. Wash any splashes from skin or eyes immediately with water.

Do not eat, drink or smoke whilst using the product. Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves.

Care should be taken to avoid accidental self-injection. In case of accidental injection, seek medical advice immediately and show the package leaflet or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Local tissue reactions may occasionally occur at the injection site. Normal sterile precautions should be taken.

In cattle, gastrointestinal disturbances may occasionally occur

4.7 Use during pregnancy, lactation or lay

There is no restriction on the use of this product during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Antagonistic effects due to concurrent administration of macrolides, and tetracyclines may occur. Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.

4.9 Amounts to be administered and administration route

Intravenous, subcutaneous or intramuscular use.

Repeated injections should be made at different injection sites.

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

Cattle:

5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 3-5 days.

Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 5 days.

The product can be administered by slow intravenous or subcutaneous administration.

Not more than 10 ml should be administered at any one subcutaneous injection site.

Pigs:

2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 kg bw, once daily by intramuscular injection for 3 days.

Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by intramuscular injection for 3 days.

In pigs, the injection should be made in the neck at the ear base.

Not more than 3 ml should be administered at any one intramuscular injection site.

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

Do not exceed the recommended dose.

In accidental overdose (lethargy, anorexia) there is no antidote and treatment should be symptomatic.

No signs of over dosage were observed in pigs following administration of the product at five times the recommended therapeutic dose.

4.11 Withdrawal period(s)

Cattle:
Following intravenous injection
Meat and offal:	5 days.
Milk:	3 days
Following subcutaneous injection:
Meat and offal:	12 days.
Milk:	4 days.
Pigs: Intramuscular Use
Meat and offal:	13 days.

5. PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones ATC Vet Code: QJ01MA90

5.1 Pharmacodynamic properties

Mode of action

Two enzymes essential in DNA replication and transcription, DNA gyrase and topoisomerase IV, have been identified as the molecular targets of fluoroquinolones. Target inhibition is caused by non-covalent binding of fluoroquinolone molecules to these enzymes. Replication forks and translational complexes cannot proceed beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and mRNA synthesis triggers events resulting in a rapid, drug concentration-dependent killing of pathogenic bacteria. The mode of action of enrofloxacin is bactericidal and bactericidal activity is concentration dependent.

Antibacterial spectrum

Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp. (e.g. Pasteurella multocida), against Gram-positive bacteria such as Staphylococcus spp. (e.g. Staphylococcus aureus) and against Mycoplasma spp. at the recommended therapeutic doses.

Types and mechanisms of resistance

Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gramnegative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins. All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones. Cross-resistance within the fluoroquinolone class of antimicrobials is common.

5.2 Pharmacokinetic particulars

Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 higher than that found in the serum, have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system.

Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

n-butanol

Potassium hydroxide (for pH adjustment),

Water for injections

6.2 Incompatibilities

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

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 5 years Shelf-life after first opening the immediate packaging: 28 days.

6.4. Special precautions for storage

Do not store above 25°C.

After first opening the immediate packaging: do not store above 25°C.

6.5 Nature and composition of immediate packaging

Container material: Type I Amber Glass

Container closure: Grey teflonised chlorobutyl rubber stopper with an aluminium cap.

Container colour: Amber

Container volumes: 100ml, 250ml No of containers in a carton:

1 x 100 ml, 5 x 100 ml, 10 x 100 ml, 12 x 100 ml, 15 x 100 ml, 20 x 100 ml 1 x 250 ml, 5 x 250 ml, 10 x 250 ml, 12 x 250 ml, 15 x 250 ml, 20 x 250 ml.

Not all pack sizes may be marketed

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

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

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway Ireland

8. MARKETING AUTHORISATION NUMBER

Vm 08749/4018

9. DATE OF FIRST AUTHORISATION

07 April 2010

10. DATE OF REVISION OF THE TEXT

August 2015

Approved: 04 September 2015