SUMMARY OF PRODUCT CHARACTERISTICS

LANFLOX 100 mg/ml Solution for use in drinking water for Chickens and Turkeys [IE, FR, HU, NL, DE, RO, UK]

ENROVETO 100 mg/ml Solution for use in drinking water for Chickens and Turkeys [BE]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Enrofloxacin 100 mg

Excipients:

Benzyl Alcohol (E 1519) 14 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for use in drinking water

An aqueous, clear, yellowish solution.

4. CLINICAL PARTICULARS

Chickens and Turkeys

4.2. Indications for use, specifying the target species

Treatment of infections caused by the following bacteria susceptible to enrofloxacin:

Chickens

Mycoplasma gallisepticum,

Mycoplasma synoviae,

Avibacterium paragallinarum,

Pasteurella multocida,

Escherichia coli.

Turkey

Mycoplasma gallisepticum,

Mycoplasma synoviae,

Pasteurella multocida,

Escherichia coli.

4.3. Contraindications

Do not use in birds producing eggs for human consumption.

Do not use for prophylaxis.

Do not use when resistance/ cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment.

Do not use in cases of hypersensitivity to the active substanceor to any of the excipients.

Treatment of Mycoplasma spp infections may not eradicate the organism.

Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of E.coli to fluoroquinolones and emergence of resistant organisms. Resistance has also been reported in Mycoplasma synoviae in the EU.

Before use, header tanks should be emptied, thoroughly cleaned and then filled with a known volume of clean water before adding the required amount of product. The resulting mixture should be stirred.

Before use, header tanks should be inspected at regular intervals for presence of dust, algae formation and sedimentation.

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.

Wherever possible, fluoroquinolones should be used based on susceptibility testing.

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

If there is no clinical improvement within two to three days susceptibility testing should be repeated and therapy should be changed, if appropriate.

Wear impervious gloves when handling the product.

Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions.

In the case of eye or skin contact, rinse the affected area with clean water and if irritation occurs, seek medical attention.

Wash hands and exposed skin after use.

Do not eat, drink or smoke whilst using the product.

People with known hypersensitivity to fluoroquinolones should avoid contact with the product.

None

4.7. Use during pregnancy, lactation or lay

Not permitted for use in laying birds producing eggs for human consumption.

4.8. Interaction with other medicinal products and other forms of interaction

Concurrent use of enrofloxacin with other antimicrobials, tetracyclines and macrolide antibiotics, may result in antagonistic effects.

Absorption of enrofloxacin may be reduced if the product is administered together with substances containing magnesium or aluminium.

Do not combine enrofloxacin with steroidal anti-inflammatory products.

4.9. Amounts to be administered and administration route

For oral administration via the drinking water. This may be put directly into the header tanks, or via water proportioner systems.

10 mg enrofloxacin/kg bodyweight per day for 3-5 consecutive days.

Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms. If no clinical improvement is achieved within 2-3 days, alternative antimicrobial therapy should be considered based on susceptibility testing.

Medication of the water supply should be continuous during the treatment period and no other source of water should be available.

Medicated water should be made every day, immediately prior to provision. Carefully calculate the total body mass to be treated and the total daily water consumption before each treatment.

The uptake of medicated water depends on age and clinical condition of the birds, ambient temperature, and light regime. In order to obtain the correct dosage the concentration of the product should be adjusted accordingly. Taking into consideration that 10 mg enrofloxacin per kg body weight corresponds to 0.1 ml of the product per kg body weight; the following calculation should be made to provide the required amount of the product per litre of drinking water:

0.1	X	Average bodyweight of birds to be treated (kg)	X	Number of birds	=	ml product per litre of drinking water
Total water consumption (l) of the flock at the previous day

Care should be taken that the intended dose is completely ingested.

Use appropriate and properly calibrated dosing equipment.

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

Do not exceed the recommended dose. In accidental overdose there is no antidote and treatment should be symptomatic.

4.11. Withdrawal period

Meat and offal: Chickens 7 days

Turkeys 13 days

Not authorised for use in birds producing eggs for human consumption.

Do not administer to layer replacement birds within 14 days of coming into lay.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:quinolone and quinoxaline antibacterials, fluoroquinolones

ATCvet code:QJ01MA90

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action with activity against a range of Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials – they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double standard helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.

Antibacterial spectrum

Enrofloxacin is active against many Gram-negative bacteria, against Gram-positive bacteria and Mycoplasma spp.

In vitro susceptibility has been shown in strains of (i) Gram-negative species such as Escherichia coli, Pasteurella multocida and Avibacterium (Haemophilus) paragallinarum and (ii) Mycoplasma gallisepticum and Mycoplasma synoviae. (See section 4.5)

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 Gram-negative 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.

The pharmacokinetics of enrofloxacin are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2 – 3 times 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 and the aqueous humour.

The degree of metabolism depends on the species and ranges between 50-60%. Biotransformation at hepatic level of enrofloxacin results in the active metabolite, ciprofloxacin. In general, metabolism is by hydroxylation and oxidation processes to oxofluoroquinolones. Other reactions that also occur are N-dealkylation and conjugation with glucoronic acid.

Excretion occurs by biliary and renal route, with excretion in the urine predominating.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Benzyl alcohol (E 1519)

Potassium hydroxide

Purified water

6.2. Incompatibilities

Do not mix with any other veterinary medicinal product.

Increased influx of the air (admixing CO2 from the air) into medicated drinking water may result in precipitation of enrofloxacin.

High concentrations of calcium and magnesium in the water system may result in precipitation of enrofloxacin during intermediate dilution in the dosage devices.

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: 3 months

Shelf-life after dilution according to directions: 24 hours

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

White high-density polyethylene containers of three capacities: 250-mL jars, 1-L bottles and 5-L barrels. Containers are closed with a seal screw cap of the same material with induction disk.

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

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

7. MARKETING AUTHORIZATION HOLDER

Vetpharma Animal Health, S.L.

Les Corts, 23

08028 Barcelona

Spain

8. MARKETING AUTHORISATION NUMBER

Vm: 32509/4002

9. DATE OF FIRST AUTHORISATION

Date: 12 March 2010

10. DATE OF REVISION OF THE TEXT

Date: May 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

12 June 2014