SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Enrotron 5 mg/ml oral solution for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains:

Active substance:

Enrofloxacin 5.0 mg

Excipients:

Benzyl alcohol (E-1519) 14.0 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution

Clear slightly yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs (piglets)

4.2 Indications for use, specifying the target species

Treatment of infections of the respiratory and alimentary tract caused by enrofloxacin-sensitive microorganisms. In particular:

• Treatment of neonatal diarrhoea and septicaemia caused by enrofloxacin-sensitive E. coli

• Treatment of respiratory infections caused by enrofloxacin-sensitive Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp.

• Enzootic pneumonia

To be used where clinical experience and/or sensitivity testing indicates enrofloxacin as the drug of choice.

4.3 Contraindications

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

Do not use in case of disturbances in growth of cartilage and/or during injury of locomotory system particularly on functionally loaded joints or due to body weight loaded joints.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

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

Do not use in case of confirmed or suspected resistance to quinolones, since a high degree of cross resistance between enrofloxacin and other quinolones does exist.

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.

Susceptibility testing should be performed before treatment is initiated.

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.

Do not use for prophylaxis.

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

Those with known hypersensitivity to (fluoro)quinolones should avoid contact with this product.

Avoid contact with skin and eyes.

Rinse any splashes from skin or eyes immediately with water.

Wash hands and exposed skin after use.

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

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Not applicable.

4.8 Interaction with other medicinal products and other forms of interaction

Concurrent administration 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.

Dosage

1.7 mg enrofloxacin per kg bodyweight daily for 3 to 5 days; equivalent to 1 ml per 3 kg bodyweight.

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

Administration route

The product is administered orally directly into the mouth of the animals using the dispenser.

The dosing pump of the dispenser delivers 1 ml per pump stroke.

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

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

4.11 Withdrawal period(s)

Meat and offal: 7 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: quinolone and quinoxaline antibacterials, fluoroquinolones. ATCvet code: QJ01MA90

5.1 Pharmacodynamic properties

Enrofloxacin belongs to the chemical class of fluoroquinolones. It exerts its bactericide effect by interaction with the A subunit of the DNA gyrase. The DNA gyrase is a topoisomerase, which controls the bacterial replication (catalyses the supercoiling of chromosomal DNA strands).

Fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the cell membrane.

For enrofloxacin, the inhibitory and bactericidal concentrations are very close to each other; they are identical or differ by one or two dilution steps.

Atlowconcentrations enrofloxacinpossessesantimicrobial activityagainstmost gram-negative bacteria, againstmany gram-positive bacteriaandagainstmycoplasmas.

Consequently, the product is effective in primary or secondary infections with these microorganisms.

Resistance to fluoroquinolones occurs primarily by alteration in bactericidal cell wall penetration. Permeability changes occur either via decreased permeability of the hydrophilic pores or through alteration of the active transport (efflux) pump, thereby decreasing the intracellular content of fluoroquinolones.

5.2 Pharmacokinetic particulars

In pigs peak concentration in serum is reached 1 – 2 hours after oral administration of enrofloxacin.

This concentration in µg/ml relates in terms of numbers to 1/3 of the administered dose in mg/kg. Absorption in new born and young piglets is faster than in older piglets

The concentration of the active ingredient in the intestinal wall is higher than that found in the plasma.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol (E-1519)

Potassium hydroxide (for pH adjustment)

Hypromellose

Hydrochloric acid, dilute (for pH adjustment)

Water, purified

6.2 Incompatibilities

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

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

6.4. Special precautions for storage

Keep this container tightly closed.

Discard unused material.

6.5 Nature and composition of immediate packaging

100 ml, 250 ml opaque polyethylene bottle with opaque polyethylene temper evident screw cap and white pump dispenser which are presented in a cardboard box as well as the 12 x 100 ml and 6 x 250 ml sizes.

Pack sizes: 1 x 100 ml; 12 x 100 ml; 1 x 250 ml; 6 x 250 ml

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 product should be disposed of in accordance with local / national requirements.

7. MARKETING AUTHORISATION HOLDER

Marketing authorisation holder

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

8. MARKETING AUTHORISATION NUMBER

24745/4020

9. DATE OF FIRST AUTHORISATION

20 June 2013

10. DATE OF REVISION OF THE TEXT

June 2013

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 20/06/2013