Summary of product characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

MASTERFLOX 40 mg/ml solution for injection for pigs (AT, CY, CZ, DE, EE, EL, ES, IE, IT, LT, LV, PL, PT, SK, UK)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains:

Active substance:

Marbofloxacin40 mg.

Excipients:

disodiumedetate0.1 mg

For a full list of the excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear yellow solution, with no visible particles.

4. CLINICAL PARTICULARS

4.1. Target species

Pig (pig for fattening).

4.2. Indications for use, specifying the target species

Treatment of respiratory infections caused by strains of Actinobacilluspleuropneumoniae, Pasteurellamultocida, Mycoplasma hyopneumoniaesusceptible to marbofloxacin.

4.3. Contraindications

Do not use in cases where the pathogen involved is resistant to marbofloxacin and other (fluoro)quinolones (cross-resistance).

Do not administer to animals known to be hypersensitive to marbofloxacin, other quinolones, or to any of the excipients.

4.4. Special warnings for each target species

None.

4.5. Special precautions for use

This product does not contain an antimicrobial preservative.

Special precautions for use in animals

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.

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

People with known hypersensitivity to (fluoro)quinolonesor any of the excipients should avoid contact with the veterinary medicinal product.

Avoid contact of the skin and eyes with the product. In case of accidental spillage onto skin or eyes, rinse the affected area with large amounts of water.

Avoid accidental self-injection, since this can cause local irritation.In case of self-injection or ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

4.6. Adverse reactions (frequency and seriousness)

Intramuscular administration may cause transient local reactions such as oedema, pain and swelling at the injection site and inflammatory lesions which may persist for 6 days.

4.7. Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

Use only according to the benefit-risk assessment by the responsible veterinarian.

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

None known.

4.9. Amounts to be administered and administration route

For intramuscular use.

The recommended dosage is 2 mg marbofloxacin/kg body weight (equivalent to 0.5 ml of the product/ 10 kg body weight) in a single daily intramuscular injection, for 3-5 consecutive days.

To ensure administration of a correct dose, body weight should be determined as accurately as possible, to avoid underdosing.

The preferred injection site is the neck area.

The vial may be broached up to 20 times. The user should choose the most appropriate vial size according to the bodyweight and number of animals to be treated.

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

No signs of overdosage have been observed administering marbofloxacin at up to 3 times the recommended dose.

Overdose may cause acute signs in the form of neurological disorders which should be treated symptomatically. Do not exceed the recommended dose.

4.11. Withdrawal period(s)

Pigs

Meat and offal: 6 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterialsfor systemic use, Fluoroquinolones.

ATC Vet code: QJ01MA93.

5.1. Pharmacodynamic properties

Marbofloxacin is a synthetic bactericidal antimicrobial belonging to the fluoroquinolone group, which acts by inhibition of DNA gyrase. It has a broad-spectrum activity in vitro against Gram-positive bacteria, Gram-negative bacteria (Pasteurellamultocidaand Actinobacilluspleuropneumoniae)and against Mycoplasmas (Mycoplasma hyopneumoniae).

Resistance to Streptococcussppmay occur.

Strains with MIC ≤ 1 µg/ml are susceptible to marbofloxacin whereas strains with MIC ≥ 4 µg/ml are resistant to Marbofloxacin.

Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump or mutation of enzymes responsible for molecule binding.

5.2. Pharmacokinetic particulars

After intramuscular administration in swine at the recommended dose of 2 mg/kg b.w., marbofloxacin is rapidly absorbed and reaches its maximum plasma concentration of 1.5 µg/ml in less than one hour.

Marbofloxacin is readily absorbed and its bioavailability is close to 100%. It is weakly bound to plasma proteins (less than 10%), extensively distributed and in most tissues (liver, kidney, lungs, bladder, uterus, digestive tract) it achieves higher concentrations than in plasma.

Marbofloxacin is eliminated slowly (t_1/2= 8-10 hours) predominantly in the active form in urine (2/3) and faeces (1/3).

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Disodium edetate

Gluconolactone

Mannitol

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: 2 years.

Shelf-life after first opening the immediate packaging: 28 days.

6.4. Special precautions for storage

Store in the original package.Protect from light.

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

6.5. Nature and composition of immediate packaging

50 ml, 100 ml, 250 ml ambertype II glass vials, closed with chlorobutylrubber stoppertype I and aluminium collar.

Cardboard box containing 1 x 50 ml, 1 x 100 ml, 1 x 250 ml and 6 x 100 ml.Not all packs 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 medicinalproducts or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

FATRO S.p.A.

Via Emilia, 285

Ozzano Emilia - Bologna

Italy

8. MARKETING AUTHORISATION NUMBER

Vm 11557/4001

9. DATE OF FIRST AUTHORISATION

01 July 2014

10. DATE OF REVISION OF THE TEXT

July 2015