SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Marbonor 100 mg/ml Solution for Injection for cattle and pig

2. Qualitative and quantitative composition

Each ml contains:

Active Substance:

Marbofloxacin 100.0 mg

Excipients:

Monothioglycerol 1.0 mg

Metacresol 2.0 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection.

Clear yellow to amber solution.

4. Clinical Particulars

4.1 Target species

Cattle and Pig

4.2 Indications for use, specifying the target species

Cattle

Treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolyticaand Mycoplasma bovis.
Treatment of acute mastitis caused by Echerichia colistrains sensitive to marbofloxacin during the lactation period.

Sows

Treatment of Metritis Mastitis Agalactia Syndrome (postpartum dysgalactia syndrome, PDS) caused by bacterial strains sensitive to marbofloxacin.

4.3 Contraindications

Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).

Do not use in animals with known hypersensitivity to fluoroquinolones or to any of the excipients.

4.4 Special Warnings for each target species

The efficacy data showed that the product has insufficient efficacy for the treatment of acute forms of mastitis induced by Gram-positive bacteria.

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

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

If the product comes into contact with skin or eyes, rinse with copious amounts of water.

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

Wash hands after use.

Accidental self-injection can induce a slight irritation

In case of accidental self-injection or ingestion, seek medical advice immediately and show package leaflet or the label to the physician

4.6 Adverse reactions (frequency and seriousness)

Administration by the intramuscular route may cause transient local reactions such as pain and swelling at the injection site and inflammatory lesions which may persist for at least 12 days after injection. However, in cattle subcutaneous route was shown to be better tolerated locally than intramuscular route. Therefore, the subcutaneous route is recommended in heavy cattle.

4.7 Use during pregnancy, lactation or lay

May be used in pregnant and lactating cows and sows.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

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

The recommended dosage is 2 mg/kg (1 ml/50kg) in a single daily injection by intramuscular, subcutaneous or intravenous routes in cattle and by intramuscular route in pigs. For the injections, the neck should be preferred in cattle and pigs

Treatment durations are 3 days in pigs and 3 to 5 days in cattle.

The vial may be broached up to 35 times. The user should choose the most appropriate vial size according to the target species to be treated.

No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively.

Signs such as neurological disorders may occur when the dose is exceeded.

Such signs should be treated symptomatically

Cattle: Meat and offal: 6 days.

Milk: 36 hours

Pigs: Meat and offal: 4 days.

5. pharmacological properties

Pharmacotherapeutic Group:Antibacterials for systemic use, Flouroquinolones

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 of activity in-vitro against Gram-negative (Pasteurella multocida, Mannheimia haemolytica, E. coli), Gram-positive bacteria as well as Mycoplasmaspp.

The marbofloxacin in vitroactivity against pathogens isolated in 2004 from bovine respiratory diseases during a clinical field trial in France, Germany, Spain and Belgium, is good: MIC values were reported as being 0.015 and 0.25 µg/ml for M. haemolytica(MIC₉₀= 0.124 µg/ml; MIC₅₀= 0.025 µg/ml)and between 0.004 and 0.12 µg/ml for P. multocida(MIC₉₀= 0.022 µg/ml; MIC₅₀= 0.009 µg/ml).

Strains with MIC≤1μg/ml are sensitive to marbofloxacin whereas strains with MIC≥4μg/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 properties

After subcutaneous or intramuscular administration in cattle and pigs, at the recommended dose of 2 mg/kg bodyweight, marbofloxacin is readily absorbed and reaches peak plasma concentrations of 1.5 μg/ml within 1 hour. The bioavailability of marbofloxacin is almost 100%.

Marbofloxacin is weakly bound to plasma proteins (less than 10% in pigs and 30 % in cattle), extensively distributed and achieves a higher concentration in most tissues, (liver, kidney, skin, lung, bladder, uterus and digestive tract) than in plasma

In cattle, marbofloxacin is eliminated slowly in pre-ruminant calves but faster in ruminant cattle (t_1/2 = 5-9 hours and 4 – 7 hours respectively). In pre-ruminant calves elimination of the active form is predominantly via urine, (¾ urine, ¼ faeces). In ruminant cattle the active form is eliminated equally in urine and faeces.

In pigs, the active form of marbofloxacin is eliminated slowly (t_1/2= 8 – 10 hours) predominantly urine (2/3) and faeces (1/3).

6. Pharmaceutical particulars

6.1 List of excipients

Monothioglycerol

Metacresol

Disodium Edetate

Gluconolactone

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

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

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

Do not store above 25^oC.

Protect from light.

The product is packaged in 20 ml, 50 ml, 100 ml 250 ml and 500 ml amber type II glass vials, 60 ml, 100 ml, 250 ml and 500 ml amber co-ex plastic (polypropylene) vials.

The vials are closed with chlorobutyl rubber stoppers sealed with aluminium caps.

Not all pack sizes may be marketed.

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 AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER

Vm 02000/4331

9. DATE OF THE FIRST AUTHORISATION

Date:27 February 2013

10. DATE OF REVISION OF THE TEXT

Date:August 2013

Approved:14/08/2013