Solution for injection. Clear yellow greenish to yellow brownish solution. Each ml contains 160 mg marbofloxacin and 15 mg benzyl alcohol (E 1519).

In cattle:

- Therapeutic treatment of respiratory infections in cattle caused by sensitive strains of Pasteurella multocida and Mannheimia haemolytica.

In lactating cows:

- Treatment of acute mastitis caused by sensitive strains of Escherichia coli.

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

Where there is slight cloudiness or visible particles present, such cloudiness or particles disappear when the bottle is shaken before use.

- Therapeutic treatment of respiratory infections

10 mg/kg body weight i.e. 10 ml /160 kg body weight in a single intramuscular injection.

- Treatment of acute mastitis caused by sensitive strains of Escherichia coli

10 mg/kg body weight i.e. 10 ml/160 kg body weight in a single intramuscular or intravenous injection.

If the volume to be injected intramuscularly is more than 20 ml, it should be divided between two or more injection sites.

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

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

The efficacy of the product has not been tested on mastitis caused by Gram positive bacteria.

Official and local antimicrobial policies should be taken into account when this 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, use of the product should only be 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.

•People with known hypersensitivity to (fluoro)quinolones should avoid using this product.

•In case of contact with skin or eyes, rinse with plenty of water. Care should be taken to avoid accidental self-injection.

•Accidental self-injection can induce a slight irritation.

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

•Wash hands after use.

In very rare cases, administration by the intramuscular route may cause rare transient local reactions such as pain and swelling at the injection site which may persist up to 7 days after injection.

Fluoroquinolones are known to induce arthropathies. In cattle, such lesions were observed after a three days treatment with the 16% marbofloxacin solution. These lesions did not induce clinical signs and should be reversible, particularly if they were to be observed after a single administration.

In very rare cases, anaphylactic-type reactions with a potentially fatal outcome might occur.

Studies in laboratory animals (rats, rabbits) did not show any evidence of a teratogenic, embryotoxic or maternotoxic effect associated with the use of marbofloxacin. Safety of the product at 10 mg/kg has not been determined in pregnant cows or in suckling calves when used in cows. Use therefore according to the benefit/risk assessment carried out by the responsible veterinarian.

None known.

Lesions of the joint cartilage were observed in some animals treated at 10 mg/kg or 30 mg/kg for three times the recommended treatment duration, but did not induce clinical signs. Moreover, no sign of overdosage was observed throughout this study.

Overdosage may cause signs such as acute neurological disorders which should be treated symptomatically.

Meat and offal: 5 days

Milk : 48 hours

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: 3 years

Shelf life after first opening the immediate packaging: 28 days

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

Cardboard box containing one 100 ml vial

ATC Vet code: QJ01MA93

Pharmacotherapeutic group: antibacterials for systemic use, Fluoroquinolones

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group, which acts by inhibition of DNA gyrase. The in vitro activity of marbofloxacin has been demonstrated towards Pasteurella multocida, Mannheimia haemolytica and Escherichia coli.

The marbofloxacin in vitro activity against pathogens isolated in 2007 from bovine respiratory diseases is good: MIC values are comprised between 0.008 and 0.5 µg/ml for M. haemolytica (MIC90 = 0.139 µg/ml; MIC50 = 0.021 µg/ml), between 0.004 and 0.5 µg/ml for P. multocida (MIC90 = 0.028 µg/ml; MIC50 = 0.012 µg/ml).

In 2008, the marbofloxacin MIC50 for E. coli isolated from bovine mastitis was 0.021 µg/ml and the MIC90 was 0.038 µg/ml.

Strains with MIC ≤ 1 µg/ml are sensitive 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.

After a single intramuscular administration in cattle at the recommended dose of 10 mg/kg body weight, the maximum plasma concentration of marbofloxacin (Cmax) is 7.915 µg/ml reached in 1.28 h (Tmax) for an exposure (AUCINF) of 52.7 µg.h/mL. Bioavailability after intramuscular injection is complete (more than 90%). Marbofloxacin is extensively distributed. Binding to plasma proteins is about 30%. After intravenous or intramuscular administration, marbofloxacin concentrations in milk increase rapidly and the AUCINF , Tmax and Cmax values obtained in plasma and milk after both administration routes are similar. Marbofloxacin is eliminated slowly (T1/2λz = 17.50 h) predominantly as the active form in urine and faeces.