- 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 is more than 20 ml, it should be divided between two or more injection sites.

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.

Contra-indications, warnings, etc

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).

Special warnings

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

Special precautions for use in animals

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.

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

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

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

Care should be taken to avoid accidental self-injection. In the event of accidental self-administration, the user should immediately seek professional medical care.

Accidental self-injection can induce a slight irritation.

Adverse reactions (frequency and seriousness)

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 three days of 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.

No other adverse effect was observed on cattle.

Use during pregnancy, lactation or lay

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.

Interaction with other medicinal products and other forms of interaction

None known.

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

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.

Withdrawal period(s)

Meat and offal: 5 days

Milk : 48 hours

Incompatibilities

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

Pharmaceutical precautions

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.

Legal category

POM-V

Packaging Quantities

Cardboard box containing one 100 ml or 50 ml vial

Further information

ATC Vet code: QJ01MA93

Pharmacotherapeutic group: antibacterials for systemic use, Fluoroquinolones

Pharmacodynamic properties

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.

Pharmacokinetic particulars

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.

Marketing Authorisation Holder (if different from distributor)

-

Marketing authorisation number

Vm 08007/4130.

Significant Changes

New administration route (IV)

Addition of a new indication (mastitis)

GTIN (Global Trade Item No)

Forcyl 160 mg/ml Solution for Injection for Cattle 100ml

03605874256613

Forcyl 160 mg/ml Solution for Injection for Cattle 50ml

03605874319448