Marbofloxacin 5.0 mg/20.0mg/80.0mg

For the full list of excipients, see pharmaceutical particulars

Tablet. Beige brown spotted round tablets with a score line on one side.

Tablet. Beige brown spotted round tablets with a cross-snap tab on one side. The tablet can be divided into halves or quarters.

Tablet. Beige brown spotted oblong tablets, deep score line upper side, score line lower side. The tablet can be divided into halves.

Marbofloxacin is indicated in the treatment of the following infections caused by susceptible strains of organisms

Skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis). Urinary tract infections (UTI) associated or not with prostatitis or epididymitis. Respiratory tract infections

Skin and soft tissue infections (wounds, abscesses, phlegmons). Upper respiratory tract infections

Skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis). Urinary tract infections (UTI) associated or not with prostatitis or epididymitis. Respiratory tract infections.

Do not use in dogs aged less than 12 months, or less than 18 months for exceptionally large breeds of dogs, such as Great Danes, Briard, Bernese, Bouvier and Mastiffs, with a longer growth period. Do not use in cats aged less than 16 weeks. Do not use marbocare flavour 20mg and 80mg tablets in cats. For the treatment of this species use marbocare flavour 5mg tablets. Do not use in animals with known hypersensitivity to marbofloxacin or other (fluoro)quinolones or to any of the excipients. Do not use in cases of confirmed or suspected resistance to fluoroquinolones (cross resistance).

A low urinary pH could have an inhibitory effect on the activity of marbofloxacin.

The fluoroquinolones have been shown to induce erosion of articular cartilage in juvenile dogs and care should be taken to dose accurately especially in young animals. However, at the therapeutic recommended dosage, no severe side effects are to be expected in dogs and cats. Some fluoroquinolones at high doses may have an epileptogenic potential. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy. 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, use of fluoroquinolones should 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 effectiveness of treatment with other quinolones due to the potential for cross-resistance. Official and local antimicrobial policies should be taken into account when the product is used.

People with known hypersensitivity to (fluoro)quinolones should avoid using this product. Avoid contact of the skin and eyes with the product. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use.

Mild side effects such as vomiting, softening of faeces, modification of thirst or transient increase in activity may very rarely occur. These signs cease spontaneously after treatment and do not necessitate cessation of treatment.

Studies in laboratory animals (rats, rabbits) showed no teratogenicity, embryotoxicity and maternotoxicity with marbofloxacin at therapeutic doses. The safety of marbofloxacin has not been assessed in pregnant and lactating cats and dogs. Use only accordingly to the benefit/risk assessment by the responsible veterinarian in pregnant and lactating animals.

Fluoroquinolones are known to interact with orally administered cations (Aluminium, Calcium, Magnesium, Iron). In such cases, the bioavailability may be reduced. When administered together with theophylline, the half-life and thus the plasma concentration of theophylline increase. Hence, in case of concurrent administration the dose of theophylline should be reduced. Do not use in combination with tetracyclines, macrolides because of the potential antagonist effect.

For oral administration.

The recommended dose rate is 2 mg/kg/day in a single daily administration.

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

In skin and soft tissue infections, treatment duration is at least 5 days. Depending on the course of the disease, it may be extended up to 40 days.

In urinary tract infections, treatment duration is at least 10 days. Depending on the course of the disease, it may be extended up to 28 days.

In respiratory infections, treatment duration is at least 7 days and depending on the course of the disease, it may be extended up to 21 days.

CATS (marbocare flavour 5mg tablets only):

For skin and soft tissue infections (wounds, abscesses, phlegmons) treatment duration is 3 to 5days.

For upper respiratory infections treatment duration is 5 days.

Overdosage may cause acute signs in the form of neurological disorders, which should be treated symptomatically.

Not applicable.

Pharmacotherapeutic group: Antibacterials for systemic use;

Fluoroquinolones; Marbofloxacin.

ATC vet code: QJ01MA93

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group which acts by inhibition of DNA gyrase. It is effective against a wide range of Gram positive bacteria (in particular Staphylococci, Streptococci) and Gram negative bacteria (Escherichia coli, Salmonella typhimurium, Citrobacter freundii, Enterobacter cloacae, Serratia marcescens, Morganella morganii, Proteus spp, Klebsiella spp, Shigella spp, Pasteurella spp, Haemophilus spp, Moraxella spp, Pseudomonas spp, Brucella canis) as well as Mycoplasma spp.

Bacterial strains with a MIC ≤ 1 µg/ml are susceptible, strains with a MIC of 2 µg/ml are intermediately susceptible and strains with a MIC ≥ 4 µg/ml are resistant to marbofloxacin (CLSI, 2004).

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

Marbofloxacin is not active against anaerobes, yeasts or fungi.

After oral administration in dogs and cats at the recommended dose of 2 mg/kg, marbofloxacin is readily absorbed and reaches maximal plasma concentrations of 1.5 µg/ml within 2 hours

Its bioavailability is close to 100%.

It is weakly bound to plasma proteins (less than 10%), extensively distributed and in most tissues (liver, kidney, skin, lung, bladder, digestive tract) it achieves higher concentrations than in plasma. Marbofloxacin is eliminated slowly (t½ß = 14 h in dogs and 10h in cats) predominantly in the active form in urine (2/3) and faeces (1/3).

Lactose monohydrate, Povidone (K90), Silica, colloidal hydrated, Crospovidone (Type A), Castor Oil, Hydrogenated, Dessicated pork liver powder, Dried yeast, Magnesium stearate

Not applicable.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life of tablet portions: 96 hours

This veterinary medicinal product does not require any special storage conditions. Unused divided tablets should be returned to the blister pack and any divided tablet portions remaining after 96 hours (4 days) should be discarded.

The product is packaged in Aluminium- PVC/aluminium/polyamide blister.

Box containing 1 blister of 10 tablets (10 tablets). Box containing 2 blisters of 10 tablets (20 tablets). Box containing 10 blisters of 10 tablets (100 tablets)

Box containing 2 blisters of 6 tablets (12 tablets). Box containing 12 blisters of 6 tablets (72 tablets)

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Emdoka Bvba, John Lijsenstraat 16, Hoogstraten B-2321, Belgium

5mg: UK (GB) Vm 34534/4003, UK (Northern Ireland) Vm 34534/4003

20mg: UK (GB) Vm 34534/4004, UK (Northern Ireland) Vm 34534/4004

80mg: UK (GB) Vm 34534/4005, UK (Northern Ireland) Vm 34534/4005

4 September 2013

November 2018