Three preparations available.

Each tablet contains:

Marfloquin 5 mg containing 5 mg marbofloxacin. For use in dogs and cats.

Marfloquin 20 mg containing 20 mg marbofloxacin. For use in dogs.

Marfloquin 80 mg containing 80 mg marbofloxacin. For use in dogs.

Light brownish yellow, round, biconvex, marble tablets with bevelled edges and with possible dark and white spots, scored on one side.

The tablets can be divided into halves.

Marfloquin 5 mg tablets are indicated for use in cats and dogs. Marfloquin 20 mg and 80 mg tablets are indicated for use in dogs only.

Treatment of infections caused by strains of microorganisms susceptible to marbofloxacin.

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. For cats only use the 5mg formulation.

Do not use in animals with known hypersensitivity to marbofloxacin or other (fluoro)quinolones or to any of the excipients of the product.

Do not use in cases of resistance against quinolones, since (almost) complete cross-resistance exists against other fluoroquinolones.

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

Pyoderma occurs mostly secondary to an underlying disease, thus, it is advisable to determine the underlying cause and to treat the animal accordingly.

High doses of some fluoroquinolones may have epileptogenic potential. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy. However, at the therapeutic recommended dosage, no severe side-effects are to be expected in dogs and cats. 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. At the recommended dose rate, no lesions of the articular joints were encountered in clinical studies.

Official and local antimicrobial policies should be taken in to account when the veterinary medicinal 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, 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 (fluoro)quinolones and may decrease 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 accidental ingestion seek medical attention and show product label and/or package leaflet to the doctor.

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 (rat, rabbit) showed no embryotoxicity, teratogenicity and maternotoxicity with marbofloxacin at therapeutic doses.

The safety of marbofloxacin has not been assessed in pregnant and lactating cats and dogs.

Use only according 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 of marbofloxacin may be reduced. Concurrent administration of theophylline products may be followed by inhibited theophylline clearance.

For oral administration. The recommended dose rate is 2 mg/kg/day in single daily administration. Where appropriate, in dogs only, the use of combinations of whole or half tablets of different strengths (5 mg, 20 mg or 80 mg) will allow accurate dosing.

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 and 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 and 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.

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

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.

ATCvet code: QJ01MA93

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group which acts by inhibition of DNA gyrase and of topoisomerase IV. It is effective against a wide range of Gram positive bacteria (including Streptococci and in particular Staphylococci) and Gram negative bacteria (Escherichia coli, Citrobacter freundii, Proteus spp., Klebsiella spp, Shigella spp., Pasteurella spp., Pseudomonas spp.) as well as Mycoplasma spp.

A secondary literature report of microbiological susceptibility data whose source included two European field surveys, each involving hundreds of canine and feline pathogens susceptible to marbofloxacin, was published in 2014.

Susceptibility break points have been determined as ≤1 µg/ml for sensitive, 2 µg/ml for intermediate and ≥4 µg/ml for resistant bacterial strains.

Marbofloxacin is not active against anaerobes, yeast or fungi. Cases of resistance have been observed in Streptococcus.

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 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 (K 90), Yeast powder, Meat flavour, Crospovidone, Castor oil (hydrogenated), Silica (Colloidal Anhydrous), Magnesium stearate

Not applicable.

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

Shelf life of half-tablets: 5 days.

Store in the original package in order to protect from light.

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

Marfloquin 5 mg Tablets and Marfloquin 20 mg Tablets: Polyvinylchloride-aluminium-oriented polyamide/Aluminium cold formed blister containing 10 tablets. Boxes with the instruction leaflet with 100 tablets.

Marfloquin 80 mg Tablets: Polyvinylchloride-aluminium-oriented polyamide/Aluminium cold formed blister containing 6 tablets. Boxes with the instruction leaflet with 12 tablets and 72 tablets.

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.

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

06 March 2013

February 2018

Nil