Marfloquin 80 mg Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Marbofloxacin…….80 mg

Excipients:

Qualitative composition of excipients and other constituents

Lactose monohydrate

Povidone (K 90)

Yeast powder

Meat flavour

Crospovidone

Hydrogenated castor oil

Colloidal anhydrous silica

Magnesium stearate

Light brownish yellow, capsule shaped, biconvex, marble tablets with possible dark and white spots and scored on the both sides.

The tablets can be divided into halves.

3

Pharmacological properties

4.1 ATCvet code : QJ01MA93

4.2 Pharmacodynamics

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.

4.3 Pharmacokinetics

After oral administration in dogs 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) predominantly in the active form in urine (2/3) and faeces (1/3).

3

Target species

Dogs.

3

Indications

Treatment of infections caused by strains of microorganisms susceptible to marbofloxacin in dogs:

- 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.

3

Dosage

Oral use.

The recommended dose rate is 2 mg/kg/day (1 tablet for 40 kg per day) in single daily administration.

Where appropriate, the use of combinations of whole or half tablets of different strengths (80 mg, 20 mg or 5 mg) will allow accurate dosing.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Duration of treatment:

- for 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;

- for 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;

- for 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.

3

Contraindications

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. For the treatment of this species, a 5 mg tablet is available.

Do not use in cases of hypersensitivity to marbofloxacin or other (fluoro)quinolones or to any of the excipients.

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

3

Adverse reactions

Dogs:

Very rare (<1 animal / 10 000 animals treated, including isolated reports): Vomiting1, soft faeces1, Modification of thirst1, Hyperactivity1,2

1Ceases spontaneously after treatment and do not necessitate cessation of treatment.

2Transient.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

High doses of some fluoroquinolones may have epileptogenic potential. Cautious use is recommended in dogs diagnosed as suffering from epilepsy. However, at the therapeutic recommended dosage, no severe side-effects are to be expected in dogs. 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 veterinary medicinal 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.

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

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

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation in dogs.

Laboratory studies in rats and rabbits have not produced any evidence of foetotoxic, teratogenic and maternotoxic effects with marbofloxacin at therapeutic doses.

Use only according to the benefit-risk assessment by the responsible veterinarian.

3

Interactions

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.

3

Overdose

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

3

Special warnings

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.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Polyvinylchloride-aluminium-oriented polyamide/Aluminium cold formed blister.

Pack sizes:

Cardboard box containing 2 blisters of 6 tablets.

Cardboard box containing 12 blisters of 6 tablets.

Not all pack sizes may be marketed.

3

Storage

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

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

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life of half-tablets: 5 days.

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

Vm 01656/4049

8 DATE OF FIRST AUTHORISATION

06 March 2013

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 15 October 2025

3

Registration holder

KRKA, d.d., Novo mesto

3