Marfloxin 20 mg, 100 tablets

STATEMENT OF ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each tablet contains 5 mg marbofloxacin.
Light yellow-brown, round, biconvex, marbled tablets with bevelled edges and possible darker or lighter spots, marked on one side.
The tablets can be divided into equal halves.

INDICATION(S)

Treatment of infections caused by bacterial strains susceptible to marbofloxacin.
Dogs
− Skin and soft tissue infections (pyoderma, impetigo, folliculitis, furunculosis, cellulitis);
− Urinary tract infections (UTIs) with or without prostatitis or epididymitis;
− Respiratory tract infections.
Cats
− skin and soft tissue infections (open lesions, abscesses, phlegmons);
− upper respiratory tract infections.

CONTRAINDICATIONS

Do not use in dogs under 12 months of age, or under 18 months in very large breeds such as Great Danes, Briards, Bernese, Bouviers and Mastiffs, in which the growth period is longer.

Do not use in cats under 16 weeks of age.

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

ADVERSE REACTIONS

Occasionally, mild adverse reactions such as vomiting, soft faeces, thirst or temporary hyperactivity may occur. These clinical signs disappear spontaneously upon termination of treatment and do not require discontinuation of treatment.
If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

TARGET SPECIES
Cats and dogs.

DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
Oral administration.
The recommended dose is 2 mg/kg body weight/day (1 tablet per 2.5 kg body weight per day) in a single dose.
If necessary and only in dogs, the combination of whole tablets and half tablets of different strengths (5 mg, 20 mg or 80 mg) allows for an adequate dosage.

FOR DOSAGE see METHOD OF ADMINISTRATION

To avoid underdosing, body weight should be determined as accurately as possible.

Duration of treatment
Dogs
– in skin and soft tissue infections, the duration of treatment is at least 5 days and, depending on the course of the disease, may be up to 40 days.
– in urinary tract infections, the duration of treatment is at least 10 days and, depending on the course of the disease, may reach 28 days.
– in respiratory infections, the duration of treatment is at least 7 days and, depending on the course of the disease, may reach 21 days.
Cats
– in skin and soft tissue infections (open lesions, abscesses, phlegmons) the duration of treatment is 3 – 5 days.
– in upper respiratory infections, the duration of treatment is 5 days.

SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.
Store in the original package in order to protect from light.
This medicine does not require any special temperature storage conditions.
Do not use after the expiry date which is stated on the carton after EXP.
Shelf life of the tablets divided in half: 5 days.

SPECIAL WARNING(S)

Some fluoroquinolones have epileptogenic potential when administered in high doses. Caution is advised in dogs with epilepsy. However, severe adverse reactions are not expected in dogs and cats at therapeutic doses. In particular, no joint lesions were observed in clinical studies at the recommended doses.
A low urinary pH may have an inhibitory effect on the activity of mabofloxacin
Pyoderma occurs mainly as a secondary condition to an underlying disease, therefore appropriate diagnosis and treatment of the animal is preferable.
The product should be used taking into account official, local antimicrobial policies for the use of antibiotics. Fluoroquinolones should be reserved for the treatment of diseases that have responded or are expected to respond inadequately to other classes of antibiotics. When possible, fluoroquinolones should only be used on the basis of an antibiogram. Use of the product outside the instructions in the SPC may increase the prevalence of bacteria resistant to fluoroquinolones and decrease the effectiveness of treatment with other quinolones, due to the potential for cross-resistance.
Studies in laboratory animals (rats, rabbits) have not demonstrated teratogenic, fetotoxic, maternotoxic effects at therapeutic doses of marbofloxacin. However, specific studies have not been conducted in cats and dogs during pregnancy and lactation. Use only according to the benefit/risk assessment carried out by the responsible veterinarian.
It is known that fluoroquinolones may interact with orally administered cations (aluminium, calcium, magnesium, iron). In these cases, the bioavailability of marbofloxacin may be reduced. Concomitant administration of theophylline-containing products may result in decreased clearance of theophylline.
Overdose may result in acute neurological disorders, requiring symptomatic treatment.
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 with water after use.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from the use of such products should be disposed of in accordance with local requirements.
Ask your veterinarian how to dispose of medicines no longer required. These measures will help to protect the environment.