4.1 Target species
DOGS
4.2 Indications for use, specifying the target species
Marbofloxacin is indicated in the treatment of:
skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis) caused by susceptible strains of organisms.
urinary tract infections (UTI) associated or not with prostatitis caused by susceptible strains of organisms.
respiratory tract infections caused by susceptible strains of organisms.
4.3 Contra-indications
Marbofloxacin should not be used in dogs aged less than 12 months, or less than 18 months for exceptionally large breeds of dogs, such as Great Danes, Briard, Bernese Bonvier and Mastiffs, with a longer growth period.
Not suitable for infections resulting from strict anaerobes, yeast or fungi.
Do not use in cats. For the treatment of this species, a 5 mg tablet is available.
4.4 Special warnings for each target species
Nil
4.5 Special precautions for use
(i) Special precautions for use in animals
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.
The fluoroquinolones are also known for their potential neurological side effects. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy.
A low urinary pH could have an inhibitory effect on the activity of marbofloxacin.
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 the effectiveness of treatment with other quinolones due to the potential for cross resistance.
(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to fluoroquinolones should avoid using this product. In case of accidental ingestion seek medical attention and show product label and/or package leaflet to the doctor. Wear gloves when handling or dividing tablets. Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
At the therapeutic recommended dosage, no severe side-effects are to be expected in dogs and cats. In particular, no lesions of the articular joints were encountered in clinical studies at the recommended dose rate.
Mild side effects such as vomiting, softening of faeces, modification of thirst or transient increase in activity may occasionally occur. These signs cease spontaneously after treatment and do not necessitate cessation of treatment.
4.7 Use during pregnancy, lactation or lay
Studies in pregnant rats and rabbits showed no side effects on pregnancy. However no specific studies have been carried out in pregnant dogs.
4.8 Interaction with other medicinal products and other forms of interaction
Fluoroquinolones are known to interact with orally administered cations (Aluminium, Calcium, Magnesium, Iron). In such cases, the bioavailability may be reduced.
