Target species
Dogs.
4.2 Indications for use, specifying the target species
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.
4.3 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.
4.4 Special warnings for each target species
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.
4.5 Special precautions for use
Special precautions for use in animals
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 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.
4.6 Adverse reactions (frequency and seriousness)
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.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
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 dogs.
Use only according to the benefit/risk assessment by the responsible veterinarian in pregnant and lactating animals
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 of marbofloxacin may be reduced. Concurrent administration of theophylline products may be followed by inhibited theophylline clearance.
