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.
Do not use marbocare flavour 20mg and 80mg tablets in cats. For the treatment of this species use marbocare flavour 5mg tablets.
Do not use in animals with known hypersensitivity to marbofloxacin or other (fluoro)quinolones or to any of the excipients.
Do not use in cases of confirmed or suspected resistance to fluoroquinolones (cross resistance).
Special warnings for each target species
A low urinary pH could have an inhibitory effect on the activity of marbofloxacin.
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. However, at the therapeutic recommended dosage, no severe side effects are to be expected in dogs and cats.
Some fluoroquinolones at high doses may have an epileptogenic potential. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy.
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 effectiveness of treatment with other quinolones due to the potential for cross-resistance. Official and local antimicrobial policies should be taken into account when the product is used.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to (fluoro)quinolones should avoid using this product. Avoid contact of the skin and eyes with the 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.
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)
Use during pregnancy, lactation or lay
Studies in laboratory animals (rats, rabbits) showed no teratogenicity, embryotoxicity and maternotoxicity with marbofloxacin at therapeutic doses.
The safety of marbofloxacin has not been assessed in pregnant and lactating cats and dogs. Use only accordingly to the benefit/risk assessment by the responsible veterinarian in pregnant and lactating animals.
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.
When administered together with theophylline, the half-life and thus the plasma concentration of theophylline increase. Hence, in case of concurrent administration the dose of theophylline should be reduced.
Do not use in combination with tetracyclines, macrolides because of the potential antagonist effect.
Amounts to be administered and administration route
For oral administration.
The recommended dose rate is 2 mg/kg/day in a single daily administration.
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. 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. 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.
CATS (marbocare flavour 5mg tablets only):
For skin and soft tissue infections (wounds, abscesses, phlegmons) treatment duration is 3 to 5days.
For upper respiratory infections treatment duration is 5 days.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosage may cause acute signs in the form of neurological disorders, which should be treated symptomatically.