Do not use in animals with known hypersensitivity to fluoroquinolones or to any of the excipients.
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
The efficacy of the product has not been tested on mastitis caused by Gram positive bacteria.
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account when this 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. Wherever possible, use of the product should only 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.
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.
•In case of contact with skin or eyes, rinse with plenty of water. Care should be taken to avoid accidental self-injection.
•Accidental self-injection can induce a slight irritation.
•In case of accidental self-injection, seek medical advice immediately and show the label or the package leaflet to the physician.
•Wash hands after use.
Adverse reactions (frequency and seriousness)
In very rare cases, administration by the intramuscular route may cause rare transient local reactions such as pain and swelling at the injection site which may persist up to 7 days after injection.
Fluoroquinolones are known to induce arthropathies. In cattle, such lesions were observed after a three days treatment with the 16% marbofloxacin solution. These lesions did not induce clinical signs and should be reversible, particularly if they were to be observed after a single administration.
In very rare cases, anaphylactic-type reactions with a potentially fatal outcome might occur.
Use during pregnancy, lactation or lay
Studies in laboratory animals (rats, rabbits) did not show any evidence of a teratogenic, embryotoxic or maternotoxic effect associated with the use of marbofloxacin. Safety of the product at 10 mg/kg has not been determined in pregnant cows or in suckling calves when used in cows. Use therefore according to the benefit/risk assessment carried out by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Overdose (symptoms, emergency procedures, antidotes), if necessary
Lesions of the joint cartilage were observed in some animals treated at 10 mg/kg or 30 mg/kg for three times the recommended treatment duration, but did not induce clinical signs. Moreover, no sign of overdosage was observed throughout this study.
Overdosage may cause signs such as acute neurological disorders which should be treated symptomatically.
Meat and offal: 5 days
Milk : 48 hours
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.