, use of the product should only be based on susceptibility testing. Use of the product deviating from the instructions given in this 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. Other precautions None 4.6 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. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 4.7 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 only according to the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction None known.
Vat Rate: 20%