Do not use in dogs suffering from perforation of the tympanic membrane. Before treating with the product, the integrity of the tympanic membrane must be verified.
Do not use in cases of hypersensitivity to the active substances, to other azole antifungal agents or to any other fluoroquinolones or to any of the excipients.
Do not use in animals, where resistance of causative agents to marbofloxacin and/or clotrimazole is known.
Do not administer to pregnant or lactating bitches.
Avoid contact with eyes in animals. In case of accidental contact, rinse thoroughly with water.
Special precautions for use in animals
Before treating with the product, the integrity of the tympanic membrane must be verified. Use of the product should be based on susceptibility testing of the bacteria and/or fungi isolated from the animal. If this is not possible, therapy should be based on local (regional) epidemiological information about susceptibility of the target pathogens.
Official and local antimicrobial policies should be taken into account when the veterinary medicinal product is used. Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antibiotics.
Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species. The use of the product in young animals is not recommended. Prolonged and intensive use of topical corticosteroid preparations is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed wound healing. Avoid contact with eyes in animals. In case of accidental contact, rinse thoroughly with water.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity (allergy) to (fluoro)quinolones, (cortico)steroids or antifungals and to other ingredients in the veterinary medicinal product should take care to avoid contact with the veterinary medicinal product during administration. Avoid contact of the skin and eyes with the veterinary medicinal product. In case of accidental spillage onto skin or eyes, rinse the affected area with large amounts of water. Take care to avoid accidental ingestion. In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician. Wash hands after use.
Adverse reactions
Rare (1 to 10 animals / 10,000 animals treated): Deafness1
Undetermined frequency (cannot be estimated from the available data): Changes in biochemical and haematological parameters (e.g., Elevated serum alkaline phosphatase (ALP), Elevated alanine aminotransferase (ALT)/Elevated aspartate aminotransferase (AST), Neutrophilia)2
1 - Mainly in elderly dogs and mostly of a transient nature.
2 - Associated with corticosteroid drugs
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Overdose
Changes in biochemical and haematological parameters (such as increase of alkaline phosphatase, aminotransferase, some limited neutrophilia, eosinopaenia, lymphopaenia) are observed with three fold the recommended dosage; such changes are not serious and will reverse once the treatment has stopped.