Contraindications
Do not use in animals with perforated ear drums since Polymyxin B is known to be a potential ototoxic agent. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Adverse reactions (frequency and seriousness)
Dog, cat:
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Deafness1
Undetermined frequency (cannot be estimated from the available data):
Local immune deficiency2,3
Skin thinning2
Delayed healing2
Teleangiectasia2
Increased vulnerability of the skin (with bleeding)2
Reference
1 In animals treated for otitis externa, especially in older dogs. Treatment should be discontinued.
2 With prolonged use due to the contained glucocorticoid.
3 Associated with increased susceptibility to infection.
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 the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Use during pregnancy, lactation or lay Pregnancy and lactation:
Corticosteroids are not recommended for use in pregnant animals.
Interaction with other medicinal products and other forms of interaction
Do not use concomitantly with medicines that induce ototoxicity.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose, no other adverse events are known other than those mentioned in section 4.6. In case of accidental ingestion by licking, no toxic effects were observed.
Pharmaceutical precautions
Special precautions for use
Special precautions for use in animals For external use only. Due to the likely variability (temporal, geographical) in the emergence of bacterial resistance to polymyxin B, bacteriological sampling and sensitivity testing (antibiogram) is recommended. If there is overgrowth of resistance bacteria and/or fungi, treatment with this product should be discontinued and treatment with an appropriate alternative should be initiated.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to prednisolone, polymyxin B or miconazole should avoid contact with the veterinary medicinal product. The veterinary medicinal product may cause irritation to skin and eyes. Avoid contact with skin or eyes. Personal protective equipment consisting of single use disposable gloves should be worn when applying the veterinary medicinal product to animals. In case of accidental spillage, skin or eyes should be rinsed immediately with plenty of water. Take care to avoid accidental ingestion, especially by a child. In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician. Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging:
6 months
Special precautions for storage
Store below 25 °C. Store in the original container in order to protect from light.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
