Contra-indications
Do not use:
∙ in cases of hypersensitivity to the active substances of the veterinary medicinal product, as well as to other corticosteroids, to other azole antifungal agents, or to any of the excipients.
∙ in cases of skin viral infection.
∙ in cases in cases of large skin lesions and of poorly healing or fresh wounds.
∙ in animals with perforation of the tympanic membrane.
∙ in animals, where resistance of causative agents to polymyxin B and/or miconazole is known.
∙ on the mammary glands of lactating bitches and queens.
Special warnings for each target species
As the product is a prescription only medicine, treatment should be closely supervised by a veterinary practitioner. Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.
Special precautions for use in animals
Special precautions for safe use in the target species:
For external use only.
Before treating with the product, the integrity of the tympanic membrane must be verified.
Avoid contact with eyes in animals. In case of accidental contact, rinse thoroughly with water.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach. This antimicrobial combination should only be used where diagnostic testing has indicated the need for simultaneous administration of each of the active substances.
Use of the product should be based on identification and susceptibility testing of the target pathogen(s).
If this is not possible, therapy should be based on epidemiological information and knowledge of the susceptibility of the target pathogens at the local or regional level.
Use of the product should be in accordance with official, national and regional antimicrobial policies.
If there is overgrowth of resistance growth of resistant bacteria and/or fungi the use of treatment with this veterinary medicinal product should be discontinued and treatment with an appropriate alternative treatment should be initiated.
In cases of persistent infestations with Otodectes cynotis (ear mites) systemic treatment with an appropriate acaricide should be considered.
Systemic corticosteroid effects are possible, especially when the product is used under an occlusive dressing, on extensive skin lesions, with increased skin blood flow, or if the product is ingested by licking.
Oral ingestion of the product by treated animals or animals having contact with treated animals should be avoided.
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 product may cause irritation to skin and eyes.
Corticosteroids may produce irreversible effects in the skin. They can be absorbed and may have harmful effects, especially with frequent and extensive contact or in pregnancy.
Avoid contact with skin or eyes. Always wear single use disposable gloves when applying the product to animals. In case of accidental contact, skin or eyes should be rinsed immediately with plenty of water. Wash hands after use.
Accidental ingestion of the product by a child may cause gastro-intestinal disturbances. Do not leave the filled dropper unattended. In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions
Cats and Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Deafness* Impaired hearing* |
*Mainly in elderly dogs. If this occurs, treatment should be stopped. Decreased hearing or deafness is generally temporary in nature.
Prolonged use of topical steroids can cause skin discoloration and delay wound healing.
The conventional adverse effects of corticosteroids can occur (disturbance of biochemical parameters such as increased cortisol and hepatic enzyme levels).
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 the package leaflet for respective contact details.
Interaction with other medicinal products and other forms of interaction
No data available
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The use is not recommended during pregnancy. Application in the area of the mammary gland in dams with suckling infants should be avoided due to the possibility of direct drug intake by the nursing offspring.
Overdose (symptoms, emergency procedures, antidotes)
No other symptoms than those mentioned in section adverse events are expected.