Target species
Dogs.
Indications for use, specifying the target species
For the treatment of acute surface pyoderma, such as acute moist dermatitis (‘hot spots’) and intertrigo (skin fold dermatitis), caused by Gram-positive bacteria sensitive to fusidic acid.
Contraindications
•Do not use in cases of deep pyoderma.
•Do not use in cases of pyotraumatic furunculosis and pyotraumatic folliculitis with ‘satellite’ lesions of papules or pustules.
•Do not use where fungal, viral infection or demodicosis is present.
•Do not apply to the eye.
•Do not use over large surface areas or for prolonged treatment.
•Do not use in cases of impetigo or acne.
•Do not use in cases of unstabilised or untreated Cushing’s syndrome or diabetes mellitus.
•Do not use in cases of pancreatitis.
•Do not use in cases of gastrointestinal ulcers.
•Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.
•Do not use in the case of resistance to fusidic acid.
Special warnings for each target species
Pyoderma is often secondary in nature. The underlying cause should be identified and treated.
Special precautions for use
Special precautions for safe use in the target species.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
It is recommended that use of the product should be based on bacteriological sampling and susceptibility testing. If this is not possible, therapy should be based on epidemiological information about susceptibility of the target bacteria. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to fusidic acid.
Use of the product in association with occlusive bandages or dressings should be avoided.
Betamethasone valerate can be absorbed percutaneously and may cause temporary suppression of adrenal function.
In dogs with treated or stabilised Cushing’s syndrome, only use the product after careful consideration of the benefit risk balance by the responsible veterinary surgeon.
Avoid eye contact. In case of accidental contact, rinse thoroughly with water.
The dog should be prevented from licking treated lesions and so ingesting the product.
Where there is a risk of self-trauma or a risk of accidental transfer to the eye, for example, application of the product on the forelimb, preventative measures such as the use of a protective collar should be considered.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to the active ingredients or to any of the excipients should avoid contact with the veterinary medicinal product.
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. Pregnant women should take special care to avoid accidental exposure.
Personal protective clothing consisting of single-use impermeable gloves must be worn when applying this product to animals.
Wash hands after having applied the product.
Care should be taken to avoid contact with treated areas of the animal, for the duration of the treatment period.
Care should be taken to avoid accidental ingestion by a child. In the case of accidental ingestion, seek medical advice immediately and show the package leaflet to the physician.
Adverse reactions (frequency and seriousness)
Target species: Dogs
Undetermined frequency | Systemic disorder (e.g. suppression of adrenal function1 , thinning of the epidermis1 , delayed healing1 ). Pigmentation disorder (e.g. depigmentation of the skin2 ). Hypersensitivity3 . |
1 May be triggered by prolonged and intensive use of topical corticosteroid preparations or treatment of a large cutaneous surface (>10%).
2 May be caused by locally applied steroids.
3 If develops, discontinue use.
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The use is not recommended during pregnancy and lactation. The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Laboratory studies have demonstrated that topical application of betamethasone in pregnant females may lead to malformations in neonates. Small amounts of betamethasone can pass the blood-milk-barrier.
Interaction with other medicinal products and other forms of interaction
Concurrent treatment with steroids and NSAIDs may increase the risk for the development of gastrointestinal ulcers.
Administration routes and dosage
Cutaneous use.
First, the hairs covering the lesions should be gently clipped. The affected area should then be thoroughly cleaned with an antiseptic wash before daily application of the gel. The amount applied should cover the affected area in a thin layer. Apply approximately 0.5 cm length of gel per 8 cm2 of lesion, twice daily, for a minimum period of 5 days. Treatment should continue for 48 hours after the lesion has resolved. The treatment period should not exceed 7 days. If there is no response within three days, or the condition deteriorates, the diagnosis should be re-evaluated.
Overdose (symptoms, emergency procedures, antidotes), if necessary
For possible signs see "Adverse reactions (frequency and seriousness)" above.
Withdrawal period(s)
Not applicable.