Summary of medicine characteristics - Cortavance
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Hydrocortisone aceponate 0.584 mg/ml
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Cutaneous spray, solution.
4. CLINICAL PARTICULARS4.1 Target species
Dogs.
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4.2 Indications for use, specifying the target species
For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
For alleviation of clinical signs associated with atopic dermatitis in dogs.
4.3 Contraindications
Do not use on cutaneous ulcers.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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4.4 Special warnings for each target species
None.
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4.5 Special precautions for use
Special precautions for use in animals
Clinical signs of atopic dermatitis such as pruritus and skin inflammation are not specific for this disease and therefore other causes of dermatitis such as ectoparasitic infestations and infections which cause dermatological signs should be ruled out before treatment is started, and underlying causes should be investigated.
In the case of concurrent microbial disease or parasitic infestation, the dog should receive appropriate treatment for such condition.
In the absence of specific information, the use in animal suffering from Cushing’s syndrome shall be based on the risk-benefit assessment.
Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) shall be based on the risk-benefit assessment and subject to regular clinical evaluations.
Total body surface treated should not exceed approximately 1/3 of the dog’s surface corresponding for example to a treatment of two flanks from the spine to the mammary chains including the shoulders and the thighs. See also section 4.10. Otherwise, use only according to the risk-benefit assessment of the responsible veterinary surgeon and subject the dog to regular clinical evaluations as further described in section 4.9.
Care should be taken to avoid spraying into the eyes of the animal.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The active substance is potentially pharmacologically active at high doses of exposure.
The formulation may cause eye irritation following accidental ocular contact.
The formulation is flammable.
Wash hands after use. Avoid contact with eyes.
To avoid skin contact, recently treated animals should not be handled until the application site is dry.
To avoid inhalation of the product, apply the spray in a well-ventilated area.
Do not spray on naked flame or any incandescent material.
Do not smoke while handling the veterinary medicinal product.
Replace the bottle in the outer carton and in a safe place out of the sight and the reach of children immediately after use.
In case of accidental skin contact, avoid hand-to-mouth contact and wash the exposed area immediately with water.
In case of accidental eye contact, rinse with abundant quantities of water.
If eye irritation persists, seek medical advice.
In case of accidental ingestion, especially by children, seek medical advice immediately and show the leaflet or the label to the physician.
Other precautions
The solvent in this product may stain certain materials including painted, varnished or other household surfaces or furnishings. Allow the application site to dry before permitting contact with such materials.
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4.6 Adverse reactions (frequency and seriousness)
Transient local reactions at the application site (erythema and/or pruritus) can occur in very rare cases.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs. Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
No data available.
In the absence of information, it is recommended not to apply other topical preparations simultaneously on the same lesions.
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4.9 Amounts to be administered and administration route
Cutaneous use.
Before administration, screw the pump spray on the bottle.
The veterinary medicinal product is then applied by activating the pump spray, from a distance of about 10 cm of the area to be treated.
The recommended dosage is 1.52 ^g of hydrocortisone aceponate/cm2 of affected skin per day. This dosage can be achieved with two pump spray activations over a surface to be treated equivalent to a square of 10 cm x 10 cm.
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– For treatment of inflammatory and pruritic dermatoses, repeat the treatment daily for 7 consecutive days.
In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the veterinary medicinal product to the risk-benefit assessment.
If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian.
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– For alleviation of clinical signs associated with atopic dermatitis, repeat the treatment daily for at least 14 and up to 28 consecutive days.
An intermediary control by the veterinarian at day 14 should be made to decide if further treatment is needed. The dog should be re-evaluated regularly with regard to HPA suppression or skin atrophy, both being possibly asymptomatic.
Any prolonged use of this product, to control atopy, should be at the benefit risk assessment of the responsible veterinary surgeon. It should take place after a re-evaluation of the diagnosis and also a consideration of the multi-modal treatment plan in the individual animal.
Presented as a volatile spray, this veterinary medicinal product does not require any massage.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Tolerance studies of multiple doses were assessed over a period of 14 days in healthy dogs using 3 and 5 times the recommended dosage corresponding to the two flanks, from the spine to the mammary chains including the shoulder and the thighs (1/3 of the dog’s body surface area). These resulted in a reduced capacity for production of cortisol that is fully reversible within 7 to 9 weeks after the end of treatment.
In 12 dogs suffering from atopic dermatitis, after topical application once a day at the recommended therapeutic dosage for 28 to 70 (n=2) consecutive days, no noticeable effect on the systemic cortisol level was observed.
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4.11 Withdrawal period(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Corticosteroids, dermatological preparations.
ATCvet code: QD07AC16.
5.1 Pharmacodynamic properties
The veterinary medicinal product contains the active substance hydrocortisone aceponate. Hydrocortisone aceponate is a dermocorticoid with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to a quick improvement of skin lesions observed in case of inflammatory and pruritic dermatosis. In case of atopic dermatitis, improvement will be slower.
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5.2 Pharmacokinetic particulars
Hydrocortisone aceponate belongs to the diesters class of the glucocorticosteroids.
The diesters are lipophilic components ensuring an enhanced penetration into the skin associated to a low plasma availability. Hydrocortisone aceponate thus accumulates in the dog’s skin allowing local efficacy at low dosage. The diesters are transformed inside the skin structures. This transformation is responsible for the potency of the therapeutic class. In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
Topical application of diesters results in high therapeutic index: high local activity with reduced systemic secondary effects.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Propylene glycol methyl ether.
6.2 Major incompatibilities
None known.
6.3 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.
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
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6.5 Nature and composition of immediate packaging
Box containing a polyethylene terephtalate (PET) or high density polyethylene (HDPE) bottle filled with 31 ml or 76 ml of solution, closed with an aluminium screw cap or a white plastic screw cap and a pump spray.
Carton box with a PET bottle of 31 ml
Carton box with a PET bottle of 76 ml
Carton box with a HDPE bottle of 31 ml
Carton box with a HDPE bottle of 76 ml
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
VIRBAC
Pre avenue 2065 m LID
06516 Carros
FRANCE
8. MARKETING AUTHORISATION NUMBER
EU/2/06/069/001
EU/2/06/069/002
EU/2/06/069/003
EU/2/06/069/004
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 09/01/2007
Date of latest renewal: 13/09/2011