Virbac Cortavance 76ml

Virbac Cortavance 76ml
HYDROCORTISONE ACEPONATE TOPICAL SPRAY SOLUTION
VETERINARY USE ONLY

■ DESCRIPTION: CORTAVANCETM Topical Spray is formulated with the active ingredient, hydrocortisone aceponate, 0.584 mg per
mL in a suitable solvent, propylene glycol methyl ether for dermatologic use in dogs. Hydrocortisone aceponate is a dermocorticoid
with a potent intrinsic glucocorticoid activity.
■ THERAPEUTIC CLASSIFICATION: Glucocorticoid
■ INDICATIONS: CORTAVANCETM Topical Spray is indicated for the symptomatic treatment of inflammatory and pruritic skin
conditions in dogs.
■ DOSAGE AND ADMINISTRATION: Before administration, remove the cap and screw the pump spray on the bottle. The product
is applied by activating the pump. Spray from a distance of about 10 cm above the area of skin to be treated. The recommended dose
is 1.52 µg of hydrocortisone aceponate per cm2
of skin surface. This dose can be achieved with 2 pump spray activations over a
10 cm x 10 cm square surface area of skin. Leave treated area to dry. Presented as a volatile spray, this product does not require any
massage. Care should be taken to avoid spraying in the eyes of the dog. Repeat treatment once daily for 7 consecutive days. If no
improvement is seen within 7 days, treatment should be re-evaluated by the veterinarian.
■ CONTRAINDICATIONS: Do not use on cutaneous ulcers.
■ CAUTIONS: Total body surface treated with CORTAVANCETM Topical Spray should not exceed a surface corresponding to, for
example, two flanks from the spine to mammary chains including the shoulders and thighs (1/3 of dog’s body).
Avoid spraying in the eyes of the dog. In the case of concurrent microbial, fungal infections and flea infestations, dogs should receive
appropriate treatment. If a favourable response does not occur promptly, treatment should be discontinued until the infection has
been adequately controlled. Not for use in animals with hyperadrenocorticism (Cushing’s Disease). Since glucocorticoids are known
to slow growth, use in young animals (under 7 months of age) is not recommended. Not for use in breeding, pregnant or lactating
animals, as the safety of CORTAVANCETM Topical Spray has not been established. As with all glucocorticoids, the use of this product
may adversely affect the Hypothalamic Pituitary Adrenal axis (HPA axis). Do not exceed the recommended dose or duration of treatment.
Not for use in sick or debilitated animals. It is not recommended to apply other topical preparations simultaneously on the same lesion.
■ WARNINGS: Keep out of reach of children. In case of accidental contact with skin, it is recommended to wash thoroughly with
water. Wash hands after use. Avoid contact with eyes. In case of accidental eye contact, rinse with abundant quantities of water.
In case of eye irritation, seek medical advice. Avoid inhalation of CORTAVANCETM Topical Spray.
In case of accidental ingestion, seek medical advice immediately and show the labelling to the physician. Spray in a well ventilated
area. Flammable. Do not spray on naked flame or any incandescent material.
■ ADVERSE REACTIONS: Although not all adverse reactions are reported, the following adverse reaction information is based on
voluntary post-approval drug experience reporting. It is generally recognized that this method of reporting results in significant
under-reporting of adverse drug reactions. It should be noted that suspected ADRs listed here reflect reporting and not causality.
Transient local reactions at the application site (erythema and/or pruritis) can occur in very rare cases (less than 1 in 10,000 animals).
■ CLINICAL PHARMACOLOGY: Hydrocortisone aceponate belongs to the diester class of glucocorticoids.
Diesters are lipophilic substances of low plasma availability that effectively penetrate the skin to accumulate at the site of
inflammation without significant systemic absorption. Once inside the skin, the diesters are transformed to deliver anti-inflammatory
activity. In laboratory animals, hydrocortisone aceponate is eliminated like endogenous cortisol, through the urine and faeces.
■ SAFETY AND EFFICACY STUDY INFORMATION: The safety of CORTAVANCETM Topical Spray in dogs was demonstrated in two
studies using 1X, 3X and 5X the therapeutic dose for 14 consecutive days in young dogs. Dogs with 3X and 5X the recommended
dose for twice the recommended duration of treatment resulted in a reduced capacity for production of cortisol that was reversible
within 7 to 9 weeks after the end of treatment. No adverse effects were seen during the clinical studies. Clinical efficacy of
CORTAVANCETM Topical Spray has been demonstrated in a multi-site, controlled clinical field trial in dogs under normal conditions
of use. In this study, 105 dogs (54 dogs treated with CORTAVANCETM Topical Spray; 51 dogs as positive control) representing
33 breeds were diagnosed with the following skin dermatoses:
Skin Dermatoses %
Flea Allergy Dermatitis ……………………………………. 29%
Acute Moist Dermatitis (hot spot)………………………. 19%
Contact Allergy Dermatitis……………………………….. 16%
Atopic Dermatitis …………………………………………… 10%
Licking Dermatitis ……………………………………………. 7%
Allergy Dermatitis…………………………………………….. 5%
Undetermined Dermatitis ………………………………… 14%
At day 7 (the day after last treatment), 50% (27/54) had recovered, 42.6% (24/54) had improvement in skin lesions and 7.4% (4/54)
had no improvement. After 7 days of treatment, CORTAVANCETM Topical Spray had significantly reduced pruritus scores and skin
lesion scores.
■ STORAGE: Store below 25°C. Do not freeze. Keep container closed when not in use and protected from light and humidity.
Use within 6 months after opening.