Cortavance 0.584 mg/ml Cutaneous Spray Solution for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Hydrocortisone Aceponate

Available from:

Virbac

ATC code:

QD07AC16

INN (International Name):

Hydrocortisone Aceponate

Pharmaceutical form:

Cutaneous spray, solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Anti Inflammatory corticosteroid

Authorization status:

Authorized

Authorization date:

2007-01-09

Summary of Product characteristics

Issued: July 2021
AN: 00259/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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 PARTICULARS
4.1
TARGET SPECIES
Dogs.
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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.
Issued: July 2021
AN: 00259/2020
Page 2 of 6
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 t