Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Hydrocortisone Aceponate
Ecuphar NV
QD07AC16
Hydrocortisone Aceponate
Cutaneous spray, solution
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Anti Inflammatory corticosteroid
Authorized
2018-08-27
Unlimited Renewal: November 2023 AN: 02308/2023 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hydrocortisone aceponate Ecuphar 0.584 mg/ml cutaneous spray solution for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains: ACTIVE SUBSTANCE Hydrocortisone aceponate0.584 mg Equivalent to 0.460 mg of hydrocortisone For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous spray, solution. Clear colourless to slightly yellow 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. Unlimited Renewal: November 2023 AN: 02308/2023 Page 2 of 5 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 animals 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 Read the complete document