国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
hydrocortisone aceponate
Ecuphar
QD07AC
hydrocortisone aceponate
Dogs
Corticosteroids, dermatological preparations
For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.For alleviation of clinical signs associated with atopic dermatitis in dogs.
Revision: 3
Authorised
2018-08-27
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: HYDROCORTISONE ACEPONATE ECUPHAR 0.584 MG/ML CUTANEOUS SPRAY SOLUTION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Ecuphar NV Legeweg 157-i 8020 Oostkamp Belgium Manufacturer responsible for batch release: DIVASA-FARMAVIC, S.A. Ctra. Sant Hipòlit, km 71 08503 Gurb-Vic, Barcelona Spain 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Hydrocortisone aceponate Ecuphar 0.584 mg/ml cutaneous spray solution for dogs hydrocortisone aceponate 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Hydrocortisone aceponate 0.584 mg/ml. Clear colourless to slightly yellow solution. 4. INDICATION(S) For symptomatic treatment of inflammatory and pruritic dermatoses in dogs. For alleviation of clinical signs associated with atopic dermatitis in dogs. 5. CONTRAINDICATIONS Do not use on cutaneous ulcers. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 6. ADVERSE REACTIONS 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: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 17 If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Dogs. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Cutaneous use. Before administration, screw the pump spray on the bottle. The veterinary medicinal product 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 aceponate 0.584 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. 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. 3 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. Other 阅读完整的文件