Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
resocortol butyrate
Intervet International BV
QD07AC90
resocortol butyrate
Dogs
Corticosteroids, dermatological preparations
Treatment of acute localised moist dermatitis.
Revision: 4
Withdrawn
2000-11-16
Medicinal product no longer authorised 12/15 B. PACKAGE INSERT Medicinal product no longer authorised 13/15 PACKAGE INSERT 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Pruban 0.1 % cream for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE Resocortol butyrate: 1mg/g 4. INDICATION Treatment of acute localised moist dermatitis. 5. CONTRA-INDICATIONS Do not use in dogs with extensive lesions. The maximum total surface of lesions (treated in cm 2 ) should not exceed 10 times the body weight (in kg). For example, the total surface area treated of a dog weighing 5 kg should not exceed 50 cm 2 ). Do not use in dogs with infected lesions of bacterial, viral, fungal or parasitic origin or with ulcerated lesions. Do not use in animals suffering from Cushing’s syndrome. Do not use in dogs used for breeding and in lactating or pregnant bitches. Do not use in puppies under 6 months of age. 6. ADVERSE REACTIONS On rare occasions hyperaemia of the treated area has been observed. Lesions should be monitored closely for signs of infection. In case of diabetes mellitus, the potential systemic effects of the product may influence glycaemia. Overdosing, i.e. application rate of more than twice a day, or extension of the duration of treatment, increases the risk of glucocorticoid systemic effects particularly when administered on extensive lesions. 7. TARGET SPECIES Dogs. Medicinal product no longer authorised 14/15 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION For topical administration to the skin. Apply a 1 cm strip (0.2 g) of cream per 10 cm 2 of lesion. 9. ADVICE ON CORRECT ADMINISTRATION During initial treatment apply the cream twice daily. Treat for 7 to 14 days. The treatment period should not exceed 14 days. Clean the affected areas and clip the hair covering the lesions before applicati Прочетете целия документ
Medicinal product no longer authorised 1/15 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2/15 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pruban 0.1 % cream for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE(S) Resocortol butyrate 1 mg/g 3. PHARMACEUTICAL FORM White to off-white cream 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE Treatment of acute localised moist dermatitis. 4.3 CONTRA-INDICATIONS Do not use in dogs with extensive lesions. Do not use in dogs with infected lesions of bacterial, viral, fungal or parasitic origin or with ulcerated lesions. Do not use in animals suffering from Cushing’s syndrome. Do not use in puppies under 6 months of age. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Since glucocorticosteroids can slow growth, use in young, growing animals should be well controlled and large lesions should not be treated. 4.5 SPECIAL PRECAUTION(S) FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Lesions should be monitored closely for signs of infection. In case of diabetes mellitus, the potential systemic effects of the product may influence glycaemia. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS This product belongs to the class of dermocorticoids. The therapeutic use of these substances in humans has been recognised to induce local side effects such as skin thinning, skin weakness, delayed healing process and secondary infections. Avoid contact with the product. Wear disposable gloves when applying the product. Wash hands after use. Medicinal product no longer authorised 3/15 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) On rare occasions hyperaemia of the treated area has been observed. 4.7 USE DURING PREGNANCY AND LACTATION Do not use in dogs for breeding nor in lactating or pregnant bitches. 4.8 INTERACTION WITH OTHER VETERINARY MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Do not apply other topical preparations concomitantly to the same lesions Прочетете целия документ