LABELLING AND PACKAGE LEAFLET A. LABELLING DATA TO BE MARKED ON THE EXTERIOR OF THE PACKAGING DATA TO BE MARKED ON THE DIRECT PACKAGING DESCRIPTION AND TYPE OF THE PACKAGING 1. NAME OF THE VETERINARY MEDICAL PRODUCT ALPHADERM PLUS external spray solution for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each ml of product contains: Active substances: Marbofloxacin.. Ketoconazole.... Prednisolone 1.0 mg 2.0 mg 0.9 mg Excipients: Dimethyl sulfoxide (DMSO), polysorbate 80, propylene-glycol, ethanol (96%), purified water. 3. PHARMACEUTICAL FORM External spray solution 4. PACKAGE SIZE 100 ml. 5. TARGET SPECIES Dogs. 6. INDICATION(S) Treatment of acute dermatitis in dogs, caused by marbofloxacin sensitive bacteria, especially St. aureus, St. intermedius, St. pseudointermedius, St. chromogenes, Str. canis, Ps. 1
aeruginosa, and ketoconazole sensitive fungi, especially Malassezia pachydermatis, Microsporum canis. 7. METHOD AND ROUTE(S) OF ADMINISTRATION The recommended dose level of the product for dogs is 2 sprays (0.217 ml) two times per day, for 7-14 days. After 7 day application the responsible practitioner should decide if further 7 day treatment is necessary or not. Only for external use. Shake well before use. 8. WITHDRAWAL PERIOD(S) Not applicable. 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.. 10. EXPIRY DATE EXP {2digits/year} Once opened use within 28 days. 11. SPECIAL STORAGE CONDITIONS The product has to be stored under 25 C. Protect from daylight. Protect from moisture. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICAL PRODUCT OR WASTE MATERIALS, IF ANY Dispose of waste material in accordance with local requirements. 13. THE WORD FOR ANIMAL TREATMENT ONLY, AND THE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. To be supplied only on veterinary prescription. 14. THE WORDS KEEP OUT OF REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER ALPHA-VET Állatgyógyászati Kft., H- 1194 Budapest, Hoffher A. u. 38.-40 Tel.: +36-22-516-416 Fax: +36-22-516-419 2
E-mail: alpha-vet@alpha-vet.hu 16. MARKETING AUTHORIZATION NUMBER(S) 17. MANUFACTURER S BATCH NUMBER Batch {number} 3
B. PACKAGE LEAFLET PACKAGE LEAFLET ALPHADERM PLUS external spray solution for dogs 1. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: ALPHA-VET Állatgyógyászati Kft., H- 1194 Budapest, Hoffher A. u. 38-40. Manufacturer for the batch release: ALPHA-VET Állatgyógyászati Kft., H- 1194 Budapest, Hoffher A. u. 38-40. 2. NAME OF THE VETERINARY MEDICAL PRODUCT ALPHADERM PLUS external spray solution for dogs 3. STATEMENT OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS Each ml of product contains: Active substances: Marbofloxacin.. Ketoconazole.... Prednisolone 1.0 mg 2.0 mg 0.9 mg Excipients: Dimethyl sulfoxide (DMSO), polysorbate 80, propylene-glycol, ethanol (96%), purified water. 4. INDICATION(S) Treatment of acute dermatitis in dogs, caused by marbofloxacin sensitive bacteria, especially St. aureus, St. intermedius, St. pseudointermedius, St. chromogenes, Str. canis, Ps. aeruginosa, and ketoconazole sensitive fungi, especially Malassezia pachydermatis, Microsporum canis. 4
5. CONTRAINDICATION(S) Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product. The safety of preparation has not been established during pregnancy or lactation. 6. ADVERSE REACTIONS Mild erythematous lesions have been observed following the application. Other adverse reactions are not known. In case of unwanted adverse reactions please contact immediately the responsible veterinarian. 7. TARGET SPECIES Dogs. 8. DOSAGE FOR EACH SPECIES AND METHOD OF ADMINISTRATION The recommended dose level of the product for dogs is 2 sprays (0.217 ml) two times per day, for 7-14 days. After 7 day application the responsible practitioner should decide if further 7 day treatment is necessary or not. Only for external use. Shake well before use. 9. ADVICE ON CORRECT ADMINISTRATION The altered skin surface should be meticulously cleaned before treatment. Excess hair around the treatment area should be cut. 10. WITHDRAWAL PERIOD(S) Not applicable. 11. SPECIAL STORAGE PRECAUTIONS The veterinary product should be kept out of reach of children! The product has to be stored under 25 C. Protect from daylight. Protect from moisture. The product can be applied until the expiry date displayed on package. Shelf-life after first opening the immediate packaging: 28 days 12. SPECIAL WARNING(S) There are no special warnings. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICAL PRODUCT OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 5
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 15. OTHER INFORMATION With any other questions concerning this veterinary product contact the local representative of the marketing authorisation holder. 6