Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate
Chanelle Pharmaceuticals Manufacturing Limited
QS02CA01
Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate
Ear drops, suspension
POM: Prescription Only Medicine as defined in relevant national legislation
prednisolone and antiinfectives
2023-02-23
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Chanear 23.0 mg/ml + 5.0 mg/ml + 5500 IU/ml ear drops, suspension for cats and dogs. _ _ Chanear ear drops, suspension for cats and dogs (FR) Aurifence 23.0 mg/ml + 5.0 mg/ml + 5500 IU/ml ear drops, suspension for cats and dogs. (BE, NL) Orelin 23.0 mg/ml + 5.0 mg/ml + 5500 IU/ml ear drops, suspension for cats and dogs. (IT) _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: _ _ ACTIVE SUBSTANCES: _ _ Miconazole Nitrate 23.0 mg (equivalent to 19.98 mg miconazole) Prednisolone Acetate 5.0 mg (equivalent to 4.48 mg prednisolone) Polymyxin B Sulfate 5500 IU EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Silica, Colloidal Anhydrous Paraffin, liquid White to off-white ear drops, suspension. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cats and dogs 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the treatment of otitis externa and small, localised, superficial skin infections caused by mixed infections with the following miconazole and polymixin B susceptible bacteria and fungi: − Gram-positive bacteria: _Staphylococcus_ spp. and _Streptococcus_ spp. − Gram-negative bacteria: _Pseudomonas_ spp. and _Escherichia coli _ − Fungi: _Malassezia pachydermatis_ , _Candida_ spp., _Microsporum_ spp. and _Trichophyton _ spp. Treatment of _Otodectes cynotis_ (ear mites) infestations where there is concurrent infection with bacteria and fungi susceptible to polymyxin B and miconazole. 3.3 CONTRAINDICATIONS Do not use: - in cases of hypersensitivity to the active substances of the veterinary medicinal product, as well as to other corticosteroids, to other azole antifungal agents, or to any of the excipients; - in cases of skin viral infection; - in cases of large skin lesions and of poorly healing or fresh wounds; - in animals with perforation of the tympanic membrane; - in animals where resistance of causative agents to polymyxin B and/or miconazole is known; - on the mammary glands of lactating bitches and queens. 3.4 SPECIAL WARNINGS Bac Прочитайте повний документ