Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: VMD (Veterinary Medicines Directorate)
Miconazole Nitrate, Polymyxin B Sulphate, Prednisolone Acetate
Richter Pharma AG
QS02CA01
Miconazole Nitrate, Polymyxin B Sulphate, Prednisolone Acetate
Cutaneous/ear drops suspension
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Antimicrobial; Anti Inflammatory; Antimycotic
Authorized
2015-03-05
Revised: January 2023 AN: 02966/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Aurimic ear drops and cutaneous suspension for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml (40 drops) contains: ACTIVE SUBSTANCES: Miconazole nitrate 23.0 mg (equivalent to 19.98 mg miconazole) Prednisolone acetate5.0 mg (equivalent to 4.48 mg prednisolone) Polymyxin B sulfate 0.5293 mg (equivalent to 5500 IU polymyxin B sulfate) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops and cutaneous suspension White suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of otitis externa and small localised superficial skin infections in dogs and cats caused by infections with the following miconazole and polymyxin B sensitive bacteria and fungi: • Gram-positive bacteria _Staphylococcus_ spp. _Streptococcus_ spp. • Gram-negative bacteria _Pseudomonas_ spp. _Escherichia_ _coli_ • Fungi Revised: January 2023 AN: 02966/2022 Page 2 of 6 _Malassezia_ _pachydermatis_ _Candida_ spp. _Microsporum_ spp. _Trichophyton_ spp. Treatment of _Otodectes_ _cynotis_ (ear mites) infestations where there is concurrent infection with miconazole and polymyxin B sensitive pathogens. 4.3 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 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 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in Lesen Sie das vollständige Dokument