দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate
Chanelle Pharmaceuticals Manufacturing Limited
QD01AC52
Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate
Ear drops, suspension
POM: Prescription Only Medicine as defined in relevant national legislation
miconazole, combinations
2023-02-23
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Otisur 23.0 mg/ml + 5.0 mg/ml + 5500 IU/ml ear drops, suspension for cats and dogs. 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 polymyxin B sulfate 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 Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated. Cross-resistance has been shown between polymyxin B and colistin in _E. coli_ . Use of the product should be carefully সম্পূর্ণ নথি পড়ুন