Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate
Richter Pharma AG
QS02CA01
Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate
23.0, 5.0, 0.5293 milligram(s)/millilitre
Ear drops, suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
prednisolone and antiinfectives
Antibacterial
Authorised
2015-03-13
Health Products Regulatory Authority 04 October 2019 CRN008XW8 Page 1 of 5 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 acetate 5.0 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. _- Escherichiacoli_ Fungi _- Malasseziapachydermatis_ _- Candida_ spp. _- Microsporum_ spp. _- Trichophyton_ spp. Health Products Regulatory Authority 04 October 2019 CRN008XW8 Page 2 of 5 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 shoul Preberite celoten dokument