Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DIETHANOLAMINE FUSIDATE, FRAMYCETIN SULFATE, NYSTATIN, PREDNISOLONE
Dechra Veterinary Products A/S
QS02CA01
DIETHANOLAMINE FUSIDATE, FRAMYCETIN SULFATE, NYSTATIN, PREDNISOLONE
5
Ear Drops Suspension
POM
Canine, Feline
Prednisolone and antiinfectives
Antibacterial
Authorised
2004-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Canaural ear drops, suspension for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EXCIPIENTS: For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Ear drops, suspension. A yellow oily 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 including the ear mite_ Otodectes cynotis_ infestation in the dog and cat. 4.3 CONTRAINDICATIONS Do not use in animals with a perforated ear drum. Do not use concomitantly with products known to be ototoxic. Do not use in animals with known hypersensitivity to the active substances or the excipient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES For external use only. To be used under veterinary supervision. 1 g of suspension contains: ACTIVE SUBSTANCES: Diethanolamine fusidate 5 mg Framycetin sulphate 5 mg Nystatin 100,000 IU Prednisolone 2.5 mg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _5_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _0_ _5_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE Official, national and regional antimicrobial policies should be taken into account when the product is used. SPECIAL PRECAUTIONS FOR USE IN ANIMALS Following recovery the ears should be checked at regular intervals for any sign of re-infection. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PE Read the complete document