Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
MICONAZOLE NITRATE
Ceva Santé Animale
QD08AC52
MICONAZOLE NITRATE
20/20
Shampoo
POM
Canine
Chlorhexidine, combinations
Antifungal
Authorised
2016-04-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Adaxio Shampoo for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES: Chlorhexidine digluconate 20 mg (equivalent to chlorhexidine 11.26 mg) Miconazole nitrate 20 mg (equivalent to miconazole 17.37 mg) EXCIPIENTS: Methylchloroisothiazolinone 0.0075 mg Methylisothiazolinone 0.0025 mg Benzoic acid (E210) 1.35 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Shampoo. A clear light yellow to yellow liquid. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and control of seborrhoeic dermatitis associated with _Malassezia_ _pachydermatis_ and/or _Staphylococcus pseudintermedius_. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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_ _7_ _/_ _0_ _2_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _2_ _1_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Official, national and regional antimicrobial policies should be taken into account when the product is used. Take care to avoid the animal inhaling the product or getting it into eyes, auditory canal, nose or mouth during shampooing. In case of accidental contact with eyes, rinse with ple Pročitajte cijeli dokument