Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Fusidic acid; Betamethasone valerate
Dechra Veterinary Products A/S
QD07CC01
Fusidic acid; Betamethasone valerate
0.5, 0.1 percent weight/weight
Gel
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
betamethasone and antibiotics
Antibacterial
Authorised
2004-03-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Trigoderm Gel 0.5 % w/w Fusidic acid, 0.1 % w/w Betamethasone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM White gel 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the topical treatment of surface pyoderma in the dog such as acute moist dermatitis ('hot spots') and intertrigo (skin fold dermatitis). 4.3 CONTRAINDICATIONS Do not use in animals with hypersensitivity to any of the components. Discontinue use if hypersensitivity develops to the product. Do not use for the treatment of deep pyoderma as glucocorticoids are contra-indicated in this condition. Do not use where fungal infection is present. Do not apply to the eye. ACTIVE SUBSTANCES: Fusidic acid 0.5 % w/w Betamethasone (as the valerate ester) 0.1 % w/w PRESERVATIVES: Methylparahydroxybenzoate (E218) 0.27 % w/w Propylparahydroxybenzoate (E216) 0.03 % w/w For a full list of excipients see section 6.1. 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_ _ _ _0_ _9_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _9_ _6_ _3_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The dog should be prevented from licking treated lesions and so ingesting the product. Where there is a risk of trauma, preventative measures such as the use of an Elizabethan collar should be considered. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL P Lire le document complet