Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Trilostane
Dechra Ltd
QH02CA01
Trilostane
10 Milligrams per capsule
Capsule, hard
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
trilostane
Hormone
Authorised
2010-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetoryl 10 mg hard capsules for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Hard capsule. Ivory body and black cap with the capsule strength printed on the body of the capsule. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: for the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing’s disease and syndrome). 4.3 CONTRAINDICATIONS Do not use in animals suffering from primary hepatic disease and/or renal insufficiency. Do not use in dogs weighing less than 3 kg. Do not use where there is suspected hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES An accurate diagnosis of hyperadrenocorticism is essential. Where there is no apparent response to treatment, the diagnosis should be re-evaluated. Dose increases may be necessary. Veterinarians should be aware that dogs with hyperadrenocorticism are at increased risk of pancreatitis. This risk may not diminish following treatment with trilostane. 1 capsule contains: Active substance: Trilostane 10 mg Excipients: Titanium dioxide (E171) 0.942 mg Ferric oxide (yellow) (E172) 0.035 mg Ferric oxide (black) (E172) 0.532 mg 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_ _1_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _ Les hele dokumentet