国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Trilostane
Dechra Ltd
QH02CA01
Trilostane
120 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 120 mg hard capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Hard capsules. 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 For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing’s disease and syndrome) in dogs. 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 20 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. EACH CAPSULE CONTAINS: ACTIVE SUBSTANCE: Trilostane 120 mg EXCIPIENTS: Titanium dioxide (E171) 1.885 mg Yellow iron oxide (E172) 0.071 mg Black iron oxide (E172) 1.064 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_ _2_ _0_ _6_ 阅读完整的文件