País: Portugal
Idioma: anglès
Font: HMA (Heads of Medicines Agencies)
trilostane 10 mg
Arnolds Veterinary Products Limited
QH02CA01
Capsule, hard
trilostane
Dogs
2012-02-03
Revised: January 2013 AN: 01395/2011 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF VETERINARY MEDICINAL PRODUCT VETORYL 10 mg hard capsules for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES An accurate diagnosis of hyperadrenocorticism is essential. Revised: January 2013 AN: 01395/2011 Page 2 of 7 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. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS As the majority of cases of hyperadrenocorticism are diagnosed in dogs between the ages of 10 – 15 years, other pathological p Llegiu el document complet