Vetoryl 10mg
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
02-08-2013
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Active ingredient:
trilostane 10 mg
Available from:
Arnolds Veterinary Products Limited
ATC code:
QH02CA01
Pharmaceutical form:
Capsule, hard
Therapeutic group:
trilostane
Therapeutic area:
Dogs
Authorization date:
2012-02-03
Summary of Product characteristics
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
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