Vetoryl 10 mg hard capsules for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trilostane

Available from:

Dechra Ltd

ATC code:

QH02CA01

INN (International Name):

Trilostane

Dosage:

10 Milligrams per capsule

Pharmaceutical form:

Capsule, hard

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

trilostane

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2010-10-01

Summary of Product characteristics

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.
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