Vetoryl 120 mg hard capsules

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

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下载 产品特点 (SPC)
12-06-2017

有效成分:

Trilostane

可用日期:

Dechra Ltd

ATC代码:

QH02CA01

INN(国际名称):

Trilostane

剂量:

120 Milligrams per capsule

药物剂型:

Capsule, hard

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗组:

Dogs

治疗领域:

trilostane

疗效迹象:

Hormone

授权状态:

Authorised

授权日期:

2010-10-01

产品特点

                                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.
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