CORTEXONAVET 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Dexamethasone sodium phosphate

Sẵn có từ:

Laboratorios SYVA, S.A.U

Mã ATC:

QH02AB02

INN (Tên quốc tế):

Dexamethasone sodium phosphate

Liều dùng:

2 milligram(s)/millilitre

Dạng dược phẩm:

Solution for injection

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Nhóm trị liệu:

Cats, Cattle, Dogs, Horses, Pigs

Khu trị liệu:

dexamethasone

Chỉ dẫn điều trị:

Corticosteroid

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2016-02-05

Đặc tính sản phẩm

Health Products Regulatory Authority
04 December 2020
CRN009RRF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CORTEXONAVET 2 mg/ml solution for injection for cattle, horses, pigs,
dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Dexamethasone
2.0​
mg​
​
(as dexamethasone sodium phosphate)
​
​
​
EXCIPIENTS:
​
​
​
Benzyl alcohol (E1519)
​15.6
mg​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution, free from visible particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, horses, pigs, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Horses, cattle, pigs, dogs and cats:
Treatment of inflammatory or allergic conditions.
Cattle:
Treatment of primary ketosis (acetonaemia). Induction of parturition
Horses:
Treatment of arthritis, bursitis or tenosynovitis.
4.3 CONTRAINDICATIONS
Except in emergency situations, do not use in animals suffering from
diabetes mellitus, renal insufficiency, cardiac insufficiency
hyperadrenocorticism, or osteoporosis.
Do not use in viral infections during the viraemic stage or in cases
of systemic mycotic infections.
Do not use in animals suffering from gastrointestinal or corneal
ulcers, or demodicosis.
Do not administer by the intra-articular route where there is evidence
of fractures, bacterial joint infections and aseptic bone
necrosis.
Do not use in known cases of hypersensitivity to the active substance,
to corticosteroids and to any of the excipients of the
product.
Refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
04 December 2020
CRN009RRF
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Anti-inflammatory corticosteroids, such as dexamethasone, are known to
exert a wide range of side effects. Whilst single high
doses are generally well tolerated, the