Cortico Veyxin 10 mg/ml suspension for injection for cattle, horses, dogs and cats

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Prednisolone acetate

Disponibil de la:

Veyx-Pharma GmbH

Codul ATC:

QH02AB06

INN (nume internaţional):

Prednisolone acetate

Dozare:

10.0 milligram(s)/millilitre

Forma farmaceutică:

Suspension for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Zonă Terapeutică:

prednisolone

Statutul autorizaţiei:

Authorised

Data de autorizare:

2018-09-21

Caracteristicilor produsului

Health Products Regulatory Authority
28 September 2018
CRN000TRZ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cortico Veyxin 10 mg/ml suspension for injection for cattle, horses,
dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
​
ACTIVE SUBSTANCE:
​
​
Prednisolone acetate
10 mg
​
equivalent to prednisolone
​8.95 mg
​
EXCIPIENTS:
​
​
Benzyl alcohol (E1519)
​9.45 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
The suspension after shaking is white and homogenous.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, horse, dog and cat.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In horses, cattle, dogs and cats:
Supportive
treatment
of
acute
non-infectious
arthritis,
bursitis,
tenosynovitis
or
allergic skin disease.
In cattle:
Supportive treatment of primary ketosis (acetonaemia).
4.3 CONTRAINDICATIONS
Do not use in case of:

Hypersensitivity to the active substance, to corticosteroids or to any
of the
excipients

Gastrointestinal ulcers, poorly healing wounds, ulcers and fractures
Health Products Regulatory Authority
28 September 2018
CRN000TRZ
Page 2 of 8

Viral infections during the viraemic stage or in cases of systemic
mycotic
infections

In cows, during the last one-third of pregnancy

General immunodeficiency

Glaucoma, cataract and corneal ulcers

Osteoporosis, hypocalcaemia

Hyperadrenocorticism (e.g. Cushing's syndrome)

Hypertension

Pancreatitis

Diabetes mellitus

Renal insufficiency
Please see also section 4.5 _Special precautions for use in animals_
and section 4.8
_Interaction with other medicinal products and other forms of
interaction_.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Except in cases of acetonaemia, corticoid administration is to induce
an improvement
in clinical signs rather than a cure. The treatment should be combined
with treatment
of the underlying disease and/or environmental control.
4.5 SPECIAL PRE