PREDNICORTONE 5 MG TABLETS FOR DOGS AND CATS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-12-2015
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Active ingredient:
PREDNISOLONE
Available from:
Le Vet Beheer B.V.
ATC code:
QH02AB06
INN (International Name):
PREDNISOLONE
Dosage:
5 Milligram
Pharmaceutical form:
Tablets
Prescription type:
POM
Therapeutic group:
Canine, Feline
Therapeutic area:
Prednisolone
Therapeutic indications:
Corticosteroid
Authorization status:
Authorised
Authorization date:
2015-10-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Prednicortone 5 mg tablets for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains
ACTIVE SUBSTANCE:
Prednisolone
5 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Light brown with brown spots, round and convex flavoured tablet with a cross-shaped break line on one side.
Tablets can be divided into 2 or 4 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the symptomatic treatment or as adjunct treatment of inflammatory and immune-mediated diseases in dogs and
cats.
4.3 CONTRAINDICATIONS
Do not use in animals suffering from viral or mycotic infections.
Do not use in animals suffering from diabetes mellitus or hyperadrenocorticism. Do not use in animals with
osteoporosis.
Do not use in animals suffering from cardiac or renal dysfunction.
Do not use in animals suffering from corneal ulcers.
Do not use in animals with gastro-intestinal ulceration.
Do not use in animals with burns.
Do not use concomitantly with live attenuated vaccines.
Do not use in the case of glaucoma.
Do not use during pregnancy (see section 4.7).
Do not use in known cases of hypersensitivity to the active substance, to corticosteroids or to any of the excipients.
See also section 4.8.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 08/12/2015_
_CRN
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