DERMIPRED 5 MG TABLETS FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-11-2016
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Active ingredient:
PREDNISOLONE
Available from:
Ceva Santé Animale
ATC code:
QH02AB06
INN (International Name):
PREDNISOLONE
Dosage:
5 Milligram
Pharmaceutical form:
Tablets
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Prednisolone
Therapeutic indications:
Corticosteroid
Authorization status:
Authorised
Authorization date:
2016-11-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dermipred 5 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Prednisolone
5.0 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Oblong shaped beige to light brown tablet, with one score line on one side.
The tablets can be divided into two equal parts
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the symptomatic treatment or as adjunct treatment of inflammatory and immune-mediated dermatitis in dogs.
4.3 CONTRAINDICATIONS
Do not use in animals with:
-
Viral, mycotic or parasitic infections that are not controlled with an appropriate treatment
-
Diabetes mellitus
-
Hyperadrenocorticism
-
Osteoporosis
-
Heart failure
-
Severe renal insufficiency
-
Corneal ulceration
-
Gastro-intestinal ulceration
-
Glaucoma
Do not use concomitantly with attenuated live vaccines
Do not use in known cases of hypersensitivity to the active substance, to other corticosteroids, or to any of the
excipients.
See also sections 4.7 and 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
________________________________________________________________________________________________________________________
_Date Printed 11/11/2016_
_CRN 7021354_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
In cases where a bacterial infection is present the product should be used in association with suitable antibacterial
therapy. Pharmacologically-active dose levels
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