Dermipred 5 mg Tablets for Dogs

Summary of Product characteristics

                                Revised: September 2022
AN: 01489/2022
Page 1 of 7
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.
Revised: September 2022
AN: 01489/2022
Page 2 of 7
See also sections 4.7 and 4.8.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Glucocorticoids 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 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
may
result
adrenal
insufficiency.
This
may
become
apparent
particularly
after
withdrawal of corticosteroid treatment. This effect may be minimised
by institution of
alternate-day therapy if practical. The dosage should be reduced and
withdrawn
gradually to avoid precipitation of adrenal insuffici
                                
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