Dermipred 20 mg tablets for dogs

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Prednisolone

Commercializzato da:

Ceva Santé Animale

Codice ATC:

QH02AB06

INN (Nome Internazionale):

Prednisolone

Dosaggio:

20 mg/tablet

Forma farmaceutica:

Tablet

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Dogs

Area terapeutica:

prednisolone

Indicazioni terapeutiche:

Corticosteroid

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2016-11-11

Scheda tecnica

Health Products Regulatory Authority
16 July 2021
CRN00C3H1
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dermipred 20 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
​
Prednisolone
​20.0 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round shaped beige to light brown tablet, with double score line on
one side.
The tablets can be divided into two or four 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
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.
Health Products Regulatory Authority
16 July 2021
CRN00C3H1
Page 2 of 5
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 r