Dermipred 5 mg tablets for dogs

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Prednisolone

Mevcut itibaren:

Ceva Santé Animale

ATC kodu:

QH02AB06

INN (International Adı):

Prednisolone

Doz:

5 mg/tablet

Farmasötik formu:

Tablet

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik grubu:

Dogs

Terapötik alanı:

prednisolone

Terapötik endikasyonlar:

Corticosteroid

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2016-11-11

Ürün özellikleri

Health Products Regulatory Authority
16 July 2021
CRN00C3H1
Page 1 of 5
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
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 reduced
and w