Prednisolone 5 mg Tablets

Држава: Велика Британија

Језик: Енглески

Извор: VMD (Veterinary Medicines Directorate)

Активни састојак:

Prednisolone

Доступно од:

Dechra Limited

АТЦ код:

QH02AB06

INN (Међународно име):

Prednisolone

Фармацеутски облик:

Tablet

Тип рецептора:

POM-V - Prescription Only Medicine – Veterinarian

Терапеутска група:

Cats, Dogs

Терапеутска област:

Anti Inflammatory corticosteroid

Статус ауторизације:

Authorized

Датум одобрења:

2003-08-15

Карактеристике производа

Revised: August 2023
AN: 00184/2023
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prednisolone 5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Qualitative composition
Prednisolone
EXCIPIENTS
For a full list of excipients, see
section 6.1.
Quantitative composition
5 mg per tablet
3.
PHARMACEUTICAL FORM
Tablet.
White, circular, flat faced tablets with a breakline and PL5 imprinted
on one
face and CP or DP on the reverse.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats and dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of inflammatory and allergic diseases, including
some
autoimmune diseases and some neoplastic conditions in cats and dogs.
Inflammatory,
allergic
and
autoimmune
processes
may
be
involved
in
cutaneous,
alimentary,
respiratory,
musculo-skeletal
and
haematological
manifestations of disease.
4.3
CONTRAINDICATIONS
Do not use in animals with renal insufficiency, diabetes mellitus or
corneal
ulceration.
Do not use in animals receiving vaccines containing live organisms.
Do not use in pregnant animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
There are no special warnings required for either target species.
Revised: August 2023
AN: 00184/2023
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Pharmacologically-active dose levels may lead to atrophy of the
adrenal
cortex,
resulting
in
adrenal
insufficiency.
This
may
become
apparent
particularly after withdrawal of corticosteroid treatment. Adrenal
insufficiency
may be minimised by institution of alternate-day therapy if practical.
The
dosage should be reduced and withdrawn gradually to avoid
precipitation of
adrenal insufficiency.
ii.
Special precautions for the person administering the veterinary
medicinal
product to animals
Impermeable gloves should be worn whilst administering the product.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Administration of single high doses are generally tolerate