Prednidale 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:

1998-08-14

Карактеристике производа

Revised: August 2023
AN: 00184/2023
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Prednidale 5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Prednisolone 5 mg/tablet
For a full list of excipients, see section 6.1.
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.
No data has been provided to demonstrate reproducible halving of the
tablets.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
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
CONTRA-INDICATIONS
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withdrawn gradually to avoid precipitation of adrenal insufficiency.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 to be taken by the person administering the
veterinary medicinal
product to animals
Gloves
should
be
worn
to
administer
the
product
and
you
should
wash
hands
immediately after administration of the product.
iii.
Other precautions
No special precautions require