Prednidale 25 mg Tablets for Dogs

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:

Dogs

Терапеутска област:

Anti Inflammatory corticosteroid

Статус ауторизације:

Authorized

Датум одобрења:

2007-11-19

Карактеристике производа

Revised: September 2016
AN: 00798/2016
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Prednidale 25 mg Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Prednisolone
25 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, 11 mm circular tablets.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
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 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 the target species.
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
Revised: September 2016
AN: 00798/2016
Page 2 of 4
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 The dosage should be reduced and withdrawn gradually to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.
In the event of accidental ingestion, particularly by a child, seek
medical
advice and show the doctor the label or package leaflet.
iii.
Other precautions
No special precautions required.
4.6
ADVERSE REACTIONS (FREQUENCY AN