Dexafast 2 mg/ml Solution for Injection for Horses, Cattle, Pigs, Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Dexamethasone

Available from:

Livisto Int'l S.L.

ATC code:

QH02AB02

INN (International Name):

Dexamethasone

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Cattle, Dogs, Horses, Pigs

Therapeutic area:

Anti Inflammatory corticosteroid

Authorization status:

Authorized

Authorization date:

2018-12-24

Summary of Product characteristics

Revised: October 2021
AN: 00793/2021 & 00795/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dexafast 2 mg/ml solution for injection for horses, cattle, pigs, dogs
and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Dexamethasone
2.0 mg
(as dexamethasone sodium phosphate)
EXCIPIENT:
Benzyl alcohol (E1519)
15.6 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, cattle, pigs, dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Horses, cattle, pigs, dogs and cats:
Treatment of inflammatory or allergic conditions.
Cattle:
Induction of parturition.
Treatment of primary ketosis (acetonaemia).
Horses:
Treatment of arthritis, bursitis or tenosynovitis.
4.3
CONTRAINDICATIONS
Except in emergency situations, do not use in animals suffering from
diabetes
mellitus,
renal
insufficiency,
cardiac
insufficiency,
hyperadrenocorticism
or
osteoporosis.
Revised: October 2021
AN: 00793/2021 & 00795/2021
Page 2 of 7
Do not use in viral infections during the viraemic stage or in cases
of systemic
mycotic infections.
Do
not
use
in
animals
suffering
from
gastrointestinal
or
corneal
ulcers,
or
demodicosis.
Do not administer intra-articularly where there is evidence of
fractures, bacterial joint
infections and aseptic bone necrosis.
Do
not
use
in
known
cases
of
hypersensitivity
to
the
active
substance,
to
corticosteroids and to any other ingredient of the product.
See also section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Response
to
long-term
therapy
should
be
monitored
at
regular
intervals
by
a
veterinary surgeon. Use of corticosteroids in horses has been reported
to induce
laminitis. Therefore horses treated with such preparations should be
monitored
frequently during the treatment period.
Because of the pharmacological propert