Dexa-ject 2 mg/ml Solution for Injection for Cattle, Horses, Pigs, Dogs and Cats

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Dexamethasone

Dostępny od:

Dopharma Research B.V.

Kod ATC:

QH02AB02

INN (International Nazwa):

Dexamethasone

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Cats, Cattle, Dogs, Horses, Pigs

Dziedzina terapeutyczna:

Anti Inflammatory corticosteroid

Status autoryzacji:

Authorized

Data autoryzacji:

2012-08-24

Charakterystyka produktu

Revised: July 2017
AN: 01391/2016
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs,
dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml:
_ACTIVE SUBSTANCE:_
Dexamethasone
2 mg
as dexamethasone sodium phosphate
2.63 mg
_EXCIPIENTS_:
Benzyl alcohol (E1519)
15 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, horses, 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.
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.
Revised: July 2017
AN: 01391/2016
Page 2 of 7
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 properties of the active ingredie