Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexamethasone sodium phosphate

Available from:

Dopharma Research B.V.

ATC code:

QH02AB02

INN (International Name):

Dexamethasone sodium phosphate

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Cattle, Dogs, Horses, Pigs

Therapeutic area:

dexamethasone

Therapeutic indications:

Corticosteroid

Authorization status:

Authorised

Authorization date:

2012-10-05

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 (AT, BE, BG, CZ, DE, EE, EL,
ES, FR, HR, HU, IE, IT, LT, LV, NL, PL, RO, SK, UK(NI)).
Dexaject 2 mg/ml solution for injection for cattle, horses, pigs, dogs
and cats (DK, FI, IS, NO, SE).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Dexamethasone
2 mg
as dexamethasone sodium phosphate
2.63 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Benzyl alcohol (E1519)
15 mg
Sodium chloride
Sodium citrate
Citric acid, anhydrous (pH adjustment)
Sodium hydroxide (pH adjustment)
Water for injections
Clear, colourless, aqueous solution for injection.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle, horses, pigs, dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH 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.
3.3
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.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
See also section 3.7.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Response to long-term therapy should be monitored at regular intervals
by a veterinary surgeon. Use of
co