DEXASHOT 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:

Vet-Agro Multi-Trade Company Sp z o.o.

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 area:

dexamethasone

Authorization status:

Authorised

Authorization date:

2019-06-21

Summary of Product characteristics

Health Products Regulatory Authority
02 July 2021
CRN009ZY5
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DEXASHOT 2 mg/ml solution for injection for cattle, horses, pigs, dogs
and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
Dexamethasone
​
2 mg
​
As dexamethasone sodium phosphate
​
2.63 mg
​
EXCIPIENTS:
​
​
Benzyl alcohol (E 1519)
​
15.6 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.
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.
Health Products Regulatory Authority
02 July 2021
CRN009ZY5
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Care should be taken not to overdose Channel Island breeds of cattle.
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. Therefor