Diurizone Injectable

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydrochlorothiazide; Dexamethasone

Available from:

Vetoquinol Ireland Limited

ATC code:

QC03AX01

INN (International Name):

Hydrochlorothiazide; Dexamethasone

Dosage:

50, 0.5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Non food-producing horses

Therapeutic area:

hydrochlorothiazide, combinations

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

1989-10-01

Summary of Product characteristics

Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Diurizone Injectable
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES
Hydrochlorothiazide
50
mg
Dexamethasone
0.5
mg
EXCIPIENT
Benzyl Alcohol
0.01
ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A colourless, slightly viscous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
Horses declared as not being intended for slaughter for human
consumption.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Cattle:_
Congestion and oedema of the udder
Persistent oedema during lactation
Pulmonary congestion and oedema
Oedema of surgical wounds
Oedema of allergic conditions
_Horses:_
Generalised congestion and oedema
Oedema of sheath
AnasarcaOedema in allergic conditions
4.3 CONTRAINDICATIONS
Do not use in pregnant animals. Do not use in animals with viral
infections, during the viraemic phase. Do not use in animals
with diabetes mellitus, congestive heart failure, chronic nephritis,
osteoporosis or glaucoma. Do not use in animals with hepatic
encephalopathy. Do not use in cases of severe hypokalemia. Do not use
in animals with known hypersensitivity to the active
ingredients. Do not use in horses for the treatment of laminitis.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For intravenous administration, use a tepid solution and inject
slowly.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
The association of Hydrochlorothiazide and Dexamethasone acetate may
induce hepatic encephalopathy.
Corticosteroids may delay wound healing and the immunosuppressant
actions may weaken resistance to or exacerbate existing
infections.
In the