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DIURIZONE

Main information

  • Trade name:
  • DIURIZONE INJECTABLE
  • Available from:
  • Vetoquinol Ireland Limited
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • DIURIZONE INJECTABLE
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Cardiovascular
  • Therapeutic area:
  • Bovine

Other information

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Status

  • Source:
  • IMB
  • Authorization date:
  • 01-10-1989
  • Last update:
  • 09-08-2016

Summary of Product characteristics

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IRISH MEDICINES BOARD ACT 1995, as amended

European Communities (Animal Remedies) (No. 2) Regulations 2007

VPA: 10983/011/001

Case No: 7006343

The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby

grants to:

Vetoquinol Ireland Limited

10 Lad Lane, Lower Baggot Street, Dublin 2, Ireland

an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the

Veterinary Medicinal Product:

Diurizone Injectable

The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in

the Schedule.

The authorisation,unless revoked, shall continue in force from 30/09/2009.

Signed on behalf of the Irish Medicines Board

________________

A person authorised in that behalf by the said Board.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/07/2010 CRN 7006343 page number: 1

Part II

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Diurizone Injectable

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

Anasarca

Oedema 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

Each ml contains:

Active Substances

Hydrochlorothiazide 50 mg

Dexamethasone 0.5 mg

Excipient

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/07/2010 CRN 7006343 page number: 2

4.4 Special warnings for each target species

None.

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 presence of bacterial infection, anti-bacterial therapy is required when steroids are used.

In the presence of viral infections, steroids may worsen or hasten the progress of disease.

Due to the risk of hypokalaemia in ruminants treated with corticosteroids, potassium levels should be monitored.

Moreover, risks may be associated according to the length of therapy:

In the case of long term corticosteroid therapy, Cushings’ syndrome, tissue atrophy, reduction of muscular weight,

osteoporosis, diminution of skin thickness, immuno depression, or the inhibition of ACTH release by antehypophysis

inducing the suppression of corticoid production by the adrenal cortex may be observed.

In the case of short term therapy: polyuria, polydipsia, euphoria, ataxia, disorientation, aggressiveness, risks of urinary,

skin or pulmonary infectious complications, gastro-intestinal ulceration or decrease of the hypophyseal ACTH response

may occur.

However, it is not necessary to use a special protocol such as progressive diminution of doses, if the treatment lasts less

than 15 days.

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.

4.7 Use during pregnancy, lactation or lay

Pregnancy:

Do not use during pregnancy.

Lactation:

The use of the product in lactating cows may cause a reduction in milk yield.

4.8 Interaction with other medicinal products and other forms of interaction

The use of attenuated live virus vaccines is not to be recommended, the immunosuppressive action of corticoids may

cause generalised disease.

Lack of or reduction of the hypoglycemic activity of insulin, metformine or hypoglycemic sulfonamides if combined

with a corticoid and/or hydrochlorothiazide.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/07/2010 CRN 7006343 page number: 3

4.9 Amounts to be administered and administration route

Diurizone injection may be administered by intravenous, intramuscular, subcutaneous injection.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

See section 5.

4.11 Withdrawal Period(s)

Cattle:

Meat and offal: 28 days

Milk: 7 days

Treated horses may never be slaughtered for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Cardiovascular system, low-ceiling diuretics, thiazides, hydrochlorothiazide, combinations

ATC vet code: QC03AX01

Dexamethasone is a synthetic glucocorticoid the anti-inflammatory activity of which is increased by a C16 methylation

and the presence of a C9 fluorine atom. However the mineralocorticoid activity is reduced.

The anti-inflammatory effect is the primary action which is obtained by stabilisation of cell membranes, maintaining

the micro circulation of the inflamed zone and prevention of oedema, while preserving normal cell permeability.

Dexamethasone possesses other physiological and pharmacological functions such as:

modification of glucose, protein and lipid-metabolisms, with especially induction of the neoglucogenesis inducing

an increase in blood glucose levels, the deposit of hepatic glycogen, lipid demobilisation and protein catabolism.

regulation of circulation by reduction of peripheral resistance, improvement in venous circulation and increase in

cardiac output.

an anti allergic action obtained by membrane stabilisation, acting on histamine.

Given at high dose or following prolonged administration, Dexamethasone may induce tissue atrophy, skin fragility

and immunodepression.

Hydrochlorothiazide is a diuretic acting by inhibition of sodium resorption. An increase in water excretion occurs,

facilitating oedema resorption.

Hydrochlorothiazide also eliminates chloride ions.

Potassium and bicarbonate diuresis is not observed in ruminants. Hydrochlorothiazide does not induce hypokalemia or

Cattle and adult Horses:

Preventative treatment: 10 ml daily for 3 days.

Curative treatment:

Congestion and mild oedema: 10 ml daily for 2 or 3 days

Congestion and severe oedema: 20 ml daily for 2 days and 10 ml the third day.

Foals - Calves:

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/07/2010 CRN 7006343 page number: 4

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Dimethylacetamide

Propylene glycol

Macrogol 300

Benzyl alcohol

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary

medicinal products.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and composition of immediate packaging

50 ml amber type II glass vial closed with chlorobutyl stopper and sealed with an aluminium cap.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be

disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Vetoquinol Ireland Limited

10 Lad Lane

Lower Baggot Street

Dublin 2

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10983/011/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30th September 2009

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/07/2010 CRN 7006343 page number: 5

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