COLVASONE 2 MG/ML SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DEXAMETHASONE SODIUM PHOSPHATE

Available from:

Norbrook Laboratories Limited

ATC code:

QH02AB02

INN (International Name):

DEXAMETHASONE SODIUM PHOSPHATE

Dosage:

2 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Canine, Equine - Food, Feline

Therapeutic area:

Dexamethasone

Therapeutic indications:

Corticosteroid

Authorization status:

Authorised

Authorization date:

1989-10-01

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10999/043/001
Case No: 7007756
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:
NORBROOK LABORATORIES LIMITED
STATION WORKS, NEWRY, CO. DOWN BT35 6JP
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:
COLVASONE 2 MG/ML SOLUTION FOR INJECTION
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in the said Schedule.
The authorisation,unless revoked, shall continue in force from 09/06/2010.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/06/2010_
_CRN 7007756_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Colvasone 2mg/ml Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, sterile solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
Cattle
Dogs
Cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dexamethasone is a synthetic corticosteroid with potent anti-inflammatory action.
Colvasone can be used for:
1) Intravenous therapy in case