DUPHALYTE SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CALCIUM CHLORIDE HEXAHYDRATE MAGNESIUM SULFATE POTASSIUM CHLORIDE THIAMINE HYDROCHLORIDE RIBOFLAVIN SODIUM PHOSPHATE PYRIDOXINE HYDROCHLORIDE CYANOCOBALAMIN NICOTINAMIDE DEXPANTHENOL GLUCOSE ANHYDROUS ARGININE HYDROCHLORIDE CYSTEINE HYDROCHLORIDE MONOHYDRATE HISTIDINE HYDROCHLORIDE ISOLEUCINE LEUCINE LYSINE HYDROCHLORIDE METHIONINE PHENYLALANINE THREONINE TRYPTOPHAN, DL VALINE MONOSODIUM L-GLUTAMATE MONODYDRATE

Available from:

Fort Dodge Animal Health Limited

ATC code:

QB05BB

Pharmaceutical form:

Solution for Injection

Therapeutic group:

Electrolytes

Therapeutic area:

Bovine

Authorization date:

1996-10-01

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10861/022/001
Case No: 7001488
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:
FORT DODGE ANIMAL HEALTH LIMITED
FLANDERS ROAD, HEDGE END, SOUTHAMPTON SO30 4QH, UNITED KINGDOM
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:
DUPHALYTE 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 previously revoked, shall continue in force from 30/09/2006.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/03/2009_
_CRN 7001488_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphalyte Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection. A clear yellow solution.
ACTIVE SUBSTANCES
Per ml
Calcium chloride hexahydrate
0.23 mg
Magnesium sulphate heptahydrate
0.29 mg
Potassium chloride
0.20 mg
Thiamine hydrochloride
0.10 mg
Riboflavin (as sodium phosphate )
0.04 mg
Pyridoxine hydrochlo