Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

An injectable solution of electrolytes, vitamins, amino-acids and dextrose, designed for fluid support therapy in animals. Each ml contains:

VITAMINS
Thiamine hydrochloride	0.167mg
Riboflavin (as Riboflavin sodium phosphate)	0.084mg
Pyridoxine hydrochloride	0.20mg
Cyanocobalamin	0.05mcg
Nicotinamide	2.25mg
Dexpanthenol ELECTROLYTES	0.10mg
Calcium chloride hexahydrate	0.23mg
Magnesium sulphate heptahydrate	0.29mg
Potassium chloride AMINO ACIDS	0.20mg
L-arginine hydrochloride	0.025mg
L-cysteine hydrochloride monohydrate	0.01mg
Monosodium glutamate monohydrate	0.04mg
L-histidine hydrochloride monohydrate	0.01mg
L-isoleucine	0.01mg
L-leucine	0.04mg
L-lysine hydrochloride	0.03mg
L-methionine	0.01mg
DL-phenylalanine	0.03mg
L-threonine	0.02mg
DL-tryptophane	0.01mg
DL-valine	0.05mg
Anhydrous dextrose EXCIPIENTS	45.46mg
Methyl hydroxybenzoate (preservative)	1.80mg
Propyl hydroxybenzoate (preservative)	0.20mg
Phenol (preservative)	0.10mg
Disodium edetate dihydrate (preservative)	0.15mg

Uses

As supportive maintenance therapy in conditions of fluid loss in horses, cattle, pigs, dogs and cats.

Dosage and administration

Horses

By slow intravenous injection only.

Cattle and pigs

By slow intravenous injection only.

Dogs and cats

By slow intravenous injection only.

Calves and young pigs under three years of age

Following initial intravenous administration, follow-up therapy, if required, may be administered by the subcutaneous route. In such cases, the dose should be divided and administered at two or more sites.

ADMINISTER SLOWLY

Horses Cattle Sows and Boars	Up to 100ml per 50kg bodyweight
Foals, calves and younger pigs	Up to 30ml per 5 kg bodyweight
Dogs Cats	Up to 50ml per 5kg bodyweight

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Aseptic precautions must be observed when using the product.

Administer very slowly when the injection is given intravenously. Too rapid injection may cause nausea and distress. If this occurs, discontinue until animal returns to normal and continue at slower rate.

The product should be at normal body temperature when administered.

When administered to calves or young pigs by the subcutaneous route, pain may occur at the injection site. This is usually of a transient nature. Care should be taken to reduce such reactions to a minimum. For welfare reasons it is essential that adequate instructions are given to operators.

As some vitamins are sensitive to oxidising substances and/or pH changes, Duphalyte should not be mixed for administration with any other product. For this reason do not mix Duphalyte with other medicinal products.

Withdrawal period:

Cattle, horses, swine (meat): Zero days

Cattle (milk): Zero hours.

Operator warning:

Care should be taken to avoid accidental self-injection.

Wash hands after use.

Pharmaceutical precautions

Keep out of reach and sight of children.

Do not store above 25°C.

Do not freeze.

Protect from light.

Following withdrawal of the first dose, use the product within 28 days.

When the container is broached for the first time, using the in-use shelf-life which is specified on this data sheet, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.

Legal category

POM-V

Packaging Quantities

500ml polypropylene bottles

Further information

Disposal:

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Marketing authorisation number

Vm 01596 / 4303.