Introduction

FDAH

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Duphafral Extravite is a pale yellow to brown sterile solution for injection containing four members of the B‑complex vitamins together with Vitamin C. Each ml contains:

Thiamine Hydrochloride (Vitamin B1)	35 mg
Riboflavin Sodium Phosphate (Vitamin B2)	0.5 mg
Pyridoxine Hydrochloride (Vitamin B6)	7.0 mg
Nicotinamide	23 mg
Ascorbic acid (Vitamin C)	70 mg
Chlorocresol as preservative	1.0 mg
Disodium edetate anhydrous	0.1 mg

Uses

Duphafral Extravite may be used in the following cases:

1.Wherever deficiency of the Vitamin B group is suspected in horses, cattle or sheep.

2.In treatment of cerebrocortical necrosis in cattle and sheep.

3.In treatment of bracken poisoning in horses.

Dosage and administration

Administer by subcutaneous, deep intramuscular or slow intravenous injection. The dose should be repeated daily as required. Normal aseptic precautions should be observed.

Horses, cattle:	20–30 ml
Calves and foals:	5–10 ml
Sheep:	5–10 ml

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Anaphylactoid reactions, particularly in the horse, may occur following intravenous administration. When this route is used Duphafral Extravite should be given slowly, and may be diluted with sterile saline or dextrose saline solution. This may be achieved by drawing the sterile diluting solution into a syringe followed by the required volume of Duphafral Extravite. This diluted product must be administered immediately after preparation and must not be stored. Aseptic precautions should be observed.

There may be slight irritation at the site of injection when the product is given by the subcutaneous or intramuscular routes.

Withdrawal period for meat/milk

Cattle, horses, sheep (meat): Zero days.

Cattle, sheep (milk): Zero hours.

User warnings:

Care should be taken to avoid accidental self-injection. Wash hands after use.

Pharmaceutical precautions

Do not store above 25°C. Protect from light. Keep out of the reach and sight of children. Keep container in outer carton. Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

When the container is broached (opened) 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-VPS

Packaging Quantities

Multidose vials of 100 ml.

Further information

Disposal:

Dispose of used containers in the farm refuse. Used containers should not be recycled.