SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Duphafral Extravite

Solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances:

Thiamine Hydrochloride 35 mg/ml

Riboflavin Sodium Phosphate 0.5 mg/ml

Pyridoxine Hydrochloride 7.0 mg/ml

Nicotinamide 23 mg/ml

Ascorbic Acid 70 mg/ml

Excipient(s):

Chlorocresol (preservative) 1.0 mg/ml

Disodium edetate anhydrous 0.1 mg/ml

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection

A clear, pale yellow liquid, free from visible particles

4. CLINICAL PARTICULARS

4.1 Target species

Horses

Cattle

Sheep

4.2 Indications for use, specifying the target species

For the treatment of cerebrocortical necrosis in cattle and sheep, for the treatment of Vitamin B deficiencies in horses, cattle or sheep and for the treatment of bracken poisoning in horses.

4.3 Contraindications

Anaphylactoid reactions, particularly in the horse, may occur following intravenous administration. When this route is used, the product should be given slowly and may be diluted with sterile saline or dextrose saline solution.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

None

Care should be taken to avoid accidental self-injection.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

There may be slight irritation at the site of injection when the product is given by the subcutaneous or intramuscular routes. This should resolve naturally within a short period of time.

4.7 Use during pregnancy, lactation or lay

Duphafral Extravite can be safely administered to pregnant and lactating animals.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

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

Horses and Cattle 20 - 30 ml

Calves and Foals 5 - 10 ml

Sheep 5 - 10 ml

If dose volume exceeds 20 ml, it should be divided and injected into two sites.

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

Not applicable.

4.11 Withdrawal period

Cattle, horses, sheep (meat): Zero days

Cattle, sheep (milk): Zero hours

5. PHARMACOLOGICAL PROPERTIES

Thiamine Hydrochloride (Vitamin B1) acts as a co-enzyme in the breakdown of glucose and glycogen. Riboflavin Sodium Phosphate (Vitamin B2) is phosphorylated to form the co-enzymes Riboflavin-5-phosphate and Flavin Adenine Dinucleotide (FAD) which act as hydrogen recipients and donors.

Pyridoxine Hydrochloride (Vitamin B6) is converted to pyridoxal phosphate which functions as a co-enzyme with the transaminases and decarboxylases in the metabolism of proteins and amino acids. Nicotinamide is converted into the essential co-enzymes Nicotinamide Adenine Dinucleotide (NAD) and Nicotinamide Adenine Dinucleotide Phosphate (NADP).

Vitamin C (Ascorbic Acid) is involved in the conversion of folic acid to tetrahydrofolic acid and the conversion of proline to hydroxyproline which is essential to the formation of collagen.

ATCvet code:QA11EB

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Chlorocresol

Disodium edetate anhydrous

Propylene Glycol

Sodium hydroxide

Water for Injections

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

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

6.4. Special precautions for storage

Do not store above 25°C.

Protect from light.

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

Discard unused material.

6.5 Nature and composition of immediate packaging

Cardboard cartons containing 50ml or 100 ml amber Type II glass vials, sealed with bromobutyl bungs and aluminium caps.

Not all pack sizes are marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm42058/4040

9. DATE OF FIRST AUTHORISATION

Date:21 December 1993

10. DATE OF REVISION OF THE TEXT

Date:February 2014

APPROVED 28/02/14