Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

White to off-white granules with broad-spectrum antibacterial activity. Presented in aluminium foil sachets. Duphatrim Granules for Horses are for oral administration to horses after mixing with feed. Each sachet contains 37.5 g of product containing:

Trimethoprim	2.5 g
Sulphadiazine	12.5 g

Uses

For the treatment of bacterial infections in horses.

Duphatrim Granules for Horses is a broad-spectrum antibacterial, active against a wide range of Gram-positive and Gram-negative organisms. Together the active ingredients produce a double blockade of folinic acid synthesis in bacteria resulting in a level of activity much greater than that obtained from either drug alone.

When susceptible organisms are present Duphatrim Granules for Horses may be effective in treating the following conditions:

Alimentary tract infections including diarrhoea.

Respiratory tract infections including pneumonia, pleurisy and strangles.

Wounds, septicaemia and general infections.

Dosage and administration

The daily dose is 30 mg combined active ingredients per kg bodyweight (25 mg sulphadiazine and 5 mg trimethoprim per kg bodyweight). Each sachet contains one daily dose for a 500 kg horse.

Dosage guide:
BODYWEIGHT	DAILY DOSE
	Weight of Duphatrim Granules For Horses	No of Scoops
100 kg	7.5 g	½
200 kg	15.0 g	1
300 kg	22.5 g	1½
400 kg	30.0 g	2
500 kg	37.5 g	Whole Sachet

The scoop provided dispenses 15g of granules.

Treatment should be continued for up to 5 days or until 2 days after symptoms have resolved.

After careful estimation of the weight of the horse, the required dose of Duphatrim Granules for Horses should be mixed well with the horses feed prior to administration. Add to feed immediately before administration. Discard any remaining medicated feed.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in horses with known sulphonamide sensitivity, with hepatic damage or with blood dyscrasias.

Do not use in horses intended for human consumption.

The horse must have been declared as not intended for human consumption in accordance with the UK's Horse Passport Legislation.

Operator warning

Avoid direct contact with skin and eyes. If contact occurs, wash affected area with copious amounts of water. Seek medical advice if irritation persists. Gloves should be worn whilst handling this product. Wash hands and exposed skin after use. Avoid inhaling dust from the product. The use of a mask is recommended if the product is handled regularly. Handle only in a well ventilated area.

Pharmaceutical precautions

Do not store above 25°C.

Keep out of the reach and sight of children.

Any unused drug in open sachets remaining after the course of treatment should be discarded.

Legal category

POM-V

Packaging Quantities

Cartons of 20 sachets, each sachet containing 37.5 g of Duphatrim Granules for Horses.

Further information

Disposal

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

Marketing authorisation number

Vm 01596/4172.