Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Scored white bolus-shaped antibacterial tablet. Each bolus contains:-

Trimethoprim Ph.Eur	200 mg
Sulfadiazine Ph.Eur	1.0 g

Uses

Duphatrim Boluses are primarily indicated for oral use in pre-ruminant calves for the treatment of bacterial scours but may be used for the treatment of acute salmonellosis and bacterial pneumonia.

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. In vitro Duphatrim Bolus is effective against most common Gram-positive and Gram-negative bacteria including Escherichia coli, Klebsiella spp, Pasteurella spp, Salmonella spp, Staphylococcus spp.

The boluses are particularly effective against Escherichia coli and Salmonella spp infections.

Dosage and administration

For calves, the daily dose is one bolus per 40 kg (90 lb) bodyweight given orally, providing 30 mg of combined active ingredients per kg bodyweight daily.

Treatment should be repeated daily until two days after symptoms have resolved, but in cases of salmonellosis and bacterial pneumonia treatment should be continued for five consecutive days. Treatment must not continue for more than five days. Duphatrim Boluses may be administered whole, by hand or balling gun, or dispersed in water.

Dosage by dispersion in water: Disperse each bolus by shaking in about 300 ml of water in a dosing bottle. This may be facilitated by crushing the bolus before placing it in the bottle. After dosing by this method any unused material should be discarded.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Animals must not be slaughtered for human consumption during treatment.

Cattle may be slaughtered for human consumption only after 15 days from the last treatment.

Duphatrim Bolus should not be used in animals with functionally mature rumens.

User Warnings:

Protective gloves should be worn to avoid skin sensitisation, which may occur when crushing the bolus of this product.

Wash hands after use.

Avoid direct contact with skin and eyes. If contact occurs, wash affected area with copious amounts of water. Seek medical advice if irritation persists.

Pharmaceutical precautions

Do not store above 25°C. Store in a dry place. Protect from light.

Keep out of reach and sight of children.

Disposal

Disposal

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

Legal category

POM-V

Packaging Quantities

Plastic tubs containing 20 boluses.

Further information

Nil.

Marketing authorisation number

Vm 01596/4191.