Introduction

Company name: Animalcare Limited

Address: Common Road

Dunnington

York YO19 5RU

Telephone: 01904 487687

Fax: 01904 487611

Email: animalcare@animalcare.co.uk

Presentation

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

Trimethoprim	200 mg
Sulfadiazine	1.0 g

Uses

Trimacare Boluses are primarily indicated for oral use in calves for the treatment of bacterial scours but may also be used for treatment of acute salmonellosis and bacterial pneumonia. Together the active ingredients produce a double blockade of folinic acid synthesis in bacteria giving a level of activity many times greater than that obtained from either drug alone. In vitro Trimacare Bolus is effective against most common Gram-positive and Gram-negative bacteria including Escherichia coli, Klebsiella spp., Pasteurella spp., Salmonella spp. and Staphylococcus spp.

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

Use of this product should be based on susceptibly testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Dosage and administration

CALVES: The daily dose is one bolus per 40 kg (90lb) bodyweight given orally, providing 30mg of combined active constituents per kg bodyweight daily.

Treatment should be repeated daily until two days after the symptoms have resolved, but in cases of salmonellosis and bacterial pneumonia, treatment should be continued for five consecutive days. Treatment must not be continued for more than five days.

Trimacare Boluses may be administered whole, by hand or by 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

Animals must not be slaughtered for human consumption during treatment. Calves may be slaughtered for human consumption only after 15 days from the last treatment.

Trimacare Bolus should not be used in animals with a functionally mature rumen.

User Warnings

Take care to avoid skin and eye contact. Protective gloves should be worn whilst handling this product. Wash hands and exposed skin after use.

Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics. Allergic reactions to these substances may occasionally be serious.

1. Do not handle this product if you know you are sensitive to sulphonamides

2. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.

Pharmaceutical precautions

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

Protect from light.

Keep out of the reach of children

Legal category

POM-V

Packaging Quantities

Plastic tubs containing 20 boluses

Further information

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

Marketing authorisation number

2000/4148.