Introduction

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Terramycin Soluble Powder 5% is a yellow/orange, free flowing powder containing 55 g oxytetracycline hydrochloride per kg in a water-soluble base.

Uses

Terramycin is indicated for the treatment of a range of bacterial infections caused by, or associated with, oxytetracycline sensitive organisms. A wide range of Gram-positive and Gram-negative bacteria, certain mycoplasma species and rickettsiae, have been shown to be sensitive in vitro to oxytetracycline.

Cattle (over 160 kg bodyweight)

Respiratory disease.

Calf

Bacterial enteritis.

Pig

Respiratory disease.

Dosage and administration

Administration

Terramycin Soluble Powder 5% is recommended for oral administration and may be given in the drinking water or as a drench.

A period of treatment for 3–5 days is usually sufficient.

Dosage

Calf

1–2 level measures per 54 kg bodyweight twice daily (9–18 mg oxytetracycline hydrochloride per kg bodyweight per day).

Ruminating cattle

½–1 level measure per 120 kg bodyweight twice daily (2–4 mg oxytetracycline hydrochloride per kg bodyweight per day).

Pig

1–3 level measures per 24 kg bodyweight daily (10–30 mg oxytetracycline hydrochloride per kg bodyweight per day).

4.5–14 g oxytetracycline hydrochloride per 50 litres (11 gallons) of drinking water i.e. 1×250 g pack medicates 155 litres (34 gallons) at the lower dosage level.

Contra-indications, warnings, etc

The use of tetracyclines during the period of tooth development, including late pregnancy, may lead to tooth discolouration.

Interactions may occur with solutions with high calcium, magnesium or sodium content.

The safety margin of oxytetracycline in the target species is very wide and toxic signs are unlikely to be seen. Large overdoses are potentially nephrotoxic.

Acutely ill animals are unlikely to consume an adequate dose unless treated by drinking water or drench methods.

When given via the drinking water remove all other sources of water until the medicated water has been consumed.

Following oral dosage in ruminating animals changes in the ruminal flora may occur but these have generally been found to be of a transitory and reversible nature. Administration of Terramycin at the recommended dosage will usually result in only a small depression of cellulose digestion.

To reconstitute the powder in drinking water, it should be agitated in vigorously in a small volume of water and added to the bulk tank when fully dissolved.

Bacterial resistance may develop after long term use of oxytetracycline. This is particularly likely in Enterobacteria and Salmonella, many of which are already resistant.

Salmonella shedding in treated animals will continue where organisms are resistant.

Wash hands after use.

Withdrawal periods

Cattle: Meat – 10 days.

Milk – zero days.

Milk for human consumption must not be taken during treatment.

Pigs: 7 days.

For animal treatment only.

Keep out of reach of children.

Pharmaceutical precautions

Store in a dry place.

Do not store above 25°C.

Any medicated water remaining after 24 hours should be discarded.

Any unused product or waste material should be disposed of in accordance with national requirements.

Legal category

POM-V

Packaging Quantities

Available in a 250 g securitainer, supplied with a measure. One level measure of Terramycin Soluble Powder 5% contains approximately 240 mg oxytetracycline hydrochloride.

Marketing authorisation number

Vm 00057/4084.

Significant Changes

Terramycin Soluble Powder 5%

Pfizer Limited

Deletion of chickens & turkeys from target species.

11/07/2008