Introduction

Company name: Elanco Animal Health

Address: Eli Lilly and Company Limited

Lilly House

Priestley Road, Basingstoke

Hampshire, RG24 9NL

Telephone: 01256 353131

Fax: 01256 779510

Email: elanco.uk.info@lilly.com

Website: www.elanco.com

Presentation

Apralan Soluble Powder is a tan-brown to brown soluble powder available in bottles and sachets.

Each sachet contains 1 g apramycin activity.

Each bottle contains apramycin sulphate equivalent to 50 g apramycin activity in 220 ml powder. A measure is pressed on to the bottle cap. The smaller measure provides a 4.4 ml dose (1 g apramycin activity) and the top mark on the measure a 22.0 ml dose (5 g apramycin activity). The powder should be poured into the cap and tapped gently to level it with the desired dose mark.

Uses

Pigs

For the treatment of bacterial enteritis associated with organisms susceptible to apramycin.

Calves

For the treatment of colibacillosis and salmonellosis.

Poultry

For the treatment of Escherichia coli septicaemia and salmonellosis in young birds.

Dosage and administration

Apralan Soluble Powder should be administered in the only source of drinking water, or in milk or reconstituted milk replacer, to provide the following dosage:

Pigs

To be administered via the drinking water. Treated pigs should consume sufficient medicated drinking water to obtain 7.5–12.5 mg apramycin activity per kg of bodyweight daily for seven days. This may be achieved by adding 1 small measure (4.4 ml), or 1 sachet of Apralan Soluble Powder per 20 litres of water.

Calves

One to two sachets to be administered in the drinking water, milk or milk replacer to provide 20–40 mg of apramycin activity per kg of bodyweight daily according to the severity of the disease. Continue treatment for five days.

Poultry

To be administered in the drinking water to provide 250 or 500 mg of apramycin activity/litre for five days. This may be achieved by adding 50 g apramycin activity per 100 or 200 litres of water.

Directions for administration

Add the appropriate quantity of Apralan Soluble Powder to five to ten times its own volume of water. Stir well and allow solution to stand for a few minutes then stir again. When completely dissolved, add to the full volume of drinking water, milk or reconstituted milk replacer and stir well.

Any medicated water, which is not consumed within 24 hours, should be discarded.

Solutions in milk and reconstituted milk replacer should be prepared immediately before use. Any medicated milk or milk replacer, which is not consumed within one hour, should be discarded.

Contra-indications, warnings, etc

In the event of skin contact, wash thoroughly with soap and water.

Do not use in known cases of hypersensitivity to apramycin.

Not for use in laying poultry when eggs are intended for human consumption.

Toxic to cats.

Drinking systems should be clean and free of rust to avoid reduction of activity.

Keep out of reach of children.

For animal treatment only.

Withdrawal periods

Pigs

Treated pigs must not be slaughtered for human consumption within 14 days of the last treatment.

Calves

Treated calves must not be slaughtered for human consumption within 28 days of the last treatment.

Poultry

Treated chickens must not be slaughtered for human consumption within 7 days of last treatment.

Pharmaceutical precautions

Keep in a well-closed container and store below 25°C. The shelf life of Apralan Soluble Powder is 24 months. An expiry date is printed on each pack.

Legal category

POM-V

Packaging Quantities

Apralan Soluble Powder is supplied in cartons of 50 sachets each containing 1 g apramycin activity or in bottles containing 50 g activity.

Further information

Nil.

Marketing authorisation number

Vm 00006/4084.