Introduction

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

A sterile, pale yellow, aqueous solution of spectinomycin dihydrochloride BP containing 100 mg spectinomycin activity per ml, for parenteral administration to calves.

Uses

For the treatment of respiratory disease in calves due to infection with bacteria sensitive to spectinomycin.

Dosage and administration

Administer by intramuscular injection.

Calves: 20-30 mg/kg bodyweight per a day (equivalent to 10-15 ml per 50 Kg bodyweight), once daily for a maximum of 5 days.

Contra-indications, warnings, etc

Calves must not be slaughtered for human consumption during treatment.

Calves may be slaughtered for human consumption only after 32 days from the last treatment.

Special precautions for use

It is prudent to reserve the use of spectinomycin for clinical conditions which have resulted poorly to other classes of antimicrobials. Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

Special precautions to be taken by the person administering the product to animals

Care should be taken to avoid accidental self-injection. In case of accidental injection seek medical advice.

Avoid contact with skin and eyes. Wash any splashes off immediately with plenty of water. Wash hands thoroughly after use.

For animal treatment only.

Keep out of reach and sight of children.

Pharmaceutical precautions

Do not store above 25°C.

Protect from light.

Following the withdrawal of the first dose, use the product within 28 days. Discard any unused material.

Legal category

POM-V

Packaging Quantities

Multidose 100 ml glass vial.

Further information

Nil.

Marketing authorisation number

Vm 15052/4012.