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 viscous yellow liquid containing 50 mg spectinomycin activity (as the dihydrochloride pentahydrate) per ml.

Uses

Piglets:	For the treatment and control of infectious bacterial enteritis associated with Escherichia coli sensitive to spectinomycin.
Lambs:	For the prevention of bacterial neonatal disease (e.g.watery mouth disease) in lambs which are at risk of colostrum deprivation.

Dosage and administration

Route of administration

Oral.

Insert the doser in the bottle and push the piece of clear plastic tubing over the end of the pump spout. Press the plunger a few times to fill both the pump and plastic extension tube with medication.

The preparation should be administered well back on the tongue. Each pump of the plunger delivers 1 ml of solution containing 50 mg of spectinomycin.

When not in use, remove the dosing pump from the bottle. Place the clear plastic tube in the neck of the bottle and press the plunger a few times to return any medication in the pump to the bottle. Replace the original cap on the bottle. Before storing for future use, always rinse out the doser with water to prevent the pump parts from sticking.

Dosage

Piglets:	Piglets under 4.5 kg (10 lb) – 1 pump (1 ml) twice daily. Piglets between 4.5 kg (10 lb) and 7.0 kg (15 lb) – 2 pumps (2 ml) twice daily. Treatment may be continued twice daily for 3–5 days. If pigs do not improve within 48 hours, re-diagnosis is suggested.
Lambs:	1 pump (1 ml) once only as soon as possible after birth.

Contra-indications, warnings, etc

Do not use in animals with known hypersensitivity to the active ingredient.

Do not use in pigs over 4 weeks of age or over 7 kg bodyweight.

Use with caution in animals suffering from renal damage.

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

Do not handle in case of known hypersensivity to spectinomycin.

In case of accidental splashing on to the skin or eyes, wash the affected area with plenty of clean running water.

Wash hands thoroughly after use.

Withdrawal periods

Animals must not be slaughtered for human consumption during treatment.

Lambs may be slaughtered for human consumption only after 10 days from the last treatment.

Pigs may be slaughtered for human consumption only after 12 days from the last treatment.

Keep out of reach and sight of children. For animal treatment only.

Dispose of any unused product and empty containers in accordance with local authority regulations.

Pharmaceutical precautions

Store below 25°C.

Legal category

POM-V

Packaging Quantities

100 ml multiple-dose plastic bottle with a convenient plastic doser.

Further information

Nil.

Marketing authorisation number

Vm 15052/4006.