Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

Suspension for injection.

Each 5-ml dose contains (at least) E. coli K99 antigen, at least 1.15 SA.U, Y antigen, at least 0.9 SA.U, 31A antigen, at least 1.6 SA.U, F41 antigen, at least 0.7 SA.U; Inactivated bovine rotavirus, at least 3.0 SN.U; Inactivated bovine coronavirus, at least 1.9 SN.U; Aluminium hydroxide (Al+++) 3.5 mg; Saponin 1.5 mg; Thiomersal* at most 0.5 mg.

* Multidose containers only

Uses

For administration to pregnant cows and heifers to stimulate serological and colostral antibodies against rotavirus and coronavirus antigens and against K99, Y, 31A and F41 antigens of Escherischia coli in susceptible animals, which may be passed to the calf to reduce neonatal diarrhoea infection caused by agents containing these antigens.

Dosage and administration

Shake well before use.

Inject one 5-ml dose subcutaneously according to the following schedule:

Pregnant cows and heifers

Primary vaccination

First injection: 1 to 2 months before calving.

Second injection: 2 to 4 weeks after first injection, at least 2 weeks prior to calving.

Boosters

No data has been provided to support the use of a single dose booster regime. However, experience in the field suggests that a single dose of the vaccine administered two weeks before calving may provide enhanced antibody levels in the colostrum against the component antigens.

Ensure that each calf rapidly ingests a sufficient quantity of colostrum.

Contra-indications, warnings, etc

For animal treatment only.

There are no contra-indications.

A local reaction at the site of injection (approx 10 cm), may appear after vaccination. This usually disappears within 14 days. A slight increase in mean rectal temperature (approx 0.5°C) may be observed on the day following the injection. Any injection of bacterial cells, even inactivated, may occasionally cause hypersensitivity reactions. In such case, a symptomatic treatment should be provided. No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated. Do not mix with any other vaccine or immunological product.

Withdrawal period

Zero days.

Pharmaceutical precautions

Keep out of the reach and sight of children.

Open bottles should be used immediately.

Store between +2°C and +8°C, protected from light.

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

Legal category

POM-VPS

Packaging Quantities

10-dose (50ml) bottle.

Further information

Overdose: After administration of a double dose of vaccine, a local reaction at the site of injection may appear as a slight oedema evolving to a firm swelling, usually disappearing within 14 days of vaccination. A slight transient temperature rise (mean 0.7οC) may be observed for two days following the injection.

Marketing authorisation number

Vm 08327/4106.