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

Each dose of 2 ml contains: Inactivated PRRS virus: 2.5 log10 IF units*, o/w oily excipient**, q.s. 2 ml, Gentamycin: traces.

* IF units: ImmunoFluorescence antibody titre obtained after two injections in pigs.

**containing hydrogenated polyisobutene as adjuvant.

Uses

Reduction of the reproductive disorders caused by Porcine Reproductive and Respiratory Syndrome Virus (European strain) in a contaminated environment: vaccination of sows and gilts reduces the number of early farrowings and the number of still-births.

Dosage and administration

One dose of 2 ml is administered by deep intramuscular route, in the neck muscles behind the ear, according to the following vaccination scheme:

Primary vaccination

Gilts: 2 injections 3-4 weeks apart, at least 3 weeks before mating.

Sows: 2 injections 3-4 weeks apart (vaccination of all the sows of the herd within a short period is recommended).

Revaccination

One injection at day 60-70 of each gestation, starting with the first pregnancy following primary vaccination.

Contra-indications, warnings, etc

For animal treatment only. There are no known contraindications. Apply the usual aseptic procedures. Vaccinate only healthy animals. Apply the usual procedures for the handling of animals.

Vaccination may induce a transient oedema (at most 3 cm) lasting generally less than one week, and small local reactions (granulomas), without any effect on the health and reproductive performance of the animals. Larger reactions (up to 7 cm diameter) have been observed occasionally after frequent repeated revaccination. Vaccination may rarely cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be carried out.

No undesirable effect has been observed in trials after the administration of the vaccine in pregnant or lactating animals.

No adverse effect on the serological response has been observed when the vaccine is administered simultaneously, but via a separate site, with the MERIAL range of inactivated vaccines against parvovirosis, influenza, and Aujeszky’s disease. It is recommended that no other vaccine should be administered at the same time as the product.

Withdrawal period

Zero days.

Operator Safety

In case of accidental injection, seek medical advice immediately and show the package leaflet to the physician.

To the user

This product is a mineral oil-based compound. Accidental self-injection may result in severe pain and swelling and could result in the loss of the affected finger or thumb if prompt medical attention is not given.

Ensure that the method of restraint, handling and administration, e.g. by the use of guarded needles, minimises the risk of accidental injection/self-injection.

If you are accidentally injected with this product, clean and disinfect the wound immediately.

Go AT ONCE to the nearest accident and emergency (casualty) department of a hospital and show the information printed below to the doctor (or nurse) on duty.

Seek prompt medical advice even if only a very small amount is injected.

If pain persists for more than 12 hours after medical examination, seek further medical advice.

To the Doctor

Even if very tiny amounts have been injected, accidental injection with this oil-based product is particularly irritating.

The accidental injection can cause intense swelling which may, for example, result in ischaemic necrosis and the loss of a digit in exceptional cases. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Pharmaceutical precautions

Keep out of reach of children.

Use immediately after opening.

Shake before use.

Do not mix with any other medicinal product.

Store in a refrigerator (2°C – 8°C ). Protect from light.

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

Legal category

POM-V

Packaging Quantities

Box of 1 bottle of 5 doses.

Box of 1 bottle of 25 doses.

Further information

In PRRS infected herds, viral infection is heterogeneous and varies over time. In such context, the implementation of a vaccination program is a tool to improve the reproductive parameters and may contribute to the overall disease control in conjunction with sanitary measures.

Marketing authorisation number

Vm 08327/4204.