Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

An inactivated, oil adjuvanted Porcine Reproductive and Respiratory Syndrome (PRRS) virus vaccine containing at least 2.5 log10 Immuno Fluorescence units PRRS virus P120 strain per 2 ml dose.

Uses

For reduction of the reproductive disorders in sows and gilts caused by Porcine Reproductive and Respiratory Syndrome virus (European strain), in a contaminated environment. Vaccination reduces the number of early farrowings and number of still births.

Dosage and administration

Administer a 2 ml dose by deep intramuscular injection, in the neck muscles behind the ear, according to the following vaccination scheme:

Primary vaccination course

Gilts: Two injections three to four weeks apart, at least three weeks before mating.

Sows

Two injections three to four weeks apart. Vaccination of all sows in the herd within a short period is recommended.

Revaccination

One injection at 60 – 70 days of each pregnancy, starting from the first pregnancy following the primary vaccination course.

Contra-indications, warnings, etc

Vaccination may induce a transient oedema (up to 3 cm) generally lasting less than one week, and a small local reaction (granulomas) without any adverse effects on the health and performance of the animal. Larger reactions (up to 7 cm diameter) have been occasionally observed after frequent repeated vaccinations.

Vaccination may rarely cause hypersensitivity reactions. In such cases appropriate symptomatic treatment should be carried out.

Vaccinate only healthy animals.

Use normal procedures for handling animals.

No adverse effects on serological response have been observed when the vaccine is administered simultaneously (but via a separate injection site) with inactivated vaccines against parvovirus, influenza and Aujeszky disease. It is recommended that no other vaccine should be administered at the same time as the product.

No undesirable effects were observed after administering the vaccine to pregnant or lactating animals.

Withdrawal period

Zero days.

User precautions

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the Doctor.

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, eg 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 & 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.

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

Pharmaceutical precautions

Store at 2°C to 8°C (in a refrigerator), protected from light.

Do not mix with other medicinal products.

Use immediately after opening.

Legal category

POM-V

Packaging Quantities

Glass injection vials (Type I) with rubber stoppers and aluminium seals containing

10 ml (5 doses) or 50 ml (25 doses).

Further information

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

Marketing authorisation number

Vm 00015/4064.