Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

An emulsion for injection. One dose of 2ml contains inactivated porcine parvovirus, strain S-80: inducing an HIA* titre of at least 160 (in rabbits). Inactivated Erysipelothrix rhusiopathiae, strain B-7 (serotype 2): RP**≥1.8 in accordance with the EP monograph.

*HIA - haemagglutination inhibiting antibody

**Relative Potency compared to a reference serum obtained from a vaccine that has given satisfactory protection in vaccinated pigs.

Uses

For the active immunisation of pigs (gilts and sows) to prevent reproductive disorders caused by porcine parvovirus and to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1. The onset of immunity starts 3 weeks after vaccination and duration of the protection is 6 months.

Dosage and administration

One dose of 2 ml per animal by intramuscular injection in the neck.

Vaccination Schedule:

- Primary Vaccination:

Gilts from 5 months of age and sows:

Two injections 3-4 weeks apart.

The second dose should be given at least 4 weeks before mating.

- Revaccination:

One dose during each lactation period 3 to 4 weeks before mating.

Correct administration:

The vaccine is to be administered aseptically.

Shake well before administration and intermittently during the process of vaccination.

Avoid stress in the animals around the time of vaccination.

Administer only to animals in good health condition.

Contra-indications, warnings, etc

Do not use less than 3 weeks before mating.

Do not use in pregnant sows.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product.

Following first vaccination transient hyperthermia up to 1°C above normal for up to 24 hours after vaccination in up to 25% of pigs.

Local tissue reactions in the form of visible swelling (granulomas) at the injection sites may occur in 33% of the vaccinated animals for up to 16 days. The area of reaction can be diffuse and reach 2-5 cm in diameter.

Following second vaccination transient hyperthermia up to 1°C above normal for 24-48 hours after vaccination in up to 40% of pigs.

Local tissue reactions in the form of visible swelling (granulomas) at the injection sites may occur in 90% of the vaccinated animals for up to 10 days. The area of reaction can be diffuse and reach 2-5 cm in diameter.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

OPERATOR WARNING

To the user

This product contains mineral oil.

Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.

If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.

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

To the physician

This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. 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.

WITHDRAWAL PERIOD

Zero days.

Pharmaceutical precautions

Keep out of reach and sight of children. Store and transport (2°C - 8°C). Protect from light. Do not freeze. Do not use after the expiry date stated on the carton after EXP. Once broached, use immediately.

DISPOSAL

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

Legal category

POM-V

Packaging Quantities

Carton box with 1 glass vial of 20 ml and carton box with two vials of 50 ml.

Not all pack sizes may be marketed.

Further information

For Animal Treatment Only.

Marketing authorisation number

Vm 01596/4312.