Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Per dose of 2ml:

Active Substance(s):

Inactivated Erysipelothrix rhusiopathiae, strain B-7 (serotype 2): RP*≥1.8 in accordance with the EP Monograph.

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

Adjuvants:

Marcol 52 (Mineral Oil) 730.14mg

Montanide 888 (Emulsifier) 74.32mg

Simulsol 5100 (Emulsifier) 69.95mg

Uses

For the active immunisation of pigs (gilts and sows) 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 2ml per animal by deep intramuscular injection in the neck.

Vaccination Schedule

Primary Vacccination:

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.

Adverse Reactions:

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 60% of pigs as maximum.

Local tissue reactions in the form of visible swellings (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.

Special Warnings

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 the reach and sight of children.

Store and transport refrigerated (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 within 2 hours.

Legal category

POM-V

Packaging Quantities

Carton box with two vials of 50ml.

Further information

Disposal:

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

Marketing authorisation number

Vm 01596/4322.

Significant Changes

Suvaxyn Ery

Fort Dodge Animal Health

Presentation

10/07/2007