Suvaxyn Parvo/E

Introduction

Company name: Zoetis UK Limited

Address: 5th Floor

6 St Andrew Street

London EC4A 3AE

Telephone: 0845 300 8034

Fax: 01737 332521

Email: UKVetLine@zoetis.com

Website: www.zoetis.co.uk

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.

Adjuvants: Marcol 52 - 730.14 mg, Montanide 888 - 74.32 mg, Simulsol 5100 - 69.95 mg

*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 of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Do not mix with any other vaccine/immunological 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 mild diffuse visible swelling (granulomas) at the injection sites may occur in 92% of the vaccinated animals for at least 14 days in 25% of the pigs reacting. The area of reaction can vary from 5 cm to 10 cm in diameter.

An overdose of the product can result in transient hyperthermia of 1-2°C above normal for 24 hours after vaccination in 80% of pigs. Local tissue reactions in the form of visible swelling (granulomas) in the majority of vaccinated pigs for at least 28 days. The area of reaction can be diffuse from 5 to 10 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 label and carton. Once broached, use immediately.

DISPOSAL

Any unused product or waste material should be disposed of in accordance with national 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 00057/4382.

GTIN (Global Trade Item No)

10 dose:

08714015013604

2 x 25 dose:

08714015013611