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

Emulsion and suspension for emulsion for injection containing inactivated porcine circovirus type 2 (PCV2) (≥2.1 log10 ELISA Units per reconstituted 2ml dose).

Uses

Passive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2-linked mortality. Duration of immunity: up to 5 weeks after transfer of passive antibodies through colostrum intake. Can be used during pregnancy.

Dosage and administration

Reconstitute immediately after removal from the refrigerator (or other cold storage).

To use the vaccine, shake vigorously the vial of antigen suspension and inject its content into the vial of emulsion containing adjuvant. Gently mix before use. The reconstituted vaccine is a homogeneous white emulsion. Use within 3 hours after mixing.

Administer one 2 ml dose by deep intramuscular injection in accordance with the following vaccination schedule:

Basic vaccination:

· Gilts: One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before mating.

One further injection must be given, at least 2 weeks before farrowing.

· Sows: One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before farrowing.

Revaccination:

· One injection at each gestation, at least 2 to 4 weeks before farrowing.

Contra-indications, warnings, etc

Keep out of the reach and sight of children.

Vaccinate only healthy animals.

Apply usual procedures for the handling of animals.

Apply usual aseptic procedures.

For animal treatment only.

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 concurrently within 14 days before or after vaccination with the product.

Slight and transient local reactions normally occur after the administration of one dose of vaccine, mainly swelling (up to 2 cm2 on average) and redness (up to 3 cm2 on average), and in some cases oedema (up to 17 cm2 on average). These reactions resolve spontaneously within 4 days on average without any consequence on the health or performance of vaccinated pigs.

In clinical studies, the post-mortem examination of the injection sites performed at most 50 days after the vaccination revealed limited lesions such as a discoloration and a granuloma in the majority of animals, as well as necrosis or fibrosis in approximately half of the animals.

Within the 2 days following the injection, an average increase in rectal temperature of up to 1.4OC can occur. Rarely, increases in rectal temperature of higher than 2.5OC, lasting less than 24 hours, have been observed.

In rare cases, slight apathy or reduction in appetite may be observed, which should resolve spontaneously.

Vaccination may exceptionally cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be provided.

Exceptionally abortion may occur after vaccination.

No other adverse reactions except those mentioned above were observed after the administration of a double dose of vaccine.

Operator safety

To the user:

This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a join 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 leaflet 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 Periods

Zero days.

Pharmaceutical precautions

Do not mix with any other medicinal product. Store and transport refrigerated (2OC - 8OC). Do not freeze.

Store in the original package in order to protect from light. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

25 doses: 1 vial of suspension (25 dose size) + 1 vial of emulsion (25 dose size).

Further information

The reconstituted vaccine contains an inactivated porcine circovirus type 2 (PCV2) in an oily adjuvant (o/w). It is intended to stimulate active immunity in gilts and sows to provide passive immunity in piglets, through colostrum intake.

Marketing authorisation number

EU/2/07/075/001-4.

Significant Changes