Introduction

vet00301

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

Each dose of 1 ml of inactivated vaccine contains : Porcine circovirus type 2 ORF2 protein: minimum RP* 1.0, maximum RP* 3.75 (*Relative Potency - ELISA test - by comparison with a reference vaccine, Adjuvant : carbomer.

Uses

For active immunisation of pigs over the age of 2 weeks against Porcine Circovirus Type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related diseases (PCVD). In addition, vaccination has been shown to reduced PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.

Onset of immunity : as early as 2 weeks post vaccination

Duration of immunity : at least 17 weeks.

Dosage and administration

Single intramuscular (IM) injection of one dose (1 ml) to pigs, irrespective of bodyweight. Shake well before use. Use vaccination devices according to the manufacturer's instructions. Avoid multiple vial broaching.

Contra-indications, warnings, etc

Withdrawal period : Zero days

A mild and transient hyperthermia very commonly occurs on the day of vaccination. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. Only healthy animals should be vaccinated. Do not use during pregnancy and lactation.

No safety or efficacy information is available on the compatibility of this vaccine with any other vaccine. It is therefore recommended that no other vaccines should be administered on the same day or at different times. Do not mix with any other vaccine or immunological product.

Disposal Advice : Waste materials should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Keep out of the reach and sight of children. Store and transport refrigerated (2°C -8°C). Do not freeze. Protect from light. Do not use after the expiry date (EXP) which is stated on the carton and the bottle. Use immediately after opening. Avoid introduction of contamination during use.

Legal category

POM-V

Packaging Quantities

High density polyethylene bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses) with a chlorobutyl stopper and lacquered aluminium seal. Each bottled is packed individually in a cardboard box. Not all pack sizes may be marketed.

Further information

This vaccine is designed to stimulate the development of an active immune response to Porcine Circovirus type 2. Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu

Marketing authorisation number

EU/2/07/079/001 : 10 ml.

EU/2/07/079/002 : 50 ml.

EU/2/07/079/003 : 100 ml.

EU/2/07/079/004 : 250 ml.