Porcilis Pesti (Classical Swine Fever Virus (CSFV) -E2...) - QI09AD04

Updated on site: 21-Sep-2017

Medication name: Porcilis Pesti
Substance: Classical Swine Fever Virus (CSFV) -E2 subunit antigen
Manufacturer: Intervet International BV

What benefit has Porcilis Pesti shown during the studies?

All the vaccinations prevented death when the piglets were exposed to CSF virus at a later date. Viraemia was only prevented by two injections (as recommended in the vaccination schedule for Porcilis Pesti). Antibodies to the CSF antigen showed that the piglets developed immunity after 2 weeks, which was maintained for 6 months.

What is the risk associated with Porcilis Pesti?

Porcilis Pesti can cause a swelling at the injection site for up to 4 weeks after each injection of the vaccine. Temporary hyperthermia (increased temperature) may occur after the second injection. Abscesses may be seen at the injection site. It is recommended that the second vaccination is given at a different site than the first vaccination.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Porcilis Pesti contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger. If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected. The package leaflet should be taken to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

Why has Porcilis Pesti been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Pesti are greater than any risks to immunise pigs from the age of 5 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever. They recommended that Porcilis Pesti should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Porcilis Pesti:

The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Pesti to Intervet International B.V. on 9 February 2000, which was renewed in February 2005.

The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended). Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.

This summary was last updated in December 2006.

EMEA 2007