Porcilis PCV

porcine circovirus type 2 ORF2 subunit antigen

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use. 

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Porcilis PCV?

Porcilis PCV is a vaccine for use in pigs, which is available as an emulsion for injection. It contains a protein (antigen) from the porcine circovirus type-2 virus (PCV2). The vaccine does not contain any live PCV2.

What is Porcilis PCV used for?

Porcilis PCV is used to vaccinate pigs from three days of age against PCV2 infection. This helps to reduce the amount of virus in the animal’s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.

The vaccine is given by injection into a muscle in the neck, in the area behind the ear. Onset of protection against PCV2 occurs from as early as two weeks after the injection and lasts for 22 weeks.

How does Porcilis PCV work?

PCV2 is known to cause a wide variety of syndromes in pigs, together known as PCV2-related diseases (PCVD). It is generally accepted that infection with PCV2 is essential but not sufficient to cause disease. PCV2-associated infections may include clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).

Porcilis PCV is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Porcilis PCV contains small amounts of a protein from PCV2. When a pig is given the vaccine, the pig’s immune system recognises the protein as ‘foreign’ and reacts by building up an active immune response. Through this the immune system will be able to react more quickly when it is exposed to the virus. This active immune response helps to protect the pig against the disease caused by this virus.

How has Porcilis PCV been studied?

Porcilis PCV has been studied in pigs in a number of trials. These studies have been performed under laboratory conditions as well as under typical farming conditions representative of different pig production systems. Measures of effectiveness that were monitored included weight gain and mortality as well as faecal and nasal shedding. The immune response to vaccination was monitored by determining antibody titres in the vaccinated animals.

What benefit has Porcilis PCV shown during the studies?

The trials showed that vaccination of pigs with Porcilis PCV helps to reduce the amount of virus in the animal’s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.

What is the risk associated with Porcilis PCV?

In pigs, transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm). These reactions resolve spontaneously over a period of approximately 14 to 21 days without any major consequence on the general health status of the animals. Immediate systemic hypersensitivity-like reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and / or excitation, which normally resolve within minutes without requiring treatment. A transient increase in body temperature, normally not exceeding 1°C, may occur until two days after vaccination. Occasionally, an increase of rectal temperature up to 2.5°C lasting less than 24 hours may occur. Some piglets may be depressed and show reduced feed intake for up to five days. Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.

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

Porcilis PCV 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 leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

What is the time allowed before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

The withdrawal period is zero days.

Why has Porcilis PCV been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV exceed the risks for the active immunisation of pigs, over the age of three days, against PCV2, and recommended that Porcilis PCV be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Porcilis PCV

The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis PCV to Intervet International BV on 12 January 2009. Information on the prescription status of this product may be found on the outer package.

Name Language First published Last updated
Porcilis PCV : EPAR - Summary for the public BG = bălgarski 2009-01-14  
Porcilis PCV : EPAR - Summary for the public ES = español 2009-01-14  
Porcilis PCV : EPAR - Summary for the public CS = čeština 2009-01-14  
Porcilis PCV : EPAR - Summary for the public DA = dansk 2009-01-14  
Porcilis PCV : EPAR - Summary for the public DE = Deutsch 2009-01-14  
Porcilis PCV : EPAR - Summary for the public ET = eesti keel 2009-01-14  
Porcilis PCV : EPAR - Summary for the public EL = elliniká 2009-01-14  
Porcilis PCV : EPAR - Summary for the public EN = English 2009-01-14  
Porcilis PCV : EPAR - Summary for the public FR = français 2009-01-14  
Porcilis PCV : EPAR - Summary for the public IT = italiano 2009-01-14  
Porcilis PCV : EPAR - Summary for the public LV = latviešu valoda 2009-01-14  
Porcilis PCV : EPAR - Summary for the public LT = lietuvių kalba 2009-01-14  
Porcilis PCV : EPAR - Summary for the public HU = magyar 2009-01-14  
Porcilis PCV : EPAR - Summary for the public MT = Malti 2009-01-14  
Porcilis PCV : EPAR - Summary for the public NL = Nederlands 2009-01-14  
Porcilis PCV : EPAR - Summary for the public PL = polski 2009-01-14  
Porcilis PCV : EPAR - Summary for the public PT = português 2009-01-14  
Porcilis PCV : EPAR - Summary for the public RO = română 2009-01-14  
Porcilis PCV : EPAR - Summary for the public SK = slovenčina 2009-01-14  
Porcilis PCV : EPAR - Summary for the public SL = slovenščina 2009-01-14  
Porcilis PCV : EPAR - Summary for the public FI = suomi 2009-01-14  
Porcilis PCV : EPAR - Summary for the public SV = svenska 2009-01-14  

This EPAR was last updated on 22/03/2017 .

Authorisation details

Product details

Product details for Porcilis PCV
NamePorcilis PCV
Agency product numberEMEA/V/C/000135
Active substance

porcine circovirus type 2 ORF2 subunit antigen

International non-proprietary name (INN) or common name

adjuvanted inactivated vaccine against porcine circovirus

Species Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AA07






Publication details

Publication details for Porcilis PCV
Marketing-authorisation holder

Intervet International BV

Revision6
Date of issue of marketing authorisation valid throughout the European Union12/01/2009

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

18/02/2017  Porcilis PCV -EMEA/V/C/000135 -IB/0010

Name Language First published Last updated
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22
Porcilis PCV : EPAR - Product Information SV = svenska 2010-01-20 2017-03-22

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27
Porcilis PCV : EPAR - All Authorised presentations SV = svenska 2009-01-12 2014-01-27

Pharmacotherapeutic group

Immunologicals for suidae

Therapeutic indication

For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce weight loss associated with porcine-circovirus-type-2 infection occurring during the fattening period.

Onset of immunity: 2 weeks

Duration of immunity: 22 weeks

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Porcilis PCV : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2010-01-20 2017-03-22
CVMP post-authorisation summary of positive opinion for Porcilis PCV SV = svenska 2009-12-11  

Initial marketing-authorisation documents

Name Language First published Last updated
Porcilis PCV : EPAR - Procedural steps taken before authorisation SV = svenska 2009-01-26  
Porcilis PCV : EPAR - Scientific Discussion SV = svenska 2009-01-26  
Committee for medicinal products for veterinary use summary of opinion: Porcilis PCV SV = svenska 2008-11-14