Circovac

inactivated porcine circovirus type 2 (PCV2)

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This is a summary of the European public assessment report (EPAR) for Circovac. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Circovac.

For practical information about using Circovac, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Circovac and what is it used for?

Circovac is a vaccine used to protect pigs against porcine circovirus type 2 (PCV2). Circovac is used to reduce the changes in and damage to lymphoid tissues (cells and tissues that make up the lymphatic system, such as lymph nodes) associated with PCV2 infection in piglets and to help reduce the risk of dying from this infection. PCV2 infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin). Circovac contains an inactivated (killed) porcine circovirus type 2 (PCV2) strain.

How is Circovac used?

Circovac is available as an emulsion for injection and can only be obtained with a prescription. The vaccine is given to female pigs before and/or during pregnancy. Their piglets then obtain temporary protection against PCV2 when they drink the colostrum (first milk) from their vaccinated mothers. This is called ‘passive immunisation’. In this case, the effect of the vaccine lasts for up to 5 weeks.

Circovac can also be given directly to piglets from three weeks of age (active immunisation). In this case, the effect of the vaccine lasts for at least 14 weeks. Circovac is given by injection into a muscle. For the initial vaccination the number of injections needed and the dose varies according to the type of female pig being treated: gilts (female pigs that have not yet had piglets) should receive one 2 ml injection three times; sows (female pigs that have had piglets before) should receive one 2 ml injection twice. The timing of the injection is adjusted according to the dates of mating and farrowing (giving birth). In all cases the last dose is given at least two weeks before the expected date of farrowing. Sows should be revaccinated at each pregnancy with one injection two to four weeks before farrowing. Piglets should be vaccinated with one 0.5 ml injection once.

How does Circovac work?

Porcine circovirus type 2 (PCV2) is known to infect, and cause a wide variety of clinical signs and syndromes in pigs. The infection of piglets occurs mostly during the first 6 weeks of life, when the immune system of piglets is still maturing. Symptoms include weight loss (or failure to grow), enlarged lymph nodes, difficulties in breathing, and, less commonly, diarrhoea, pale skin and jaundice (yellowing of the skin).

Circovac is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Circovac contains PCV2 strain that has been inactivated so it cannot cause the disease. When it is given directly to pigs, the immune system of the animal recognises the virus as ‘foreign’ and makes antibodies against it. In the future, if the animals are exposed to PCV2, the immune system will be able to produce antibodies more quickly. This will help protect them against the disease. When given to the mother, her antibodies are transferred to the piglets through the colostrum and provide temporary protection.

Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with an emulsion. The resulting emulsion is then injected. The emulsion contains an ‘adjuvant’ (a compound containing oil) to enhance the immune response.

What benefits of Circovac have been shown in studies?

Laboratory and field studies have been conducted with Circovac in pregnant pigs and piglets of various breeds. The studies showed that vaccination of the mothers with Circovac can reduce the incidence of damage associated with PCV2 infection in the lymphoid tissues of their piglets. Although the outcome of some of the studies was partially compromised by the complex nature of PCV2 infections, the large number of pigs involved (from 63 farms) and the variety of experimental and clinical conditions showed a reduction in the overall death rates of piglets related to PCV2 infections of between 3.6% and 10%.

What are the risks associated with Circovac?

Circovac can cause a temporary redness or swelling at or around the injection site, which can last for up to four days after the injection. Following injection, pigs may have an increased rectal temperature of about 1.4 °C for up to two days, and in some pigs of up to 2.5 °C, but this should not last more than 24 hours after the injection. Other rarer side effects in the injected pigs are reduced activity and food intake, but these are also temporary. For a full list of all side effects reported with Circovac, see the package leaflet.

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

Circovac contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – this could result in the loss of the finger if prompt medical attention is not given. If someone is accidentally injected with this product, they must seek medical advice immediately even if only a very small amount is injected. The package leaflet should be shown to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.

The withdrawal period for meat from pigs treated with Circovac is zero days, which means that there is no mandatory waiting time.

Why is Circovac approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Circovac’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Circovac

The European Commission granted a marketing authorisation valid throughout the EU for Circovac on 21 June 2007.

For more information about treatment with Circovac animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Circovac : EPAR - Summary for the public BG = bălgarski 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public ES = español 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public CS = čeština 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public DA = dansk 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public DE = Deutsch 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public ET = eesti keel 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public EL = elliniká 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public EN = English 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public FR = français 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public IT = italiano 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public LV = latviešu valoda 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public LT = lietuvių kalba 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public HU = magyar 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public MT = Malti 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public NL = Nederlands 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public PL = polski 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public PT = português 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public RO = română 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public SK = slovenčina 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public SL = slovenščina 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public FI = suomi 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public SV = svenska 2007-07-31 2017-09-19
Circovac : EPAR - Summary for the public HR = Hrvatski 2007-07-31 2017-09-19

This EPAR was last updated on 19/09/2017 .

Authorisation details

Product details

Product details for Circovac
NameCircovac
Agency product numberEMEA/V/C/000114
Active substance

inactivated porcine circovirus type 2 (PCV2)

International non-proprietary name (INN) or common name

adjuvanted inactivated vaccine against porcine circovirus type 2

Species Pigs (gilts and sows)
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AA07







Publication details

Publication details for Circovac
Marketing-authorisation holder

CEVA-Phylaxia Oltóanyagtermelõ Zrt.

Revision9
Date of issue of marketing authorisation valid throughout the European Union21/06/2007

Contact address:

CEVA-Phylaxia Oltóanyagtermelõ Zrt.
Szállás u. 5.
1107 Budapest
Hungary

Product information

Product information

13/06/2017  Circovac -EMEA/V/C/000114 -T/0014

Name Language First published Last updated
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19
Circovac : EPAR - Product Information HR = Hrvatski 2008-11-20 2017-09-19

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
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09
Circovac : EPAR - All Authorised presentations HR = Hrvatski 2007-07-31 2013-09-09

Pharmacotherapeutic group

Immunologicals for suidae

Therapeutic indication

Sows and gilts

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.

Piglets

Active immunisation of piglets to reduce faecal excretion of PCV2 and virus load in blood, and as an aid to reduce PCV2-linked clinical signs, including wasting, weight loss and mortality, as well as to reduce virus load and lesions in lymphoid tissues associated with PCV2 infection.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Circovac : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-10-05 2017-09-19
CVMP post-authorisation summary of positive opinion for Circovac HR = Hrvatski 2010-10-15  

Initial marketing-authorisation documents

Name Language First published Last updated
Circovac : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2007-07-31  
Circovac : EPAR - Scientific Discussion HR = Hrvatski 2007-07-31