Ingelvac Circoflex
European Medicines Agency Veterinary Medicines
EMEA/V/C/126
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) INGELVAC CIRCOFLEX EPAR summary for the public
This document is a summary of the European Public Assessment Report. 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 document 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 Ingelvac CircoFLEX?
Ingelvac CircoFLEX is a vaccine for use in pigs, which is available as a suspension for injection. It contains a protein (antigen) from the porcine circovirus type 2 virus (PCV2). The vaccine does not contain any live PCV2 and the antigen cannot replicate in the animal.
What is Ingelvac CircoFLEX used for?
Ingelvac CircoFLEX is used to vaccinate pigs from two weeks of age against PCV2 infection. This helps to reduce deaths, signs of disease such as weight loss, and damage to lymphoid tissue associated with this infection. It can also reduce shedding of the virus from the nose, the level of the virus in the blood and lymphoid tissue, and the duration of blood infection (viraemia) with the virus.
The vaccine is given by injection into a muscle. Onset of protection against PCV2 occurs from as early as two weeks after the injection and lasts for at least 17 weeks.
How does Ingelvac CircoFLEX work?
Porcine circovirus type 2 (PCV2) is known to cause a wide variety of clinical signs and syndromes in pigs, some of which may be caused by PCV2 in combination with other agents. PCV2 associated infections may include symptoms such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
Ingelvac CircoFLEX is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Ingelvac CircoFLEX 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. In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus. This active immune response will help to protect the pig against the disease caused by this virus.
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How has Ingelvac CircoFLEX been studied?
Ingelvac CircoFLEX has been studied in a number of trials involving pigs of various breeds. These studies have been performed under laboratory as well as under typical European farming conditions. The main measure of effectiveness was the rate of weight gain in the vaccinated pigs, but the studies also looked at other parameters including symptoms, the level of PCV2 in the blood and the number of runts.
What benefit has Ingelvac CircoFLEX shown during the studies?
The trials showed that vaccination of pigs with Ingelvac CircoFLEX reduced weight loss in the piglets. It also reduced the levels of PCV2 in the blood, symptoms of PCV2 infection, the number of runts and death rates.
What is the risk associated with Ingelvac CircoFLEX?
Ingelvac CircoFLEX can cause a mild, temporary increase in body temperature, usually on the day of vaccination.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
There are no special precautions for the person who gives Ingelvac CircoFLEX or comes into contact with the animal.
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 Ingelvac CircoFLEX been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ingelvac CircoFLEX exceed the risks for the active immunisation of pigs, over the age of two weeks, against PCV2, and recommended that Ingelvac CircoFLEX be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.
Other information about Ingelvac CircoFLEX:
The European Commission granted a marketing authorisation valid throughout the European Union for Ingelvac CircoFLEX to Boehringer Ingelheim Vetmedica GmbH on 13 February 2008. Information on the prescription status of this product may be found on the outer package.
This summary was last updated on 13 February 2008.
©EMEA 2008 2/2