Ingelvac CircoFLEX
Authorised
This medicine is authorised for use in the European Union
inactivated porcine circovirus vaccine
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Ingelvac CircoFLEX.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 Ingelvac CircoFLEX.
For practical information about using Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Ingelvac CircoFLEX is a vaccine used to protect pigs from the two weeks of age against porcine circovirus type 2 (PCV2). 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). Ingelvac CircoFLEX contains the active substance porcine circovirus type 2 ORF2 protein.
Ingelvac CircoFLEX is available as a suspension for injection and can only be obtained with a prescription. It is given by injection into the muscle as a single dose. The vaccine starts to be effective 2 weeks after vaccination and protection lasts for 17 weeks.
For further information, see the package leaflet.
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.
Ingelvac CircoFLEX has been studied in a number of trials involving pigs of various breeds. These studies were performed under laboratory as well as under typical European farming conditions. 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, clinical signs of PCV2 infection, the number of runts and death rates.
The most common side effect with Ingelvac CircoFLEX (which may affect more than 1 in 10 animals) is a mild and short lived increase in body temperature on the day of vaccination.
For the full list of restrictions and all side effects reported with Ingelvac CircoFLEX, see the package leaflet.
No special precautions are required.
The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
The withdrawal period for meat from pigs treated with Ingelvac CircoFLEX is ‘zero days’, which means there is no mandatory waiting time.
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Ingelvac CircoFLEX’s benefits are greater than its risks and recommended that it be approved for use in the EU.
The European Commission granted a marketing authorisation valid throughout the EU for Ingelvac CircoFLEX on 13 February 2008.
For more information about treatment with Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Product information
Latest procedure affecting product information:
WS/1921
15/07/2021
Product details
- Name of medicine
- Ingelvac CircoFLEX
- Active substance
- porcine circovirus type 2 ORF2 protein
- International non-proprietary name (INN) or common name
- inactivated porcine circovirus vaccine
- Species
- Pigs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI09AA07
Pharmacotherapeutic group
Immunologicals for suidaeTherapeutic indication
For active immunisation of pigs over the age of two weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2-related disease (PCVD).
In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.
Onset of protection occurs as early as two weeks post vaccination and lasts for at least 17 weeks.
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