Suvaxyn Circo
Authorised
This medicine is authorised for use in the European Union
porcine circovirus vaccine (inactivated, recombinant)
MedicineVeterinaryAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo.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 Suvaxyn Circo.
For practical information about using Suvaxyn Circo, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Suvaxyn Circo is a veterinary vaccine used to protect pigs over the age of 3 weeks against porcine circovirus type 2 (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).
Suvaxyn Circo contains an inactivated (killed) active substance derived from porcine circovirus type 2.
Suvaxyn Circo, which is available as a liquid for injection, is given to pigs from three weeks of age as a single injection into the muscle in the neck behind the ear. Protection starts three weeks after vaccination and lasts for 23 weeks after vaccination. Suvaxyn Circo is only available on prescription.
For further information, see the package leaflet.
Suvaxyn Circo is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The vaccine contains small amounts of a protein from PCV2 that have been killed (inactivated) so that they do not cause disease. When Suvaxyn Circo is given to pigs the animals’ immune system recognises the viral protein as ‘foreign’ and makes antibodies against it. In the future, if the animals come into contact with the virus the immune system will be able to respond quickly to destroy the virus. This will help protect the pigs against porcine circovirus infections.
Suvaxyn Circo also contains adjuvants (ingredients that strengthen the immune response) called squalane, poloxamer 401 and polysorbate 80.
The studies on the effectiveness of Suvaxyn Circo were carried out with a similar vaccine, Suvaxyn Circo+MH RTU, which contains PCV2 and the bacteria Mycoplasma hyopneumoniae. Suvaxyn Circo+MH RTU is already approved in the EU.
The effectiveness of Suvaxyn Circo+MH RTU was first studied in several laboratory studies in pigs. The purpose of these studies was to establish how long it took pigs to be fully protected and how long the protection against PCV2 lasted. The studies showed that the vaccine had its full effect against PCV2 by three weeks after vaccination. Protection lasted 23 weeks after vaccination for PCV2.
The effectiveness of Suvaxyn Circo+MH RTU against PCV2 infection was also studied in three field studies. The field studies showed that Suvaxyn Circo reduced the PCV2 viraemia (presence of virus in the blood) compared to pigs given dummy vaccination.
The most common side effects with Suvaxyn Circo (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature during the first 24 hours after vaccination and swelling (generally no wider than 2 cm) at the injection site which may last for up to 2 days.
For the full list of restrictions and side effects with Suvaxyn Circo, 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 Suvaxyn Circo is ‘zero’ days, which means there is no mandatory waiting time.
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Suvaxyn Circo’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 Suvaxyn Circo on 7 February 2018.
The full EPAR for Suvaxyn Circo can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with Suvaxyn Circo, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Product information
Latest procedure affecting product information: WS/1852/G
25/10/2018
Product details
- Name of medicine
- Suvaxyn Circo
- Active substance
- porcine circovirus vaccine (inactivated, recombinant)
- International non-proprietary name (INN) or common name
- porcine circovirus vaccine (inactivated, recombinant)
- Species
- Pigs (for fattening)
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI09AA07
Pharmacotherapeutic group
- Immunologicals for suidae
- Inactivated viral vaccines
Therapeutic indication
For active immunisation of pigs from 3 weeks of age against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
News on Suvaxyn Circo
This page was last updated on