Suvaxyn Circo+MH RTU
Authorised
This medicine is authorised for use in the European Union
porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo+MH RTU.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+MH RTU.
For practical information about using Suvaxyn Circo+MH RTU, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Suvaxyn Circo+MH RTU is a veterinary vaccine used to protect pigs over the age of 3 weeks against infections with porcine circovirus and the bacteria Mycoplasma hyopneumoniae.
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).
Mycoplasma hyopneumoniae infectionin pigs causes a disease of the airways called enzootic pneumonia. Affected pigs often have a cough and fail to thrive.
Suvaxyn Circo+MH RTU contains inactivated (killed) active substances derived from porcine circovirus type 2 and Mycoplasma hyopneumoniae bacteria.
Suvaxyn Circo+MH RTU, 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+MH RTU is only available on prescription.
For further information, see the package leaflet.
Suvaxyn Circo+MH RTU 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 and whole Mycoplasma hyopneumoniae bacteria that have been killed (inactivated) so that they do not cause disease. When Suvaxyn Circo+MH RTU is given to pigs the animals’ immune system recognises the viral protein and bacteria as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to the virus or the bacteria the immune system will be able to respond more quickly. This will help protect the pigs against porcine circovirus and Mycoplasma hyopneumoniae infections.
Suvaxyn Circo+MH RTU also contains adjuvants (ingredients that strengthen the immune response) called squalene, poloxamer 401 and polysorbate 80.
The effectiveness of the vaccine was first studied in a number of 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 and Mycoplasma hyopneumonia lasted. The studies showed that the vaccine had its full effect against PCV2 and Mycoplasma hyopneumonia by three weeks after vaccination. Protection lasted 23 weeks after vaccination for PCV2 and Mycoplasma hyopneumonia.
The effectiveness of Suvaxyn Circo+MH RTU against PCV2 infection was also studied in three field studies. The field studies showed that Suvaxyn Circo+MH RTU reduced the PCV2 viraemia (presence of virus in the blood) compared to pigs given dummy vaccination.
The most common side effect with Suvaxyn Circo+MH RTU (which may affect more than 1 in 10 pigs) are an increase in body temperature (on average 1 °C) in the first 24 hours after vaccination which resolves within 48 hours without treatment. Swelling, less than 2 cm in diameter, heat, redness at the injection site and pain to the touch which may last up to 2 days were also seen.
For the full list of all side effects reported with Suvaxyn Circo+MH RTU, see the package leaflet.
None.
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+MH RTU for 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+MH RTU’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+MH RTU on 6 November 2015.
For more information about treatment with Suvaxyn Circo+MH RTU, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Product information
Latest procedure affecting product information:
IB-0018
14/10/2021
Product details
- Name of medicine
- Suvaxyn Circo+MH RTU
- Active substance
- Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
- Inactivated Mycoplasma hyopneumoniae, strain P-5722-3
- International non-proprietary name (INN) or common name
- porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
- Species
- Pigs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI09AL
Pharmacotherapeutic group
Inactivated viral and inactivated bacterial vaccinesTherapeutic 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.
For active immunisation of pigs over the age of 3 weeks against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae.
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