Suvaxyn Circo+MH RTU

Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein/Inactivated Mycoplasma hyopneumoniae, strain P-5722-3.

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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.

What is Suvaxyn Circo+MH RTU and what is it used for?

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.

How is Suvaxyn Circo+MH RTU used?

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.

How does Suvaxyn Circo+MH RTU work?

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.

 

What benefits of Suvaxyn Circo+MH RTU have been shown in studies?

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.

What are the risks associated with Suvaxyn Circo+MH RTU?

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.

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

None.

What is the withdrawal period in food-producing animals?

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.

Why is Suvaxyn Circo+MH RTU approved?

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.

Other information about Suvaxyn Circo+MH RTU

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.

Name Language First published Last updated
Suvaxyn Circo+MH RTU : EPAR - Summary for the public BG = bălgarski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public ES = español 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public CS = čeština 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public DA = dansk 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public DE = Deutsch 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public ET = eesti keel 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public EL = elliniká 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public EN = English 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public FR = français 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public IT = italiano 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public LV = latviešu valoda 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public LT = lietuvių kalba 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public HU = magyar 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public MT = Malti 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public NL = Nederlands 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public PL = polski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public PT = português 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public RO = română 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public SK = slovenčina 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public SL = slovenščina 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public FI = suomi 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public SV = svenska 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Summary for the public HR = Hrvatski 2015-12-22 2017-06-15

This EPAR was last updated on 15/06/2017 .

Authorisation details

Product details

Product details for Suvaxyn Circo+MH RTU
NameSuvaxyn Circo+MH RTU
Agency product numberEMEA/V/C/003924
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) codes QI09AL


Publication details

Publication details for Suvaxyn Circo+MH RTU
Marketing-authorisation holder

Zoetis Belgium SA

Revision3
Date of issue of marketing authorisation valid throughout the European Union06/11/2015

Contact address:

Zoetis Belgium SA
Rue Laid Burniat, 1
1348 Louvain-la-Neuve
Belgium

Product information

Product information

17/05/2017  Suvaxyn Circo+MH RTU -EMEA/V/C/003924 -II-0004-G

Name Language First published Last updated
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - Product Information HR = Hrvatski 2015-12-22 2017-06-15

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
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15
Suvaxyn Circo+MH RTU : EPAR - All Authorised presentations HR = Hrvatski 2015-12-22 2017-06-15

Pharmacotherapeutic group

Immunologicals for Suidae, inactivated viral and inactivated bacterial vaccines for pigs.

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.

For active immunisation of pigs over the age of 3 weeks against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Suvaxyn Circo+MH RTU : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-07-20 2017-06-15

Initial marketing-authorisation documents

Name Language First published Last updated
Suvaxyn Circo+MH RTU : EPAR - Public assessment report HR = Hrvatski 2015-12-22  
CVMP summary of positive opinion for Suvaxyn Circo + MH RTU HR = Hrvatski 2015-09-11