Porcilis PCV M Hyo

porcine circovirus type 2 ORF2 subunit antigen, Mycoplasma hyopneumoniae strain ATCC 25934 (inactivated)

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This 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 summary 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 Porcilis PCV M Hyo?

Porcilis PCV M Hyo is a veterinary vaccine that contains porcine circovirus type 2 (PCV2) subunit antigen and an inactivated (killed) strain of Mycoplasma hyopneumoniae bacteria. Porcilis PCV M Hyo is available as an emulsion for injection.

What is Porcilis PCV M Hyo used for?

Porcilis PCV M Hyo is used to protect pigs against two separate infections, porcine circovirus and Mycoplasma hyopneumoniae.

  • Porcine circovirus type 2 (PCV2) infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin);
  • Infection with the bacterium Mycoplasma hyopneumoniae in pigs causes a disease of the airways called enzootic pneumonia. Affected pigs often have a cough and fail to thrive.

The vaccine is given to pigs from three weeks of age as a single injection into the neck muscle. Protection against PCV2 starts at two weeks after vaccination and for Mycoplasma hyopneumoniae it starts four weeks after vaccination. Protection lasts for 22 weeks after vaccination for PCV2 and for 21 weeks after vaccination for Mycoplasma hyopneumoniae.

How does Porcilis PCV M Hyo work?

Porcilis PCV M Hyo 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 Porcilis PCV M Hyo is given to pigs the animals’ immune system recognises the virus 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.

Porcilis PCV M Hyo contains the adjuvants light mineral oil and aluminium hydroxide to enhance the immune response.

How has Porcilis PCV M Hyo been studied?

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 for pigs to be fully protected and the length of time protection lasts against PCV2 and Mycoplasma hyopneumoniae.

The effectiveness of Porcilis PCV M Hyo was investigated in 10 field studies involving pig farms where signs of PCV2 and/or Mycoplasma hyponeumoniae infections had been detected. In each study around 300 suckling piglets were vaccinated with Porcilis PCV M Hyo and a second group of around 300 suckling piglets received a dummy injection. The main measures of effectiveness were average daily weight gain during the finishing period, the level of PCV2 in the blood and a score for the severity of damage (lesions) to the lung.

What benefit has Porcilis PCV M Hyo shown during the studies?

The laboratory studies showed that the vaccine had its full effect against PCV2 by two weeks and against Mycoplasma hyopneumoniae by four weeks. Protection lasted 22 weeks after vaccination for PCV2 and 21 weeks after vaccination for Mycoplasma hyopneumoniae.

The field studies showed that vaccination with Porcilis PCV M Hyo reduced PCV2 levels in the blood and the severity of lung lesions caused by Mycoplasma hyopneumoniae and the loss of daily weight gain during the finishing period (the fattening period prior to slaughter).

What is the risk associated with Porcilis PCV M Hyo?

The most common side effect (seen in more than 1 in 10 pigs) with Porcilis PCV M Hyo is a short lived increase in body temperature of up to 2 °C on the day of vaccination.

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

Porcilis PCV M Hyo is an emulsion containing mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – this could result in the loss of the finger if prompt medical attention is not given. If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected. The package leaflet should be shown to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption. The withdrawal period for Porcilis PCV M Hyo is zero days.

Why has Porcilis PCV M Hyo been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV M Hyo exceed the risks for the approved indication and recommended that Porcilis PCV M Hyo be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Porcilis PCV M Hyo:

The European Commission granted a marketing authorisation valid throughout the European Union, for Porcilis PCV M Hyo on 7 November 2014. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Porcilis PCV M Hyo : EPAR - Summary for the public BG = bălgarski 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public ES = español 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public CS = čeština 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public DA = dansk 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public DE = Deutsch 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public ET = eesti keel 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public EL = elliniká 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public EN = English 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public FR = français 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public IT = italiano 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public LV = latviešu valoda 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public LT = lietuvių kalba 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public HU = magyar 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public MT = Malti 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public NL = Nederlands 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public PL = polski 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public PT = português 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public RO = română 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public SK = slovenčina 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public SL = slovenščina 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public FI = suomi 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public SV = svenska 2014-11-14  
Porcilis PCV M Hyo : EPAR - Summary for the public HR = Hrvatski 2014-11-14  

This EPAR was last updated on 16/10/2017 .

Authorisation details

Product details

Product details for Porcilis PCV M Hyo
NamePorcilis PCV M Hyo
Agency product numberEMEA/V/C/003796
Active substance

porcine circovirus type 2 ORF2 subunit antigen, Mycoplasma hyopneumoniae strain ATCC 25934 (inactivated)

International non-proprietary name (INN) or common name

porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)

Species Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AL


Publication details

Publication details for Porcilis PCV M Hyo
Marketing-authorisation holder

Intervet International B.V.

Revision3
Date of issue of marketing authorisation valid throughout the European Union07/11/2014

Contact address:

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

05/10/2017  Porcilis PCV M Hyo -EMEA/V/C/003796 -II-0006-G

Name Language First published Last updated
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2017-10-16

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
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  
Porcilis PCV M Hyo : EPAR - All Authorised presentations HR = Hrvatski 2014-11-14  

Pharmacotherapeutic group

Inactivated viral and inactivated bacterial vaccines for pigs

Therapeutic indication

For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, and severity of lung lesions caused by Mycoplasma hyopneumoniae infection. To reduce the loss of daily weight gain during the finishing period in face of infections with Mycoplasma hyopneumoniae and/or PCV2 (as observed in field studies).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Porcilis PCV M Hyo : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2015-12-21 2017-10-16

Initial marketing-authorisation documents

Name Language First published Last updated
Porcilis PCV M Hyo : EPAR - Public assessment report HR = Hrvatski 2014-11-14  
CVMP summary of positive opinion for Porcilis PCV M Hyo HR = Hrvatski 2014-09-12