Porcilis PCV M Hyo

Porcine circovirus type 2 (PCV2) ORF2 subunit antigen, Mycoplasma hyopneumoniae J strain inactivated

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An overview of Porcilis PCV M Hyo and why it is authorised in the EU

Porcilis PCV M Hyo is a veterinary vaccine used to protect pigs against two separate infections, caused by 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.

Porcilis PCV M Hyo contains porcine circovirus type 2 (PCV2) subunit antigen (a protein derived from part of the virus) and an inactivated (killed) strain of Mycoplasma hyopneumoniae bacteria.

How is Porcilis PCV M Hyo used?

Porcilis PCV M Hyo is available as an injection and can only be obtained with a prescription.

The vaccine is given to pigs from three days of age as two injections into the neck muscle at least 18 days apart, or from three weeks of age as a single injection into the neck muscle. The two-dose vaccination schedule is recommended when PCV2 and/or Mycoplasma hyopneumoniae infections occur early.

With two-dose vaccination, protection against PCV2 starts at 18 days after the first injection and for Mycoplasma hyopneumoniae it starts 3 weeks after the second injection. With single-dose vaccination, protection against PCV2 starts at two weeks after the injection and for Mycoplasma hyopneumoniae it starts four weeks after the injection. For both vaccination schedules protection lasts for 22 weeks after (the last) injection for PCV2 and for 21 weeks after (the last) injection for Mycoplasma hyopneumoniae.

For more information about using Porcilis PCV M Hyo, see the package leaflet or contact your veterinarian or pharmacist.

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.

What benefits of Porcilis PCV M Hyo have been shown in studies?

Laboratory studies in pigs showed that with two-dose vaccination the vaccine had its full effect against PCV2 by 18 days after first injection and against Mycoplasma hyopneumoniae by three weeks after the second injection, whilst with single-dose vaccination the vaccine had its full effect against PCV2 by two weeks and against Mycoplasma hyopneumoniae by four weeks. With both vaccination schedules protection lasted 22 weeks after (the last) injection for PCV2 and 21 weeks after (the last) injection for 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 hyopneumoniae infections had been detected. In each study around 300 suckling piglets were vaccinated once with Porcilis PCV M Hyo and a second similar-sized group of piglets received a dummy injection. In three of the studies there was a third similar-sized group of pigs that were vaccinated using the two-dose schedule. The field studies showed that both single and repeated vaccination with Porcilis PCV M Hyo reduced PCV2 levels in the blood and the severity of lung damage (lesions) caused by Mycoplasma hyopneumoniae as well as the loss of daily weight gain during the finishing period (the fattening period prior to slaughter). The repeated dose vaccination often gave slightly better results than the single vaccination.

What are the risks 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 in food-producing animals?

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 is Porcilis PCV M Hyo authorised in the EU?

The European Medicines Agency decided that Porcilis PCV M Hyo’s benefits are greater than its risks and it can be authorised for use in the EU. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Porcilis PCV M Hyo

Porcilis PCV M Hyo received a marketing authorisation valid throughout the EU for Porcilis PCV M Hyo on 7 November 2014.

Name Language First published Last updated
Porcilis PCV M Hyo : EPAR - Medicine overview BG = bălgarski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview ES = español 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview CS = čeština 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview DA = dansk 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview DE = Deutsch 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview ET = eesti keel 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview EL = elliniká 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview EN = English 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview FR = français 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview IT = italiano 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview LV = latviešu valoda 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview LT = lietuvių kalba 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview HU = magyar 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview MT = Malti 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview NL = Nederlands 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview PL = polski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview PT = português 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview RO = română 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview SK = slovenčina 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview SL = slovenščina 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview FI = suomi 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview SV = svenska 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Medicine overview HR = Hrvatski 2014-11-14 2018-09-04

This EPAR was last updated on 04/09/2018 .

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 (PCV2) ORF2 subunit antigen, Mycoplasma hyopneumoniae J strain inactivated

International non-proprietary name (INN) or common name

porcine circovirus (inactivated) and porcine enzootic pneumonia vaccine

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.

Revision4
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

27/06/2018  Porcilis PCV M Hyo -EMEA/V/C/003796 -II/0007

Name Language First published Last updated
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04
Porcilis PCV M Hyo : EPAR - Product Information HR = Hrvatski 2014-11-14 2018-09-04

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

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