Porcilis Pcv
European Medicines Agency Veterinary Medicines
EMEA/V/C/135
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PORCILIS PCV EPAR summary for the public
This document 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 document 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?
Porcilis PCV is a vaccine for use in pigs, which is available as an emulsion for injection. It contains a protein (antigen) from the porcine circovirus type 2 virus (PCV2). The vaccine does not contain any live PCV2.
What is Porcilis PCV used for?
Porcilis PCV is used to vaccinate pigs from three days of age against PCV2 infection. This helps to reduce the amount of virus in the animal’s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
The vaccine is given by injection into a muscle in the neck, in the area behind the ear. Onset of protection against PCV2 occurs from as early as two weeks after the injection and lasts for 22 weeks.
How does Porcilis PCV work?
Porcine circovirus type 2 (PCV2) is known to cause a wide variety of syndromes in pigs, together known as Porcine circovirus type 2-related diseases (PCVD). It is generally accepted that infection with PCV2 is essential but not sufficient to cause disease. PCV2 associated infections may include 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).
Porcilis PCV is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Porcilis PCV contains small amounts of a protein from PCV2. When a pig is given the vaccine, the pig’s immune system recognises the protein as ‘foreign’ and reacts by building up an active immune response. Through this the immune system will be able to react more quickly when it is exposed to the virus. This active immune response helps to protect the pig against the disease caused by this virus.
How has Porcilis PCV been studied?
Porcilis PCV has been studied in pigs in a number of trials. These studies have been performed under laboratory conditions as well as under typical farming conditions representative of different pig production systems. Measures of effectiveness that were
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monitored included weight gain, mortality as well as faecal and nasal shedding. The immune response to vaccination was monitored by determining antibody titres in the vaccinated animals.
What benefit has Porcilis PCV shown during the studies?
The trials showed that vaccination of pigs with Porcilis PCV helps to reduce the amount of virus in the animal’s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
What is the risk associated with Porcilis PCV?
In pigs transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm). These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals. Immediate systemic hypersensitivitylike reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment. A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination. Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur. Some piglets may be depressed and show a reduced feed intake for up to 5 days. Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Porcilis PCV contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
What is the time allowed before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
The withdrawal period is zero days.
Why has Porcilis PCV been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV exceed the risks for the active immunisation of pigs, over the age of three days, against PCV2, and recommended that Porcilis PCV be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.
Other information about Porcilis PCV:
The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis PCV to Intervet International BV on 12/ 01/ 2009. Information on the prescription status of this product may be found on the outer package.
This summary was last updated in January 2009.
©EMEA 2009 2/2