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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/295851/2014

EMEA/V/C/003681

EPAR summary for the public

Versican Plus Pi

Canine parainfluenza virus vaccine (live attenuated)

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 Versican Plus Pi?

Versican Plus Pi is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type 2. Versican Plus Pi is available as a lyophilisate (freeze-dried pellet) with a solvent that are made up into a suspension for injection.

What is Versican Plus Pi used for?

Versican Plus Pi is used to protect dogs against canine parainfluenza virus, which causes kennel cough.

The vaccine is given to puppies from six weeks of age as an injection under the skin which is repeated three to four weeks later. For revaccination, a single dose of Versican Plus Pi is required annually.

How does Versican Plus Pi work?

Versican Plus Pi is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. The virus in Versican Plus Pi is alive but has been attenuated (weakened) so that does not cause disease. When Versican Plus Pi is given to dogs, the animals' immune system recognises the viruses as 'foreign' and makes antibodies against them. In the future, if the animals are exposed to this infection, the immune system will be able to respond more quickly. This will help protect them against kennel cough.

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How has Versican Plus Pi been studied?

The effectiveness of Versican Plus Pi was investigated in a field study involving 129 dogs. The field study involved the larger vaccine combinations Versican Plus DHPPi/L4 and Versican Plus DHPPi/L4R, which are also intended to protect against kennel cough in addition to other diseases, to demonstrate effectiveness of Versican Plus Pi. The dogs were either vaccinated twice with a three to four week interval or they received a single annual booster vaccination. The measure of effectiveness was levels of antibodies before and after vaccination.

What benefit has Versican Plus Pi shown during the studies?

The field study showed that vaccination with Versican Plus Pi resulted in protective levels of antibodies for parainfluenza virus ranging from 73 to 97%.

What is the risk associated with Versican Plus Pi?

The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.

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

In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

Why has Versican Plus Pi been approved?

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

Other information about Versican Plus Pi:

The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi on 4 July 2014. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in May 2014.

Versican Plus Pi EMA/295851/2014