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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/336268/2014

EMEA/V/C/003683

EPAR summary for the public

Versican Plus Pi/L4

Canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine

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/L4?

Versican Plus Pi/L4 is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa). Versican Plus Pi/L4 is available as a lyophilisate (freeze-dried pellet) with solvent for injection.

What is Versican Plus Pi/L4 used for?

Versican Plus Pi/L4 is used to protect dogs against:

•    canine parainfluenza virus, which causes kennel cough;

•    leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation).

The vaccine is given to puppies from six weeks of age as an injection, under the skin, and repeated three to four weeks later. For revaccination a single dose of Versican Plus Pi/L4 is required annually.

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© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

How does Versican Plus Pi/L4 work?

Versican Plus Pi/L4 is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. The canine parainfluenza virus in Versican Plus Pi/L4 is alive but has been attenuated (weakened) so that it does not cause disease; it is combined with killed (inactivated) strains of Leptospira bacteria. When Versican Plus Pi/L4 is given to dogs the animals' immune system recognises the viruses and bacteria as 'foreign' and makes antibodies against them. In the future, if the animals are exposed to these viruses or bacteria again the immune system will be able to respond more quickly. This will help protect them against kennel cough and leptospirosis.

Versican Plus Pi/L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.

How has Versican Plus Pi/L4 been studied?

The effectiveness of Versican Plus Pi/L4 was investigated in a field study involving 129 dogs. The dogs were either vaccinated twice with a three or 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/L4 shown during the studies?

The field study showed that after vaccination with Versican Plus Pi/L4 the percentage of dogs with protective levels of antibodies for parainfluenza virus ranged from 73 to 97% and for leptospira 59 to 96%. Responses in puppies were lower than adult dogs in some cases, because of antibodies inherited from their mothers.

What is the risk associated with Versican Plus Pi/L4?

The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi/L4 is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.

In situations where puppies are expected to inherit very high antibody levels from the bitch the vaccination protocol should be planned accordingly.

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/L4 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi/L4 exceed the risks for the approved indications and recommended that Versican Plus Pi/L4 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/L4:

The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi/L4 on 31 July 2014. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in June 2014.

Versican Plus Pi/L4

EMA/336268/2014

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