Versican Plus Pi/L4R

Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 and rabies virus, strain SAD Vnukovo-32 (all 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 Versican Plus Pi/L4R?

Versican Plus Pi/L4R is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type 2, inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislavaand Grippotyphosa) as well as rabies virus. Versican Plus Pi/L4R is available as a lyophilisate (freeze-dried pellet) with solvent for injection.

What is Versican Plus Pi/L4R used for?

Versican Plus Pi/L4R 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);
  • rabies, a viral zoonotic (communicable to man) disease that affects the central nervous system (brain and spinal cord), leading to death. It is typically transmitted through bites of infected animals.

The vaccine is given to puppies from eight to nine weeks of age as an injection, under the skin, and repeated once the puppies reach twelve weeks of age. For revaccination a single dose of Versican Plus Pi/L4R is required annually.

How does Versican Plus Pi/L4R work?

Versican Plus Pi/L4R 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/L4R is alive but has been attenuated (weakened) so that it does not cause disease; it is combined with killed (inactivated) strains of Leptospira bacteria and rabies virus. When Versican Plus Pi/L4R 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 infections the immune system will be able to respond more quickly. This will help protect them against kennel cough, leptospirosis and rabies.

Versican Plus Pi/L4R contains an adjuvant (aluminium hydroxide) to enhance the immune response.

How has Versican Plus Pi/L4R been studied?

The effectiveness of Versican Plus Pi/L4R 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/L4R shown during the studies?

The field study showed that after vaccination with Versican Plus Pi/L4R the percentage of dogs with protective levels of antibodies for parainfluenza virus ranged from 73 to 97%, for leptospira 59 to 96% and for rabies virus 86 to 100%. 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/L4R?

The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi/L4R 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/L4R been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi/L4R exceed the risks for the approved indications and recommended that Versican Plus Pi/L4R 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/L4R:

The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi/L4R on 31 July 2014. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Versican Plus Pi/L4R : EPAR - Summary for the public BG = bălgarski 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public ES = español 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public CS = čeština 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public DA = dansk 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public DE = Deutsch 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public ET = eesti keel 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public EL = elliniká 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public EN = English 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public FR = français 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public IT = italiano 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public LV = latviešu valoda 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public LT = lietuvių kalba 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public HU = magyar 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public MT = Malti 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public NL = Nederlands 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public PL = polski 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public PT = português 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public RO = română 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public SK = slovenčina 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public SL = slovenščina 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public FI = suomi 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public SV = svenska 2014-10-20  
Versican Plus Pi/L4R : EPAR - Summary for the public HR = Hrvatski 2014-10-20  

This EPAR was last updated on 10/04/2017 .

Authorisation details

Product details

Product details for Versican Plus Pi/L4R
NameVersican Plus Pi/L4R
Agency product numberEMEA/V/C/003682
Active substance

Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 and rabies virus, strain SAD Vnukovo-32 (all inactivated)

International non-proprietary name (INN) or common name

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

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI07AJ


Publication details

Publication details for Versican Plus Pi/L4R
Marketing-authorisation holder

Zoetis Belgium S.A.

Revision3
Date of issue of marketing authorisation valid throughout the European Union31/07/2014

Product information

Product information

23/03/2017  Versican Plus Pi/L4R -EMEA/V/C/003682 -IG/0747

Name Language First published Last updated
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi/L4R : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10

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
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12
Versican Plus Pi/L4R : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20 2016-08-12

Pharmacotherapeutic group

Immunologicals for canidae, live and inactivated viral and bacterial vaccines

Therapeutic indication

Active immunization of dogs from six weeks of age to prevent clinical signs and reduce viral excretion cause by canine parainfluenza virus, to prevent clinical signs, infection and urinary excretion cause by Leptospira serovars bratislava, canicola, grippotyphosa and icterohaemorrhagiae and to prevent mortality, clinical signs and infection cause by rabies virus.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Versican Plus Pi/L4R : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-05-20 2017-04-10

Initial marketing-authorisation documents

Name Language First published Last updated
Versican Plus Pi/L4R : EPAR - Public assessment report HR = Hrvatski 2014-10-20  
CVMP summary of positive opinion for Versican Plus Pi/L4R HR = Hrvatski 2014-06-06