Versican Plus DHPPi/L4
Authorised
This medicine is authorised for use in the European Union
live, attenuated Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus inactivated
MedicineVeterinaryAuthorised
Overview
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).
Versican Plus DHPPi/L4 is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria. Versican Plus DHPPi/L4 is available as a lyophilisate (freeze-dried pellet) with a solvent for injection.
Versican Plus DHPPi/L4 is used to protect dogs against:
- canine distemper, an infectious disease which is sometimes called ‘hard pad’ since dogs can develop thickening of the skin on the foot pads, as well as runny nose, cough, fever, vomiting, diarrhoea, excessive salivation and in some cases fits;
- canine adenovirus type 1, which causes an acute liver infection that may produce signs of jaundice (yellowing of the skin and eyes);
- canine parvovirus disease, an infection that may severely affect puppies, resulting in lethargy, fever, vomiting and bloody diarrhoea;
- canine parainfluenza virus and canine adenovirus type 2, which cause kennel cough;
- leptospirosis, a bacterial disease that may be transmitted via infected urine and results 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, repeated three to four weeks later. For revaccination, a single dose of Versican Plus DHPPi/L4 is required every three years for distemper, canine adenovirus (type 1 and type 2) and parvovirus. Annual revaccination is required for protection against parainfluenza virus and leptospirosis.
Versican Plus DHPPi/L4 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The viruses in Versican Plus DHPPi/L4 are alive but they have been attenuated (weakened) so that they do not cause disease; they are combined with killed (inactivated) strains of Leptospira bacteria. When Versican Plus DHPPi/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 infections, the immune system will be able to respond more quickly. This will help protect them against distemper, adenovirus liver infection, parvovirosis, kennel cough and leptospirosis.
Versican Plus DHPPi/L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
The effectiveness of Versican Plus DHPPi/L4 was initially investigated in a field study involving 129 dogs. 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.
Laboratory studies were conducted subsequently to determine the period of protection against distemper, canine adenovirus (type 1 and 2) and parvovirus. In these studies dogs were vaccinated twice with a three week interval and were challenged with canine distemper virus, canine adenovirus and canine parvovirus three years after the second vaccination. The measures of effectiveness were clinical signs, body temperature and level of antibodies.
The field study showed that vaccination with Versican Plus DHPPi/L4 resulted in levels of antibodies that were sufficient to protect against canine distemper virus and canine adenovirus in all dogs. The percentage of dogs with protective levels of antibodies for parvovirus ranged from 73 to 100%, for parainfluenza virus 73 to 97% and for leptospira 59 to 96%. Responses in puppies were lower than in adult dogs in some cases, because of antibodies inherited from their mothers.
The laboratory studies showed the period of protection to be three years for canine distemper, canine adenovirus and canine parvovirus.
The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi/L4 is a shortlived 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.
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi/L4 exceed the risks for the approved indications and recommended that Versican Plus DHPPi/L4 be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.
The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus DHPPi/L4 on 7 May 2014. Information on the prescription status of this product may be found on the label/outer package.
Product information
Latest procedure affecting product information: IB/0014
17/04/2019
Product details
- Name of medicine
- Versican Plus DHPPi/L4
- Active substance
- canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all 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...
- International non-proprietary name (INN) or common name
- live, attenuated Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus inactivated
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI07AI02
Pharmacotherapeutic group
- Immunologicals for canidae
- live canine distemper virus + live canine adenovirus + live canine parainfluenza virus + live canine parvovirus + inactivated leptospira
Therapeutic indication
Active immunisation of dogs from 6 weeks of age:
- to prevent mortality and clinical signs caused by canine distemper virus,
- to prevent mortality and clinical signs caused by canine adenovirus type 1,
- to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,
- to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus,
- to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
- to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,
- to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and to prevent clinical signs and reduce infection and urinary excretion caused by L. interrogans serogroup Grippotyphosa serovar Grippotyphosa.
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