Versican Plus L4
Authorised
This medicine is authorised for use in the European Union
Canine leptospirosis vaccine (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 L4 is a veterinary vaccine that contains inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislavaand Grippotyphosa). Versican Plus L4 is available as a suspension for injection.
Versican Plus L4 is used to protect dogs against 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 L4 is required annually.
Versican Plus L4 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The strains of Leptospira bacteria in Versican Plus L4 are killed (inactivated) so that they do not cause disease. When Versican Plus L4 is given to dogs the animals’ immune system recognises the bacteria as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to these Leptospira bacteria the immune system will be able to respond more quickly. This will help protect them against leptospirosis.
Versican Plus L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
The effectiveness of Versican Plus 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.
The field study showed that after vaccination with Versican Plus L4 the percentage of dogs with protective levels of antibodies for leptospira ranged from 59 to 96%. Responses in puppies were lower than adult dogs in some cases, because of antibodies inherited from their mothers.
The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus L4 is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
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 L4 exceed the risks for the approved indication and recommended that Versican Plus 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 L4 on 31 July 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/0009
17/04/2019
Product details
- Name of medicine
- Versican Plus L4
- Active substance
- 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 (all inactivated)
- International non-proprietary name (INN) or common name
- Canine leptospirosis vaccine (inactivated)
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI07AB01
Pharmacotherapeutic group
- Immunologicals for canidae
- Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Therapeutic indication
Active immunisation of dogs from six weeks of age to prevent clinical signs, infection and urinary excretion caused by Leptospira serovars bratislava, canicola, grippotyphosa and icterohaemorrhagiae. Onset of immunity: Immunity has been demonstrated from 4 weeks after completion of the primary course. Duration of immunity: At least one year following the primary vaccination course.
News on Versican Plus L4
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