Versican Plus P Lyophilisate and Solvent for Suspension for Injection for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Canine parvovirus

Available from:

Zoetis UK Limited

ATC code:

QI07AD01

INN (International Name):

Canine parvovirus

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2016-06-08

Summary of Product characteristics

Revised: June 2023
AN: 02166/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus P lyophilisate and solvent for suspension for injection
for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
LYOPHILISATE (LIVE ATTENUATED):
MINIMUM
MAXIMUM
Canine parvovirus Type 2b, strain CPV-2b Bio 12/B
10
4.3
TCID
50
*
10
6.6
TCID
50
*
*
Tissue culture infectious dose 50%.
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
LYOPHILISATE:
Trometamol
Edetic Acid
Sucrose
Dextran 70
SOLVENT:
Water for injections (_Aqua ad _
_iniectabilia)_
The visual appearance is as follows:
Lyophilisate: spongy matter of white colour.
Solvent: clear colourless liquid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Active immunisation of dogs from 6 weeks of age:

to prevent clinical signs, leucopoenia and viral excretion caused by
canine
parvovirus.
Onset of immunity:
3 weeks after the first vaccination.
Revised: June 2023
AN: 02166/2022
Page 2 of 7
Duration of immunity:
At least three years following the primary vaccination course.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
A good immune response is reliant on a fully competent immune system.
Immunocompetence of the animal may be compromised by a variety of
factors
including poor health, nutritional status, genetic factors, concurrent
medicinal therapy
and stress.
Immunological responses to CPV may be delayed due to maternally
derived antibody
interference. However, the vaccine has been proven to be protective
against virulent
challenge in the presence of maternally derived antibodies to CPV at
levels equal or
higher to those likely to be encountered under field conditions. In
situations where
very high maternally derived antibody levels are expected, the
vaccination protocol
should be planned accordingly.
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target