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

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Canine adenovirus, Canine distemper virus, Canine parvovirus

Available from:

Zoetis UK Limited

ATC code:

QI07AD02

INN (International Name):

Canine adenovirus, Canine distemper virus, 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:

2016-04-08

Summary of Product characteristics

Revised: December 2020
AN: 00612/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus DHP 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 distemper virus, strain CDV Bio 11/A
10
3.1
TCID
50
*
10
5.1
TCID
50
Canine adenovirus Type 2, strain CAV-2 Bio 13
10
3.6
TCID
50
*
10
5.3
TCID
50
Canine parvovirus Type 2b, strain CPV-2b Bio 12/B
10
4.3
TCID
50
*
10
6.6
TCID
50
SOLVENT:
Water for injections (_Aqua ad iniectabilia_)
1 ml
*
Tissue culture infectious dose 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
The visual appearance is as follows:
Lyophilisate: spongy matter of white colour.
Solvent: clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 and

to prevent clinical signs, leucopoenia and viral excretion caused by
canine
parvovirus.
Onset of immunity:

3 weeks after the first vaccination
Revised: December 2020
AN: 00612/2020
Page 2 of 6
Duration of immunity:
At least three years following the primary vaccination course for CDV,
CAV-1, CAV-2
and CPV. The duration of immunity against CAV-2 was not established by
challenge.
It was shown that 3 years after the vaccination CAV-2 antibodies are
still present.
Protective immune response against CAV-2 associated respiratory
disease is
considered to last at least 3 years
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
A good immune response is reliant on a fully competent immu