Versican Plus DHPPi 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 parainfluenza virus, Canine parvovirus

Available from:

Zoetis UK Limited

ATC code:

QI07AD04

INN (International Name):

Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus

Pharmaceutical form:

Lyophilisate 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:

2014-07-04

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus DHPPi lyophilisate and solvent for suspension for
injection for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
MINIMUM
MAXIMUM
LYOPHILISATE (LIVE ATTENUATED):
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
*
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
10
3.1
TCID
50
*
10
5.1
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,
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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 and
to prevent clinical signs (nasal and ocular discharge) and reduce
viral excretion
caused by canine parainfluenza virus.
Onset of immunity:
3 weeks after the first vaccination for CDV, CAV, CPV, and
3 weeks after completion of the primary course for CPiV.
Duration of immunity:
At least three years following the primary vaccination course for
canine distemper
virus, canine adenovirus type 1, canine adenovirus type 2 and canine
parvovirus.
The duration of immunity against CAV-2