Versican DHPPi/L3R
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
24-01-2013
Summary of Product characteristics
(SPC)
24-01-2013
Active ingredient:
canine adenovirus 4.9 GKID50, canine distemper virus 4.7 GKID50, canine parainfluenza virus 4.6 GKID50, canine parvovirus 6.1 GKID50, leptospira interrogans serogroup canicola 32 MALR, leptospira interrogans serogroup icterohaemorragiae 32 MALR, Rabies virus, inactivated 2 IU
Available from:
Pfizer Limited
ATC code:
QI07AJ06
Pharmaceutical form:
Suspension for injection
Therapeutic group:
live canine distemper virus + live canine adenovirus + live parainfl.virus + live canine parvovirus + inactivated rabies + inact
Therapeutic area:
Dogs Non Food
Authorization date:
2011-12-21
Patient Information leaflet
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican DHPPi/L3R, lyophilisate and solvent for suspension for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per 1 ml dose:
ACTIVE SUBSTANCES:
Freeze-dried fraction (live attenuated)_ _
Minimum
Maximum_ _
Canine Distemper virus, strain CDVU 39
10
3.0
TCID
50
*
10
4.7
TCID
50
Canine Adenovirus Type 2, strain CAV2-Bio 13
10
3.5
TCID
50
*
10
4.9
TCID
50
Canine Parvovirus, strain CPV-Bio 12
10
4.5
TCID
50
*
10
6.1
TCID
50
Canine Parainfluenza Type 2 virus, strain CPiV-2-Bio 15
10
3.0
TCID
50
*
10
4..6
TCID
50
Liquid fraction (inactivated)
_Leptospira interrogans_ serovar Icterohaemorrhagiae_,_ strain MSLB 1008
ARL** titre
≥ 1:32
_Leptospira interrogans _serovar Canicola, strain MSLB 1010
ARL** titre
≥ 1:32
_Leptospira kirschneri _serovar Grippotyphosa_,_ strain MSLB 1009
ARL** titre
≥ 1:64
Inactivated rabies virus, strain SAD Vnukovo-32
≥2.0 IU***
*
Tissue culture infectious dose-50 %
**
Antibody micro agglutination -lytic reaction
*** International units
ADJUVANT:
Aluminium hydroxide gel
1.8 - 2.2 mg
EXCIPIENT:
For a 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:
Lyophilised vaccine is spongy matter, cream and white colour
Solvent:
Pink colour with fine sediment
Reconstituted vaccine:
Pink/red, or yellowish colour with light opalescence
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
3
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican DHPPi/L3R, lyophilisate and solvent for suspension for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per 1 ml dose:
ACTIVE SUBSTANCES:
Freeze-dried fraction (live attenuated)_ _
Minimum
Maximum_ _
Canine Distemper virus, strain CDVU 39
10
3.0
TCID
50
*
10
4.7
TCID
50
Canine Adenovirus Type 2, strain CAV2-Bio 13
10
3.5
TCID
50
*
10
4.9
TCID
50
Canine Parvovirus, strain CPV-Bio 12
10
4.5
TCID
50
*
10
6.1
TCID
50
Canine Parainfluenza Type 2 virus, strain CPiV-2-Bio 15
10
3.0
TCID
50
*
10
4..6
TCID
50
Liquid fraction (inactivated)
_Leptospira interrogans_ serovar Icterohaemorrhagiae_,_ strain MSLB 1008
ARL** titre
≥ 1:32
_Leptospira interrogans _serovar Canicola, strain MSLB 1010
ARL** titre
≥ 1:32
_Leptospira kirschneri _serovar Grippotyphosa_,_ strain MSLB 1009
ARL** titre
≥ 1:64
Inactivated rabies virus, strain SAD Vnukovo-32
≥2.0 IU***
*
Tissue culture infectious dose-50 %
**
Antibody micro agglutination -lytic reaction
*** International units
ADJUVANT:
Aluminium hydroxide gel
1.8 - 2.2 mg
EXCIPIENT:
For a 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:
Lyophilised vaccine is spongy matter, cream and white colour
Solvent:
Pink colour with fine sediment
Reconstituted vaccine:
Pink/red, or yellowish colour with light opalescence
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
3
Read the complete document
