Versican DHPPi/L3R
Valsts: Grieķija
Valoda: angļu
Klimata pārmaiņas: HMA (Heads of Medicines Agencies)
Lietošanas instrukcija
(PIL)
24-01-2013
Produkta apraksts
(SPC)
24-01-2013
Aktīvā sastāvdaļa:
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
Pieejams no:
Pfizer Limited
ATĶ kods:
QI07AJ06
Zāļu forma:
Suspension for injection
Ārstniecības grupa:
live canine distemper virus + live canine adenovirus + live parainfl.virus + live canine parvovirus + inactivated rabies + inact
Ārstniecības joma:
Dogs Non Food
Autorizācija datums:
2011-12-21
Lietošanas instrukcija
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
Izlasiet visu dokumentu
Produkta apraksts
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
Izlasiet visu dokumentu
