Versican Plus DHPPi/L4

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091...

MAH:

Zoetis Belgium SA

ATC_code:

QI07AI02

INN:

live, attenuated Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus inactivated

therapeutic_group:

Dogs

therapeutic_area:

live canine distemper virus + live canine adenovirus + live canine parainfluenza virus + live canine parvovirus + inactivated leptospira, Immunologicals for canidae

therapeutic_indication:

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,to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus,to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and to prevent clinical signs and reduce infection and urinary excretion caused by L. interrogans serogroup Grippotyphosa serovar Grippotyphosa.

leaflet_short:

Revision: 6

authorization_status:

Authorised

authorization_date:

2014-05-06

PIL

17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
VERSICAN PLUS DHPPI/L4 LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR
INJECTION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE
FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Bioveta, a.s.,
Komenského 212,
683 23 Ivanovice na Hané,
CZECH REPUBLIC
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus DHPPi/L4 lyophilisate and suspension
for suspension for injection for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
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
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
10
3.1
TCID
50
*
10
5.1
TCID
50
SUSPENSION (INACTIVATED):
_Leptospira interrogans_
serogroup Icterohaemorrhagiae
serovar Icterohaemorrhagiae strain MSLB 1089
ALR** titre ≥ 1:51
_Leptospira interrogans _
serogroup Canicola
_ _
serovar Canicola, strain MSLB 1090
ALR** titre ≥ 1:51
_Leptospira kirschneri _
serogroup Grippotyphosa
_ _
serovar Grippotyphosa
_,_
strain MSLB 1091
ALR** titre ≥ 1:40
_Leptospira interrogans _
serogroup Australis
serovar Bratislava
_,_
strain MSLB 1088
ALR** titre ≥ 1:51
ADJUVANT:
Aluminium hydroxide
1.8–2.2 mg.
*
Tissue culture infectious dose 50%.
19
**
Antibody micro agglutination-lytic reaction.
Lyophilisate: spongy matter of white colour.
Suspension: whitish colour with fine sediment.
4.
INDICATION(S)
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 prev

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus DHPPi/L4 lyophilisate and suspension 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
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
10
3.1
TCID
50
*
10
5.1
TCID
50
SUSPENSION (INACTIVATED):
_Leptospira interrogans_
serogroup Icterohaemorrhagiae
serovar Icterohaemorrhagiae strain MSLB 1089
ALR** titre ≥ 1:51
_Leptospira interrogans _
serogroup Canicola
serovar Canicola, strain MSLB 1090
ALR** titre ≥ 1:51
_Leptospira kirschneri _
serogroup Grippotyphosa
serovar Grippotyphosa
_,_
strain MSLB 1091
ALR** titre ≥ 1:40
_Leptospira interrogans_
serogroup Australis
_ _
serovar Bratislava
_,_
strain MSLB 1088
ALR** titre ≥ 1:51
*
Tissue culture infectious dose 50%.
**
Antibody micro agglutination-lytic reaction.
ADJUVANT:
Aluminium hydroxide
1.8–2.2 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
The visual appearance is as follows:
Lyophilisate: spongy matter of white colour.
Suspension: whitish colour with fine sediment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
3
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,
−
to prevent clinical signs, leucopoenia and viral excretion caused by
canine parvovirus,
−
to prevent clinical signs (nasal and