Versican Plus Pi/L4

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (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 and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 (all inactivated)

Available from:

Zoetis Belgium SA.

ATC code:

QI07AI08

INN (International Name):

canine parainfluenza virus and Leptospira

Therapeutic group:

Dogs

Therapeutic area:

Immunologicals for canidae, Live viral and inactivated bacterial vaccines

Therapeutic indications:

Active immunisation of dogs from six weeks of age. - to prevent clinical signs and reduce viral excretion caused by canine parainfluenza virus, - to prevent clinical signs, infection and urinary excretion caused by Leptospira serovars bratislava, canicola, grippotyphosa and icterohaemorrhagiae. Onset of immunity: Immunity has been demonstrated from 3 weeks after completion of the primary course for CPiV and from 4 weeks after completion of the primary course for Leptospira components. Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus Pi/L4.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2014-07-30

Patient Information leaflet

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
VERSICAN PLUS PI/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 Pi/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 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%.
**
Antibody micro agglutination-lytic reaction.
18
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 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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus Pi/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 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
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of dogs from 6 weeks of age:
3
−
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. kirschneri_
serogroup Grippotyphosa serovar Grip