Versican Plus Pi/L4R
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
17-05-2019
Vara einkenni
(SPC)
17-05-2019
Opinber matsskýrsla
(PAR)
20-10-2014
Virkt innihaldsefni:
canine parainfluenza virus, leptospira and rabies virus.
Fáanlegur frá:
Zoetis Belgium S.A.
ATC númer:
QI07AJ
INN (Alþjóðlegt nafn):
canine parainfluenza virus, leptospira and rabies virus
Meðferðarhópur:
Dogs
Lækningarsvæði:
Immunologicals for canidae, Live and inactivated viral and bacterial vaccines
Ábendingar:
Active immunization of dogs from six weeks of age to prevent clinical signs and reduce viral excretion cause by canine parainfluenza virus, to prevent clinical signs, infection and urinary excretion cause by Leptospira serovars bratislava, canicola, grippotyphosa and icterohaemorrhagiae and to prevent mortality, clinical signs and infection cause by rabies virus.
Vörulýsing:
Revision: 5
Leyfisstaða:
Authorised
Leyfisdagur:
2014-07-30
Upplýsingar fylgiseðill
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
VERSICAN PLUS PI/L4R 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/L4R 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
Rabies virus, strain SAD Vnukovo-32
≥ 2.0 IU***
ADJUVANT:
Aluminium hydroxide
1.8 - 2.2 mg.
*
Tissue culture infectious dose 50 %.
**
Antibody micro agglutination-lytic reaction.
***
International units.
19
Lyophilisate: spongy matter of white colour.
Suspension: pink colour with fine sediment.
4.
INDICATION(S)
Active immunisation of dogs from 8-9 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
Lestu allt skjalið
Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus Pi/L4R 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
Rabies virus, strain SAD Vnukovo-32
≥ 2.0 IU***
*
Tissue culture infectious dose 50 %.
**
Antibody micro agglutination-lytic reaction.
***
International units.
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: pink 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 8-9 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 and
_L. interrogans_
serogroup Icterohaemorrhagiae
serovar Icterohaemorrhagiae,
−
to prevent clinical signs and reduce infection and urinary excr
Lestu allt skjalið
