Versican Plus L4
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
17-05-2019
Valmisteyhteenveto
(SPC)
17-05-2019
Julkisesta arviointikertomuksesta
(PAR)
20-10-2014
Aktiivinen ainesosa:
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 (all inactivated)
Saatavilla:
Zoetis Belgium S.A.
ATC-koodi:
QI07AB01
INN (Kansainvälinen yleisnimi):
Canine leptospirosis vaccine (inactivated)
Terapeuttinen ryhmä:
Dogs
Terapeuttinen alue:
Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia), Immunologicals for canidae
Käyttöaiheet:
Active immunisation of dogs from six weeks of age 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 4 weeks after completion of the primary course. Duration of immunity: At least one year following the primary vaccination course.
Tuoteyhteenveto:
Revision: 4
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2014-07-30
Pakkausseloste
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
VERSICAN PLUS L4 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 L4 suspension for injection for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
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.
*
Antibody micro agglutination-lytic reaction.
Appearance: whitish liquid with fine sediment.
17
4.
INDICATION(S)
Active immunisation of dogs from 6 weeks of age:
−
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 Grippotyphosa.
Onset of immunity:
4 weeks after the completion of primary course.
Duration of immunity:
At least one year following the primary vaccination course for all
components of Versican Plus L4.
5.
CONTRAINDICATIONS
N
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus L4 suspension for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
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
*
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
Suspension for injection.
The visual appearance is as follows:
Whitish liquid 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:
−
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
3
−
to prevent clinical signs and reduce infection and urinary excretion
caused by
_L. kirschneri_
serogroup Grippotyphosa serovar Grippotyphosa
_._
Onset of immunity:
4 weeks after completion of the primary course.
Duration of immunity:
At least one year following the primary vaccination course for all
components of Versican Plus L4.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
A good immune response is reliant on a fully competent immune system.
Immunocompetence of the
animal may be compromised by a variety of factors including poor
hea
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