Purevax RCPCh FeLV

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), attenuated Chlamydophila felis (905 strain)

MAH:

Boehringer Ingelheim Vetmedica GmbH

ATC_code:

QI06AJ05

INN:

vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia, feline leukeamia and feline Chlamydophila infections

therapeutic_group:

Cats

therapeutic_area:

Immunologicals for felidae,

therapeutic_indication:

Active immunisation of cats aged 8 weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs;against Chlamydophila felis infection to reduce clinical signs;against feline panleucopenia to prevent mortality and clinical signs;against leukaemia to prevent persistent viraemia and clinical signs of the related disease.Onsets of immunity are 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.The duration of immunity is one year after the last re-vaccination for the chlamydiosis and feline leukaemia components, and one year after primary vaccination course and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.

leaflet_short:

Revision: 15

authorization_status:

Authorised

authorization_date:

2005-02-23

PIL

15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
PUREVAX RCPCH FELV LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR
INJECTION
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for the batch release:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l'Aviation
69800 Saint Priest
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh FeLV lyophilisate and solvent for suspension for
injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per dose of 1 ml or 0.5 ml:
LYOPHILISATE:
ACTIVE SUBSTANCES:
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)
.......................
≥
10
4.9
CCID
50
1
Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens
...........
≥
2.0 ELISA U.
Attenuated
_Chlamydophila felis_
(905 strain) ...................................................
≥
10
3.0
EID
50
2
Attenuated feline panleucopenia virus (PLI IV)
.............................................
≥
10
3.5
CCID
50
1
EXCIPIENT:
Gentamicin, at most
..........................................................................................
34 µg
SOLVENT:
ACTIVE SUBSTANCE:
FeLV recombinant canarypox virus (vCP97)
..................................................
≥
10
7.2
CCID
50
1
1
cell culture infective dose 50%.
2
egg infective dose 50%.
Lyophilisate: homogeneous beige pellet.
Solvent: clear colourless liquid with presence of cell debris in
suspension.
4.
INDICATION(S)
Active immunisation of cats aged 8 weeks and older:
-
against feline viral rhinotracheitis to reduce clinical signs,
-
against calicivirus infection to reduce clinical signs,
-
against C
_hlamydophila felis_
infection to reduce clinical signs,
-
against feline panleucopenia to prevent mortality and clinical signs,
17
-
against leukaemia to prevent persistent viraemia and clin

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh FeLV lyophilisate and solvent for suspension for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml or 0.5ml:
Lyophilisate
:
ACTIVE SUBSTANCES:
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)
.......................
≥
10
4.9
CCID
50
1
Inactivated feline calicivirus (FCV 431 and G1 strains) antigens
....................
≥
2.0 ELISA U.
Attenuated
_Chlamydophila felis_
(905 strain) ...................................................
≥
10
3.0
EID
50
2
Attenuated feline panleucopenia virus (PLI IV)
.............................................
≥
10
3.5
CCID
50
1
EXCIPIENT:
Gentamicin, at most
..........................................................................................
34 µg
Solvent
:
ACTIVE SUBSTANCE:
FeLV recombinant canarypox virus (vCP97)
..................................................
≥
10
7.2
CCID
50
1
1
cell culture infective dose 50%
2
egg infective dose 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: homogeneous beige pellet.
Solvent: clear colourless liquid with presence of cell debris in
suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats aged 8 weeks and older:
-
against feline viral rhinotracheitis to reduce clinical signs,
-
against calicivirus infection to reduce clinical signs,
-
against
_Chlamydophila felis_
infection to reduce clinical signs,
-
against feline panleucopenia to prevent mortality and clinical signs,
-
against leukaemia to prevent persistent viraemia and clinical signs of
the related disease.
Onset of immunity: Rhinotracheitis, calicivirus,
_ Chlamydophila felis_
and panleucopenia components:
1 week after primary vaccination course.
Feline leukaemia component: 2 weeks after primary vaccination course.
3
Duration of immunity:
-
Rhinotrache