Purevax RCPCh

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

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

Saadav alates:

Boehringer Ingelheim Vetmedica GmbH

ATC kood:

QI06AJ03

INN (Rahvusvaheline Nimetus):

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

Terapeutiline rühm:

Cats

Terapeutiline ala:

Immunologicals for felidae,

Näidustused:

Active immunisation of cats aged eight 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.Onsets of immunity have been demonstrated one week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components.The duration of immunity is one year after the last re-vaccination for the chlamydiosis component, and oneyear after primary vaccination and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.

Toote kokkuvõte:

Revision: 17

Volitamisolek:

Authorised

Loa andmise kuupäev:

2005-02-23

Infovoldik

15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
PUREVAX RCPCH 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
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
..........................................................................................................................
28 µg
SOLVENT:
Water for
injection.......................................................................................................
q.s. 1 ml or 0.5 ml.
1
cell culture infective dose 50%
2
egg infective dose 50%
Lyophilisate: homogeneous beige pellet.
Solvent: clear colourless liquid.
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
_Chlamydophila felis_
infection to reduce clinical signs,
-
against feline panleucopenia to prevent mortality and clinical signs.
17
Onsets

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh lyophilisate and solvent for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 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
..........................................................................................................................
28 µg
Solvent:
Water for injections
.....................................................................................................
q.s. 1 ml or 0.5 ml.
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.
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.
Onsets of immunity have been demonstrated 1 week after primary
vaccination course for
rhinotracheitis, calicivirus,
_Chlamydophila felis_
and panleucopenia components.
Duration of immunity:
-
Rhinotracheitis, calicivirosis and panleucopenia components: 1 year
after primary vaccination