Purevax RCPCh
Land: Europäische Union
Sprache: Niederländisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
06-04-2022
Fachinformation
(SPC)
06-04-2022
Öffentlichen Beurteilungsberichts
(PAR)
09-03-2021
Wirkstoff:
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)
Verfügbar ab:
Boehringer Ingelheim Vetmedica GmbH
ATC-Code:
QI06AJ03
INN (Internationale Bezeichnung):
vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline Chlamydophila infections
Therapiegruppe:
Cats
Therapiebereich:
Immunologicals voor felidae,
Anwendungsgebiete:
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 van immuniteit zijn aangetoond een week na de primaire vaccinatiekuur voor rhinotracheitis, calicivirus, Chlamydophila felis en panleucopenie componenten. 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.
Produktbesonderheiten:
Revision: 17
Berechtigungsstatus:
Erkende
Berechtigungsdatum:
2005-02-23
Gebrauchsinformation
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
Lesen Sie das vollständige Dokument
Fachinformation
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
Lesen Sie das vollständige Dokument
