Purevax RCPCh
Country: Unjoni Ewropea
Lingwa: Olandiż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
06-04-2022
Karatteristiċi tal-prodott
(SPC)
06-04-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
09-03-2021
Ingredjent attiv:
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)
Disponibbli minn:
Boehringer Ingelheim Vetmedica GmbH
Kodiċi ATC:
QI06AJ03
INN (Isem Internazzjonali):
vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline Chlamydophila infections
Grupp terapewtiku:
Cats
Żona terapewtika:
Immunologicals voor felidae,
Indikazzjonijiet terapewtiċi:
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.
Sommarju tal-prodott:
Revision: 17
L-istatus ta 'awtorizzazzjoni:
Erkende
Data ta 'l-awtorizzazzjoni:
2005-02-23
Fuljett ta 'informazzjoni
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
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
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
Aqra d-dokument sħiħ
